PARIET 20MG TABLETS 28'S

PARIET 20MG TABLETS 28'S

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 gastro-oesophageal reflux disease (symptomatic GORD).

• Zollinger-Ellison Syndrome.

• In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori (H. pylori) in patients with peptic ulcer disease.

Pregnancy and lactation

Pregnancy

There are no data on the safety of rabeprazole in human pregnancy.

Reproduction studies performed in rats and rabbits have revealed no evidence of impaired fertility or harm to the foetus due to rabeprazole sodium, although low foeto-placental transfer occurs in rats. PARIET is contraindicated during pregnancy.

Breast feeding

It is not known whether rabeprazole sodium is excreted in human breast milk. No studies in breast-feeding women have been performed. Rabeprazole sodium is however excreted in rat mammary secretions. Therefore PARIET should not be used during breast feeding.

Undesirable effects

The most commonly reported adverse drug reactions, during controlled clinical trials with rabeprazole were headache, diarrhoea, abdominal pain, asthenia, flatulence, rash and dry mouth. The majority of adverse events experienced during clinical studies were mild or moderate in severity, and transient in nature.