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DESMOPRESSIN SPRAY 10 MICROGRAMS/DOSE NASAL SPRAY SOLUTION

Active substance(s): 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.
• 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. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects gets serious, or you notice any side effects not listed in this leaflet,
tell your doctor or pharmacist.

In this leaflet:

Pregnancy and breast-feeding

1 What Desmopressin Spray is and what it is used for.
2 Before you take Desmopressin Spray.
3 How to take Desmopressin Spray.
4 Possible side effects.
5 How to store Desmopressin Spray.
6 Further information.
The name of your medicine is “Desmopressin Spray,
10 micrograms/dose, nasal spray, solution” (referred to
as Desmopressin Spray throughout this leaflet).

Tell your doctor or pharmacist:
• if you are pregnant or trying to become pregnant
• if you are breast-feeding or planning to start
breast-feeding.

Driving and using machines
Desmopressin Spray has no known effect on the ability
to drive and use machines.

3 HOW TO TAKE Desmopressin Spray
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.

Desmopressin Spray should only be used by the nasal
route. Always take Desmopressin Spray exactly as your
doctor has told you. You should check with your doctor
or pharmacist if you are not sure. The usual doses are
given below.

Treatment of diabetes insipidus
Adults: 1 or 2 sprays each day (when taking 2 sprays
use a different nostril for each spray).
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).

2 BEFORE YOU TAKE Desmopressin Spray
Do not take Desmopressin Spray:

To test how well your kidneys are working:

• If you are allergic (hypersensitive) to desmopressin.
• If you are allergic to any of the other ingredients in
the spray (these are listed in Section 6, Further
information).
• 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).

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.

• 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)

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.
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.

Take special care with 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.

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.

Make sure you do not run out of Desmopressin
Nasal 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
Taking Desmopressin Spray with food and drink amount of fluid left over in the bottle which it is not
possible to use. Please make sure that your nasal spray
Your doctor will tell you to reduce your fluid intake while is replaced in advance of you taking 60 sprays and
taking Desmopressin Spray to avoid your body retaining within 4 weeks of first opening/using the product so
too much fluid. Otherwise this can lead to headache,
that you can be certain that you will not run out of
nausea (feeling sick), tummy cramps, and in severe
medicine, especially if you have to re-prime the spray
cases it can cause fits.
between uses.

Taking 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.

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, Desmopressin Spray can sometimes
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
(probably affecting up to 1 in 10 people):
• Conjunctivitis (red eyes caused by an infection)
• asthenia (weakness)
Uncommon side effects
(probably affecting fewer than 1 in 100 people):
• Nasal congestion
• epistaxis (nose bleeds)
• rhinitis (runny nose)
• nausea (feeling sick)
• abdominal cramps
• vomiting
• headache
Rare side effects
(probably affecting fewer than 1 in 1,000 people):
• Cerebral oedema (water on the brain)
• hyponatremia (low levels of sodium in the blood)
Very rare
(probably affecting fewer than 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.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

Do not use after the expiry date stated on the carton
and label. The expiry date refers to the last day of
that month.

6 FURTHER 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 6ml 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:
PH&T S.p.A
Via Marostica, 1
I - 20146 Milan
Italy

Manufacturer:
Alfa Wassermann S.p.A
Via Enrico Fermi, 1
65020 Alanno (PE)
Italy

Distributor:
Aspire Pharma Ltd
Bellamy House,
Winton Road,
Petersfield,
Hampshire,
GU32 3HA
United Kingdom
04/2013

5 HOW TO STORE Desmopressin Spray
Keep Desmopressin Spray out of the reach and
sight of children.
Store in the original package.
Do not store above 25°C.
Store in an upright position.
Discard after 4 weeks from first opening.

01193620
1010111-P4.1

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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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