Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Carbocisteine
Key Pharmaceuticals Ltd
R05CB; R05CB03
Carbocisteine
375 milligram(s)
Capsule, hard
Mucolytics; carbocisteine
Not marketed
2020-03-06
PACKAGE LEAFLET: INFORMATION FOR THE USER CARBOCISTEINE 375 MG CAPSULES, HARD Carbocisteine Your medicine is called carbocisteine 375 mg capsules, hard, but it will be referred to as carbocisteine capsules throughout this leaflet. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. WHAT CARBOCISTEINE CAPSULES ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARBOCISTEINE CAPSULES 3. HOW TO TAKE CARBOCISTEINE CAPSULES 4. POSSIBLE SIDE-EFFECTS 5. HOW TO STORE CARBOCISTEINE CAPSULES 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT CARBOCISTEINE CAPSULES ARE AND WHAT THEY ARE USED FOR Carbocisteine capsules 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. Carbocisteine 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARBOCISTEINE CAPSULES. DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF: • you are allergic (hypersensitive) to carbocisteine or any of the other ingredients of this medicine (listed in section 6). 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 bef Les hele dokumentet
Health Products Regulatory Authority 06 March 2020 CRN008K59 Page 1 of 4 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. Health Products Regulatory Authority 06 March 2020 CRN008K59 Page 2 of 4 4.5 INTERACTION Les hele dokumentet