Iglu Sugar Free Pastilles

Pastille

4.1 Therapeutic indications For the relief of mouth ulcers and sore gums4.2 Posology and method of administration Adults, the elderly and children of 3 years and above: Dissolve one pastille in the mouth at 2 hourly intervals. Do not take more than 8 pastilles per day.4.3 Contraindications Hypersensitivity to benzalkonium chloride, benzoin or any of the other ingredients. Contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.4.4 Special warnings and precautions for use None4.5 Interaction with other medicinal products and other forms of interaction None known4.6 Fertility, pregnancy and lactation *Pregnancy* There is no or inadequate evidence of the safety of the active ingredients in this medicine in human pregnancy. The potential risk for humans is unknown. In the absence of sufficient data, the use during pregnancy is not recommended. *Lactation* It is not known whether the active ingredients of this product are excreted in human breast milk. In the absence of sufficient data, the use during lactation is not recommended. *Fertility* Studies of the effects on fertility have not been investigated4.7 Effects on ability to drive and use machines None known4.8 Undesirable effects Sensitivity to benzalkonium chloride may occur in some people. **Reporting of suspected adverse reactions** Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.4.9 Overdose Symptoms of overdose are unlikely unless the recommended dosage is grossly exceeded, when nausea and vomiting may be seen. Treat by discontinuation, giving milk and egg whites and observation.

5.1 Pharmacodynamic properties Benzalkonium chloride is an antiseptic detergent. Benzoin tincture is included as a mild antiseptic and a mucosal protective.5.2 Pharmacokinetic properties The product is used by being allowed to dissolve in the mouth, and its action is therefore dependent on local distribution in the buccal cavity and contact with the affected areas.5.3 Preclinical safety data None specific to the product.

6.1 List of excipients Sorbitol liquid, non crystallising Acacia Peppermint Oil Simethicone Antifoam (water, polydimethyl siloxane and silica mix, polyoxyethylene 20 sorbitan monostearate, glyceryl monostearate, sodium carboxymethyl cellulose, methyl-4-hydroxybenzoate, propyl-4-hydroxybenzoate, hydrogen chloride) Vegetable oil Carnauba wax Water6.2 Incompatibilities None known6.3 Shelf life 36 months6.4 Special precautions for storage Do not store above 25°C. Store in the original package in order to protect from moisture.6.5 Nature and contents of container 24 pastilles, blister packed and contained in a printed carton 45 g pastilles contained in a laminate bag integral with a printed carton.6.6 Special precautions for disposal and other handling None specific to packs