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

Active substance(s): SALMON CALCITONIN

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Package Leaflet: Information for the user

Miacalcic can be given for the following conditions:
–– Prevention of bone loss in patients who have suddenly become immobile.
For example, patients who are bed-bound because of a fracture.
–– Paget’s disease of bone in patients who cannot take other treatments for
this condition, for example patients with serious kidney problems.
Paget’s disease is a slowly progressing illness which can cause a change
in the size and shape of certain bones.
–– Treatment of high calcium levels in the blood (hypercalcemia) due to
cancer.

Miacalcic® 50 IU/1 ml
solution for injection and infusion
Miacalcic 100 IU/1 ml
solution for injection and infusion
®

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).

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. See section 4.
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

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.
Please tell your doctor if you have been diagnosed with cancer. In clinical
trials, patients treated with calcitonin for osteoporosis and osteoarthritis
have shown an increase in the risk of cancer following long term treatment.
Your doctor will decide if calcitonin is a suitable treatment for you and for
how long you can be treated.
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.

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.

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);

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Pregnancy, breast-feeding and fertility
Miacalcic should not be used by pregnant women. If you are breast-feeding
use of Miacalcic is not recommended.
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 contain 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.
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.
Your doctor will decide the correct dose and how long you should receive
calcitonin treatment depending on your condition.
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, normally for up to 3 months. In some
cases, you doctor might decide to extend your treatment up to
6 months.
–– 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.
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.

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–– containing lithium, as the dose of lithium may need to be changed;
–– containing bisphosphonate (used to treat osteoporosis).

Jed Carter

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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 or joints,
–– pain in muscles,
–– dizziness,
–– headache,
–– changes in the way things taste (taste disturbance),
–– cancer (following long term treatment)

Not known (frequency cannot be estimated from the available data):
–– Trembling
–– Reduced level of calcium in the blood, sometimes leading to cramps
–– Hives
In rare cases, the effectiveness of Miacalcic may be reduced.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly (see details below). By reporting side effects you can help
provide more information on the safety of this medicine.
United Kingdom:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
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.

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,
–– disturbed vision,
–– frequent need to pass urine,
–– allergic reactions including skin rash and itching, rash on entire body
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.

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
colourless.
Do not throw away any medicines 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.

2182283_GB_p1_LFT.indd 2

Brewery House,
The Maltings,
Silvester Street
Kingston-Upon-Hull
HU1 3HA
Tel: +44 (0) 1482 973000

x Yes
Live Text:
/
No
WO:
1462658
Comp. Description: Leaflet MIACALCIC LIAM GB
Comp. Number New: 2182283 GB
Comp. Number Old: 2173857 GB
Format/Dimension: 420x148mm
Tech. Drawing No.: 799.4.9165/07

/

Both

Production Site:
CTM:
Printing Colours:

Stein
Docherty, Leanne
Black

Technical Colours: Cutting
Dimensions

Minimum Font Size: 8.0pt
Font Type: News Gothic
08/12/2015

This leaflet was last revised in November 2015.
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

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 calcitonin
(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.
Marketing Authorisation Holder
Novartis Pharmaceuticals UK Limited, Trading as Sandoz Pharmaceuticals,
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, England.
Manufacturer
Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, England, United Kingdom.

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Proof Number: 1
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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 calcitonin
(salmon, synthetic).
–– The other ingredients are acetic acid, sodium acetate trihydrate, sodium
chloride and water for injection.
–– These are for single use only.

Jed Carter

! P LEASE TU R N OV E R P R I N T I N G O N !
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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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