Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
HYOSCINE BUTYLBROMIDE
Boehringer Ingelheim Limited
A03BB01
HYOSCINE BUTYLBROMIDE
10 Milligram
Coated Tablets
Product not subject to medical prescription
Belladonna alkaloids, semisynthetic, quaternary ammonium compounds
Authorised
1979-04-01
PACKAGE LEAFLET: INFORMATION FOR THE USER READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING BUSCOPAN 10MG COATED TABLETS, BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to use it again. • Ask your pharmacist if you need more information or advice. • You must stop taking and talk to your pharmacist or doctor if you do not feel better after two weeks of treatment, or if you feel worse. • If you get any side effects, talk to your pharmacist or doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Buscopan 10mg Coated Tablets are and what they are used for 2. What you need to know before you take Buscopan 10mg Coated Tablets 3. How to take Buscopan 10mg Coated Tablets 4. Possible side effects 5. How to store Buscopan 10mg Coated Tablets 6. Contents of the pack and further information 1. WHAT BUSCOPAN 10MG COATED TABLETS ARE AND WHAT THEY ARE USED FOR Buscopan 10mg Coated Tablets are tablets that contain ‘hyoscine butylbromide’. They belong to a group of medicines called ‘anti-spasmodics’. This medicine is used to relieve abdominal cramps which cause pain and discomfort associated with your digestive tract, and in Irritable Bowel Syndrome (IBS). It works by relaxing the cramping muscles of your stomach and bowel. WHAT ARE ABDOMINAL CRAMPS? Abdominal cramps (or spasms) are due to the sudden, irregular tightening up of muscles in the wall of your stomach or bowel. WHAT IS IRRITABLE BOWEL SYNDROME (IBS)? Irritable Bowel Syndrome or IBS is a group of symptoms that can include abdominal pain, cramps, spasms, bloating, and a change in bowel habit (diarrhoea or constipation). These symptoms may come and go over a period of time and you may not have all these symptoms. You can use Buscopan 10mg Coated Tablets to help relieve the pain of the cramping spasm but it is important to see a doctor to then have a diagnosis of IBS confirmed. While the precise cause of abdominal cramps and Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Buscopan 10 mg Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg hyoscine butylbromide. Excipient(s) with known effect: Sucrose (41.2mg per tablet) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated tablet Round, white, biconvex sugar-coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Buscopan 10mg Coated Tablets are indicated for the relief of spasm of the gastrointestinal tract and for the symptomatic relief of Irritable Bowel Syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Relief of spasm of gastrointestinal tract Adults and children over 12 years: Two tablets (20 mg) four times daily. For the symptomatic relief of Irritable Bowel Syndrome Adults and children over 12 years: The recommended starting dose is 1 tablet up to three times daily, this can be increased up to 2 tablets four times daily if necessary. If symptoms do not improve or if they worsen after 2 weeks of treatment a doctor should be consulted. Buscopan 10mg Coated Tablets should not be taken on a continuous daily basis or for extended periods without investigating the cause of abdominal pain. No specific information on the use of this product in the elderly is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported. _Paediatric population_ Buscopan 10mg Coated Tablets are not recommended for use in children under 12 years of age. Method of administration Oral use. Buscopan 10mg Coated Tablets should be swallowed whole with adequate water. HEALTH PRODUCTS REGULATORY AUTHORITY ___________________________________________________________________________________________________________________ Read the complete document