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DESMOMELT 120 MICROGRAMS ORAL LYOPHILISATE

Active substance(s): DESMOPRESSIN ACETATE

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DesmoMelt 120 micrograms oral lyophilisate
®

DesmoMelt 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:
• DesmoMelt 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 DesmoMelt, 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 DesmoMelt.
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
1.
2.
3.
4.
5.
6.

this leaflet:
What DesmoMelt is and what it is used for
Before you take DesmoMelt
How to take DesmoMelt
Possible side effects
How to store DesmoMelt
Further information

1. What DesmoMelt is what it is used for
DesmoMelt are oral lyophiliates, they look like tables but
are much softer and lighter. Intended for sublingual use
(to be placed under the tongue where it will dissolve
completely). They are reffered to as DesmoMelt or
melt(s) in this leaflet.
DesmoMelt is available in two strengths: 120 or 240
micrograms. It contains Desmopressin acetate, an
antidiuretic (reduces urine production).
DesmoMelt 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 DesmoMelt
There are general restrictions, precautions and
warnings which apply to all patients using DesmoMelt.
General restrictions:
Do not take DesmoMelt 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 DesmoMelt, 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 DesmoMelt 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 DesmoMelt:
• 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 DesmoMelt, 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 DesmoMelt
PATIENT INSTRUCTION
It is important to use your medicine as directed by your
doctor. DesmoMelt 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.
Do NOT take more than the prescribed dose in any 24
hour period.
If you have the impression that the effect of DesmoMelt
is too strong or too weak, talk to your doctor or
pharmacist.
The usual dose is:
The usual starting dose is one DesmoMelt
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 DesmoMelts 120 micrograms or one DesmoMelt
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 DesmoMelt than you should, talk to
your doctor or pharmacist immediately.
If you forget to take this medicine:
Do not use a double dose to make up for a forgotten
dose. If you forget to take this medicine please consult
your doctor or pharmacist for advice.

Most people using DesmoMelt find it causes them no
problems. However, common side effects can include:
• headache
• stomach pain
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.

5. Storing DesmoMelt
Keep DesmoMelt out of the reach and sight or children.
Store in the original package in order to protect from
moisture and light.
Do not take this medicine after the expiry date on the
packaging. The expiry date refers to the last day of that
month.
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.

6. Further information
• Each carton contains 30 melts in blister strips of 10
melts per strip.
• This medicine contains the active ingredient,
desmopressin (as acetate). It is available in two
strengths:120 or 240 micrograms of desmopressin
(as acetate).
• Other ingredients in this medicine are gelatin,
mannitol and citric acid.
• 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.
Marketing Authorisation Holder:
Ferring Pharmaceuticals Ltd.,
The Courtyard, Waterside Drive,
Langley, Berkshire SL3 6EZ (UK).
Manufacturer:
Ferring GmbH, Wittland 11, D-24109 Kiel, Germany.
DesmoMelt 120 micrograms oral lyophilisate
PL 03194/0094
DesmoMelt 240 micrograms oral lyophilisate
PL 03194/0095

4. Possible side effects

This leaflet was last revised in February 2013.

Like all medicines DesmoMelt can have side effects.

DesmoMelt is a trademark of Ferring BV.

You should avoid drinking large amounts of fluid while
you are being treated with DesmoMelt, 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 DesmoMelt if you experience:
• usually 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.

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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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