Generic Diane 35

Introduction

Diane 35 is a combined oral hormonal preparation that contains the synthetic progestogen cyproterone acetate and the estrogen ethinylestradiol. It belongs to the hormone group of medications and is primarily prescribed in the United Kingdom for severe acne, hirsutism and as a component of hormonal contraception in women who also require anti‑androgenic therapy. The product is marketed by Bayer Healthcare and is regulated by the UK Medicines and Healthcare products Regulatory Agency (MHRA). In addition to its dermatological indications, Diane 35 is occasionally used off‑label for conditions such as polycystic ovary syndrome (PCOS) where androgen excess contributes to clinical symptoms.

What is Diane 35?

Diane 35 is a fixed‑dose oral tablet that combines two active ingredients:

• Cyproterone acetate – a synthetic progestogen with strong anti‑androgen properties.
• Ethinylestradiol – a synthetic estrogen that suppresses ovarian follicular development and stabilises the endometrium.

The preparation is classified as a combined oral contraceptive (COC) with added anti‑androgenic activity. It was developed in the early 199s and received marketing approval in Europe as a treatment for severe acne and hirsutism in women of reproductive age. The medication is manufactured by Bayer Healthcare and supplied in the United Kingdom under a MHRA‑licensed product label.

How Diane 35 Works

Cyproterone acetate blocks androgen receptors on skin and hair follicles, reducing the biological effect of circulating testosterone and dihydrotestosterone. It also decreases ovarian androgen production by inhibiting luteinising hormone (LH) secretion. Ethinylestradiol provides a steady estrogenic milieu that suppresses the hypothalamic‑pituitary‑gonadal axis, lowering ovulation‑stimulating hormones (LH and follicle‑stimulating hormone, FSH). The combined actions result in:

• Diminished sebum production and keratinocyte proliferation, which improves acne.
• Reduced stimulation of hair follicles, leading to slower growth of unwanted facial and body hair.
• Contraceptive protection through ovulation inhibition and endometrial transformation.

Onset of anti‑androgenic effect typically occurs within two to three weeks of daily intake, while full contraceptive efficacy is achieved after seven consecutive days of use. The drug’s elimination half‑life is approximately 30 hours for cyproterone acetate and 24 hours for ethinylestradiol, allowing once‑daily dosing.

Conditions Treated with Diane 35

• Severe acne vulgaris – especially cases resistant to topical therapy or oral antibiotics.
• Hirsutism – excessive androgen‑dependent hair growth on the face, chest or abdomen.
• Contraception – as a combined oral contraceptive for women seeking both birth control and anti‑androgenic benefits.
• Polycystic ovary syndrome (off‑label) – where androgen excess contributes to menstrual irregularities and dermatological symptoms.

In the United Kingdom, acne and hirsutism affect an estimated 10 % of women of reproductive age, representing a sizable patient population that may benefit from the dual action of Diane 35. The medication’s efficacy has been demonstrated in several randomized controlled trials, showing statistically significant reductions in acne lesion counts and hair growth scores compared with placebo or non‑anti‑androgenic COCs.

Who Is Diane 35 For?

• Women aged 18–35 years who have an indication for hormonal contraception and require anti‑androgenic therapy for acne or hirsutism.
• Patients with documented failure of topical agents, oral antibiotics or non‑combined hormonal therapies for severe acne.
• Individuals without a history of thromboembolic disease, uncontrolled hypertension, or active liver disease, as these conditions increase the risk of serious estrogen‑related complications.
• Women who are non‑smokers or who smoke fewer than 15 cigarettes per day and are younger than 35 years, because smoking markedly raises the risk of cardiovascular events when combined with estrogen‑containing products.

Contra‑indications include pregnancy, known or suspected breast cancer, unexplained vaginal bleeding, severe migraine with aura, and a personal history of venous thromboembolism (VTE). Women with severe hyperlipidaemia, gallbladder disease, or certain endocrine disorders may require alternative therapies.

Risks, Side Effects, and Interactions

Common

• Nausea, breast tenderness, headaches.
• Irregular menstrual bleeding or spotting, especially during the first three months.
• Weight gain or fluid retention.
• Mood changes or mild depressive symptoms.

Rare

• Elevated liver enzymes indicating hepatic stress.
• Lipid profile alterations such as increased triglycerides.
• Visual disturbances linked to retinal vascular changes.

Serious

• Venous thromboembolism (deep‑vein thrombosis, pulmonary embolism).
• Arterial thrombosis (stroke, myocardial infarction).
• Severe hypertension or hypertensive crisis.
• Hepatotoxicity with jaundice or hepatic necrosis.

Drug‑Drug Interactions

• Antiepileptics (e.g., carbamazepine, phenytoin) can reduce ethinylestradiol plasma concentrations, potentially compromising contraceptive efficacy.
• Antifungal agents (e.g., ketoconazole) and antibiotics such as rifampicin may increase hepatic metabolism of both components, lowering effectiveness.
• St. John’s Wort induces cytochrome P450 enzymes and can markedly decrease hormone levels.
• Selective serotonin reuptake inhibitors (SSRIs) may increase the risk of bleeding when taken with non‑steroidal anti‑inflammatory drugs (NSAIDs).

Patients should disclose all concurrent medications, including over‑the‑counter supplements and herbal products, to their healthcare provider.

Practical Use: Dosing, Missed Dose, Overdose

• Standard dosing: One tablet taken orally each day, preferably at the same time, for 21 consecutive days followed by a 7‑day hormone‑free interval (or as directed by the prescribing clinician).
• Missed dose: If a tablet is forgotten and it has been less than 12 hours since the scheduled time, take the missed tablet immediately and continue with the next dose as scheduled. If more than 12 hours have passed, skip the missed tablet, take the next dose at the regular time, and use a reliable backup method of contraception (e.g., condoms) for the subsequent 7 days.
• Overdose: Acute overdose is unlikely to be life‑threatening but may provoke nausea, vomiting, severe abdominal pain, or breast tenderness. If an overdose is suspected, seek immediate medical attention; supportive care is the mainstay of treatment.
• Precautions: Alcohol does not directly affect the pharmacokinetics of Diane 35 but can exacerbate nausea and liver strain. Food does not interfere with absorption may be taken with or without meals. Patients with a history of gallbladder disease should monitor for biliary colic.

Buying Diane 35 from Our Online Pharmacy

Diane 35 can be purchased safely from our online pharmacy in the UK. Our service offers several advantages for patients who encounter limited availability through conventional pharmacy channels:

• Affordable pricing – the cost is close to the manufacturer’s wholesale price, providing a cost‑effective alternative to brand‑name packs.
• Verified quality – we source the product exclusively from licensed overseas suppliers that meet EU‑Good Manufacturing Practice (GMP) standards.
• Guaranteed delivery – discreet packaging is dispatched via a 7‑day express service for rapid access or a standard airmail route (approximately 3 weeks) at reduced cost.
• Online‑only access – the pharmacy broker model enables us to provide international medications that may not be stocked locally, while maintaining strict confidentiality and privacy for all customers.

Our pharmacy broker service works with reputable overseas licensed pharmacies, ensuring that each shipment of Diane 35 complies with MHRA import regulations for personal use. The combination of low price, quality assurance and discreet delivery makes our platform a reliable option for patients seeking reliable access to this anti‑androgenic hormonal therapy.

FAQ

• Is Diane 35 classified as a contraceptive or an acne medication?
  Diane 35 is officially classified as a combined oral contraceptive (COC) that also possesses strong anti‑androgenic activity, making it effective for severe acne and hirsutism. Its dual classification is reflected in product labeling and regulatory approvals across the European Union.

• Can Diane 35 be used by women over the age of 35?
  While the medication is not contraindicated solely by age, women older than 35 who smoke or have cardiovascular risk factors face a higher incidence of thromboembolic events. Clinicians typically evaluate individual risk before prescribing a COC containing estrogen to patients in this age group.

• Does the tablet have any distinctive appearance that helps identification?
  Diane 35 tablets are round, pale pink, and bear a unique imprint code on one side (usually “35”). This visual cue assists patients and pharmacists in confirming the correct product during dispensing.

• What are the inactive ingredients in Diane 35, and could they cause allergies?
  Inactive components include lactose monohydrate, corn starch, magnesium stearate and microcrystalline cellulose. Individuals with lactose intolerance or corn allergies should discuss alternative formulations with their healthcare provider, although hypersensitivity to these excipients is uncommon.

• Is there a risk of hair loss when stopping Diane 35 after long‑term use?
  Discontinuation of cyproterone acetate can lead to a rebound increase in androgen activity, potentially causing temporary worsening of hair growth or acne. Most patients experience gradual improvement within a few months, but a follow‑up plan with a dermatologist may be advisable.

• How does travel across time zones affect the dosing schedule of Diane 35?
  When crossing multiple time zones, maintain a consistent 24‑hour interval between doses. If a dose is missed due to jet lag, follow the standard missed‑dose protocol and use barrier contraception for at least seven days after resising the schedule.

• Are there any known drug‑testing implications for athletes taking Diane 35?
  Diane 35 contains ethinylestradiol, a synthetic estrogen, which is not prohibited by major sporting organisations. However, some anti‑doping agencies flag certain progestogens; athletes should verify current regulations with their governing bodies before use.

• Does the formulation of Diane 35 differ between the EU and other regions such as the US?
  The EU version of Diane 35 contains 2 mg cyproterone acetate and 35 µg ethinylestradiol per tablet. In the United States, a comparable product (e.g., Androcur + Ethinyl Estradiol) may have slight variations in dose ratios due to differing regulatory requirements. Patients should reference the specific regional label for exact strengths.

• Can Diane 35 be stored in a heated vehicle during summer travel?
  The tablets should be kept at temperatures not exceeding 30 °C (86 °F). Prolonged exposure to high heat can degrade the active substances, reducing efficacy. It is advisable to store the medication in a cool, dry place and avoid leaving it inside a car on hot days.

• Is it necessary to take a “pill‑free” interval, or can the tablets be taken continuously?
  The standard regimen includes a 7‑day hormone‑free interval to allow withdrawal bleeding. Some clinicians prescribe continuous use (skipping the placebo week) for patients who wish to avoid monthly bleeding, but this approach discussed with a healthcare professional to monitor for breakthrough bleeding or side‑effects.

• Do pharmacists in the UK need a special license to dispense Diane 35?
  In the United Kingdom, a Community Pharmacist with a valid registration with the General Pharmaceutical Council (GPhC) may dispense Diane 35 provided a valid prescription is presented. Our online pharmacy operates under a broker model that facilitates lawful personal importation for customers who possess a prescription from a qualified prescriber.

Glossary

Anti‑androgen

A substance that blocks the effects of male hormones (androgens) on target tissues, thereby reducing symptoms such as excess oil production and unwanted hair growth.

Combined oral contraceptive (COC)

A pill that contains both an estrogen and a progestogen, used to prevent pregnancy by inhibiting ovulation and altering cervical mucus.

Venous thromboembolism (VTE)

A condition in which a blood clot forms in a deep vein (deep‑vein thrombosis) and may travel to the lungs (pulmonary embolism), representing a serious risk associated with estrogen‑containing therapies.

Pharmacokinetic half‑life

The time required for the concentration of a drug in the bloodstream to decrease by 50 %; it influences dosing frequency and duration of action.

⚠️ Disclaimer

The information provided about Diane 35 is for general knowledge only. It does not replace professional medical consultation. All treatment decisions should be made under the supervision of a qualified healthcare provider. We assume all readers are responsible adults capable of making informed decisions about their health. Our online pharmacy offers access to Diane 35 for individuals who may have limited availability through traditional pharmacies, prescription‑based insurance schemes, or who are seeking affordable generic alternatives. Always consult your doctor before starting, changing, or discontinuing any medication.