Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
RANITIDINE HYDROCHLORIDE
GlaxoSmithKline (Ireland) Limited
A02BA; A02BA02
RANITIDINE HYDROCHLORIDE
150 milligram(s)
Effervescent tablet
Product subject to prescription which may be renewed (B)
H2-receptor antagonists; ranitidine
Not marketed
1990-06-27
Reason for Update: Type II to update in line with PSUSA -erlotinib and Minor amendments Market: IE Agency Approval Date: Text Date: 16/10/2019 Text Issue and Draft No.: Issue 05 Draft 01 PACKAGE LEAFLET: INFORMATION FOR THE USER ZANTAC 150 MG EFFERVESCENT TABLETS RANITIDINE (AS HYDROCHLORIDE) 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1 What Zantac is and what it is used for 2 What you need to know before you take Zantac 3 How to take Zantac Effervescent Tablets 4 Possible side effects 5 How to store Zantac 6 Contents of the pack and other information 1 WHAT ZANTAC IS AND WHAT IT IS USED FOR Zantac contains a medicine called ranitidine. This belongs to a group of medicines called H 2 -receptor antagonists. It lowers the amount of acid in your stomach. FOR ADULTS (INCLUDING THE ELDERLY) Zantac is used to: treat ulcers in the stomach, or the part of the gut it empties into (the duodenum) prevent stomach ulcers when they are a side effect of some medicines treat problems caused by acid in the food pipe (oesophagus) or too much acid in the stomach. Both of these can cause pain or discomfort sometimes known as ‘indigestion’, ‘dyspepsia’ or ‘heartburn’ treat other conditions where reduction of acid in the stomach is likely to be beneficial treat Zollinger-Ellison syndrome – a condition in which there is increased production of the hormone gastrin FOR CHILDREN (3 TO 18 YEARS) Zantac is used to: treat ulcers in the stomach, or the part of the gut it empties int Read the complete document
Health Products Regulatory Authority 11 June 2020 CRN009MDZ Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zantac 150 mg Effervescent Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each effervescent tablet contains 150 mg ranitidine (as hydrochloride) Excipients-contains Aspartame (E951) 30.0 mg, Sorbitol (E420) 1.14 mg and Sodium 328 mg For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Effervescent tablet. A white to pale yellow round bevelled tablets marked GS LHK on one side and flat on the other which effervesces on dissolution in water to give a clear orange/grapefruit flavoured solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of duodenal ulcer and benign gastric ulcer including that associated with non-steroidal anti-inflammatory agents. Prevention of non-steroidal anti-inflammatory drug (including aspirin) associated duodenal ulcers, especially in patients with a history of peptic ulcer disease. Zantac Tablets are also indicated for treatment of post-operative ulcer, reflux oesophagitis, Zollinger-Ellison syndrome and other conditions where reduction of gastric acid secretion is likely to be beneficial. CHILDREN (3 TO 18 YEARS) Short term treatment of peptic ulcer Treatment of gastro-oesophageal reflux, including reflux oesophagitis and symptomatic relief of gastro-oesophageal reflux disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS (INCLUDING THE ELDERLY) / ADOLESCENTS (12 YEARS AND OVER) The usual initial dosage is 150 mg bd or 300 mg nocte. This may be increased to ranitidine 300 mg twice daily without an increased incidence of unwanted effects. Subsequently a maintenance dose of 150 mg nocte may be used. Smoking is associated with a higher rate of ulcer relapse, and such patients should be advised to stop smoking. In those who fail to comply with such advice, a dose of 300 mg at night provides additional therapeutic benefit over the standard dose. The standard dosage regimen for post-operative ulc Read the complete document