Land: Malta
Språk: engelsk
Kilde: Malta Medicines Authority
CARBOCISTEINE
Dompe Farmaceutici SpA Via San Martino 12, 20122, Milan, Italy
R05CB03
CARBOCISTEINE 9 % (W/V)
SYRUP
CARBOCISTEINE 9 % (W/V)
OTC
COUGH AND COLD PREPARATIONS
Authorised
2007-01-03
Page 1 of 3 Package insert FLUIFORT 90 mg/ml syrup Carbocysteine lysine salt monohydrate COMPOSITION 100 ml solution contain: Active ingredient: carbocysteine lysine salt monohydrate equal to 9 g carbocysteine lysine salt; Excipients: saccharose, natural cherry aroma, methyl-p-parahydroxybenzoate, caramel, purified water. PHARMACEUTICAL FORM AND CONTENT: Fluifort 90 mg/ml syrup – 1 bottle to 200 ml PHARMACOTHERAPEUTIC CLASS Cough and cold preparation. Mucolytics MARKETING AUTHORIZATION HOLDER Dompé farmaceutici S.p.A - Via San Martino, 12, 20122 Milano (Italy) MANUFACTURER AND FINAL CONTROL Dompé farmaceutici S.p.A. – Via Campo di Pile, L’Aquila (Italy) INDICATIONS Mucolytic drug, fluidifying agent in the acute and chronic diseases of the respiratory system. CONTRAINDICATIONS Hypersensitivity to the active ingredient or to any of the excipients. Gastric-duodenal ulcer. Pregnancy and lactation (see “Special warnings”). Children aged less than 2 years. PRECAUTIONS FOR USE No tolerance or addiction effects are known. INTERACTIONS Controlled clinical trials did not point out any interaction with the most common medicines used for the treatment of upper airways disorders or with food and laboratory tests. SPECIAL WARNINGS Mucolytic agents could induce bronchial obstruction in children below 2 years. Indeed bronchial mucus drainage capability is limited in this year, because of the physiologic features of the respiratory tract. They should not be used in children below 2 years. Each dose to 15 ml provides 6 g saccharose. This must be considered when treating patients with diabetes mellitus. The medicine contains methyl-para-hydroxybenzoate, known for the possibility of causing urticaria. Para-hydroxybenzoates may generally cause delayed reactions, such as contact dermatitis, and rarely immediate reactions with urticaria and bronchospasm. Fluifort 90 mg/ml syrup does not contain gluten; therefore, it may be administered to patients suffering from celiac disease. Fluifort 90 mg/ml syrup does not contain aspar Les hele dokumentet
Page 1 of 4 SUMMARY OF PRODUCT’S CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fluifort 90 mg/ml syrup 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 100 ml syrup contain: active ingredient: carbocysteine lysine salt monohydrate equivalent to 9 g carbocysteine lysine salt Excipients: Saccharose, methyl-p-hydroxybenzoate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Syrup 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mucolytic drug, fluidifying agent in the acute and chronic diseases of the respiratory system. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION A graduated cup is enclosed in the package. To open the bottle hardly press the cap and turn anticlockwise. Adults:15 ml 2-3 times daily or as directed by a health care professional Children: older than 5 years: 5 ml 2-3 times daily or as directed by a health care professional from 2 to 5 years: 2,5 ml 2-3 times daily or as directed by a health care professional In consideration of the pharmacokinetic properties and of the high tolerability, the recommended posology may be kept in patients with renal and liver failure, too. DURATION OF TREATMENT: Carbocysteine monohydrate lysine salt may be used for longer periods of time; in this case, please follow the recommendations of the physician. 4.3 CONTRAINDICATIONS Hypersensitivity to the active ingredient or to any of the excipients. Gastric-duodenal ulcer. Pregnancy and lactation. Children aged less than 2 years. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Mucolytics can cause bronchial obstruction in children aged less than 2 years. Due to the physiological characteristics of the airways, the ability to drain bronchial mucus is limited in this age group. For this reason, mucolytic agents should not be used in children under 2 years of age (see paragraph 4.3). No tolerance or addiction phenomena are known. Patients with rare inherited problems of glucose intolerance, glucose-galactose malabsorption or lack of the saccharose-isomaltase enzyme should not take this medicines. The medicine Les hele dokumentet