RABEPRAZOLE ACCORD Gastro-resistant tablet Ref.[7344] Active ingredients: Rabeprazole

Posology

Adults/elderly

Active Duodenal Ulcer and Active Benign Gastric Ulcer

The recommended oral dose for both active duodenal ulcer and active benign gastric ulcer is 20 mg to be taken once daily in the morning.

Most patients with active duodenal ulcer heal within four weeks. However a few patients may require an additional four weeks of therapy to achieve healing. Most patients with active benign gastric ulcer heal within six weeks. However again a few patients may require an additional six weeks of therapy to achieve healing.

Erosive or Ulcerative Gastro-Oesophageal Reflux Disease (GORD)

The recommended oral dose for this condition is 20 mg to be taken once daily for four to eight weeks.

Gastro-Oesophageal Reflux Disease Long-term Management (GORD Maintenance)

For long-term management, a maintenance dose of Rabeprazole 20 mg or 10 mg once daily can be used depending upon patient response.

Symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease (symptomatic GORD)

10 mg once daily in patients without oesophagitis. 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 10 mg once daily when needed.

Zollinger-Ellison Syndrome

The recommended adult starting dose is 60 mg once a day. The dose may be titrated upwards to 120 mg/day based on individual patient needs. Single daily doses up to 100 mg/day may be given. 120 mg dose may require divided doses, 60 mg twice daily. Treatment should continue for as long as clinically indicated.

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 20 mg twice daily + clarithromycin 500 mg twice daily and amoxicillin 1 g twice daily.

Special populations

Renal and hepatic impairment

No dosage adjustment is necessary for patients with renal or hepatic impairment.

See section 4.4 for the use of Rabeprazole tablets in the treatment of patients with severe hepatic impairment.

Paediatric population

Rabeprazole tablets are not recommended for use in children due to a lack of data on safety and efficacy.

Method of administration

For indications requiring once daily treatment Rabeprazole 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 Rabeprazole tablets should not be chewed or crushed, but should be swallowed whole.

Experience to date with deliberate or accidental overdose is limited. The maximum established exposure has not exceeded 60 mg twice daily, or 160 mg once daily. Effects are generally minimal, representative of the known adverse event profile and reversible without further medical intervention. No specific antidote is known. Rabeprazole sodium is extensively protein bound and is, therefore, not dialysable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilised.

2 years.

Blister packs: Store below 25°C. Store in the original package in order to protect from moisture.

Tablet containers: Store below 25°C. Keep the container tightly closed in order to protect from moisture.

Blister packs (Al-OPA-PVC/Al).

Tablet cotainers (HDPE) with plastic closure (LDPE) and a desiccant.

Tablet containers (HDPE) with a plastic screw cap with an integrated desiccant.

Pack sizes:

Blister packs: 7, 14, 20, 28, 30, 56, 60, 98, 100 and 120 tablets.

Tablet containers: 30, 100 and 250 tablets.

Not all pack sizes may be marketed.

No special requirements.