Alti-Piroxicam

Generic Name: piroxicam (Oral route)

pir-OX-i-kam

Oral route(Capsule)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Piroxicam is contraindicated for the treatment of perioperative pain in the setting of CABG surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Commonly used brand name(s)

In the U.S.

• Feldene

In Canada

• Alti-Piroxicam

Available Dosage Forms:

• Capsule


• Tablet

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Oxicam

Uses For Alti-Piroxicam

Piroxicam is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis (e.g., osteoarthritis and rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. This medicine does not cure arthritis and will help you only as long as you continue to take it.

This medicine is available only with your doctor's prescription.

Before Using Alti-Piroxicam

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of piroxicam in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of piroxicam in the elderly. However, elderly patients may be more sensitive to the adverse stomach effects (e.g., ulcers, bleeding) of piroxicam than younger adults, and are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving piroxicam.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ketorolac


• Pentoxifylline

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab


• Ardeparin


• Argatroban


• Beta Glucan


• Bivalirudin


• Certoparin


• Cilostazol


• Citalopram


• Clopidogrel


• Clovoxamine


• Dabigatran Etexilate


• Dalteparin


• Danaparoid


• Desirudin


• Dicumarol


• Dipyridamole


• Enoxaparin


• Escitalopram


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Ginkgo


• Heparin


• Lepirudin


• Methotrexate


• Nadroparin


• Nefazodone


• Parnaparin


• Paroxetine


• Pemetrexed


• Protein C


• Reviparin


• Rivaroxaban


• Sertraline


• Sibutramine


• Tacrolimus


• Ticlopidine


• Tinzaparin


• Tirofiban


• Vilazodone


• Zimeldine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol


• Acenocoumarol


• Acetohexamide


• Alacepril


• Alprenolol


• Amiloride


• Anisindione


• Arotinolol


• Atenolol


• Azilsartan Medoxomil


• Azosemide


• Befunolol


• Bemetizide


• Benazepril


• Bendroflumethiazide


• Benzthiazide


• Betaxolol


• Bevantolol


• Bisoprolol


• Bopindolol


• Bucindolol


• Bumetanide


• Bupranolol


• Buthiazide


• Candesartan Cilexetil


• Canrenoate


• Captopril


• Carteolol


• Carvedilol


• Celiprolol


• Chlorothiazide


• Chlorpropamide


• Chlorthalidone


• Cilazapril


• Clopamide


• Cyclopenthiazide


• Cyclosporine


• Delapril


• Desvenlafaxine


• Dilevalol


• Duloxetine


• Enalaprilat


• Enalapril Maleate


• Eprosartan


• Esmolol


• Ethacrynic Acid


• Fosinopril


• Furosemide


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Hydrochlorothiazide


• Hydroflumethiazide


• Imidapril


• Indapamide


• Irbesartan


• Labetalol


• Landiolol


• Levobetaxolol


• Levobunolol


• Lisinopril


• Lithium


• Losartan


• Mepindolol


• Methyclothiazide


• Metipranolol


• Metolazone


• Metoprolol


• Milnacipran


• Moexipril


• Nadolol


• Nebivolol


• Nipradilol


• Olmesartan Medoxomil


• Oxprenolol


• Penbutolol


• Pentopril


• Perindopril


• Pindolol


• Piretanide


• Polythiazide


• Propranolol


• Quinapril


• Ramipril


• Sotalol


• Spirapril


• Spironolactone


• Talinolol


• Tasosartan


• Telmisartan


• Temocapril


• Tertatolol


• Timolol


• Tolazamide


• Tolbutamide


• Torsemide


• Trandolapril


• Triamterene


• Trichlormethiazide


• Valsartan


• Venlafaxine


• Xipamide


• Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or


• Bleeding problems or


• Blood clots or


• Edema (fluid retention or body swelling) or


• Heart attack, history of or


• Heart disease (e.g., congestive heart failure) or


• Hepatitis, history of or


• Hypertension (high blood pressure) or


• Kidney disease or


• Stomach ulcers or bleeding, history of or


• Stroke, history of—Use with caution. May make these conditions worse.

• Aspirin-sensitive asthma, history of or


• Aspirin sensitivity, history of—Should not be used in patients with these conditions.

• Heart surgery (e.g., coronary artery bypass graft [CABG] surgery)—Should not be used to relieve pain right before or after the surgery.

• Liver disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

Proper Use of piroxicam

This section provides information on the proper use of a number of products that contain piroxicam. It may not be specific to Alti-Piroxicam. Please read with care.

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Taking too much of this medicine may increase the chance of unwanted effects.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  
  • For osteoarthritis and rheumatoid arthritis:
    
    • Adults—20 milligrams (mg) once a day or 10 mg two times a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Alti-Piroxicam

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.

This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or using certain other medicines (such as a steroid or a blood thinner).

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, white spots in the mouth or on the lips; or unusual tiredness or weakness.

Some possible warning signs of serious side effects that can occur during treatment with this medicine may include black, tarry stools; decreased urination; severe stomach pain; skin rash; swelling of the face, fingers, feet, or lower legs; unusual bleeding or bruising; unusual weight gain; vomiting of blood or material that looks like coffee grounds; or yellow skin or eyes. Also, signs of serious heart problems could occur such as chest pain, tightness in the chest, fast or irregular heartbeat, unusual flushing or warmth of the skin, weakness, or slurring of speech. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs (NSAIDs). Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Using this medicine in the last months of a pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Do not use this medicine during the later part of a pregnancy unless your doctor tells you to.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Alti-Piroxicam Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Bloating


• bloody or black, tarry stools


• burning upper abdominal or stomach pain


• cloudy urine


• constipation


• decrease in urine output or decrease in urine-concentrating ability


• headache


• heartburn


• indigestion


• itching skin


• loss of appetite


• nausea or vomiting


• pale skin


• severe abdominal or stomach pain, cramping, or burning


• severe and continuing nausea


• skin rash


• swelling


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting of blood or material that looks like coffee grounds


• weight loss

Less common

• Bleeding gums


• blood in the urine


• bloody nose


• blurred vision


• burning feeling in the chest or stomach


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• chest pain


• clay-colored stools


• confusion


• cough or hoarseness


• dark urine


• difficult or labored breathing


• difficult, burning, or painful urination


• difficulty with swallowing


• dilated neck veins


• dizziness


• extreme fatigue


• fainting


• fever or chills


• flushing or redness of the skin


• frequent urge to urinate


• increased sensitivity of the skin to sunlight


• increased thirst


• increased volume of pale, dilute urine


• large, flat, blue, or purplish patches in the skin


• lightheadedness


• lower back or side pain


• nervousness


• noisy breathing


• numbness or tingling in the hands, feet, or lips


• pain or burning in the throat


• peeling of the skin


• pinpoint red or purple spots on the skin


• pounding in the ears


• rapid, shallow breathing


• redness or other discoloration of the skin


• redness, swelling, or soreness of the tongue


• severe sunburn


• shortness of breath


• slow, fast, pounding, or irregular heartbeat or pulse


• sore throat


• sores, ulcers, or white spots on the lips or tongue or inside the mouth


• stomach upset


• swelling of the face, fingers, feet, or lower legs


• swelling or inflammation of the mouth


• swollen glands


• tenderness in the stomach area


• tightness in the chest


• unpleasant breath odor


• unusually warm skin


• weakness or heaviness of the legs


• weight gain


• wheezing


• yellow eyes or skin

Rare

• Anxiety


• back or leg pains


• burning, dry, or itching eyes


• cold sweats


• coma


• cracks in the skin


• diarrhea


• discharge, excessive tearing


• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position


• dry mouth


• flushed, dry skin


• fruit-like breath odor


• general body swelling


• general feeling of discomfort or illness


• high fever


• increased hunger


• increased urination


• inflammation of the joints


• irregular, fast or slow, or shallow breathing


• joint pain


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• light-colored stools


• loss of heat from the body


• muscle aches and pains


• nightmares


• no blood pressure


• no breathing


• no pulse


• pain or discomfort in the arms, jaw, back, or neck


• pains in the stomach, side, or abdomen, possibly radiating to the back


• pale or blue lips, fingernails, or skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• red skin lesions, often with a purple center


• red, irritated eyes


• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid


• runny nose


• scaly skin


• seeing, hearing, or feeling things that are not there


• seizures


• severe headache


• shakiness


• shivering


• sleepiness


• slurred speech


• sneezing


• sores, welting, or blisters


• stiff neck or back


• stomach pain, continuing


• suddenly sweating


• swollen, painful, or tender lymph glands in the neck, armpit, or groin


• trouble sleeping

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Agitation


• depression


• hives


• hostility


• irritability


• muscle twitching


• pain or discomfort in the chest, upper stomach, or throat


• rapid weight gain


• stupor


• swelling of the ankles or hands


• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach


• belching


• continuing ringing or buzzing or other unexplained noise in the ears


• excess air or gas in the stomach or intestines


• hearing loss


• passing gas


• stomach discomfort or upset

Less common

• Feeling of constant movement of self or surroundings


• hair loss or thinning of the hair


• lack or loss of strength


• sensation of spinning


• shakiness in the legs, arms, hands, or feet


• sleeplessness


• trembling or shaking of the hands or feet


• unable to sleep

Rare

• Change in hearing


• changes in appetite


• inability to sit still


• mood alterations


• need to keep moving


• restlessness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Alti-Piroxicam side effects (in more detail)

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More Alti-Piroxicam resources

• Alti-Piroxicam Side Effects (in more detail)
• Alti-Piroxicam Use in Pregnancy & Breastfeeding
• Drug Images
• Alti-Piroxicam Drug Interactions
• Alti-Piroxicam Support Group
• 15 Reviews for Alti-Piroxicam - Add your own review/rating

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Rifinah 150mg / 100mg Tablets

1. Name Of The Medicinal Product

Rifinah 150/100mg Tablets

2. Qualitative And Quantitative Composition

Active substances (per tablet):

Rifampicin 150mg

Isoniazid 100mg

Excipients with known effect (per tablet):

Sucrose 110.06mg

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Coated tablet

Cyclamen, smooth, shiny, round, curved sugar coated tablet.

4. Clinical Particulars

4.1 Therapeutic Indications

Rifinah is indicated in the treatment of all forms of tuberculosis, including fresh, advanced and chronic cases.

4.2 Posology And Method Of Administration

For oral administration.

Another antituberculosis drug may be given concurrently with Rifinah until the susceptibility of the infecting organism to rifampicin and isoniazid has been confirmed.

Adults: Patients should be given the following single daily dose preferably on an empty stomach at least 30 minutes before a meal or 2 hours after a meal:

Rifinah 150: Patients weighing less than 50kg - 3 tablets.

Rifinah 300: Patients weighing 50kg or more - 2 tablets.

Use in the elderly: Caution should be exercised in such patients especially if there is evidence of liver impairment.

4.3 Contraindications

Rifinah is contraindicated in

• patients who are hypersensitive to rifamycins or isoniazid or any of the excipients (see section 6.1);

• the presence of jaundice;

• concurrent treatment with the combination of saquinavir/ritonavir (see section 4.5 Interaction with other medicinal products and other forms of interaction).

4.4 Special Warnings And Precautions For Use

Rifinah is a combination of 2 drugs, each of which has been associated with liver dysfunction.

All tuberculosis patients should have pre-treatment measurements of liver function.

Adults treated for tuberculosis with Rifinah should have baseline measurements of hepatic enzymes, bilirubin, serum creatinine, a complete blood count and a platelet count (or estimate).

Patients should be seen at least monthly during therapy and should be questioned specifically about symptoms associated with adverse reactions.

All patients with abnormalities should have follow-up, including laboratory testing, if necessary. However, because there is a higher frequency of isoniazid-associated hepatitis among persons older than 35 years of age, a transaminase measurement should be obtained at baseline and at least monthly during therapy in this age group. Other factors associated with an increased risk of hepatitis include daily use of alcohol, chronic liver disease, intravenous drug use and being a black or Hispanic woman.

If the patient has no evidence of pre-existing liver disease and normal pre-treatment liver function, liver function tests need only be repeated if fever, vomiting, jaundice or other deterioration in the patient's condition occurs.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Rifampicin

Rifampicin should be given under the supervision of a respiratory or other suitably qualified physician.

Patients with impaired liver function should only be given rifampicin in cases of necessity, and then with caution and under close medical supervision. In these patients, lower doses of rifampicin are recommended and careful monitoring of liver function, especially serum glutamic pyruvic transaminase (SGPT) and serum glutamic oxaloacetic transaminase (SGOT) should initially be carried out prior to therapy, weekly for two weeks, then every two weeks for the next six weeks. If signs of hepatocellular damage occur, rifampicin should be withdrawn.

Rifampicin should also be withdrawn if clinically significant changes in hepatic function occur. The need for other forms of antituberculosis therapy and a different regimen should be considered. Urgent advice should be obtained from a specialist in the management of tuberculosis. If rifampicin is re-introduced after liver function has returned to normal, liver function should be monitored daily.

In patients with impaired liver function, elderly patients, malnourished patients and possibly children under two years of age, caution is particularly recommended when instituting therapeutic regimens in which isoniazid is to be used concurrently with rifampicin.

In some patients, hyperbilirubinaemia can occur in the early days of treatment. This results from competition between rifampicin and bilirubin for hepatic excretion. An isolated report showing a moderate rise in bilirubin and/or transaminase level is not in itself an indication for interrupting treatment; rather the decision should be made after repeating the tests, noting trends in the levels and considering them in conjunction with the patient's clinical condition.

Because of the possibility of immunological reaction including anaphylaxis (see section 4.8 Undesirable effects) occurring with intermittent therapy (less than 2 to 3 times per week) patients should be closely monitored. Patients should be cautioned against interruption of dosage regimens since these reactions may occur.

Rifampicin has enzyme induction properties that can enhance the metabolism of endogenous substrates including adrenal hormones, thyroid hormones and vitamin D. Isolated reports have associated porphyria exacerbation with rifampicin administration.

Isoniazid

Use of isoniazid should be carefully monitored in patients with current chronic liver disease or severe renal dysfunction.

Severe and sometimes fatal hepatitis associated with isoniazid therapy may occur and may develop even after many months of treatment. The risk of developing hepatitis is age related. Therefore, patients should be monitored for the prodromal symptoms of hepatitis, such as fatigue, weakness, malaise, anorexia, nausea or vomiting. If these symptoms appear or if signs suggestive of hepatic damage are detected, isoniazid should be discontinued promptly, since continued use of the drug in these cases has been reported to cause a more severe form of liver damage.

Care should be exercised in the treatment of elderly or malnourished patients who may also require vitamin B6 supplementation with the isoniazid therapy.

Use of isoniazid should be carefully monitored in patients with slow acetylator status, epilepsy, history of psychosis, history of peripheral neuropathy, diabetes, alcohol dependence, HIV infection or porphyria.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Food Interaction

Because isoniazid has some monoamine oxidase inhibiting activity, an interaction with tyramine-containing foods (cheese, red wine) may occur. Diamine oxidase may also be inhibited, causing exaggerated response (e.g. headache, sweating, palpitations, flushing, hypotension) to foods containing histamine (e.g. skipjack, tuna, other tropical fish). Tyramine- and histamine-containing foods should be avoided by patients receiving Rifinah.

Interactions with Other Medicinal Products

Cytochrome P-450 enzyme interaction

Rifampicin is known to induce and isoniazid is known to inhibit certain cytochrome P-450 enzymes. In general, the impact of the competing effects of rifampicin and isoniazid on the metabolism of drugs that undergo biotransformation through the affected pathways is unknown. Therefore, caution should be used when prescribing Rifinah with drugs metabolised by cytochrome P-450. To maintain optimum therapeutic blood levels, dosages of drugs metabolised by these enzymes may require adjustment when starting or stopping Rifinah.

Interactions with Rifampicin

Examples of drugs metabolised by cytochrome P-450 enzymes are:

• Antiarrhythmics (e.g. disopyramide, mexiletine, quinidine, propafenone, tocainide),

• Antiepileptics (e.g. phenytoin),

• Hormone antagonist (antiestrogens e.g. tamoxifen, toremifene, gestinone),

• Antipsychotics (e.g. haloperidol, aripiprazole),

• Anticoagulants (e.g. coumarins),

• Antifungals (e.g. fluconazole, itraconazole, ketoconazole, voriconazole),

• Antivirals (e.g. saquinavir, indinavir, efavirenz, amprenavir, nelfinavir, atazanavir, lopinavir, nevirapine),

• Barbiturates,

• Beta-blockers (e.g. bisoprolol, propanolol),

• Anxiolytics and hypnotics (e.g. diazepam, benzodiazepines, zopiclone, zolpidem),

• Calcium channel blockers (e.g. diltiazem, nifedipine, verapamil, nimodipine, isradipine, nicardipine, nisoldipine),

• Antibacterials (e.g. chloramphenicol, clarithromycin, dapsone, doxycycline, fluoroquinolones, telithromycin),

• Corticosteroids,

• Cardiac glycosides (e.g. digitoxin, digoxin),

• Clofibrate,

• Systemic hormonal contraceptives,

• Oestrogen,

• Antidiabetic (e.g. chlorpropamide, tolbutamide, sulfonylureas, rosiglitazone),

• Immunosuppressive agents (e.g. ciclosporin, sirolimus, tacrolimus),

• Irinotecan,

• Thyroid hormone (e.g. levothyroxine),

• Losartan,

• Analgesics (e.g. methadone, narcotic analgesics),

• Praziquantel,

• Progestogens,

• Quinine,

• Riluzole,

• Selective 5-HT3 receptor antagonists (e.g. ondansetron),

• Statins metabolised by CYP 3A4 (e.g. simvastatin),

• Theophylline,

• Tricyclic antidepressants (e.g. amitriptyline, nortriptyline),

• Cytotoxics (e.g. imatinib),

• Diuretics (e.g. eplerenone).

Patients using oral contraceptives should be advised to change to non-hormonal methods of birth control during Rifinah therapy. Also, diabetes may become more difficult to control.

When rifampicin is given concomitantly with the combination saquinavir/ritonavir, the potential for hepatotoxicity is increased. Therefore, concomitant use of Rifinah with saquinavir/ritonavir is contraindicated (see section 4.3 Contraindications).

Other Interactions

When the two drugs were taken concomitantly, decreased concentrations of atovaquone and increased concentrations of rifampicin were observed.

Concurrent use of ketoconazole and rifampicin has resulted in decreased serum concentrations of both drugs.

Concurrent use of rifampicin and enalapril has resulted in decreased concentrations of enalaprilat, the active metabolite of enalapril. Dosage adjustments should be made if indicated by the patient's clinical condition.

Concomitant antacid administration may reduce the absorption of rifampicin.

Daily doses of rifampicin should be given at least 1 hour before the ingestion of antacids.

When rifampicin is given concomitantly with either halothane or isoniazid, the potential for hepatotoxicity is increased. The concomitant use of rifampicin and halothane should be avoided. Patients receiving both rifampicin and isoniazid should be monitored closely for hepatotoxicity.

When rifampicin is taken with para-aminosalicylic acid (PAS), rifampicin levels in the serum may decrease. Therefore, the drugs should be taken at least eight hours apart.

Interactions with Isoniazid

The following drugs may interact with isoniazid:

• Antiepileptics (e.g. carbamazepine and phenytoin).

There may be an increased risk of distal sensory neuropathy when isoniazid is used in patients taking stavudine.

Concomitant use of zalcitabine with isoniazid has been shown to approximately double the renal clearance if isoniazid in HIV infected patients.

Administration of prednisolone 20mg to 13 slow acetylators and 13 fast acetylators for receiving isoniazid 10mg/kg reduced plasma concentrations of isoniazid by 25% and 40%, respectively. The clinical significance of this effect has not been established.

The effect of acute alcohol intake (serum levels 1g/L maintained for 12 hours) on the metabolism of isoniazid (300mg/d for 2 days) was studies in 10 healthy volunteers in a controlled cross over design. The metabolism of isoniazid and its metabolite, acetyl isoniazid, was not modified by this acute alcohol intake. The metabolism of isoniazid may be increased in chronic alcoholics; however this effect has not been quantified.

Appropriate adjustments of these drugs should be made.

Other Interactions

Para-aminosalicylic acid may increase the plasma concentration and elimination half-life of isoniazid by competing for acetylating enzymes.

General anaesthetics may increase the hepatotoxicity of isoniazid.

The absorption of isoniazid is reduced by antacids.

The risk of CNS toxicity is increased when isoniazid is given with cycloserine.

Isoniazid may reduce plasma concentration of ketoconazole and increase plasma concentration of theophylline.

Interference with laboratory and diagnostic tests

Therapeutic levels of rifampicin have been shown to inhibit standard microbiological assays for serum folate and Vitamin B12. Thus, alternative assay methods should be considered. Transient elevation of BSP and serum bilirubin has been reported. Rifampicin may impair biliary excretion of contrast media used for visualization of the gallbladder, due to competition for biliary excretion. Therefore, these tests should be performed before the morning dose of rifampicin.

4.6 Pregnancy And Lactation

Pregnancy

Rifampicin

Rifampicin has been shown to be teratogenic in rodents when given in large doses. There are no well controlled studies with Rifinah in pregnant women. Although rifampicin has been reported to cross the placental barrier and appear in cord blood, the effect of rifampicin, alone or in combination with other antituberculosis drugs, on the human foetus is not known.

When administered during the last few weeks of pregnancy, rifampicin can cause post-natal haemorrhages in the mother and infant, for which treatment with Vitamin K1 may be indicated.

Isoniazid

It has been reported that in both rats and rabbits, isoniazid may exert an embryocardial effect when administered orally during pregnancy, although no isoniazid-related congenital anomalies have been found in reproduction studies in mammalian species (mice, rats, rabbits).

Therefore, Rifinah should be used in pregnant women or in women of child bearing potential only if the potential benefit justifies the potential risk to the foetus.

Lactation

Rifampicin and isoniazid are excreted in breast milk and infants should not be breast fed by a patient receiving Rifinah unless in the physician's judgement the potential benefit to the patient outweighs the potential risk to the infant.

In breast-fed infants whose mothers are taking isoniazid, there is a theoretical risk of convulsions and neuropathy (associated with vitamin B6 deficiency), therefore they should be monitored for early signs of these effects and consideration should be given to treating both mother and infant prophylactically with pyridoxine.

4.7 Effects On Ability To Drive And Use Machines

Isoniazid has been associated with vertigo, visual disorders and psychotic reactions (see section 4.8). Patients should be informed of these, and advised that if affected, they should not drive, operate machinery or take part in any activities where these symptoms may put either themselves or others at risk.

4.8 Undesirable Effects

Rifampicin

Reactions to rifampicin occurring with either daily or intermittent dosage regimens include:

Cutaneous reactions which are mild and self-limiting may occur and do not appear to be hypersensitivity reactions. Typically they consist of flushing and itching with or without a rash. Urticaria and more serious hypersensitivity reactions occur but are uncommon. Exfoliative dermatitis, pemphigoid reaction, erythema multiforme including Stevens-Johnson syndrome, Lyells syndrome and vasculitis have been reported rarely.

Gastrointestinal reactions consist of anorexia, nausea, vomiting, abdominal discomfort, and diarrhoea. Pseudomembranous colitis has been reported with rifampicin therapy.

Hepatitis can be caused by rifampicin and liver function tests should be monitored (see section 4.4. Special warnings and precautions for use).

Central Nervous System: Psychoses have been rarely reported.

Thrombocytopenia with or without purpura may occur, usually associated with intermittent therapy, but is reversible if drug is discontinued as soon as purpura occurs. Cerebral haemorrhage and fatalities have been reported when rifampicin administration has been continued or resumed after the appearance of purpura.

Disseminated intravascular coagulation has also been rarely reported.

Eosinophilia, leucopenia, oedema, muscle weakness and myopathy have been reported to occur in a small percentage of patients treated with rifampicin.

Agranulocytosis has been reported very rarely reported.

Rare reports of adrenal insufficiency in patients with compromised adrenal function have been observed.

Reactions usually occurring with intermittent dosage regimens and probably of immunological origin include:

• 'Flu Syndrome' consisting of episodes of fever, chills, headache, dizziness, and bone pain appearing most commonly during the 3rd to the 6th month of therapy. The frequency of the syndrome varies but may occur in up to 50 % of patients given once-weekly regimens with a dose of rifampicin of 25 mg/kg or more.

• Shortness of breath and wheezing.

• Decrease in blood pressure and shock.

• Anaphylaxis.

• Acute haemolytic anaemia.

• Acute renal failure usually due to acute tubular necrosis or acute interstitial nephritis.

If serious complications arise, e.g. renal failure, thrombocytopenia or haemolytic anaemia, rifampicin should be stopped and never restarted.

Occasional disturbances of the menstrual cycle have been reported in women receiving long-term antituberculosis therapy with regimens containing rifampicin.

Rifampicin may produce a reddish colouration of the urine, sweat, sputum and tears. The patient should be forewarned of this. Soft contact lenses may be permanently stained.

Isoniazid

Hypersensitivity reactions: Fever, anaphylactic reactions.

Nervous system: Vertigo; polyneuritis, presenting as paresthesia, muscle weakness, loss of tendon reflexes, etc, is unlikely to occur with the recommended daily dose of Rifinah. The incidence is higher in "slow acetylators”. Other neurotoxic effects, which are uncommon with conventional doses, are convulsions, toxic encephalopathy, optic neuritis and atrophy, memory impairment and toxic psychosis. The possibility that the frequency of seizures may be increased in patients with epilepsy should be borne in mind.

Cutaneous: Rash, acne, Stevens-Johnson syndrome, exfoliative dermatitis and pemphigus.

Hematologic: Eosinophilia, agranulocytosis, thrombocytopenia, anemia, aplastic anaemia and haemolytic anaemia.

Gastrointestinal: Pancreatitis, constipation, dry mouth, nausea, vomiting and epigastric distress.

Hepatic: Severe and sometimes fatal hepatitis may occur with isoniazid therapy.

Reproductive system and breast disorders: gynaecomastia

Investigations: anti-nuclear antibodies

Metabolism and Nutrition Disorders: hyperglycaemia

Miscellaneous: Pellagra, systemic lupus erythematosus-like syndrome.

4.9 Overdose

• Signs and Symptoms

Rifampicin

Nausea, vomiting, abdominal pain, pruritus, headache and increasing lethargy will probably occur within a short time after acute ingestion; unconsciousness may occur when there is severe hepatic disease. Transient increases in liver enzymes and/or bilirubin may occur. Brownish-red or orange colouration of the skin, urine, sweat, saliva, tears and faeces will occur, and its intensity is proportional to the amount ingested. Facial or periorbital oedema has also been reported in paediatric patients. Hypotension, sinus tachycardia, ventricular arrhythmias, seizures and cardiac arrest were reported in some fatal cases.

The minimum acute lethal or toxic dose is not well established. However, nonfatal acute overdoses in adults have been reported with doses ranging from 9 to 12 g rifampicin. Fatal acute overdoses in adults have been reported with doses ranging from 14 to 60 g. Alcohol or a history of alcohol abuse was involved in some of the fatal and nonfatal reports. Nonfatal overdoses in paediatric patients ages 1 to 4 years old of 100 mg/kg for one to two doses have been reported.

Isoniazid

Isoniazid overdosage produces signs and symptoms within 30 minutes to 3 hours after ingestion. Nausea, vomiting, dizziness, slurring of speech, blurring of vision, and visual hallucinations (including bright colours and strange designs) are among the early manifestations. With marked overdosage, respiratory distress and CNS depression, progressing rapidly from stupor to profound coma are to be expected, along with severe, intractable seizures. Severe metabolic acidosis, acetonuria and hyperglycaemia are typical laboratory findings.

• Management:

In cases of overdosage with Rifinah, gastric lavage should be performed as soon as possible. Following evacuation of the gastric contents, the instillation of activated charcoal slurry into the stomach may help absorb any remaining drug from the gastrointestinal tract. Antiemetic medication may be required to control severe nausea and vomiting.

Intensive supportive measures should be instituted, including airway patency, and individual symptoms treated as they arise .

If acute isoniazide overdose is suspected, even in asymptomatic patients, the administration of intravenous pyridoxine (vitamin B6) should be considered. In patients with seizures not controlled with pyridoxine, anticonvulsant therapy should be administered . Sodium bicarbonate should be given to control metabolic acidosis . Haemodialysis is advised for refractory cases; if this is not available, peritoneal dialysis can be used along with forced diuresis.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Antimycobacterials, Combinations of drugs for treatment of tuberculosis

ATC code: J04AM02

Rifampicin and isoniazid are active bactericidial antituberculosis drugs which are particularly active against the rapidly growing extracellular organisms and also have bactericidal activity intracellularly. Rifampicin has activity against slow- and intermittently-growing M. tuberculosis.

Rifampicin inhibits DNA-dependent RNA polymerase activity in susceptible cells. Specifically, it interacts with bacterial RNA polymerase but does not inhibit the mammalian enzyme. Cross-resistance to rifampicin has only been shown with other rifamycins.

Isoniazid acts against actively growing tubercle bacilli.

5.2 Pharmacokinetic Properties

Rifampicin

Rifampicin is readily absorbed from the stomach and the duodenum. Peak serum concentrations of the order of 10 µg/ml occur about 2-4 hours after a dose of 10mg/kg body weight on an empty stomach.

In normal subjects the biological half-life of rifampicin in serum averages about 3 hours after a 600mg dose and increases to 5.1 hours after a 900mg dose. With repeated administration, the half-life decreases and reaches average values of approximately 2-3 hours. At a dose of up to 600 mg/day, the half-life does not differ in patients with renal failure and consequently, no dosage adjustment is required.

After absorption, rifampicin is rapidly eliminated in the bile and an enterohepatic circulation ensues. During this process, rifampicin undergoes progressive deacetylation, so that nearly all the drug in the bile is in this form in about 6 hours. This metabolite retains essentially complete antibacterial activity. Intestinal reabsorption is reduced by deacetylation and elimination is facilitated. Up to 30 % of a dose is excreted in the urine, with about half of this being unchanged drug. Absorption of rifampicin is reduced when the drug is ingested with food.

Rifampicin is widely distributed throughout the body. It is present in effective concentrations in many organs and body fluids, including cerebrospinal fluid. Rifampicin is about 80 % protein bound. Most of the unbound fraction is not ionized and therefore is diffused freely in tissues.

Isoniazid

After oral administration isoniazid produces peak blood levels within 1 to 2 hours which decline to 50% or less within 6 hours. Ingestion of isoniazid with food may reduce its absorption . It diffuses readily into all body fluids (cerebrospinal, pleural and ascitic fluids), tissues, organs and excreta (saliva, sputum and faeces). From 50 to 70% of a dose of isoniazid is excreted in the urine in 24 hours.

Isoniazid is metabolised primarily by acetylation and dehydrazination.. The rate of acetylation is genetically determined.

Pharmacokinetic studies in normal volunteers have been shown that the two ingredients in Rifinah have comparable bioavailability whether they are given together as individual dose forms or as Rifinah.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tablet core:

Sodium lauryl sulphate

Calcium stearate

Sodium carboxymethylcellulose

Magnesium stearate

Microcrystalline cellulose

Magnesium carbonate – light

Carnauba wax

Colophony

Beeswax white

Hard paraffin

Sugar coating:

Acacia

Gelatin

Kaolin

Talc

Titanium dioxide (E171)

Colloidal silicon dioxide

Polyvinylpyrollidone K30

Sucrose

Erythrosine (E127)

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

4 years.

6.4 Special Precautions For Storage

Store below 25°C. If it proves necessary to open a blister pack, Rifinah should be dispensed in amber glass or plastic containers. Protect from moisture.

6.5 Nature And Contents Of Container

Blister packs of 84 tablets (4 week calendar packs) in cardboard cartons.

Blister material is PVC / PVDC and aluminium foil / PVC.

6.6 Special Precautions For Disposal And Other Handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

8. Marketing Authorisation Number(S)

Rifinah 150: PL 04425/0041

9. Date Of First Authorisation/Renewal Of The Authorisation

19 April 1999

10. Date Of Revision Of The Text

03 February 2012

LEGAL CLASSIFICATION

POM

Gemeprost

Gemeprost 1mg Pessary

gemeprost

Is this leaflet hard to see or read? Phone 01483 505515 for help

Read all of this leaflet carefully before you are given this medicine

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask you doctor or nurse.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

In this leaflet:

• 1. What Gemeprost Pessary is and what it is used for.


• 2. Before you are given Gemeprost Pessary


• 3. How you are given Gemeprost Pessary


• 4. Possible side effects


• 5. How Gemeprost Pessary is stored


• 6. Further information

What Gemeprost Pessary is and what it is used for

Gemeprost Pessary contains a medicine called gemeprost. This belongs to a group of medicines called prostaglandins. It works by making the womb contract. Gemeprost is normally given to women in the following situations:

• To make the operation to terminate a pregnancy in the first three months easier.


• To terminate a pregnancy between the fourth and sixth month.


• To terminate a pregnancy between the fourth and sixth month, if the unborn baby (foetus) has already died.

Before you are given Gemeprost Pessary

Do not use Gemeprost Pessary if:

• You are allergic (hypersensitive) to gemeprost or any of the other ingredients of this medicine (See section 6: Further information). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.



• You are allergic or sensitive to prostaglandin medicines such as alprostadil, bimatoprost, latanoprost, travoprost or misoprostol.



• You have or have had placenta previa (light or heavy vaginal bleeding which may be sudden, painless and recurring). Your doctor should check on this and may perform a ultrasound scan.



• You have kidney problems.



• You have had an operation on your womb, like a caesarean section.

Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or nurse before you are given the first pessary.

Take special care with Gemeprost Pessary

Talk to your doctor or nurse before you are given this medicine if:

• You have breathing problems.


• You have glaucoma (raised pressure in the eye which affects your sight).


• You have any heart problems.


• You have dizziness, lightheadedness or fainting. This may be due to low blood pressure


• You have a rare genetic disease known as sickle cell anaemia


• You have epilepsy


• You have unusual vaginal discharge, pain when passing water or increased need to pass water. These may be signs of cervicitis


• You have vaginal pain, itching or discharge. These may be signs of vaginitis


• You have an illness where the level of glucose in your blood is not controlled properly (diabetes mellitus)


• You have a problem with your blood clotting

Taking or using other medicines

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without prescription. This includes medicines you can buy without prescription, including herbal medicines. This is because gemeprost can affect the way some other medicines work. Also some medicines can affect the way gemeprost works.

In particular, tell your doctor you are taking any of the following.

Medicines used to speed up labour such as oxytocin. This can increase the effect of Gemeprost.

How you will be given Gemeprost Pessary

• Gemeprost pessaries will be given to you by a doctor or nurse.


• The pessaries are inserted into your vagina.


• The number of pessaries given to you will depend on the reason for its use.

The doctor or nurse will keep an eye on you while you are being treated with Gemeprost
pessaries.

Gemeprost pessaries can be given in one of the following ways in these situations:

Termination of pregnancy in the first three months to make the operation easier

• One pessary inserted three hours before the operation.


• If the operation is delayed for more than three hours, you will be kept under observation. This is because termination may occur anyway.


• If you start to bleed, tell the doctor or nurse.

Termination of pregnancy between the fourth and sixth month

• One pessary inserted every three hours.


• Up to 5 pessaries are normally given.


• Sometimes you may need up to five more pessaries.


• If the termination has not happened by this time, your doctor or nurse will use another method to finish the termination.

Termination of a pregnancy between the fourth and sixth month, if the unborn baby (foetus) has already died

• One pessary will be inserted every three hours.


• Up to 5 pessaries are normally given to you.

After the treatment, the doctor or nurse will check to make sure the termination has been completed properly.

It is important to keep your appointment if you are due a follow-up examination after this treatment.

Gemeprost Side Effects

Like all medicines, Gemeprost Pessary can cause side effects, although not everybody gets them.

Very rare allergic reactions that can occur with prostaglandins such as Gemeprost

You could notice the following signs of an allergic reaction:

• Flushing, fainting, fever and chills


• Itching and redness all over your body


• Tight chest and difficulty in breathing


• Back pain

If you think that Gemeprost is causing an allergic reaction, tell your doctor straight away.

Very rare side effects

• Splitting or tearing of the womb. This usually happens in women who have had several children or a previous operation on the womb (such as a caesarian section).


• Heart and circulation problems.

Other side effects

If you have any of the following side effects, do not worry. However if they are troublesome, talk to your doctor or nurse.

These side effects usually last for a short time.

• Bleeding from your vagina and mild pain in your womb (like period pain)


• Feeling sick (nausea) and being sick (vomiting)


• Diarrhoea


• Headache and flushing


• Muscle weakness and backache


• Feeling dizzy, light headed and faint


• High temperature and chills (shivering)


• Difficulty in breathing


• Very fast and uneven heartbeat (palpitations)


• Fall in blood pressure


• Chest pain or in some cases with tightness, crushing or squeezing pressure on the chest and may radiate to the neck, shoulder or arms (coronary spasm)


• Heart attack

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or nurse.

How to store Gemeprost Pessary

• Keep this medicine in a safe place where children cannot see or reach them


• Store below minus 10°C in a freezer


• Do not use Gemeprost Pessary after the expiry date stated on the box and the foil pouches. The expiry date refers to the last day of that month.


• Before use, each pessary should be allowed to warm up to room temperature

Medicines should not be disposed of via wastewater or household waste. Ask your doctor or nurse how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What Gemeprost Pessary contains

• The active substance is gemeprost.


• The other ingredients are Witepsol S 52 and dehydrated ethanol.

What Gemeprost Pessary looks like and contents of the pack

The pessary is a bullet-shaped waxy solid, 2-3 centimetres long and it comes in boxes of 5 pessaries.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

Tel:01483 505515

Fax:01483 535432

email:uk-medicalinformation@sanofi-aventis.com

Manufacturer

Gruppo Lepetit S.r.l.

Loc. Valcanello

03012

Anagni

Italy

This leaflet does not contain all the information about your medicine. If you have any questions
or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in 03/2008

^©Sanofi-aventis, 2000 - 2007

89016217

Coldec D Controlled-Release Tablets

Pronunciation: kar-bi-NOX-ah-meen/soo-doe-eh-FED-rin
Generic Name: Carbinoxamine/Pseudoephedrine
Brand Name: Examples include Coldec D and Rondec-TR

Coldec D Controlled-Release Tablets are used for:

Relieving congestion, sneezing, and watery eyes due to colds, flu, or hay fever.

Coldec D Controlled-Release Tablets are an antihistamine and decongestant combination. It works by blocking the action of histamine and reducing the symptoms of an allergic reaction. It also relieves nasal congestion by causing vasoconstriction and shrinkage of the nasal mucous membranes and promoting drainage.

Do NOT use Coldec D Controlled-Release Tablets if:

• you are allergic to any ingredient in Coldec D Controlled-Release Tablets


• you have severe high blood pressure, severe heart disease (coronary artery disease, ischemic heart disease), angle-closure glaucoma, or a peptic ulcer, or if you are unable to urinate due to bladder problems (urinary retention)


• you are having an asthma attack


• you are taking sodium oxybate (GHB), or if you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Coldec D Controlled-Release Tablets:

Some medical conditions may interact with Coldec D Controlled-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have asthma; diabetes; heart disease; high blood pressure; increased inner eye pressure; a blockage of your stomach, intestines, or bladder; an overactive thyroid; difficulty urinating; an enlarged prostate; or seizures

Some MEDICINES MAY INTERACT with Coldec D Controlled-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Barbiturates (eg, phenobarbital), furazolidone, MAO inhibitors (eg, phenelzine), tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, antacids) because side effects, such as increased drowsiness, headache, high blood pressure, or elevated body temperature, may occur


• Sodium oxybate (GHB) because side effects, such as an increase in sleep duration and drowsiness leading to unconsciousness or coma, may occur


• Bromocriptine or droxidopa because the actions and side effects of these medicines may be increased


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Coldec D Controlled-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Coldec D Controlled-Release Tablets:

Use Coldec D Controlled-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Coldec D Controlled-Release Tablets may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Swallow Coldec D Controlled-Release Tablets whole. Do not crush or chew before swallowing. Some brands of Coldec D Controlled-Release Tablets may be broken in half before they are taken. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand may be broken in half.


• If you miss a dose of Coldec D Controlled-Release Tablets and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Coldec D Controlled-Release Tablets.

Important safety information:

• Coldec D Controlled-Release Tablets may cause drowsiness, dizziness, or change in vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Coldec D Controlled-Release Tablets. Using Coldec D Controlled-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• If you have trouble sleeping, ask your pharmacist or doctor about the best time of day to take Coldec D Controlled-Release Tablets.


• Do not take diet or appetite control medicines while you are taking Coldec D Controlled-Release Tablets without checking with your doctor.


• Coldec D Controlled-Release Tablets contains pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.


• Use Coldec D Controlled-Release Tablets with caution in the ELDERLY because they may be more sensitive to its effects, especially sleeplessness.


• Use Coldec D Controlled-Release Tablets with extreme caution in CHILDREN younger than 12 months of age. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Coldec D Controlled-Release Tablets, discuss with your doctor the benefits and risks of using Coldec D Controlled-Release Tablets during pregnancy. It is unknown if Coldec D Controlled-Release Tablets are excreted in breast milk. If you are or will be breast-feeding while you are using Coldec D Controlled-Release Tablets, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Coldec D Controlled-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Appetite loss; diarrhea; dizziness; drowsiness; dry mouth, throat, or nose; headache; heartburn; nausea; nervousness; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; difficulty breathing; difficulty urinating; double vision; fast or irregular heartbeat; frequent or painful urination; hallucinations; seizures; severe headache and dizziness; severe nervousness; tremor; weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Coldec D side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased mental alertness; fast or irregular heartbeat; fever; hallucinations; nausea; seizures; sleeplessness; sweating; trouble breathing; unusual drowsiness or dizziness; tremors; vomiting.

Proper storage of Coldec D Controlled-Release Tablets:

Store Coldec D Controlled-Release Tablets at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Coldec D Controlled-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Coldec D Controlled-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Coldec D Controlled-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Coldec D Controlled-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Coldec D resources

• Coldec D Side Effects (in more detail)
• Coldec D Use in Pregnancy & Breastfeeding
• Coldec D Drug Interactions
• Coldec D Support Group
• 0 Reviews for Coldec D - Add your own review/rating

Compare Coldec D with other medications

• Cold Symptoms
• Hay Fever

Beechams Max Strength Sore Throat Relief Lemon and Honey Lozenges

1. Name Of The Medicinal Product

Beechams Max Strength Sore Throat Relief Lemon and Honey Lozenges

2. Qualitative And Quantitative Composition

Hexylresorcinol 2.5mg and Benzalkonium Chloride Solution 1.2mg

3. Pharmaceutical Form

Lozenge

4. Clinical Particulars

4.1 Therapeutic Indications

Symptomatic relief of sore throat, the associated pain and pharyngitis.

4.2 Posology And Method Of Administration

Adults (including the elderly) and children over the age of 12: One lozenge dissolved slowly in the mouth every three hours or as required. Do not take more than 8 lozenges in 24 hours.

Children aged 7 to 12 years: One lozenge dissolved slowly in the mouth every three hours or as required. Do not take more than 4 lozenges in 24 hours. Not to be given to children under 7 years.

4.3 Contraindications

Hypersensitivity to any of the active ingredients or excipients.

Patients with metabolic disorders relating to glucose/sucrose ingestion or fructose intolerance

4.4 Special Warnings And Precautions For Use

Keep out of the reach and sight of children

If symptoms persist consult your doctor.

Do not exceed the stated dose

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Contains 2.5 g of total glucose and sucrose per lozenge. This should be taken into account in patients with diabetes mellitus.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None

4.6 Pregnancy And Lactation

There is a lack of evidence of safety of the product in human pregnancy and in animals, but both hexylresorcinol and benzalkonium chloride have been used widely in lozenges for many years without apparent ill consequence. However, as with all medicines, caution should be exercised during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None

4.8 Undesirable Effects

Gastrointestinal Disorders: Local irritations or inflammations in the mouth and throat.

4.9 Overdose

The oral toxic dose of benzalkonium chloride is between 1 and 3g, symptoms of overdose are unlikely with a product containing such a low level.

An overdose of hexylresorcinol may cause minor gastrointestinal irritation.

After withdrawal of the product, treatment is symptomatic.

Theoretically symptoms are possible in children if at least 50 lozenges are consumed in a short space of time. In such extreme overdose related to menthol ingestion, symptoms may include nausea, vomiting, diarrhoea, profuse sweating and intense thirst.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Hexylresorcinol is a local anaesthetic effective for topical use on the mucous membranes of the mouth and throat. Mild antiseptic activity has also been demonstrated.

Benzalkonium chloride is a quaternary ammonium compound with antiseptic activity typical of this group.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

There are no preclinical data of any relevance additional to that already included in other sections of the SmPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sucrose, levomenthol, propylene glycol, honey flavour, lemon flavour, caramel, beta-carotene and liquid glucose.

6.2 Incompatibilities

Benzalkonium chloride is incompatible with other anionic surfactants, citrates, iodides, nitrates, permanganates, salicylates, tartrates and alkalis. Incompatibilities have also been reported with other substances including aluminium, hydrogen peroxide, kaolin and some sulphonamides.

Hexylresorcinol is also incompatible with alkalis and oxidising agents.

6.3 Shelf Life

Three years

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

Blisters (PVC 250 microns/PVdC 60 microns/Aluminium 20 microns)

Pack sizes 10, 12, 20.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Beecham Group Plc

908 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as: GlaxoSmithKline Consumer Healthcare, Brentford, Middlesex, TW8 9GS, UK

8. Marketing Authorisation Number(S)

PL 00079/0385

9. Date Of First Authorisation/Renewal Of The Authorisation

26 April 2002

10. Date Of Revision Of The Text

26/01/2011

Jatrosom

Jatrosom may be available in the countries listed below.

Ingredient matches for Jatrosom

Tranylcypromine

Tranylcypromine sulfate (a derivative of Tranylcypromine) is reported as an ingredient of Jatrosom in the following countries:

• Germany

International Drug Name Search

Nitrostat oral/sublingual

Generic Name: nitroglycerin (oral/sublingual) (NYE troe GLI ser in (OR al/sub LIN gwal))

Brand Names: Nitro-Time, Nitrolingual, Nitrolingual Duo Pack, Nitromist, Nitrostat

What is nitroglycerin?

Nitroglycerin is in a group of drugs called nitrates. Nitroglycerin dilates (widens) blood vessels, making it easier for blood to flow through them and easier for the heart to pump.

Nitroglycerin is used to treat or prevent attacks of chest pain (angina).

Nitroglycerin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about nitroglycerin?

Do not use nitroglycerin if you are taking sildenafil (Viagra, Revatio), tadalafil (Cialis), or vardenafil (Levitra). Serious, life-threatening side effects can occur if you take nitroglycerin while you are using sildenafil.

Nitroglycerin can cause severe headaches, especially when you first start using it. These headaches may gradually become less severe as you continue to use nitroglycerin. Do not stop taking the medication. Ask your doctor before using any headache pain medication.

What should I discuss with my healthcare provider before taking nitroglycerin?

Do not use nitroglycerin if you are taking sildenafil (Viagra, Revatio), tadalafil (Cialis), or vardenafil (Levitra). Serious, life-threatening side effects can occur if you take nitroglycerin while you are using sildenafil.

Do not use this medication without the advice of a doctor if you have early signs of a heart attack (chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling). Seek emergency medical attention if you have symptoms of a heart attack.

You should not use this medication if you are allergic to nitroglycerin or other nitrates such as isosorbide dinitrate (Dilatrate, Isordil, Isochron) or isosorbide mononitrate (Imdur, ISMO, Monoket), or if you have:

• 
  

  severe anemia (a lack of red blood cells); or

  
  


• 
  

  a brain injury, hemorrhage, or tumor.

  
  

To make sure you can safely take nitroglycerin, tell your doctor if you have any of these other conditions:

• 
  

  congestive heart failure;

  
  


• 
  

  a history of heart attack, stroke, or head injury;

  
  


• 
  

  low blood pressure;

  
  


• 
  

  glaucoma;

  
  


• 
  

  migraine headaches; or

  
  


• liver disease.

FDA pregnancy category C. It is not known whether nitroglycerin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether nitroglycerin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Nitroglycerin can cause severe headaches, especially when you first start using it. These headaches may gradually become less severe as you continue to use nitroglycerin. Do not stop taking the medication. Ask your doctor before using any headache pain medication.

How should I take nitroglycerin?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

If possible, try to rest or stay seated when you use this medication. Nitroglycerin can cause dizziness or fainting.

If you use nitroglycerin sublingual spray to treat an angina attack: At the first sign of an attack, apply the spray directly on or under your tongue. Close your mouth after each spray. Do not inhale the spray. Do not shake the spray before or during use. You may use additional sprays every 5 minutes, but not more than 3 sprays in 15 minutes.

You may use nitroglycerin spray within 5 to 10 minutes before an activity you think might cause chest pain. Follow your doctor's instructions.

The nitroglycerin sublingual tablet should be placed under your tongue and allowed to dissolve slowly. Do not chew or swallow it. You may use additional tablets every 5 minutes, but not more than 3 tablets in 15 minutes.

Seek emergency medical attention if your chest pain gets worse or lasts more than 5 minutes, especially if you have trouble breathing or feel weak, dizzy, or nauseated, or lightheaded. You may feel a slight burning or stinging in your mouth when you use this medication. However, this sensation is not a sign of how well the medication is working. Do not use more medication just because you do not feel a burning or stinging. Do not crush, chew, break, or open an extended-release capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using nitroglycerin.

Keep this medicine on hand at all times in case of an angina attack. Get your prescription refilled before you run out of medicine completely.

If you take nitroglycerin on a regular schedule to prevent angina, do not stop taking it suddenly or you could have a severe attack of angina. Store the tablets in the glass container at room temperature, away from moisture and heat. Keep the spray away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot.

What happens if I miss a dose?

Since nitroglycerin is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 2 hours away. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of nitroglycerin can be fatal.

Overdose symptoms may include a severe throbbing headache, confusion, fever, fast or pounding heartbeats, dizziness, vision problems, nausea, vomiting, bloody diarrhea, trouble breathing, cold or clammy skin, feeling light-headed, fainting, and seizures.

What should I avoid while taking nitroglycerin?

Nitroglycerin can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of nitroglycerin, such as dizziness, drowsiness, feeling light-headed, or fainting.

Nitroglycerin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  fast, slow, pounding, or uneven heart rate;

  
  


• 
  

  blurred vision or dry mouth;

  
  


• 
  

  nausea, vomiting, sweating, pale skin, feeling like you might pass out; or

  
  


• 
  

  fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

  
  

Less serious side effects may include:

• 
  

  mild burning or tingling with the tablet in your mouth;

  
  


• 
  

  warmth, redness, or tingly feeling under your skin; or

  
  


• 
  

  feeling weak or dizzy.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect nitroglycerin?

Many drugs can interact with nitroglycerin. Below is just a partial list. Tell your doctor if you are using:

• 
  

  alteplase (Activase);

  
  


• 
  

  aspirin or heparin;

  
  


• 
  

  bladder or urinary medications such as oxybutynin (Ditropan) or tolterodine (Detrol);

  
  


• 
  

  blood pressure medication;

  
  


• 
  

  bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);

  
  


• 
  

  dihydroergotamine (D.H.E. 45, Migranal) or ergotamine (Ergomar, Cafergot, and others);

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), clomipramine (Anafranil), imipramine (Tofranil), and others;

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), and others;

  
  


• 
  

  a calcium channel blocker such as diltiazem (Tiazac, Cardizem), nifedipine (Procardia), nimodipine (Nimotop), verapamil (Calan, Covera, Verelan), and others;

  
  


• 
  

  irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, and others), or propantheline (Pro-Banthine);

  
  


• 
  

  any medication that causes dry mouth; or

  
  


• 
  

  medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), thioridazine (Mellaril), and others.

  
  

This list is not complete and there are many other drugs that can interact with nitroglycerin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Nitrostat resources

• Nitrostat Side Effects (in more detail)
• Nitrostat Use in Pregnancy & Breastfeeding
• Drug Images
• Nitrostat Drug Interactions
• Nitrostat Support Group
• 1 Review for Nitrostat - Add your own review/rating

Compare Nitrostat with other medications

• Angina
• Angina Pectoris Prophylaxis
• Heart Attack
• Heart Failure
• High Blood Pressure

Where can I get more information?

• Your pharmacist can provide more information about nitroglycerin.

See also: Nitrostat side effects (in more detail)