Држава: Малта
Језик: Енглески
Извор: 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
OTC
DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
Authorised
2019-03-01
PACKAGE LEAFLET: INFORMATION FOR THE USER MEBEVERINE HYDROCHLORIDE IBS 135MG FILM-COATED TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • 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. • You must talk to a doctor if you do not feel better or if you feel worse after 14 days. 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 IBS 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). This 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 and pain. 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 you develop new symptoms or if these symptoms continue for more than 14 days. YOUR DIET AND LIFESTYLE CAN ALSO HELP TREAT IBS: How you restrict your diet depe Прочитајте комплетан документ
Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mebeverine Hydrochloride IBS 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. 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 relief of Irritable Bowel Syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _ _ Duration of use is not limited. Page 2 of 8 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. If symptoms persist for more than 2 weeks, consult your doctor. Warning: Do not exceed the stated dose. _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 and/or hepatic impaired patients. METHOD OF ADMINISTRATION For oral use. The film-coated tablets should be swallowed with a sufficient amount of water (at least 100 ml water). Tablets should not be chewed because of the unpleasant taste. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS Прочитајте комплетан документ