Gynovel (Norethisterone Acetate, Estradiol)

Gynovel is indicated for the prevention of pregnancy in women of reproductive age who desire a reliable, reversible contraceptive method.

• Suppression of ovulation through combined estrogen and progestogen activity.
• Stabilization of the endometrial lining to reduce breakthrough bleeding.
• Regulation of menstrual cycle length and flow.
• Provision of a convenient once‑daily oral dosing schedule.
• Option for use in women seeking a combined hormonal contraceptive without a need for additional barrier methods.

Like other combined oral contraceptives, Gynovel may cause a range of side effects that vary in frequency and severity, often mild and transient.

Common

• Nausea or mild stomach upset.
• Headache or mild migraine.
• Breast tenderness or enlargement.
• Irregular spotting or breakthrough bleeding.
• Mood changes or mild depression.

Serious

• Deep vein thrombosis or pulmonary embolism.
• Stroke or transient ischemic attack.
• Severe hypertension.
• Liver dysfunction or jaundice.
• Allergic reaction with rash or angioedema.

Before prescribing Gynovel, clinicians should evaluate individual risk factors and counsel patients on important safety considerations.

• Do not use if you have a history of thromboembolic disorders, stroke, or myocardial infarction.
• Avoid if you are pregnant, breastfeeding, or suspect pregnancy.
• Screen for uncontrolled hypertension, diabetes with vascular complications, or liver disease before initiation.
• Smoking more than 15 cigarettes per day significantly increases cardiovascular risk, especially in women over 35.
• Review any personal or family history of hormone‑sensitive cancers before starting therapy.
• Be aware that certain migraine patterns (with aura) are contraindications.
• Inform patients that sudden discontinuation may lead to return of fertility and possible menstrual changes.

Gynovel can interact with several medications, affecting its efficacy or increasing the risk of adverse events.

Avoid

• Strong enzyme inducers such as rifampin, carbamazepine, phenytoin, or St John’s wort, which may lower contraceptive effectiveness.
• Certain antiviral agents (e.g., protease inhibitors) that alter hormone metabolism.

Use with caution

• Anticoagulants (warfarin) as hormonal changes may affect clotting parameters.
• Antidepressants (SSRIs) that can increase the risk of bleeding.
• Antihypertensive drugs, particularly those affecting fluid balance.
• Herbal supplements containing phytoestrogens.