Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ranitidine hydrochloride
Bristol Laboratories Ltd
A02BA02
Ranitidine hydrochloride
150mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030100; GTIN: 5060013941191
160 mm 430 mm FRONT 25 mm 5 mm 5 mm 5 mm 5 mm 5 mm 1515 5 m m 5 mm 160 mm 430 mm BACK 5 mm 5 mm 5 mm 5 mm 5 mm 5 mm 5 mm 510520003GB01 PRODUCT NAME RANITIDINE T ABLET S PACKAGING MATERIAL PACK INSERT ARTWORK SIZE : Foil Repeat Length ------ SIZE : S trip Size ------ SIZE : Carton/Label ------ SIZE : PI - Open Size PI - Close Size L. 160 X H. 430 MM L. 160 X H. 25 MM PM S TYLE/T YPE : ------ SIZE : Foil Width ------ SAP CODE : REFERENCE ARTWORK PARTY ARTWORK REASON OF CHANGE : NEW DEVELOPMENT PROOF 1 COUNTRY : UK PACK SIZE : BARCODE NO. : ---------------- PHARMACODE : 1515 NO. OF COLOURS : 1 MIN. FONT SIZE : 9 PT. FINAL 510520003GB01 Emcure - Hinjawadi BLACK REMARK (IF ANY) : ------ DEVELOPED FOR : Mr. Mayur ---------------- ‘” Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ranitidine 150 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Ranitidine Hydrochloride equivalent to 150 mg ranitidine. For excipients see 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Appearance: White to yellowish, circular, convex, film-coated tablets, diameter 10 mm marked with letters “R” and “I” either side of the scoreline on one face. 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 gastrooesophageal 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. 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 For oral administration. _Adults: _The usual dosage is 150 mg twice daily, taken in the morning and evening. Alternatively, patients with duodenal ulceration, gastric ulceration or oesophageal reflux disease may be treated with a single bedtime dose of 300 mg. It is not necessary to Perskaitykite visą dokumentą