Страна: Мальта
мова: англійська
Джерело: Medicines Authority
BUTAMIRATE CITRATE
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
R05DB13
BUTAMIRATE CITRATE 1.5 mg
SYRUP
BUTAMIRATE CITRATE 1.5 mg
OTC
COUGH AND COLD PREPARATIONS
Withdrawn
2015-04-13
Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Pintal 1.5 mg/ ml syrup 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of syrup contains 1.5 mg butamirate citrate equivalent to 0.924 mg butamirate. Excipient with known effect: 1 ml of oral suspension contains 450 mg of sorbitol. 1 ml of oral suspension contains 125 mg of glycerol. 3. PHARMACEUTICAL FORM Syrup Colourless or pale yellow liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of non-productive cough. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Adults _ Recommended dose - 15 ml up to 4 times daily Treatment is limited to the symptomatic period. Medical advice should be sought if the cough lasts longer than 4-5 days or if fever, dyspnoea or chest pain develops. _Patients with renal or hepatic impairment_ Data is lacking in patients with impaired renal or hepatic function. Patients with renal and/or liver disease may be at greater risk for adverse effects from butamirate due to drug and metabolite accumulation. Method of administration Pintalsyrup should be taken orally. 4.3. CONTRAINDICATIONS Page 2 of 5 - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Children and adolescents under 18 years of age. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Before prescribing an antitussive treatment, the causes of the cough should be investigated to assess the need for aetiological treatment. If the cough persists after taking the antitussive treatment at the usual dose, the dose should not be increased; instead, the clinical situation should be reviewed. Antitussives should not be used for prolonged periods. Due to inhibition of the cough reflex by butamirate, the concomitant administration of expectorants must be avoided because this can lead to the stagnation of mucus in the respiratory tract, increasing the risk of bronchospasm and respiratory tract infections. This medicinal product contains sorbitol. Patients with rare hereditary problems Прочитайте повний документ
Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Pintal 1.5 mg/ ml syrup 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of syrup contains 1.5 mg butamirate citrate equivalent to 0.924 mg butamirate. Excipient with known effect: 1 ml of oral suspension contains 450 mg of sorbitol. 1 ml of oral suspension contains 125 mg of glycerol. 3. PHARMACEUTICAL FORM Syrup Colourless or pale yellow liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of non-productive cough. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Adults _ Recommended dose - 15 ml up to 4 times daily Treatment is limited to the symptomatic period. Medical advice should be sought if the cough lasts longer than 4-5 days or if fever, dyspnoea or chest pain develops. _Patients with renal or hepatic impairment_ Data is lacking in patients with impaired renal or hepatic function. Patients with renal and/or liver disease may be at greater risk for adverse effects from butamirate due to drug and metabolite accumulation. Method of administration Pintalsyrup should be taken orally. 4.3. CONTRAINDICATIONS Page 2 of 5 - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Children and adolescents under 18 years of age. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Before prescribing an antitussive treatment, the causes of the cough should be investigated to assess the need for aetiological treatment. If the cough persists after taking the antitussive treatment at the usual dose, the dose should not be increased; instead, the clinical situation should be reviewed. Antitussives should not be used for prolonged periods. Due to inhibition of the cough reflex by butamirate, the concomitant administration of expectorants must be avoided because this can lead to the stagnation of mucus in the respiratory tract, increasing the risk of bronchospasm and respiratory tract infections. This medicinal product contains sorbitol. Patients with rare hereditary problems Прочитайте повний документ