1. Name of the medicinal product
 PARIET  10mg gastro-resistant tablet
PARIET 20mg gastro-resistant tablet
2. Qualitative and quantitative composition
10mg rabeprazole sodium, equivalent to 9.42mg rabeprazole
20mg rabeprazole sodium, equivalent to 18.85mg rabeprazole
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant tablet.
10mg: Pink, film coated biconvex tablet with 'E 241' printed on one side.
20mg: Yellow, film coated biconvex tablet with 'E 243' printed on one side.
4. Clinical particulars
4.1 Therapeutic indications
 PARIET tablets are indicated for the treatment of:
Active duodenal ulcer
Active benign gastric ulcer
Symptomatic erosive or ulcerative gastro-oesophageal reflux disease (GORD).
Gastro-Oesophageal Reflux Disease Long-term Management (GORD Maintenance)
Symptomatic treatment of moderate to very severe gastrooesophageal reflux disease (symptomatic GORD)
Zollinger-Ellison Syndrome
In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacte
4.2 Posology and method of administration
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 20mg 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 20mg 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 PARIET 20mg or 10mg once daily can be used depending upon patient response.
Symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease (symptomatic GORD): 10mg 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 10mg 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 120mg/day based on individual patient needs. Single daily doses up to 100mg/day may be given. 120mg dose may require divided doses, 60mg 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.
PARIET 20mg twice daily + clarithromycin 500mg twice daily and amoxicillin 1g twice daily.
For indications requiring once daily treatment PARIET 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 PARIET tablets should not be chewed or crushed, but should be swallowed whole.