Diane 35 (Cyproterone acetate + Ethinylestradiol) – Patient Information

Diane 35 is an oral combined hormonal medicine containing two active ingredients:

• Cyproterone acetate (often abbreviated as CPA)
• Ethinylestradiol (EE), an oestrogen

This page explains what Diane 35 is, how it works, typical use, how to take it, key safety considerations, and practical tips. It is written for patients and is suitable for an online pharmacy website in Australia.

Quick overview

Basic product information

Diane 35 is a combined hormonal tablet. It contains a progestogenic component (cyproterone acetate) and an oestrogen (ethinylestradiol). The exact strength per tablet depends on the product formulation sold in your region.

Brand notes (Australia): Product availability can vary. Your pharmacy will confirm the exact pack size and tablet strength for the Diane 35 product supplied.

How Diane 35 works (mechanism of action)

Cyproterone acetate and ethinylestradiol work together to reduce the effects of androgens (male-type hormones) in the body.

• Cyproterone acetate acts as an anti-androgen:
  • It helps block androgen receptors in skin and other tissues.
  • It can reduce androgen-driven problems such as acne and excessive hair growth (hirsutism) in people where hormones contribute to symptoms.
• Ethinylestradiol is an oestrogen:
  • It helps reduce ovarian androgen production.
  • It also increases sex hormone-binding globulin (SHBG), which reduces free (active) androgens in circulation.

Clinical effect: Acne may improve by reducing oil production and inflammation. Hirsutism may improve more gradually as hair follicles respond over time.

Pharmacokinetics (how the body handles it)

Pharmacokinetics describe absorption, distribution, metabolism, and elimination. Individual results vary.

Absorption

After oral intake, both cyproterone acetate and ethinylestradiol are absorbed through the gastrointestinal tract. Maximum blood levels typically occur within a few hours after a dose.

Distribution

Ethinylestradiol binds strongly to serum proteins, especially albumin. Cyproterone acetate is also protein-bound.

Metabolism

Both components are metabolised primarily in the liver. Cyproterone acetate and ethinylestradiol undergo biotransformation to inactive or less active metabolites.

Elimination

Elimination occurs via metabolic pathways with excretion through urine and bile/faeces (depending on the metabolite). The effective half-life differs between components, which is why regular daily dosing is important.

Practical takeaway: Missing tablets can reduce hormone levels and may lead to breakthrough bleeding or return of androgen-related symptoms.

Typical uses in practice

Diane 35 is mainly used for hormonal conditions where androgens contribute. Depending on the Australian prescribing and product-label context, common therapeutic aims include:

• Acne (particularly moderate to severe acne) that has not adequately responded to other treatments
• Acne with evidence of androgen-related features (e.g., with increased facial/body hair)
• Hirsutism (excessive hair growth) associated with androgen sensitivity

Important: It is not appropriate for everyone with acne or hair growth. Your clinician/pharmacist may evaluate other causes (such as thyroid or adrenal issues, medication-related androgen effects, or polycystic ovary syndrome).

Timing and how to take Diane 35

When to start

There are different start options depending on your situation (for example, if starting after a break, switching from another hormonal medicine, or after pregnancy/breastfeeding). Follow the instructions provided with your pack and the advice you receive.

Daily schedule (cycle structure)

Most Diane 35 packs are arranged as a structured cycle (commonly 21 active tablets, followed by a tablet-free interval, depending on the specific pack). To help you remember:

• Choose a consistent time each day.
• Take the tablet once daily.
• If your pack includes a tablet-free interval, take note of the break days so you restart on time.

If you miss a dose

Missing tablets can cause spotting and may reduce effectiveness for symptom control.

• One missed tablet: Take it as soon as you remember (unless it’s close to the next dose).
• More than one missed tablet: Follow the pack instructions or seek advice from a pharmacist/clinician.
• Additional contraception: If you are using the medicine for pregnancy prevention, use appropriate backup contraception as advised.

Tip: If you miss a dose and are unsure, check the patient information leaflet for your exact pack or ask your pharmacist for guidance.

Food interactions

General guidance: Diane 35 can usually be taken with or without food. Food does not meaningfully reduce absorption for most people.

• Taking it after a meal may help if you feel nauseated.
• Do not skip doses because of meals—aim for consistency.

Alcohol and medicine interactions

Alcohol

Moderate alcohol intake is not generally expected to directly change how Diane 35 works.

• However, heavy or frequent alcohol use can affect liver function and may worsen side effects such as nausea, headache, or mood changes.
• Alcohol may also contribute to dehydration and adherence problems (missed doses), which can reduce effectiveness.

When to be extra cautious

Talk to a pharmacist if you:

• Have liver disease or abnormal liver function tests
• Are taking other medicines that affect liver enzymes
• Have a history of clotting problems

Medicine interactions (important)

Certain medicines can reduce or increase hormone levels by affecting liver enzymes or intestinal transporters. This can influence both bleeding patterns and treatment effectiveness.

Common interaction categories

• Enzyme-inducing medicines (may reduce hormone levels):
  • Some anti-epileptics (e.g., carbamazepine, phenytoin, phenobarbital, topiramate in certain situations)
  • Some antibiotics/antifungals (specific agents can vary)
  • Herbal products, notably St John’s wort
• Medicines that may raise hormone levels:
  • Some antifungals and antiviral agents may increase hormone exposure

Other medicines and herbal supplements

Always tell your pharmacist about:

• Prescription medicines
• Over-the-counter medicines
• Vitamins, supplements, and herbal remedies

Practical advice: If you start a new medicine while taking Diane 35, ask whether you need extra precautions (for example, backup contraception or closer monitoring of breakthrough bleeding).

Safety profile and who should avoid Diane 35

Diane 35 is generally well tolerated by many people, but it is associated with certain risks typical of combined hormonal products. The most important safety issue is the risk of blood clots (venous thromboembolism) and, in some circumstances, cardiovascular events.

Blood clot (thrombosis) risk

Combined oral contraceptives (and similar combined hormonal products) are associated with an increased risk of:

• Deep vein thrombosis (DVT)
• Pulmonary embolism (PE)
• Stroke and heart attack in people with risk factors

Risk may be higher if you:

• Smoke cigarettes (especially if aged >35)
• Have a history of blood clots
• Have certain clotting disorders
• Have migraine with aura
• Have high blood pressure, diabetes with vascular disease, or other cardiovascular risk factors
• Are overweight/obese
• Have prolonged immobilisation (e.g., after surgery or during long travel)

Warning signs – seek urgent medical help

If you experience any of the following, get urgent medical assistance:

• Leg swelling, pain, warmth, or redness (possible DVT)
• Sudden shortness of breath, chest pain, coughing blood (possible PE)
• Sudden severe headache, weakness/numbness on one side, trouble speaking (possible stroke)
• Severe chest pain or symptoms suggestive of heart attack
• Vision changes or severe migraine (especially with aura)

Other possible side effects

Common or notable side effects may include:

• Nausea
• Breast tenderness
• Headache
• Changes in bleeding pattern (spotting, irregular bleeding, missed withdrawal bleed)
• Mood changes
• Changes in libido

Most side effects improve in the first couple of cycles for many people, but persistent symptoms should be reviewed.

Contraindications (when it may be unsuitable)

Diane 35 may not be suitable for people with certain conditions. Do not use it if you have been told you should avoid combined hormonal medicines, for example:

• Current or previous blood clot
• Some liver diseases or liver tumours
• Known or suspected hormone-dependent malignancies (as assessed by a clinician)
• Unexplained vaginal bleeding
• Severe uncontrolled hypertension or other serious cardiovascular disease

Because eligibility depends on individual risk factors, it’s important to discuss your medical history with a healthcare professional before starting.

Practical use tips

• Take at the same time daily: Helps maintain steadier hormone levels.
• Use reminders: Calendar alerts or phone alarms can reduce missed doses.
• Track symptoms and bleeding: Acne/hair improvements can take time; note any new or worsening symptoms.
• Do not double up blindly: If you miss tablets, follow the leaflet guidance or ask a pharmacist.
• Plan around surgery/immobility: If you have an upcoming procedure or prolonged travel, ask healthcare professionals about temporary risk reduction steps.
• Be cautious with new medicines: Enzyme-inducing medicines can interfere with effectiveness.

How long until it works?

Androgen-related symptoms often improve gradually.

• Acne: Some improvement may be seen within a few months; more sustained improvement usually requires several cycles.
• Hirsutism: Hair growth cycles are slow. Changes can take longer (often many months) and may be incomplete for some people.

If you do not see improvement after an appropriate trial period, your clinician may reassess diagnosis, consider alternative treatments, or review the appropriateness of continuing Diane 35.

Alternative options

Depending on your specific condition, alternatives may include:

For acne

• Topical therapies (e.g., retinoids, benzoyl peroxide, topical antibiotics where appropriate)
• Oral antibiotics for limited duration in selected cases
• Spironolactone (anti-androgen option in some patients)
• Other combined hormonal products (with different progestogens)
• Isotretinoin for severe, treatment-resistant acne under strict monitoring

For hirsutism

• Anti-androgen medicines (e.g., spironolactone in appropriate patients)
• Combined hormonal therapies tailored to the individual’s hormone profile
• Cosmetic hair reduction such as laser or electrolysis (often combined with medical therapy)

The “best” alternative depends on your medical history, preferences, clot risk, migraine history, and whether pregnancy prevention is also needed.

Market and legal context for Australia

In Australia, combined hormonal medicines are regulated and must meet local safety, quality, and labelling requirements. The availability and indication wording for Diane 35 may vary depending on regulatory updates and local product information at the time of purchase.

Because Diane 35 is associated with specific risks (particularly thromboembolic risk), Australian healthcare guidance may emphasise:

• Appropriate patient selection
• Consideration of alternative options when suitable
• Ongoing assessment of risk factors (e.g., smoking status, migraine with aura, blood pressure, clot history)

Recent guidance note: Like other combined hormonal products, Diane 35 safety information can be updated over time by regulators and professional bodies. Always rely on the most current information in the product leaflet supplied with your pack and the advice from a qualified healthcare professional.

Delivery, availability, and how to order online

Online pharmacies in Australia commonly supply medicines subject to Australian regulations and eligibility requirements. Availability may be influenced by:

• Supplier stock levels
• Whether the item is currently in demand
• Pack size and formulation in circulation

Delivery timeframes: Delivery speed depends on your location and the pharmacy’s dispatch schedule. Your checkout page typically shows estimated delivery dates.

What you’ll receive: A sealed product pack with patient information. Always check:

• Product name and strength
• Expiry date
• Correct pack format for your dosing schedule

Storage: Store at room temperature, away from moisture and heat, and keep out of reach of children. Follow the instructions on the pack.

FAQ

Is Diane 35 the same as an acne cream?

No. Diane 35 is a tablet taken by mouth that acts through hormones. It is not an external topical acne product.

When will my acne improve?

Many people need several months to see meaningful improvement. If there is little or no improvement after an adequate trial period, talk with a healthcare professional about reassessing the plan.

Can I take Diane 35 with food?

Yes. It can usually be taken with or without food. If it upsets your stomach, take it after a meal.

What happens if I miss a tablet?

How you respond depends on how many tablets were missed and where you are in the pack cycle. Follow the instructions in your leaflet or ask a pharmacist for advice. Do not assume that missing one dose has no effect—breakthrough bleeding and reduced symptom control can occur.

Can I drink alcohol while taking Diane 35?

Moderate alcohol is generally not expected to directly interfere. However, heavy drinking can affect liver function and overall health, and may make it harder to stay consistent with daily dosing.

Will Diane 35 interact with other medicines?

Yes, some medicines and herbal products can affect hormone levels. Tell your pharmacist about everything you take, including antibiotics, anti-epileptics, antifungals, antivirals, and St John’s wort.

What side effects should I watch for?

Common effects include nausea, breast tenderness, headache, and changes in bleeding. Seek urgent medical help for signs of blood clots (leg pain/swelling, sudden shortness of breath, chest pain, stroke-like symptoms).

Is Diane 35 suitable for everyone with acne or excess hair?

No. Diane 35 is most suitable when androgen-related causes are likely and when the benefits outweigh the risks for your individual situation. Risk factors (such as smoking, clot history, migraine with aura, and high blood pressure) matter.

What are common alternatives if Diane 35 isn’t right for me?

Alternatives may include other hormonal options, anti-androgens such as spironolactone (for selected patients), topical acne therapies, antibiotics, or isotretinoin for severe acne—depending on diagnosis and severity.

How should I store Diane 35?

Keep tablets at room temperature away from moisture and heat. Keep them in the original packaging, and store out of reach of children.

Important patient reminder

This information is intended to help you understand Diane 35. It does not replace advice from a qualified healthcare professional. If you are unsure whether Diane 35 is appropriate for you, or if you develop new symptoms or side effects, speak with a pharmacist or clinician promptly—especially if you experience signs of a blood clot.