国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Carbocisteine
Kent Pharma (UK) Ltd
R05CB03
Carbocisteine
375mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03070000
BBBA3995 _Continued over page_ _Continued top of next column_ CARBOCISTEINE 375MG CAPSULES PACKAGE LEAFLET: INFORMATION FOR THE USER 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 only. Do not pass it on to others. It may harm them, even if their symptoms 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 • are PREGNANT or planning to become pregnant • are BREAST FEEDING. OTHER MEDICINES AND CARBOCISTEINE 375MG CAPSULES Tell your doctor or pharmacist if you are taking, have recently taken 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Carbocisteine 375 mg Capsules, Hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 375 mg carbocisteine Excipient(s) with known effect Each Carbocisteine 375 mg Hard Capsule contains 22.5 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard Yellow cap and yellow body, size ‘0’ hard gelatine capsule, filled with white to off white granular powder imprinted with C on cap and 375 on body. 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 and 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. _ _ _Paediatric population _ Carbocisteine 375 mg Capsules, hard are not recommended for children. Method of administration For oral use. 4.3 CONTRAINDICATIONS This medicine is contraindicated in case of: - 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. Patients with rare hereditary problems of galactose intolerance, the Lapp 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 完全なドキュメントを読む