Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
1. Why am I taking MINIRIN Melt?
MINIRIN Melt contains the active ingredient desmopressin, which is a synthetic version
of a naturally occurring substance produced in the brain called vasopressin. It is
used for several conditions including primary nocturnal enuresis (bedwetting) in patients over 6 years of age and cranial diabetes insipidus.
2. What should I know before I take MINIRIN Melt?
Do not take if you have ever had an allergic reaction to desmopressin or any of the
ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with MINIRIN Melt and affect how it works.
4. How do I take MINIRIN Melt?
MINIRIN Melt is placed under the tongue (sublingual). It will dissolve in seconds
without the need for water.
Bedwetting (nocturnal enuresis) - one (120 mcg) to two (240 mcg) wafers under the
tongue at bedtime
Cranial diabetes insipidus - doses up to 120 micrograms three times daily are often
used.
5. What should I know while taking MINIRIN Melt?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking MINIRIN Melt.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine. It may affect other medicines used during surgery.
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Things you should not do
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Do not take MINIRIN Melt to treat any other complaints unless your doctor tells you
to do so.
Do not stop taking your medicine or change the dosage without checking with your doctor.
If you stop taking it suddenly, your condition may worsen.
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Driving or using machines
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This medicine is not expected to affect your ability to drive a car or operate machinery.
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Looking after your medicine
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Keep MINIRIN Melt in the original container to protect from moisture and light until
it is time to take it.
Store it in a cool dry place, where the temperature stays below 25°C, away from moisture,
heat or sunlight.
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6. Are there any side effects?
All medicines can have side effects. Most of them are minor and temporary but some
may need medical attention.
Tell your doctor if you experience any side effects, including headache, stomach pain,
nausea or vomiting, rapid weight gain, confusion or drowsiness. These are signs and
symptoms of hyponatraemia (low sodium levels in the blood), a rare, but serious possible
side effect of MINIRIN Melt. For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient:
desmopressin
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking MINIRIN Melt. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking MINIRIN Melt.
Where to find information in this leaflet:
1. Why am I taking MINIRIN Melt?
MINIRIN Melt contains the active ingredient desmopressin, which is a synthetic version
of a naturally occurring substance produced in the brain called vasopressin.
MINIRIN Melt has a few different actions on the body including on the kidney to reduce
the amount of urine produced.
MINIRIN Melt is used for several conditions including:
Primary nocturnal enuresis (bedwetting) in patients over 6 years of age who have a
normal ability to concentrate urine and who have not responded to treatment with an
enuresis alarm or in whom an enuresis alarm is contraindicated or inappropriate.
Cranial diabetes insipidus (large amounts of urine being produced day and night and
constant thirst).
2. What should I know before I take MINIRIN Melt?
Warnings
Do not take MINIRIN Melt if:
you are allergic to desmopressin, or any of the ingredients listed at the end of this
leaflet
you are in the habit of drinking large amounts of fluid
you have cardiac insufficiency (shortness of breath, swelling of the feet or legs
due to fluid build-up)
you have kidney disease where you pass little or no urine
you have low levels of sodium in your bloodstream
you have a disease which causes excessive release of anti-diuretic hormone
you are breast-feeding
you are a child under the age of 6 years. Safety and effectiveness in children younger
than 6 years have not been established
the expiry date printed on the pack has passed
the packaging is torn or shows signs of tampering.
Always check the ingredients to make sure you can take this medicine.
Check with your doctor if you:
have any other medical conditions especially the following:
a known allergy to anti-diuretic hormone
too little or too much fluid in the body
heart or blood vessel disease or any other disease for which you take diuretics
low blood pressure
cystic fibrosis or any other disease which causes fluid or salt imbalance
any disease of the blood clotting cells (platelets)
serious problems with bladder function or with passing urine
raised pressure within your head (increased intracranial pressure)
take any medicines for any other condition.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
MINIRIN Melt should only be taken by a pregnant woman if necessary. Your doctor can
discuss with you the risks and benefits involved.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is recommended that you do not breastfeed while taking MINIRIN Melt.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with MINIRIN Melt and affect how it works.
Medicines that may
increase
the effect of MINIRIN Melt include:
loperamide, a medicine used to stop diarrhoea
medications which are known to release antidiuretic hormone (e.g. tricyclic antidepressants,
selective serotonin reuptake inhibitors, chlorpromazine or carbamazepine) or some
medications which are known to treat high blood sugar (diabetes), as they can increase
the risk of fluid buildup in the body
non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to relieve pain and
inflammation. NSAIDs may induce water retention/low sodium levels in the blood (hyponatraemia).
These medicines may affect how well MINIRIN Melt works. You may need different amounts
of your medicines, or you may need to take different medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect MINIRIN Melt.
4. How do I take MINIRIN Melt?
How much to take
Some of the details for MINIRIN Melt will vary depending on the purpose for which
it is taken.
Bedwetting (nocturnal enuresis)
the usual starting dose for treatment of bedwetting is one wafer (120 micrograms)
under the tongue at bedtime. If this dose does not adequately help resolve the bedwetting,
your doctor may recommend that you increase the dose to 240 micrograms under the tongue
(two 120 micrograms wafers, OR one 240 micrograms wafer) at bedtime.
if after four weeks of MINIRIN Melt treatment there has been no resolution of the
bedwetting, treatment should be stopped.
fluid intake should be limited in preparation for your dose of MINIRIN Melt (see 'Things
to be careful of')
Cranial diabetes insipidus
the dose you need will be adjusted to suit your personal requirements.
doses up to 120 micrograms three times daily are often used.
your doctor will advise you about the dose most suitable for you.
Follow the instructions provided and take MINIRIN Melt until your doctor tells you
to stop.
When to take MINIRIN Melt
Bedwetting (nocturnal enuresis)
take MINIRIN Melt at bedtime.
Cranial diabetes insipidus
take MINIRIN Melt at times specified by your doctor.
How long to take MINIRIN Melt
Continue taking your medicine for as long as your doctor tells you.
This medicine helps to control your condition but does not cure it. It is important
to keep taking your medicine even if you feel well.
Bedwetting (nocturnal enuresis)
MINIRIN Melt for bedwetting is usually taken for periods up to 3 months.
After this period, you should have at least one week without MINIRIN Melt to check
if your bedwetting has stopped. Your doctor will decide whether continued treatment
with MINIRIN is needed.
Cranial diabetes insipidus
Your doctor will advise you.
How to take MINIRIN Melt
When it is time for your dose, peel off the back of the foil on one of the blisters
starting in the corner with the arrow.
Carefully push on the foil to remove the wafer. Do not try to push MINIRIN Melt through
the blister foil.
Place MINIRIN Melt under the tongue (sublingual). It will dissolve in seconds without
the need for water.
Please read the detailed instruction leaflet in the box of MINIRIN Melt carefully.
If you forget to take MINIRIN Melt
MINIRIN Melt should be taken regularly at the same time each day.
Bedwetting (nocturnal enuresis)
If you miss your dose at the usual time, skip the missed dose and take the next dose
when you are meant to.
Cranial diabetes insipidus
Take the next dose as soon as you remember. You will then have to adjust the time
of the following dose.
When this is done, go back to taking your medicine as you would normally. You should
talk to your doctor about this situation.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you take too much MINIRIN Melt
If you think that you have taken too much MINIRIN Melt, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Symptoms of an overdose may include confusion, drowsiness, continuing headache, nausea
or vomiting, rapid weight gain due to a buildup of water in the body, or, in severe
cases, convulsions.
5. What should I know while taking MINIRIN Melt?
Things you should do
If you are about to be started on any new medicine, remind any doctor, dentist or
pharmacist you visit that you are taking MINIRIN Melt.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine.
It may affect other medicines used during surgery.
If you become pregnant while taking this medicine, tell your doctor immediately.
If you are about to have any blood tests, tell your doctor that you are taking this
medicine.
It may interfere with the results of some tests.
Keep all your doctor's appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working
and to prevent unwanted side effects.
Things you should not do
Do not take MINIRIN Melt to treat any other complaints unless your doctor tells you
to do so.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not stop taking your medicine or change the dosage without checking with your doctor.
If you stop taking it suddenly, your condition may worsen.
Things to be careful of
Bedwetting (nocturnal enuresis)
You must avoid drinking fluids from one hour before taking MINIRIN Melt until the
next morning (at least eight hours).
Over this period, drink no more than a few sips of water or other fluids. This is
because a high fluid intake during this period can increase the chance that you will
feel unwell (e.g headache, nausea, dizziness).
Remember to drink normally throughout the day.
This is very important to prevent dehydration during daytime.
Cranial diabetes insipidus
Carefully follow your doctor's instruction about fluid intake.
It is very important to keep your body water in balance.
Driving or using machines
This medicine is not expected to affect your ability to drive a car or operate machinery.
Looking after your medicine
Keep MINIRIN Melt in the original container to
protect from moisture and light until it is time to take it.
If you store them out of the blister pack, they will not keep well.
Store it in a cool dry place, where the temperature stays below 25°C, away from moisture,
heat or sunlight.
For example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat and dampness can destroy some medicines.
Follow the instructions in the carton on how to take care of your medicine properly.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date. The expiry date refers to the last
day of that month.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
If you are over 65 years of age, commencing MINIRIN Melt treatment is not recommended.
The elderly may be at an increased risk of some side effects.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Do not be alarmed by the following lists of side effects. You may not experience any
of them.
Side effects
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Side effects
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What to do
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Hyponatraemia or low sodium levels in the blood may have the following signs or symptoms:
headache
stomach pain
nausea.
Hyponatraemia can potentially become a serious side effect, see below.
Uncommon side effects (affect less than 1 in 100 users):
fatigue
diarrhoea.
Rare side effects (affect less than 1 in 1000 users):
sleepiness
Side effects (unknown frequency):
sweating
nosebleed.
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These side effects are not usually serious but can become serious.
Speak to your doctor if you have any of these side effects and they bother or worry
you.
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Serious side effects
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Serious side effects
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What to do
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high blood pressure
bladder problems
emotional or behavioural
disturbances
hallucinations.
*Hypersensitivity or allergic reactions (uncommon side effects - affect less than
1 in 100 users):
shortness of breath, wheezing or
difficulty breathing
swelling of the face, lips, tongue
or other parts of the body
rash, itching or hives on the skin.
*Hyponatraemia or low sodium levels in the blood may have the following serious signs
or symptoms:
confusion or drowsiness
continuing headache
nausea or vomiting
rapid weight gain or swelling of hands, ankles or feet, which may be due to a buildup
of water in your body
convulsions, fitting and blackouts (including coma)
*These side effects are rare.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking MINIRIN Melt.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What MINIRIN Melt contains
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Active ingredient
(main ingredient)
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desmopressin (free base)
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Other ingredients
(inactive ingredients)
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gelatin
mannitol
citric acid.
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Potential allergens
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contains sulfites and fish products
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MINIRIN Melt 120 mcg: Contains desmopressin (free base) 120 mcg (equivalent to 136 mcg desmopressin (acetate)).
MINIRIN Melt 240 mcg: Contains desmopressin (free base) 240 mcg (equivalent to 272 mcg desmopressin (acetate)).
Do not take this medicine if you are allergic to any of these ingredients.
What MINIRIN Melt looks like
Minirin Melts are supplied in packs of 30s.
MINIRIN Melt 120 micrograms is a white, round, sublingual (under the tongue) wafer,
marked with two drop shaped figures on one side. (AUST R 121721)
Minirin Melt 240 micrograms is a white, round, sublingual (under the tongue) wafer,
marked with three drop shaped figures on one side. (AUST R 121722)
Who distributes MINIRIN Melt
Ferring Pharmaceuticals Pty Ltd
Suite 2, Level 1, Building 1
20 Bridge Street
Pymble, NSW 2073
This leaflet was prepared in March 2024.
®Trademark of Ferring
AU-MN-2300001_v.4.0