NOCDURNA ORAL LYOPHILISATE 50MCG

TABLET, ORALLY DISINTEGRATING

**POSOLOGY AND METHOD OF ADMINISTRATION** Posology - Women: 25 mcg daily, one hour before bedtime, administered sublingually without water. - Men: 50 mcg daily, one hour before bedtime, administered sublingually without water. In the event of signs or symptoms of water retention and/or hyponatremia (headache, nausea/vomiting, weight gain, and, in severe cases, convulsions) treatment should be interrupted and reassessed. When restarting treatment strict fluid restriction should be enforced and serum sodium levels monitored (see section Special warnings and precautions for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). NOCDURNA® should be discontinued if the serum sodium level falls below the lower limit of normal range (i.e. 135 mmol/L). Special Populations _Elderly patients (65 years of age and older)_ Elderly patients are at increased risk of developing hyponatraemia with desmopressin treatment and may also have impaired renal function. Caution should therefore be exercised in this age group and daily doses above 25 mcg for females and 50 mcg for males should not be used. In elderly patients, serum sodium must be within the normal range, before initiating treatment, in the first week (4–8 days after initiation) and again at one month. NOCDURNA® should be discontinued if the serum sodium level falls below the lower limit of normal range (see section Special warnings and precautions for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Continued therapy must be carefully reconsidered in elderly patients who show no evidence of therapeutic benefit beyond 3 months. _Renal impairment_ NOCDURNA® is contraindicated in patients with moderate and severe renal insufficiency (see section Contraindications). _Hepatic impairment_ No dose adjustment is needed for patients with hepatic impairment (see section Pharmacokinetic properties – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Paediatric population_ There is no relevant use of NOCDURNA® in the paediatric population for the indication of symptomatic treatment of nocturia due to idiopathic nocturnal polyuria. Method of administration NOCDURNA® is placed under the tongue where it dissolves without the need for water. Food intake may reduce the intensity and duration of the antidiuretic effect at low doses of desmopressin (see section Pharmacokinetic properties – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).