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SUMMARY OF PRODUCT CHARACTERISTICS

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.

28 November 2014

DATE OF REVISION OF THE TEXT

25/11/2014