País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
MEBEVERINE HYDROCHLORIDE
Imbat Limited
A03AA
MEBEVERINE HYDROCHLORIDE
135 milligram(s)
Coated tablet
Product subject to prescription which may be renewed (B)
Synthetic anticholinergics, esters with tertiary amino group
Authorised
2009-08-14
PACKAGE LEAFLET: INFORMATION FOR THE USER COLOFAC 135 MG 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. WHAT IS IN THIS LEAFLET 1. What Colofac is and what it is used for 2. What you need to know before you take Colofac 3. How to take Colofac 4. Possible side effects 5. How to store Colofac 6. Contents of the pack and other information 1. WHAT COLOFAC IS AND WHAT IT IS USED FOR WHAT COLOFAC IS The name of your medicine is Colofac 135 mg tablets (called Colofac in this leaflet). Colofac 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 COLOFAC IS USED FOR Colofac 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). Colofac 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 COLOFAC DO NOT TAKE COLOFAC if you are allergic to mebeverine hydrochloride or any of the other ingredients of this medicine(listed in Section 6). Do not take Colofac if the above applies Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Colofac 135mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Mebeverine Hydrochloride 135 mg. Excipients: also includes lactose and sucrose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated-tablet. _Product imported from the UK:_ White, round, sugar-coated tablet with no markings. 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 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. Adults and children over 10 years: One tablet three times a day preferably 20 minutes before meals. 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: Colofac should not be used in children aged 3 years and younger as no clinical data are available. For children from 3- 10 years Colofac 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 dosage adjustment is deemed necessary in elderly, renal and/or hepatic impaired patients. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. I R I S H M E D I C I N E S B O A R D ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Llegiu el document complet