DESMOPRESSIN ACETATE 0.2MG TABLETS

Active substance: DESMOPRESSIN ACETATE

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DESMOPRESSIN ACETATE 0.1 mg
AND 0.2 mg TABLETS
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 any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
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 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
WHAT DESMOPRESSIN ACETATE IS AND
1 WHAT IT IS USED FOR
nocturia, keep your fluid intake to a minimum
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
urination) older than 5 years
Fertility, Pregnancy and breast-feeding
• frequent urination during the night in adults
If you are pregnant or breast-feeding, think you
(nocturia). Please read section 2 carefully for
may be pregnant or are planning to have a baby,
important information on the safe use of
ask your doctor or pharmacist for advice before
Desmopressin acetate in this case.
taking this medicine.

2

BEFORE YOU TAKE DESMOPRESSIN
ACETATE

Desmopressin acetate can be used during
pregnancy and breast-feeding only if prescribed by
a doctor. Only limited experience from use of
Do not take Desmopressin acetate
Desmopressin acetate in pregnant women with
• if you are allergic (hypersensitive) to desmopressin
diabetes insipidus exists.
acetate or any of the other ingredients of the
tablets (see section 6. Further information)
Ask your doctor or pharmacist for advice before
• if you drink unusually large amounts of fluid
taking any medicine.
• if you suffer from heart problems or other diseases
needing treatment with diuretics (water tablets)
Driving and using machines
• if you suffer from reduced kidney function
There is no evidence to suggest that Desmopressin
• if you know you have low level of sodium in your acetate affects the ability to drive and use
blood (hyponatraemia)
machines.
• if you suffer from the "Syndrome of Inappropriate
Secretion of Antidiuretic Hormone" (SIADH)
Important information about some of the
• if you suffer from Von Willebrand’s disease type
ingredients of Desmopressin acetate
IIB (hereditary bleeding disorder)
This medicine contains lactose. If you have been
• if you suffer from a rare blood disorder called
told by your doctor that you have an intolerance to
Thrombotic thrombocytopenic purpura (TTP).
some sugars, then please contact your doctor
before taking this medicinal product.
Take special care with Desmopressin acetate
• In connection with fluid intake. Keep your fluid
intake to a minimum from 1 hour before you
3 HOW TO TAKE DESMOPRESSIN ACETATE
take a tablet until 8 hours after a dose.
Always take Desmopressin acetate exactly as your
Tell your doctor before taking Desmopressin
doctor has told you. You should check with your
acetate if you have cystic fibrosis as your doctor
doctor or pharmacist if you are not sure.
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.

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
• Do not take Desmopressin acetate with food, as
the effect of the tablets may be reduced.

• 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)
If any of the side effects gets serious, or if you
three times a day. Your doctor may increase the
dose depending on how well your symptoms are notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
controlled.
• Bed-wetting (involuntary nightly urination)
Children over 5 years: 200 micrograms (0.2 mg)
HOW TO STORE DESMOPRESSIN ACETATE
at bedtime. Your doctor may increase the dose up
to 400 micrograms (0.4 mg) at bedtime depending Keep out of the reach and sight of children.
on how well the bed-wetting is controlled. The
Do not use Desmopressin acetate after the expiry
need for continued treatment is normally checked date which is stated on the carton and blister or
every three months by introducing a treatment
bottle after 'EXP'. The expiry date refers to the last
free period of at least one week.
day of that month.
• Frequent urination during the night (nocturia)
Blister: Do not store above 30°C.
Adults: 100 micrograms (0.1 mg) at bedtime.
The dose may be increased to 200 micrograms
Bottle: Do not store above 30°C, keep the bottle
(0.2 mg) and subsequently up to a maximum of
tightly closed in order to protect from moisture.
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.

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.
When using this medicine for bed-wetting or nocturia
Each 0.1 mg tablet contains 0.1 mg equivalent to
keep your fluid intake to a minimum from 1 hour
0.089 mg desmopressin. Each 0.2 mg tablet
before you take a tablet until 8 hours after a dose.
contains 0.2 mg, equivalent to 0.178 mg
desmopressin.
If you take more Desmopressin acetate than you
• The other ingredients are lactose monohydrate,
should
maize starch, povidone, starch pregelatinised,
An overdose may lengthen the effect of
silica, colloidal anhydrous and magnesium
desmopressin and increase the risk of water build-up
stearate.
in the body and low levels of sodium in your blood.
What Desmopressin acetate looks like and
Symptoms of severe water build-up include fits and
contents of the pack
unconsciousness.If you take more Desmopressin
Desmopressin acetate 0.1 mg tablets are white,
acetate than prescribed, contact your doctor,
biconvex, oval tablets with the inscription ‘D’, score
pharmacist or the nearest hospital at once.
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 forgotten dose.
Desmopressin acetate 0.2 mg tablets are white,
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
You should only change or stop your treatment if
the other side.
advised by your doctor.
If you have further questions on the use of this
medicinal product ask your doctor or pharmacist.

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 September 2012.

86049-ZA

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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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