Country: Израел
Језик: Енглески
Извор: Ministry of Health
ESOMEPRAZOLE
TARO INTERNATIONAL LTD, ISRAEL
A02BC05
TABLETS
ESOMEPRAZOLE 40 MG
PER OS
Required
ASTRA ZENECA AB., SWEDEN
ESOMEPRAZOLE
ESOMEPRAZOLE
Nexium tablets are indicated in adults for:Gastroesophageal Reflux Disease (GERD)- treatment of erosive reflux esophagitis- long-term management of patients with healed esophagitis to prevent relapse- symptomatic treatment of gastroesophageal reflux disease (GERD)In combination with an appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori and:- healing of Helicobacter pylori associated duodenal ulcer and- prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcers.Patients requiring NSAID therapy- healing of gastric ulcers associated with NSAID therapy. - prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk.Prolonged treatment after i.v. induced prevention of rebleeding of peptic ulcers.Nexium 40 mg tablets are indicated in adolescents from the age of 12 years for;Gastroesophageal Reflux Disease (GERD)- treatment of erosive reflux esophagitis
2021-05-31
Page 1 of 8 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed with a doctor’s prescription only NEXIUM ® 20 mg NEXIUM ® 40 mg Tablets Tablets Active ingredient: Active ingredient: Each tablet contains: Each tablet contains: esomeprazole 20 mg (as magnesium trihydrate) esomeprazole 40 mg (as magnesium trihydrate) Inactive ingredients and allergens: See section 2 under ‘Important information about some of this medicine’s ingredients’ and section 6 ‘Further information’. Read the entire leaflet carefully before you start using this medicine. This leaflet contains concise information about this medicine. If you have any further questions, contact your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them even if it seems to you that their illness is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? In adults, Nexium 20 mg and 40 mg are intended: • For treatment of heartburn, with or without inflammation of the gullet, caused by reflux of gastric acid. Nexium reduces the production of acid and helps heal the gullet by reducing pain and inflammation. • For treatment of ulcers in the upper part of the gut or stomach caused by _Helicobacter pylori_ bacteria. Nexium in combination with suitable antibiotics treats the infection, and leads to healing of the ulcer and prevention of recurrence. • For healing of gastric ulcer caused by use of non-steroidal anti-inflammatory drugs (NSAIDs), which are also used to treat arthritis (rheumatism). • For prevention of formation of gastric ulcers, if you might possibly develop them as a result of taking non-steroidal anti-inflammatory drugs (NSAIDs), which are also used to treat arthritis (rheumatism). • For prolonged treatment with Nexium tablets to prevent recurrent bleeding of a gastric or duodenal ulcer, after primary intravenous Nexium treatment. In adolescents, Nexium 20 mg is intended: • For treatment o Прочитајте комплетан документ
Nexium Tablets– notification April 2022 SUMMARY OF PRODUCT CHARACTERISTICS 1. Name of the Medicinal Product NEXIUM ® Tablets 20 mg NEXIUM ® Tablets 40 mg 2. Qualitative and Quantitative Composition NEXIUM ® Tablets 20 mg - Each tablet contains: 20 mg esomeprazole (as magnesium trihydrate). NEXIUM ® Tablets 40 mg - Each tablet contains: 40 mg esomeprazole (as magnesium trihydrate). Excipients with known effect: Nexium Tablets 20 mg: Sucrose 28 mg. Nexium Tablets 40 mg: Sucrose 30 mg. For a full list of excipients, see section 6.1. 3. Pharmaceutical Form Gastro-resistant tablet 20 mg: A light pink, oblong, biconvex, film-coated tablet engraved 20 mg on one side and A EH on the other side. 40 mg: A pink, oblong, biconvex, film-coated tablet engraved 40 mg on one side and A EI on the other side. 2 4. Clinical Particulars 4.1 Therapeutic indications Nexium Tablets are indicated in adults for: Gastroesophageal Reflux Disease (GERD) - treatment of erosive reflux esophagitis. - long-term management of patients with healed esophagitis to prevent relapse. - symptomatic treatment of gastroesophageal reflux disease (GERD). In combination with an appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori and - healing of Helicobacter pylori associated duodenal ulcer and - prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcers. Patients requiring NSAID therapy - healing of gastric ulcers associated with NSAID therapy. - prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk. Prolonged treatment after i.v. induced prevention of rebleeding of peptic ulcers. Nexium Tablets 40 mg are indicated in adolescents from the age of 12 years for: Gastroesophageal Reflux Disease (GERD) - treatment of erosive reflux esophagitis. Nexium Tablets 20 mg are indicated in adolescents from the age of 12 years for: 3 Gastroesophageal Reflux Disease (GERD) - treatment of erosive reflux esophagitis. - long-term management of patients with he Прочитајте комплетан документ