Product Information for the User

Calcitonin Almirall 100 IU/mL Injectable Solution

Synthetic salmon calcitonin

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

• Keep this product information, as you may need to read it again.

If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed only to you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

Calcitonina Almirall can be administered in the following cases:

• Prevention of bone loss in situations of sudden immobilization. For example, patients who must stay in bed due to a fracture.

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

• Treatment of elevated levels of calcium in the blood (hypercalcemia) due to cancer.

No use Calcitonina Almirall:

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Calcitonina.

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

If you suspect an 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 an appropriate treatment for you and for how long you should continue 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 Medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

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

It is essential to inform your doctor if you are taking or have taken recently any of the following medications:

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

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

The safety of using Calcitonina Almirall in pregnant women is unknown, so 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 Operating Machines

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

Warnings about Excipients

This medication contains less than 1 mmol (23 mg) of sodium per ampoule, making it essentially "sodium-free".

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

Remember to use your medication.

Your doctor will decide on the correct dose and for how long you should continue treatment with calcitonina.

Dosage

Use in adults over 18 years old

• 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.

Administration Form

Calcitonina Almirall can be administered subcutaneously or intramuscularly.

It can be administered before bedtime to reduce nausea and vomiting that may appear, especially at the beginning of treatment.

If you use more Calcitonina Almirall than you should

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

In case of overdose or accidental ingestion, you can also consult the Toxicological Information Service. Phone 915 620 420.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

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

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

Poorly frequent adverse reactions (may affect up to 1 in 100 patients) are: diarrhea, inflammatory reactions at the site of subcutaneous or intramuscular injection, 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 4-6 hours after administration (in patients with Paget's disease and young patients) and development of neutralizing antibodies to calcitonin.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

Do not use this medication after the expiration date that appears on the packaging and outer carton after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Calcitonina Almirall

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

Appearance of the product and contents of the packaging

Calcitonina Almirall is presented in the form of an injectable solution, transparent and colorless. Each package contains 10 colorless glass ampoules of 100 U.I.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

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

Responsible for manufacturing

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

Date of the last review of this leaflet: March 2013

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/