Cooper – Vocadys Sore Throat Lozenges (Lidocaine/Enoxolone/Erysimum) – Pack of 30

1. Product Name Cooper – Vocadys Sore Throat Lozenges (Lidocaine/Enoxolone/Erysimum) – Pack of 30 2. Ingredients Per lozenge (3 g): Enoxolone – 10.0 g Lidocaine hydrochloride – 0.8 g Dry, aqueous Erysimum (wallflower) extract on maltodextrin – 4.0 g – of which maltodextrin: 1.6 mg maximum Sucrose (excipient) For a full list of excipients, see section 6.1. 3. Dosage Form Throat lozenge 4. Product Information 4.1. Therapeutic IndicationsTo relieve sore throat. 4.2. Directions for Use and DosageTake between meals. Suck lozenges slowly. Do not chew. Adults: 4 to 8 lozenges a day. Leave at least 1 hour between doses. Children 6 to 15 years: 2 to 4 lozenges a day. Leave at least 2 hours between doses. 4.3. Contra-indicationsDo NOT: – give to children under 6. – use if you are allergic to local anaesthetics, enoxolone or any of this medicine's other ingredients. 4.4. Warnings and Precautions for UseWarnings Contains sucrose (2.2 g per lozenge). Do not use if you are fructose-intolerant or have glucose-galactose malabsorption or a sucrase-isomaltase deficiency. Use with caution if you are diabetic or on a low-sugar diet. As anaesthesia of the oropharynx presents a choking risk: – children under 12 must be supervised while taking this medicine; and – this medicine must not be taken just before eating or drinking. Repeated or prolonged topical anaesthetic treatment of the mucus membrane can increase the risk of adverse systemic effects such as central nervous system dysfunction (including seizures) and cardiovascular system depression. Contains terpene derivatives. Excessive use on babies and children may cause seizures or similar neurological disorders. Use with caution if you have a history of epilepsy. Do not exceed the recommended dose or length of treatment (see section titled"Dosage" above). Precautions for Use – If your symptoms persist after five days, or you develop a fever, consult your doctor so that your treatment can be re-assessed. – Warning: If you are a professional sportsperson, note that this product contains an active principle (a local anaesthetic) that can be picked up by routine dope testing. – Due to the presence of terpene derivatives, use with caution if you are epileptic. 4.5. Pregnancy and Breast-FeedingUse while breast-feeding is NOT recommended due to: – the lack of kinetic data regarding the passage of terpene derivatives into breast milk; and – the potential neurological toxicity of terpene derivatives when ingested by babies. 4.6. Possible Side Effects– Increased sensitivity to local anaesthetics – Short-term swelling of the tongue and choking risk (see subsection 4.4 above) – Due to presence of terpene derivatives; or in case of excessive dose: –– risk of seizures in babies and children; and –– restlessness and confusion in elderly people. 5. Pharmacodynamic Properties Pharmacotherapeutic Group: Local Anaesthetic/Local Anti-Inflammatory (R: Respiratory System) Contains terpene derivatives to lower the seizure threshold. 6. Pharmaceutical Information 6.1. ExcipientsLevomenthol, reconstituted mandarin essential oil (mixture of essential oils of mandarin, clementine and orange), glycerol, sucrose, liquid glucose, gelatine, purified water, coating sugar 6.2. Shelf Life3 years 6.3. Storage InstructionsStore below 25°C. 7. Marketing Authorisation Holder COOPERATION PHARMACEUTIQUE FRANCAISE PLACE LUCIEN-AUVERT 77020 MELUN CEDEX FRANCE 8. Marketing Authorisation No. 326 844-7: Pack of 30 lozenges (packaging: polypropylene) 9. Prescription and Delivery Conditions Non-prescription medicine