Rinstead Sugar Free Pastilles
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS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.
Interaction with other medicinal products and other forms of interaction
4.5
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
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Merck Sharp & Dohme Ltd.
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
10 DATE OF REVISION OF THE TEXT
22/01/2011