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|Miacalcin Spray

Miacalcin Spray

Miacalcin Spray is used for:

Treating osteoporosis (fragile or brittle bones) in certain women who have been past menopause for more than 5 years. It should be used along with adequate calcium and vitamin D intake. It may also be used for other conditions as determined by your doctor.

Miacalcin Spray is a polypeptide hormone. It works by stopping bone loss and increasing the density or strength of bone.

Do NOT use Miacalcin Spray if:

• you are allergic to any ingredient in Miacalcin Spray

Contact your doctor or health care provider right away if any of these apply to you.

Before using Miacalcin Spray:

Some medical conditions may interact with Miacalcin Spray. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Miacalcin Spray. However, no specific interactions with Miacalcin Spray are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Miacalcin Spray may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Miacalcin Spray:

Use Miacalcin Spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Miacalcin Spray. Talk to your pharmacist if you have questions about this information.
• Before priming the pump and using a new bottle, allow the medicine to reach room temperature.
• The pump must be primed before the first use of each new bottle. To prime the pump, hold the bottle upright and press the 2 white side arms toward the bottle until a faint spray is seen. Only prime the pump before the first use of a new bottle.
• Use Miacalcin Spray in only 1 nostril each day. Alternate nostrils every day.
• To use Miacalcin Spray, hold your head in the upright position. Place the nozzle of the pump into the nostril and press the pump firmly towards the bottle. It is not necessary to inhale while spraying Miacalcin Spray.
• Keep track of how many doses you use from the bottle. Do not use more than 30 doses from one bottle, even if the bottle does not appear to be empty. After 30 doses, the pump may not deliver the correct amount of medicine with each spray.
• If you miss a dose of Miacalcin Spray, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Miacalcin Spray.

Important safety information:

• Follow the diet program given to you by your health care provider. Miacalcin Spray works better if used along with calcium and vitamin D. Ask your doctor about appropriate calcium and vitamin D supplements.
• Lab tests, including urine tests and nasal examinations, may be performed while you use Miacalcin Spray. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Miacalcin Spray with caution in the ELDERLY; they may be more sensitive to its effects.
• Miacalcin Spray should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Miacalcin Spray while you are pregnant. It is not known if Miacalcin Spray is found in breast milk. Do not breast-feed while using Miacalcin Spray.

Possible side effects of Miacalcin Spray:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back or joint pain; headache; runny nose; stuffy nose.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); nasal irritation, soreness, or pain; nosebleeds; sores in nose.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include nausea or vomiting.

Store new, unassembled nasal spray bottles in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Protect from freezing. Store bottles that are in use at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in an upright position for up to 35 days. Throw away all unrefrigerated bottles after 35 days. Keep Miacalcin Spray out of the reach of children and away from pets.

General information:

• If you have any questions about Miacalcin Spray, please talk with your doctor, pharmacist, or other health care provider.
• Miacalcin Spray is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Miacalcin Spray. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.