ESOMEPRAZOLE Tablets Gastro-Resistant 20 Milligram
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
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(SPC)
28-04-2024
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Virkt innihaldsefni:
ESOMEPRAZOLE MAGNESIUM (AMORPHOUS)
Fáanlegur frá:
Teva Pharma B.V.
Skammtar:
20 Milligram
Lyfjaform:
Tablets Gastro-Resistant
Leyfisdagur:
2011-02-25
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Esomeprazole 20 mg Gastro-resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: 20 mg esomeprazole as esomeprazole magnesium (amorphous).
Excipients:
Each tablet also contains not more than 27.45 mg Sucrose.
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gastro-resistant tablet
Light brick red to brown coloured, oval, biconvex, film-coated tablets with ‘E5’ debossed on one side and plain on
other side
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Esomeprazole 20mg Gastro-resistant tablets are indicated for:
GASTROESOPHAGEAL REFLUX DISEASE (GORD)
-
treatment of erosive reflux oesophagitis
-
long-term management of patients with healed esophagitis to prevent relapse
-
symptomatic treatment of gastroesophageal reflux disease (GORD)
IN COMBINATION WITH APPROPRIATE ANTIBACTERIAL THERAPEUTIC REGIMENS 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 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.
TREATMENT OF ZOLLINGER ELLISON SYNDROME
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The tablets should be swallowed whole with liquid. The tablets should not be chewed or crushed.
For patients who have difficulty in swallowing the tablets can also be dispersed in half a glass of non-carbonated water.
No other liquids should be used as the enteric coating may be dissolved. Stir until the tablets disintegrate and drink the
liquid with the pellets immediately or within 30 minutes. Rinse t
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