Miacalcin is a man-made form of a hormone that occurs naturally in the thyroid gland.

Miacalcin nasal spray is used to treat osteoporosis in women who have been in menopause for at least 5 years. It should be used along with adequate calcium and vitamin D intake.

Miacalcin nasal spray should be reserved for patients for whom alternative treatments are not suitable e.g. patients where other therapies are not suitable or for patients who are intolerant or unwilling to use other treatments.

To make sure you are not allergic to Miacalcin, your doctor may perform an allergy skin test before your first dose of Miacalcin Nasal Spray.

Before using Miacalcin, tell your doctor if you have any nasal or sinus problems such as nasal deformities, a chronic infection, or nasal pain.

Avoid using any other nasal sprays or medicines at the same time you use Miacalcin unless your doctor has told you to.

Call your doctor at once if you have any type of severe irritation of your nose, or if you feel light-headed or faint.

Less serious nasal irritation is more likely to occur, such as minor bleeding, redness, itching, tenderness, dryness, crusting, scabs, or nasal congestion.

To be sure Miacalcin is not causing harmful side effects to the inside of your nose, your doctor may want to check your nasal passages often. Visit your doctor regularly.

Use Miacalcin Nasal Spray exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

To make sure you are not allergic to calcitonin, your doctor may perform an allergy skin test before your first dose of this medicine.

Miacalcin comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Store unopened bottle of Miacalcin in the refrigerator but do not allow it to freeze.

Once you put the bottle and pump assembly together, you may keep the medicine at room temperature, away from light and heat. Store the bottle upright with the pump attached.

Before your first use of the assembled bottle and pump, you must prime the spray. Allow the medicine to reach room temperature before priming.

To prime Miacalcin, press the pump at least 5 times until a fine mist appears. Prime the spray only before your first use of the newly assembled bottle.

To use the nasal spray:

• Blow your nose gently. Keep your head upright and insert the tip of bottle into one nostril. Hold the nasal spray upright with your first and second fingers on each side of the pump and your thumb on the bottom of the bottle.

• Pump the spray unit firmly to spray the medicine into your nostril. You do not need to sniff or inhale deeply.

• Do not blow your nose for at least a few minutes after using the nasal spray.

• If the spray gets in your eyes or mouth or on your skin, rinse with water.

Miacalcin is usually given as one spray per day into only one of your nostrils. Use the other nostril the next day and continue alternating back and forth for each daily dose.

Miacalcin spray delivers a fine mist into the nose. Even if you do not feel the spray while using it, the medication is still being absorbed by your nasal passages.

Each bottle contains 30 doses of Miacalcin. Throw away the medicine after 30 uses, even if there is still medicine left in the bottle.

To be sure this medication is not causing harmful side effects to the inside of your nose, your doctor may want to check your nasal passages often.

Your doctor may have you take extra vitamin D while you are using Miacalcin. Take only the amount of vitamin D that your doctor has prescribed.

You should not use this Miacalcin nasal spray if you are allergic to salmon calcitonin.

To make sure Miacalcin is safe for you, tell your doctor if you have:

• high levels of calcium in your blood (hypercalcemia); or

• any nasal or sinus problems such as nasal deformities, a chronic infection, or nasal pain.

Using Miacalcin may increase your risk of developing certain types of cancer. Ask your doctor about your specific risk.

FDA pregnancy category C. It is not known whether Miacalcin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether calcitonin nasal passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid using any other nasal sprays or nasal medicines at the same time you use Miacalcin unless your doctor has told you to.

Get emergency medical help if you have any of these signs of an allergic reaction to Miacalcin: hives; fast heartbeats; feeling lightheaded; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• severe nasal irritation; or

• low levels of calcium in your blood--numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes.

Common Miacalcin side effects may include:

• bleeding from your nose;

• runny or stuffy nose;

• dryness, itching, tenderness, or general discomfort of your nose; or

• crusting, scabs, or sores inside your nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with calcitonin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.