Diane 35 (Cyproterone acetate + Ethinylestradiol) — Patient Information (UK)

Diane 35 is a combined hormonal medicine containing two active ingredients: cyproterone acetate and ethinylestradiol. It is used to treat certain hormone-related skin and hair problems and, in some cases, also acts as a contraceptive.

This guide is written to be patient-friendly and practical. It explains how Diane 35 works, how the body handles the medicine, how to take it, likely side effects, important safety information, and frequently asked questions relevant to the United Kingdom.

Quick overview

• Medicine: Diane 35
• Active ingredients: Cyproterone acetate + Ethinylestradiol
• What it’s used for: Specifically licensed for certain forms of acne and excess hair growth caused by androgen sensitivity (in appropriate patients).
• Form: Oral tablets (taken by mouth)
• Type: Combined oral contraceptive (COC) and anti-androgen therapy

Basic product information

How Diane 35 works (mechanism of action)

Diane 35 combines: Ethinylestradiol (an estrogen) and Cyproterone acetate (a progestogen with strong anti-androgen effects).

Anti-androgen effect:

• Cyproterone acetate helps reduce the effect of androgens (male-type hormones that also occur in females).
• It can improve conditions such as acne and hirsutism (excess unwanted hair), especially when these are driven by androgen activity.

Combined hormonal effect:

• Ethinylestradiol and cyproterone acetate affect the hormonal feedback loop with the brain and ovaries.
• This can help prevent ovulation in many users (the medicine is a combined oral contraceptive).
• It also leads to more predictable hormone levels, which can help regulate menstrual cycles.

Pharmacokinetics (what the body does with the medicine)

Pharmacokinetics describes how the medicine is absorbed, processed, and removed from the body. While individual experiences vary, the key principles are:

Absorption

• After taking by mouth, the tablets are absorbed through the gastrointestinal tract.
• Peak blood levels typically occur within a few hours after dosing.

Distribution

• Ethinylestradiol binds to blood proteins (notably sex hormone-binding globulin).
• Cyproterone acetate is also highly bound to plasma proteins.

Metabolism

• Both active ingredients are metabolised (broken down) in the liver.
• Enzyme activity can influence drug levels—this is one reason some other medicines can interact with Diane 35.

Elimination

• Metabolites are cleared mainly via bile and urine.
• Because the medicine is taken daily in a cycle, steady levels are usually reached after a few days.

Practical takeaway: consistent daily use helps maintain hormone levels; missed doses can reduce effectiveness and increase breakthrough bleeding.

What Diane 35 is used for (indications)

Diane 35 is used to treat androgen-related conditions, particularly:

• Moderate to severe acne, especially if it has not responded adequately to standard acne therapies.
• Signs of androgen excess, such as hirsutism (excess unwanted hair) and related skin changes, in appropriate individuals.

In the UK, prescribing practice generally emphasises using Diane 35 for the above indications in suitable patients, and using careful risk assessment due to the clot risk associated with combined hormonal products.

Typical dosing and how to take it (timing)

Diane 35 is taken as a 21-day course followed by a 7-day break, during which a withdrawal bleed often occurs. Always follow the instructions that came with your specific pack.

Standard schedule

• Day 1–21: take one tablet daily
• Day 22–28: no tablets (7-day break)
• Start the next pack on Day 29 (regardless of bleeding status)

Best time to take your tablet

• Choose a time you can keep consistently (for example, evenings after dinner).
• If you’re taking other medicines in the day, taking Diane 35 at a consistent time can help you remember and reduce missed doses.

If you miss a dose

Missing doses can lower protection and increase the chance of breakthrough bleeding. The best advice depends on how many tablets were missed and where you are in the pack. If this happens, follow the guidance in the patient information leaflet for your product, or seek medical advice.

General safety note: If you have missed tablets and you are concerned about pregnancy risk, use additional contraception and seek timely advice.

Food interactions

Food is not usually a major issue with Diane 35 tablets. Most users can take it with or without food.

• If food causes an upset stomach, taking the tablet with a light meal may help.
• If you vomit shortly after taking your tablet (or you have severe diarrhoea), absorption may be affected—this can be treated as a missed dose situation. Follow the leaflet advice for vomiting/diarrhoea.

Alcohol and medicine interactions

Alcohol

Moderate alcohol intake is not usually expected to directly interact with Diane 35. However:

• Heavy drinking can affect liver function and may worsen side effects for some people.
• Alcohol can contribute to missed doses if it affects your routine.

Other medicine interactions (important)

Some medicines can reduce hormone levels or increase side effects by affecting liver enzymes. This may reduce effectiveness and alter bleeding patterns. Examples include:

• Enzyme-inducing medicines (some anti-epileptics such as carbamazepine, phenytoin; and some treatments for tuberculosis such as rifampicin/rifabutin)
• Some antifungals (depending on product and dosing)
• Certain antibiotics (interaction potential varies; guidance is important)
• Herbal preparations containing St John’s wort
• Medicines that affect HIV/HCV treatment pathways (interaction can depend on the regimen)

Because interaction risk varies by medicine, it’s safest to check with a pharmacist or prescriber when starting or stopping any other treatment.

Safety profile: key risks to understand

Like all combined hormonal products, Diane 35 has important benefits and important risks. The most significant risk is: venous thromboembolism (VTE) (blood clots in veins) and, less commonly, arterial thromboembolism (blood clots in arteries such as stroke).

Who needs extra caution

Risk may be higher if you:

• Smoke (especially if you are older)
• Have a personal history of blood clots
• Have a strong family history of blood clots at a young age
• Have migraine with aura
• Are significantly overweight
• Have certain clotting disorders
• Are having major surgery or prolonged immobilisation (for example, long-term casting or extended bed rest)

Warning signs — seek urgent medical help

Contact emergency services or seek urgent medical attention if you develop symptoms suggestive of a clot, such as:

• Leg swelling or pain (often one-sided), warmth, or redness
• Sudden shortness of breath or coughing blood
• Chest pain that may worsen with breathing
• Sudden severe headache, weakness on one side, trouble speaking, or vision changes

Other common side effects

• Nausea
• Breast tenderness
• Headache
• Changes in mood
• Breakthrough bleeding or spotting, especially in the first months
• Changes in menstrual pattern during initial cycles

Serious but less common effects

Serious side effects are uncommon, but you should read the leaflet for full details. Notify a healthcare professional promptly if you experience:

• Severe abdominal pain
• Yellowing of the skin or eyes (jaundice)
• Severe leg pain or swelling
• Unexplained shortness of breath

Practical use tips for better outcomes

• Take at the same time daily to reduce missed doses.
• Use a calendar or app to track the 21-day course and 7-day break.
• Plan for breakthrough bleeding—it’s common early on and often settles after a few cycles.
• Give skin time to respond: acne and hair-related improvements typically take several weeks to months.
• Don’t stop abruptly because of minor spotting—get advice if you’re concerned.
• Check other products (including herbal supplements) before combining.
• If you’re going to have surgery or prolonged immobilisation, ask your healthcare team in advance about temporary risk reduction strategies.

Alternatives to Diane 35

Alternatives depend on the underlying problem (acne versus androgen-related hair growth) and your personal risk factors. Options may include:

Non-hormonal acne treatments

• Topical retinoids (e.g., adapalene, tretinoin)
• Topical benzoyl peroxide
• Topical antibiotics in selected cases
• Oral antibiotics for limited durations where appropriate
• Isotretinoin for severe acne in appropriate clinical circumstances (with strict safety monitoring)

Hormonal options

• Other combined hormonal contraceptives with anti-androgen effects may be considered depending on availability and suitability.
• Anti-androgens such as spironolactone are used in some settings for androgen-driven symptoms, but require careful monitoring and may not be suitable for everyone.

Discuss options with a pharmacist or clinician, particularly if you have risk factors for clotting or migraines.

Market and legal context in the UK (what you should know)

Diane 35 has been available in the UK for many years as a combined hormonal medicine with anti-androgen effects. As with all combined oral contraceptives, there is strong regulatory focus on safety, including the risk of VTE and arterial events.

In the UK, guidance has evolved over time following safety communications from regulatory bodies and medical literature. For acne and hair indications, prescribing practice typically considers whether alternatives are appropriate and whether the benefits outweigh risks for the individual patient.

Important: Advice for suitability is individual. Your age, smoking status, migraine history, body weight, family history, and other medical conditions all affect risk.

Recent guidance considerations (UK)

• Healthcare professionals are expected to follow up-to-date safety communications regarding clot risk and eligibility.
• Patients are advised to report symptoms promptly and understand warning signs for clots.
• Clinicians generally review ongoing need for hormonal therapy and re-check risk periodically.

Delivery and availability (UK)

Availability may vary by pharmacy and region. Many online pharmacies in the UK can supply Diane 35 subject to stock and standard checks. Delivery times commonly depend on:

• Local courier service and your postcode
• Order cut-off times
• Whether the item is in stock or needs procurement

When ordering online, ensure you have: accurate personal details for verification and delivery. Do not use medicines that appear damaged, discoloured, or past expiry date.

FAQ

1) Is Diane 35 the same as a regular contraceptive pill?

Diane 35 is a combined oral contraceptive, but it also includes an anti-androgen component (cyproterone acetate). This is why it may be used for hormone-related acne or hair problems in suitable individuals.

2) How long does it take to work for acne?

Acne improvements are often gradual. Some people notice changes within the first few months, but a more reliable assessment typically takes several months. If there is no improvement, a clinician may review the treatment plan.

3) Will I get a period during the 7-day break?

Many users bleed during the break, but bleeding patterns can vary, especially early in treatment. If bleeding changes significantly or you miss expected bleeding, follow the leaflet advice and seek advice if you’re concerned about pregnancy risk.

4) Can I take Diane 35 with other medicines?

Some medicines can interfere with hormonal medicines. It’s safest to ask a pharmacist before starting new treatments, including herbal supplements like St John’s wort.

5) What if I drink alcohol?

Moderate alcohol intake is usually not a direct interaction. However, very heavy drinking may affect your health and increase the chance of missed tablets.

6) Are there people who should not use combined hormonal medicines?

Yes. Combined medicines may be unsuitable for certain individuals, such as those with a history of blood clots, certain migraine types, or other major risk factors. Suitability is assessed before starting and reviewed if conditions change.

7) What should I do if I vomit or have severe diarrhoea?

If vomiting occurs soon after taking a tablet, absorption may be incomplete. Severe diarrhoea can also affect absorption. Treat it as a missed dose according to the patient information leaflet and seek advice if uncertain.

8) Can I stop Diane 35 once my symptoms improve?

Treatment duration is individual. Some people need ongoing management of androgen-related symptoms, while others may reassess after improvement. If you consider stopping, discuss with a healthcare professional first, especially if you rely on it for contraception or have clot risk factors.

9) Does Diane 35 affect fertility?

Combined hormonal contraceptives are not known to cause long-term infertility. Normal fertility typically returns after stopping, but individual circumstances vary.

10) Where can I find full side effects information?

The patient information leaflet included with your pack provides detailed information on side effects, warnings, and interactions. It’s important to read it carefully.

References and important note

Medicines information can evolve. For the most current guidance in the UK, check the leaflet supplied with your product and consult a qualified healthcare professional if you have questions about suitability, interactions, or side effects.