Uncoated, white, round, convex tablets scored on one side and engraved '0.2' on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Desmopressin tablets are indicated for the treatment of primary nocturnal enuresis.
4.2 Posology and method of administration
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 0.2mg at bedtime and only if needed should the dose be increased to 0.4mg.
The need for continued treatment should be reassessed after 3 months by means of a period of at least 1 week without desmopressin tablets.
Desmopressin tablets are contraindicated in cases of cardiac insufficiency and other conditions requiring treatment with diuretic agents. Desmopressin tablets should only be used in patients with normal blood pressure.
Before prescribing desmopressin 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.
4.4 Special warnings and precautions for use
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 tablets would be less than normal.
When desmopressin tablets are used for the treatment of enuresis, fluid intake must be limited from 1 hour before taking the tablets at bedtime until the next morning and in any case for a minimum of 8 hours after administration.
Patients being treated for primary nocturnal enuresis should be warned to avoid ingesting water while swimming and to discontinue desmopressin 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