Pays: Pays-Bas
Langue: néerlandais
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
PRUCALOPRIDESUCCINAAT 2,6 mg/stuk SAMENSTELLING overeenkomend met ; PRUCALOPRIDE 2 mg/stuk
PRUCALOPRIDESUCCINAAT 2,6 mg/stuk SAMENSTELLING overeenkomend met ; PRUCALOPRIDE 2 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171)
Oraal gebruik
1900-01-01
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT STERCORE1 MG filmomhulde tabletten STERCORE 2 MG filmomhulde tabletten 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 Stercore is and what it is used for 2. What you need to know before you take Stercore 3. How to take Stercore 4. Possible side effects 5. How to store Stercore 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR Stercore contains the active substance prucalopride. Prucalopride 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. Stercore 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 STERCORE DO NOT TAKE STERCORE - 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 or pharmacist before taking Stercore - if you suffer from severe kidney disease. - if you suffer from severe liver disease. - if you are currently under supervision by a doctor for a serious medical probl Lire le document complet
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDEL Stercore1 mg filmomhulde tabletten Stercore 2 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains either 1 mg or 2 mg prucalopride (as succinate). Excipient with known effect: lactose. Each tablet of 1 mg contains 78.02 mg lactose monohydrate. Each tablet of 2 mg contains 156.012 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet 1 mg: White, round, bioconvex, film-coated tablets embossed ‘10’ on one side, plain on the other side, with diameter of nucleus 6 mm. 2 mg: Pink, round, bioconvex, film-coated tablets embossed ‘20’ on one side, plain on the other side, with diameter of nucleus 8 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Stercore 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 the 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 _ 2 The dose for patients with severe renal impairment (GFR <30 ml/min/1.73 m2) is 1 mg once daily (see sections 4.3 and 5.2). No Lire le document complet