Rinstead Sugar Free Pastilles

1. Name Of The Medicinal Product

Rinstead Sugar Free Pastilles

2. Qualitative And Quantitative Composition

Menthol BP 0.033% w/w

Cetylpyridinium chloride BP 0.128% w/w

3. Pharmaceutical Form

Pastille.

4. Clinical Particulars

4.1 Therapeutic Indications

For the temporary relief of pain and discomfort from recurrent mouth ulcers and denture sore spots.

4.2 Posology And Method Of Administration

Adults and children over 12 years:

Allow one pastille to dissolve slowly in the mouth about every two hours.

4.3 Contraindications

Hypersensitivity to cetylpyridinium chloride or menthol or to any component of the formulation.

4.4 Special Warnings And Precautions For Use

If symptoms persist, a physician or dentist should be consulted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

The safety of Rinstead Sugar Free Pastilles in pregnancy and lactation has not been established. Therefore, this product should only be used in pregnancy when considered essential by a physician.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Sensitisation to the product is a possible undesirable effect.

4.9 Overdose

If overdose is suspected, this should be treated symptomatically with gastric lavage and supportive therapy, if indicated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Menthol, applied locally in low concentrations, provides a soothing effect.

Cetylpyridinium chloride is an antiseptic, active against a wide spectrum of micro-organisms.

5.2 Pharmacokinetic Properties

Menthol is excreted in the urine and bile as a glucuronide.

Cetylpyridinium chloride is poorly absorbed and is excreted mainly via the faeces.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tartaric acid

Amaranth, Rinstead Oils

Sodium ricinoleate (50% sln)

Acesulfame potassium

Acacia gum

Sorbitol

Silicone Antifoam

Vegetable Oil

Beeswax

Water

6.2 Incompatibilities

None known

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

Store below 25°C

6.5 Nature And Contents Of Container

Aluminium foil/clear PVC blister strips contained in a cardboard carton. Pack sizes of 12, 24, 30, 36 and 48 pastilles.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UK

8. Marketing Authorisation Number(S)

PL 00025/0586

9. Date Of First Authorisation/Renewal Of The Authorisation

16 April 1996 / 16 April 2001

10. Date Of Revision Of The Text

22 January 2011

11. LEGAL CATEGORY

GSL

© Merck Sharp & Dohme Limited 2011. All rights reserved.

Rinstead SFP/01-11/02