Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Prucalopride succinate
Takeda Pharmaceuticals International AG Ireland
A06AX05
prucalopride
Other drugs for constipation
Constipation
Resolor is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.
Revision: 29
Authorised
2009-10-14
30 B. PACKAGE LEAFLET 31 PACKAGE LEAFLET: INFORMATION FOR THE USER RESOLOR 1 MG FILM-COATED TABLETS RESOLOR 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 Resolor is and what it is used for 2. What you need to know before you take Resolor 3. How to take Resolor 4. Possible side effects 5. How to store Resolor 6. Contents of the pack and other information 1. WHAT RESOLOR IS AND WHAT IT IS USED FOR Resolor contains the active substance prucalopride. Resolor 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. Resolor 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 RESOLOR DO NOT TAKE RESOLOR: - 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 Resolor. Take special care with Resolor and tell your doctor if you: - suffer from severe kidney disease, - suffer from severe liver disease, - are currently under supervision by a doctor for a serious medic Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Resolor 1 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 1 mg prucalopride (as succinate). Excipients with known effect: Each film-coated tablet contains 142.5 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). White to off-white, round, biconvex tablets marked “PRU 1” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Resolor 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_: The dose for patients with severe renal impairment (GFR <30 ml/min/1.73 m 2 ) is 1 mg once daily (see sections 4.3 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 Lestu allt skjalið