البلد: ماليزيا
اللغة: الإنجليزية
المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Bisacodyl
PAHANG PHARMACY SDN. BHD.
Bisacodyl
105Tablet Tablets
KRKA
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ NOVOLAX TABLET Bisacodyl (5mg) 1 WHAT IS IN THIS LEAFLET 1. What Novolax is used for 2. How Novolax works 3. Before you use Novolax 4. How to use Novolax 5. While you are using it 6. Side effects 7. Storage and Disposal of Novolax 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT NOVOLAX IS USED FOR Novolax is used: for relief of acute and chronic constipation. for evacuation of the colon in preparation for the radiologic examination or surgical operation of abdomen. Novolax is intended for use in adults and children over 4 years of age. HOW NOVOLAX WORKS Novolax coated tablets contain the active substance bisacodyl, a laxative, which acts in stimulation of defecation, reduction of transit time, and softening of the stool. This specifically stimulates the natural evacuation process in the lower region of the gastrointestinal tract. The tablets are effective in 6 to 12 hours. BEFORE YOU USE NOVOLAX - _When you must not use it_ if you are allergic (hypersensitive) to bisacodyl or any of the other ingredients of Novolax; if you have an abdominal condition sudden in onset, such as appendicitis; if you have a blocked bowel (intestinal obstruction); if you have noticed intestinal bleeding. - _Before you start use it_ Prolonged excessive use may lead to fluid and electrolyte imbalance and hypokalemia. Intestinal loss of fluids can promote dehydration which may be harmful and Novolax Tablets should be discontinued and only be restarted under medical supervision. Stimulant laxatives including bisacodyl do not help with weight loss. - _Taking other medicines_ Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Use of adrenocorticosteroids or diuretics with Novolax may increases the risk of abnormal concentration of electrolytes in the body which may affect the heart. Concomitant use of other laxatives may اقرأ الوثيقة كاملة
1.3.1 Bisacodyl SPC, Labeling and Package Leaflet SmPCPIL163126_3 – Updated: 29.06.2021 Page 1 of 5 NOVOLAX _Bisacodyl _ NAME OF THE MEDICINAL PRODUCT Novolax 5 mg coated tablets QUALITATIVE AND QUANTITATIVE COMPOSITION Each coated tablet contains 5 mg bisacodyl. The coated tablets are round, biconvex, yellow, coated tablets with smooth and shiny surface. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS _In acute constipation: _atonic, spastic, constipation due to haemorrhoids, changes of nutrition. _In Chronic constipation:_ habitual, constipation in bed-ridden patients. For evacuation of the colon in preparation for the radiological examination or surgical operation of abdomen. POSOLOGY AND METHOD OF ADMINISTRATION Posology Children aged 10 years or younger with chronic constipation should only be treated under the guidance of a physician. Bisacodyl should not be used in children younger than 4 years old. Short-term treatment for constipation: _ _ _Adults and children over 10 years: _ 1 - 2 coated tablets (5 - 10 mg) daily before bedtime. _ _ _Children 4 - 10 years: _ 1 coated tablet (5 mg) daily before bedtime. For preparation of diagnostic procedures and preoperatively Should only be used under medical supervision. _ _ _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 4-10 years of age: _ 1.3.1 Bisacodyl SPC, Labeling and Package Leaflet SmPCPIL163126_3 – Updated: 29.06.2021 Page 2 of 5 1 coated tablet (5 mg) in the evening and 1 suppository (5 mg) on the following morning is recommended. Method of administration The tablets should be swallowed whole with some liquid (not milk). They should not be chewed or crushed as they might irritate the gastric mucous membrane. During treatment with Novolax, sufficient amounts of liquid should be consumed. The tablets are best taken in the evening at bedtime, but they can also be taken in the morning. They produc اقرأ الوثيقة كاملة