DESMOPRESSIN 360 MICROGRAMS/ML ORAL SOLUTION

Active substance: DESMOPRESSIN ACETATE

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Desmopressin 360 micrograms/ml oral solution

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Desmopressin 360 micrograms/ml oral 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 any further questions, ask your doctor or 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 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 360 micrograms/ml oral solution is and what it is used for
2.
What you need to know before you take Desmopressin 360 micrograms/ml oral
solution
3.
How to take Desmopressin 360 micrograms/ml oral solution
4.
Possible side effects
5.
How to store Desmopressin 360 micrograms/ml oral solution
6.
Contents of the pack and other information
1.

What Desmopressin 360 micrograms/ml oral solution is and what it is used
for

The ingredient that makes Desmopressin work (the active substance) is called
desmopressin. Desmopressin is very similar to a substance that is produced naturally in
the body (the pituitary hormone vasopressin), which temporarily reduces the amount of
urine produced by the body. This medicine is intended for oral use only.
Desmopressin is used to treat:
- Central diabetes insipidus, a desease characterised by causing extreme thirst and
continuous production of large volumes of dilute urine as a result of an insuficient
production of the hormone vasopressin.
- Bed-wetting (involuntary nightly urination or primary nocturnal enuresis) in
patients older than 5 years with normal capacity of concentrate urine.

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What you need to know before you take Desmopressin 360 micrograms/ml
oral solution

Do not take Desmopressin :
-

if you are allergic (hypersensitive) to desmopressin or any of the other
ingredients of this medicine (listed in section 6).
if you drink unusually large amounts of fluid (have habitual or psychogenic
polydipsia)
if you take medicines which increase urine production (diuretics),
if you suffer from heart problems.
If you suffer predisposition or have low level of sodium in your blood
(hyponatremia)
if you suffer from reduced kidney function
if you have uncontrolled blood pressure
if you suffer from the “Syndrome of Inappropriate high Secretion of Antidiuretic
Hormone” (SIADH)

Warnings and precautions
Talk to your doctor or pharmacist before taking Desmopressin
When taking Desmopressin, avoid excessive fluid intake because it may lead to a build
up of water in the body and/or decrease in blood sodium with or without side effects
(see section 4 – Possible side effects).
Special care with Desmopressin is required to avoid build up of water in the body and
decreased blood sodium:
-

-

If you are elderly
If you have a medical condition causing fluid and/or electrolyte imbalance in
the body, such as an infections, fever, stomach upset If you suffer from a serious
bladder problem or impaired urine outflow
If you suffer from asthma, epilepsy and migraine
If you have reduced renal function and / or cardiovascular disease. In
chronic renal disease the antidiuretic effect of Desmopressin would be less than
usual.

Other medicines and Desmopressin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, especially:




tricyclic or SSRI antidepressants (used to treat depression)
carbamazepine (used to treat epilepsy)
chlorpromazine (used to treat psychosis or schizophrenia)
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medicines for pain and/or inflammation called non-steroidal antiinflammatory drugs (NSAIDs) e.g. indometacin, ibuprofen, acetylsalicylic acid.
loperamide (used to treat diarrhoea),
diuretic agents.

These medicinal products increase the risk of build up of water, which dilutes the salt in
the body.


Dimeticone (used in the treatment of due to intestinal gas), due to decreased
absorption of desmopressin.

Desmopressin with food and drink
At low doses, Desmopressin may be affected by food intake. If you notice that
Desmopressin is less effective, then you should take medicine without food before
increasing the dose.
When using this medicine for bed-wetting keep your fluid intake to a minimum from
1 hour before you take the Desmopressin dose until 8 hours after a dose.
Pregnancy, breast-feeding and fertility
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.
It is preferable to avoid using Desmopressin during pregnancy.
Desmopressin passes into breast milk. If you are going to be treated with desmopressin,
you should stop breast-feeding.
Driving and using machines
Desmopressin does not affect your ability to drive and use machines.
Important information about some of the ingredients of Desmopressin
This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate,
which may cause allergic reactions (possibly delayed).
3.

How to take Desmopressin 360 micrograms/ml oral solution

Always take this medicine exactly as your doctor has told you. Check with your doctor
or pharmacist if you are not sure.

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Usual doses
Treatment of central diabetes insipidus:
Adults and Children: Your doctor will prescribe the dose most suitable for you. The
usual starting dose is 0.25 ml (90 micrograms) three times daily. Subsequently, the
doctor will adjust the dose according to individual patient response. The usual daily
dose is between 0.5 ml (180 micrograms) to 3 ml (1080 micrograms) of Desmopressin.
The maintenance dose ranges from 0.25 to 0.5 ml (90 – 180 micrograms) of
Desmopressin three times per day.
It is important to note if symptoms of build up of water in the body and / or decreased
blood sodium appear (see section 4 – Possible side effects). If so, treatment will be
stopped and the dose will be changed.
Bed-wetting (involuntary nightly urination or primary nocturnal enuresis) in
patients older than 5 years:
Adults and Children: The usual starting dose is 0.5 ml (180 micrograms) of
Desmopressin one hour before bedtime. The dose may be increased up to 1 ml (360
micrograms) of Desmopressin if the starting dose is not enough. The need for continued
treatment is normally checked every three months by introducing a treatment free period
of at least one week.
Elderly: If the doctor decides to treat you, your blood sodium levels should be measured
before and three days after starting the treatment and if the dose is increased or at any
time your doctor finds it necessary.
Monitoring the fluid intake is important. If symptoms of build up of water in the body
and / or decreased blood sodium (see section 4 – Possible side effects), discontinue
treatment. Once treatment is restored, fluid intake will be rigorously controlled.
Instructions for use:
1. Open the bottle (in the first opening the seal is broken).

2. Insert the oral syringe into the pourer and turn the bottle upside down to fill it with
the dose to be administered.

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3. Take the oral syringe out of the bottle and check to see that the correct amount
appears in the bottom of the syringe.
4. Hold the syringe to your mouth and release the dose into your mouth.

5. Rinse with water after each use and close the bottle. Keep the bottle in the outer
carton to protect from light.

If you take more Desmopressin than you should
An overdose may lengthen the effect of desmopressin and increase the risk of water
build up in the body and / or low levels of sodium in your blood. Symptoms may
include headache, nausea and vomiting, weight gain and in severe cases convulsions. It
is recommended to stop the treatment, restrict fluids intake and a symptomatic treatment
if necessary.
If you take more Desmopressin than prescribed, contact your doctor or pharmacist
immediately.
If you forget to take Desmopressin
Do not take a double dose to make up for a forgotten dose.
If you stop taking Desmopressin
Do not stop taking Desmopressin before completing the treatment as it may not have the
expected effect. You should only change or stop your treatment if advised by your
doctor
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets
them.

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Stop taking Desmopressin and see a doctor or go to a hospital straight away if the
following occur:
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Common (occurs in less than 1 in 10 users): symptoms of a build-up of water in
the body such as unusually bad or prolonged headache, feeling or being sick,
unexplained weight gain and in serious cases, fits, unconsciousness.

-

Very rare (occurs in less than 1 in 10,000 users): allergic reactions such as rash,
itching, fever, swelling of your lips, face, throat or tongue causing difficulties in
swallowing or breathing.

Tell you doctor or pharmacist if you notice any of the following other side effects:
-

Very common (occurs in more than 1 in 10 users): headache.
Common (occurs in less than 1 in 10 users): abdominal pain, nausea.
Very rare (occurs in less than 1 in 10,000 users): emotional disturbances in
children, allergic reactions.

If you get any side effects, talk to your doctor or pharmacist. This includes any
posssible affects not listed in this leaflet. You can also report side effects directly via
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 360 micrograms/ml oral solution

Keep this medicine out of the sight and reach of children
Do not store above 30ºC. Store in the original package.
After first opening the product should be stored below 25ºC for up to 4 weeks.
Do not take this medicine after the expiry date which is stated on the label and carton
after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via waterwater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will help
protect the environment.

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Contents of the pack and other information

What Desmopressin contains



The active substance is desmopressin. Each ml of the oral solution contains 360
micrograms of desmopressin (as acetate).
The other ingredients are:
o
o
o
o

sodium methyl parahydroxybenzoate (E-219),
sodium propyl parahydroxybenzoate (E-217),
hydrochloric acid (for pH adjustment) and
purified water.

What Desmopressin looks like and contents of the pack
Desmopressin is a clear solution filled into an amber glass bottle and capped with low
density polyethylene (LDPE) pourer, provided with a high density polyethylene
(HDPE) screw cap. The bottle contains 15 ml of solution. A graduated 1.5 ml dosing
syringe is supplied in each pack. The syringe is graduated from 0 to 1.5 ml, with
divisions of 0.1 ml. The graduation corresponding to the doses of 0.25 ml, 0.5 ml and
1.0 ml are specifically marked.
Marketing Authorisation Holder and Manufacturer
Holder
GP-Pharm, S.A.
Polígono Industrial Els Vinyets – Els Fogars, sector 2
Carretera Comarcal C244, Km 22,
08777 – Sant Quintí de Mediona (Barcelona) SPAIN
Tel: +34 93 8192200
Fax: +34 93 8192210
Manufacturer
Laboratorio Reig Jofré S.A.
Gran Capità 10
08970 Sant Joan Despí – Barcelona
Spain
This leaflet was revised in 12/2013
Other sources of information
Detailed information on this medicine is available on the web-site of
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United Kingdom/Medicines and Healthcare Products Regulatory Agency.

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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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