DESMOPRESSIN ACETATE

For oral use.

Treatment of Diabetes Insipidus:

Dosage is individual in diabetes insipidus but clinical experience has shown that the total daily dose normally lies in the range of 200micrograms to 1200micrograms. A suitable starting dose in adults and children is 100micrograms three times daily.

This dosage regimen should then be adjusted in accordance with the patient’s response. For the majority of patients, the maintenance dose is 100micrograms to 200micrograms three times daily.

Post-hypophysectomy polyuria/polydipsia:

The dose of Desmopressin acetate Tablets should be controlled by measurement of urine osmolality.

Primary nocturnal enuresis:

Children (from 5 years of age) and adults (up to 65 years of age) with normal urine concentrating ability who have primary nocturnal enuresis should take 200micorgrams at bedtime and only if needed should the dose be increased to 400micrograms.

The need for continued treatment should be reassessed after 3 months by means of a period of at least 1 week without Desmopressin acetate tablets.

Gastrointestinal tract:

Stomach pain, nausea, abdominal cramps, vomiting Nervous system disorders: Headache Very rare; emotional disturbance in children.

Skin/General:

Allergic skin reactions and more severe general allergic reactions Treatment with desmopressin without concomitant reduction of fluid intake may lead to water retention/hyponatraemia with accompanying symptoms of headache, nausea, vomiting, weight gain, decreased serum sodium and in serious cases, convulsions.

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. uk/yellowcard).

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine. Care should be taken with patients who have reduced renal function and/or cardiovascular disease or cystic fibrosis.

In chronic renal disease the antidiuretic effect of Desmopressin acetate Tablets would be less than normal. When Desmopressin acetate Tablets are used for the treatment of enuresis, fluid intake must be limited from 1 hour before until 8 hours after administration.

Patients being treated for primary nocturnal enuresis should be warned to avoid ingesting water while swimming and to discontinue Desmopressin acetate Tablets during an episode of vomiting and/or diarrhoea until their fluid balance is once again normal.

Precautions to prevent fluid overload must be taken in: - conditions characterised by fluid and/or electrolyte imbalance - patients at risk for increased intracranial pressure It is important to monitor body weight and blood pressure during treatment with desmopressin.

Hypersensitivity to desmopressin or any of the excipients. Cardiac insufficiency and other conditions requiring treatment with diuretic agents. When used to control primary nocturnal enuresis Desmopressin acetate Tablets should only be used in patients with normal blood pressure.

Before prescribing Desmopressin acetate Tablets the diagnoses of psychogenic polydipsia and alcohol abuse should be excluded. Desmopressin should not be prescribed to patients over the age of 65 for the treatment of primary nocturnal enuresis.

Hyponatraemia. Syndrome of inappropriate secretion of antidiuretic hormone.