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DESMOPRESSIN ACETATE 0.1MG TABLETS

Active substance(s): DESMOPRESSIN ACETATE

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Desmopressin Acetate
0.1mg Tablets
Package leaflet: information for the user
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 further questions, ask your doctor or
pharmacist
• This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours
• If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4
• This medicine is available in another strength and
may be referred to throughout the leaflet.
What is in this leaflet:
1. What Desmopressin acetate is and what it is used
for
2. What you need to know before you take
Desmopressin acetate
3. How to take Desmopressin acetate
4. Possible side effects
5. How to store Desmopressin acetate
6. Contents of the pack and other information

1

What Desmopressin acetate is and what
it is used for

The ingredient that makes the tablet work (the active
substance) is called desmopressin.
Desmopressin is an antidiuretic, which reduces the
amount of urine produced by the kidneys.
Desmopressin acetate is used to treat
• 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)
• bed-wetting in children (involuntary nightly
urination) older than 5 years
• frequent urination during the night in adults
(nocturia). Please read section 2 carefully for
important information on the safe use of
Desmopressin acetate in this case.
• This medicine is available in another strength and
may be referred to throughout the leaflet.

2

What you need to know before you take
Desmopressin acetate

Do not take Desmopressin acetate
• if you are allergic to active substance or any of the
other ingredients of this medicine (listed in section 6)
• if you drink unusually large amounts of fluid
• if you suffer from heart problems or other diseases
needing treatment with diuretics (water tablets)
• if you suffer from reduced kidney function
• if you know you have low level of sodium in your
blood (hyponatraemia)
• if you suffer from the "Syndrome of Inappropriate
Secretion of Antidiuretic Hormone" (SIADH)
• if you suffer from Von Willebrand’s disease type IIB
(hereditary bleeding disorder)
• if you suffer from a rare blood disorder called
Thrombotic thrombocytopenic purpura (TTP).
Warnings and precautions
Talk to your doctor or pharmacist before taking
Desmopressin acetate
• In connection with fluid intake. Keep your fluid
intake to a minimum from 1 hour before you take a
tablet until 8 hours after a dose
• Tell your doctor before taking Desmopressin acetate
if you have cystic fibrosis as your doctor will need to
monitor your blood sodium level

• If you are elderly
• If you have a medical condition causing fluid
and/or electrolyte imbalance in the body,
such as an infection, fever or stomach upset
• If you suffer from a serious bladder problem or
impaired urine outflow
• If you suffer from asthma, epilepsy and migraine.
Other medicines and Desmopressin acetate
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines obtained without a prescription,
especially:
• tricyclic or SSRI antidepressants (used to treat
depression)
• carbamazepine (used to treat epilepsy)
• chlorpromazine (used to treat psychosis or
schizophrenia)
• loperamide (used to treat diarrhoea)
medicines for pain and/or inflammation called
non-steroidal anti-inflammatory drugs (NSAIDs) e.g.
indometacin, ibuprofen.
These medicinal products increase the risk of build-up
of water, which dilutes the salt in the body.
dimeticone (used in the treatment of symptoms due
to intestinal gas), due to decreased absorption of
desmopressin.
Taking Desmopressin acetate with food and drink
• Do not take Desmopressin acetate with food, as
the effect of the tablets may be reduced
• Before you start treatment with this medicine, your
doctor should give you advice about fluid intake
• When using this medicine for bed-wetting or
nocturia, keep your fluid intake to a minimum from
1 hour before you take a tablet 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 and unconsciousness. If you have
any of these symptoms, stop the treatment and
contact your doctor at once.
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.”
Desmopressin acetate can be used during pregnancy
and breast-feeding only if prescribed by a doctor. Only
limited experience from use of Desmopressin acetate in
pregnant women with diabetes insipidus exists.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
There is no evidence to suggest that Desmopressin
acetate affects the ability to drive and use machines.
Desmopressin acetate contains lactose
This medicine contains lactose. If you have been told
by your doctor that you have an intolerance to some
sugars, then please contact your doctor before taking
this medicinal product.

3 How to take Desmopressin acetate
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
Desmopressin acetate treatment of frequent urination
during the night in adults (nocturia) should be started
and controlled by specialists with experience in this
treatment.
(continued overleaf)

• Divide the tablets in half or swallow whole. The score
line is only there to help you break the tablet if you
have difficulty swallowing it whole
• Do not take Desmopressin acetate with food, as
the effect of the tablets may be reduced
• During treatment with Desmopressin acetate your
body weight, the sodium level in your blood and/or
blood pressure should be monitored regularly.
The recommended dose
• Central diabetes insipidus
Adults and children: 100 micrograms (0.1mg) three
times a day. Your doctor may increase the dose
depending on how well your symptoms are
controlled.
• Bed-wetting (involuntary nightly urination)
Children over 5 years: 200 micrograms (0.2mg) at
bedtime. Your doctor may increase the dose up to
400 micrograms (0.4mg) at bedtime depending on
how well the bed-wetting is controlled. The need for
continued treatment is normally checked every three
months by introducing a treatment free period of at
least one week.
• Frequent urination during the night (nocturia)
Adults: 100 micrograms (0.1mg) at bedtime. The
dose may be increased to 200 micrograms (0.2mg)
and subsequently up to a maximum of
400 micrograms (0.4mg) with 1-week intervals.
Before starting treatment your urine production
should be measured. If nocturia is not improved after
four weeks, see your doctor as the treatment should
be stopped.
Elderly: treatment for nocturia in the elderly is not
recommended. 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.
When using this medicine for bed-wetting or nocturia
keep your fluid intake to a minimum from 1 hour
before you take a tablet until 8 hours after a dose.
If you take more Desmopressin acetate than you
should
An overdose may lengthen the effect of desmopressin
and increase the risk of water build-up in the body and
low levels of sodium in your blood. Symptoms of
severe water build-up include fits and
unconsciousness. If you take more Desmopressin
acetate than prescribed, contact your doctor,
pharmacist or the nearest hospital at once.
If you forget to take Desmopressin acetate
Do not take a double dose to make up for a forgotten
dose.
If you stop taking Desmopressin acetate
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.
Stop the treatment and contact your doctor at once
if the following occur
• 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
• allergic reactions such as rash, itching, fever,
swelling of the mouth, tongue or airways causing
difficulties in swallowing or breathing.

Tell your doctor or pharmacist if you notice any of the
following other side effects:
• Very common may affect more than 1 in 10 people:
headache
• Common may affect up to 1 in 10 people: dry
mouth, abdominal pain, feeling sick, dizziness,
swelling of arms and legs, weight gain, frequent
urination
• Very rare may affect up to 1 in 10,000 people:
emotional disturbances in children, allergic reactions
• Not known frequency cannot be estimated from the
available data: build-up of water in the body, low
levels of sodium.
Reporting of side effects
If you get 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 acetate

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton and bottle after 'EXP'.
The expiry date refers to the last day of that month.
Do not store above 30ºC. Keep the bottle tightly closed
in order to protect from moisture.
If your tablets become discoloured or show any other
signs of deterioration, consult your pharmacist who will
tell you what to do.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment.

of the pack and further
6 Contents
information
What Desmopressin acetate contains
• The active substance is desmopressin acetate. Each
tablet contains 0.1mg desmopressin acetate
equivalent to 0.089mg desmopressin.
• The other ingredients are lactose monohydrate,
maize starch, povidone, starch pregelatinised, silica,
colloidal anhydrous and magnesium stearate.
What Desmopressin acetate looks like and contents
of the pack
Desmopressin acetate 0.1mg tablets are white,
biconvex, oval tablets with the inscription ‘D’, score
mark and ‘0.1’ on the one side and plain on the other
side.
The score line is only to facilitate breaking for ease of
swallowing and not to divide into equal doses.
They are packed in 30ml white opaque PE bottles with
a white opaque PP cap with desiccant and
child-resistant closure.
Desmopressin 0.1mg tablets are available in packs of
90 tablets.
PL holder: Manx Healthcare Ltd, Taylor Group House,
Wedgnock Lane, Warwick, CV34 5YA
PL 14251/0043
Procured from within the EU POM
Manufacturer: Pharmachemie B.V., Swensweg 5, 2031
GA Haarlem, The Netherlands
To request a copy of this leaflet in large print, audio or
Braille, please call 01926 482511
This leaflet was last revised in September 2016
WIP URN: 190916-XXXX-PIL-01

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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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