Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Omeprazole
Wockhardt UK Ltd
A02BC01
Omeprazole
10mg
Gastro-resistant capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030500
* Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND UK-Eire-Artwork-Support@accord-healthcare.com Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. FMD info NA (not a carton) No Yes Details OMEPRAZOLE 10MG & 20MG GASTRO-RESISTANT CAPSULES PIL- UK Black BBBA3101 R.Wrey 03/10/18 08/10/18 R.Wrey 140 x 540 8pt Liconsa 03/10/18 04/10/18 3 Version 2 01.11.2017 OMEPRAZOLE 10 MG AND 20 MG GASTRO-RESISTANT CAPSULES BBBA3101 _Continued over page_ _Continued top of next column_ 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 OMEPRAZOLE CAPSULES ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE OMEPRAZOLE CAPSULES 3 HOW TO TAKE OMEPRAZOLE CAPSULES 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE OMEPRAZOLE CAPSULES 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT OMEPRAZOLE CAPSULES ARE AND WHAT THEY ARE USED FOR Omeprazole capsules contain the active substance omeprazole. It belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces. Omeprazole is used to treat the following conditions: In adults: • ‘Gastro-oesophageal reflux disease’ (GORD). This i Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Omeprazole 10mg hard gastro-resistant capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 10 mg of omeprazole. Excipient(s) with known effect: • Each 10mg capsule contains 51 to 58mg of sucrose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsule, hard (gastro-resistant capsule). Omeprazole 10 mg capsules: hard gelatine capsules with opaque yellow capsule containing off-white to cream-white spherical microgranules. 4.1 THERAPEUTIC INDICATIONS _ _ Omeprazole capsules is indicated for in: Adults • Treatment of duodenal ulcers • Prevention of relapse of duodenal ulcers • Treatment of gastric ulcers • Prevention of relapse of gastric ulcers • In combination with appropriate antibiotics, _Helicobacter pylori_ (H. pylori_) _ • Eradication in peptic ulcer disease • Treatment of NSAID-associated gastric and duodenal ulcers • Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk • Treatment of reflux esophagitis • Long-term management of patients with healed reflux esophagitis • Treatment of symptomatic gastro-esophageal reflux disease • Treatment of Zollinger-Ellison syndrome Paediatric use _Children over 1 year of age and _ ≥ _ 10 kg _ • Treatment of reflux esophagitis •. Symptomatic treatment of heartburn and acid regurgitation in gastro- esophageal reflux disease _ _ _Children and adolescents over 4 years of age _ • In combination with antibiotics in treatment of duodenal ulcer caused by _H. _ _pylori _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Posology Adults _ _ _Treatment of duodenal ulcers _ The recommended dose in patients with an active duodenal ulcer is Omeprazole 20 mg once daily. In most patients healing occurs within two weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further two weeks treatment period. In patients with poorly responsive duodenal ulcer Perskaitykite visą dokumentą