Nocturnal Enuresis An Overview

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Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Introduction • • • • • • •

Current definitions Prevalence ALSPAC study Causes and risk factors Impact on children Parental attitudes and strategies Why should we treat early?

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Incontinence Continuous incontinence

Daytime incontinence

Neveus et al. J Urol 2006;174:314-324

Intermittent incontinence

Enuresis / Nocturnal enuresis

Nocturnal incontinence

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Nocturnal Enuresis Bedwetting at night

Any type of wetting episode that occurs in Involuntary voiding of urine during sleep at discreet amounts during sleep in a child least 2 times a week in a at least 5 yrs old1 child aged 5 yrs or over2

1. Neveus et al. J Urol 2006;174:314-324 2. DSM IV Classification 1994

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Nocturnal Enuresis

Primary

Secondary

The child has never been dry or dry for < 6 months previously

The child has been previously dry for at least 6 months

Neveus et al. J Urol 2006;174:314-324

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Nocturnal Enuresis Monosymptomatic

No daytime symptoms 68.5%

Non-monosymptomatic Presence of daytime symptoms 31.5%

von Gontard A. Enuresis. In Rey JM (ed), IACAPAP e-Textbook of Child and Adolescent Mental Health. Geneva: International Association for Child and Adolescent Psychiatry and Allied Professions 2012.

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Classification of Enuresis Primary

Primary Mono symptomatic Enuresis

Primary Nonmono symptomatic Enuresis

Secondary

Secondary Mono symptomatic Enuresis

von Gontard A. Enuresis. In Rey JM (ed), IACAPAP e-Textbook of Child and Adolescent Mental Health. Geneva: International Association for Child and Adolescent Psychiatry and Allied Professions 2012.

Secondary Nonmono symptomatic Enuresis

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Non-monosymptomatic enuresis Daytime symptoms • Daytime incontinence • Sense of urgency • Voiding frequency increased • Hesitancy, straining, intermittency • Holding manoeuvres

• Post micturition dribble Neveus et al. J Urol 2006;174:314-324

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Daytime symptoms Holding methods

Frequency of voiding Urgency

Hesitancy Daytime wetting

Neveus et al. J Urol 2006;174:314-324

Straining

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Functional urinary incontinence Urge incontinence Voiding postponement Dysfunctional voiding von Gontard A. Enuresis. In Rey JM (ed), IACAPAP e-Textbook of Child and Adolescent Mental Health. Geneva: International Association for Child and Adolescent Psychiatry and Allied Professions 2012.

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

How common is enuresis? Prevalence worldwide

• 2-3 times more common than daytime urinary continence • 1.5 to 2 times more common in boys

Country

Age group

Prevalence

China

6 -16 years

4.3%

Taiwan

6-11 years

8%

Turkey

5-7 years

14.9%

Sudan

7 years

17.4%

Ethiopia

6-15 years

20.8%

UK

7.5 years

15.5%

von Gontard A. Enuresis. In Rey JM (ed), IACAPAP e-Textbook of Child and Adolescent Mental Health. Geneva: International Association for Child and Adolescent Psychiatry and Allied Professions 2012. Butler RJ et al. BJUI. 205;96:4040-410

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Hong Kong study Differences in characteristics of nocturnal enuresis between children and adolescents : a critical appraisal from a large epidemiological study Chung K Yeung et al

Chung K et al. BJU International 2006;97:1069-1073

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Differences in PNE characteristics between children and adolescents • Epidemiological study in Hong Kong • Evaluated differences in PNE according to age (5–19 years) • 21,000 questionnaires to determine: • • • • •

Presence/absence of bedwetting Diurnal incontinence Wetting frequency Systemic illness Family history

Chung K et al. BJU International 2006;97:1069-1073

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Results: prevalence • 21,000 questionnaires

• 16,512 were completed • 512 children had PNE

78.6% 3.1%

210 ( 41%) 302 (59%)

Prevalence of PNE according to age: 5 years=16.1% 7 years=10.1% 9 years=3.1% 19 years=2.2% Chung K et al. BJU International 2006;97:1069-1073

• 21% - daytime wetting • Daytime wetting more in adolescents 29.2% vs 13.6% Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

ALSPAC study Avon Longitudinal Study of Parents And Children

Butler R et al. BJU International 2005;96:404-410

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

ALSPAC study • To determine the prevalence of NE • 13,971 infants followed at 7.5 yrs

73.5% (8269) Questionairres Returned • 1260 children wet the bed (15.5%) - most wet once or less a week • DSM IV criteria • 112 wet 2-5 times/week • 84 (1%) wet every night Butler R et al. BJU International 2005;96:404-410

2.6% 1.4% 1% Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

ALSPAC study •

More boys affected 20.2% vs. 10.5% • 266 children (3.3%) wet both day and night • 189 (2.3%) bedwetting + soiling • 28.9% - daytime urgency

Severity in 100 • 12 children wet less than once a week • 3 children wet at least twice a week • One child wet every night

At 7.5 yrs of age • 16 out of 100 children wet the bed • In a class of 30 children 4 or 5 children affected Butler R et al. BJU International 2005;96:404-410

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

ALSPAC study Conclusions • At 7.5 yrs high incidence 15.5%

• Only 2.6% met DSM IV criteria • Small percentage had both daytime wetting and bedwetting • Daytime urgency increased with severity of NE

Butler R et al. BJU International 2005;96:404-410

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Causes and Risk factors Genetics • 70% to 80% have affected relatives • Higher concordance rate in monozygotic twins than di-zygotic twins • Autosomal dominant mode of inheritance but 1/3 are sporadic • loci on chromosomes 8, 12, 13 and 22 have been identified in linkage studies

Von Gontard et al. J Urol. 2001;166:2438-2443.

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Genetics of Nocturnal Enuresis

•

43 - 44%

Von Gontard et al. J Urol. 2001;166:2438-2443.

Family history of bedwetting

77% Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

What is the impact? “I am furious, I want to punch myself and I want to give myself a black eye because I still wet the bed.” 7 year old, UK “I will be wearing nappies until I grow up.

I will never stop wetting my bed.”

Reproduced with permission of Dr C Yemula, Consultant Community Paediatrician, Bedfordshire.

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Low self-esteem • Feel different • Fear of being discovered • Avoid school trips

•

Moody • Ashamed • Embarrassed • Feels guilty

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Teasing and bullying at school Daytime wetting • 11-Year-old girl • ADHD, Asperger’s syndrome and daytime accidents • Teased at school “Stinky, Pyssi pants” • Parents changed the school

Reproduced with permission of Dr C Yemula, Consultant Community Paediatrician, Bedfordshire.

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Parental intolerance Punishment

Risk of emotional & physical abuse

• Parent shows concern for themselves / laundry costs • Believes the child is lazy • Thinks bedwetting is controllable • Prepared to punish the child

Can lead to drop out / early withdrawal from alarm treatment

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

How do parents feel? •

Guilty

• Embarrassed • Helpless • Stressed • Worried about their child Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

What do parents try?

Restrict fluids

• ‘Wait and Watch’ • ‘The child will grow out of it’ Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Severity of PNE versus age 20

3 / wk

Age 19

10.3%

14% 14.3%

30% 30%

89.7% > 3 / wk

56% 55.7%

48.3% 41.4%

2 lit/m2 Body Surface Area (BSA) • Nocturnal Polyuria - Excess urine at night More than 130% of Expected Bladder Capacity1 1.

Waking test

Pull up test

2.

Wet weight – dry weight + 1st morning wee 1. Butler R, Clinical Psychology Review 2004;24:909-931 2. Neveus et al. J Urol 2006;176:314-324.

Ideally 7 nights Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Bowel diary – 14 days • • • • • • •

Date of bowel action Spontaneous or prompted Shape of stool Any pain / straining Any bleeding Any soiling Previous call to stool ignored

The Bristol Stool Form Scale. The Rome Foundation (2009) Available at: http://www.theromefoundation.org/education/algorithm/pdfs/Recurrent_abdominal_pain_discomfort.pdf. Last accessed: 06/11/14

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Frequency – Volume Chart for 7 days

Name of the child ....................................................................................Date of birth............................ Date completed ...........................................................

Please mark time of measurement and indicate Bedtime

Urine volume

Day 1 Drink volume

Wet patch u/v/p

Urine volume

Day 2 Drink Volume

Wet Patch u/v/p

Day 3 Toilet Wet visit patch yes/no u/v/p

Day 4 Toilet Wet visit patch yes/no u/v/p

Day 5 Toilet Wet visit patch yes/no u/v/p

Day 6 Toilet Wet visit patch yes/no u/v/p

Day 7 Toilet Wet visit patch yes/no u/v/p

6 am 7 am 8 am 9 am 10 am 11 am 12 midday 1 pm 2 pm 3 pm 4 pm 5 pm 6 pm 7 pm 8 pm 9 pm 10 pm 11 pm Bowels opened Wet night

Yes or No

Wet patch - please indicate U (underpants only), V (visible on trousers), P (puddle on floor/chair) and add D (if child dashes to toilet) CY2011

Reproduced with permission of Dr C Yemula, Consultant Community Paediatrician, Bedfordshire.

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Pull-up test or waking test for at least 2 nights Day and date

Only if your child is wearing pull ups at night Pull up when Pull up dry when wet Weight in gm Weight in (A) gm (B)

1st morning urine volume in ml (C)

Always make sure your child passes urine before sleep time so that the bladder is empty Amount of urine produced at night time (B) Wet weight of pull up – (A) dry weight of pull up (1gm =1ml) + (C) 1st morning urine volume in ml E.g. (B – A) + C or C+D+E

Alternative waking test if your child is not wearing pull ups Waking your child at night a couple of times and measure urine volume in ml (for 2 nights only) Add up the volumes (D+E) + 1st morning wee (C)

Day 1 Date

1st time (D) = 2nd time (E) =

Day 2 Date

1st time (D) = 2nd time (E)=

Day 3 Date

Day 4 Date Day 5 Date Day 6 Date

Day 7 Date

CY2011

Reproduced with permission of Dr C Yemula, Consultant Community Paediatrician, Bedfordshire.

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Assessing severity

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Ultrasound scan findings •

• •

Residual volume >20ml Bladder wall thickness Renal duplication

Urodynamics • • •

Maximum flow rate Flow curve shape Cystometry

Neveus et al. J Urol 2006;176:314-324.

Bladder capacity – Residual volume Bladder capacity = > 90% normal

• Resistant cases

• H/O recurrent UTI

• Known or suspected neurological abnormality Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Summary Baseline chart History

Examination

Drinking and voiding chart

Apply three systems Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Treatment options Self-help measures

Education

Management of PNE Alarms

NICE clinical guideline 111. 2010

Medications

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

NICE guidelines Oct 2010 • Patient centred care • Inform – not the child’s fault, no punitive measures

• Don’t exclude children under 7 • Alarm / medication treatment – based on age, frequency of bedwetting, motivation and needs of child and family

NICE clinical guideline 111. 2010

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Advice for fluid intake • Adequate daily fluid intake is important for managing bedwetting

• Restrict drinks only in last hour before bed, if on desmopressin. • Caffeine-based drinks should be avoided

blackcurrant

NICE clinical guideline 111. 2010

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

NICE guidelines Oct 10 Advice on daily fluid intake Age (years)

Sex

Total drink intake per day (ml)

4–8

Female Male

1000 – 1400 1000 - 1400

9 - 13

Female Male Female Male

1200 - 2100 1400 - 2300 1400 – 2500 2100 - 3200

14 - 18

NICE clinical guideline 111. 2010

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Regular voiding

Advice

Avoid holding manoeuvres

Go to the toilet as soon as you feel the need  Regular intervals  Relax while passing urine 

NICE clinical guideline 111. 2010

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Other Self-help Measures

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

NICE guidelines Oct 10 Advice on lifting and waking • Will not promote long-term dryness • Waking in the short-term management only • Self waking in young people Before other treatments • Address abnormal fluid intake • Toileting patterns • Rewards NICE clinical guideline 111. 2010

Advice on reward systems • Explain that reward systems used alone or with other treatments Rewards may be given for • Fluids – drinking recommended levels • Toilet visit before sleeping • Helping to change bed sheet

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Sleep arousal disturbance underlies all nocturnal enuresis

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

What is an alarm? A battery operated device used in children with bedwetting problems

How does it work? • Alarm sounds when patient’s clothes or sheets become wet. • Improves arousal to a full bladder • Increase bladder capacity Evans et al. Journal of Pediatric Urology. 2011;7:21-29.

Bed Mat

Body Worn

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Enuresis alarm • Pad or metal sensor connected to a bell by a wire. • Sensor gets wet, closes the electrical circuit and sets the alarm off. • Child wakes and finishes voiding in the toilet. • Before returning to sleep the child must wipe down the sensor with a wet then a dry cloth and reset the alarm. Harari & Moulden. J.Paediatr. Child Health 2000;36:78-81. Hjalmas et al. J urol 2004;171:2545-2561

When is it useful? • Motivated child and family • Commitment of effort and time.

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

When is it not useful? • Bedwetting is very infrequent (less than 1 – 2 wet beds per week). • Parents or carers are having emotional difficulty coping with the burden of bedwetting . • Parents or carers are expressing anger, negativity or blame towards the child or young person. Result seen in about 3 weeks and continue until dry for 2 weeks Use up to 16 wks and review if no benefit NICE clinical guideline 111. 2010

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Monitoring • Result seen in about 3 weeks and continue until dry for 2 weeks • Signs of improvement – – – –

Smaller wet patch Less frequent and increasing interval Child wakes to alarm Dry nights

• Use up to 16 wks and review if no benefit NICE clinical guideline 111. 2010

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Alarm Progress Chart Alarm triggered

Dry bed Any comments

Date Time

Child woke up Yes / No

Size of wet patch Small/ medium/ large

Yes /No

• Monitor child’s progress • Provide support • Home visits by the nurse Signs of improvement – Smaller wet patch – Less frequent and increasing interval – Child wakes to alarm – Dry nights

Name of the child…………………………………………….. Date of Birth ……………………………………………………. Type of alarm- Bed mat / Body worn

Reproduced with permission of Dr C Yemula, Consultant Community Paediatrician, Bedfordshire. NICE clinical guideline 111. 2010

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Predictive factors for success Good motivation Tolerant parents Supportive family No daytime wetting

No multiple wetting at night Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Alarm success rates • Review articles 1980 – 2002 • 38 studies • Heterogeneity in terms of outcome parameters made comparison problematic but the most common definition of success was ‘14 consecutive dry nights’ and the most common relapse criterion was ‘> 1 wet night per week’. • Overall success rates across the studies 30-87% • Success 65% and relapse 42%

Those who respond 2/3 sleep through 1/3 develop nocturia

Butler et al. Scand J Urol Nephrol 2005:39:349-357 von Gontard A. Enuresis. In Rey JM (ed), IACAPAP e-Textbook of Child and Adolescent Mental Health. Geneva: International Association for Child and Adolescent Psychiatry and Allied Professions 2012. Hjalmas et al. J Urol 2004; 171: 2545-2561

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Current medication options

Desmopressin Oxybutynin Imipramine Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

How does desmopressin work? Plasma vasopressin levels

• Usually plasma vasopressin levels double at night. PNE can occur when this night time increase fails to happen1 • Desmopressin mimics the natural nocturnal antidiuretic effect of vasopressin and helps to normalise urinary output at night 2,3

1. Rittig S et al. Am J Physiol 1989;256 :F664-F671. 2. Van Kerrebroeck PEV. Br J Urol Int 2002;89:420-425. 3. Lawless MR Pediatrics in Review 2001;22(12): 399-406.

Urinary excretion rates

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

What are the benefits? • Immediate effect • Less wet nights • Can be used short and long term • Sleep-overs, school trips and holidays

Butler RJ, Holland P. Scand J Urol Nephrol 2000;34:270-277

When is it useful? • Family history of wetting • No daytime wetting • Infrequent wetting • Increased urine volume at night • Normal Functional Bladder Capacity Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Available formulations DesmoMelt and desmopressin tablets are licensed for the treatment of primary nocturnal enuresis (PNE) in children and adults aged 5 - 65yrs • Melt form - Desmomelt – 120 micrograms – 240 micrograms

• Desmopressin tablet - Desmotab – 0.2 mg tablet DesmoMelt SmPC June 2011 DesmoSpray SmPC June 2011

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Monitoring • Keep a diary to monitor fluid intake and output • Avoid use during vomiting / diarrhoea • Stop the medication for at least 1 week, once every 3 months¹ • Reassess to see if the child still needs it • Gradual withdrawal may be helpful – structured withdrawal over 8 weeks was successful in 70-74% cases2 1. NICE clinical guideline 111. 2010 2. Butler RJ , Holland P. J Urology 2001;166:2463-2466.

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Patient Preference (PALAT Study) Proportion of patients preferring melt or tablet formulation (%)

80

p=0.112

p=0.009

p=0.203

All (n=210)

50% reduction) 37.5 : 32.2

•

High rate of withdrawal in Alarm group

•

Both treatments are safe and effective

•

Child and parent’s preference to be considered for treatment

Evans et al. Journal of Pediatric Urology. 2011;7:21-29.

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

NICE guidelines Desmopressin Start DesmMelt 120 mcg or Desmotabs 0.2 mg at bedtime If not completely dry after 1 - 2 wks Increase the dose to 240 mcg / 0.4 mg

Assess response at 4 wks – smaller wet patches, fewer wetting episodes and fewer nights If partial / no response Give medication 1-2 hrs before bedtime Stop treatment if no response

If response + Continue for 3 months Withdraw to assess response

If partial response consider continuing for up to 6 months

NICE clinical guideline 111. 2010

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

DesmoMelt VS DesmoTabs • DesmoMelt -

-

higher peak urine osmolality longer duration of action

Prof Johan Vande Walle, Ghent University Study, 2010.

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

When to use combination treatments • If there is no response to initial treatment with an alarm, consider offering a combination of both alarm and desmopressin. • Consider an anticholinergic combined with desmopressin for children and young people who have been assessed by a healthcare professional with expertise in the management of bedwetting that has not responded to an alarm and/or desmopressin and have any of the following: – bedwetting that has partially responded to desmopressin alone – bedwetting that has not responded to desmopressin alone – bedwetting that has not responded to a combination of alarm and desmopressin

NICE clinical guideline 111. 2010

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

When to use combination treatments

DesmoMelt or Desmotabs + Alarm

NICE clinical guideline 111. 2010

DesmoMelt or Desmotabs + Anticholinergic drug e.g. oxybutynin

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

Summary Assessment using three systems

Educate the child and family Resources

Fluids, toileting and rewards

Alarm/medications

Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a

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. Adverse events should also be reported to Ferring Pharmaceuticals Ltd. Tel: 0844 9310050. Email: [email protected] Prescribing information can be found on the final slide Date of Preparation: November 2014 Job Bag No: MN/1214/2013/UK(1)a