Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
1. NAME OF THE MEDICINAL PRODUCT
NEXIUM 40 mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40 mg esomeprazole (as magnesium trihydrate).
Excipients: Sucrose 30 mg.
For a full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Gastro-resistant tablet
40 mg: A pink, oblong, biconvex, film-coated tablet engraved 40 mg on one side and on the other side.
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 weeks treatment is recommended for patients in whom oesophagitis has not healed or who have persistent symptoms.
Adults
Prolonged treatment after IV induced prevention of rebleeding of peptic ulcers.
40 mg once daily for 4 weeks after IV induced prevention of rebleeding of peptic ulcers.
Treatment of Zollinger Ellison Syndrome
The recommended initial dosage is Nexium 40 mg twice daily. The dosage should then be individually adjusted and treatment continued as long as clinically indicated. Based on the clinical data available, the majority
