NOVELON (Desogen)0.15/.03mg – 21 tablet

Desogestrel and Ethinyl Estradiol Information

What is this drug used for?

• It is used to prevent pregnancy.
• It may be given to you for other reasons. Talk with the doctor.

Possible side effects

Desogestrel and Ethinyl Estradiol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• Feeling more or less hungry.
• Dizziness or headache.
• Weight gain or loss.
• Upset stomach or throwing up.
• Stomach pain or cramps.
• Bloating.
• Period (menstrual) changes. These include spotting or bleeding between cycles.
• Enlarged breasts.
• Tender breasts.
• Lowered interest in sex.
• Hair loss.
• Feeling nervous and excitable.

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of gallbladder problems like pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; fever with chills; bloating; or very upset stomach or throwing up.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Depression or other mood changes.
• Trouble sleeping.
• Feeling very tired or weak.
• Eyesight changes or loss, bulging eyes, or change in how contact lenses feel.
• Not able to pass urine or change in how much urine is passed.
• A lump in the breast, breast pain or soreness, or nipple discharge.
• Vaginal itching or discharge.
• Spotting or vaginal bleeding that is very bad or does not go away.
• This drug may cause you to swell or keep fluid in your body. Tell your doctor if you have swelling, weight gain, or trouble breathing.
• Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.

Medication Safety Issues

Sound-alike/look-alike issues:

Storage and Stability

Store at controlled room temperature.

Adverse Reactions

Frequency not defined. Reactions listed are based on reports in clinical trials or observational studies with ethinyl estradiol/desogestrel or other oral contraceptives.

Central nervous system: Depression, headache, migraine, mood changes

Dermatologic: Erythema multiforme, erythema nodosum, skin rash, urticaria

Endocrine & metabolic: Decreased libido, fluid retention, increased libido, weight gain, weight loss

Gastrointestinal: Abdominal pain, diarrhea, nausea, vomiting

Genitourinary: Breast hypertrophy, breast tenderness, mastalgia, vaginal discharge

Hypersensitivity: Hypersensitivity reaction

Ophthalmic: Contact lens intolerance