ESOMEPRAZOLE TEVA PHARMA BV
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Available from:
Teva Pharma B.V.
Dosage:
40 Milligram
Pharmaceutical form:
Tablets Gastro-Resistant
Authorization date:
2011-12-21
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Esomeprazole Teva Pharma B.V. 40 mg Gastro-resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 40 mg esomeprazole (as magnesium dihydrate).
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gastro-resistant tablet
A pink, oblong, biconvex, film coated tablet, with “40” engraved on one side and dimensions of approximately 17.2 x
8.7 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults
Esomeprazole Teva Pharma B.V. tablets are indicated for:
GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD):
-Treatment of erosive reflux oesophagitis
-Long-term management of patients with healed oesophagitis to prevent relapse
-Symptomatic treatment of gastro-oesophageal reflux disease (GORD)
IN COMBINATION WITH APPROPRIATE ANTIBACTERIAL THERAPEUTIC REGIMENS FOR THE ERADICATION OF _HELICOBACTER PYLORI_:
-Healing of _Helicobacter pylori _associated duodenal ulcer
-Prevention of relapse of peptic ulcers in patients with _Helicobacter pylori _associated ulcers
PATIENTS REQUIRING CONTINUED 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.
TREATMENT OF ZOLLINGER ELLISON SYNDROME.
Adolescents from the age of 12 years
GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
- treatment of erosive reflux oesophagitis
- long-term management of patients with healed oesophagitis to prevent relapse
- symptomatic treatment of gastro-oesophageal reflux disease (GORD)
IN COMBINATION WITH ANTIBIOTICS IN TREATMENT OF DUODENAL ULCER CAUSED BY _HELICOBACTER PYLORI_.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The tablets should be sw
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