Diane 35 (Cyproterone acetate and ethinylestradiol) – Patient Information (UK)
Diane 35 is a combined hormonal medicine containing cyproterone acetate and ethinylestradiol. It is used in women where treatment is aimed at reducing the effects of androgens (“male-type hormones”) and also provides contraceptive protection.
This page explains how Diane 35 works, how it’s usually taken, key safety information, potential interactions, and practical tips. Always follow the instructions given by your healthcare professional and read the Patient Information Leaflet supplied with the medicine.
Basic product information
| Information | Detail |
|---|---|
| Medicine name | Diane 35 |
| Active ingredients | Cyproterone acetate + Ethinylestradiol |
| Type | Combined oral contraceptive (COC) with anti-androgen activity |
| What it’s used for | Androgen-related skin conditions (e.g., acne, oily skin, excess hair) in suitable patients, and contraception |
| How it’s taken | Oral tablets in a cyclic schedule |
How Diane 35 works (mechanism of action)
Diane 35 contains two hormones with complementary roles:
- Ethinylestradiol (an oestrogen) increases the production of sex hormone-binding globulin (SHBG). This helps reduce the amount of free, biologically active testosterone. Oestrogens also suppress certain ovarian hormone signals involved in follicle development.
- Cyproterone acetate is an anti-androgen. It competes with androgens at receptor sites and reduces androgen effects in the body. This can improve conditions linked to increased androgen activity, such as acne, oily skin, and some forms of unwanted hair growth.
Together, these actions can: reduce androgen symptoms and also provide contraceptive protection by suppressing ovulation.
Typical use in the UK
In the United Kingdom, Diane 35 is generally considered when a woman has both:
- moderate to severe signs of androgen-related skin conditions (for example acne), and
- appropriate need for hormonal treatment and contraception (as guided by local clinical recommendations).
It may be used for conditions such as:
- Acne (particularly when other treatments are unsuitable or ineffective)
- Oily skin associated with androgen excess
- Hirsutism (excess facial/body hair) due to androgen-related causes
- Other androgen-dependent symptoms assessed by a clinician
Note: The exact suitability depends on your individual medical history and risk factors, especially clot risk (see Safety Profile).
When Diane 35 starts working (timing and expectations)
Timing can vary for contraception versus skin benefits:
- Contraceptive protection depends on when you start your first pack and whether backup contraception is needed. Follow the start instructions your clinician or leaflet provides.
-
Skin improvements are gradual. Many people notice:
- some improvement within several weeks
- more noticeable change after 3–6 months
If your symptoms do not improve after an appropriate trial period, talk to your clinician about alternative options.
Dosing and how to take Diane 35
Diane 35 is taken by mouth. Typical use is a cyclic regimen of tablets in each pack, followed by a break or placebo interval, depending on the product schedule supplied. Your pharmacist or leaflet will specify the exact number of tablets per pack and the timing of the hormone-free days.
General dosing principles
- Take one tablet daily at about the same time each day.
- Swallow whole with water if needed.
- Finish the current pack as instructed, even if you feel better.
If you miss a tablet
Missing tablets can reduce contraceptive effectiveness and may affect bleeding pattern. The correct advice depends on how many pills are missed and when in the cycle you missed them.
- Check the Patient Information Leaflet for the exact missed-pill guidance.
- In many cases, you may need backup contraception (such as condoms) for a period.
- If you had unprotected sex around the time you missed pills, seek advice promptly.
Food interactions
In general, food does not significantly affect the absorption of combined oral contraceptives. Diane 35 can typically be taken with or without food.
However, if you experience vomiting or severe diarrhoea soon after taking a tablet, the medicine may not have been fully absorbed. Treat this like a missed dose:
- Follow missed-tablet guidance from the leaflet
- Consider backup contraception for the recommended time
- Contact a healthcare professional for tailored advice if symptoms are severe or persistent
Alcohol and medicine interactions
Alcohol does not usually directly reduce the effectiveness of combined oral contraceptives in the way some drug interactions do. That said, heavy alcohol intake can contribute to missed doses and can worsen nausea or vomiting.
When to be cautious with alcohol
- If you drink to the point of vomiting, consider the “vomiting after a dose” guidance.
- If alcohol causes you to miss tablets, use backup contraception as advised.
Other medicine interactions (important)
Some medicines can lower contraceptive hormone levels and increase the risk of pregnancy, or affect the anti-androgen effect. Examples often include medicines that induce liver enzymes.
Tell your clinician or pharmacist about any medicines you take, including:
- certain anti-epileptic medicines
- some medicines for tuberculosis
- some treatments for HIV
- the antibiotic rifampicin (and related agents)
- St John’s wort (a herbal remedy)
Some drugs may increase the risk of bleeding or affect hormone metabolism. Always check for interactions before starting a new medicine.
Pharmacokinetics (how the body processes it)
Pharmacokinetics describes absorption, distribution, metabolism, and elimination of a medicine. While individual levels vary, the following gives a general understanding:
Absorption
After oral administration, the hormones are absorbed through the digestive tract. Peak blood levels occur after ingestion, though timing may vary between individuals.
Distribution
Ethinylestradiol and cyproterone acetate circulate in the bloodstream, and distribution can be influenced by plasma proteins. Binding to sex hormone-binding globulin (SHBG) is relevant for hormonal effects.
Metabolism
Both hormones are metabolised mainly in the liver. Cyproterone acetate undergoes metabolic pathways that can be influenced by liver enzyme activity.
Elimination
The inactive metabolites are removed from the body primarily through the urine and bile/faeces. Drug clearance varies among people.
If you have liver disease, your clinician may advise against use or require closer monitoring.
Safety profile: key risks to understand
Like all combined hormonal contraceptives, Diane 35 may increase the risk of certain serious conditions. Most people do not experience these side effects, but it’s important to know what to watch for.
Blood clots (venous thromboembolism, VTE)
Combined oral contraceptives can raise the risk of blood clots, including:
- DVT (deep vein thrombosis)
- PE (pulmonary embolism)
Seek urgent medical help if you develop:
- pain/swelling in one leg
- sudden shortness of breath
- chest pain (especially when breathing)
- coughing blood
Arterial events (e.g., stroke, heart attack)
The risk of arterial problems is influenced by age, smoking, migraine history, blood pressure, and other factors.
Get urgent help if you have signs of stroke or heart attack such as:
- sudden weakness/numbness on one side
- trouble speaking
- sudden vision changes
- severe sudden headache unlike usual migraines
- chest pain/pressure
Migraine and headache
New-onset or worsening migraine (particularly with aura) may require reassessment of treatment.
Breast and reproductive tissue changes
Hormonal contraceptives can influence bleeding patterns and may rarely be associated with certain breast or cervical conditions. Regular check-ups are recommended as advised by your clinician.
Other important considerations
- High blood pressure: monitor if you have risk factors.
- Liver disease: combined oral contraceptives may be unsuitable.
- Diabetes with vascular complications: may increase risk.
- Smoking increases clot/arterial risk, especially in women aged 35 and over.
When not to use Diane 35
Do not use (or stop and seek advice urgently) if you have conditions where combined contraceptives are contraindicated. These are detailed in the leaflet but commonly include:
- current or previous blood clots
- certain types of migraine
- significant liver problems
- some hormone-dependent cancers
- unexplained vaginal bleeding
- known pregnancy
Your healthcare professional can confirm whether Diane 35 is appropriate for you.
Practical use tips
- Pick a consistent time (e.g., after breakfast or at bedtime) to reduce missed doses.
- Use reminders on your phone or calendar.
- Plan for travel: keep tablets in your hand luggage; continue as scheduled.
- Monitor symptoms: track acne/hirsutism changes and any new side effects.
- Check interactions: ask before starting new medicines, including herbal products.
- Be clot-aware: understand warning signs, especially around long flights or surgery.
What to do during surgery or long travel
Risk of clots can increase during periods of immobility. If you have surgery or prolonged bed rest, you may need advice about pausing or continuing combined hormonal contraception. Seek clinician guidance well in advance.
Alternative options (for acne and androgen-related symptoms)
Treatment choice depends on your specific symptoms, severity, preference, and medical history. Alternatives may include:
- Other acne/dermatology treatments (for example topical therapies or oral antibiotics where appropriate)
- Anti-androgen medicines (used in selected cases, sometimes with other contraception strategies)
- Different hormonal contraceptives with or without anti-androgen properties
- Non-hormonal approaches depending on cause and severity
If Diane 35 isn’t suitable, ask your clinician about the most appropriate alternative for androgen-related symptoms and contraceptive needs.
Market and legal context in the United Kingdom
In the UK, combined oral contraceptives are regulated medicines. Diane 35 has been the subject of additional regulatory scrutiny in Europe due to clot-risk considerations associated with certain combined products. Public health messaging has emphasised careful patient selection and awareness of risk factors.
In practice, clinicians generally consider Diane 35 primarily when it is the most appropriate option for women with androgen-related skin conditions who also require hormonal contraception, and when other treatments are unsuitable.
Guidance and risk communications can evolve as new evidence emerges. It’s important to use the medicine as advised by a clinician and to review your risk profile regularly.
Recent guidance and risk awareness
Regulatory updates over recent years have focused on:
- emphasising the clot risk associated with combined hormonal products
- ensuring appropriate indication use (especially for androgen-related skin conditions)
- improving awareness of warning signs for blood clots and serious arterial events
- encouraging clinicians to regularly review whether benefits continue to outweigh risks
If you’re already taking Diane 35, don’t stop suddenly without medical advice—speak to your clinician for a personalised review.
Delivery and availability in the UK (online pharmacy information)
Availability can vary by supplier and stock levels. When ordering from an online pharmacy, you can typically expect:
- Secure packaging to protect tablets and preserve product integrity
- UK delivery options depending on the service (e.g., standard and/or tracked delivery)
- Typical dispatch times shown at checkout or on the product page
If you need the medicine urgently, check the estimated delivery timeframe at checkout. Also confirm you are ordering the correct strength and pack format.
FAQ
1) Is Diane 35 a contraceptive?
Yes. Because it contains ethinylestradiol and cyproterone acetate, it can provide contraceptive protection by suppressing ovulation. However, the way you start your first pack (and whether you use backup contraception at first) depends on your cycle timing.
2) How long does it take for acne to improve?
Many people notice changes after several weeks, with clearer improvements usually after 3–6 months. If there is little benefit after an appropriate period, ask your clinician about alternatives.
3) Can I take Diane 35 with food?
Yes. Diane 35 can usually be taken with or without food. If you vomit or have severe diarrhoea soon after taking a tablet, absorption may be affected.
4) Does alcohol affect Diane 35?
Alcohol does not usually directly reduce effectiveness, but heavy drinking can lead to vomiting or missed tablets. Follow missed-dose guidance if you vomit after a dose.
5) What medicines interact with Diane 35?
Some medicines can reduce hormone levels or affect metabolism. Common examples include certain anti-epileptics, TB medicines, some HIV medicines, rifampicin, and herbal products such as St John’s wort. Tell your pharmacist about everything you take.
6) What side effects are common?
Common side effects can include nausea, breast tenderness, headache, mood changes, and changes in bleeding pattern (spotting or irregular bleeding, especially in the first months). Most improve over time, but seek advice if symptoms are severe or persistent.
7) What are the warning signs of a blood clot?
Seek urgent medical help for symptoms such as leg pain/swelling, sudden breathlessness, chest pain, coughing blood, sudden weakness, or sudden severe headache.
8) Can I use Diane 35 if I have migraine?
Migraine history matters. Certain types—especially migraine with aura—may make combined hormonal contraception unsuitable. Discuss your migraine pattern with a clinician.
9) What if I miss tablets?
Missed tablets can reduce protection and change bleeding. The correct advice depends on how many tablets were missed and where you are in the cycle. Always refer to the Patient Information Leaflet for the specific missed-pill instructions.
10) Are there alternatives if Diane 35 isn’t suitable?
Yes. Alternatives may include other acne treatments, other hormonal contraceptives, or anti-androgen approaches depending on your condition and medical history. Your clinician can guide the best option for your needs.
Important: This information is a general guide for patients in the United Kingdom. Your individual suitability depends on your medical history and risk factors. If you have questions about whether Diane 35 is right for you, speak to a healthcare professional.
