Nchi: Malta
Lugha: Kiingereza
Chanzo: Medicines Authority
CARBOCISTEINE
Bristol Laboratories Limited
R05CB03
CARBOCISTEINE
HARD CAPSULE
CARBOCISTEINE 375 milligram(s)
POM
COUGH AND COLD PREPARATIONS
Authorised
2019-01-30
Page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CARBOCISTEINE 375 MG CAPSULES, HARD CARBOCISTEINE 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 signs of illness 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 is and what it is used for 2. What you need to know before you take Carbocisteine 3. How to take Carbocisteine 4. Possible side effects 5. How to store Carbocisteine 6. Contents of the pack and other information 1. WHAT CARBOCISTEINE IS AND WHAT IT IS USED FOR Carbocisteine 375mg Capsules, Hard (called Carbocisteine Capsules 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 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 DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF: • You are allergic to active substance 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. If you are not sure, talk to your doctor or pharmacist before taking Carbocisteine Capsules. Page 2 of 4 WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking this medicine if: • You are elderly. • You have had an ulcer in your st Soma hati kamili
Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Carbocisteine 375 mg Capsules, Hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 375mg of Carbocisteine. Excipient(s) with known effect: Each capsule contains 8.5mg of lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsules, Hard (capsule) Size “1” hard gelatin capsule having yellow cap & yellow body printed with “375” in black ink and containing a white to off white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Carbocisteine is a mucolytic agent for the adjunctive therapy of respiratory tract disorders characterised by excessive or viscous mucus, including chronic obstructive airways disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _POSOLOGY _ _ADULTS INCLUDING THE ELDERLY: _ Dosage is based upon an initial daily dosage of 2250mg Carbocisteine in divided doses, reducing to 1500mg 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: _ This formulation is not recommended for children. The normal daily dosage is 20mg/kg body weight in divided doses. It is recommended that this is achieved with Paediatric Syrup. _METHOD OF ADMINISTRATION _ Carbocisteine capsules are for oral use. 4.3 CONTRAINDICATIONS • Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. • Use in patients with active peptic ulceration. Page 2 of 5 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. _IMPORTANT INFORMATION REGARDING THE INGREDIENTS OF THIS MEDICINE _ Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not tak Soma hati kamili