FORTICAL (Generic)

This medication is used to treat brittle bone disease (osteoporosis) in women who are at least 5 years past "the change of life" (menopause). Calcitonin works by slowing bone loss to help maintain strong bones and reduce your risk of fractures.

This product has been withdrawn from the Canadian market due to safety problems.

Read the patient and product information sheets if available from your pharmacist before you start using calcitonin and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

This medication is for use in the nose as directed, usually one spray in one nostril each day, alternating nostrils daily. It is recommended to use this medication at the lowest effective dosage and for the shortest possible duration to treat your condition. Patients treated long-term with this medication have shown a rare risk of developing cancer. Discuss the benefits and risks of long term treatment with this medication.

Remove a new bottle from the refrigerator and allow it to reach room temperature. Follow the instructions on how to prime the pump the first time you use a new bottle. Once the pump is primed, it does not have to be reprimed if the bottle is properly stored in an upright position. Consult your pharmacist if you have any questions.

To use the nasal spray, remove the protective cap, keep your head upright and insert the tip into a nostril. Press down firmly on the pump to deliver the medication. Replace the protective cap. Use the other nostril the next day.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day.

(See also How to Use section).

Runny nose, nose bleeds, nasal irritation, dry nose with crusting, headache, dizziness, nausea, flushing of the face, or back pain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: nasal sores, muscle cramps/spasms, numbness/tingling of the arms/legs.

Get medical help right away if you have any very serious side effects, including: seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking calcitonin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low level of calcium in the blood.

This medication is used mainly in women after menopause. Therefore, it is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have any questions about this product.

Store unopened bottles in the refrigerator. Do not freeze. Once the bottle is opened and the pump is primed, store at room temperature in an upright position away from light and moisture. Discard the unused portion after the number of days/doses noted on the package. If you are unsure when to discard your brand, ask your pharmacist. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is: lithium.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Do not share this medication with others.

Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. Since you may also need to take calcium and vitamin D supplements and make lifestyle changes, consult your doctor for specific advice.

Laboratory and/or medical tests (e.g., bone density tests, nasal exams) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.