Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Carbocisteine
Healthcare Pharma Ltd
R05CB03
Carbocisteine
375mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03070000; GTIN: 5060013770968
FONTS SIZE : Generic Name font size : 12 pt. Composition fonts size : 10 pt. FONTS : Zurich CnBT CARBOCISTEINE 375 MG CAPSULES POM LEAFLET SIZE : 160 X 280 MM MPLLCAR0375CPCOMFPLXXX077V04 160 mm 280 mm PACKAGE LEAFLET: INFORMATION FOR THE USER CARBOCISTEINE 375 MG CAPSULES 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 Capsule is and what it is used for 2. What you need to know before you take Carbocisteine Capsule 3. How to take Carbocisteine Capsule 4. Possible side effects 5. How to store Carbocisteine Capsule 6. Contents of the pack and other information 1. WHAT CARBOCISTEINE CAPSULE IS AND WHAT IT IS USED FOR Carbocisteine 375 mg 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 CAPSULE DO NOT TAKE CARBOCISTEINE CAPSULES IF: • You are allergic to carbocisteine or any of the other ingredients of this medicine (listed in Section 6) • S igns of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat or tongue • Y ou 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, tal Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Carbocisteine 375 mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Carbocisteine 375 mg Excipient(s) with known effect: Each capsule contains 22.00 mg lactose monohydrate. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsule Yellow size ‘1’ hard gelatin capsules imprinted with ‘C’ on cap and ‘375mg’ on body with black ink containing white to off white granular powder or friable plug. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Carbocisteine is a mucolytic agent for the adjunctive therapy of respiratory tract disorders characterized by excessive, viscous mucus, including chronic obstructive airways disease. 4.2 POSOLOGY AND METHOD OF 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: _ This formulation is not recommended for children. 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. 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, total lactase deficiency or glucose-galactose malabsoprtion 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 There are no available data on carbocisteine use in pregnant women. No conclusions can be drawn regarding whether or not ca Læs hele dokumentet