NIZATIDINE Capsule, hard Ref.[9149] Active ingredients: Nizatidine

As nizatidine is partially metabolised by the liver and principally excreted by the kidneys, patients with impaired liver or kidney function should be treated with caution. (see section 4.2.)

Symptomatic response to nizatidine therapy does not preclude the presence of gastric malignancy.

There is evidence that oral nizatidine does not affect the serum levels of concomitantly-administered aminophylline, theophylline, chlordiazepoxide, diazepam, lidocaine, phenytoin, ibuprofen, metoprolol, warfarin or lorazepam.

Nizatidine does not inhibit the hepatic cytochrome P450-linked drug metabolising enzyme system, but may increase absorption of salicylates when they are used in very high dosage. However, nizatidine and other histamine H₂-receptor antagonists can reduce the gastric absorption of drugs whose absorption is dependent on an acidic gastric pH. Approximately 35% of nizatidine is bound to plasma protein. Warfarin, diazepam, paracetamol, propantheline, phenobarbitone, and propranolol did not affect plasma protein binding of nizatidine in vitro.

Absorption of nizatidine is not clinically significantly affected by food intake, anticholinergic agents, or antacids.

Pregnancy

The safety of nizatidine for use during pregnancy has not been established. Animal studies have shown no evidence of impaired fertility or teratogenicity attributable to nizatidine. Nizatidine should only be used in pregnant women, or in those planning pregnancy, if considered absolutely necessary, and then with caution.

Breast-feeding

Studies conducted in lactating women have shown that 0.1% of the administered oral dose of nizatidine is secreted in human milk in proportion to plasma concentrations. Because of the growth depression in pups reared by lactating rats treated with nizatidine, it should be administered to nursing mothers only if considered absolutely necessary.

There is no influence of nizatidine on the ability to drive or use machines.

In large scale clinical trials, sweating and urticaria were significantly more common in nizatidine-treated patients when compared with placebo. In these trials, 1.9% of treated patients experienced somnolence, compared to 1.6% of placebo patients (non-significant).

In the same trials, patients treated with both nizatidine and placebo had mild, transient, asymptomatic elevations of transaminases or alkaline phosphatase; rare instances of marked elevations (>500 iu/l) occurred in nizatidine-treated patients. The overall rate of occurrences of elevated liver enzymes and elevations to 3 times the upper limit of normal, however, did not differ significantly from placebo. All abnormalities were reversible after discontinuation of nizatidine. Hepatitis and jaundice have been reported. Rare cases of cholestatic or mixed hepatocellular and cholestatic injury with jaundice have also been reported, with reversal of the abnormalities after discontinuation.

The following effects have also been rarely reported, thrombocytopenic purpura, fatal thrombocytopenia, leucopenia, agranulocytosis, anaemia, exfoliative dermatitis, vasculitis, arthralgia, myalgia, gynaecomastia, impotence, hyperuricaemia, fever, nausea and reversible mental confusion.

Rare episodes of hypersensitivity reactions (eg, bronchospasm, laryngeal oedema, rash, pruritus and eosinophilia), serum sickness and anaphylaxis have been reported.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Not applicable.