国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Mebeverine hydrochloride
Azure Pharmaceuticals Ltd
A03AA04
Mebeverine hydrochloride
135 milligram(s)
Film-coated tablet
mebeverine
Marketed
2019-11-22
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MEBEVERINE HYDROCHLORIDE 135 MG FILM-COATED TABLETS (mebeverine hydrochloride) 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 Mebeverine hydrochloride 135 mg Film-coated Tablets are and what they are used for 2. What you need to know before you take Mebeverine hydrochloride 135 mg Film-coated Tablets 3. How to take Mebeverine hydrochloride 135 mg Film-coated Tablets 4. Possible side effects 5. How to store Mebeverine hydrochloride 135 mg Film-coated Tablets 6. Contents of the pack and other information 1. WHAT MEBEVERINE HYDROCHLORIDE 135 MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR Mebeverine hydrochloride 135 mg Film-coated Tablets contain the active substance mebeverine hydrochloride. This belongs to a group of medicines called antispasmodics. This medicine is used to treat symptoms of irritable bowel syndrome (IBS) and similar problems such as chronic irritable colon, spastic constipation, mucous colitis and spastic colitis. Irritable bowel syndrome (IBS) is a very common condition which causes spasm and pain in the gut or intestine. The intestine is a long muscular tube which food passes down so it can be digested. If the intestine goes into spasm and squeezes too tightly, you get pain. The way this medicine works is by relieving the spasm, pain and other symptoms of IBS by relaxing muscles of the gut. The main symptoms of irritable bowel syndrome (IBS) include: Stomach pain and spasm Persistent diarrhoea, or alternating 阅读完整的文件
Health Products Regulatory Authority 25 November 2019 CRN009500 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mebeverine hydrochloride 135 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 135 mg of Mebeverine hydrochloride. Excipients with known effect: Each tablet contains 97 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White colored, circular biconvex shaped, film-coated tablets, plain on both the sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For use in the management of irritable bowel syndrome, (particularly gastrointestinal spasm). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The film-coated tablets should be swallowed with a sufficient amount of water (at least 100 ml water). They should not be chewed because of the unpleasant taste. Duration of use is not limited. If one or more doses are missed, the patient should continue with the next dose as prescribed; the missed dose(s) should not be taken in addition to the regular dose. _Adults (including the elderly):_ One tablet three times a day, preferably 20 minutes before meals. After a period of several weeks, when the desired effect has been obtained, the dosage may be gradually reduced. _Warning:_ Do not exceed the stated dose. _Paediatric Population:_ Mebeverine coated tablets are not recommended for use in children and adolescents below 18, due to insufficient data on safety and efficacy. _ _ _Special Population:_ No posology studies in elderly, renal and/or hepatic impaired patients have been performed. No specific risk for elderly, renal and/or hepatic impaired patients could be identified from available post-marketing data. No dosage adjustment is deemed necessary in elderly, renal and/or hepatic impaired patients. Method of administration For oral administration. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Health Products Re 阅读完整的文件