Levlen (8) Oral

Tell your doctor immediately if any of these rare but very serious side effects occur:

• lumps in the breast
• severe stomach/abdominal/pelvic pain
• mental/mood changes (e.g., depression, suicidal thoughts, persistent trouble sleeping)
• unusual tiredness
• dark urine
• yellowing eyes/skin

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Levlen (8) Oral Precautions

See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to any estrogens (e.g., ethinyl estradiol, mestranol) or any progestins (e.g., norethindrone, desogestrel); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this product, consult your doctor or pharmacist if you have:

• history of stroke or other blood clots (e.g., in the legs, eyes, lungs)
• severe high blood pressure
• abnormal breast exam
• cancer (especially endometrial or breast cancer)
• diabetes that has caused kidney/eye/nerve/blood vessel disease
• severe headaches
• history of heart disease (e.g., heart attack, chest pain)
• heart valve disease
• liver problems (e.g., liver tumor, active liver disease)
• current or suspected pregnancy
• recent major surgery
• long periods of sitting or lying down (e.g., immobility such as being bedridden)
• history of yellowing eyes/skin (jaundice) during pregnancy or while using hormonal birth control (e.g., pills, patch)
• unexplained vaginal bleeding
• heavy tobacco use (especially if 35 or over)

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