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Diane 35 (Cyproterone Acetate; Ethinylestradiol) Buyer and Patient Handbook in South Africa

What is Diane 35?

Diane 35 is a combined oral contraceptive pill that belongs to the class of combined estrogen-progestogen hormonal agents. It is primarily prescribed to treat severe Acne and to manage symptoms of Hirsutism in women, while also providing reliable contraception. The product is authorized by the South African Health Products Regulatory Authority (SAHPRA) and contains 2 mg cyproterone acetate (an anti-androgen) and .035 mg ethinylestradiol (a synthetic estrogen) per tablet.

Who Should Use Diane 35?

• Women of reproductive age seeking hormonal acne control.
• Individuals diagnosed with hirsutism (excess facial/body hair).
• Patients who also desire reliable contraception.
• Those without a history of thrombo-embolic disease, liver dysfunction, or hormone-sensitive cancers.

How Does It Work?

Diane 35 blocks the effects of male hormones (androgens) on the skin, reducing oil production and hair growth, while the estrogen component stabilises the uterine lining to prevent pregnancy. Think of it as a “traffic controller” that diverts androgen signals away from the skin and ensures the hormonal “road” remains clear for contraception.

Why Choose Diane 35?

The combination of a strong anti-androgen with a low-dose estrogen delivers dual benefit: effective acne/hirsutism control and contraception in a single daily pill. Compared with a standard contraceptive, the added cyproterone acetate addresses skin-related issues without the need for separate acne medication.

Dosage, Administration, Lifestyle and Dietary Recommendations

Recommended Dosage

• One tablet daily for 21 consecutive days, followed by a 7-day pill-free interval.
• Each tablet contains 2 mg cyproterone acetate / .035 mg ethinylestradiol.

How to Take

• Take the pill at the same time each day, preferably with water.
• Food does not affect absorption, so it can be taken with or without meals.

Missed Dose

• If you are < 12 hours late, take the missed tablet immediately and continue with the next dose as scheduled.
• If > 12 hours late, take the missed tablet as soon as you remember, discard any other tablet for that day, and use a backup method (e.g., condom) for the next 7 days.

Overdose

• Seek emergency medical care if more than one tablet is taken accidentally.
• Symptoms may include nausea, vomiting, or unusual bleeding.

Special Populations

• Elderly: Not indicated; the pill is intended for reproductive-age women.
• Adolescents: Use only after a thorough medical evaluation.
• Liver disease: Contraindicated; impaired metabolism can increase hormone levels.
• Renal impairment: No dose adjustment needed, but medical review is advised.

Lifestyle & Diet

• Avoid smoking while taking Diane 35, especially if over 35 years old.
• Grapefruit juice may increase estrogen levels - limit intake.
• Moderate alcohol consumption; excessive intake can heighten clot risk.

Precautions and Warnings

• Do not use if you have a history of deep-vein thrombosis, pulmonary embolism, or stroke.
• Contraindicated in pregnancy; the pill provides no benefit if you are already pregnant.
• Regularly monitor blood pressure; hormonal contraceptives can cause modest increases.
• Report any unexplained vaginal bleeding, severe headache, or visual changes immediately.

Drug Interactions

Potential Side Effects

Common Side Effects

• Nausea
• Breast tenderness
• Spotting between periods
• Headache

Less Common Side Effects

• Mood swings
• Weight fluctuations
• Decreased libido

Serious Side Effects

• Severe abdominal Pain (possible blood clot) - call emergency services
• Sudden vision loss - seek immediate medical attention
• Unusual bruising or bleeding - consult a healthcare professional

Who Should Avoid This Medication?

• Women with a known allergy to cyproterone acetate, ethinylestradiol, or any excipient.
• History of hormone-dependent cancers (e.g., breast, ovarian).
• Active liver disease or unexplained liver dysfunction.
• Current pregnancy or breastfeeding.

Storage Instructions

• Keep tablets in the original blister pack, away from moisture.
• Store at room temperature (15-30 °C).
• Keep out of reach of children and pets.

Diane 35 Alternatives

Frequently Asked Questions

How quickly will my acne improve?

Most users notice a reduction in acne lesions within 4-6 weeks, but full benefit may take up to 3 months.

Can drink coffee while taking Diane 35?

Yes, moderate coffee intake does not affect the pill’s effectiveness.

Will the pill cause weight gain?

Weight changes are uncommon; any fluctuation is usually modest and linked to fluid retention rather than fat gain.

Is Diane 35 safe for long-term use?

When prescribed appropriately and monitored regularly, long-term use is considered safe for most women.

What happens if I miss two consecutive pills?

Take the most recent missed pill as soon as you remember, discard the earlier one, and use a backup method for the next 7 days.

Can I start Diane 35 immediately after my period ends?

Yes, beginning on the first day of your menstrual cycle provides immediate contraceptive protection.

Does the pill interact with antiretroviral therapy?

Some antiretrovirals (e.g., protease inhibitors) may reduce contraceptive effectiveness; discuss alternatives with your clinician.

Why am I experiencing spotting during the pill-free week?

Spotting is common during the hormone-free interval; it usually resolves after a few cycles.

Glossary

• Anti-androgen: A substance that blocks the effects of male hormones (androgens) on the body.
• Thrombo-embolism: A blood clot that can travel through the bloodstream and block vessels.
• Bioavailability: The proportion of a drug that enters the systemic circulation and can have an active effect.

Disclaimer

The information provided here is for general educational purposes only and does not replace professional medical advice. Off-label uses are not discussed; any such consideration must be made with a qualified healthcare provider. Readers are responsible for their own health decisions. Our online pharmacy offers convenient access to approved medicines in South Africa, but all purchases are subject to verification of eligibility and local regulations. Always consult a qualified clinician before starting, stopping, or changing any medication.