国: マルタ
言語: 英語
ソース: Medicines Authority
MEBEVERINE HYDROCHLORIDE
Aspire Pharma (Malta) Limited Trident Park, Notabile Gardens No. 2, Level 3, Mdina Road Central Business District Birkirkara CBD2010 , Malta
A03AA04
MEBEVERINE HYDROCHLORIDE 135 mg
FILM-COATED TABLET
MEBEVERINE HYDROCHLORIDE 135 mg
POM
DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
Authorised
2019-03-01
PACKAGE LEAFLET: INFORMATION FOR THE USER MEBEVERINE HYDROCHLORIDE 135MG FILM-COATED TABLETS 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 Tablets are and what they are used for 2. What you need to know before you take Mebeverine Tablets 3. How to take Mebeverine Tablets 4. Possible side effects 5. How to store Mebeverine Tablets 6. Contents of the pack and other information 1. WHAT MEBEVERINE TABLETS ARE AND WHAT THEY ARE USED FOR Mebeverine Hydrochloride 135 mg Film-coated Tablets contain the active ingredient 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. The main symptoms of irritable bowel syndrome (IBS) include: • stomach pain and spasm • feeling bloated and having wind • having diarrhoea (with or without constipation) • small, hard, pellet-like or ribbon-like stools (faeces) These symptoms may vary from person to person. Talk to your doctor if these symptoms do not improve after a while, if 完全なドキュメントを読む
Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mebeverine Hydrochloride 135mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 135mg mebeverine hydrochloride. Excipient with known effect: Each film-coated tablet contains 97 mg lactose monohydrate equivalent to 92.15 mg of lactose (see section 4.4). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet. (Tablet) White to off-white, round film-coated tablets debossed with M135 on one side and plain on other side with 10mm diameter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic treatment of irritable bowel syndrome and other conditions usually included in this grouping, such as: chronic irritable colon, spastic constipation, mucous colitis, spastic colitis. Mebeverine is effectively used to treat the symptoms of these conditions, such as: colicky abdominal pain and cramps, persistent, non-specific diarrhoea (with or without alternating constipation) and flatulence. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Page 2 of 8 POSOLOGY _ _ 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. _Paediatric population: _ Mebeverine hydrochloride 135 mg film-coated tablets are not recommended for use in children and adolescents below 18 years, 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 完全なドキュメントを読む