País: Holanda
Língua: holandês
Origem: 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
Druppels voor oraal gebruik, oplossing
CITROENZUUR 1-WATER (E 330) ; NATRIUMBENZOAAT (E 211) ; SORBITOL (D-)(E 420) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER VOOR INJECTIE,
Oraal gebruik
Sodium Picosulfate
Hulpstoffen: CITROENZUUR 1-WATER (E 330); NATRIUMBENZOAAT (E 211); SORBITOL (D-)(E 420); TRINATRIUMCITRAAT 2-WATER (E 331); WATER VOOR INJECTIE;
2016-02-02
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PIKOPIL DRUPPELS VOOR ORAAL GEBRUIK, OPLOSSING, 7.5 MG/ML 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. 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 whith makes you feel or be sick - sudden, severe abdominal pain just before intake - a bowel problem called “ileus” where your small intestine is blocked. Do not take Pikopil if any o Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Pikopil druppels voor oraal gebruik, oplossing, 7.5 mg/ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains sodium picosulfate monohydrate equivalent to 7.5 mg sodium picosulfate anhydrous (1 ml = 15 drops). Excipient with known effect: 1 ml oral solution contains 450 mg sorbitol For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral drops, solution Clear colorless or yellowish solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short term relief of chronic or habitual constipation. 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. The selected dose of Pikopil should not be taken more than once a day. _ _ Unless otherwise prescribed by the doctor, the usual dose is: Adults: 8 to 12 drops (4 – 6 mg) at once. _ _ If necessary, the number of drops can be increased or reduced, so that the dose is found that it is most suitable. _ _ _Paediatric population _ Children over 6 years: 8 to 12 drops (4 – 6 mg) at once. Children 4 to 6 years: 6 drops (3 mg) at once. In children younger than 4 years Pikopil is less effective as in these children the intestinal microflora is not sufficiently developed yet to convert sodium picosulfate into its active metabolite. _ _ Method of administration Pikopil should be taken in the evening so that at the following morning defecation occurs. Pikopil is liquid, has a neutral taste and can be taken with or without additional liquid. Pikopil is delivered in a dropper bottle allowing to adjust the required amount. _ _ As for all intestinal irritants, Pikopil should basically not be taken longer than three subsequent days. The maintenance of an adequate fluid intake during treatment is essential, especially for younger patients and the elderly who are more susceptible to the effects of dehy Leia o documento completo