Consumer Information for: SYNAREL

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.

What the medication is used for

SYNAREL is used in the treatment of endometriosis, including pain relief and reduction of endometriosis lesions. The treatment is recommended for a period of 6 months only.

What it does

SYNAREL temporarily reduces estrogen in the body, thereby temporarily relieving the symptoms of endometriosis.

When it should not be used

Do not take SYNAREL if you:

  • are allergic to nafarelin acetate, or any similar gonadotropin-releasing hormone (GnRH) analogue, or any of the ingredients in SYNAREL.
  • are pregnant or think that you are pregnant;
  • are planning to become pregnant;
  • have abnormal vaginal bleeding of unknown cause;
  • are breastfeeding.
What the medicinal ingredient is

Nafarelin acetate.

What the non-medicinal ingredients are

Benzalkonium chloride, glacial acetic acid, hydrochloric acid, sorbitol, sodium hydroxide, purified water.

What dosage form it comes in

Each 8 mL bottle of SYNAREL (nafarelin acetate) contains nafarelin acetate nasal solution 2 mg/mL. Each bottle is supplied with a metered spray pump.

The 8 mL bottle contains enough solution for 60 sprays, enough to last 30 days using two sprays per day. After the stated number of sprays has been delivered a small amount of liquid may be left in the bottle. Do not try to use up that leftover amount because you might get too low a dose, which could interfere with the effectiveness of your treatment. Dispose of the bottle and do not reuse

Warnings and precautions

Signs and symptoms of endometriosis can worsen at the beginning of therapy with SYNAREL.

Menstruation should stop with use of SYNAREL. During the first 2 months of SYNAREL use, vaginal bleeding (often called breakthrough bleeding) may occur. This may also occur if you miss one or more doses of SYNAREL. You should advise your doctor or pharmacist, if regular menstruation persists.

You must use a non-hormonal method of birth control while taking SYNAREL to prevent pregnancy. You should discuss effective non-hormonal methods of birth control with your doctor. If you think you are pregnant while taking SYNAREL, you should stop using the drug and contact your doctor immediately. SYNAREL may hurt the unborn baby.
SYNAREL is not recommended for use in a patient younger than 18 years of age.

BEFORE you use SYNAREL talk to your doctor or pharmacist if:

  • you are pregnant or think that you are pregnant
  • you are planning to become pregnant
  • you are breastfeeding
  • you have or have family history of osteoporosis, or use drug that can reduce bone mass such as anticonvulsants, corticosteroid, or use alcohol and/or tobacco. SYNAREL can cause thinning of the bone.