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DESMOPRESSIN SPRAY 10 MICROGRAMS/DOSE NASAL SPRAY SOLUTION

Active substance(s): DESMOPRESSIN / DESMOPRESSIN / DESMOPRESSIN

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Package leaflet: Information for the user

Desmopressin Spray 10 micrograms/dose Nasal Spray solution
Desmopressin
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 Spray,
10 micrograms/dose, nasal spray, solution” (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

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• 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.

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.

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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).

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.

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 it 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.
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

5 How to store Desmopressin Spray

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.

Keep Desmopressin Spray out of the sight and
reach of children.
Store in the original package.
Do not store above 25°C.
Store in an upright position.
Do not use this medicine after the expiry date, which is
stated on the carton and label. The expiry date refers to
the last day of that month.
Discard 4 weeks after first opening. Do not throw away
any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no
longer use. These measures will help protect the
environment.

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme
(website: www.mhra.gov.uk/yellowcard). By reporting
side effects, you can help provide more information on
the safety of this medicine.

6 Contents of the pack and other information
What Desmopressin Spray contains:
• The active substance is desmopressin (as acetate
trihydrate) 100 micrograms/ml
• 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 nasal spray solution containing
100 micrograms desmopressin acetate trihydrate
per ml of solution.
Each spray delivers 10 micrograms of desmopressin
acetate trihydrate. The bottle contains 60 doses
(sprays). There will always be a small amount of fluid
left over in the bottle which it is not possible to use.
The spray is contained in a brown glass bottle fitted
with a metering pump.
Marketing Authorisation Holder:
NTC srl.
Via Luigi Razza, 3
20124 Milano,
Italy
Manufacturer:
Labiana Pharmaceuticals S.L.U.
Calle Casanova n. 27-31
08757 – Corbera de LLobregat, Barcelona
Spain
Distributor:
Aspire Pharma Ltd
Unit 4, Rotherbrook Court,
Bedford Road,
Petersfield,
Hampshire,
GU32 3QG
United Kingdom
This leaflet was last revised 11/2016
1690080-A00
1010111-P8.1

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Aspire Pharma Limited
Desmopressin Nasal Spray alternative version
10 micrograms/dose?
Black
Leaflet
432mm x 148mm
Yes
4 May 2010
Address and date change
8.1
31 October 2016
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8pt Helvetica Condensed
InDesign CS6
T962 (formerly R679)

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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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