DESMOPRESSIN ACETATE 0.2MG TABLETS

Active substance: DESMOPRESSIN ACETATE

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DESMOPRESSIN ACETATE 0.1 mg
AND 0.2 mg TABLETS

TEVA UK Ref:

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

Version:

1

24 March 2014

PACKAGE LEAFLET: INFORMATION
FOR THE USER
Read all of this leaflet carefully before you start
taking this medicine.
• 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. 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.
IN THIS LEAFLET:
1. What Desmopressin acetate is and what it is
used for
2. Before you take Desmopressin acetate
3. How to take Desmopressin acetate
4. Possible side effects
5. How to store Desmopressin acetate
6. Further information

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 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 buildup 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
WHAT DESMOPRESSIN ACETATE IS AND
nocturia, keep your fluid intake to a minimum
WHAT IT IS USED FOR
from 1 hour before you take a tablet until 8 hours
after a dose
The ingredient that makes the tablet work (the
• Too much fluid intake may lead to a build-up of
active substance) is called desmopressin.
water, which dilutes the salt in the body. This can
Desmopressin is an antidiuretic, which reduces the
occur with or without warnings or symptoms,
amount of urine produced by the kidneys.
which include unusually bad or prolonged
Desmopressin acetate is used to treat
headache, feeling or being sick, unexplained
• a chronic disease called diabetes insipidus which
weight gain and in serious cases, fits and
causes extreme thirst and continuous production of
unconsciousness. If you have any of these
large volumes of dilute urine. Important: Not to be
symptoms, stop the treatment and contact your
confused with diabetes mellitus (sugar diabetes)
doctor at once.
• bed-wetting in children (involuntary nightly
Fertility, Pregnancy and breast-feeding
urination) older than 5 years
If you are pregnant or breast-feeding, think you
• frequent urination during the night in adults
may be pregnant or are planning to have a baby,
(nocturia). Please read section 2 carefully for
ask your doctor or pharmacist for advice before
important information on the safe use of
taking this medicine.
Desmopressin acetate in this case.
Desmopressin acetate can be used during
BEFORE YOU TAKE DESMOPRESSIN
pregnancy and breast-feeding only if prescribed by
ACETATE
a doctor. Only limited experience from use of
Desmopressin acetate in pregnant women with
Do not take Desmopressin acetate
• if you are allergic (hypersensitive) to desmopressin diabetes insipidus exists.

1

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acetate or any of the other ingredients of the
tablets (see section 6. Further information)
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).

Take special care with 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.

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.
Important information about some of the
ingredients of Desmopressin acetate
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 Desmopressin acetate exactly as your
doctor has told you. You should 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
the effect of the tablets may be reduced

24 March 2014

1
Version:

• During treatment with Desmopressin acetate your • Very rare (occurs in less than 1 in 10,000 users):
body weight, the sodium level in your blood and/or
emotional disturbances in children, allergic
blood pressure should be monitored regularly.
reactions
• Not known (cannot be estimated from the
Usual doses
current data): build-up of water in the body, low
• Central diabetes insipidus
levels of sodium.
Adults and children: 100 micrograms (0.1 mg)
Reporting of side effects
three times a day. Your doctor may increase the
dose depending on how well your symptoms are If you get side effects, talk to your doctor or
pharmacist. This includes any possible side effects
controlled.
not listed in this leaflet.
• Bed-wetting (involuntary nightly urination)
Children over 5 years: 200 micrograms (0.2 mg) You can also report side effects directly via the
at bedtime. Your doctor may increase the dose up Yellow Card Scheme at:
to 400 micrograms (0.4 mg) at bedtime depending www.mhra.gov.uk/yellowcard
on how well the bed-wetting is controlled. The
By reporting side effects you can help provide more
need for continued treatment is normally checked information on the safety of this medicine.
every three months by introducing a treatmentfree 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.
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.

TEVA UK Ref:

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

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.

5

HOW TO STORE DESMOPRESSIN ACETATE

Keep out of the reach and sight of children.
Do not use Desmopressin acetate 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.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.

6

FURTHER INFORMATION

What Desmopressin acetate contains
• The active substance is desmopressin acetate.
Each 0.1 mg tablet contains 0.1 mg equivalent to
0.089 mg desmopressin. Each 0.2 mg tablet
contains 0.2 mg, equivalent to 0.178 mg
desmopressin.
• The other ingredients are lactose monohydrate,
maize starch, povidone, starch pregelatinised,
silica, colloidal anhydrous and magnesium
stearate.

What Desmopressin acetate looks like and
If you forget to take Desmopressin acetate
Do not take a double dose to make up for a forgotten contents of the pack
Desmopressin acetate 0.1 mg tablets are white,
dose.
biconvex, oval tablets with the inscription ‘D’, score
If you stop taking Desmopressin acetate
mark and ‘0.1’ on the one side and plain on the
You should only change or stop your treatment if
other side.
advised by your doctor.
Desmopressin acetate 0.2 mg tablets are white,
If you have further questions on the use of this
biconvex, round tablets with the inscription ‘D’,
medicinal product ask your doctor or pharmacist.
score mark and ‘0.2’ on the one side and plain on
the other side.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Desmopressin acetate 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 (occurs in more than 1 in 10
users): headache
• Common (occurs in less than 1 in 10 users): dry
mouth, abdominal pain, feeling sick, dizziness,
swelling of arms and legs, weight gain, frequent
urination

They are packed in OPA/Alu/PVC – Aluminium
blisters or 30 ml white opaque PE bottles with a
white opaque PP cap with desiccant and
child-resistant closure:
Desmopressin 0.1 mg tablets are packed in 7, 10, 15,
30, 50 (hospital pack), 60, 90 and 100 tablets.
Desmopressin 0.2 mg tablets are packed in 10, 15,
30, 50 (hospital pack), 60, 90, 100 and 200 (2x100)
tablets.
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 March 2014.
86049-ZB

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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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