Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
MEBEVERINE HYDROCHLORIDE
Abbott Healthcare Products Ltd
MEBEVERINE HYDROCHLORIDE
135 Milligram
Coated Tablets
Product subject to prescription which may be renewed (B)
Withdrawn
2013-04-30
PACKAGE LEAFLET: INFORMATION FOR THE USER MEBECON 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 or nurse. • 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 or nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Mebecon is and what it is used for 2. What you need to know before you take Mebecon 3. How to take Mebecon 4. Possible side effects 5. How to store Mebecon 6. Contents of the pack and other information 1. WHAT MEBECON IS AND WHAT IT IS USED FOR WHAT MEBECON IS The name of your medicine is Mebecon 135 mg coated tablets_ _(called Mebecon in this leaflet). Mebecon contains a medicine called mebeverine hydrochloride. This belongs to a group of medicines called antispasmodics, which act on your 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. This medicine works by relieving the spasm and pain. WHAT MEBECON IS USED FOR Mebecon is used to relieve the symptoms of irritable bowel syndrome (IBS). These symptoms vary from person to person but can include: • stomach pain and cramps • feeling bloated and having wind • diarrhoea, constipation or a combination of both • small, hard, pellet-like or ribbon-like stools (faeces). Mebecon is also used to relieve cramps and pain in your stomach or gut caused by other medical conditions. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEBECON DO NOT TAKE MEBECON: • if you a Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mebecon 135 mg Coated tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each coated tablet contains Mebeverine hydrochloride 135 mg. Excipients: also includes Lactose monohydrate 97.0 mg per tablet and sucrose 79.0 mg per tablet. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Coated Tablet. White, circular, sugar coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of irritable bowel syndrome (particularly gastrointestinal spasm). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use. The coated tablets should be swallowed with a sufficient amount of water (at least 100ml water). They should not be chewed because of the unpleasant taste. Adults and children over 10 years: 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. Duration of use is not limited. However, after a period of several weeks when the desired effect has been obtained, the dosage may be gradually reduced. In case of missed dose(s), the patient should continue with the next dose as prescribed; do not take the missed dose(s) in addition to the regular dose. Children under 10 years: Mebecon should not be used in children aged 3 years and younger as no clinical data is available for this age group. For children from 3 – 10 years mebeverine 135mg tablets should not be used due to the high content of the active substance. 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 Citiți documentul complet