Nazione: Malta
Lingua: inglese
Fonte: Medicines Authority
OTILONIUM BROMIDE
A. Menarini Industrie Farmaceutiche Riunite S.r.L. Via Sette Santi 3, 50131, Florence, Italy
A03AB06
OTILONIUM BROMIDE 40 mg
FILM-COATED TABLET
OTILONIUM BROMIDE 40 mg
POM
DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
Authorised
2006-05-30
PACKAGE LEAFLET: INFORMATION FOR THE USER SPASMOMEN ® 40 MG FILM-COATED TABLETS Otilonium bromide 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 SPASMOMEN is and what it is used for 2. What you need to know before you take SPASMOMEN 3. How to take SPASMOMEN 4. Possible side effects 5. How to store SPASMOMEN 6. Contents of the pack and other information 1. WHAT SPASMOMEN IS AND WHAT IT IS USED FOR SPASMOMEN tablets contain 40 mg of otilonium bromide which belongs to a group of medicines called “synthetic anticholinergics”. SPASMOMEN has a selective and intense antispasmodic action on the smooth muscle of the digestive tract and is therefore indicated in all hyperkinetic or spastic states which may exist in various locations and may also vary in cause and extent and are attributable to a pathological contraction of the fibrocells of the smooth muscle. If used at the recommended therapeutic dose, the medicine causes no side effects whatsoever and, in particular, does not precipitate atropine-like effects. SPASMOMEN is used to treat irritable bowel and painful, spastic states of the distal enteric tract in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SPASMOMEN _ _ DO NOT TAKE SPASMOMEN: - if you are allergic to Otilonium or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking SPASMOMEN. The medicine must be used with caution in patients with glaucoma, prostatic hypertrophy, pyloric stenosis. Keep out o Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT _SPASMOMEN 40 MG – FILM-COATED TABLETS _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 40 mg of otilonium bromide. Excipient(s) with known effect: approximately 28 mg of lactose monohydrate per tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. White to almost-white round shaped, biconvex film-coated tablets of 5.4 mm diameter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Irritable Bowel Syndrome (IBS); relief of abdominal pain, distension and motility disorders characterised by smooth muscle spasm. Spasmomen is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology 1 Tablet 2-3 times a day, according to the physician's judgement. Special populations _ _ _ _ _Patients with hepatic or renal impairment _ Dose adjustment is not necessary (see section 5.2). _Elderly _ Dose adjustment is not necessary. _Paediatric population _ Clinical data on the use of otilonium bromide 40 mg coated tablets in paediatric patients below 18 years is limited, therefore this medicinal product is not recommended for use in this population. Method of administration Oral administration. Tablets should be swallowed whole, with a glass of water, preferably 20 minutes before meal. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE To be used with caution in subjects with glaucoma, prostatic hypertrophy and pyloric stenosis. This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'. 4.5 INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No interaction studies of otilonium bromide with other product Leggi il documento completo