DDAVP MELT 240MCG ORAL LYOPHILISATE

Active substance: DESMOPRESSIN ACETATE

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®

DDAVP Melt 60 micrograms oral lyophilisate
®

DDAVP Melt 120 micrograms oral lyophilisate
®

DDAVP 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:
• DDAVP Melt is used to treat
- diabetes insipidus (a condition that causes extreme
thirst and the continuous production of large
volumes of dilute urine)
- post-hypophysectomy polyuria/polydipsia (extreme
thirst and the continuous production of large
volumes of dilute urine following surgical removal of
the pituitary gland).
• You should avoid drinking large amounts of fluid while
you are being treated with DDAVP 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 headache,
confusion, unexplained weight gain, ankle swelling,
nausea or vomiting, STOP USING DDAVP Melt. You
should tell your doctor or immediately 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 DDAVP Melt is and what it is used for
Before you take DDAVP Melt
How to take DDAVP Melt
Possible side effects
How to store DDAVP Melt
Further information

1. What DDAVP Melt is what it is used for
DDAVP 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 it will dissolve
completely). They are referred to as DDAVP Melt or melt(s)
in this leaflet.
DDAVP Melt is available in three strengths: 60, 120 or 240
micrograms. It contains Desmopressin acetate, an
antidiuretic (reduces urine production). It is used:
• to treat diabetes insipidus (a condition that
causes extreme thirst and the continuous production of
large volumes of dilute urine). IMPORTANT: This should
not be confused with diabetes mellitus (sugar diabetes)
• to treat post-hypophysectomy polyuria/polydipsia
(extreme thirst and the continuous production of large
volumes of dilute urine following surgical removal of the
pituitary gland).

2. Before you take DDAVP Melt
There are general restrictions, precautions and warnings
which apply to all patients using DDAVP Melt.
General restrictions:
Do not take DDAVP 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
You should avoid drinking large amounts of fluid while
you are being treated with DDAVP 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 DDAVP 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.
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 imflammation
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 DDAVP 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) and proteinuria
(protein in the urine).
Breast-feeding:
If you are breast-feeding ask your doctor or pharmacist for
advice before taking DDAVP Melt.

3. How to take DDAVP Melt
PATIENT INSTRUCTIONS
It is important to use your medicine as directed by your
doctor. DDAVP 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.

Most people using DDAVP Melt 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 DDAVP Melt
Keep DDAVP Melt out of the reach and sight of children.

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.

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

4. Carefully take a melt out of its blister. Place the melt
under the tongue and allow it to dissolve completely.

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

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 DDAVP Melt
is too strong or too weak, talk to your doctor or
pharmacist.
The usual doses are:
Treatment of diabetes insipidus:
Your doctor will prescribe the dose most suitable for you.
The most common doses in adults and children are either
one DDAVP Melt 60 micrograms or one DDAVP Melt 120
micrograms three times a day.
Treatment of extreme thirst and the continuous production of large volumes of dilute urine following surgical
removal of the pituitary gland:
Your doctor will prescribe the most suitable dose for you
based on the concentration of your urine.
If you take more of this medicine than you should:
If you take more DDAVP Melt 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 are a patient with diabetes insipidus, please consult
your doctor or pharmacist for advice.

4. Possible side effects
Like all medicines DDAVP Melt can have side effects.
You should avoid drinking large amounts of fluid while
you are being treated with DDAVP 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 DDAVP 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 any of the above side effects, you should
contact your doctor or go to the nearest casualty
department immediately.

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 100 melts in blister strips of 10
melts per strip.
• This medicine contains the active ingredient,
desmopressin (as acetate). It is available in three
strengths: 60, 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 one, two or three drops,
indicating a strength of 60, 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.
DDAVP Melt 60 micrograms oral lyophilisate
PL 03194/0091
DDAVP Melt 120 micrograms oral lyophilisate
PL 03194/0092
DDAVP Melt 240 micrograms oral lyophilisate
PL 03194/0093
This leaflet was last revised in February 2013.
DDAVP is a trademark of Ferring BV.

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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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