Diane 35 in Spain: What It Treats, Clot Risk and Who Should Avoid It

Diane 35 treats moderate to severe hormone-driven acne and excess hair growth (hirsutism) in women of childbearing age, when other treatments have not worked. It combines cyproterone acetate and ethinylestradiol, also prevents pregnancy, and needs a prescription. This guide is by Dr. Pedro Yelamo Vera, an English-speaking GP licensed in Spain (Colegiado No. 484814280) who sees patients by video in English and Spanish.

What is Diane 35 used for?

The Spanish product information lists moderate to severe acne driven by male-type hormones (androgens), with or without oily skin, and hirsutism, in women of childbearing age. For acne, it is used only when skin treatments and antibiotic tablets have not worked. The Spanish medicines agency (AEMPS) reviewed these medicines in 2013 and limited their use to these conditions.

What exactly is Diane 35?

"Diane 35" is the name used in many countries. The Spanish medicines database (CIMA) lists Diane 2 mg/0.035 mg and Diane Diario 2 mg/0.035 mg, made by Bayer. Diane Diario has 21 hormone tablets and 7 tablets with no active ingredient. Cyproterone blocks the effect of male-type hormones on the skin. Ethinylestradiol is an oestrogen.

Is Diane 35 a contraceptive pill?

It works as a hormonal contraceptive, but it is not approved just to prevent pregnancy. It must not be taken with any other hormonal contraceptive, because that raises the clot risk. If you only need birth control, there are other options: see our guide to contraception in Spain.

What is the blood clot risk with Diane 35?

Like combined pills, it raises the risk of clots in the veins, such as a deep vein clot or a clot in the lungs. The AEMPS says this risk is 1.5 to 2 times that of pills with levonorgestrel. It is highest in the first year, and when you restart after a break of a month or more. The risk is higher with:

• older age and smoking, most of all from age 35;
• obesity (a BMI over 30);
• surgery, a serious leg injury, or long periods without moving;
• a close relative who had a clot at a young age;
• the weeks after giving birth.

Tell your doctor before planned surgery or a long time off your feet. You may need to stop it some weeks before.

Who should not take Diane 35?

• Anyone taking another hormonal contraceptive.
• Anyone who has had a blood clot, a heart attack, angina or a stroke.
• People with a clotting disorder (thrombophilia).
• Migraine with aura, very high blood pressure, diabetes with blood vessel damage, or very high blood fats.
• Serious liver disease or a liver tumour, or a hormone-sensitive breast or genital cancer.
• A meningioma now or in the past, or unexplained vaginal bleeding.
• Pregnancy or breastfeeding.
• Some hepatitis C treatments.

How long is Diane 35 taken for?

It takes at least three months to see a change. Your doctor checks from time to time if you still need it. Before you start and during treatment, you need a check of your history, your blood pressure and any tests the doctor thinks are needed.

Do you need a prescription for Diane 35 in Spain?

Yes. It is prescription-only, and the doctor needs to know about past clots, migraine, smoking, your blood pressure and your other medicines first.

What other safety points matter?

It can lower your mood or cause depression. If your mood changes, see your doctor soon. It does not protect against HIV or other sexually transmitted infections. If you become pregnant, stop it and get advice.

In English: what is the equivalent?

In the UK this combination is called co-cyprindiol, and the brand is Dianette. It is prescription-only there too, for the same kind of acne and hirsutism. It is not approved in the US. Spanish pharmacies need a prescription from a doctor licensed in Spain, so a UK prescription is normally refused. Bring your pill box to the visit.

When to see a doctor

• Low mood or sadness that does not lift.
• New or worse headaches.
• You have surgery coming up or will be off your feet.
• Your acne or hair growth is no better after several months.

When to call 112

• Pain or swelling in one leg with breathlessness or chest pain.
• Sudden breathlessness, a sudden cough or bad chest pain.
• Weakness on one side, trouble speaking or sudden loss of vision.
• A sudden, very bad headache.

Frequently asked questions about Diane 35

Getting a medical assessment

If you have acne or excess hair growth and want advice, you can book a video consultation with Dr. Pedro Yelamo Vera, a physician registered in Spain. You can also read about acne care, PCOS and isotretinoin for acne. A prescription is never guaranteed: it is issued only where clinically appropriate after a genuine evaluation, as a private electronic prescription under Spanish law. This service is for urgent, non-emergency care. In an emergency, call 112.

This guide is general information. It does not replace the package leaflet or the advice of your doctor or pharmacist.