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Information on Calcitonin, a hormone used to regulate calcium levels in the blood and reverse bone loss. It covers the uses of Calcitonin, precautions before use, dosage instructions, and possible side effects. The document also includes information on how to store Calcitonin and its contents.
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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.
What is in this leaflet :
Calcitonin 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.
Calcitonin can be given for the following conditions:
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.
Use of Calcitonin is not recommended in patients under 18 years of age.
Calcitonin can be used by older people without any specific requirements.
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:
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.
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.
The solution contained in Calcitonin ampoules contain less than 23 mg sodium per 1 ml and can therefore be considered as sodium-free.
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 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.
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.
Uncommon side effects (may affect up to 1 in 100 people):
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):
In rare cases, the effectiveness of Calcitonin 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
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 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.
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.
Calcitonin 50 IU/ml and 100 IU/ml is a solution for injection and infusion.
Calcitonin ampoules are made of uncoloured glass that contain 1 ml of clear, colourless solution for injection and infusion.
Calcitonin 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.
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.
Marketing Authorisation Holder Essential Pharma Ltd 7 Egham Business Villlage Crabtree Road Egham, Surrey TW20 8RB United Kingdom
Manufacturer Famar Health Care Services Madrid, S.A.U. Avda. Leganés, 62, Alcorcón, 28923 Madrid, Spain
This leaflet was last revised in December 2016.