GINETTE-35 (Diane-35)0.035mg 2mg

Cyproterone and Ethinylestradiol Information

What is this drug used for?

• It is used to treat pimples (acne).

Possible side effects

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

• Upset stomach or throwing up.
• Headache.
• Feeling nervous and excitable.
• Weight gain or loss.
• Feeling more or less hungry.
• Runny nose.
• Stuffy nose.
• Period (menstrual) changes. These include lots of bleeding, spotting, or bleeding between cycles.

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 gallstones like sudden pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; or fever with chills.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Swelling, warmth, numbness, change of color, or pain in a leg or arm.
• Shortness of breath.
• Swelling in the arms or legs.
• Coughing up blood.
• Fast breathing.
• Anxiety.
• Dizziness or passing out.
• A fast heartbeat.
• A heartbeat that does not feel normal.
• Low mood (depression).
• Mood changes.
• Very bad belly pain.
• Change in eyesight, eye pain, or very bad eye irritation.
• Change in how contact lenses feel in the eyes.
• A lump in the breast or breast soreness.
• Vaginal bleeding that is not normal.
• Change in sex interest.
• The chance of heart attack or stroke due to blood clots may be raised. Call your doctor right away if you have signs of heart attack like chest pain that may spread to the arms, neck, jaw, back, or stomach; abnormal sweating; or feeling sick or throwing up. Call your doctor right away if you have signs of stroke like weakness on 1 side of the body; eyesight, speech, or balance problems; drooping on 1 side of the face; feeling confused; or severe headache.

Medication Safety Issues

Safety concerns:

Product Availability

Not available in the US

Storage and Stability

Store at 15°C to 30°C (59°F to 86°F). Protect from light (Cyestra 35).

Adverse Reactions

1% to 10%:

Cardiovascular: Varicosity (3%), edema (2%)

Central nervous system: Headache (5%), nervousness (4%), depression (3%), dizziness (1%)

Dermatologic: Chloasma (4%)

Endocrine & metabolic: Change in libido (3%)

Gastrointestinal: Nausea (2%)

Genitourinary: Dysmenorrhea (10%), breast tenderness (7%)

<1%, postmarketing and/or case reports: Abortion, cellulitis, cervical dysplasia, confusion, conjunctival irritation, drowsiness, eczema, enlargement of salivary glands, flatulence, flushing, hepatic focal nodular hyperplasia, hepatitis, hepatomegaly (without abnormal liver function tests), herpes zoster, hyperprolactinemia, hyperthyroidism, hypoesthesia, insomnia, livedo reticularis, liver enzyme abnormalities, mass (subcutaneous), missed abortion, neurodermatitis, ovarian cyst, palpitations, paresthesia, seizure, skin discoloration (blue spots), skin photosensitivity, skin pigmentation, skin rash, urinary tract infection, urticaria, uterine fibroids, visual disturbance, xeroderma