国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Carbocisteine
Alliance Healthcare (Distribution) Ltd
R05CB03
Carbocisteine
375mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03070000
MUCODYNE 375MG CAPSULES (carbocisteine) PATIENT INFORMATION LEAFLET 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. * If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Your medicine is called Mucodyne 375mg Capsules but will be called Mucodyne Capsules throughout this leaflet. IN THIS LEAFLET: What Mucodyne Capsules are and what they are used for Before you take Mucodyne Capsules How to take Mucodyne Capsules Possible side effects How to store Mucodyne Capsules Further information WHAT MUCODYNE CAPSULES ARE AND WHAT THEY ARE USED FOR Mucodyne 375mg Capsules (called Mucodyne Capsules in this lea flet) 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. Mucodyne 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. BEFORE YOU TAKE MUCODYNE CAPSULES DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF: * You are allergic (hypersensitive) to carbocisteine or any of the other ingredients of Mucodyne Capsules (listed in Section 6 below) 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. Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Mucodyne Capsules. WARNINGS AND PRECAUTIONS Talk to your doctor before taking this medicine if: * You are elderly. * Have had an ulcer in your stomach or gut. * You are taking other medicine 完全なドキュメントを読む
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 Although tests in mammalian species have revealed no teratogenic effects, carbocisteine is not recommended during the first trimester of pregnancy. Breastfeeding It is unknown whether carbocisteine and / or its metabolites are excreted in human milk. A risk to the ne 完全なドキュメントを読む