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Fortical

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Fortical

PATIENT INFORMATION

Fortical
[for-ti-kal]
(calcitonin-salmon [rDNA origin]) Nasal Spray

Fortical Nasal Spray - Illustration

Read this Patient Information before you start using Fortical Nasal Spray and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is Fortical Nasal Spray?

Fortical Nasal Spray is a prescription medicine used to treat osteoporosis in women more than 5 years after menopause. Fortical Nasal Spray should be used for women who cannot use other treatments or who choose not to use other treatments for osteoporosis.

It is not known if Fortical Nasal Spray lowers the chance of having bone fractures.

Calcitonin-salmon the active ingredient in Fortical Nasal Spray has not been shown to be effective in women less than 5 years after menopause.

It is not known if Fortical Nasal Spray is safe and effective in children under 18 years of age.

Who should not use Fortical Nasal Spray?

Do not use Fortical Nasal Spray if you:

  • are allergic to calcitonin-salmon or any of the ingredients in Fortical Nasal Spray. See the end of this leaflet for a complete list of ingredients in Fortical Nasal Spray.

What should I tell my healthcare provider before using Fortical Nasal Spray?

Before you use Fortical Nasal Spray, tell your healthcare provider if you:

  • have any other medical conditions
  • have low calcium levels in your blood
  • are pregnant or plan to become pregnant. It is not known if Fortical Nasal Spray can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Fortical Nasal Spray passes into your breast milk. You and your healthcare provider should decide if you will use Fortical Nasal Spray or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Especially tell your healthcare provider if you take:

  • lithium. Your healthcare provider may need to change your dose of lithium while you use Fortical Nasal Spray.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use Fortical Nasal Spray?

  • For detailed instructions, see the Instructions for Use at the end of this Patient Information leaflet.
  • Use Fortical Nasal Spray exactly as your healthcare provider tells you to use it.
  • Do not use Fortical Nasal Spray until your healthcare provider shows you and you understand how to use it correctly.
  • Use 1 spray of Fortical Nasal Spray, 1 time each day, in 1 nostril (inside your nose).
    • Start with 1 spray in your left nostril on your first day, followed by 1 spray in your right nostril on the second day.
    • Continue to switch nostrils for your dose each day.
  • Your healthcare provider should check your nose before you start using Fortical Nasal Spray and often while you are using it.
  • Tell your healthcare provider if you start to have discomfort (irritation) in your nose that bothers you while you use Fortical Nasal Spray.
  • Your healthcare provider should prescribe calcium and vitamin D to help prevent low calcium levels in your blood while you use Fortical Nasal Spray.
  • Take your calcium and vitamin D as your healthcare provider tells you to.
  • There are 30 doses (sprays) of Fortical Nasal Spray in each bottle. After 30 doses, each spray may not give you the right amount of medicine, even if the bottle is not completely empty. Keep track of the number of doses of medicine used from your bottle.
  • If you use too much Fortical Nasal Spray, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of Fortical Nasal Spray?

Fortical Nasal Spray may cause serious side effects, including:

  • allergic reactions. Some people have had an allergic reaction when using Fortical Nasal Spray. Some reactions may be serious and can be life threatening. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of these symptoms of an allergic reaction.
    • trouble breathing
    • swelling of your face, throat or tongue
    • fast heartbeat
    • chest pain
    • feel dizzy or faint
      If you might be allergic to calcitonin-salmon, your healthcare provider should do a skin test before you use Fortical Nasal Spray.
  • low calcium levels in your blood (hypocalcemia). Fortical Nasal Spray may lower the calcium in your blood. If you have low blood calcium before you start using Fortical Nasal Spray, it may get worse during treatment. Your low blood calcium must be treated before you use Fortical Nasal Spray. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your healthcare provider right away if you have any of these symptoms of low blood calcium:
    • numbness or tingling in your fingers, toes, or around your mouth

Your healthcare provider should:

    • do blood tests while you use Fortical Nasal Spray
    • prescribe calcium and vitamin D to help prevent low calcium levels in your blood while you use Fortical Nasal Spray.

Take your calcium and vitamin D as your healthcare provider tells you to.

  • nose irritation
    Irritation of your nose can happen while you are using Fortical Nasal Spray, especially if you are over 65 years of age. Call your healthcare provider right away if you have any of these symptoms of nose irritation:
    • crusting
    • dryness
    • redness or swelling
    • nose sores (ulcers)
    • nose bleeds

Your healthcare provider may stop your treatment with Fortical Nasal Spray until your nose irritation symptoms go away.

  • risk of cancer
    People who use calcitonin-salmon, the medicine in Fortical Nasal Spray, may have an increased risk of cancer. Your healthcare provider should check while you are using Fortical to see if it is still right for you.
  • increase of certain cells (sediment) in your urine
    Your healthcare provider should test your urine often while you are using Fortical Nasal Spray.

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

  • runny nose
  • nose bleeds
  • nasal problems
  • back pain
  • muscle pain
  • headache

These are not all the possible side effects of Fortical Nasal Spray. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider right away if you have any side effect that bothers you or does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How do I store Fortical Nasal Spray?

  • Store open bottles of Fortical Nasal Spray at room temperature, 68°F to 77°F (20°C to 25°C).
  • Store unopened bottles of Fortical Nasal Spray in the refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze.
  • Store Fortical Nasal Spray bottles in an upright position.
  • Safely throw away Fortical Nasal Spray in the trash after you have used 30 doses (sprays).

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

General Information about the safe and effective use of Fortical Nasal Spray.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Fortical Nasal Spray for a condition for which it was not prescribed. Do not give Fortical Nasal Spray to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information Leaflet summarizes the most importantinformation about Fortical Nasal Spray. If you would like moreinformation about Fortical Nasal Spray talk with your healthcareprovider. You can ask your pharmacist or healthcare provider forinformation about Fortical Nasal Spray that is written for healthprofessionals.

For more information, go to www.upsher-smith.com or call 1-888650-3789.

What are the ingredients in Fortical Nasal Spray?

Active Ingredient: calcitonin-salmon

Inactive Ingredients: sodium chloride, citric acid, phenylethyl alcohol, benzyl alcohol, polysorbate 80, hydrochloric acid or sodium hydroxide and purified water.

Instructions for Use

Fortical
[for-ti-kal]
(calcitonin-salmon [rDNA origin]) Nasal Spray

For Nasal Use

Only Important information about your Fortical Nasal Spray:

  • A single spray of Fortical Nasal Spray contains 1 daily dose ofmedicine.
  • Each Fortical Nasal Spray bottle contains the right amount of medicine. The bottle may not be completely filled to the top. This is normal.
  • This package contains 1 bottle of Fortical Nasal Spray and 1 screw-on pump.

Fortical Nasal Spray and 1 screw-on pump - Illustration

  • Store unopened bottles of Fortical Nasal Spray in the refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze.
  • After you open your bottle of Fortical Nasal Spray, store it at room temperature between 68°F to 77°F (20°C to 25°C) in an upright position. Do not shake the bottle.

Preparing your Fortical Nasal Spray

Remove the bottle from your refrigerator and let it reach room temperature.

Step 1.Opening the Bottle. Set bottle on a flat surface like a table or counter top. Hold the bottle firmly while unscrewing the cap to avoid spilling any Fortical Nasal Spray.

Important: If your pharmacist attached the pump for you, skip to Step 4.

Opening the Bottle - Illustration

Step 2. Unwrapping the Pump. Carefully cut the wrapper with scissors or knife, and tear away from the pump. Be careful not to cut, bend, or touch the feed tube at the bottom.

Unwrapping the Pump - Illustration

Step 3. Attaching the Pump. Hold the bottle on a flat surface (like a table), and screw the pump onto bottle by gripping the grooves of the pump and twisting clockwise until the pump is tightly sealed to the bottle.

Attaching the Pump - Illustration

Step 4. Removing Cap. To remove the cap from the pump, twist slightly while pulling up. Save the cap to replace after each use.

Removing Cap  -  Illustration

Step 5. Removing the Lock Tab. Grasp the lock tab between the thumb and forefinger, while holding the bottle on a flat surface. Pull sideways to remove the tab and unlock the pump.

Removing the Lock Tab -  Illustration

Step 6. Prime New Pump Before First Use. Before you use a new bottle of Fortical Nasal Spray for the first time, you will need to prime it. This will make sure you get the right dose of medicine each time you use it. After you attach the pump to the bottle, and the pump and bottle have reached room temperature, you should:

Priming New Pump - Illustration

  • Hold the bottle upright.
  • With your index and middle fingers on each side of the top of the pump, and with your thumb under the bottle, push the pump down.
  • Push the pump down at least 5 times, until you see a full spray.
  • If the pump is not delivering a full spray during or after priming, contact Upsher-Smith at 1888-650-3789. Do not place anything into the opening of the pump.

You only need to prime a new bottle. Do not re-prime it before each use.

Step 7. Using Fortical Nasal Spray

Using Fortical Nasal Spray - Illustration

  • Change (alternate) between using the right nostril 1 day and the left nostril the next day.
  • Hold your head and the bottle in an upright, vertical position. Put the spray tip into your nostril at the same angle as your nasal passage.
  • Press the pump all the way down 1 time. You do not need to inhale.
  • If you do not hold the bottle upright during use, the pump may not be able to give you the right dose of medicine.
  • Do not waste medication by testing the sprayer. It is all right if some of the spray drips out of your nostril. 1 spray will give you the correct daily dose of Fortical Nasal Spray.

Step 8. Replace The Lock Tab After Use Then Clean the Spray Tip.

Replacing The Lock Tab - Illustration

  • Replace the lock tab to prevent wasting medicine by accidently depressing the pump. Simply slide the lock tab on by pushing it sideways against the grooves in the pump.
  • Clean the spray tip by gently wiping it with a clean, damp cloth or tissue. Dry the tip with a cloth or tissue before replacing the cap. Do not place the tip or bottle in water.

Step 9. Replace The Cap.

Hold the top of the pump as shown and slide the cap back over the tip carefully.

Do not put the Fortical Nasal Spray back in the refrigerator

Replacing The Cap - Illustration

Step 10. Storing your Fortical Nasal Spray. Store Fortical Nasal Spray in an upright position. Tighten the pump securely to the bottle (see Step 3 and 4 in the Patient Instructions for Use). This will help to make sure there is a good seal between the pump and the bottle.

When should I throw away Fortical Nasal Spray?

  • Unopened, refrigerated bottles can be used until the expiration date stamped on the bottle and box.
  • Throw away Fortical Nasal Spray after you use 30 doses (sprays).

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 7/24/2014
This monograph has been modified to include the generic and brand name in many instances.

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