Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ranitidine hydrochloride
Dowelhurst Ltd
A02BA02
Ranitidine hydrochloride
150mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030100
Reason for Update: Type II to update in line with PSUSA -erlotinib and Minor amendments Market: UK Agency Approval Date: Text Date: 16/10/2019 Text Issue and Draft No.: Issue 09 Draft 01 LOGO GSK PACKAGE LEAFLET: INFORMATION FOR THE USER ZANTAC EFFERVESCENT TABLETS 150 MG AND 300 MG RANITIDINE 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, 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. 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: • heal and stop ulcers in the stomach, or the part of the gut it empties into (the duodenum) • help clear up infection in your stomach, when taken with antibiotic medicines (medicines taken to treat germs) • stop stomach ulcers when they are a side effect of some medicines • stop ulcers from bleeding • improve 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’ • stop acid coming up from the stomach while under anaesthetic during an operation. For children (3 to 18 years) Zantac is used to: • heal u Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zantac Tablets 150 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains ranitidine 150 mg (as the hydrochloride). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults Duodenal ulcer and benign gastric ulcer, including that associated with non- steroidal anti-inflammatory agents. Prevention of non-steroidal anti-inflammatory drug (NSAID) (including aspirin) associated duodenal ulcers, especially in patients with a history of peptic ulcer disease. Treatment of duodenal ulcers associated with _Helicobacter pylori_ infection. Post-operative ulcer. Oesophageal reflux disease including long term management of healed oesophagitis. Symptomatic relief in gastro-oesophageal reflux disease. Zollinger-Ellison Syndrome. Chronic episodic dyspepsia, characterised by pain (epigastric or retrosternal) which is related to meals or disturbs sleep but not associated with the above conditions. Prophylaxis of gastrointestinal haemorrhage from stress ulceration in seriously ill patients Prophylaxis of recurrent haemorrhage with bleeding peptic ulcers. Before general anaesthesia in patients at risk of acid aspiration (Mendelson's syndrome), particularly obstetric patients during labour. For appropriate cases, Zantac injection is also available (see separate SPC). 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) Usual dosage is 150 mg twice daily, taken in the morning and evening. Duodenal ulcer, gastric ulcer: The standard dosage regimen is 150 mg twice daily or 300 mg at night. It is not necessary to time the dose in relation to meals. In most cases of duodenal ulcer, benign gastric ulcer and post-operative ulcer, healing occurs within 4 weeks. Healin Прочитайте повний документ