Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PANTOPRAZOLE
Takeda Malaysia Sdn Bhd
PANTOPRAZOLE
14Tablet Tablets; 14 Tablet Tablets; 7 Tablet Tablets
Takeda GmbH
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ CONTROLOC 40MG TABLETS _ _ Pantoprazole sodium (40mg) __________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What Controloc is used for 2. How Controloc works 3. Before you use Controloc 4. How to use Controloc 5. While you are using it 6. Side Effects 7. Storage and Disposal of Controloc 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT CONTROLOC IS USED FOR Controloc is used in adults and children 12 years and older: - Treatment of moderate and severe reflux oesophagitis (inflammation or irritation of esophagus caused by a return flow of fluid from stomach) In adults: - Treatment of gastric and intestinal ulcers - Hormone producing tumors in the pancreas causing excess acid in the stomach (Zollinger-Ellison Syndrome) and other pathological hypersecretory conditions. - Eradication of H. pylori in people with peptic ulcer in combination with two appropriate antibiotics HOW CONTROLOC WORKS Controloc belongs to a medicine group known as proton pump inhibitors (PPIs). Controloc reduces the amount of acid in your stomach. Controloc may help your acid- related symptoms, but you could still have serious stomach problems. Talk with your doctor. BEFORE YOU USE CONTROLOC - _When you must not use it _ - You should not take Controloc if you are allergic to pantoprazole or any of the other ingredients of this medicine. - You have moderate to severe liver and kidney problems - You have mild gastrointestinal complain - _Before you start to use it _ Before you take Controloc, tells your doctor if you : • Are pregnant or plan to become pregnant. It is not known if Controloc can harm your unborn baby. • Are breast-feeding or planning to breast-feed. Your doctor should decide if you will take Controloc or breast-feed. You should not do both without first talking with your doctor. • Have reduced body stores or risk factors for reduced vitamin B12 absorption • Docto read_full_document
CONTROLOC ® 40 MG GASTRO-RESISTANT TABLETS ACTIVE INGREDIENT: PANTOPRAZOLE SODIUM SESQUIHYDRATE NAME AND STRENGTH OF ACTIVE SUBSTANCES Each gastro-resistant tablet contains 45.1mg pantoprazole sodium sesquihydrate (corresponding to 40mg pantoprazole) and the following excipients: Sodium carbonate; Mannitol; Crospovidone; Povidone K90; Calcium stearate; Hypromellose 2910; Povisone K25; Titanium dioxide E171; Yellow ferric oxide E172; Propylene glycol; Triethyl citrate; Methaacrylic acid – ethyl acrylate Copolymer (1:1); Polysorbate 80; Sodium Laurisulfate; Printing ink. PRODUCT DESCRIPTION Gastro-resistant tablet. Yellow, oval, biconvex film-coated tablet imprinted with “P40” in brown ink on one side. PHARMACOLOGICAL PROPERTIES PHARMCODYNAMICS PROPERTIES PHARMACOTHERAPEUTIC / INDICATION GROUP / ACTION MECHANISM Selective proton pump inhibitor, substituted benzimidazole, ATC code: A02BC02 _Mechanism of action _ Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the stomach by specific blockade of the proton pumps of the parietal cells. Pantoprazole is converted to its active form in the acidic environment in the parietal cells where it inhibits the H+, K+-ATPase enzyme, i.e. the final stage in the production of hydrochloric acid in the stomach. The inhibition is dose-dependent and affects both basal and stimulated acid secretion. In most patients, freedom from symptoms is achieved within 2 weeks. As with other proton pump inhibitors and H2 receptor inhibitors, treatment with pantoprazole reduces acidity in the stomach and thereby increases gastrin in proportion to the reduction in acidity. The increase in gastrin is reversible. Since pantoprazole binds to the enzyme distal to the cell receptor level, it can inhibit hydrochloric acid secretion independently of stimulation by other substances (acetylcholine, histamine, gastrin). The effect is the same whether the product is given orally or intravenously. The fasting gastrin values increase under pantoprazole. On sh read_full_document