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DESMOPRESSIN ACETATE 0.1MG TABLETS

Active substance(s): DESMOPRESSIN ACETATE

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Desmopressin acetate 0.1 mg
& 0.2 mg tablets

TEVA UK Ref:

231-30-86049-ZC LEA DESMOPRESSIN A/S TAB TUK frDEB

Version:

1

20 May 2015

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.
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

• 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,
What Desmopressin acetate is and
your doctor should give you advice about fluid
what it is used for
intake.
• When using this medicine for bed-wetting or
The ingredient that makes the tablet work (the
nocturia, keep your fluid intake to a minimum
active substance) is called desmopressin.
from 1 hour before you take a tablet until 8 hours
Desmopressin is an antidiuretic, which reduces the
after a dose.
amount of urine produced by the kidneys.
• Too much fluid intake may lead to a build-up of
Desmopressin acetate is used to treat
water, which dilutes the salt in the body. This can
• a chronic disease called diabetes insipidus which
occur with or without warnings or symptoms,
causes extreme thirst and continuous production
which include unusually bad or prolonged
of large volumes of dilute urine. Important: Not
headache, feeling or being sick, unexplained
to be confused with diabetes mellitus (sugar
weight gain and in serious cases, fits and
diabetes).
unconsciousness. If you have any of these
• bed-wetting in children (involuntary nightly
symptoms, stop the treatment and contact your
urination) older than 5 years.
doctor at once.
• frequent urination during the night in adults
Pregnancy,
breast-feeding and fertility
(nocturia). Please read section 2 carefully for
important information on the safe use of
“If you are pregnant or breast-feeding, think you
Desmopressin acetate in this case.
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
What you need to know before you take taking this medicine.”

1

2

Desmopressin acetate

Do not take Desmopressin acetate
• if you are allergic to active substance or any of
the other ingredients of this medicine (liste 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.

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.
• 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 • Very rare may affect up to 1 in 10,000 people:
the effect of the tablets may be reduced.
emotional disturbances in children, allergic
• During treatment with Desmopressin acetate your
reactions
body weight, the sodium level in your blood and/ • Not known frequency cannot be estimated from
or blood pressure should be monitored regularly.
the available data: build-up of water in the body,
low levels of sodium.
The recommended dose

TEVA UK Ref:

231-30-86049-ZC LEA DESMOPRESSIN A/S TAB TUK frDEB

Version:

1

20 May 2015

• Central diabetes insipidus
Adults and children: 100 micrograms (0.1 mg)
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 (0.2 mg)
at bedtime. Your doctor may increase the dose up
to 400 micrograms (0.4 mg) 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 (0.1 mg) at bedtime.
The dose may be increased to 200 micrograms
(0.2 mg) and subsequently up to a maximum of
400 micrograms (0.4 mg) 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.

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 this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which
is stated on the carton and blister or bottle after 'EXP'.
The expiry date refers to the last day of that month.
Blister: Do not store above 30°C.
Bottle: Do not store above 30°C, keep the bottle
tightly closed in order to protect from moisture.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6

Contents of pack and other information

What Desmopressin acetate contains
When using this medicine for bed-wetting or nocturia • The active substance is desmopressin acetate.
keep your fluid intake to a minimum from 1 hour
Each 0.1 mg tablet contains 0.1 mg equivalent to
before you take a tablet until 8 hours after a dose.
0.089 mg desmopressin. Each 0.2 mg tablet
contains 0.2 mg, equivalent to 0.178 mg
If you take more Desmopressin acetate than you
desmopressin.
should
• The other ingredients are lactose monohydrate,
An overdose may lengthen the effect of
maize starch, povidone, starch pregelatinised,
desmopressin and increase the risk of water
silica, colloidal anhydrous and magnesium stearate.
build-up in the body and low levels of sodium in
What
Desmopressin acetate looks like and
your blood. Symptoms of severe water build-up
contents of the pack
include fits and unconsciousness.If you take more
Desmopressin acetate than prescribed, contact your Desmopressin acetate 0.1 mg tablets are white,
doctor, pharmacist or the nearest hospital at once. biconvex, oval tablets with the inscription ‘D’, score
mark and ‘0.1’ on the one side and plain on the
If you forget to take Desmopressin acetate
other side.
Do not take a double dose to make up for a
Desmopressin acetate 0.2 mg tablets are white,
forgotten dose.
biconvex, round tablets with the inscription ‘D’,
If you stop taking Desmopressin acetate
score mark and ‘0.2’ on the one side and plain on
the other side.
You should only change or stop your treatment if
advised by your doctor.
The score line is only to facilitate breaking for ease
If you have any further questions on the use of this of swallowing and not to divide into equal doses.
medicine, ask your doctor or pharmacist.
They are packed in OPA/Alu/PVC – Aluminium blisters
or 30 ml white opaque PE bottles with a white opaque
Possible side effects
PP cap with desiccant and child-resistant closure:

4

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

Desmopressin 0.1 mg tablets are packed in 7, 10, 15,
30, 50 (hospital pack), 60, 90 and 100 tablets

Stop the treatment and contact your doctor at
once if the following occur

Desmopressin 0.2 mg tablets are packed in 10, 15,
30, 50 (hospital pack), 60, 90, 100 and 200 (2x100)
tablets

• 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.

Not all mentioned pack sizes may be marketed.
Marketing Authorisation Holder
Teva UK Limited, Eastbourne, BN22 9AG.
Manufacturer
Teva Pharmaceutical Works Private Limited
Company, Pallagi út 13, 4042 Debrecen, Hungary
Marketing Authorisation Number: PL 00289/1010
and PL 00289/1011
This leaflet was last reviewed in April 2015
86049-ZC

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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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