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SYNAREL® (nafarelin acetate) Medication Guide

MEDICATION GUIDE
SYNAREL
(sin-na-rell)
(nafarelin acetate) nasal solution

What is the most important information I should know about SYNAREL?

  • Some people taking GnRH agonists like SYNAREL have had new or worsened mental (psychiatric) problems. Mental (psychiatric) problems may include emotional symptoms such as:
    • crying
    • irritability
    • restlessness (impatience)
    • anger
    • acting aggressive
Call your child's doctor right away if your child has any new or worsening mental symptoms or problems while taking SYNAREL
  • Some people taking GnRH agonists like SYNAREL have had seizures. The risk of seizures may be higher in people who:
    • have a history of seizures.
    • have a history of epilepsy.
    • have a history of brain or brain vessel (cerebrovascular) problems or tumors.
    • are taking a medicine that has been connected to seizures such as taking bupropion or selective serotonin reuptake inhibitors (SSRIs).
Seizures have also happened in people who have not had any of these problems.
Call your child's doctor right away if your child has a seizure while taking SYNAREL.
What is SYNAREL?
SYNAREL is a gonadotropin releasing hormone (GnRH) medicine used for the treatment of children with central precocious puberty (CPP).
Do not give SYNAREL if your child:
  • is allergic to gonadotropin releasing hormone (GnRH), GnRH agonist medicines, or any of the ingredients in SYNAREL. See the end of this Medication Guide for a complete list of ingredients in SYNAREL.
  • has unusual vaginal bleeding that has not been checked by her doctor.
  • is pregnant or may become pregnant. SYNAREL can cause birth defects or loss of the baby. If your child becomes pregnant call your doctor.
  • is breastfeeding or plans to breastfeed. It is not known if SYNAREL passes into breast milk. You and your child's doctor should decide if your child will take SYNAREL or breastfeed. Do not breastfeed while taking SYNAREL.
Before your child takes SYNAREL, tell your doctor about all of your child's medical conditions, including if they:
  • have a history of mental (psychiatric) problems.
  • have or have had a history of seizures.
  • have a history of epilepsy.
  • have a history of brain or brain vessel (cerebrovascular) problems or tumors
  • are taking a medicine that has been connected to seizures such as bupropion or selective serotonin reuptake inhibitors (SSRIs).
Tell your doctor about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should your child take SYNAREL?
  • Your child's doctor should do tests to make sure your child has CPP before treating your child with SYNAREL.
  • Keep all scheduled visits to the doctor. If scheduled doses are missed, your child may start having signs of puberty again. The doctor will do regular exams and blood tests to check for signs of puberty.
  • Take SYNAREL exactly as your doctor tells you to take it. See detailed "Instructions for Use" at the end of this Medication Guide for information about the right way to use SYNAREL.
  • Your child's doctor will tell you how much SYNAREL your child is to take and when to take it. If your doctor increases your child's daily dose of SYNAREL, 1 bottle will not last the standard 7 days. Talk with your child's doctor to make sure your child has enough SYNAREL to take their prescribed dose every day.
What should your child avoid while taking SYNAREL?
  • Your child should avoid sneezing while taking SYNAREL or right after using it, if possible. This could reduce the amount of medicine your child's body absorbs.
  • If your child needs to use a nasal decongestant spray while being treated with SYNAREL, they should not use the decongestant spray for at least 2 hours after taking the dose of SYNAREL.
What are the possible side effects of SYNAREL?
SYNAREL may cause serious side effects, including:
  • See "What is the most important information I should know about SYNAREL"
  • in the first month of treatment, SYNAREL can cause an increase in some hormones. During this time you may notice more signs of puberty in your child, including vaginal bleeding and breast enlargement in girls. Within 1 month of treatment, you should see signs in your child that puberty is stopping.
The side effects of SYNAREL include:
  • allergic reactions such as shortness of breath, chest pain, hives, rash, and itching
  • acne
  • temporary increase in pubic hair
  • body odor
  • flaky, scaly skin
  • hot flashes
  • stuffy or runny nose (rhinitis)
  • white or brown vaginal discharge
These are not all of the possible side effects of SYNAREL. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General Information about the safe and effective use of SYNAREL.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SYNAREL for a condition for which it is not prescribed. Do not give SYNAREL to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your doctor or pharmacist for information about SYNAREL that is written for health professionals.
What are the ingredients in SYNAREL?
Active ingredient: nafarelin acetate
Inactive ingredients: benzalkonium chloride, glacial acetic acid, sodium hydroxide or hydrochloric acid (to adjust pH), sorbitol, and purified water

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