Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
CARBOCISTEINE
Teva UK Limited
CARBOCISTEINE
375 Milligram
Capsules Hard
Product subject to prescription which may be renewed (B)
Withdrawn
2014-06-03
1 PACKAGE LEAFLET: INFORMATION FOR THE USER CARBOCISTEINE TEVA 375 MG CAPSULES, HARD 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Carbocisteine Teva is and what it is used for 2. Before you take Carbocisteine Teva 3. How to take Carbocisteine Teva 4. Possible side effects 5. How to store Carbocisteine Teva 6. Further information 1. WHAT CARBOCISTEINE TEVA IS AND WHAT IT IS USED FOR Carbocisteine Teva 375 mg capsules, hard (called Carbocisteine Teva in this leaflet) 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 Teva is 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. BEFORE YOU TAKE CARBOCISTEINE TEVA DO NOT TAKE CARBOCISTEINE TEVA IF YOU - ARE ALLERGIC (HYPERSENSITIVE) TO carbocisteine or any of the other ingredients of Carbocisteine Teva (see list of ingredients in section 6). An allergic reaction may include 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 Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Carbocisteine Teva 375mg capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 375 mg carbocisteine. Excipients: Lactose monohydrate (13.75 mg/capsule). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsules, hard Turmeric yellow, size 1 gelatin capsules, hard, imprinted "6C1" on cap and "375" on body with black ink, containing white to off-white granular powder 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 For oral administration. _ADULTS INCLUDING THE 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. _CHILDREN:_ The capsule formulation is not recommended for use in children. 4.3 CONTRAINDICATIONS Hypersensitivity to carbocisteine or any of the other ingredients. Use in patients with active peptic ulceration. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Caution is recommended in patients with peptic ulcers. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None stated. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 27/05/2013_ _CRN 2129325_ _page Lire le document complet