INDICATION and IMPORTANT SAFETY INFORMATION for FORTICAL® (calcitonin-salmon [rDNA origin]) Nasal Spray for intranasal use
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.
IMPORTANT SAFETY INFORMATION
Contraindication: Do not use Fortical Nasal Spray if you are allergic to calcitonin-salmon or any of the ingredients in Fortical Nasal Spray.
Fortical Nasal Spray may cause allergic reactions. 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, or feeling dizzy or faint. 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. 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 and prescribe calcium and vitamin D to help prevent low calcium levels in your blood while you use Fortical Nasal Spray.
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), or nose bleeds.
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.
Before you use Fortical Nasal Spray, tell your healthcare provider if you have any other medical conditions or have low calcium levels in your blood. Tell your doctor if you are pregnant or plan to become pregnant, as it is not known if Fortical Nasal Spray can harm your unborn baby. Tell your doctor if you 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.
Do not use Fortical Nasal Spray until your healthcare provider shows you and you understand how to use it correctly. Use Fortical Nasal Spray exactly as your healthcare provider tells you to use it.
The most common side effects are runny nose, nose bleeds, nasal problems, back pain, muscle pain, and headache. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA.
This safety information is not all-inclusive. For more information, talk to your health care provider and read the Patient Information Leaflet for Fortical Nasal Spray. You can also visit www.upsher-smith.com or call
Upsher-Smith Laboratories, Inc.
© 2014 Upsher-Smith Laboratories, Inc., Maple Grove, MN 55369 107430.02