מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Pholcodine
Thornton & Ross Ltd
R05DA08
Pholcodine
1mg/1ml
Oral solution
Oral
Schedule 5 (CD Inv)
Valid as a prescribable product
BNF: 03090100; GTIN: 5011309025118
PHOLCODINE LINCTUS 200ML PAGE 1 PAGE 3 PAGE 2 קרא את המסמך השלם
OBJECT 1 PHOLCODINE LINCTUS BP Summary of Product Characteristics Updated 09-Nov-2017 | Thornton & Ross Ltd 1. Name of the medicinal product Pholcodine Linctus 2. Qualitative and quantitative composition Pholcodine monohydrate 5.0mg/5ml. Each 5ml of syrup contains 4g of sucrose Each 5ml of syrup contains 3.3 vol% of ethanol (alcohol) For a full list of excipients, see section 6.1. 3. Pharmaceutical form ORAL SOLUTION. A deep orange/ red viscous liquid with a characteristic odour. 4. Clinical particulars 4.1 Therapeutic indications Cough suppressant for the relief of acute non-productive cough associated with upper respiratory tract infections. 4.2 Posology and method of administration Oral use Recommended Doses Adults and children over 12 years: 5-10ml. The elderly: Adult dose is appropriate. Dosage Schedule The dosage may be repeated after 4 hours if required but not more than 4 doses in any 24 hours. 4.3 Contraindications Contraindicated in patients with hypersensitivity to the active substance or to any of the excipients; and in cases of liver failure. It should not be administered to patients in or at risk of developing respiratory failure or during an attack of asthma. Patients with chronic bronchitis, chronic obstructive pulmonary disease (COPD), bronchiolitis or bronchiectasis due to sputum retention. Pholcodine monohydrate should be avoided in patients being treated with monoamine oxidase inhibitors or within 2 weeks of cessation of their use (see section 4.5). Children under 12 years of age. 4.4 Special warnings and precautions for use Pholcodine Linctus should be used with caution in patients with renal, hepatic or respiratory disease, including a history of asthma. Pholcodine Linctus and other cough suppressants may cause sputum retention and this may be harmful in patients with chronic bronchitis and bronchiectasis. Ask a doctor before use if you suffer from a chronic or persistent cough, if you have asthma, are suffering from an acute asthma attack or where cough is accompanied by excessive secretion קרא את המסמך השלם