Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Esomeprazole
Pinewood Laboratories Ltd
A02BC; A02BC05
Esomeprazole
20 milligram(s)
Gastro-resistant capsule, hard
Product subject to prescription which may be renewed (B)
Proton pump inhibitors; esomeprazole
Marketed
2010-02-12
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NEXAZOLE 20 MG HARD GASTRO-RESISTANT CAPSULES NEXAZOLE 40 MG HARD GASTRO-RESISTANT CAPSULES esomeprazole 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 or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Nexazole is and what it is used for 2. What you need to know before you take Nexazole 3. How to take Nexazole 4. Possible side effects 5. How to store Nexazole 6. Contents of the pack and other information 1. WHAT NEXAZOLE IS AND WHAT IT IS USED FOR Nexazole contains a medicine called esomeprazole. This belongs to a group of medicines called "proton pump inhibitors". They work by reducing the amount of acid that your stomach produces. Nexazole is used for: Adults - "Gastroesophageal reflux disease" (GERD). 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. This medicine is given to: - heal your gullet if it has become damaged or inflamed - stop these conditions coming back - give you relief from the unpleasant symptoms that often occur with these conditions - Ulcers in the stomach or upper part of the gut (intestine) that are infected with bacteria called " _Helicobacter pylori_ ". If you have this condition, your doctor may also prescribe this medicine in combination with certain antibiotics to: - heal duodenal ulcers associated with bacteria _Helicobacter pylori_ - prevent the recurrence of ulcers associated with this bacteria - Stomach ulcers caused by medicines called NSAIDs (Non-Ster Read the complete document
Health Products Regulatory Authority 15 February 2024 CRN00DD62 Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nexazole 20 mg hard gastro-resistant capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard gastro-resistant capsule contains 20 mg esomeprazole (as magnesium dihydrate). Excipient (s) with known effect: 20 mg gastro-resistant capsules sucrose 28,464–32,556 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard gastro-resistant capsule The body and the cap of the capsule are slightly pink. The content of capsules are white to almost white pellets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nexazole capsules are indicated in adults for: GASTROESOPHAGEAL REFLUX DISEASE (GERD): Treatment of erosive reflux esophagitis Long-term management of patients with healed esophagitis to prevent relapse Symptomatic treatment of gastroesophageal reflux disease (GERD) IN COMBINATION WITH APPROPRIATE ANTIBACTERIAL THERAPEUTIC REGIMENS FOR THE ERADICATION OF _HELICOBACTER PYLORI_: Healing of _Helicobacter pylori_ associated duodenal ulcer Prevention of relapse of peptic ulcers in patients with _Helicobacter pylori_ associated ulcers PATIENTS REQUIRING CONTINUED NSAID THERAPY: Healing of gastric ulcers associated with NSAID therapy Prevention of gastric and duodenal ulcers associated with NSAID therapy, in patients at risk PROLONGED TREATMENT AFTER I.V. INDUCED PREVENTION OF REBLEEDING OF PEPTIC ULCERS TREATMENT OF ZOLLINGER ELLISON SYNDROME Nexazole capsules are indicated in adolescents from the age of 12 years for: GASTROESOPHAGEAL REFLUX DISEASE (GERD) treatment of erosive reflux esophagitis long-term management of patients with healed esophagitis to prevent relapse symptomatic treatment of gastroesophageal reflux disease (GERD) IN COMBINATION WITH ANTIBIOTICS IN TREATMENT OF DUODENAL ULCER CAUSED BY _HELICOBACTER PYLORI_ Health Products Regulatory Authority 15 February 2024 CRN00DD62 Page 2 of 14 4.2 POSOLO Read the complete document