ESOMEPRAZOLE ARROW
Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
SPC
(SPC)
03-05-2024
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documentation_request_send
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active_ingredient:
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
MAH:
Arrow Generics Limited
dosage:
40 Milligram
pharmaceutical_form:
Tablets Gastro-Resistant
authorization_date:
2012-01-20
SPC
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Esomeprazole Arrow 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 Arrow tablets are indicated for:
GASTROOESOPHAGEAL REFLUX DISEASE (GORD):
-Treatment of erosive reflux oesophagitis
-Long-term management of patients with healed oesophagitis to prevent relapse
-Symptomatic treatment of gastrooesophageal 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
GASTROOESOPHAGEAL REFLUX DISEASE (GORD)
-
treatment of erosive reflux oesophagitis
-
long-term management of patients with healed oesophagitis to prevent relapse
-
symptomatic treatment of gastrooesophageal 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 swallowed whole with liquid. The
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