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W H Y B E D W E T T I N G C A N
A N D S H O U L D B E T R E A T E D
Dry nights
mean good mornings
Higher levels of compliance and efficacy
with MINIRIN Melt
than MINIRIN tablet
1
Date of preparation May 2016
MN/1072/2016/EMDEO
MN/1062/2016/UK
Reference:
1.Juul KV
et al.
Eur J Pediatr 2013;
172
:1235-1242
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:
April 2012.
Adverse events should be reported. Reporting forms and
information can be found at
www.mhra.gov.uk/yellowcard.AdverseeventsshouldalsobereportedtoFerringPharmaceuticals
Ltd. Tel: 0844 9310050. Email:
medical@ferring.comMinirin Melt is marketed as DesmoMelt 120µg and 240µg in the United Kingdom