País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Bisacodyl
Teva UK Ltd
A06AB02
Bisacodyl
5mg
Gastro-resistant tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01060200
PACKAGE LEAFLET: INFORMATION LEAFLET FOR THE USER Bisacodyl 5mg Gastro-resistant Tablets (Bisacodyl) 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 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 5 days of treatment. What is in this leaflet 1. What Bisacodyl is and what it is used for 2. What you need to know before you take Bisacodyl 3. How to take Bisacodyl 4. Possible side effects 5. How to store Bisacodyl 6. Contents of the pack and other information 1. WHAT BISACODYL IS AND WHAT IT IS USED FOR • Bisacodyl 5mg Gastro-resistant tablets contain a medicine called bisacodyl. This belongs to a group of medicines called laxatives. • Bisacodyl is used for the short-term relief from occasional constipation. • Bisacodyl can also be used in a hospital to empty a person’s bowel before child birth, surgery or radiological investigations. • Bisacodyl gently stimulate the muscles of the bowel (large intestine). This brings predictable, overnight relief from constipation. • Bisacodyl 5mg Gastro-resistant Tablets have a special coating that helps to ensure the medicine works only where it is needed. • Bisacodyl 5mg Gastro-resistant Tablets do not help with weight loss. 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 oth Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bisacodyl 5 mg, gastro-resistant tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Bisacodyl 5 mg. Excipients: This product contains 64.42 mg lactose monohydrate, 53.00 mg sucrose and 0.04 mg tartrazine lake (E102) per tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant tablets for oral administration. Yellow shiny biconvex sugar coated and enteric coated tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For short-term relief of occasional constipation. Constipation, either chronic or of recent onset, whenever a stimulant laxative is required. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ROUTE OF ADMINISTRATION: Oral. Short-term treatment for constipation: _Adults and children over 12 years_: 1 – 2 tablets (5 – 10 mg) daily._ _ It is recommended to start with the lowest dose. The dose might 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. Bisacodyl 5 mg gastro-resistant tablets should not be used in children and adolescents under the age of 12 years . Method of administration They should be swallowed whole with an adequate amount of fluid. The coated tablets should not be taken together with products which reduce the acidity of the upper gastrointestinal tract, such as milk, antacids or proton pump inhibitors, in order not to prematurely dissolve the enteric coating. No specific information on the use of this product in the elderly is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported 4.3 CONTRAINDICATIONS Bisacodyl 5 mg, gastro-resistant tablets are contrainidicated in patients with ileus, intestinal obstruction, acute abdominal conditions including appendicitis, acute inflammatory bow Leia o documento completo