Fortical®
calcitonin-salmon (rDNA origin) Nasal Spray

Assembly and Usage Instructions

Easy-To-Use

Fortical® Nasal Spray

IMPORTANT:

• Keep sealed bottle in refrigerator (36-46°F) until opened. Do NOT Freeze.
• Allow Fortical® Nasal Spray to reach room temperature before first use.
• After opening - store at room temperature, 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F).
• Store unit in an upright position and tighten the pump securely to the bottle (see Step 3 and 4 for instructions). Upright storage and a properly tightened pump will help to ensure a proper seal between the pump and the bottle.
• Fortical® Nasal Spray remains effective up to 30 days from the time it is opened. After 30 days, it should be discarded. Discard 30 days after first use.

Assembly Instructions

1. Opening the Bottle. If your pharmacist attached the pump for you, skip to step 4. Otherwise, set bottle on table or counter top, and hold firmly while unscrewing cap to avoid spilling any Fortical® Nasal Spray.
2. Unwrapping the Pump. Carefully cut shrink wrap with scissors or knife, and tear away from pump, being careful not to cut, bend, or contaminate feed tube at bottom.
3. Attaching the Pump. Holding bottle on a flat surface (like a table), screw pump onto bottle by gripping the grooves of the pump and twisting clockwise until the pump is tightly sealed to the bottle.
4. Removing Cap. To remove cap from pump, twist slightly while pulling up. Save the cap to replace after each use.
5. Removing the Lock Tab. Grasp the lock tab between thumb and forefinger, while holding the bottle on a flat surface. Then pull sideways to remove the tab and unlock the pump.
   
   Save the lock tab, and push it back onto the pump after each use to avoid accidentally wasting any Fortical® Nasal Spray.
   Once the new pump is primed, it is NOT necessary to re-prime it before each use.
6. Prime New Pump Before First Use. To ensure the proper dose, you need to prime the new pump after attaching it to the bottle once the pump and bottle have reached . room temperature. Hold the bottle upright. With your index and middle fingers on each side of the top of the pump, and your thumb under the bottle, push the pump down. Repeat until you see a full spray, which may take up to 5-7 depressions. If the pump is not delivering a full spray during or after priming, contact Upsher-Smith at the phone number referenced on the back of these instructions. Do not place anything into the opening of the pump.

Using Fortical Nasal Spray

Fortical® Nasal Spray is easy to use. One spray into one nostril once a day delivers your recommended daily dose.

You can spray Fortical® Nasal Spray into either nostril. Simply hold your head and the unit in an upright, vertical position, and place the spray tip into your nostril at the same angle as your nasal passage. Then press the pump all the way down one time. You do not need to inhale. If the unit is not held upright Fdaocu crriuntrigac t ueas delo, stIhel.elupusmtpramatiyo nont b#e 7able to deliver an

You may not feel the spray, because the mist is so fine. But do not waste medication by testing the sprayer. It is all right if some of the spray drips out of your nostril. Just one spray will give you the correct dose.

Alternate Nostrils. We suggest you not spray Fortical® Nasal Spray into the same nostril each day. Instead, use the right nostril one day, and the left nostril the next day.

Use Fortical® Nasal Spray Every Day. A single spray each day delivers 200 International Units of calcitonin-salmon. Supplemental calcium and vitamin D should be taken as directed by your health care provider. Together, they offer an alternative to help defend against postmenopausal osteoporosis. Each bottle of Fortical® Nasal Spray contains enough doses to last approximately 30 days.

7. Replace The Lock Tab After Use. Replacing the lock tab can prevent wasting medication by accidentally depressing the pump. Simply slide the lock tab on by pushing it sideways against the grooves in the pump.

8. Replace The Cap. Slide the cap back over the spray tip carefully, while holding the top of the pump.

Do NOT return the bottle to the refrigerator. After priming the pump, store Fortical® Nasal Spray in an upright position at room temperature, 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). Discard 30 days after first use.

Cleaning the Pump. You can clean the spray tip by gently wiping it with a clean, damp cloth or tissue. Then dry the tip with cloth or tissue before replacing the cap. Do not submerse the tip or bottle in water.

What you should know about Fortical® calcitonin-salmon (rDNA origin) Nasal Spray

What is Fortical® Nasal Spray? Fortical® Nasal Spray is used to treat osteoporosis in postmenopausal women with low bone mass.

What does Fortical® Nasal Spray do? Fortical® Nasal Spray contains calcitonin, a scientifically-engineered protein that is similar to a natural protein found in the human body. The precise way this protein works is still being studied. But it is generally understood that calcitonin slows down the activity of osteoclasts (the cells that remove old bone material). Reducing the amount of old bone material that is removed, while new bone building continues, results in increased bone mass.

Why is Fortical® a nasal spray? It is both convenient and easy to use. It is also an effective way to quickly get Fortical® Nasal Spray into your blood stream. It is easily absorbed into the blood vessels lining your nasal passage.

Is Fortical® Nasal Spray a substitute for calcium supplements? No. Fortical® Nasal Spray is not a source of calcium. It works with the calcium and vitamin D supplements recommended by your doctor, and can help you gain maximum benefit from calcium replacement therapy. It is important to take all of the calcium and vitamin D supplements your doctor directs each day.

How much calcium does my body need each day?

This 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. If you are not getting enough calcium in your daily diet, your doctor may recommend a calcium supplement.

Vitamin D is necessary for your body to process calcium to build bone material. That is why your doctor may have recommended that you add a vitamin D supplement to your diet.

Why is osteoporosis a greater concern after menopause? Following menopause, the amount of estrogen produced by a woman's body dramatically decreases. Estrogen helps balance bone growth and keep bones strong. When it is reduced, your body may remove old bone cells faster than it replaces them with new bone cells. As a result, bones can become weak and brittle, and more susceptible to fractures. This condition is known as postmenopausal osteoporosis.

What are the dangers of postmenopausal osteoporosis? In addition to broken wrists, hips and other bones - postmenopausal osteoporosis can lead to a curved spine, rounded shoulders and even loss of height. It can be a painful, disabling condition.

That is why your doctor has recommended Fortical® Nasal Spray to help protect against this condition.

How much Fortical® Nasal Spray should I use each day? A single spray into either nostril will deliver the correct daily dose of Fortical® Nasal Spray (200 International Units of calcitonin-salmon in a 0.09 mL solution).

Is age a concern? Fortical® Nasal Spray can be used at any age. No unusual side effects or any increase in other side effects have been reported for elderly patients.

Is there any reason a person should not use Fortical® Nasal Spray? This product should not be used by anyone who is allergic to the calcitonin- salmon protein, or pregnant or nursing women.

Why is Fortical® Nasal Spray in a brown bottle? Some of the components of the formulation of Fortical® Nasal Spray are sensitive to light. To maintain the product's stability, amber glass is required to avoid direct exposure to light.

Other warnings and precautions. While no formal studies have been completed to test drug interaction with calcitonin-salmon, there are no known drug interactions. As usual, however, you should tell your doctor and pharmacist what other prescription and non-prescription medications you are taking.

A nasal exam should be completed before using this medication and if you experience nasal discomfort while using it. In clinical studies, nasal irritation occurred in approximately 6% of participants.

As with any protein, some people may have a systemic allergic reaction to calcitonin-salmon. If you are allergic to the calcitonin-salmon protein, you should not use this product.

Please be aware that using Fortical® Nasal Spray directly from a refrigerator without being warmed to room temperature may cause local discomfort.

Possible side effects. Most patients do not experience any side effects with Fortical® Nasal Spray. As with any medication, however, some people may notice some side effects. These side effects are usually mild, and do not cause patients to discontinue treatment.

The most common side effects include: nasal symptoms (such as runny nose, crusting or nosebleed), back and/or joint pain and headache.

If you have any questions, concerns or unusual symptoms, contact your doctor.

This medication is intended for a particular condition. Do not use it to treat any other condition, or give it to others.

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

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