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DESMOPRESSIN NASAL SPRAY 10 MICROGRAMS/DOSE

Active substance(s): DESMOPRESSIN ACETATE

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Desmopressin Nasal Spray
10 micrograms/dose
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• 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 you have any further questions, ask your doctor or pharmacist.
•  If you have any of the side effects, or if you notice any side effects not
listed, please tell your doctor or pharmacist.

In this leaflet:
1 What Desmopressin is and what it is 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 is and what it is used for

The ingredient that makes the spray work (the active substance) is called
desmopressin. Desmopressin is an antidiuretic, which reduces the amount of
urine produced by the kidneys.
Desmopressin nasal spray is used to:
• treat and diagnose a chronic disease called diabetes insipidus which causes
extreme thirst and continuous production of large volumes of dilute urine.
Important: Not to be confused with diabetes mellitus (sugar diabetes)
• treat frequent urination during the night in adults (nocturia) associated
with multiple sclerosis
• investigate kidney function.

2 Before you use Desmopressin nasal spray

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Do not use Desmopressin nasal spray if you:

• are allergic (hypersensitive) to desmopressin or any of the other ingredients
in Desmopressin nasal spray (see section 6)
• drink unusually large amounts of fluid (polydipsia)
• suffer from heart problems, high blood pressure or other diseases
needing treatment with diuretics (water tablets)
• are elderly (over the age of 65 years)
• suffer with alcohol abuse.
• have moderate or severe kidney problems
• have been told you have hyponatraemia (very low levels of sodium in
your blood)

• have syndrome of inappropriate ADH secretion (SIADH).

Check with your doctor or pharmacist before
using Desmopressin nasal spray if you have:

• kidney disease or bladder problems
• cystic fibrosis
• a medical condition causing fluid and/or electrolyte imbalance in the
body (with symptoms such as being sick, diarrhoea, fever)
• increased pressure in the skull (intracranial pressure)
• are elderly or have low sodium levels in your blood
• are on a low potassium diet.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
Especially:
• tricyclic antidepressants (used to treat depression e.g. amitriptyline or
imipramine)
• carbamazepine (used to treat epilepsy)
• chlorpromazine (used to treat psychosis or schizophrenia)
• indomethacin (painkillers called non-steroidal anti-inflammatory drugs
(NSAIDs)).

Fluid intake

• Before you start treatment with this medicine, your doctor should give you
advice about fluid intake.
• When using this medicine for nocturia or to investigate kidney function,
keep your fluid intake to a minimum from 1 hour before a dose until 8
hours after a dose.
• Too much fluid intake may lead to a build up of water, which dilutes the
salt in the body. This can occur with or without warnings or symptoms,
which include unusually bad or prolonged headache, feeling or being sick,
unexplained weight gain and in serious cases, fits or swelling of the brain.
If you have any of these symptoms, stop the treatment and contact your
doctor at once.

Pregnancy and breastfeeding

Desmopressin nasal spray can be used during breastfeeding but should only
be used in pregnancy as directed by a doctor.
Ask your doctor or pharmacist for advice before taking any medicine.

Important information about one of the ingredients of
Desmopressin nasal spray

This medicine contains 0.042mg potassium per dose. To be taken into
consideration by patients with reduced kidney function or patients on a
controlled potassium diet.

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Pharacode

Desmopressin Nasal Spray Solution 10mcg 6ml Bottle PIL - UK
item no: AAAH6238

dimensions: 150 x 170

print proof no: 4

pharmacode:

origination date: 30.01.15

min pt size: 7

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 20.05.15

Technical Approval

revised by: S.Anson

date sent: 30.01.15

supplier: Cipla

technically app. date: 20.05.15

Non Printing Colours
1. Pharmacode
2.
3.

Pharacode

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Tests

Your blood pressure and weight may be monitored whilst you are using this
medicine.

3 How to use Desmopressin nasal spray

Always use Desmopressin nasal spray exactly as your doctor has told you. If
you are not sure, check with your doctor or pharmacist.
Usual doses: Where 2 sprays are required you should give 1 spray into each
nostril unless directed otherwise.
• Nocturia
Adults under 65 years old- 1 or 2 sprays at bedtime. Do not repeat the
dose in a 24 hour period. Do not drink for 8 hours after using the spray
except to satisfy thirst.
• Diabetes insipidus
Treatment: Adults and children – 1 or 2 sprays once or twice a day.
Diagnosis: Adults and children – 2 sprays.
• To investigate kidney function
Adults – 2 sprays into each nostril
Children aged 1 – 15 year old – 1 spray into each nostril
Children under 1 year old – 1 spray
When using this medicine for diabetes insipidus or kidney function
investigations keep your fluid intake to a minimum (not more than 0.5 litres)
from 1 hour before a dose until 8 hours after a dose.

Instructions for use:
1. B low your nose, then remove the dust cap on the spray
bottle.
2. To ensure the correct dose, it is important that the bottom
of the plastic tube inside the bottle is covered with the fluid.
Before you use the spray for the first time, the pump must
be filled. To do this, press the pump down 5 times or until
you get a fine mist. The spray is then ready for use. If the
nasal spray is not used daily, the pump has to be filled again
before use.
3. Hold the spray bottle as shown in the picture.
4. Tilt your head back slightly and insert the tip of the spray
into the nostril. Hold your breath without sniffing. Press
the spray once. If you have to take more than one dose,
alternate between the right and left nostril.

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5. Replace the dust cap. Store the bottle at room temperature.

If you use more Desmopressin nasal spray than you should

An overdose may lengthen the effect of desmopressin and increase the risk
of water build up in the body and low blood salt, symptoms include fits. If you
use more Desmopressin nasal spray than prescribed, contact your doctor,
pharmacist or the nearest hospital at once.

If you forget to use Desmopressin nasal spray

Do not use a double dose to make up for a forgotten dose.

If you stop using Desmopressin nasal spray

You should only change or stop your treatment if advised by your doctor.

4 Possible side effects

Like all medicines, Desmopressin nasal spray can cause side effects, although
not everybody gets them.
Stop using the spray and tell your doctor as soon as possible if you
have any of the following symptoms:
• itching, skin rashes, swelling of the face, lips or throat, difficulty in
breathing - they may be a sign of an allergic reaction.
• s ymptoms of a build up of water in the body, reducing the amount of
salt in the body: unusually unexplained weight gain, headache, feeling and /
or being sick, and in serious cases, fits or brain swelling.
Other effects which have been reported include:
• unusual changes in moods (aggression has been reported in children)
• tummy pain, blocked or runny nose, nosebleeds.
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 nasal spray

Keep out of the reach and sight of children.
Store Desmopressin nasal spray below 25°C.
Do not use Desmopressin nasal spray after the expiry date, stated on the pack.
Always return any left over medicine to you pharmacist.

6 Further information

What Desmopressin nasal spray contains

• the active substance (the ingredient that makes the spray work) is
desmopressin acetate. Each spray contains 10micrograms (0.1mg in 1ml) of
the active substance.
• the other ingredients are potassium sorbate, sodium chloride, hydrogen
chloride and purified water.

What Desmopressin nasal spray looks like and contents of the pack
Desmopressin nasal spray is a solution in an amber, glass bottle with a nasal
applicator.
Pack size 6ml.
Marketing Authorisation Holder
Actavis Group PTC ehf., Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
Manufacturer
Balkanpharma-Dupnitsa AD, 3, Samokovsko shosse Str., 2600 Dupnitsa, Bulgaria
Distributor
Actavis, Barnstaple, EX32 8NS, UK
This leaflet was last revised in January 2015.

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AAAH6238

Actavis, Barnstaple, EX32 8NS, UK

Pharacode

Desmopressin Nasal Spray Solution 10mcg 6ml Bottle PIL - UK
item no: AAAH6238

dimensions: 150 x 170

print proof no: 4

pharmacode:

origination date: 30.01.15

min pt size: 7

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 20.05.15

Technical Approval

revised by: S.Anson

date sent: 30.01.15

supplier: Cipla

technically app. date: 20.05.15

Non Printing Colours
1. Pharmacode
2.
3.

Pharacode

Pharacode

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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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