国家: 马来西亚
语言: 英文
来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
OMEPRAZOLE
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
OMEPRAZOLE
14 Capsules
Sandoz Grup Saglik Urunleri Ilaclari San. Ve Tic. A.S.
PROBITOR CAPSULES Omeprazole (20mg) _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ 1 WHAT IS IN THIS LEAFLET: 1. What Probitor Capsules is used for 2. How Probitor Capsules works 3. Before you use Probitor Capsules 4. How to use Probitor Capsules 5. While you are using Probitor Capsules 6. Side effects 7. Storage and disposal of Probitor Capsules 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT PROBITOR CAPSULES IS USED FOR Probitor Capsules is used to treat the following conditions: • Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer). • Ulcers which are infected with bacteria called ‘ _Helicobacter _ _pylori_ ’. If you have this condition, your doctor may also prescribed antibiotics to treat the infection and allow the ulcer to heal. • Ulcers caused by medicines called NSAIDs (Non-Steroidal Anti- Inflammatory Drugs). • Reflux oesophagitis. This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn. • Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome). • Prevention in people with in increased risk of NSAIDs associated ulcer, gastroduodenal erosions or indigestion symptoms. HOW PROBITOR CAPSULES WORKS Probitor Capsules contains the active substance omeprazole. It belongs to a group of medicine called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces. BEFORE YOU USE PROBITOR CAPSULES - _When you must not use it _ DO NOT TAKE PROBITOR CAPSULES_ _ • if you are allergic (hypersensitive) to omeprazole or any of the other ingredients of Probitor. _ _ • if you are allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole). _ _ • If you are taking a medicine containing nelfinavir (for HIV infection). _ _ If you are not sure, talk to your doctor or pharmacist before 阅读完整的文件
PROBITOR ® 20 MG CAPSULES 1. NAME OF THE MEDICINAL PRODUCT Probitor 20 mg Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant capsule contains 20 mg omeprazole. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant capsule. White cap, white body containing almost white to light brown pellets. Not interchangeable with tablet form. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of duodenal and benign gastric ulcers including those complicating NSAID therapy. • Treatment of NSAIDs associated peptic and gastro-duodenal erosions. • Prophylactic treatment in patients with an increased risk of NSAIDs associated peptic ulcer, gastro- duodenal erosions or dyspeptic symptoms. • _Helicobacter pylori_ associated peptic ulcer disease. • Reflux oesophagitis. • Zollinger-Ellison syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For duodenal and benign gastric ulcers, the usual dose is 20 mg omeprazole once daily. Symptom resolution is rapid. The majority of patients with duodenal ulcer are healed after 4 weeks. In severe cases, the dose may be increased to 40 mg omeprazole once daily and healing is usually achieved within 4 weeks. The majority of patients with duodenal ulcer are healed after 8 weeks. Long-term therapy for patients with a history of recurrent duodenal ulcer is recommended at a dose of 20 mg omeprazole once daily, up to one year. NSAID associated gastric ulcers, duodenal ulcers or gastro-duodenal erosions in patients with or without continued NSAID treatment, the recommended dose of omeprazole is 20 mg once daily. Symptom resolution is rapid and in most patients, healing occurs within 4 weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further 4 weeks treatment period. For the prevention of NSAID associated gastric ulcers, duodenal ulcers, gastro-duodenal erosion and dyspeptic symptoms the recommended dosage of omeprazole is 20 mg once daily. Treatment of 阅读完整的文件