Šalis: Malaizija
kalba: anglų
Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FAMOTIDINE
SUNWARD PHARMACEUTICAL SDN. BHD.
FAMOTIDINE
500 Tablet Tablets; 100 Tablet Tablets; 1000 Tablet Tablets; 500 Tablets
SUNWARD PHARMACEUTICAL SDN. BHD.
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ 1 SUNPEPCIN TABLET Famotidine (20mg, 40mg) WHAT IS IN THIS LEAFLET 1. What Sunpepcin Tablet is used for 2. How Sunpepcin Tablet works 3. Before you use Sunpepcin Tablet 4. How to use Sunpepcin Tablet 5. While you are using it 6. Side effects 7. Storage and Disposal of Sunpepcin Tablet 8. Product Description 9. Manufacturer and Product Registration Holder 10.Date of revision WHAT SUNPEPCIN TABLET IS USED FOR Treatment of active duodenal ulcer. Treatment of active benign gastric ulcer. Maintenance therapy of duodenal ulcer Short-term treatment to relieve gastroesoph- ageal reflux symptoms caused by the back- flow of stomach acid into the esophagus channels. Treatment of Pathological Hypersecretory condition where the body produces excess stomach acid. For example Zollinger- Ellison syndrome (tumor cells in the pancreas causes excess production of gas- tric acid) and Multiple Endocrine adenomas (tumors of the endocrine glands) HOW SUNPEPCIN TABLET WORKS The active ingredient in the medicine is fa- motidine. Famotidine belongs to a group of medicines called H2 antagonists or H2 block- ers. It works by reducing the amount of acid made by the stomach. This helps to reduce the pain and also allows the ulcer and/or reflux disease to heal. BEFORE YOU USE SUNPEPCIN TABLET _- When you must not use it _ If you have exhibited hypersensitivity to this product or other similar medicines. _-Before you start to use it _ You should check with your doctor:- If you have renal insufficience. If you are pregnant or breastfeeding. Famotidine should not be used during pregnancy unless the potential benefits outweigh the potential risks to the fetus. Famotidine is detectable in human milk. Hence, a decision should be made whether to discontinue nursing or discontinue the medicine. The doctor may arrange additional tests to diagnose stomach cancer before starting Sunpepcin tablet because famotidine can mask the symptoms and delay the diagnosis. _- Takin Perskaitykite visą dokumentą
Sunpepcin 20 Tablet Sunpepcin 40 Tablet Each tablet contains: Famotidine 20mg Famotidine 40mg ACTIONS AND MODE OR MECHANISM OF ACTION: Famotidine is a competitive inhibitor of histamine H 2 -receptors. It inhibits gastric secretion , that is both the acid concentration and volume of basal and stimulated gastric secretion suppresses , while changes in pepsin secretion are proportional to volume output. Famotidine had little or no effect on fasting or postprandial serum gastrin levels. Gastric emptying and exocrine pancreatic function were not affected by famotidine . PHARMACOKINETICS: Famotidine is incompletely absorbed. The bioavailability of oral doses is 40-45% and is not significantly affected by the presence of food . Famotidine undergoes minimal first-pass metabolism. After oral doses, peak plasma levels occur in 1-3 hours. Plasma level after multiple doses are similar to those after single doses. Fifteen to 20% of famotidine in plasma is protein bound. Famotidine has an elimination half-life of 2.5-3.5 hours and is prolonged in renal impairment. Famotidine is eliminated by renal (65-70%) and metabolic (30-35%) routes . Twenty five to 30% of an oral dose is recovered in the urine as unchanged compound. The only metabolite identified in man is the S-oxide. INDICATIONS: a) Treatment of active duodenal ulcer b) Treatment of active benign gastric ulcer c) Maintenance therapy for duodenal ulcer d) Short term treatment for symptomatic relief of gastroesophageal reflux disease e) Treatment of pathological hypersecretory conditions (eg. Zollinger-Ellison syndrome, multiple endocrine adenomas). SIDE EFFECTS / ADVERSE REACTIONS: Famotidine is generally well-tolerated with side-effects such as headache, dizziness, constipation and diarrhea reported rarely. Other side effects which are reported infrequently includes: Gastrointestinal : Nausea, cholestatic jaundice, liver enzyme abnormalities, vomiting, abdominal discomfort, anorexia, dry mouth Hematologic : Leukopenia, agranulocytosis, thrombocytopenia, pancytopenia. Ca Perskaitykite visą dokumentą