Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
RABEPRAZOLE SODIUM
McDermott Laboratories Ltd t/a Gerard Laboratories
A02BC04
RABEPRAZOLE SODIUM
20 Milligram
Tablets Gastro-Resistant
Product subject to prescription which may be renewed (B)
Proton pump inhibitors
Authorised
2012-10-19
PAGE 1 OF 8 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RABEPRAZOLE 10 MG GASTRO-RESISTANT TABLETS RABEPRAZOLE 20 MG GASTRO-RESISTANT TABLETS (rabeprazole sodium) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Rabeprazole is and what it is used for 2. What you need to know before you take Rabeprazole 3. How to take Rabeprazole 4. Possible side effects 5. How to store Rabeprazole 6. Contents of the pack and other information The name of your medicine is Rabeprazole 10 mg or 20 mg Gastro-resistant Tablets (referred to as Rabeprazole throughout this leaflet). 1. WHAT RABEPRAZOLE IS AND WHAT IT IS USED FOR Rabeprazole contains rabeprazole which belongs to a group of medicines called ‘Proton Pump Inhibitors’ (PPIs). They work by lowering the amount of acid that your stomach produces. RABEPRAZOLE TABLETS CAN BE USED TO TREAT THE FOLLOWING CONDITIONS: Symptomatic treatment of erosive or ulcerative ‘Gastro-Oesophageal Reflux Disease’ (GORD) commonly referred to as inflammation of the gullet caused by stomach acid and associated with heartburn, or for long-term treatment of GORD (GORD maintenance). GORD is caused when acid and food from your stomach escapes into your food pipe and can cause inflammation (oesophagus). The symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease (symptomatic GORD) also associated with heartburn. Ulcers in your stomach or the upper part of your gut (intestine). If these ulcers are infected with bacteria called ‘_Helic Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rabeprazole 20 mg Gastro-resistant Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 20 mg rabeprazole sodium, equivalent to 18.85 mg rabeprazole. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet Yellow, film-coated, round, biconvex tablet imprinted with ‘R4’ in black ink on one side of the tablet and blank on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rabeprazole tablets are indicated for the treatment of: Active duodenal ulcer Active benign gastric ulcer Symptomatic erosive or ulcerative Gastro-Oesophageal Reflux Disease (GORD) Gastro-Oesophageal Reflux Disease Long-term Management (GORD Maintenance) Symptomatic treatment of moderate to very severe Gastro-Oesophageal Reflux Disease (symptomatic GORD) Zollinger-Ellison Syndrome In combination with appropriate antibacterial therapeutic regimens for the eradication of_ Helicobacter pylori_ in patients with peptic ulcer disease. See section 4.2. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults/elderly: _Active Duodenal Ulcer and Active Benign Gastric Ulcer_: The recommended oral dose for both active duodenal ulcer and active benign gastric ulcer is 20mg to be taken once daily in the morning. Most patients with active duodenal ulcer heal within four weeks. However a few patients may require an additional four weeks of therapy to achieve healing. Most patients with active benign gastric ulcer heal within six weeks. However again a few patients may require an additional six weeks of therapy to achieve healing. _Erosive or Ulcerative Gastro-Oesophageal Reflux Disease (GORD)_: The recommended oral dose for this condition is 20mg to be taken once daily for four to eight weeks. _Gastro-Oesophageal Reflux Disease Long-term Management (GORD Maintenance)_: For long-term management, a maintenance dose of 20mg or 10mg once daily can be used depending upon patient response. _Symptomatic trea Прочетете целия документ