Ország: Málta
Nyelv: angol
Forrás: Medicines Authority
CARBOCISTEINE
Zista Pharma Limited Suite G19, The Business & Technology Centre (btc), Bessemer Drive, Stevenage, Herts SG1 2DX, United Kingdom
R05CB03
CARBOCISTEINE 375 mg
HARD CAPSULE
CARBOCISTEINE 375 mg
POM
COUGH AND COLD PREPARATIONS
Withdrawn
2019-03-05
Page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CARBOCISTEINE 375 MG HARD 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 375mg Hard Capsules is and what it is used for 2. What you need to know before you take Carbocisteine 375mg Hard Capsules 3. How to take Carbocisteine 375mg Hard Capsules 4. Possible side effects 5. How to store Carbocisteine 375mg Hard Capsules 6. Contents of the pack and other information 1. WHAT Carbocisteine 375mg Hard Capsules IS AND WHAT IT IS USED FOR Carbocisteine 375 mg Hard Capsulescontain 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. The 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 375mg Hard Capsules DO NOT TAKE CARBOCISTEINE 375MG HARD CAPSULES IF : • you are allergic to the 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 WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking this medicine if: • you are elderly. • have had an ulcer in your stomach or gut. • you are taking other medicin Olvassa el a teljes dokumentumot
January 2019 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Carbocisteine 375 mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains Carbocisteine 375 mg. Excipient with known effect: Also contains 8.50 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard Yellow coloured size ‘1’ capsule printed ‘375’ in black 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 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. METHOD OF ADMINISTRATION Carbocisteine capsules are for oral use. January 2019 Page 2 of 6 4.3 CONTRAINDICATIONS • 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. Important information regarding the ingredients of this medicine This product contains Lactose. Patients with rare hereditary problems of galactose intolerance, total 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 mammalian species hav Olvassa el a teljes dokumentumot