Ülke: Birleşik Krallık
Dil: İngilizce
Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)
Carbocisteine
Accord-UK Ltd
R05CB03
Carbocisteine
375mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03070000; GTIN: 5060034834441
BBBA8895 _Continued over page_ _Continued top of next column_ CARBOCISTEINE 375MG CAPSULES PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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 CAPSULES ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARBOCISTEINE 375MG CAPSULES 3 HOW TO TAKE CARBOCISTEINE 375MG CAPSULES 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE CARBOCISTEINE 375MG CAPSULES 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT CARBOCISTEINE 375MG CAPSULES ARE AND WHAT THEY ARE USED FOR Carbocisteine 375mg Capsules are used to help treat respiratory tract problems (problems with the breathing passages) characterised by too much sticky mucus, including chronic obstructive airways disease (lung damage with restricted airways). Carbocisteine 375mg Capsules contain carbocisteine which belongs to a group of medicines called mucolytics which cause the mucus to be less sticky and easier to cough up. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARBOCISTEINE 375MG CAPSULES DO NOT TAKE CARBOCISTEINE 375MG CAPSULES IF YOU: • are ALLERGIC to carbocisteine or any of the other ingredients of this medicine (listed in section 6) • have an ACTIVE PEPTIC (STOMACH) ULCER. WARNINGS AND PRECAUTIONS Talk to your doctor if you: • are ELDERLY • have a history of STOMACH ULCERS • are taking medicines that may cause INTESTINAL BLEEDING. OTHER MEDICINES AND CARBOCISTEINE 375MG CAPSULES Tell your doctor or pharmacist if you are taking, have recently taken or might t Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Carbocisteine 375mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains carbocisteine 375mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. Size 0 capsule with opaque blue cap and opaque yellow body, containing white to off-white odourless 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 Posology _Adults including the elderly _ Dosage is based upon an initial daily dosage of 2250 mg carbocisteine (6 capsules) in divided doses, reducing to 1500 mg (4 capsules) daily in divided doses when a satisfactory response is obtained. For example, two capsules three times a day reducing to one capsule four times a day. _Paediatric population _ This formulation is not recommended for use in children. Method of administration For oral use. 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. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION There are no known interactions with other medicinal products or other forms of interaction. 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 carbocisteine is safe for use during pregnancy. The use of carbocisteine in pregnant women is not recommended, especially during the first trimest Belgenin tamamını okuyun