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Synarel Nasal Solution

What is endometriosis?

Endometriosis is the abnormal growth of cells (endometrial cells) similar to those that form the inside of the uterus, but in a location outside of the uterus. Endometrial cells are cells that are shed each month during menstruation. The cells of endometriosis attach themselves to tissue outside the uterus and are called endometriosis implants. These implants are most commonly found on the ovaries, the Fallopian tubes, outer surfaces of the uterus or intestines, and on the surface lining of the pelvic cavity. They can also be found in the vagina, cervix, and bladder, although less commonly than other locations in the pelvis. Rarely, endometriosis implants can occur outside the pelvis, on the liver, in old surgery scars, and even in or around the lung or brain. Endometrial implants, while they can cause problems, are benign (not cancerous).

Who is affected by endometriosis?

Endometriosis affects w...

Synarel Nasal Solution

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Synarel Nasal Solution Patient Information Including Side Effects

Brand Names: Synarel

Generic Name: nafarelin nasal (Pronunciation: NAF a REL in)

What is nafarelin nasal (Synarel Nasal Solution)?

Nafarelin nasal is a man-made form of a protein that is like a hormone in the body that helps regulate the menstrual cycle, fertility, and sexual development during puberty.

Nafarelin nasal is used to treat precocious puberty in both male and female children. It is also used to treat endometriosis in women who are 18 years of age or older.

Nafarelin nasal may also be used for other purposes not listed in this medication guide.

What are the possible side effects of nafarelin nasal (Synarel Nasal Solution)?

Get emergency medical help if you have any of these signs of a rare side effect called pituitary apoplexy: sudden headache with vision changes, vomiting, confusion, slow heart rate, chest pain, weakness, fainting, or cardiac arrest.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • heavy or continued menstrual bleeding;
  • chest pain, shortness of breath;
  • fast or irregular heartbeats; or
  • pelvic pain or swelling.

Less serious side effects may include:

  • mild itching or skin rash;
  • oily skin or acne, increased body odor;
  • dandruff;
  • changes in breast size;
  • increase in pubic hair growth;
  • nasal irritation or runny nose;
  • hot flashes;
  • mild headache, muscle pain;
  • mood swings;
  • white or brownish vaginal discharge;
  • light and occasional menstrual bleeding;
  • vaginal dryness; or
  • changes in sexual desire.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about nafarelin nasal (Synarel Nasal Solution)?

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective barrier form of birth control, and tell your doctor if you become pregnant during treatment.

Do not use nafarelin nasal if you have ever had an allergic reaction to nafarelin or similar medicines such as gonadorelin (Factrel). Do not use nafarelin nasal if you are pregnant or breast-feeding, or if you have undiagnosed, abnormal vaginal bleeding.

To be sure this medication is helping your condition, your doctor will need to check your progress on a regular basis, especially during the first 6 to 8 weeks of treatment. It is important that you not miss any scheduled visits to your doctor.

When you first start using nafarelin nasal to treat precocious puberty, you may notice an increase in signs of puberty, such as enlarged breasts or vaginal bleeding. These are normal side effects of this medication during the first month of use. If such pubertal signs continue for longer than 1 month, contact your doctor.

Get emergency medical help if you have any of these signs of a rare side effect called pituitary apoplexy: sudden headache with vision changes, vomiting, confusion, slow heart rate, chest pain, weakness, fainting, or cardiac arrest.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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