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DESMOPRESSIN 0.1 MG/ML NASAL SPRAY

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

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PATIENT INFORMATION

Desmopressin Nasal Spray
desmopressin acetate
Read all of this leaflet carefully before you start
using this medicine.
Keep this leaflet, you may need to read it again.
If you have further questions, please ask your doctor
or pharmacist.
This medicine has been prescribed for you personally
and you should 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 if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
Important things you need to know:
Desmopressin Nasal Spray is used
- to treat patients with multiple sclerosis suffering
from nocturia (the need to get up at night to pass
urine), when others have failed
- to diagnose and treat cranial diabetes insipidus
(a condition that causes extreme thirst and the
continuous production of large volumes of
dilute urine)
- as a test to check if the kidneys are functioning
properly (renal function test)
You should avoid drinking large amounts of fluid while
you are being treated with Desmopressin Nasal Spray,
as this could lead to a build up of water which dilutes
the salt in the body. This is a serious problem and may
lead to convulsions.
If you experience unusually bad or prolonged
headache, confusion, unexplained weight gain, ankle
swelling, nausea or vomiting STOP USING
DESMOPRESSIN NASAL SPRAY. You should tell your
doctor immediately or go to the casualty department
at your nearest hospital.
Now read the rest of this leaflet. It includes other
important information on the safe and effective use of
this medicine that might be especially important for you.











In this leaflet:
1. What Desmopressin Nasal Spray is and what is it used for
2. Before you use Desmopressin Nasal Spray
3. How to use Desmopressin Nasal Spray
4. Possible side effects
5. How to store Desmopressin Nasal Spray
6. Further information

1. What Desmopressin Nasal Spray is and
what it is used for
Desmopressin Nasal Spray is a solution for nasal use only.
It contains Desmopressin acetate, an antidiuretic (reduces
urine production). It is used:
to treat patients with multiple sclerosis suffering from
nocturia (the need to get up at night to pass urine), when
other treatments have failed.
to diagnose and treat cranial diabetes insipidus
(a condition which causes extreme thirst and continuous
production of large volumes of dilute urine).
IMPORTANT: This should not be confused with diabetes
mellitus (sugar diabetes).
as a test to check if the kidneys are functioning properly
(renal function test).





2. Before you use Desmopressin
Nasal Spray
There are general restrictions, precautions and warnings
which apply to all patients using Desmopressin Nasal Spray
and there are additional restrictions, precautions and
warnings which apply depending on the use of
Desmopressin Nasal Spray.

General restrictions (all patients)
Do not use Desmopressin Nasal Spray if:
you have a serious heart or kidney disease
you are taking diuretics (water tablets)
you are allergic to any of the ingredients listed in section
6 of this leaflet
you drink unusually large quantities of fluids,
including alcohol.






You should avoid drinking large amounts of fluid while
you are being treated with Desmopressin Nasal Spray
as this could lead to a build up of water which dilutes
salt in the body. This is a serious problem and may lead
to convulsions.

General precautions and warnings (all patients)
Please consult your doctor before using Desmopressin
Nasal Spray if:
you have cystic fibrosis
you suffer from bladder problems e.g. incontinence
(inability to hold in urine), hesitance in starting
urination, frequent urination and/or urgent urination
you have difficulty or problems passing urine
you have an illness causing fluid and/or electrolyte
imbalance e.g. vomiting, diarrhoea, infections or fever
you have a medical condition that could be made worse
by fluid and/or electrolyte disturbance
Conditions where your blood sodium levels are too low
or you are likely to build up too much water in your body.









Additional restrictions, precautions and warnings:
In addition to the general restrictions, precautions and
warnings:
If you are a patient with nocturia (the need to get up at
night to pass urine) caused by multiple sclerosis:
Do not use Desmopressin Nasal Spray if:
you are over 65 years old
you are taking medication for high blood pressure or have
been told that your blood pressure is abnormal.




When using Desmopressin Nasal Spray:
fluid intake must be limited to a minimum from 1 hour
before taking the dose at bedtime until the following
morning (and, in any case, for at least 8 hours)
stop using Desmopressin Nasal Spray when suffering
from vomiting, diarrhoea, fever and/or infections until
you are better
avoid swallowing water while swimming to prevent a
build up of water in the body.





If you are using Desmopressin Nasal Spray for the
diagnosis of diabetes insipidus or for the renal
function test:
limit fluid intake to no more than 500ml, from 1 hour
before until 8 hours after the dose.



Patients being treated with Desmopressin Nasal
Spray for any of the conditions listed in this leaflet
Taking/using other medicines:
Please inform your doctor or pharmacist if:
you are taking or have recently taken or used any other
medicines, even those not prescribed
you are on medication for depression or epilepsy
you are taking a medicine for pain and/or inflammation
containing non-steroidal anti-inflammatory drugs
(also known as NSAIDs) e.g. indometacin.





Pregnancy
If you are pregnant or planning a pregnancy, please inform
your doctor before you use Desmopressin Nasal Spray as
blood pressure monitoring is recommended due to the
increased risk of pre-eclampsia (a condition in pregnant
women that can cause serious complications). Symptoms
of pre-eclampsia include high blood pressure, oedema
(swelling due to the build up of fluid) and proteinuria
(protein in the urine).
Breast-feeding
If you are breast-feeding ask your doctor or pharmacist for
advice before using Desmopressin Nasal Spray.
Important information about some of the ingredients
in Desmopressin Nasal Spray
Desmopressin Nasal Spray contains Benzalkonium
Chloride which may cause bronchospasm (when your
breathing airway suddenly narrows, causing coughing
and difficulty in breathing).

3. How to use Desmopressin Nasal Spray

4. Possible side effects

PATIENT INSTRUCTIONS
It is important to use your medicine as directed by your
doctor. The pharmacy label on the bottle will tell you when
to use your medicine and how much to use. If it does not, or
you are not sure, ask your doctor or pharmacist.

Like all medicines, Desmopressin Nasal Spray can cause
side effects.
You should avoid drinking large amounts of fluid while
you are being treated with Desmopressin Nasal Spray,
as this could lead to a build up of water which dilutes
salt in the body. This is a serious problem and may lead
to convulsions.
STOP USING Desmopressin Nasal Spray if you
experience:
unusually bad or prolonged headache, confusion,
unexplained weight gain, ankle swelling, nausea
or vomiting
itching, skin rashes, swelling of the face, lips or throat,
difficulty in breathing, wheeziness, chest tightness or
coughing (signs of allergic reactions)
If you experience any of the above side effects, you should
contact your doctor or go to the nearest casualty
department immediately.
Most people using Desmopressin Nasal Spray find it
causes them no problems. However, common side effects
can include:
headache
stomach pain
blocked or runny nose, nose bleeds
Very rare cases of emotional disorders including
aggression in children have also been reported.
If you experience one or more of these side effects or
any other undesirable effects, please inform your doctor
or pharmacist.

How to use Desmopressin Nasal Spray
1. Remove the protective cap.
2. When first used, prime the spray
by pressing several times until a
consistent, fine spray is seen.
3. Ensure that the dip-tube is in the
liquid when using Desmopressin
Nasal Spray. With your head tilted
slightly back, place the nozzle
just inside the nostril.
4. Hold your breath (DO NOT SNIFF)
and press the spray once.
5. Repeat this procedure using
alternate nostrils until the
prescribed dose is reached.
6. Replace the protective cap
after use.
7. Do not store above 25°C. Keep the
container in the outer carton.
8. If the spray is not used within 7
days of the previous dose, re-prime
by pressing the spray at least once
before using.
Do NOT use more than the prescribed dose in any
24 hour period.
If you have the impression that the effect of Desmopressin
Nasal Spray is too strong or too weak, talk to your doctor
or pharmacist.

The usual doses are:
Nocturia (the need to get up at night to pass urine)
caused by multiple sclerosis:
Your doctor will prescribe a dose of one or two sprays at
bedtime. If your dose is two sprays, use one spray in each
nostril. The prescribed dose should NOT be used more than
once in any 24 hour period. Your doctor will check your
blood pressure and weight at regular intervals.
Diagnosis of diabetes insipidus (adults and children)
Your doctor will prescribe a dose of two sprays. Use one
spray in each nostril.
Treatment of diabetes insipidus
Your doctor will prescribe the dose most suitable for you.
The most common dosing in adults and children is one or
two sprays into the nostril, once or twice daily. Use one spray
in each nostril if your dose is two sprays.
Renal function test
To check if the kidneys are functioning properly, your doctor
will prescribe the following single dose:
Adults: Two sprays into each nostril
Children (1-15 years): One spray into each nostril
Infants (to 1 year): One spray into one nostril

If you use more Desmopressin Nasal Spray than
you should
If you have used more Desmopressin Nasal Spray than you
should, talk to your doctor or pharmacist immediately.
If you forget to use Desmopressin Nasal Spray
Do not use a double dose to make up for a forgotten dose.
If you are a patient with nocturia caused by multiple
sclerosis, do not use Desmopressin Nasal Spray until the
usual time for your next dose.
If you are a patient with diabetes insipidus, please consult
your doctor or pharmacist for advice.








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.

5. Storing Desmopressin Nasal Spray
Keep Desmopressin Nasal Spray out of the reach and sight
of children.
Do not store above 25°C. Keep container in the outer carton.
Use by date: Do NOT use Desmopressin Nasal Spray past
the expiry date on the packaging. The expiry date refers to
the last day of that month.
If you are unsure about the storage, ask your pharmacist.
It is best to return all old and unused medicines to your
pharmacist for safe disposal.

6. Further information
Your medicine is called Desmopressin Nasal Spray. It is a
solution for nasal use only.
It is presented in a glass vial with a pump spray device.
Each vial contains a volume of 6ml to allow the delivery
of 60 sprays
Each spray contains 10 micrograms of the active
ingredient, Desmopressin acetate
Other ingredients in Desmopressin Nasal Spray are
citric acid monohydrate, disodium phosphate
dihydrate, sodium chloride, benzalkonium chloride
solution 50% and purified water.





Marketing Authorisation Holder:
Ferring Pharmaceuticals Ltd
Drayton Hall, Church Road, West Drayton, UB7 7PS, UK
Manufacturer:
Ferring GmbH
Wittland 11, D-24109 Kiel, Germany
Distributor:
Aspire Pharma Limited
Unit 4, Rotherbrook Court, Bedford Road, Petersfield,
Hampshire, GU32 3QG, United Kingdom
Desmopressin Nasal Spray PL 03194/0090
This leaflet was last revised in February 2017

1010307-P2.2

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Aspire Pharma Limited
Desmopressin Nasal Spray
PL 03194/0090
Leaflet
370mm x 180mm
Dimensions supplied
3 August 2015
Revisions to line breaks
2.2
7 February 2017
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9.5pt FF Strada Condensed
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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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