VEXPRAZOLE 40 Tablet

For the short-term treatment of duodenal ulcer, gastric ulcer and reflux oesophagitis.

If the duodenal ulcer has been demonstrated to be associated with Helicobacter pylori infection, VEXPRAZOLE 40 used in combination with appropriate antibiotics may be useful. VEXPRAZOLE 40 is indicated for the treatment of Zollinger-Ellison Syndrome.

Dosage

Should be taken in the morning.

Should be swallowed whole with a little water either before or during breakfast.

Duodenal ulcer

40mg once daily. The total treatment with intravenous and oral Pantoprazole should be 2-4 weeks. If the duodenal ulcer has been demonstrated to be associated with Helicobacter pylori infection, 40mg used in combination with appropriate antibiotics may be useful.

Gastric ulcer

40mg once daily for 4-8 weeks.

In the case of suspected gastric ulcer, malignancy of the gastric ulcer should be excluded, as treatment could conceal the symptoms and may delay diagnosis.

Reflux oesophagitis

40mg once daily in the morning for 4-8 weeks.

Zollinger-Ellison Syndrome

For the management of Zollinger-Ellison Syndrome patients should start their treatment with a daily dose of 80mg. Thereafter, the dose can be titrated up or down, as needed using measurements of gastric acid secretion as a guide. With doses above 80mg daily, the dose should be divided and given twice daily.

Long-term management a maintenance dose of one 20mg Pantoprazole tablet/day is recommended, increasing to 40mg/day if a relapse occurs. After healing of the relapse, the dose can be reduced to 20mg. Experience with long-term administration is limited.

Elderly Patients

No dosage adjustment is necessary in the elderly.

Impaired renal and liver function

No dosage adjustment is required in the presence of impaired renal function. A daily dose of 20mg should not be exceeded in patients with mild to moderately severe liver impairment.

Hypersensitivity to pantoprazole.

Safety and efficacy in children has not been established.

Severely impaired liver function.

Blood and lymphatic system

Very rare: leukopenia, thrombocytopenia

Gastro-intestinal disorders

Common: Gastro-intestinal complaints such as upper abdominal pain, diarrhoea, constipation or flatulence

Uncommon: nausea, vomiting

Rare: dry mouth

General disorders and administration site conditions

Very rare: injection site thrombophlebitis and peripheral oedema

Hepatobiliary disorders

Very rare: severe hepatocellular damage leading to jaundice with or without hepatic failure

Immune system disorders

Very rare: anaphylactic reactions including anaphylactic shock

Metabolic disorders

Very rare: increased liver enzymes (transaminases, gamma-GT), elevated triglycerides and increased body temperature

Musculoskeletal, connective tissue and bone disorders

Rare: arthralgia

Very rare: myalgia

Nervous system disorders

Common: headache

Uncommon: dizziness or disturbances in vision (blurred vision)

Psychiatric disorders

Very rare: mental depression, renal and urinary system disorders, interstitial nephritis

Skin and subcutaneous tissue disorders

Uncommon: allergic reactions such as pruritus, and skin rash

Very rare: urticaria, angioedema and severe skin reactions such as Stevens-Johnson Syndrome, erythema multiforme, Lyell Syndrome and photosensitivity.

Concomitant intake of food has no influence on the bioavailability.

VEXPRAZOLE 40mg may reduce or increase the absorption of medicines whose bioavailability is pH-dependent, e.g. ketoconazole.

The active ingredient of VEXPRAZOLE 40 is metabolised in the liver via the cytochrome P450 enzyme system. An interaction of VEXPRAZOLE 40 with other drugs or compounds which are metabolised using the same enzyme system cannot be excluded.

No clinically significant interactions were, however, observed in specific tests with a number of such drugs or compounds, namely antipyrine, caffeine, carbamazepine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, naproxen, nifedipine, phenytoin, piroxicam, theophylline, warfarin and oral contraceptives.

Symptomatic response does not preclude presence of gastric malignancy

Atrophic gastritis has been noted with long-term therapy

Pantoprazole sodium is a proton pump inhibitor (PPI) that suppresses the final step in gastric acid production by covalently binding to the (H+,K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. The binding to the (H+,K+)-ATPase results in a duration of antisecretory effect that persists longer than 24 hours for all doses tested (20-120mg).