NEXIUM Tablets Gastro-Resistant 40 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
07-05-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
ESOMEPRAZOLE
Available from:
G & A Licensing Limited
Dosage:
40 Milligram
Pharmaceutical form:
Tablets Gastro-Resistant
Authorization date:
2008-07-04
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nexium 40 mg Gastro-Resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 40mg esomeprazole (as magnesium trihydrate)
Excipient: Also includes Sucrose
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gastro resistant tablet
_Product imported from France and the United Kingdom:_
Pink, oblong, biconvex film coated tablets engraved ‘40mg’ on one side and ‘A EI’ on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
NEXIUM tablets are indicated for:
-GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
- treatment of erosive reflux oesophagitis
PROLONGED TREATMENT AFTER IV INDUCED PREVENTION OF REBLEEDING OF PEPTIC ULCERS.
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 coat may be dissolved. Stir until the tablets disintegrate and drink the liquid with the
pellets immediately or within 30 minutes. Rinse the glass with half a glass of water and drink. The pellets must not be
chewed or crushed.
For patients who cannot swallow, the tablets can be dispersed in non-carbonated water and administered through a
gastric tube. It is important that the appropriateness of the selected syringe and tube is carefully tested.
For preparation and administration instructions see section 6.6.
Adults and adolescents from the age of 12 years.
-GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
- treatment of erosive reflux oesophagitis
40 mg once daily for 4 weeks.
An additional 4
Read the complete document
