Land: Malaysia
Språk: engelska
Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
RACECADOTRIL
ABBOTT LABORATORIES (M) SDN. BHD.
RACECADOTRIL
16sachet Sachets; 10sachet Sachets; 16sachet Sachets
SOPHARTEX
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ HIDRASEC® INFANTS 10MG GRANULES FOR ORAL SUSPENSION Racecadotril (10mg) HIDRASEC® CHILDREN 30MG GRANULES FOR ORAL SUSPENSION Racecadotril (30mg) 1 WHAT IS IN THIS LEAFLET 1. What Hidrasec® is used for 2. How Hidrasec® works 3. Before you use Hidrasec® 4. How to use Hidrasec® 5. While you are using it 6. Side effects 7. Storage and disposal of Hidrasec® 8. Product description 9. Manufacturer and product registration holder 10. Date of revision WHAT HIDRASEC® IS USED FOR Hidrasec® Infants and Hidrasec® Children is used for the complementary treatment of symptoms of acute diarrhea in infants (older than 3 months) and children. It should be used together with an abundant liquid intake and the usual dietary measures, when these measures are not sufficiently effective on their own to control the diarrhoea, and when diarrhoea is treated causally. HOW HIDRASEC® WORKS Hidrasec® works reducing the amount of fluids secreted into the intestines thus making stools less watery. BEFORE YOU USE HIDRASEC® _- When you must not use it_ Do not take Hidrasec® if: • If you are allergic to racecadotril or any of the ingredients listed at the end of this leaflet • You have had swelling under the skin with the use of a medicine for high blood pressure ACE inhibitor (e.g enalapril, perindopril, etc.) • You are pregnant or breast feeding Do not use Hidrasec® if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Hidrasec®. _- Before you start to use it_ Take special care with Hidrasec® and tell your doctor if: • You have problems with your liver or kidneys If any of the above applies to you, your doctor will tell you whether it is safe for you to start taking Hidrasec®. _- Taking other medicines_ It is particularly important to tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This also concerns medicines obtained without a prescription including herbal medi Läs hela dokumentet
HIDRASEC INFANTS 10MG GRANULES FOR ORAL SUSPENSION HIDRASEC CHILDREN 30MG GRANULES FOR ORAL SUSPENSION ________________________________________________________ 1. NAME OF THE MEDICINAL PRODUCT HIDRASEC INFANTS 10mg, Granules for oral suspension. HIDRASEC CHILDREN 30 mg, Granules for oral suspension. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Hidrasec Infants 10mg Each sachet contains 10 mg of racecadotril. Each sachet contains 0.966 g of sucrose. Hidrasec Children 30mg Each sachet contains 30 mg of racecadotril. Each sachet contains 2.9 g of sucrose. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Granules for oral suspension. White powder with characteristic apricot smell. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Complementary symptomatic treatment of acute diarrhoea in infants (older than 3 months) and children together with oral rehydration. If causal treatment of acute diarrhoea is possible, racecadotril can be co-administered. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION HIDRASEC INFANTS and HIDRASEC CHILDREN are administered via the oral route, together with oral rehydration (see section 4.4). Hidrasec Infants is intended for children <13 kg The recommended dose is determined according to body weight: 1.5 mg/kg per dose (corresponding to 1 to 2 sachets), three times daily at regular intervals. In infant less than 9 kg: one 10 mg sachet 3 times daily. In infant from 9 kg to 13 kg: two 10 mg sachets 3 times daily. Hidrasec Children 30 mg is intended for children ≥13 kg. The recommended dose is determined according to body weight: 1.5 mg/kg per dose (corresponding to 1 to 2 sachets), three times daily at regular intervals. In children from 13 kg to 27 kg: one 30 mg sachet 3 times daily. In children of more than 27 kg: two 30 mg sachets 3 times daily. The duration of treatment in the clinical trials with children was 5 days. Treatment should be continued until two normal stools are recorded. Treatment should not exceed 7 days. Long-term treatment with racecadotril is not recomm Läs hela dokumentet