Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LANSOPRAZOLE
Takeda Malaysia Sdn Bhd
LANSOPRAZOLE
28Tablet Tablets
Kokando Co., Ltd.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ PREVACID FDT TABLETS _ _ Lansoprazole (15mg, 30mg) __________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What Prevacid is used for 2. How Prevacid works 3. Before you use Prevacid 4. How to use Prevacid 5. While you are using it 6. Side Effects 7. Storage and Disposal of Prevacid 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT PREVACID IS USED FOR Prevacid is used in children 12 to 17 years old: - Short-term treatment of symptomatic gastro- esophageal reflux disease (GERD) and erosive esophagitis (disease with symptoms caused by return flow of gastric acid) In adults: - Treatment of gastric, intestinal, gastrointestinal ulcers and reflux esophagitis (inflammation of the esophagus caused by the return flow of fluid from stomach) - Relief of heartburn and / or upper epigastric pain associated with acid-related indigestion - Treatment and prevention of Non-Steroidal Anti- inflammatory Drugs (NSAIDs) - associated gastric and intestinal ulcer and relief of symptoms - Hormone producing tumor in the pancreas causing excess acid in the stomach (Zollinger-Ellison- Syndrome) and other pathological hypersecretory conditions - Eradication of H. pylori in people with gastric and intestinal ulcer in combination with two appropriate antibiotics HOW PREVACID WORKS Prevacid belongs to a group known as Proton Pump Inhibitors (PPIs). Prevacid reduces the amount of acid in your stomach. Prevacid may help your acid- related symptoms, but you could still have serious stomach problems. Talk with your doctor. BEFORE YOU USE PREVACID - _When you must not use it _ You should not take Prevacid if you are allergic to lansoprazole or any of the other ingredients of this medicine. - _Before you start to use it _ Before you take Prevacid, tells your doctor if you : • have liver problems • have kidney problems • Are pregnant or plan to become pregnant. It should be used by pre Read the complete document
PREVACID ® FDT (Lansoprazole Fast Disintegrating Tablets) _PREVACID® FDT _is a preparation of lansoprazole, a proton pump inhibitor. _PREVACID® FDT _displays strong and sustained inhibition of gastric acid secretion by suppressing the activity of (H + - K + )-ATPase which exists locally in the parietal cells of gastric mucosa and plays an important role as a proton pump. Clinically, _PREVACID® FDT _attains a rapid and high healing ratio against gastric ulcer and duodenal ulcer, and the usefulness of the drug has been proven. It has also been proven to be a useful drug for treatment of stomal ulcer, reflux esophagitis and Zollinger-Ellison syndrome. COMPOSITION _PREVACID® FDT _ are white to yellowish white uncoated tablets with orange to dark brown speckles for oral administration containing the active ingredient, lansoprazole in the form of enteric-coated microgranules and are available in two dosages strengths. _PREVACID® FDT _15mg Tablets contains lansoprazole 15mg and _PREVACID® FDT _ 30mg Tablets contains lansoprazole 30mg. INDICATIONS • Gastric ulcer, duodenal ulcer, stomal ulcer and reflux esophagitis. • Relief of reflux-like symptoms (e.g. heartburn) and / or ulcer-like symptoms (e.g. upper epigastric pain) associated with acid-related dyspepsia. • Treatment and prophylaxis of NSAID-associated benign gastric ulcer, duodenal ulcers and relief of symptoms in patients requiring continued NSAID treatment. • Eradication of _H. pylori _from the upper gastrointestinal tract in patients with peptic ulcer (duodenal or benign gastric ulcer) when used in combination with appropriate antibiotics. • Zollinger-Ellison syndrome (and other Pathological hypersecretory conditions) • Short-term treatment of symptomatic GERD and erosive esophagitis for children (12-17 years of age) DOSAGE AND ADMINISTRATION Usually for adults, administer one tablet (30mg of lansoprazole) orally once a day. In duodenal ulcer, 30mg once daily for 4 weeks. In gastric ulcer and stomal ulcer, 30mg once daily for 8 weeks. In refl Read the complete document