DESMOMELT

Posology The recommended initial dose for children (from 5 years of age) and adults (up to 65 years of age) with normal urine concentrating ability who have primary nocturnal enuresis, is 120 micrograms at bedtime administered sublingually.

If this dose is not sufficiently effective, the dose may be increased up to 240 micrograms, administered sublingually. Fluid restriction should be observed. DesmoMelt is intended for treatment periods of up to 3 months. The need for continued treatment should be reassessed by means of a period of at least 1 week without DesmoMelt.

In the event of signs or symptoms of water retention and/or hyponatraemia (headache, nausea/vomiting, weight gain, and, in severe cases, convulsions) treatment should be interrupted until the patient has fully recovered. 4). If adequate clinical effect is not achieved within 4 weeks following appropriate dose titration the medication should be discontinued.

4). 3). 2). 2 above). Dose recommendations are the same as in adults. Method of administration Sublingual use, place the melt under the tongue where it dissolves without the need for water. 5).

The most serious adverse reaction with desmopressin is hyponatraemia, which is associated with headache, nausea, vomiting, decreased serum sodium, weight increase, malaise, abdominal pain, muscle cramps, dizziness, confusion, decreased consciousness and in severe cases convulsions and coma.

The cause of the potential hyponatraemia is the anticipated antidiuretic effect. The hyponatraemia is reversible and in children it is often seen to occur in relation to changes in daily routines affecting fluid intake and/or perspiration.

4. Tabulated summary of adverse reactions The table below is based on the frequency of adverse drug reactions reported in clinical trials with oral desmopressin conducted in children and adolescents for treatment of Primary Nocturnal Enuresis (PNE) (N = 1923).

9). 4). Anaphylactic reactions, Psychomotor hyperactivity and some Psychiatric reactions such as abnormal behaviour, emotional disorder, depression, hallucination & insomnia, have not been seen in clinical trials but spontaneous reports have been received.

In children, psychiatric disorders including affect lability, aggression, anxiety, mood swings & nightmare are generally reversed upon treatment discontinuation. Isolated cases of allergic skin reactions and more severe general allergic reactions have been reported.

4). 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.

Special warnings:

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 DesmoMelt would be less than normal. When DesmoMelt is used for the treatment of enuresis, the fluid intake must be limited to a minimum from 1 hour before until the next morning (at least 8 hours) after administration.

Treatment without concomitant reduction of fluid intake may lead to water retention and/or hyponatraemia with or without accompanying warning signs and symptoms (headache, nausea/vomiting, weight gain, and, in severe cases, convulsions).

All patients and, when applicable, their guardians should be carefully instructed to adhere to the fluid restrictions.

Precautions:

Severe bladder dysfunction and outlet obstruction should be considered before starting treatment. Elderly patients and patients with serum sodium levels in the lower range of normal may have an increased risk of hyponatraemia. Treatment with desmopressin should be interrupted during acute intercurrent illnesses characterised by fluid and/or electrolyte imbalance (such as systemic infections, fever, gastroenteritis).

Desmopressin should be used with caution in patients with conditions characterised by fluid and/or electrolyte imbalance. Precautions must be taken in patients at risk for increased intracranial pressure. g. tricyclic antidepressants, selective serotonin reuptake inhibitors, chlorpromazine and carbamazepine, case of concomitant treatment with NSAIDs.

1 • Known or suspected cardiac insufficiency and other conditions requiring treatment with diuretic agents. DesmoMelt should only be used in patients with normal blood pressure. • Habitual or psychogenic polydipsia (resulting in a urine production exceeding 40 ml/kg/24 hours) • Desmopressin should not be prescribed to patients over the age of 65 • Moderate and severe renal insufficiency (creatinine clearance below 50ml/min) • Known hyponatremia • Syndrome of inappropriate ADH secretion (SIADH)