国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Carbocisteine
DE Pharmaceuticals
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 阅读完整的文件
OBJECT 1 CARBOCISTEINE 375MG CAPSULES Summary of Product Characteristics Updated 11-Jul-2017 | Accord-UK Ltd • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 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. 阅读完整的文件