Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LOPERAMIDE HYDROCHLORIDE
JOHNSON & JOHNSON SDN BHD
LOPERAMIDE HYDROCHLORIDE
240Capsule Capsules
JNTL CONSUMER HEALTH (FRANCE) SAS
IMODIUM CAPSULE ® _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 Loperamide Hydrochloride (2mg) WHAT IS IN THIS LEAFLET 1. What IMODIUM ® is used for 2. How IMODIUM ® works 3. Before you use IMODIUM ® 4. How to use IMODIUM ® 5. While you are using it 6. Side effects 7. Storage and Disposal of IMODIUM ® 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT IMODIUM ® IS USED FOR IMODIUM ® is used for diarrhoea. You may also be given IMODIUM ® to reduce the number and volume of stools when you have part of your intestines removed, as this often causes diarrhoea. HOW IMODIUM ® WORKS IMODIUM ® makes the stools more solid and less frequent by reducing the intestinal muscles movement and increase the time for food to remain in the gastro-intestinal tract. BEFORE YOU USE IMODIUM ® - _When you must not use it _ • If there is blood in the stools or you have a high body temperature. • If you have an inflammation of the small and/or large intestine. • If your doctor has told you that you have a condition where slowing of the intestine movement should be avoided, for example, if you are constipated or your abdomen is swollen. • If you know you are hypersensitive (allergic) to loperamide hydrochloride or one of the other ingredients. • Not recommended for children under 6 years of age. _Pregnancy and lactation _ If you are, or think you may be pregnant, you should inform your doctor, who will decide if you can take IMODIUM ® . - _Before you start use it _ • Tell your doctor if you have allergies to any other medicines, foods, preservatives, or dyes. • Appropriate fluid and electrolyte therapy should be taken to protect against dehydration in all cases of diarrhoea especially children. • If no improvement within 48 hours for an acute diarrhea or if you suffer from liver impairment, do not take any more capsules and consult your doctor. - _Taking other medicines _ In particular, tell your doctor or pharmacist if you are taking any of the following: • Soma hati kamili
IMODIUM hard capsules, 13 June 2016 January 2023, Based on CCDS Version 10 dated 13 June 2016 CCDS V13;23 Aug 2021CCDS V13; 23 Aug 2021, UK SmPC rev 19 April 2022 1 DESCRIPTION Imodium ® contains the synthetic antidiarrhoeal for oral use, Loperamide HCl. Imodium ® is available in capsules. Each capsule contains 2mg Loperamide HCl. PHARMACEUTICAL FORM White powder filled in capsules with green cap and dark grey body PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: A07 DA03 Antipropulsives Loperamide binds to the opiate receptor in the gut wall. Consequently, it inhibits the release of acetylcholine and prostaglandins, thereby reducing propulsive peristalsis, and increasing intestinal transit time. Loperamide increases the tone of the anal sphincter, thereby reducing incontinence and urgency. PHARMACOKINETIC PROPERTIES Absorption: Most ingested loperamide is absorbed from the gut, but as a result of significant first pass metabolism, systemic bioavailability is only approximately 0.3%. Loperamide HCl formulations (hard and soft capsule, coated and uncoated tablet, chewable and orodispersable tablet, oral solution) are bioequivalent in terms of rate and extent of loperamide absorption. Distribution: Studies on distribution in rats show a high affinity for the gut wall with a preference for binding to receptors of the longitudinal muscle layer. The plasma protein binding of loperamide is 95%, mainly to albumin. Non-clinical data have shown that loperamide is a P-glycoprotein substrate. Metabolism: Loperamide is almost completely extracted by the liver, where it is predominantly metabolized, conjugated and excreted via the bile. Oxidative N-demethylation is the main metabolic pathway for loperamide, and is mediated mainly through CYP3A4 and CYP2C8. Due to this very high first pass effect, plasma concentrations of unchanged drug remain extremely low. Excretion: The half-life of loperamide in man is about 11 hours with a range of 9-14 hours. Excretion of the unchanged loperamide and the metabolites mainly occurs Soma hati kamili