Skip to Content

UK Edition. Click here for US version.

DESMOPRESSIN ACETATE 100 MICROGRAM TABLET

Active substance(s): DESMOPRESSIN ACETATE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Desmopressin Acetate
Tablets
100 & 200 microgram
The name of your medicine is Desmopressin acetate
tablets, which will be referred to as ‘Desmopressin’ or
‘Desmopressin tablets’ throughout this leaflet.
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 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 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 is and what it is used for
2. Before you take Desmopressin
3. How you take Desmopressin
4. Possible side effects
5. How to store Desmopressin
6. Further information

1 What Desmopressin is and
what it is used for
Desmopressin tablets are round, white tablets.
They contain the active ingredient desmopressin
acetate hydrate.
Desmopressin tablets are used for the treatment of:
• vasopressin-sensitive cranial diabetes insipidus
(a disease causing the passing of excessive urine
because not enough ADH [a hormone] is
produced). Vasopressin-sensitive means that the
disease can be treated with Desmopressin.
• post-hypophysectomy polyuria/polydipsia
(frequent urination or excessive drinking following
the removal of the pituitary gland).
• primary nocturnal enuresis (bed-wetting in a
person who has never developed night-time
bladder control).

2 Before you take Desmopressin
Do not take Desmopressin tablets
(and talk to your doctor) if you:
• are allergic (hypersensitive) to Desmopressin or
any of the other ingredients of Desmopressin
tablets (see list of ingredients in Section 6).
An allergic reaction may include rash, itching,
difficulty breathing or swelling of the face, lips,
throat or tongue
• have heart disease or another condition that needs
treatment with a diuretic (water tablet)
• have abnormal blood pressure and need treatment
for bed-wetting
• drink a lot of fluid because of a mental condition

• abuse alcohol
• are over the age of 65 and need treatment for
bed-wetting
• have low sodium levels
• have symptoms of ADH (antidiuretic hormone)
disorder
• have an inherited sugar disorder (galactose
intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption)
Take special care with Desmopressin tablets
(and talk to your doctor) if you:
• have a kidney disorder (you may need a
larger dose)
• have heart disease
• have cystic fibrosis
Bed Wetting
If you are being treated with Desmopressin for
bed-wetting, your fluid intake must be limited from
1 hour before until 8 hours after taking the tablets.
You should avoid drinking water while swimming
and you should stop taking Desmopressin if you are
vomiting or have diarrhoea until your fluid balance is
back to normal.
Fluid/Salt Disorder
You must be careful not to drink too much fluid if you
have a condition that causes a fluid or salt disorder or
if you are at risk of increased intracranial pressure
(pressure on the brain).
It is important to monitor body weight and blood
pressure during treatment with Desmopressin.

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. This is
especially important of the following substances as
they may interact with your Desmopressin tablets:
• antidepressants
• chlorpromazine (for mental illness)
• carbamazepine (for epilepsy)
• non-steroidal anti-inflammatory drugs (NSAIDs)
such as ibuprofen
• loperamide (for diarrhoea)
It may still be all right for you to be given
Desmopressin and your doctor will be able to decide
what is suitable for you.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant or breast-feeding.
Your doctor may want to monitor your blood pressure
if you are pregnant.
Driving and using machines
Desmopressin has no effect on driving or using
machines.
Important information about some of the
ingredients of Desmopressin tablets
Desmopressin tablets contain lactose, which is a type
of sugar. If you have been told by your doctor that
you have an intolerance to some sugars, contact your
doctor before taking this medicine.

3 How you take Desmopressin
Dosage
Desmopressin tablets are taken by mouth.
Always take Desmopressin exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
Treatment of Diabetes Insipidus:
The starting dose in adults and children is
100 micrograms, three times daily. The dose should
then be adjusted according to the patient’s response.
For most patients, the adjusted dose is 100 to
200 micrograms, three times daily.
Post-hypophysectomy polyuria/polydipsia:
The dose of Demopressin depends on the
concentration of the urine.
Primary nocturnal enuresis:
The usual dose for children (from 5 years of age)
and adults (up to 65 years of age) is 200 micrograms
at bedtime. If necessary, your doctor may increase the
dose to 400 micrograms.
The need for continued treatment should be
reassessed after 3 months by stopping treatment
with Desmopressin for at least one week.
If it appears that Desmopressin is not having an effect
at low doses, your doctor may tell you not to take the
tablets with food.
If you take more Desmopressin than you should
Go to the accident and emergency department at the
nearest hospital straight away. Take the Desmopressin
pack with you.

If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, Desmopressin tablets can cause
side effects, although not everybody gets them.
All medicines can cause allergic reactions, although
serious allergic reactions are very rare.
Stop taking Desmopressin tablets and tell your
doctor or go to the nearest hospital casualty
department straight away if you experience any of
the following:
• 
An allergic reaction. The signs may include
difficulty in breathing or swallowing, swelling of
the lips, face, throat or tongue and a rash or
itching (especially affecting the whole body).
The following side effects have been reported:
• stomach pain
• nausea (feeling sick)
• abdominal (tummy) cramps
• vomiting
• headache
• allergic skin reactions
• more severe allergic reactions
• emotional disturbance in children (very rare)
Treatment with Desmopressin without reducing
fluid intake may cause water retention or low
sodium levels. Low sodium levels can cause the
following side effects:
• headache
• nausea
• vomiting

• weight gain
• decreased sodium in the blood
• convulsions (fits – in serious cases)
Reporting of side effects
If you get any 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
(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 Desmopressin
Desmopressin tablets should be kept out of the sight
and reach of children.
Do not use Desmopressin after the expiry date which
is stated on the carton. The expiry date refers to the
last day of that month.
Store below 25°C. Store in the original package.
Keep the bottle tightly closed. Keep the bottle in the
outer carton.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer needed. These
measures will help to protect the environment.

6 Further information
What Desmopressin tablets contain
The active substance is desmopressin acetate hydrate.
The other ingredients are: lactose monohydrate,
maize starch, povidone and magnesium stearate.

What Desmopressin tablets look like and
contents of the pack
30ml plastic bottles with a tamper-proof, twist-off cap
and a silica gel desiccant insert. Each bottle contains
either 30 or 90 tablets. The tablets are white and
round. The 100μg (micrograms) tablets are marked 0.1
and the 200μg are marked 0.2.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aspire Pharma Limited
Bellamy House
Winton Road
Petersfield
Hampshire, GU32 3HA
United Kingdom.
Manufacturer
KERN Pharma S.L.
Pol. Ind. Colom II
C/Venus, 72
08228 Terrassa (Barcelona)
Spain.
This leaflet was last revised in
January 2015
PL 35533/0010
PL 35533/0011
Under licence from
PH&T S.p.A., Italy
8094717-03

1010046-P3.1

Expand view ⇕

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.

Hide