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

Active substance(s): SALMON CALCITONIN / SALMON CALCITONIN / SALMON CALCITONIN

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1. What Calcitonin is and what it is used for
Calcitonin contains the active substance calcitonin (salmon, synthetic).

Package Leaflet: Information for the user

Calcitonin 50 IU/1 ml
Solution for Injection and Infusion
Calcitonin 100 IU/1 ml
Solution for Injection and Infusion
Calcitonin 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 Calcitonin is and what it is used for
2. What you need to know before you take Calcitonin
3. How to take Calcitonin
4. Possible side effects
5. How to store Calcitonin
6. Contents of the pack and other information

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.
Calcitonin 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.

2. What you need to know before you take Calcitonin
Do not take Calcitonin
–– 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 Calcitonin tell your doctor if you suspect to be
allergic to calcitonin (salmon, synthetic). Your doctor will perform a skin
test before you start taking Calcitonin.
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.

Other medicines and Calcitonin
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, breast-feeding and fertility
Calcitonin should not be used by pregnant women. If you are breast-feeding
use of Calcitonin 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
Calcitonin may cause tiredness, dizziness and disturbed vision which could
impair your reactions. If this happens to you, do not drive or use any
machines.
Calcitonin contains sodium
The solution contained in Calcitonin ampoules contain less than 23 mg
sodium per 1 ml and can therefore be considered as sodium-free.
3. How to take Calcitonin
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.

Children and adolescent (age under 18 years)
Use of Calcitonin is not recommended in patients under 18 years of age.

Do not exceed the recommended dosage. Do not take Calcitonin 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.

Older people
Calcitonin can be used by older people without any specific requirements.

Calcitonin 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 Calcitonin 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, your
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 Calcitonin than you should
If you accidentally inject too much Calcitonin, contact your doctor
immediately. You may require medical attention.
If you forget to inject Calcitonin
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.
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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 or joints,
–– pain in muscles,
–– dizziness,
–– headache,
–– changes in the way things taste (taste disturbance),
–– cancer (following long term treatment)
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.

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.

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 Calcitonin may be reduced.

6. Contents of the pack and other information
What Calcitonin ampoules contains
–– The active substance is calcitonin (salmon, synthetic). Each 1 ml of
Calcitonin solution for injection and infusion contains
50 IU or 100 IU/ml. One IU (International Unit) corresponds to
0.167 micrograms calcitonin (salmon, synthetic).
–– The other ingredients are glacial acetic acid, sodium acetate trihydrate,
sodium chloride and water for injection.
–– These are for single use only.

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 Calcitonin
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.

What Calcitonin vials contains
–– The active substance is calcitonin (salmon, synthetic). Each 2 ml of
Calcitonin solution for injection and infusion contains 400 IU. One IU
(International Unit) corresponds to 0.167 micrograms calcitonin
(salmon, synthetic).
–– The other ingredients are glacial acetic acid, sodium acetate trihydrate,
sodium chloride, water for injection and the preservative, phenol.

The unopened ampoules and vials should be stored in a refrigerator
(2-8°C). Do not freeze.

What Calcitonin looks like and contents of the pack
Calcitonin 50 IU/ml and 100 IU/ml is a solution for injection and infusion.

The ampoules should be used immediately after opening. If you do not use
the whole of the ampoule, DO NOT keep the remainder.

Calcitonin ampoules are made of uncoloured glass that contain 1 ml of
clear, colourless solution for injection and infusion.

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 Calcitonin 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.

Marketing Authorisation Holder
Essential Pharma Ltd.
7 Egham Business Villlage,
Crabtree Road,
Egham, Surrey,
TW20 8RB,
United Kingdom
Manufacturer
Geryon Pharma Ltd
25 Compass West,
Spindus Road,
Compass Industrial Park,
Liverpool, L24 1YA,
United Kingdom
This leaflet was last revised in October 2016.

Calcitonin 50 IU/ml and 100 IU/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.
Calcitonin vials are made of clear glass and contain 2 ml of clear, colourless
solution for injection and infusion.
Each Calcitonin pack contains one vial.

Cal50-100-400IU-PL-UK-2

2191327 GB

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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