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

1.    What Calcitonin is and what it is used for

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:

-    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.

Children and adolescent (age under 18 years)

Use of Calcitonin is not recommended in patients under 18 years of age.

Older people

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

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.

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.

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, 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 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.

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.

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.

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.

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.

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 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.

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 acetic acid, sodium acetate trihydrate, sodium chloride, water for injection and the preservative, phenol.

What Calcitonin looks like and contents of the pack 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

Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, England, United Kingdom.

This leaflet was last revised in July 2016.

5/5 Cal50-100-400IU-PL-UK-1