Țară: Malaezia
Limbă: engleză
Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Bisacodyl
DKSH MALAYSIA SDN BHD
Bisacodyl
5units Units; 50units Units
ISTITUTO DE ANGELI S.R.L.
DULCOLAX ® SUPPOSITORIES FOR ADULTS Bisacodyl (10mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Dulcolax Suppositories is used for 2. How Dulcolax Suppositories works 3. Before you use Dulcolax Suppositories 4. How to use Dulcolax Suppositories 5. While you are using it 6. Side effects 7. Storage and Disposal of Dulcolax Suppositories 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT DULCOLAX SUPPOSITORIES IS USED FOR Dulcolax Suppositories is used for relief of constipation. Dulcolax Suppositories is also used to stimulate defaecation for diagnostic or operation procedures. HOW DULCOLAX SUPPOSITORIES WORKS Dulcolax Suppositories is a laxative that works by increasing the movement of the intestines, helping the stool to come out. BEFORE YOU USE DULCOLAX SUPPOSITORIES - _When you must not use it, if: _ Do not use Dulcolax Suppositories if any of the below applies to you. • you are allergic (hypersensitive) to bisacodyl or any other ingredients of this medicine (listed in Product Description) • you have severe dehydration • you have a bowel condition called “ileus” (lack of function in the intestine) • you have a acute abdominal condition such as appendicitis • you have severe abdominal pain with nausea and vomiting • you have a blocked bowel (intestinal obstruction) • you have inflammation of the bowel • you have cracking of the skin around your back passage (anal fissures) • you have inflammation or ulcers around your back passage (ulcerative proctitis) If you are not sure, talk to your pharmacist or doctor before using this medicine. - _ Before you start use it _ Stimulant laxatives including Dulcolax do not help with weight loss. _ _ _ _ _Pregnancy and lactation_ Please consult your doctor or pharmacist if you are pregnant, planning for pregnancy or breast-feeding before using any medicine. - _ Taking other medicines_ Tell your doctor if you are taking any other medicines, including any that you buy wi Citiți documentul complet
COMPOSITION 1 paediatric suppository contains 5 mg 1 suppository contains 10 mg 4,4’-diacetoxy-diphenyl-(pyridyl-2)-methane (= bisacodyl) PRODUCT DESCRIPTIONS Dulcolax Suppositories 5mg for children: Smooth, white, torpedo-shaped suppositories with a ‘chimney’ in the base. Dulcolax Suppositories 10mg for adults: White or slightly yellowish, torpedo-shaped suppositories with a smooth or slightly unctuous surface and a “chimney” in the base. PHARMACOLOGICAL PROPERTIES ATC code: A06AB02 Bisacodyl is a locally acting laxative from the diphenylmethane derivatives group having a dual action. As a contact laxative, for which also antiresorptive hydragogue effects have been described, bisacodyl stimulates after hydrolysis in the large intestine, the mucosa of both the large intestine and of the rectum. Stimulation of the mucosa of the large intestine results in colonic peristalsis with promotion of accumulation of water, and consequently electrolytes, in the colonic lumen. This results in a stimulation of defecation, reduction of transit time and softening of the stool. Stimulation of the rectum causes increased motility and a feeling of rectal fullness. The rectal effect may help to restore the “call to stool” although its clinical relevance remains to be established. As a laxative that acts on the colon, bisacodyl specifically stimulates the natural evacuation process in the lower region of the gastrointestinal tract. Therefore, bisacodyl is ineffective in altering the digestion or absorption of calories or essential nutrients in the small intestine PHARMACOKINETICS Following either oral or rectal administration, bisacodyl is rapidly hydrolyzed to the active principle bis-(p- hydroxyphenyl)-pyridyl-2- methane (BHPM), mainly by esterases of the enteric mucosa. Administration as an enteric coated tablet was found to result in maximum BHPM plasma concentrations between 4 - 10 hours post administration whereas the laxative effect occurred between 6 - 12 hours post administration. In contrast, following the ad Citiți documentul complet