Salmon calcitonin

What it is used for

Fortical ® Nasal Spray contains calcitonin salmon, a man-made protein that is similar to a protein occurring in the human body. When you spray Fortical ® Nasal Spray into your nostril, it is rapidly absorbed by the blood vessels lining your nasal passages. It then travels into your bloodstream and on to your bones where it has been shown to slow down bone loss at the spine. Slowing down bone loss, while new bone building continues, helps to increase bone mass at the spine.

Fortical ® Nasal Spray is taken with calcium and vitamin D supplements recommended by your doctor, to help slow down further bone loss. If you are not getting enough calcium and vitamin D in your daily diet, your doctor may recommend a calcium or vitamin D supplement. The amount of calcium and vitamin D needed each day can vary from person to person. Most people generally require at least 1000 mg of calcium and 400 International Units of vitamin D each day. Vitamin D is necessary for your body to use calcium to build bone material. That is why your doctor may have recommended that you add a vitamin D supplement to your diet. It is important to take all the calcium and vitamin D supplements your doctor directs each day.

How to take it

• Periodic nasal exams are recommended. Your doctor should do a nasal exam before you start using Fortical ® Nasal Spray and if you have any nasal discomfort while using it.
• Fortical ® Nasal Spray exactly as your doctor prescribes it. See the detailed Patient Instructions for Use at the end of this leaflet.
• Before using a new bottle of Fortical ® Nasal Spray for the first time, take it out of the refrigerator and let the medicine warm to room temperature. Using Fortical ® Nasal Spray directly from a refrigerator without being warmed to room temperature may cause you to have nasal discomfort.
• Before using a new bottle of Fortical ® Nasal Spray for the first time, you will need to prime the pump at least 5 times until a full spray is produced. See the detailed Assembly Instructions and Using Fortical ® Nasal Spray sections at the end of this Patient Information Leaflet for directions on how to prime a new bottle of Fortical ® Nasal Spray and how to properly use Fortical ® Nasal Spray.
• One spray in either nostril will give you the right daily dose of Fortical ® Nasal Spray. Change (alternate) between using the right nostril one day and the left nostril the next day. Each bottle of Fortical ® Nasal Spray contains enough medicine for 30 days of dosing.
• After priming the pump, do not use Fortical ® Nasal Spray for more than 30 doses. Even though the container may not be completely empty, you may not get the correct dose of medicine. Safely throw away the empty bottle of Fortical ® Nasal Spray after you have used 30 doses.
• If you miss a dose, or forget to use Fortical ® Nasal Spray, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for the missed dose.
• If you use too much Fortical ® Nasal Spray, tell your doctor.

Side effects, and when to stop

Serious allergic reactions can happen with Fortical ® Nasal Spray. See "Who should not use Fortical® Nasal Spray".

Get emergency medical help right away if you have any of the following symptoms of a serious allergic reaction:

• trouble breathing
• swelling of your face, throat or tongue
• rapid heartbeat
• chest pain
• feel faint or dizzy

The most common side effects of Fortical ® Nasal Spray include:

• nasal symptoms including: runny nose, dryness, crusting, sores, infection, redness, irritation, itching, tenderness, nosebleed, discomfort across bridge of nose
• back and joint pain
• headache

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Fortical ® Nasal Spray. For more information, ask your doctor or pharmacist.

Who should not take it

Do not use Fortical ® Nasal Spray if you are allergic to the calcitonin salmon protein.

What to say before you start

Tell your doctor about all your health conditions, including if you:

• are pregnant. It is not known if Fortical ® Nasal Spray can cause harm to an unborn baby if it is used during pregnancy.
• are breast-feeding. It is not known if Fortical ® Nasal Spray passes into your breast milk.

Tell your doctor and pharmacist about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

Storing it

• Keep new, unopened bottles of Fortical ® Nasal Spray in the refrigerator, between 36°F to 46°F (2°C to 8°C).
• Do not freeze.
• Keep the bottle of Fortical ® Nasal Spray away from light.
• Allow the Fortical ® Nasal Spray to reach room temperature before using it and for the first time.
• Tighten the pump securely to the bottle (see Step 3 and 4 in the Patient Instructions of Use - Assembly Instructions). This will help to ensure a good seal between the pump and the bottle.
• After opening a new bottle of Fortical ® Nasal Spray, store at room temperature, 68°F to 77°F (20°C to 25°C).
• Each bottle of Fortical ® Nasal Spray contains enough medicine for 30 doses. Throw away the empty bottle of Fortical ® Nasal Spray after you have used 30 doses.

Keep Fortical ® Nasal Spray and all other medicines out of the reach of children.