Land: Malta
Språk: engelsk
Kilde: Medicines Authority
Opella Healthcare France SAS T/A Sanofi 157 avenue Charles de Gaulle, 92200 Neuilly-sur-Seine , France
A06AB02
BISACODYL 5 mg
GASTRO-RESISTANT TABLET
BISACODYL 5 mg
OTC
DRUGS FOR CONSTIPATION
Authorised
2006-05-23
PACKAGE LEAFLET: INFORMATION FOR THE USER Dulcolax 5mg Gastro-resistant tablets bisacodyl READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. You need to take DULCOLAX Tablets 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 Tablets are and what they are used for 2. Before you take DULCOLAX Tablets 3. How to take DULCOLAX Tablets 4. Possible side effects 5. How to store DULCOLAX Tablets 6. Further information 1. WHAT DULCOLAX TABLETS ARE AND WHAT THEY ARE USED FOR • DULCOLAX Tablets contain a medicine called bisacodyl. This belongs to a group of medicines called laxatives • DULCOLAX Tablets are used for relief of constipation • This medicine does not help with weight loss • DULCOLAX Tablets can also be used in a hospital to empty a person’s bowel before child birth, surgery or radiological investigations • DULCOLAX Tablets 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 • DULCOLAX Tablets are gastro-resistant tablets which have a special coating that helps to ensure the medicine works only where it is needed 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 proble Les hele dokumentet
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Dulcolax 5 mg Gastro-resistant Tablets 2 . QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of bisacodyl. Excipients: Lactose monohydrate 34.90 mg Sucrose 23.38 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant tablet (tablet). Circular, biconvex, yellow, sugar-coated, enteric-coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For evacuation of the colon in constipation and in preparation for radiological investigation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION SHORT-TERM TREATMENT FOR CONSTIPATION: Adults and children over 10 years: 1 to 2 coated tablets (5 - 10 mg) daily before bedtime, or 1 suppository (10 mg) daily for immediate effect. Children 4 – 10 years: 1 coated tablet (5 mg) daily before bedtime, or 1 suppository (5 mg) daily for immediate effect. 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 daily dose should not be exceeded. In the management of constipation, once regularity has been restarted dosage should be reduced and can usually be stopped. Page 2 of 7 Children aged 10 years or younger with chronic or persistent constipation should only be treated under the guidance of a physician. Bisacodyl should not be used in children aged 4 years or younger. FOR PREPARATION OF DIAGNOSTIC PROCEDURES AND PREOPERATIVELY: For preparation of diagnostic procedures, in pre- and postoperative treatment when defaecation needs to be facilitated, DULCOLAX should be used under medical supervision. The tablets should be combined with suppositories in order to achieve complete evacuation of the intestine. Adults and children over 10 years: 2 coated tablets (10 mg) in the morning and 2 coated tablets (10 mg) in the evening and 1 suppository (10 mg) on the following morning is recommended. Children aged 4 - 10 years of age: 1 coated tablet (5 mg) in the even Les hele dokumentet