For the treatment of the following diseases where reduction of gastric acid is indicated:
Duodenal ulcer
Benign gastric ulcer
Prevention of duodenal or benign gastric ulcer recurrence
Gastric oesophageal reflux disease (including erosions, ulcerations and associated heartburn)
Gastric and/or duodenal ulcer associated with concomitant use of non-steroidal antiinflammatory
drugs

For oral administration.
Adults: For treatment of duodenal ulcer, the recommended daily dose is 300 mg in the evening.
Treatment should continue for four weeks, although this period may be reduced if healing is
confirmed earlier by endoscopy. Most ulcers will heal within four weeks, but if complete ulcer
healing has not occurred after four weeks therapy, patients should continue therapy for a further
four weeks.
For the treatment of benign gastric ulcer, the recommended daily dose is 300 mg in the evening
for four or, if necessary, eight weeks. Prior to treatment with nizatidine, care should be taken

to exclude the possibility of gastric cancer.
If preferred, the 300 mg daily dose for the treatment of duodenal or benign gastric ulcer may be
given as two divided doses of 150 mg in the morning and evening.
For the prevention of duodenal or benign gastric ulcer recurrence (prophylactic maintenance
therapy), the recommended daily dose is 150 mg in the evening.
For the treatment of gastric oesophageal reflux disease, the recommended dosage is from 150 mg
twice daily, up to 300 mg twice daily. Therapy for up to 12 weeks is indicated for erosions and
ulcerations, and associated heartburn.
For the treatment of gastric and/or duodenal ulcer associated with concomitant use of nonsteroidal
anti-inflammatory drugs, the recommended daily dose is 300 mg daily (either 300 mg at
bedtime or 150 mg twice daily, in the morning and in the evening) for up to 8 weeks. In most
patients, the ulcers will heal within 4 weeks. During treatment, the use of non-steroidal antiinflammatory
drugs may continue.
The elderly: Age does not significantly influence efficacy or safety. Normally dosage
modification is not required, except in patients who have moderate to severe renal impairment
(creatinine clearance less than 50 ml/min).

Children: Not recommended, as safety and efficacy have not been established.
Patients with impaired renal function: For patients who have moderate renal impairment
(creatinine clearance less than 50 ml/min) or patients who have severe renal impairment
(creatinine clearance less than 20 ml/min), the dosage should be reduced as follows:

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, lignocaine, 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.

Usage in 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.
Usage in lactation: 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, Axid should be administered to nursing mothers only if considered absolutely
necessary.

None stated.

In large scale clinical trials, sweating and urticaria were significantly more common in patients
treated with oral nizatidine 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 (>500iu/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. Since introduction, hepatitis and jaundice have been reported. Rare cases of
cholestatic or mixed hepatocellular and cholestatic injury with jaundice have 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.

There is little experience of overdose in humans. Tested at very high doses in animals, nizatidine
has been shown to be relatively non-toxic. Animal studies suggest that cholinergic-type effects,
including lacrimation, salivation, emesis, miosis, and diarrhoea, may occur following very large
oral doses.
Treatment: Symptomatic and supportive therapy is recommended. Activated charcoal, emesis, or
lavage may reduce nizatidine absorption. The ability of haemodialysis to remove nizatidine from
the body has not been conclusively demonstrated. However, this method is not expected to be
efficient, since nizatidine has a large volume of distribution.

Nizatidine is a potent, selective, competitive and fully reversible histamine H2-receptor
antagonist. Nizatidine significantly decreased basal and stimulated gastric acid and pepsin
concentration, in addition to the volume of gastric secretion.
In various clinical trials, nizatidine, administered as either a single daily dose (at bedtime) or in
two divided doses (morning and evening), significantly inhibited gastric acid secretion, and ulcer
pain was usually rapidly abolished.
Nizatidine has no significant effect on the serum concentrations of gastrin, gonadotrophins,
prolactin, growth hormone, antidiuretic hormone, cortisol, testosterone, 5-alphadihydrotestosterone,
or oestradiol.
Nizatidine has no antiandrogenic action.

Absorption of nizatidine after oral administration is rapid and peak plasma concentrations (700-
1800 ng/ml after 150 mg; 1400-3600 ng/ml after 300 mg dose) are usually achieved within two
hours of administration (range 0.5-3 hours). Oral bioavailability exceeds 70%, and the
elimination half-life is approximately 1.6 hours. Minor (6%) first pass hepatic metabolism
occurs, but nizatidine is principally excreted via the kidneys, about 60% as unchanged drug,
renal clearance is about 500ml/min. Metabolites include desmethyl nizatidine (7%), sulphoxide
(6%), and N-oxide (5%). Desmethyl nizatidine is an active metabolite of limited potency. More
than 90% of an oral dose of nizatidine (including metabolites) is excreted in the urine within 12
hours.

There are no preclinical data of relevance to the prescriber in addition to that summarised in
other sections of the Summary of Product Characteristics.

Microcrystalline Cellulose
Lactose Anhydrous
Sodium Lauryl Sulfate
Croscarmellose Sodium
Magnesium Stearate
Colloidal Silicon Dioxide

None known.

Do not Store above 30°C.

Immediate Container: PVC-PVDC blister with Aluminum printed foil, 88x 63 mm.
Outer Individual Carton: 280g/m2 grammage paper, dimension 90 mm x 65 mm x 23,
printing
as per drawing.
Insert/Leaflet: 50-60 g/m2 paper, both side printed.

None.