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MIACALCIC 400 I.U./2ML SOLUTION FOR INJECTION AND INFUSION

Active substance: SALCATONIN

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Miacalcic® 50 IU/1 ml
solution for injection and infusion
Miacalcic® 100 IU/1 ml
solution for injection and infusion
Miacalcic® 400 IU/2 ml
Solution for injection and infusion
Calcitonin (salmon, synthetic)
Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor
or pharmacist.
– This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
– If you get any side effects talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet.
What is in this leaflet:
1. What Miacalcic is and what it is used for
2. What you need to know before you take Miacalcic
3. How to take Miacalcic
4. Possible side effects
5. How to store Miacalcic
6. Contents of the pack and other information
1. What Miacalcic is and what it is used for
Miacalcic contains the active substance calcitonin
(salmon, synthetic).

Calcitonin is a hormone that occurs naturally in the
body of both humans and animals. It regulates the level
of calcium in the blood. Calcitonin is used to reverse
bone loss and may also help in bone formation.
Miacalcic can be given for the following conditions:
– Prevention of bone loss in patients who have
suddenly become immobile. For example patients
who have osteoporosis (thin and weak bones) and
are bed-bound because of a fracture.
– Paget’s disease of bone: A slowly progressing illness
which can cause a change in the size and shape of
certain bones.
– Treatment of high levels of calcium in the blood
(hypercalcemia) due to cancer.
2. What you need to know before you take Miacalcic
Do not take Miacalcic
– if you are allergic to calcitonin (salmon, synthetic) or
any of the other ingredients of this medicine (listed
in section 6);
– if you have a very low calcium level in your blood
(hypocalcaemia).
Warning and precautions
Before treatment with Miacalcic tell your doctor if you
suspect to be allergic to calcitonin (salmon, synthetic).
Your doctor will perform a skin test before you start
taking Miacalcic.
Children and adolescent (age under 18 years)
Use of Miacalcic is not recommended in patients under
18 years of age.
Older people
Miacalcic can be used by older people without any
specific requirements.

Other medicines and Miacalcic
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
It is particularly important to tell your doctor if you are
taking medicines:
– used to treat heart problems (e.g. digoxin) or high
blood pressure (e.g. amlodipine, diltiazem);
– containing lithium, as the dose of lithium may need
to be changed;
– containing bisphosphonate (used to treat
osteoporosis).
Pregnancy and breast-feeding
Miacalcic should not be used by pregnant and breastfeeding women.
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking
any medicine.
Driving and using machines
Miacalcic may cause tiredness, dizziness and disturbed
vision which could impair your reactions. If this
happens to you, do not drive or use any machines.
Miacalcic contains sodium
The solution contained in Miacalcic ampoules contains
less than 23 mg sodium per 1 ml and can therefore be
considered as sodium-free.
3. How to take Miacalcic
Always take this medicine exactly as your doctor has
told you. Check with your doctor, nurse or pharmacist
if you are not sure. It is advisable to administer
the medication at bedtime in order to reduce the
occurrence of nausea (feeling sick) or vomiting (being
sick) which may occur especially at the beginning of
the therapy.
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Package Leaflet: Information for the user

Do not exceed the recommended dosage. Do not take
Miacalcic if you notice that the solution is not clear and
colourless. Do not change the dose or stop treatment
without first talking to your doctor.
Miacalcic is usually given by injection either into the
tissue just under the skin (subcutaneous injection) or
into a muscle (intramuscular injection). Occasionally,
the injection is given by a slow infusion into a vein
(slow intravenous infusion).
If you will be giving yourself subcutaneous injections,
make sure you understand exactly how to prepare and
give them. Your doctor or nurse will give you precise
instructions. Do not inject yourself unless you are
confident of your ability to do so.
You should not use the injection or infusion straight
from the fridge. Let it reach room temperature
naturally first. The ampoules should be used
immediately after opening. Excess amount of Miacalcic
should be discharged.
The dosage to be used depends on your condition
and response to the medicine. Your doctor will tell you
exactly how much Miacalcic you should take.
The usual doses are:
– For prevention of bone loss: 100 IU per day or 50 IU
twice daily for 2 to 4 weeks, given into the muscle or
the tissue just under the skin.
– For Paget’s disease: 100 IU daily injected into a
muscle or into the tissue just under the skin.
– For the treatment of high calcium levels: 100 IU
every 6 to 8 hours, given into a muscle or into the
tissue just under the skin. In some cases, it may be
given by injection into a vein.
If you inject more Miacalcic than you should
If you accidentally inject too much Miacalcic,
contact your doctor immediately. You may require
medical attention.
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If you forget to inject Miacalcic
If you forget to inject yourself a dose, give it as soon
as you remember it unless it is less than 4 hours until
your next dose is due. In that case, wait and inject your
next dose at the usual time. Do not inject a double
dose to make up for a forgotten one.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them. The most
frequently observed side effects are nausea, vomiting
and redness of the face/neck.
Some side effects could be serious:
– Increased heartbeat, nettle rash (hives), difficulty
breathing, swelling of the tongue and throat,
tightness in your chest, a sudden fall in blood
pressure or shock. These may be signs of a severe
allergic reaction (anaphylaxis) and are very rare.
– Swelling of your face, limbs or entire
body (uncommon).
If you experience any of these, contact a
doctor immediately.
Other side effects:
Very common side effects (may affect more than
1 in 10 people):
– Feeling sick with or without being sick. These are less
frequent when the injection is done in the evening
and after meals.
– Sudden waves of redness of the face and/or neck,
usually observed 10 to 20 minutes after injection.
Common side effects (may affect up to 1 in 10 people):
– diarrhoea, stomach pain,
– tiredness,
– pain in bone, joints or muscles

– dizziness,
– headache,
– changes in the way things taste
Uncommon side effects (may affect up to 1 in
100 people):
– high blood pressure (hypertension),
– flu-like symptoms,
– redness and swelling at the injection site,
skin rash, itching
– disturbed vision
– frequent need to pass water,
– allergic reactions
Rare side effects (may affect up to 1 in 1,000 people):
Calcium levels in your blood can fall 4 to 6 hours after
dose administration, it is unlikely that you notice any
symptoms because of this.
Not known (frequency cannot be estimated from the
available data):
Trembling
In rare cases, the effectiveness of Miacalcic may
be reduced.
If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not listed
in this leaflet.
5. How to store Miacalcic
Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date which is
stated on the label after “exp”. The expiry date refers
to the last day of that month.
The unopened ampoules and vials should be stored in
a refrigerator (2–8°C). Do not freeze.

The ampoules should be used immediately after
opening. If you do not use the whole of the ampoule,
DO NOT keep the remainder.
Once the vial has been opened it can be kept at room
temperature (not above 25°C) for up to one month. If
there is anything left afterwards throw it away.
For infusion, use Miacalcic immediately after dilution in
0.9% w/v sodium chloride in soft PVC bags.
Do not take this medicine if you notice that the
solution is not clear and colorless.
Do not throw away any medicine via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help to protect the environment.
6. Contents of the pack and other information
What Miacalcic ampoules contains
– The active substance is calcitonin (salmon,
synthetic). Each 1 ml of Miacalcic solution for
injection and infusion contains 50 IU or 100IU/ml.
One IU (International Unit) corresponds to
0.167 micrograms calitonin (salmon, synthetic).
– The other ingredients are acetic acid, sodium acetate
trihydrate, sodium chloride and water for injection.
– These are for single use only.
What Miacalcic vials contains
– The active substance is calcitonin (salmon,
synthetic). Each 2 ml of Miacalcic solution for
injection and infusion contains 400 IU.
One IU (International Unit) corresponds to
0.167 micrograms calitonin (salmon, synthetic).
– The other ingredients are acetic acid, sodium acetate
trihydrate, sodium chloride, water for injection and
the preservative, phenol.
What Miacalcic looks like and contents of the pack
Miacalcic 50 IU/ml and 100 IU/ml is a solution for
injection and infusion.

Miacalcic ampoules are made of uncoloured glass that
contain 1 ml of clear, colourless solution for injection
and infusion.
Miacalcic 50 IU/ml and 100IU/ml solution for injection
and infusion are available in packs of 5, 10, 50 and
100 ampoules.
Not all strengths and pack sizes may be available in
your country.
Miacalcic vials are made of clear glass and contain 2 ml
of clear, colourless solution for injection and infusion.
Each Miacalcic pack contains one vial.
The product licence holder is
Novartis Pharmaceuticals UK Ltd, Trading as
Sandoz Pharmaceuticals, Frimley Business Park,
Frimley, Camberley, Surrey, GU16 7SR, England.
The manufacturer responsible for release on to the
market is
Novartis Pharmaceuticals UK Ltd, Wimblehurst Road,
Horsham, West Sussex RH12 5AB, England.
This leaflet was last revised in October 2011.
If you would like any more information, or would like
the leaflet in a different format, please contact Medical
Information at Novartis Pharmaceuticals UK Ltd,
tel. 01276 698370.
MIACALCIC is a registered Trade Mark
Copyright Novartis Pharmaceuticals UK Ltd

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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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