DesmoMelt Prescribing Information
DesmoMelt 120 and 240 micrograms oral lyophilisate.
Prescribing Information: DesmoMelt 120 and 240 micrograms oral lyophilisate; Desmotabs 0.2mg.
Please consult the full Summaries of Product Characteristics before prescribing.
Name of Product: DesmoMelt 120 micrograms oral lyophilisate; DesmoMelt 240 micrograms oral lyophilisate; Desmotabs 0.2mg; Composition: DesmoMelt: 120 or 240 micrograms of desmopressin (as acetate). Desmotabs: 0.2mg desmopressin acetate. Indications: Treatment of primary nocturnal enuresis (5 to 65 years of age). Dosage: Children and adults (5–65 years of age) with normal urine concentrating ability: DesmoMelt: Initial dose of 120 micrograms sublingually at bedtime and only if needed should the dose be increased to 240 micrograms sublingually. Desmotabs: Initial dose of one tablet (0.2mg) at bedtime and only if needed should the dose be increased to two tablets (a total of 0.4mg). Fluid restriction should be observed. The need for continued treatment should be reassessed after 3 months by means of a period of at least 1 week without desmopressin. Contraindications: Cardiac insufficiency and other conditions requiring treatment with diuretics, moderate and severe renal insufficiency. DesmoMelt and Desmotabs should only be used in patients with normal blood pressure and they should not be used in patients over the age of 65. Exclude diagnosis of psychogenic polydipsia or alcohol abuse. Special Warnings and Precautions: Take care in patients with reduced renal function and/or cardiovascular disease or cystic fibrosis. Fluid intake must be limited to a minimum from 1 hour before until 8 hours after administration. Care should be taken to avoid ingesting water while swimming. Treatment with desmopressin should be interrupted 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: illnesses characterized by fluid and/or electrolyte imbalance; patients at risk for increased intracranial pressure. Side Effects: Headache, stomach pain and nausea. Isolated cases of allergic skin reactions and more severe general allergic reactions. Very rare cases of emotional disturbances in children. Treatment with desmopressin without concomitant reduction of fluid intake may lead to water retention/hyponatraemia with or without accompanying warning symptoms of headache, nausea/vomiting, decreased serum sodium, weight gain and in serious cases convulsions. Please consult the full Summaries of Product Characteristics for further information about side effects. Basic NHS Prices: DesmoMelt: Carton containing 30 oral lyophilisates in blister strips. 30 x 120 micrograms £30.34. 30 x 240micrograms £60.68. Desmotabs: Polyethylene bottle containing 30 tablets. £29.43. Marketing Authorisation Number: DesmoMelt: 120 micrograms 03194/0094. 240 micrograms 03194/0095. Desmotabs: 03194/0046. Marketing Authorisation Holder: Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS. Legal Category: POM. Date of Preparation of Prescribing Information: May 2011.
Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should also be reported to Medical Information, Ferring Pharmaceuticals Ltd. Tel : 0844 9310050. Email: medical@ferring.com
