Šalis: Nyderlandai
kalba: olandų
Šaltinis: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
NATRIUMPICOSULFAAT 1-WATER SAMENSTELLING overeenkomend met ; NATRIUMPICOSULFAAT 0-WATER
Vital Pharma GmbH Schaberweg 28b 61348 BAD HOMBURG (DUITSLAND)
A06AB08
NATRIUMPICOSULFAAT 1-WATER COMPOSITION corresponding to ; NATRIUMPICOSULFAAT 0-WATER
Tablet
LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551),
Oraal gebruik
Sodium Picosulfate
Hulpstoffen: LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; MAÏSZETMEEL, GEPREGELATINEERD; SILICIUMDIOXIDE (E 551);
2016-02-02
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PIKOPIL TABLETTEN 5 MG PIKOPIL TABLETTEN 7,5 MG Sodium picosulfate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - 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. - You must talk to a doctor if you do not feel better or if you feel worse after 3 days. WHAT IS IN THIS LEAFLET 1. What Pikopil is and what it is used for 2. What you need to know before you take Pikopil 3. How to take Pikopil 4. Possible side effects 5. How to store Pikopil 6. Contents of the pack and other information 1. WHAT PIKOPIL IS AND WHAT IT IS USED FOR Pikopil contains an active substance called sodium picosulfate. Pikopil belongs to a group of medicines called laxatives. Pikopil works by stimulating your bowel movements. It also increases the amount of water in your bowel. Pikopil is used for short term relief of prolonged or recurrent constipation in adults and children over 4 years old. You must talk to a doctor if you do not feel better or if you feel worse after 3 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PIKOPIL DO NOT TAKE PIKOPIL, if you are/have: - allergic to sodium picosulfate, other substances belonging to a group of triarylmethane (e.g., bisacodyl) or any of the other ingredients of this medicine (listed in section 6). - severe dehydration (i.e., lost too much water from your body) - a blocked bowel (intestinal obstruction) - a serious abdominal problem such as appendicitis - acute inflammatory bowel disease - severe abdominal pain which makes you feel or be sick - sudden, severe abdominal pain just before intake - a bowel problem called “ileus” where your small intestine is blocked Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Pikopil tabletten 5 mg Pikopil tabletten 7,5 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [PIKOPIL 5 MG TABLETS] Each tablet contains sodium picosulfate monohydrate equivalent to 5 mg sodium picosulfate anhydrous. Excipient with known effect: 1 tablet contains 97.0 mg lactose [PIKOPIL 7.5 MG TABLETS] Each tablet contains sodium picosulfate monohydrate equivalent to 7.5 mg sodium picosulfate anhydrous. Excipient with known effect: 1 tablet contains 145.5 mg lactose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet [PIKOPIL 5 MG TABLETS] White to off-white, round, flat bevelled-edge tablets with a score line, diameter 7 mm,height 2.4 mm. The tablet can be divided into equal doses. [PIKOPIL 7.5 MG TABLETS] White to off-white, round, flat bevelled-edge tablets with a score line, diameter 8 mm, height 2.4 mm. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short term relief of chronic or habitual constipation. Pikopil is indicated in adults and in children aged from 4 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ It is recommended to start with the lowest dose. The dose may be adjusted up to the maximum recommended dose to produce regular stools. The maximum recommended daily dose should not be exceeded. _Adults _ 5 – 7.5 mg (corresponding to 1 – 1.5 Pikopil 5 mg tablets or 1 Pikopil 7.5 mg tablet) swallowed at bedtime. Dosage can be titrated individually. Once regularity has re-started dosage should be reduced and can usually be stopped. _ _ _Paediatric population _ _Children from 10 years of age _ 5 – 7.5 mg (corresponding to 1 – 1.5 Pikopil 5 mg tablets or 1 Pikopil 7.5 mg tablet) swallowed at bedtime. _Children from 4 to less than 10 years of age _ _2.5 – 5 mg (_corresponding to ½ – 1 Pikopil 5 mg tablet) swallowed at bedtime. Pikopil tablets 5 mg should not be used in children below 4 years of age. Pikopil tablets 7.5 mg should not be used Perskaitykite visą dokumentą