País: Malta
Idioma: anglès
Font: Medicines Authority
MEBEVERINE HYDROCHLORIDE
Brillpharma (Ireland) Limited Inniscarra, Main Street, Rathcoole, Co. Dublin, Ireland
A03AA04
MEBEVERINE HYDROCHLORIDE 135 mg
COATED TABLET
MEBEVERINE HYDROCHLORIDE 135 mg
POM
DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
Authorised
2016-08-18
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MEBEVERINE HYDROCHLORIDE 135 MG 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 this medicine is and what it is used for 2. What you need to know before you take this medicine 3. How to take this medicine 4. Possible side effects 5. How to store this medicine 6. Contents of the pack and other information 1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR This medicine contains an active substance called Mebeverine hydrochloride, which 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 passes down food, 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) Page 2 of 6 • 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 you develop new symptom Llegiu el document complet
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mebeverine hydrochloride 135 mg coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each coated tablet contains 135 mg of mebeverine hydrochloride. Excipient with known effect: Also contains 121.50 mg of lactose monohydrate and 60.00 mg of sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated tablet Round, white to off-white, sugar coated tablets, plain on both sides. 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 Posology _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 _ Page 2 of 7 This medicine is 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 use. The 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 misse Llegiu el document complet