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DESMOPRESSIN 360 MICROGRAMS/ML ORAL SOLUTION

Active substance(s): DESMOPRESSIN ACETATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Desmopressin 360 micrograms/ml
oral solution
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

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
The ingredient that makes
an infections, fever, stomach
Desmopressin oral solution work
upset. If you suffer from a
(the active substance) is called
serious bladder problem or
desmopressin. Desmopressin
impaired urine outflow
is very similar to a substance
• If you suffer from asthma,
that is produced naturally in
epilepsy and migraine
the body (the pituitary hormone
• If you have reduced renal
vasopressin), which temporarily
function and / or
reduces the amount of urine
cardiovascular disease. In
produced by the body. This medicine
chronic renal disease the
is intended for oral use only.
antidiuretic effect of
Desmopressin would be less than
Desmopressin is used to treat:
usual.
• Central diabetes insipidus, a
Other medicines and
disease characterised by causing
Desmopressin
extreme thirst and continuous
production of large volumes
Tell your doctor or pharmacist if you
of dilute urine as a result of
are taking, have recently taken or
an insuficient production of
might take any other medicines,
the hormone vasopressin.
especially:
• Bed-wetting (involuntary nightly
• tricyclic or SSRI
urination or primary nocturnal
antidepressants (used to treat
enuresis) in patients older than
depression)
5 years with normal capac• carbamazepine (used to treat
ity of concentrate urine.
epilepsy)
• chlorpromazine (used to treat
psychosis or schizophrenia)
2. What you need to
know before you take • medicines for pain and/or
inflammation called non Desmopressin
steroidal anti-inflammatory drugs
360 micrograms/ml
(NSAIDs) e.g. indometacin,
oral solution
ibuprofen, acetylsalicylic acid.
• loperamide (used to treat
Do not take Desmopressin:
diarrhoea),
• diuretic agents.
• if you are allergic (hypersensitive) to desmopressin or any of
These medicinal products increase
the other ingredients of this
the risk of build-up of water, which
medicine (listed in section 6).
dilutes the salt in the body.
• if you drink unusually large
amounts of fluid (have habitual or
• Dimeticone (used in the
psychogenic polydipsia)
treatment of due to intestinal
• if you take medicines which
increase urine production
gas), due to decreased
(diuretics),
absorption of desmopressin.
• if you suffer from heart
problems.
Desmopressin with food and
• If you suffer predisposition or
drink
have low level of sodium in your
blood (hyponatremia)
At low doses, Desmopressin may be
• if you suffer from reduced kidney affected by food intake. If you notice
function
that Desmopressin is less effective,
• if you have uncontrolled blood
then you should take medicine
pressure
without food before increasing the
• if you suffer from the “Syndrome dose.
of Inappropriate high Secretion of
Antidiuretic Hormone” (SIADH)

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 breastfeeding, 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.
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:

If you have any further questions on • The other ingredients are:
the use of this medicine, ask your
– sodium methyl
doctor or pharmacist.
parahydroxybenzoate (E219),
– sodium propyl
parahydroxybenzoate (E217),
4. Possible side effects
– hydrochloric acid (for pH
adjustment) and
Like all medicines, this medicine
– purified water.
can cause side effects, although not
everybody gets them.
What Desmopressin looks like
and contents of the pack
Stop taking Desmopressin and see
Elderly: If the doctor decides to treat a doctor or go to a hospital straight Desmopressin is a clear solution
you, your blood sodium levels
away if the following occur:
filled into an amber glass bottle and
should be measured before and
capped with low density
three days after starting the
• Common (occurs in less than 1
polyethylene (LDPE) pourer, provided
treatment and if the dose is
in 10 users): symptoms of a
with a high density polyethylene
increased or at any time your doctor
build-up of water in the body
(HDPE) screw cap. The bottle
finds it necessary.
such as unusually bad or
contains 15 ml of solution. A
prolonged headache, feeling or
graduated 1.5 ml dosing syringe is
Monitoring the fluid intake is
being sick, unexplained weight
supplied in each pack. The syringe
important. If symptoms of the
gain and in serious cases, fits,
is graduated from 0 to 1.5 ml, with
build-up of water in the body and /
and unconsciousness.
divisions of 0.1 ml. The graduation
or decreased blood sodium occur
corresponding to the doses of 0.25
(see section 4 – Possible side
• Very rare (occurs in less than 1 ml, 0.5 ml and 1.0 ml are
effects), discontinue treatment.
in 10,000 users): allergic
specifically marked.
Once treatment is restored, fluid
reactions such as rash, itching,
intake will be rigorously controlled.
fever, swelling of your lips, face, Marketing Authorisation Holder
throat or tongue causing
and Manufacturer
Instructions for use:
difficulties in swallowing or
breathing.
Marketing Authorisation Holder
1. Open the bottle
(in the first opening
Tell your doctor or pharmacist if Consilient Health Ltd.,
the seal is broken).
you notice any of the following
5th floor,
other side effects:
Beaux Lane House,
Mercer Street Lower,
• Very common (occurs in more
Dublin 2,
2. Insert the oral syringe into the
than 1 in 10 users): headache.
Ireland
pourer and turn the bottle upside
• Common (occurs in less than 1
down to fill it with the dose to be
in 10 users): abdominal pain,
Manufacturer
administered.
nausea.
• Very rare (occurs in less than 1 Laboratorio Reig Jofré S.A.
in 10,000 users): emotional
Gran Capità 10
disturbances in children, allergic 08970 Sant Joan Despí – Barcelona
reactions.
Spain
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.

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.

If you get any side effects, talk to
your doctor or pharmacist. This
This leaflet was revised in 07/2014
includes any possible effects not
listed in this leaflet. You can also
report side effects directly via 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. How to store
5. Rinse with water after each use
Desmopressin
and close the bottle. Keep the bottle 360 micrograms/ml
in the outer carton to protect from
oral solution
light.
Keep this medicine out of the sight
If you take more Desmopressin
and reach of children.
than you should
Do not store above 30ºC. Store in
An overdose may lengthen the
the original package.
effect of desmopressin and increase After first opening, the product
the risk of water build up in the
should be stored below 25ºC for up
body and / or low levels of sodium to 4 weeks.
in your blood. Symptoms may
include headache, nausea and
Do not take this medicine after the
vomiting, weight gain and in severe expiry date which is stated on the
cases convulsions. It is
label and carton after EXP. The
recommended to stop the treatment, expiry date refers to the last day of
restrict fluids intake and a
that month.
symptomatic treatment if necessary.
Do not throw away any medicines
If you take more Desmopressin than via waterwater or household waste.
prescribed, contact your doctor or
Ask your pharmacist how to throw
pharmacist immediately.
away medicines you no longer use.
These measures will help protect
If you forget to take
the environment.
Desmopressin
Do not take a double dose to make
up for a forgotten dose.

6. Contents of the pack
and other information

If you stop taking Desmopressin

What Desmopressin contains

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.

• The active substance is
desmopressin.
Each ml of the oral solution
contains 360 micrograms of
desmopressin (as acetate).
P0227

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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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