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DESMOPRESSIN 10 MICROGRAMS/DOSE NASAL SPRAY

Active substance(s): DESMOPRESSIN ACETATE TRIHYDRATE / DESMOPRESSIN ACETATE TRIHYDRATE

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Package leaflet: Information for the user

Desmopressin 10 micrograms/dose Nasal Spray
(desmopressin acetate)
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again
• If you have further questions, ask your doctor or your pharmacist
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet:
1. What Desmopressin Spray is and what it is
used for
2. What you need to know before you take
Desmopressin Spray
3. How to take Desmopressin Spray
4. Possible side effects
5. How to store Desmopressin Spray
6. Contents of the pack and other information
The name of your medicine is “Desmopressin 10
micrograms/dose Nasal Spray” (referred to as
Desmopressin Spray throughout this leaflet).

1. What Desmopressin Spray is and what it
is used for
Desmopressin Spray contains the active
ingredient desmopressin which belongs to a group
of medicines called “posterior pituitary lobe
hormones, vasopressin and analogues”.
Desmopressin is very similar to a natural hormone
in the body which can reduce the amount of urine
that the body produces.
Desmopressin Spray is used to treat diabetes
insipidus; this is a condition which causes extreme
thirst and the production of large volumes of dilute
urine.
Desmopressin Spray can also be used to test how
well your kidneys are working.

2. What you need to know before you take
Desmopressin Spray
Do not take Desmopressin Spray:
• If you are allergic to desmopressin or any of the
other ingredients of this medicine (listed in
section 6)
• If you have primary polydipsia (compulsive
water drinking) or excessive thirst due to
alcohol abuse
• If you have or have had hyponatremia (low
levels of sodium in your blood)
• If you have heart failure or any other condition
requiring treatment with a diuretic medicine
(”water tablets”)
• If you have a condition known as “syndrome of
inappropriate secretion of diuretic hormone”
(your doctor will have told you if you have this
condition)
• If you have polyuria (producing too much
urine) which has not been diagnosed as
diabetes insipidus
• If you have Type IIb von Willebrand’s disease
(your doctor will have told you if you have this
disease)
• If you have thrombotic thrombocytopenic
purpura (TTP), a blood disorder causing small
blood clots to form in blood vessels around
the body (your doctor will have told you if you
have this disorder).
Warnings and precautions:
Talk to your doctor or pharmacist before taking
Desmopressin Spray. If any of the following apply
to you, tell your doctor or pharmacist so that they
can closely monitor your treatment and any
worsening of these conditions:
• If you have heart disease
• If you have problems with your kidneys
• If you have cystic fibrosis
• If you are pregnant or trying to become
pregnant
• If you have swelling or scarring on the lining
inside your nose.
It will be normal for your doctor to monitor your
bodyweight and blood pressure during treatment
with Desmopressin Spray.
If you suffer from vomiting and/or diarrhoea,
stop taking Desmopressin Spray until you feel
better.
Other medicines and Desmopressin Spray
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. The following medicines may increase
the effect of Desmopressin Spray and lead to side
effects:
• Clofibrate (for treatment of high cholesterol)
• Chlorpromazine (for schizophrenia)
• Carbamazepine (for epilepsy)
• Tricyclic antidepressants (for depression)
• Serotonin reuptake inhibitors (for depression)
• Non steroidal anti-inflammatory medicinal
products (for pains and inflammatory
conditions).
The following medicines may reduce the effect of
Desmopressin Spray:
• Glibenclamide (for diabetes)
• Lithium (for depression).

Desmopressin may increase the effects of some
medicines used to treat low blood pressure.
Desmopressin may reduce the effects of some
medicines used to treat high blood pressure.
Please tell your doctor if you are taking or have
recently taken any other medicines, including
medicines obtained without a prescription.
Desmopressin Spray with food and drink
Your doctor will tell you to reduce your fluid intake
while taking Desmopressin Spray to avoid your
body retaining too much fluid. Otherwise this can
lead to headache, nausea (feeling sick), tummy
cramps, and in severe cases it can cause fits.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
Driving and using machines
Desmopressin Spray has no known effect on the
ability to drive and use machines.

3. How to take Desmopressin Spray
Desmopressin Spray should only be used by the
nasal route. Always take Desmopressin Spray
exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure. The
recommended doses are given below.
Treatment of diabetes insipidus
Adults: 1 or 2 sprays each day (2 sprays should be
given as one spray into each nostril)
Children and Adolescents below 18 years: 1 spray
each day.
Your doctor may increase the dose to 4 sprays
each day (taken as one spray into each nostril, in
the morning and at bedtime).
To test how well your kidneys are working:
The dosage will depend on your weight and will
vary from 1 to 4 sprays.
Before using the spray, you will be asked to empty
your bladder. Samples of your urine will then be
taken at regular intervals after you have used the
spray. Your fluid intake will also be restricted
during the first 12 hours after using the spray.
Instructions for use:
Before using Desmopressin Spray for the first time,
you must prime the nozzle (i.e. fill it with the
medicine). To do this remove the protective cap.
Then hold the bottle upright (Figure 1) and pump
the nozzle up and down 3 times, spraying into the
air until an even mist is seen. Desmopressin Spray
is now ready to use.
1. Blow your nose. Remove the protective cap.
2. Hold the bottle as shown in Figure 2.
3. Tilt your head back and insert the tip of the
nozzle into your nostril, as shown. Spray into the
nostril while breathing in slightly. When pressing
the pump down, ensure that you apply even
pressure and press down quickly to produce a
consistent spray.
4. If necessary, spray into the other nostril in the
same way.
5. Wipe the nozzle with a clean tissue and replace
the protective cap. Store the bottle in an upright
position.

Figure 1

Figure 2

If the spray is not used within 7 days of the
previous dose, re-prime by pressing the
nozzle at least once before using.
Ensure that the dip-tube is in the liquid when
using Desmopressin Spray. Hold the bottle as
upright as possible when using (see figure 2).
Make sure you do not run out of
Desmopressin Spray
The nasal spray has been designed to deliver
60 sprays of your medicine. However, it has
also been designed to contain a ‘fill overage’
so there will always be a small amount of fluid
left over in the bottle which is not possible to
use. Please make sure that your nasal spray
is replaced in advance of you taking 60
sprays and within 4 weeks of first opening/
using the product so that you can be certain
that you will not run out of medicine,
especially if you have to re-prime the spray
between uses.
(continued overleaf)

If you take more Desmopressin Spray than you
should
Talk to your doctor or pharmacist straight away
and also reduce your fluid intake. An overdose of
this medicine can lead to headache, nausea
(feeling sick), tummy cramps, and in severe cases
it can cause fits.
If you forget to take Desmopressin Spray
Do not worry. Simply leave out that dose
completely and then take your next dose at the
right time. Do not take a double dose to make up
for a forgotten dose.
If you stop taking Desmopressin Spray
The symptoms may return that you had before
starting treatment.

4. Possible side effects
Like all medicines, this medicine can cause side
effects although not everybody gets them.
All medicines can cause allergic reactions,
although serious allergic reactions are very rare.
Tell your doctor straight away if you get any
sudden wheeziness, difficulty in breathing,
swelling of the eyelids, face or lips, rash or itching
(especially affecting your whole body).
If you suffer from a headache with nausea (feeling
sick) and/or vomiting, or you have a “fit”
(convulsion), contact your doctor straight away.
The following side effects have also been
reported:
Common side effects
(may affect up to 1 in 10 people):
• conjunctivitis (red eyes caused by an infection)
• asthenia (weakness)
Uncommon side effects
(may affect up to 1 in 100 people):
• nasal congestion
• epistaxis (nose bleeds)
• rhinitis (runny nose)
• nausea (feeling sick)
• abdominal cramps
• vomiting
• headache
Rare side effects
(may affect up to 1 in 1,000 people):
• cerebral oedema (water on the brain)
• hyponatremia (low levels of sodium in the
blood)
Very rare
(may affect up to 1 in 10,000 people):
• emotional disturbance (in cases of bedwetting)
• allergic reactions, e.g. pruritus (itching),
exanthema (rash)
• fever
• bronchospasms (difficulty in breathing or
wheezing)
• anaphylaxis (serious allergic reaction which
causes difficulty in breathing or dizziness).
Due to increased water reabsorption, blood
pressure may rise and in some cases
hypertension (high blood pressure) may develop.
If you suffer from coronary heart disease, chest
pain (angina) may occur.

These side effects, except for allergic reactions,
may be prevented or disappear if the
Desmopressin dose is reduced. Tell your doctor
straight away if you get any of these side effects.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Desmopressin Spray
Keep Desmopressin Spray out of the sight and
reach of children
Store in the original package.
Do not store above 25ºC.
Store in an upright position.
Discard 4 weeks after first opening.
Do not use after the expiry date stated on the
carton and the bottle label. The expiry date refers
to the last day of that month.
If your medicine shows any signs of deterioration,
consult your pharmacist who will tell you what to
do.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. Contents of the pack and other
information
What Desmopressin Spray contains:
• Each dose (spray) contains 10 micrograms of
desmopressin acetate trihydrate
• The other ingredients are citric acid
monohydrate, disodium phosphate dihydrate,
sodium chloride and purified water.
What Desmopressin Spray looks like and the
contents of the pack:
Your medicine is a clear, colourless nasal spray
solution containing 100 micrograms
desmopressin acetate trihydrate per ml of
solution.
The 6ml bottle contains 60 doses (sprays).
There will always be a small amount of fluid left
over in the bottle which is not possible to use.
The spray is contained in a brown glass bottle
fitted with a metering pump and a blue protective
cap.
PL holder
Manx Healthcare Ltd, Taylor Group House,
Wedgnock Lane, Warwick, CV34 5YA
PL 14251/0036
Procured from within the EU POM
Manufacturer
Alfa Wassermann S.p.A., Via Enrico Fermi,
1, 65020 Alanno (PE), Italy

To request a copy of this
leaflet in large print, audio
or Braille, please call 01926
482511.
This leaflet was last revised August 2017
WIP URN: 090817-GDE05-PIL-03

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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