An information pamphlet for patients is included with the product. Patients should be aware of the following information:

1\. Since menstruation should stop with effective doses of SYNAREL, the patient should notify her physician if regular menstruation persists. The cause of vaginal spotting, bleeding or menstruation could be noncompliance with the treatment regimen, or it could be that a higher dose of the drug is required to achieve amenorrhea. The patient should be questioned regarding her compliance. If she is careful and compliant, and menstruation persists to the second month, consideration should be given to doubling the dose of SYNAREL. If the patient has missed several doses, she should be counseled on the importance of taking SYNAREL regularly as prescribed.

2\. Patients should not use SYNAREL if they are pregnant, breastfeeding, have undiagnosed abnormal vaginal bleeding, or are allergic to any of the ingredients in SYNAREL.

3\. Safe use of the drug in pregnancy has not been established clinically. Therefore, a nonhormonal method of contraception should be used during treatment. Patients should be advised that if they miss successive doses of SYNAREL, breakthrough bleeding or ovulation may occur with the potential for conception. If a patient becomes pregnant during treatment, she should discontinue treatment and consult her physician.

4\. Those adverse events occurring most frequently in clinical studies with SYNAREL are associated with hypoestrogenism; the most frequently reported are hot flashes, headaches, emotional lability, decreased libido, vaginal dryness, acne, myalgia, and reduction in breast size. Estrogen levels returned to normal after treatment was discontinued. Nasal irritation occurred in about 10% of all patients who used intranasal nafarelin.

5\. The induced hypoestrogenic state results in a small loss in bone density over the course of treatment, some of which may not be reversible. During one six-month treatment period, this bone loss should not be important. In patients with major risk factors for decreased bone mineral content such as chronic alcohol and/or tobacco use, strong family history of osteoporosis, or chronic use of drugs that can reduce bone mass such as anticonvulsants or corticosteroids, therapy with SYNAREL may pose an additional risk. In these patients the risks and benefits must be weighed carefully before therapy with SYNAREL is instituted. Repeated courses of treatment with gonadotropin-releasing hormone analogs are not advisable in patients with major risk factors for loss of bone mineral content.

6\. Inform patients that depression may occur or worsen during treatment with GnRH agonists, including SYNAREL, especially in patients with a history of depression. Advise patients to immediately report thoughts and behaviors of concern to healthcare providers [see Warnings].

7\. Patients with intercurrent rhinitis should consult their physician for the use of a topical nasal decongestant. If the use of a topical nasal decongestant is required during treatment with SYNAREL, the decongestant should not be used until at least 2 hours following dosing with SYNAREL.

Sneezing during or immediately after dosing with SYNAREL should be avoided, if possible, since this may impair drug absorption.

8\. Retreatment cannot be recommended since safety data beyond 6 months are not available.