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DESMOPRESSIN 120 MICROGRAMS ORAL LYOPHILISATE

Active substance(s): DESMOPRESSIN ACETATE / DESMOPRESSIN ACETATE / DESMOPRESSIN ACETATE

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DesmoMelt® 120 micrograms
oral lyophilisate

2897
11.08.16[2]

2. Before you take DesmoMelt
There are general restrictions, precautions and warnings which apply to
all patients using DesmoMelt.

(desmopressin acetate)
PATIENT INFORMATION LEAFLET
This medicine is available using the above name but will be referred to as
DesmoMelt throughout this leaflet.
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 this leaflet:
1. What DesmoMelt is and what it is used for
2. Before you take DesmoMelt
3. How to take DesmoMelt
4. Possible side effects
5. How to store DesmoMelt
6. Further information
1. What DesmoMelt is what it is used for
DesmoMelt are oral lyophilisates, they look like tablets but are much
softer and lighter. Intended for sublingual use (to be placed under the
tongue where it will dissolve completely).
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).

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 nonsteroidal 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 DesmoMelt
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.
4. Possible side effects
Like all medicines DesmoMelt can have side effects.
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.
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.
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 at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. Storing DesmoMelt
 Keep out of the sight and reach of 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.
 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.
 If the medicines become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
6. Further information
 This medicine contains the active ingredient, desmopressin (as
acetate).
Each unit contains 120 micrograms desmopressin (as acetate).
 Other ingredients in this medicine are gelatin, mannitol (E 421) and
anhydrous citric acid (E 330).
 The melts are flat, round and white. Each melt is marked on one side
with two drops shaped figures.
Each carton contains blisters of 30 oral lyophilisates or 100 oral
lyophilisates.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Ferring GmbH, Wittland 11, P.O. Box 2145, D-24109
Kiel, Germany. Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1
1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2897

Leaflet revision and issue date (Ref) 11.08.16[2]
DesmoMelt is a trademark of Ferring BV.

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.

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