Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Sodium picosulfate
Sanofi-Aventis Ireland Limited T/A SANOFI
A06AB; A06AB08
Sodium picosulfate
2.5 milligram(s)
Capsule, soft
Product not subject to medical prescription
Contact laxatives; sodium picosulfate
Not marketed
1999-04-01
D5A/E/PIL/20S/50S/IA DATED JAN 2019 Package Leaflet: Information for the user DULCOLAX ® Pico Perles _[picture of 4 x capsules]_ 2.5 mg capsules sodium picosulfate READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. You need to take DULCOLAX PICO PERLES as instructed in this leaflet to get the best results from it. • Keep this leaflet. You may need to read it again • Ask your pharmacist if you need more information or advice • You must contact your pharmacist or doctor if your symptoms worsen or do not improve after five days treatment • If a side effect occurs and gets troublesome, or seems serious to you, or if you experience any side effect not listed in this leaflet, please tell your pharmacist or doctor IN THIS LEAFLET: 1. What DULCOLAX PICO PERLES are and what they are used for 2. Before you take DULCOLAX PICO PERLES 3. How to take DULCOLAX PICO PERLES 4. Possible side effects 5. How to store DULCOLAX PICO PERLES 6. Further information 1. WHAT DULCOLAX PICO PERLES ARE AND WHAT THEY ARE USED FOR • DULCOLAX PICO PERLES contain a medicine called sodium picosulfate. This belongs to a group of medicines called laxatives • DULCOLAX PICO PERLES are used for relief of constipation • DULCOLAX PICO PERLES gently stimulate the muscles of the bowel (large intestine). This brings predictable, overnight relief from constipation, helping to return the body to its natural rhythm WHAT IS CONSTIPATION? Normal and regular bowel movement is important for most people. However, what is “normal and regular” varies from person to person. Some may have a bowel movement every day, others less often. Whatever it is like for you, it is best that your bowel movement has a regular pattern. • Constipation is an occasional problem for some people; for others, it may happen more often • It happens when the normal muscle actions in the bowel (large intestine) slow down. This can mean that material is not easily eliminated from the body Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dulcolax Pico Perles 2.5 mg Capsules, soft 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each soft capsule contains 2.5 mg sodium picosulfate as Sodium Picosulfate Monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, soft Round, colourless, clear capsule. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the short term management of constipation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. The following dosages are recommended to be taken at night to produce evacuation the following morning. 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 and children over 10 years of age_ Two to four capsules (5 - 10 mg) per day. _Children under 10 years of age_ Not to be taken by children under 10 years of age without medical advice. _Children aged 4 - 10 years_ One to two capsules (2.5 - 5 mg) per day. _Children under 4 years of age_ Not recommended for children under 4 years of age. Once regularity has been restarted, dosage should be reduced and can usually be stopped. The capsules should be swallowed with adequate fluid. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _4_ _/_ _0_ _8_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _6_ _5_ _7_ _9_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.3 CO Прочитать полный документ