Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Rabeprazole sodium
Actavis UK Ltd
A02BC04
Rabeprazole sodium
20mg
Gastro-resistant tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030500; GTIN: 5012617020789
Version 2 01.11.2017 RABEPRAZOLE 10MG AND 20MG GASTRO-RESISTANT TABLETS PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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, pharmacist or nurse. • 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. • The full name of the product is Rabeprazole 10mg and 20mg Gastro- resistant Tablets but within the leaflet it will be referred to as Rabeprazole tablets. WHAT IS IN THIS LEAFLET: 1 WHAT RABEPRAZOLE TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE RABEPRAZOLE TABLETS 3 HOW TO TAKE RABEPRAZOLE TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE RABEPRAZOLE TABLETS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT RABEPRAZOLE TABLETS ARE AND WHAT THEY ARE USED FOR Rabeprazole tablets belong to a group of medicines called Proton Pump Inhibitors (PPIs). Rabeprazole tablets act by reducing the amount of acid made by the stomach. Rabeprazole tablets are used to treat: • ulcer in the upper part of the intestine (duodenal ulcer) and benign stomach ulcer. • gastro-oesophageal reflux disease (GORD) with or without ulcer. GORD is commonly referred to as inflammation of the gullet caused by acid and associated with heartburn. Heartburn is a burning feeling rising from the stomach or lower chest up towards the neck. Rabeprazole tablets may be used as a long term treatment of GORD (GORD maintenance). Rabeprazole tablets may also be used for the symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease (symptomatic GORD). • Zollinger-Ellison Syndrome, which is a condition when the stomach makes ext Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rabeprazole 20mg Gastro-resistant Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Rabeprazole 20mg gastro-resistant tablet contains rabeprazole sodium 20mg corresponding to 18.85mg rabeprazole. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet. 20 mg: Yellow, coated, elliptical, biconvex tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rabeprazole 20mg Gastro-resistant 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 20 mg 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 20 mg 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 Rabeprazole 20 mg or 10 mg once daily can be used depending upon patient response. _ _ _Symp Read the complete document