Country: Իսրայել
language: անգլերեն
source: Ministry of Health
OMEPRAZOLE
ABIC LTD.
A02BC01
CAPSULES
OMEPRAZOLE 20 MG
PER OS
Required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
OMEPRAZOLE
Acute duodenal ulcer. Acute gastric ulcer. Helicobacter pylori-associated peptic ulcer disease in combination with antibiotics. Reflux esophagitis:- Treatment ; - Long-term management; - Maintenance treatment for the prevention of relapse in patients with severe reflux esophagitis. Treatment of severe reflux oesophagitis in children from one year of age and older. - Maintenance treatment for the prevention of relapse in patients with poorly responsive peptic ulcer. - Zollinger-ellison syndrome. - Treatment and prevention of NSAID - associated duodenal and gastric ulcers or erosions in high risk patients.
2020-05-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 The dispensing of this medicine is upon doctor's prescription only LOSEC ® CAPSULES 10 MG AND 20 MG COMPOSITION LOSEC ® 10 MG LOSEC ® 20 MG CAPSULES CAPSULES Each capsule contains: Each capsule contains: Omeprazole 10 mg Omeprazole 20 mg For a list of the inactive ingredients in this preparation, see section 6 – "Further information". READ THE PACKAGE INSERT CAREFULLY AND IN ITS ENTIRETY BEFORE USING THE MEDICINE. This package insert includes concise information about the medicine. If you have further questions, refer to your doctor or to a pharmacist. THIS MEDICINE WAS PRESCRIBED TO TREAT YOUR AILMENT. DO NOT PASS IT ON TO OTHERS. IT MAY HARM THEM, EVEN IF THEIR MEDICAL STATE SEEMS SIMILAR TO YOURS. THIS MEDICINE IS NOT INTENDED FOR ADMINISTRATION IN CHILDREN UNDER 1 YEAR OF AGE. 1. WHAT IS THIS MEDICINE INTENDED FOR? Inhibits acid secretion in the gastro intestinal tract. This medicine is indicated for the treatment of gastric ulcer and duodenal ulcer. Combined treatment with antibiotics in Helicobacter pylori associated peptic ulcer disease. Long term management of reflux oesophagitis and in Zollinger-Ellison syndrome. Severe reflux oesophagitis in children from one year of age and older. Maintenance treatment for the prevention of relapse in patients with poorly responsive peptic ulcer or severe reflux oesophagitis. For the treatment and prevention of gastric ulcer and duodenal ulcer caused by the treatment with NSAID in high-risk patients. THERAPEUTIC GROUP: Proton pump inhibitors (PPI). 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • you are sensitive (allergic) to the active ingredient or to any other ingredient in the preparation (see section 6), or to other proton pump inhibitors (PPI) e.g., pantoprazole, lansoprazole, rabeprazole, esomeprazole). • you suffer from pain while swallowing food, vomiting with blood, bloody or black stools. • you are taking nelfinavir (a medicine used to treat read_full_document
LOSEC 05/2016 SK ."רשואו קדבנ ונכותו תואירבה דרשמ י"ע עבקנ הז ןולע טמרופ" :רשואמ ןולע 05/2016 “This leaflet format has been determined by the Ministry of Health and the content thereof has been checked and approved.” Date of approval: May 2016. SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT LOSEC ® CAPSULES 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains omeprazole 10 or 20 mg. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Hard gelatin capsules. Losec Capsules 10 mg: hard gelatin capsules with an opaque pink body, marked 10 and an opaque pink cap marked A/OS in black ink. Each capsule contains omeprazole 10 mg as enteric coated pellets, with an aqueous based coating. Losec Capsules 20 mg: hard gelatin capsules with an opaque pink body, marked 20 and an opaque reddish-brown cap marked A/OM in black ink. Each capsule contains omeprazole 20 mg as enteric coated pellets, with an aqueous based coating. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Acute Duodenal Ulcer. • Acute Gastric Ulcer. • _Helicobacter Pylori_-Associated Peptic Ulcer Disease in combination with antibiotics. • Reflux Esophagitis. Treatment Long-Term Management Maintenance Treatment for the Prevention of Relapse in Patients with Severe Reflux Esophagitis Severe Reflux Esophagitis in Children from One Year of Age and Older LOSEC 05/2016 SK Page 2 of 15 2 • Maintenance Treatment for the Prevention of Relapse in Patients with Poorly Responsive Peptic Ulcer. • Zollinger-Ellison Syndrome. • Treatment and prevention of NSAID-associated duodenal and gastric ulcers or erosions in high risk patients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Losec capsules should be taken before meals, and are recommended to be given in the morning and swallowed whole with liquid. For patients with swallowing difficulties the capsule might be opened and the contents swallowed or suspended in a slightly acidic fluid e.g. fruit juice, yoghurt soured read_full_document