ACILESOL GASTRO- RESISTANT TABLET 20MG [SIN14910P]

Product Info

ACILESOL GASTRO- RESISTANT TABLET 20MG

[SIN14910P]

4.1 Therapeutic indications
ACILESOL tablets are indicated for the treatment of:

• Prevention of gastric and duodenal ulcer recurrences associated with low-dose aspirin therapy

• Active duodenal ulcer

• Active benign gastric ulcer

• Symptomatic erosive or ulcerative gastro-esophageal reflux disease (GERD)

• Gastro-esophageal Reflux Disease Long-term Management (GERD Maintenance)

• Symptomatic treatment of moderate to very severe gastro-esophageal reflux disease (symptomatic GERD)

• In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori in patients with peptic ulcer disease. See section 4.2

4.2 Posology and Method of Administration

Adults/elderly:

Prevention of gastric and duodenal ulcer recurrences associated with low-dose aspirin therapy: The usual dosage for adults is 5mg rabeprazole sodium administered orally once daily. The dosage may be increased to 10mg administered orally once a day in the event of insufficient effect.

Active Duodenal Ulcer, Active Benign Gastric Ulcer and Erosive or Ulcerative Gastro-Esophageal Reflux Disease (GERD): The usual adult dose is 10mg rabeprazole sodium administered orally once daily. However, the dosage may be increased up to 20mg orally once a day depending on severity of symptoms. For the treatment of active benign gastric ulcer and symptomatic erosive or ulcerative GERD, the usual administration should be restricted to up to 8 weeks, and for active duodenal ulcer, 6 weeks.

A dose of 10mg twice daily for a further 8 weeks may be administered orally to reflux esophagitis patients who do not respond to usual doses of proton pump inhibitor treatment. However, dose of 20mg twice daily may be administered to patients with severe mucosa injury.

Gastro-Esophageal Reflux Disease Long-term Management (GERD Maintenance):
For long-term management, a maintenance dose of Rabeprazole 20 mg or 10 mg once daily can be used depending upon patient response.

For the maintenance therapy of reflux esophagitis when proton pump inhibitor treatment is ineffective, dose of 10 mg twice daily may be administered orally.

Symptomatic treatment of moderate to very severe gastro-esophageal reflux disease (symptomatic GERD): 10mg once daily in patients without esophagitis. If symptom control has not been achieved during four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on-demand regimen taking 10mg once daily when needed.

Eradication of H. pylori: Patients with H. pylori infection should be treated with eradication therapy. The following combination given for 7 days is recommended.
Rabeprazole 20mg twice daily + clarithromycin 500mg twice daily and amoxicillin 1g twice daily.

For indications requiring once daily treatment ACILESOL tablets should be taken in the morning, before eating; and although neither the time of day nor food intake was shown to have any effect on rabeprazole sodium activity, this regimen will facilitate treatment compliance.

Patients should be cautioned that the ACILESOL tablets should not be chewed or crushed, but should be swallowed whole.

Renal and hepatic impairment:
No dosage adjustment is necessary for patients with renal or hepatic impairment.
See section 4.4 Special Warnings and Precautions for Use of rabeprazole in the treatment of patients with severe hepatic impairment – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Children:
Rabeprazole is not recommended for use in children, as there is no experience of its use in this group.

4.3 Contraindications:
Rabeprazole is contra-indicated in patients with known hypersensitivity to rabeprazole sodium, substituted benzimidazoles or to any excipient used in the formulation. Rabeprazole is contra-indicated in pregnancy and during breast feeding.