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|Synarel

Synarel

Synarel is used for:

Treating endometriosis, including relieving pain and reducing lesions. It is also used to treat early puberty (central precocious puberty [CPP]) in children of both sexes. It may also be used for other conditions as determined by your doctor.

Synarel is a gonadotropin-releasing hormone (GnRH) agonist analog. It works by decreasing production of certain steroids in the body, which decreases the symptoms of endometriosis or early puberty.

Do NOT use Synarel if:

• you are allergic to any ingredient in Synarel or to GnRH
• you are pregnant, may become pregnant, or are breast-feeding
• you have undiagnosed abnormal vaginal bleeding

Contact your doctor or health care provider right away if any of these apply to you.

Before using Synarel :

Some medical conditions may interact with Synarel . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• you are planning to become pregnant
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a runny or stuffy nose, osteoporosis (weak bones), or a family history of osteoporosis
• if you regularly use alcohol or tobacco
• if the patient is a child with endometriosis

Some MEDICINES MAY INTERACT with Synarel . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticonvulsants (eg, phenytoin) or corticosteroids (eg, prednisone) because the risk of decreased bone density (weak bones) may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Synarel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Synarel :

Use Synarel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Synarel . Talk to your pharmacist if you have questions about this information.
• To use a nose spray, gently blow your nose. Sit down and tilt your head back slightly. Place the tip of the spray container into the nose. Using a finger from your other hand, press against the opposite nostril to close it off. Breathe gently through the open nostril and squeeze the spray container. If you are using more than 1 spray, wait for at least 30 seconds between sprays.
• After using the medicine, rinse the tip of the spray unit in hot water and dry with a clean tissue to prevent contamination.
• If you are also using a decongestant nasal spray, do not use it within 2 hours after using Synarel . Check with your doctor if you have questions about using Synarel along with your other medicines.
• It may take 4 to 8 weeks for Synarel to work. Continue to use Synarel even if you feel well. Do not miss any doses.
• If you miss a dose of Synarel , use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
• If you miss more than 1 dose of Synarel , contact your doctor.

Ask your health care provider any questions you may have about how to use Synarel .

Important safety information:

• Avoid sneezing during or immediately after using Synarel , if possible, because Synarel "s effectiveness may be decreased.
• Do not exceed the recommended dose or use Synarel for longer than prescribed without checking with your doctor.
• If you are using Synarel for CPP, you may experience some signs of puberty (eg, vaginal bleeding, breast enlargement, increased pubic hair) or temporary body odor during the first month of treatment. This is normal. If these side effects persist or are severe, contact your doctor.
• If you are using Synarel for endometriosis, you may experience irregular or unusual vaginal bleeding during the first 2 months you use Synarel . This is normal. If you experience severe or persistent vaginal bleeding or if you have unusual vaginal bleeding that lasts longer than 2 months after you start Synarel , contact your doctor.
• If you are using Synarel for endometriosis, your menstrual period should stop while you use Synarel . Contact your doctor if your regular menstrual period continues while you are using Synarel .
• Women who may become pregnant must have a negative pregnancy test before beginning treatment with Synarel .
• Women of childbearing age should avoid becoming pregnant while using Synarel . To prevent pregnancy, use a nonhormonal form of birth control (eg, condoms) while using Synarel .
• Women who miss more than one dose of Synarel in a row may experience breakthrough vaginal bleeding and ovulation, with the possibility of pregnancy. Contact your doctor if you miss more than one dose of Synarel .
• Synarel may interfere with certain lab tests, including diagnostic tests of pituitary gonadotropic and gonadal function. Be sure your doctor and lab personnel know you are using Synarel .
• Lab tests, including gonadal sex steroid levels and growth rate, may be performed while you use Synarel . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Synarel should be used with extreme caution in CHILDREN younger than 18 years old who have endometriosis; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Synarel if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Synarel is found in breast milk. Do not breast-feed while taking Synarel .

Possible side effects of Synarel :

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; dandruff; decreased sexual desire; headache; hot flashes; mood swings; muscle pain; nasal irritation; runny nose; temporary increase or decrease in breast size; trouble sleeping; vaginal dryness; weight change.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abdominal pain; chest pain; continued menstrual periods; depression; irregular heartbeat; mental or mood changes; severe, persistent, or unusual vaginal bleeding; shortness of breath; sudden headache or vomiting; swelling of the hands or feet; vision changes; whitish or brownish vaginal discharge.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Synarel upright at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Keep Synarel out of the reach of children and away from pets.

General information:

• If you have any questions about Synarel , please talk with your doctor, pharmacist, or other health care provider.
• Synarel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Synarel . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.