Skip to Content

DESMOPRESSIN MELT 240 MICROGRAMS ORAL LYOPHILISATE

Active substance(s): DESMOPRESSIN ACETATE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Desmopressin Melt 120 micrograms oral lyophilisate
Desmopressin Melt 240 micrograms oral lyophilisate
PATIENT INFORMATION
desmopressin acetate

Read all of this leaflet carefully before you start
using this medicine.
• Keep this leaflet, you may need to read it again
• If you have further questions, please ask your doctor
or pharmacist
• This medicine has been prescribed for you personally
and you should 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.
Important things that you need to know:
• Desmopressin Melt is used to treat primary nocturnal
enuresis (bedwetting) in children (from 5 years of age)
and adults (up to 65 years of age).
• You should avoid drinking large amounts of fluid while
you are being treated with Desmopressin Melt, as this
could lead to a build up of water which dilutes the salt
in the body. This is a serious problem and may lead to
convulsions.
• If you experience unusually bad or prolonged head
ache, confusion, unexplained weight gain, ankle
swelling, nausea or vomiting STOP USING
Desmopressin Melt. You should tell your doctor
immediately or go to the casualty department at your
nearest hospital.
Now read the rest of this leaflet. It includes other
important information on the safe and effective use of
this medicine.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Desmopressin Melt is and what it is used for
Before you take Desmopressin Melt
How to take Desmopressin Melt
Possible side effects
How to store Desmopressin Melt
Contents of the pack and other information

1. What Desmopressin Melt is and
what it is used for
Desmopressin Melts are oral lyophilisates, they look like
tablets but are much softer and lighter. Intended for
sublingual use (to be placed under the tongue where they
will dissolve completely). They are referred to as
Desmopressin Melt(s) or melt(s) in this leaflet.
Desmopressin Melt is available in two strengths: 120 or 240
micrograms. It contains Desmopressin acetate, an
antidiuretic (reduces urine production).
Desmopressin Melt is used:
• to treat primary nocturnal enuresis (bedwetting) in children
(from 5 years of age) and adults (up to 65 years of age).

2. Before you take Desmopressin Melt
There are general restrictions, precautions and warnings
which apply to all patients using Desmopressin Melt.
General restrictions:
Do not take Desmopressin Melt if you:
• have a serious heart or kidney disease
• are taking diuretics (water tablets)
• are allergic to any of the ingredients listed in section 6
of this leaflet
• drink unusually large quantities of fluids, including alcohol
• are under 5 or over 65 years old
• are taking medication for high blood pressure or have
been told that your blood pressure is abnormal
You should avoid drinking large amounts of fluid while
you are being treated with Desmopressin Melt, as this
could lead to a build up of water which dilutes the salt
in the body. This is a serious problem and may lead to
convulsions.
General precautions and warnings:
Please consult your doctor before taking
Desmopressin Melt if you:
• have an illness causing fluid and/or salt imbalance e.g.
vomiting, diarrhoea, systemic infections, fever or
gastroenteritis
• have a medical condition that could be made worse by
fluid and/or electrolyte disturbance. Condition where your
blood sodium levels are too low or you are likely to build
up too much water in your body
• have cystic fibrosis
While taking Desmopressin Melt:
• fluid intake must be limited to a minimum from 1 hour
before taking the dose at bedtime until the following
morning (and, in any case, for at least 8 hours)
• stop taking this medicine when suffering from vomiting
and/or diarrhoea until you are better
• swallowing water while swimming should be avoided
because it could lead to a build up of water in the body.
Taking/using other medicines:
Please inform your doctor or pharmacist if you:
• are taking or have recently taken or used any other
medicines, even those not prescribed
• are on medication for depression or epilepsy
• are taking a medicine for pain and/or inflammation
containing non-steroidal anti-inflammatory drugs (also
known as NSAIDs) e.g. indometacin
• are taking a medicine containing loperamide for diarrhoea
Pregnancy:
If you are pregnant or planning a pregnancy, please inform
your doctor before you take Desmopressin Melt, as blood
pressure monitoring is recommended due to the increased
risk of pre-eclampsia (a condition in pregnant women that
can cause serious complications).
Symptoms of pre-eclampsia include high blood pressure,
oedema (swelling due to the build up of fluid).

3. How to take Desmopressin Melt

Most people using Desmopressin Melt find it causes them
no problems. However, common side effects can include:

PATIENT INSTRUCTION

• headache
• stomach pain

It is important to use your medicine as directed by your
doctor. Desmopressin Melt is intended for sublingual use (to
be placed under the tongue where it will dissolve completely.
1. Completely remove the end tab of a
blister strip by tearing along the
perforations, starting from the corner
with the hand symbol.
2. Now remove one blister from the strip
by tearing along the perforations.
3. Remove the foil on each blister, starting at the corner
with the printed arrow, by peeling off the foil in the
direction of the arrow.
4. Carefully take a melt out of its blister. Place the melt
under the tongue and allow it to dissolve
completely.
5. If a melt breaks into more than two pieces while you are
taking it out of its blister, do not take the broken pieces.
Take a melt from another blister.

Very rare cases of emotional disorders including aggression
in children have also been reported.
If you experience one or more of these side effects or
any other undesirable effects, please inform your doctor
or pharmacist.
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 (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 Melt
Keep Desmopressin Melt out of the sight and reach
of children.

Do NOT take more than the prescribed dose in any
24 hour period.

Store in the original package in order to protect from
moisture and light.

If you have the impression that the effect of
Desmopressin Melt is too strong or too weak, talk to your
doctor or pharmacist.

Do not take this medicine after the expiry date on the
packaging. The expiry date refers to the last day of
that month.

The usual dose:

If you are unsure about the storage, ask your pharmacist.
It is best to return all old and unused medicines to your
pharmacist for safe disposal.

The usual starting dose is one Desmopressin Melt
120 micrograms sublingually (under the tongue) at bedtime.
Depending on how well the bedwetting is controlled, your
doctor may increase the dose to either two Desmopressin
Melts 120 micrograms or one Desmopressin Melt
240 micrograms sublingually (under the tongue) at bedtime.
The need for continued treatment is normally checked every
three months.
If you take more of this medicine than you should:
If you take more Desmopressin Melts than you should, talk
to your doctor or pharmacist immediately.
If you forget to take this medicine:
Do not take double doses to make up for forgotten doses.
Take the next dose at the usual time.

4. Possible side effects
Like all medicines Desmopressin Melt can have side effects.
You should avoid drinking large amounts of fluid while
you are being treated with Desmopressin Melt, as this
could lead to a build up of water which dilutes the salt
in the body. This is a serious problem and may lead
to convulsions.
STOP USING Desmopressin Melt if you experience:
• unusually bad or prolonged headache, confusion,
unexplained weight gain, ankle swelling, nausea or
vomiting
• itching, skin rashes, swelling of the face, lips or throat,
difficulty in breathing, wheeziness, chest tightness or
coughing (signs of allergic reactions)
If you experience one or more of these side effects or any
other undesirable effects, please inform your doctor or
pharmacist.

6. Contents of the pack and other information
What Desmopressin Melt contains
• This medicine contains the active ingredient, desmopressin
(acetate). It is available in two strengths: 120 or 240
micrograms of desmopressin (as acetate).
• Other ingredients are gelatin, mannitol and citric acid.
What Desmopressin Melt looks like and contents of the pack
The melts are flat, round and white. Each melt is marked on one
side with two or three drops, indicating a strength of 120 or 240
micrograms respectively.
Each carton contains blister strips of 10 melts per strip.
Pack size: 10, 30 or 100 oral lyophilisates.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Ferring Pharmaceuticals Ltd.
Drayton Hall, Church Road,
West Drayton, UB7 7PS, (UK).
Distributor:
Aspire Pharma Ltd
Unit 4, Rotherbrook Court, Bedford Road,
Petersfield, Hampshire, GU32 3QG, UK
Manufacturer:
Ferring GmbH, Wittland 11, D-24109 Kiel, Germany.
Desmopressin Melt 120 micrograms oral lyophilisate
PL 03194/0120
Desmopressin Melt 240 micrograms oral lyophilisate
PL 03194/0121
This leaflet was last revised in March 2017.
0000000-P1.6

+ Expand Transcript

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