Maa: Malta
Kieli: englanti
Lähde: Malta Medicines Authority
PRUCALOPRIDE SUCCINATE
Dexcel Pharma GmbH Carl-Zeiss-Straße 2 63755 Alzenau, Germany
A06AX05
PRUCALOPRIDE SUCCINATE 2 mg
FILM-COATED TABLET
PRUCALOPRIDE SUCCINATE 2 mg
POM
DRUGS FOR CONSTIPATION
Licence number in the source country: NOT APPLICAPABLE
Authorised
2020-01-07
Page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE USER PRUCALOPRIDE DEXCEL 1 MG FILM-COATED TABLETS PRUCALOPRIDE DEXCEL 2 MG FILM-COATED TABLETS prucalopride 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 Prucalopride Dexcel is and what it is used for 2. What you need to know before you take Prucalopride Dexcel 3. How to take Prucalopride Dexcel 4. Possible side effects 5. How to store Prucalopride Dexcel 6. Contents of the pack and other information 1. WHAT PRUCALOPRIDE DEXCEL IS AND WHAT IT IS USED FOR Prucalopride Dexcel contains the active substance prucalopride. Prucalopride Dexcel belongs to a group of gut motility enhancing medicines (gastrointestinal prokinetics). It acts on the muscle wall of the gut, helping to restore the normal functioning of the bowel. Prucalopride is used for the treatment of chronic constipation in adults in whom laxatives do not work well enough. Not for use in children and adolescents younger than 18 years. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRUCALOPRIDE DEXCEL DO NOT TAKE PRUCALOPRIDE DEXCEL: - if you are allergic to prucalopride or any of the other ingredients of this medicine (listed in section 6). - if you are on renal dialysis, - if you suffer from perforation or obstruction of the gut wall, severe inflammation of the intestinal tract, such as Crohn’s disease, ulcerative colitis or toxic megacolon/megarectum. WARNINGS AND PRECAUTIONS Talk to your doctor before taking Prucalopride Dexcel. Take special care with Prucalopride Dexcel and tell your docto Lue koko asiakirja
1 1. NAME OF THE MEDICINAL PRODUCT Prucalopride Dexcel 2 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2 mg prucalopride (as succinate). Excipients with known effect. Each film-coated tablet contains 165.5 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Pink, round biconvex, film-coated tablets embossed with “P2” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prucalopride Dexcel is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ : 2 mg once daily with or without food, at any time of day. Due to the specific mode of action of prucalopride (stimulation of propulsive motility), exceeding the daily dose of 2 mg is not expected to increase efficacy. If the intake of once daily prucalopride is not effective after 4 weeks of treatment, the patient should be re-examined and the benefit of continuing treatment reconsidered. The efficacy of prucalopride has been established in double-blind, placebo-controlled studies for up to 3 months. Efficacy beyond three months has not been demonstrated in placebo-controlled studies (see section 5.1). In case of prolonged treatment, the benefit should be reassessed at regular intervals. Special populations _Older people (>65 years)_ : Start with 1 mg once daily (see section 5.2); if needed the dose can be increased to 2 mg once daily. _Patients with renal impairment_ : The dose for patients with severe renal impairment (GFR < 30 ml/min/1.73 m 2 ) is 1 mg once daily (see sections 4.4 and 5.2). No dose adjustment is required for patients with mild to moderate renal impairment. _Patients with hepatic impairment_ : Patients with severe hepatic impairment (Child-Pugh class C) start with 1 mg once daily which may be increased to 2 mg if required to improve efficacy and if the 1 mg dose is well tolerated (see secti Lue koko asiakirja