Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LOPERAMIDE HYDROCHLORIDE
SUNWARD PHARMACEUTICAL SDN. BHD.
LOPERAMIDE HYDROCHLORIDE
500Tablet Tablets; 1000Tablet Tablets; 100 Tablet Tablets; 50 Tablet Tablets; 80 Tablet Tablets; 500 Tablets; 1000 Tablets
SUNWARD PHARMACEUTICAL SDN. BHD.
1 _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ DIATROL TABLET Loperamide Hydrochloride ( 2mg) WHAT IS IN THIS LEAFLET 1.What Diatrol Tablet is used for 2. How Diatrol Tablet works 3. Before you use Diatrol Tablet 4. How to use Diatrol Tablet 5. While you are using Diatrol Tablet 6. Side Effects 7. Storage and Disposal of Diatrol Tablet 8. Product Description 9. Manufacturer and Product Registration Holder 10.Date of Revision WHAT DIATROL TABLET IS USED FOR Diatrol Tablet is used for control and symptomatic relief of acute, non specific diarrhea and chronic diarrhea associated with inflamantory bowel disease. In people with ileostomy(surgical procedure in which small intestine is diverted through an opening in the abdomen to move waste out of the body), it can be used to reduce the number and volume and harden the stools. HOW DIATROL TABLET WORKS The active ingredient in the medicine is loperamide prolongs the transit time of the intestinal contents. It reduces the daily faecal volume, increases the viscosity and bulk density, and diminishes the loss of fluid and electrolytes by both increasing the intestinal absorption and decreasing intestinal secretions. BEFORE YOU USE DIATROL TABLET _- When you must not use it _ Do not take Diatrol Tablet: If you have known hypersensitivity to Loperamide or other ingredients of this product. If you have colon constipation. If you have acute inflammation of the colon which can be associated with broad spectrum antibiotics. If you have acute dysentery which is characterized by blood in stools and high fever. If children under 6 years of age. If you are breastfeeding _- Before you start to use it _ You should check with your doctor:- If you are or think you may be pregnant If you are planning to become pregnant If you have diabetes If you are having acute diarrhea associat- ed with bacteria If you are depleting water and salts If you have liver failure If you are having acute diarrhea and your condition does not improve af Přečtěte si celý dokument
DIATROL TABLET Each tablet contains: Loperamide HCl 2 mg PHARMACOLOGY: In man, loperamide prolongs the transit time of the intestinal contents. It reduces the daily faecal volume, increases the viscosity and bulk density, and diminishes the loss of fluid and electrolytes by both increasing the intestinal absorption and decreasing intestinal secretions. Tolerance to the anti-diarrhoeal effects has not been observed. Clinical studies have indicated that the apparent elimination half life of loperamide in man is 10.8 hours with a range of 9.1 to 14.4 hours. Plasma levels of unchanged drug remain below 2 nanograms per ml after the intake of 2mg of Loperamide Hydrochloride. Plasma levels are highest approximately five hours after administration of the capsule dosage form. Of the total excreted in urine and faeces, most of the administered drug was excreted in faeces. INDICATIONS: Loperamide HCI is indicated for the control and symptomatic relief of acute, nonspecific diarrhoea and of chronic diarrhoea associated with inflammatory bowel disease. In patients with ileostomy it can be used to reduce the number and volume of stools and to harden their consistency. SIDE EFFECTS/ADVERSE REACTIONS: Adverse experiences recorded during clinical studies with Loperamide HCI were generally of a minor and self-limiting nature. They were more commonly observed during the treatment of chronic diarrhoea. The following complaints have been reported : abdominal pain, constipation, drowsiness or dizziness, dry mouth, nausea and vomiting, tiredness, hypersensitivity reactions (including skin rash). Post-marketing Experience: Cardiac Disorders: QTIQTc interval prolongation, Torsades de Pointes, other ventricular arrhythmias, cardiac arrest, syncope, and death (see Warnings and Precautions). PRECAUTIONS/WARNINGS: Antiperistaltic agents should not be used in acute diarrhoea associated with organisms that penetrate the intestinal mucosa eg. enteroinvasive E. Coli, Salmonella, Shigella. Fluid and electrolytes depletion may occur in patients wh Přečtěte si celý dokument