Coryfin 2.8 mg + 16.8 mg 24 tablets

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Symptomatic in the treatment of cough and hoarseness. Coryfin relieves local irritation and reduces phlegm, even in smokers.

ACTIVE INGREDIENTS

Coryfin 6.5 mg + 18 mg tablets Active ingredients: menthol ethyl glycolate 6.5 mg; sodium ascorbate 18.0 mg equal to 16 mg of ascorbic acid (Vitamin C). Excipients with known effects: glucose 0.9 g, sucrose 1.1 g. Coryfin 2.8 mg + 16.8 mg tablets Active ingredients: menthol ethyl glycolate 2.8 mg; sodium ascorbate 16.8 mg equal to 15 mg of ascorbic acid (Vitamin C). Excipients with known effects: glucose 0.9 g, sucrose 1.1 g. Coryfin 6.5 mg + 112.5 mg tablets Active ingredients: menthol ethyl glycolate 6.5 mg; sodium ascorbate 112.5 mg equal to 100 mg of ascorbic acid (Vitamin C). Excipients with known effects: glucose 0.8 g, sucrose 1 g. For the full list of excipients, see section 6.1.

EXCIPIENTS

One tablet of Coryfin 6.5 mg + 18 mg contains: menthol-eucalyptol flavouring, citric acid, sucrose, glucose. One tablet of Coryfin 2.8 mg + 16.8 mg contains: menthol, citric acid, lemon essence, sucrose, glucose. One tablet of Coryfin 6.5 mg + 112.5 mg contains: menthol, mandarin flavour, citric acid, sucrose, glucose.

CONTRAINDICATIONS AND SIDE EFFECTS

– Hypersensitivity to the active substances or to any of the excipients listed in paragraph 6.1. – Children up to 30 months of age. – Children with a history of epilepsy or febrile seizures.

DOSAGE

Dosage Coryfin 6.5 mg + 18 mg and Coryfin 2.8 mg + 16.8 mg: One tablet every 1–2 hours, up to a maximum of 8 tablets per day. Coryfin 6.5 mg + 112.5 mg: One tablet every 2–3 hours, up to a maximum of 6 tablets per day. Pediatric population In children over 30 months halved doses. Do not exceed the indicated doses. The duration of treatment should not exceed 3 days.

CONSERVATION

This medicinal product does not require any special storage conditions.

WARNINGS

This product contains terpene derivatives which, in excessive doses, can cause neurological disorders such as seizures in infants and children. Treatment must not be prolonged for more than 3 days due to the risks associated with the accumulation of terpene derivatives, such as camphor, cineole, niaouli, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needles, eucalyptus and turpentine (due to their lipophilic properties, the rate of metabolism and disposal is not known) in the tissues and brain, in particular neuropsychological disorders. A higher than recommended dose should not be used to avoid an increased risk of adverse drug reactions and disorders associated with overdose (see section 4.9). The product is flammable, it must not be brought near flames. Coryfin contains glucose. Patients suffering from rare problems of glucose-galactose malabsorption should not take this medicine. Coryfin contains sucrose. Patients suffering from rare problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine. To be taken into consideration in people suffering from diabetes mellitus.

INTERACTIONS

Coryfin must not be used concomitantly with other products (medicines or cosmetics) containing terpene derivatives, regardless of the route of administration (oral, rectal, cutaneous, nasal or inhalation).

SIDE EFFECTS

In rare cases of sensitizing or irritating effects, suspend use and institute suitable therapy. Pediatric population Due to the presence of menthol and in case of non-compliance with the recommended doses there may be a risk of convulsions in children and infants. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili.

OVERDOSE

There are no known effects of overdose. Pediatric population In case of accidental oral intake or incorrect administration in newborns and children there may be a risk of neurological disorders. If necessary, administer appropriate symptomatic treatment in specialized treatment centers.

PREGNANCY AND BREASTFEEDING

Pregnancy There are no or limited data available on the use of menthol in pregnant women. Coryfin is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive measures. Breastfeeding There is insufficient information on the excretion of menthol in breast milk. Coryfin should not be used during breastfeeding.

EFFECTS ON DRIVING ABILITY

This medicine does not affect the ability to drive or use machines.