Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
BISACODYL
Boehringer Ingelheim Limited
A06AB02
BISACODYL
10 Milligram
Suppositories
Product not subject to medical prescription
Contact laxatives
Authorised
1996-06-05
PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. You need to use DULCOLAX Suppositories 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 5 days of 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 Suppositories are and what they are used for 2. Before you use DULCOLAX Suppositories 3. How to use DULCOLAX Suppositories 4. Possible side effects 5. How to store DULCOLAX Suppositories 6. Further information 1. WHAT DULCOLAX SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR DULCOLAX Suppositories contain a medicine called bisacodyl. This belongs to a group of medicines called laxatives. • DULCOLAX Suppositories are used for relief of constipation • This medicine does not help with weight loss • DULCOLAX Suppositories are also used in hospitals to clear the bowel before surgery, X-rays or other tests • DULCOLAX Suppositories stimulate the muscles of the bowel (large intestine), helping to return the body to its natural rhythm. They have a laxative effect usually within 10 to 30 minutes 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 occa Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dulcolax 10mg Suppositories 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each suppository contains 10 mg of bisacodyl. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suppository Smooth, white torpedo-shaped suppositories. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For evacuation of the colon in constipation and in preparation for radiological investigations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION SHORT-TERM TREATMENT FOR CONSTIPATION: Adults and children over 10 years: 1 suppository (10 mg) daily for immediate effect. 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. 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 and 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. For children 4 - 10 years of age the SmPC for Dulcolax 5 mg Suppositories for Children should be consulted. INSTUCTIONS FOR USE: It is recommended to take the coated tablets at night to have a bowel movement the following morning. They should be swallowed whole with an adequate amo Read the complete document