Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Carbocisteine
Viatris UK Healthcare Ltd
R05CB03
Carbocisteine
375mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03070000; GTIN: 5016695007717
MUCODYNE 375MG CAPSULES (carbocisteine) PATIENT INFORMATION LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE * Keep this leaflet. You may need to read it again. * If you have any further questions, ask your doctor or pharmacist. * This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. * If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Your medicine is called Mucodyne 375mg Capsules but will be called Mucodyne Capsules throughout this leaflet. IN THIS LEAFLET: What Mucodyne Capsules are and what they are used for Before you take Mucodyne Capsules How to take Mucodyne Capsules Possible side effects How to store Mucodyne Capsules Further information WHAT MUCODYNE CAPSULES ARE AND WHAT THEY ARE USED FOR Mucodyne 375mg Capsules (called Mucodyne Capsules in this lea flet) contain a medicine called carbocisteine. This belongs to a group of medicines called ‘mucolytics’. It works by making mucus (phlegm) less sticky. This makes the mucus easier to cough up. Mucodyne Capsules are used for problems with the breathing passages (respiratory tract). These problems happen when too much mucus is made or the mucus is too sticky. BEFORE YOU TAKE MUCODYNE CAPSULES DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF: * You are allergic (hypersensitive) to carbocisteine or any of the other ingredients of Mucodyne Capsules (listed in Section 6 below) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue * You have an ulcer in your stomach or gut. Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Mucodyne Capsules. WARNINGS AND PRECAUTIONS Talk to your doctor before taking this medicine if: * You are elderly. * Have had an ulcer in your stomach or gut. * You are taking other medicine Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Carbocisteine 375 mg Capsules, Hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 375 mg carbocisteine Excipient(s) with known effect Each Carbocisteine 375 mg Hard Capsule contains 22.5 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard Yellow cap and yellow body, size ‘0’ hard gelatine capsule, filled with white to off white granular powder imprinted with C on cap and 375 on body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Carbocisteine is a mucolytic agent for the adjunctive therapy of respiratory tract disorders characterised by excessive, viscous mucus, including chronic obstructive airways disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and elderly _ Dosage is based upon an initial daily dosage of 2250 mg carbocisteine in divided doses, reducing to 1500 mg daily in divided doses when a satisfactory response is obtained e.g. two capsules three times a day reducing to one capsule four times a day. _ _ _Paediatric population _ Carbocisteine 375 mg Capsules, hard are not recommended for children. Method of administration For oral use. 4.3 CONTRAINDICATIONS This medicine is contraindicated in case of: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Use in patients with active peptic ulceration. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Caution is recommended in the elderly, in those with a history of gastroduodenal ulcers, or those taking concomitant medications known to cause gastrointestinal bleeding. If gastrointestinal bleeding occurs, patients should discontinue medication. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None stated. 4.6 FERTILITY, PREGNANCY AND LACTATION Pregnancy Although tests in Perskaitykite visą dokumentą