CALCITONIN ALMIRALL 100 IU INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Calcitonina Almirall 100 UI/ml Solution for Injection

Synthetic salmon calcitonin

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 symptoms 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.

Contents of the pack

1. What is Calcitonina Almirall and what is it used for
2. What you need to know before you use Calcitonina Almirall
3. How to use Calcitonina Almirall
4. Possible side effects
5. Storage of Calcitonina Almirall
6. Contents of the pack and other information

1. What is Calcitonina Almirall and what is it used for

Calcitonina Almirall can be administered in the following cases:

• Prevention of bone loss in situations of sudden immobilization. For example, patients who are bedridden due to a fracture.

• Paget's disease of the bone in people who cannot receive other treatments for this disease, such as patients with severe kidney problems. Paget's disease is a slowly progressing condition that can cause a change in the size and shape of certain bones.

• Treatment of high blood calcium levels (hypercalcemia) due to cancer.

2. What you need to know before you use Calcitonina Almirall

Do not use Calcitonina Almirall:

• if you are allergic to calcitonin or any of the other components of this medicine (listed in section 6).
• if you have hypocalcemia (low blood calcium levels).

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Calcitonina.

Allergic reactions may occur due to treatment with Calcitonina Almirall, including cases of severe allergic reactions (anaphylactic shock). However, generalized or localized redness is a common reaction due to calcitonin and is not an allergic reaction.

In case of suspected allergy to calcitonin, your doctor may decide to perform a sensitivity test before starting treatment.

Consult your doctor if you have been diagnosed with cancer. In clinical trials, patients treated with calcitonin for osteoporosis and arthritis have shown an increased risk of developing cancer with long-term treatments. Your doctor will decide if calcitonin is a suitable treatment for you and for how long you should follow it.

Use in children and adolescents

The use of Calcitonina Almirall is not recommended in patients under 18 years of age.

Use of Calcitonina Almirall with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those bought without a prescription.

Certain medicines may interact with Calcitonina Almirall; in these cases, it may be necessary to change the dose or interrupt treatment with one of them.

It is important that you inform your doctor if you are taking or have recently taken any of the following medicines:

• Cardiac glycosides and calcium channel blockers (medicines for treating heart problems or high blood pressure).
• Bisphosphonates (for the treatment of various bone-related diseases or calcium metabolism).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

It is not known if the use of Calcitonina Almirall is safe in pregnant women; therefore, Calcitonina Almirall should only be used during pregnancy when, in the opinion of your doctor, the expected therapeutic benefits justify it.

Breastfeeding

Do not use Calcitonina Almirall if you are breastfeeding.

Driving and using machines

Calcitonina Almirall may cause temporary dizziness. If you experience this adverse reaction, you should not drive or use machines.

Warnings about excipients

This medicine contains less than 1 mmol (23 mg) of sodium per ampoule, so it is considered essentially "sodium-free".

3. How to use Calcitonina Almirall

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to use your medicine.

Your doctor will decide the correct dose and how long you should follow the treatment with calcitonin.

Dosage

Use in adults over 18 years

• For the prevention of bone loss:

A dose of 100 UI per day or 50 UI twice a day for 2 to 4 weeks is recommended.

• In Paget's disease:

A dose of 100 UI per day, usually for a maximum of 3 months, is recommended. In certain cases, the doctor may decide to extend the treatment duration up to 6 months.

• For the treatment of high calcium levels:

A dose of 100 UI every 6 to 8 hours is recommended.

Method of administration

Calcitonina Almirall can be administered subcutaneously or intramuscularly.

It can be administered before bedtime to reduce nausea or vomiting that may occur, especially at the start of treatment.

If you use more Calcitonina Almirall than you should

Contact your doctor or pharmacist immediately. The reactions that can be expected in case of overdose are nausea, vomiting, redness, and dizziness.

In case of overdose or accidental ingestion, you can also contact the Toxicology Information Service. Telephone 915 620 420.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most frequently observed adverse reactions (in more than one in 10 patients) with Calcitonina Almirall are nausea (with or without vomiting), which occurs in 10% of patients and tends to decrease or disappear over time or by reducing the dose.

Redness of the skin (on the face or upper part of the body) also appears. This is not an allergic reaction but is due to the effect of the medicine and usually appears 10-20 minutes after administration.

Common adverse reactions (may affect up to 1 in 10 patients): cancer (after long-term treatments).

Uncommon adverse reactions (may affect up to 1 in 100 patients) are: diarrhea, inflammatory reactions at the subcutaneous or intramuscular injection site, skin rash, metallic taste in the mouth, dizziness, and increased urine production.

Rare adverse reactions (may affect up to 1 in 1,000 patients) are: transient decrease in blood calcium levels 4-6 hours after administration (in patients with Paget's disease and young patients) and development of neutralizing antibodies to calcitonin.

Very rare adverse reactions (may affect up to 1 in 10,000 patients) are: severe allergic reactions, such as bronchospasm (spasm of the bronchi), swelling of the tongue and throat, and in isolated cases, anaphylaxis (severe general allergic reaction).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Calcitonina Almirall

Keep this medicine out of the sight and reach of children.

Store in the refrigerator (between 2°C and 8°C). Do not freeze.

Do not use this medicine after the expiry date stated on the packaging and outer carton after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Calcitonina Almirall

• The active ingredient is synthetic salmon calcitonin. One ampoule (1 ml) contains 100 UI of synthetic salmon calcitonin.
• The other ingredients are: sodium acetate trihydrate (E-262i), glacial acetic acid (E-260), sodium chloride, and water for injectable preparations.

Appearance and packaging of the product

Calcitonina Almirall is presented as a clear and colorless solution for injection. Each pack contains 10 glass ampoules of 100 UI each.

Marketing authorization holder and manufacturer

Marketing authorization holder

Almirall, S.A. General Mitre, nº 151 08022 – Barcelona (Spain).

Manufacturer

Famar Health Care Services Madrid, S.A.U. Avda. Leganés, 62 28925 Alcorcón – Madrid (Spain).

Date of last revision of this leaflet: March 2013

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/