Ginette 35

Quick links to important sections

Ginette 35

Treatment option:

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Ginette 35

Property Description
Active ingredient Cyproterone Acetate, Ethinyl Estradiol
Form Film-coated Tablet (Oral)
Pharmacological class Antiandrogen and Estrogen Combination (ATC G03HB01)
Common use Dual-purpose hormonal regulation and contraception
Origin Synthetic (Steroidal Hormones)

What is Ginette 35 and How is it Classified?

Ginette 35 is a prescription-only hormonal medicine administered orally as a film-coated tablet. This synthetic combination product falls under the general pharmacological classification of Antiandrogens and Estrogens, utilizing the ATC code G03HB01. The medicine is generally known by the international generic term Co-cyprindiol and is recognized for its dual function, providing the activity of a Combined Oral Contraceptive (COC) while delivering specific hormonal modulation.

What are the Active Ingredients in Ginette 35?

The product contains two core active ingredients: Cyproterone Acetate and Ethinyl Estradiol. The Ethinyl Estradiol component serves as the estrogen, contributing to hormonal stability, while the Cyproterone Acetate acts as the antiandrogen, which also has progestogenic activity. The dual composition is essential to the drug's purpose, as it ensures both the anti-male hormone effect and the contraceptive benefit are delivered in a single formulation.

What is the General Purpose of This Dual-Action Medicine?

The core general purpose of this medicine is to use its anti-androgenic effect to modulate the activity of male hormones, while simultaneously ensuring reliable pregnancy prevention. Co-cyprindiol is indicated for use in women of reproductive age who require both the targeted hormonal activity against androgen-sensitive conditions and the benefit of contraception. This positions the medicine as a specialized hormonal treatment that includes protection from conception as part of its recognized function.

Regulatory References

  1. GOV.UK Drug Safety Update on Co-cyprindiol

What side effects are possible with Ginette 35?

Possible side effects and safety information

Official regulatory documentation structures the safety profile of Ginette 35 (Co-cyprindiol) by classifying adverse reactions based on incidence, system-organ class, and severity. This medicine, like all combined oral contraceptives, is associated with a specific risk profile detailed in government labels.

Frequency-Classified Adverse Reactions

The most frequently reported events, classified as Common (1/100 to <1/10), include headache, nausea, abdominal pain, depressed mood, altered mood, and increases in body weight. Uncommon reactions may involve vomiting, diarrhoea, migraine, rash, and fluid retention. Rare occurrences include contact lens intolerance, hypersensitivity reactions, and increased libido.

Serious Safety Risks

The most critical safety concerns explicitly documented in official labeling involve thromboembolic events. These include an increased risk of Venous Thromboembolism (VTE) and Arterial Thromboembolism (ATE). The excess risk of VTE is noted to be highest during the first year of initial use. Rare cases of benign and malignant liver tumors have also been documented in users. Additionally, the risk of meningioma increases with the cumulative dose exposure to the active ingredient cyproterone acetate.

Population and Exposure-Related Safety

Safety notes emphasize that the risk of VTE and ATE is amplified by factors such as increasing age and heavy smoking, particularly in women over 35. The medicine is formally restricted for use in individuals with a high risk of thrombotic diseases, current or history of severe hepatic disease, and liver tumors until liver function has fully normalized. Furthermore, women with a tendency toward chloasma (skin pigmentation) should avoid excessive exposure to sun or ultraviolet light.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documents describing overdose for medicines containing Cyproterone Acetate and Ethinyl Estradiol (Co-cyprindiol) structure the condition around specific documented manifestations and required emergency actions.

Documented Clinical Manifestations Acute overdose is officially classified as not likely to be life-threatening. However, a constellation of symptoms is associated with ingestion of a large dose. The primary manifestations relate to the hormonal content and commonly include significant nausea and vomiting. Furthermore, withdrawal bleeding may be experienced by female patients, which is a specific hormonal effect documented to occur even in prepubescent girls following accidental intake.

Overdose Profile Feature Regulatory Statement Summary
Severity Generally not expected to be life-threatening.
Antidote Status No specific antidote is known for this combination product.
Management Treatment is directed as being strictly symptomatic and supportive.
Medical Intervention Procedures such as gastric lavage or the induction of emesis may be considered by healthcare professionals if the overdose is discovered shortly after ingestion.

When Immediate Medical Help is Required Regulatory guidance explicitly mandates that immediate medical attention must be sought in all instances of suspected overdose. Individuals are required to contact emergency medical services or a local Poison Control Center for immediate professional assessment and advice. The core purpose of the emergency response is to provide necessary supportive care as officially documented in the prescribing information.

Therapeutic Uses of Ginette 35

What Ginette 35 Treats: Main Uses and Benefits

Ginette 35 (Co-cyprindiol) is a specialized combined hormonal medicine used in women of reproductive age to manage symptomatic conditions linked to excessive androgen effects, while also providing reliable pregnancy prevention. Its use is typically indicated when symptoms have not responded adequately to alternative, standard treatments.


The medicine is relevant for easing symptoms in conditions characterized by periods of heightened symptoms, including moderate to severe acne, pathological hair growth (hirsutism), and androgen-dependent alopecia.

“The treatment provides support that helps ease the overall symptom burden in chronic androgen-related manifestations.”

Symptomatic Relief and Dual Function

The core purpose is to provide symptomatic assistance by addressing groups of symptoms that may become intense or disruptive. For skin, the benefit assists with reducing the intensity of inflammatory lesions and a decrease in seborrhea (excessive oiliness), which contributes to improved comfort. For hair, it supports the management of androgen-related hair loss and assists with supporting a slowing of new, unwanted hair growth. This medicine is applied in clinical settings that involve managing these severe manifestations while providing the essential benefit of effective pregnancy prevention.

Quick Fact: Relief for Androgen-Driven Skin and Hair Symptoms Ginette 35 is commonly used to help manage chronic, disruptive symptoms like refractory acne and hirsutism when concurrent, effective contraception is appropriate.

Eligibility and Restrictions for Use

Who Can and Cannot Use Ginette 35?

Ginette 35 (Co-cyprindiol) is a specialized prescription medicine with strict eligibility criteria as defined by global regulatory bodies.

Eligibility and Restrictions

Ginette 35 is only indicated for women of reproductive age who require treatment for moderate to severe androgen-sensitive conditions (such as severe acne or hirsutism) and also require concurrent oral contraception. The medicine must not be used solely for the purpose of contraception.

Population Status Eligibility Rule
Allowed Population Women of reproductive age with specific clinical need
Pediatric Use Only indicated after menarche (onset of menstruation)
Geriatric Use Not indicated after menopause

Absolute Contraindications (Must Not Use)

Use of Ginette 35 is absolutely contraindicated for several populations due to significant health risks, as stated in official labeling:

  • Patients with a history of or current venous or arterial thromboembolism (e.g., blood clots, stroke, heart attack) or predisposing conditions.
  • Women who are pregnant or breastfeeding.
  • Patients with severe hepatic disease (liver disease) or a history of liver tumours.
  • Patients with known or suspected estrogen-dependent malignancies (cancers).
  • Those with severe diabetes mellitus with vascular complications or uncontrolled hypertension.
  • Concomitant use with another hormonal contraceptive is also prohibited.

What should I know about interactions with other medicines?

Ginette 35 (cyproterone acetate and ethinylestradiol) can interact with a variety of medicines, which may affect the concentration of the hormones in your blood. This can lead to reduced effectiveness in treating the target conditions and may compromise the contraceptive action, resulting in breakthrough bleeding or the risk of pregnancy. Conversely, Ginette 35 may also affect the action or concentration of other medicines.

Reduced Effectiveness of Ginette 35

The following classes of medicines and herbal remedies may decrease the levels of cyproterone and ethinylestradiol:

  • Medicines that increase liver enzymes: This includes certain antiepileptic drugs (e.g., phenytoin, primidone, carbamazepine, topiramate, barbiturates), and medicines for HIV/AIDS (e.g., ritonavir, nevirapine).
  • Antibiotics/Antifungals: Specific drugs such as rifampicin, rifabutin, and griseofulvin.
  • Herbal Remedies: St. John's Wort (Hypericum perforatum).

If you are taking any of these, your doctor may recommend a reliable non-hormonal barrier method of contraception, such as condoms, for the duration of the treatment and for a specified time afterward.

Other Important Interactions

  • Hepatitis C Virus (HCV) Medicines: Concomitant use with certain HCV treatment regimens (e.g., those containing ombitasvir/paritaprevir/ritonavir with or without dasabuvir) is contraindicated, as this can increase the risk of liver enzyme elevations (ALT).
  • Other Drugs: Ginette 35 can alter the plasma concentration of other medicines, potentially increasing the levels of drugs like ciclosporin and theophylline, or decreasing the effect of some anti-diabetics and anticoagulants.

Mechanism of Action

Ginette 35 operates through a dual hormonal pharmacodynamic mechanism combining the anti-androgenic progestin, cyproterone acetate (CPA), and the estrogen, ethinylestradiol (EE). These components target key cellular and endocrine systems to modulate hormone action.

CPA acts as a competitive antagonist by binding directly to androgen receptors (ARs) in target tissues like the hair follicles and sebaceous glands. This interaction inhibits the cellular binding of natural androgens (e.g., testosterone), thereby suppressing the downstream signaling that regulates gland activity and hair growth, resulting in altered end-organ response.

Simultaneously, the combination exerts a negative feedback effect on the Hypothalamic-Pituitary-Ovarian (HPO) axis. This suppression reduces the pituitary release of Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH), modifying the ovarian steroidogenesis pathway and reducing systemic androgen synthesis and concentration. Furthermore, EE significantly increases the hepatic synthesis of Sex Hormone Binding Globulin (SHBG), which binds circulating androgens, modulating the available ligand concentration for target receptors.

Dosage and Administration Information

Administration Guidelines for Ginette 35

Ginette 35 (cyproterone acetate/ethinylestradiol) is an oral medication taken in a 21-day cyclic regimen.


Administration and Dosing

Administration Scope Instruction
Route Oral (swallow whole).
Dosing Schedule One tablet daily for 21 consecutive days, followed by a 7 tablet-free day interval. A new pack must be started after the 7-day interval.
Timing Take the tablet at roughly the same time every day (at intervals not exceeding 24 hours). May be taken with or without food.
Age-Group Rules The medication is indicated only after menarche (onset of menstruation).

Missed Dose Instructions

If a tablet is delayed, the procedure depends on the time elapsed. This guideline applies only to the active tablets (the 21 hormone-containing pills) and is based on two basic rules: tablet-taking must never be discontinued for longer than 7 days, and 7 days of uninterrupted tablet-taking are required to maintain protection.

  • Less than 12 hours late: Take the missed tablet immediately and continue with the next tablet at the usual time. Contraceptive protection is maintained.
  • More than 12 hours late: Take only the most recently delayed tablet immediately and continue taking the next tablet at the usual time (omitting earlier missed tablets). Non-hormonal additional contraception (e.g., condoms, not rhythm or temperature methods) must be used for the next 7 days of tablet taking. If the missed dose occurred in the final week of the pack, the next pack must be started immediately after finishing the current one, skipping the 7-day break.

Procedural Note: Do not use this medication in combination with any other hormonal contraceptive. If vomiting or severe diarrhea occurs within 3 to 4 hours of taking an active tablet, the absorption is considered incomplete, and the missed-dose instructions must be followed.

Recent Clinical Evidence

Research evidence / Overview of studies for Ginette 35

This section provides an overview of the types of research and clinical evaluations conducted for Ginette 35 (Co-cyprindiol), focusing only on the study structure, the measured outcomes, and the limitations noted in regulatory and scientific literature.


Evidence for use in Moderate to Severe Acne

Research evidence exploring this medicine for acne has been derived from Randomized Controlled Trials (RCTs) and subsequent systematic reviews. Researchers primarily included women of reproductive age whose acne was classified as moderate to severe and whose symptoms had not responded adequately to prior standard therapies. Research has explored objective study endpoints, such as the total count of inflammatory lesions and the rate of achieving resolution or clearing of facial acne. Studies also monitored outcomes related to excessive skin oiliness, known as seborrhea. The findings describe patterns observed in these studies, where measurements of lesion counts and acne severity scores were monitored over the intermediate treatment periods of six to nine months.

Evidence for use in Pathological Hair Growth (Hirsutism)

The research evaluation exploring this medicine for pathological hair growth (hirsutism) has been conducted in RCTs and meta-analyses that explored various comparator treatments. Research examined specific physiological outcomes by using standardized instruments, such as the Ferriman-Gallwey score, which measures the degree of unwanted hair growth. Studies report how symptoms evolved in the observed populations, with trials describing patterns measured in hirsutism scoring systems. Reported outcomes were based on extended follow-up durations, with maximal observations extending to a year or more.

Research Gaps and Areas of Uncertainty

Research highlights what is known—and what is still uncertain—about this medicine. A primary limitation is that comparative evidence is lacking for certain new treatment options, and the evidence quality varies across studies due to differences in design and patient selection. The research does not determine whether an individual will respond similarly to the group patterns observed in the studies, and certainty remains low for long-term outcomes in some indications. Data for certain groups, such as children and geriatric patients, remain insufficient.

Frequently Asked Questions (FAQ)

Common questions about Ginette 35 (FAQ)

Q: What are the official clinical indications (conditions it treats) for Ginette 35?

Official regulatory documents state that Ginette 35 is indicated for the treatment of moderate to severe acne, which may be accompanied by excessive oiliness (seborrhoea), particularly when other treatments like oral antibiotics have not been effective. It is also approved for treating mild pathological excessive hair growth (hirsutism). Official documentation specifies that this product is not intended for use solely as a contraceptive.

Q: How does Ginette 35 prevent pregnancy, beyond its anti-androgen effect?

Ginette 35 is recognized by regulatory bodies as having a dual action. The combination of hormones acts to suppress ovulation, which is one of the primary mechanisms for preventing conception. Official information also notes its strong progestogenic effect, which contributes to the contraceptive reliability.

Q: Is it safe to take Ginette 35 if I have a history of migraines?

A history of migraine with focal neurological symptoms is listed as an absolute contraindication in the official product label. If you have a history of migraine without focal symptoms, official guidelines state that this is a condition requiring special care or medical supervision.

Q: If I miss a dose, when exactly do I need to use a backup contraceptive?

Official instructions specify that if a tablet is missed by more than 12 hours, contraceptive protection may be reduced. Regulatory guidelines state that additional barrier contraception (e.g., condoms) should be used for the next 7 days of continuous tablet-taking.

Q: How long will it take for my acne to start clearing up after starting Ginette 35?

Official data on treatment efficacy notes that the time until improvement can vary based on individual response. Clinical trials that explored objective outcomes related to acne and excessive hair growth tracked changes over periods ranging from six to nine months. In clinical settings, treatment may be continued for approximately three to four cycles after the condition has clinically resolved.

Q: Is it okay to start a new pack of pills early if I'm planning a trip and want to skip my period?

Official product information includes a method for delaying a period. The protocol involves omitting the 7-day tablet-free interval and immediately starting the next pack. This extension can be continued until the tablets in the second pack are finished.

How should Ginette 35 be stored and disposed of?

How to Store and Dispose of Ginette 35

Official regulatory information details the specific conditions necessary to maintain the stability and safety of Ginette 35 tablets (Co-cyprindiol).

Storage and Handling Requirements

Requirement Official Condition
Temperature Store at a temperature not exceeding 30 C (86 F).
Environmental Protect from direct light, excessive heat, and moisture.
Child Safety Must be kept securely out of the sight and reach of children.

Storage must avoid areas of high humidity, such as the bathroom. The specified temperature limit is essential to ensure the product remains stable until its expiration date.

Disposal Instructions

Regulatory documents state that there are no special requirements for the disposal of expired or unused Ginette 35. The medicine should be discarded properly according to the established pharmaceutical waste collection procedures in your local area, and should not be placed into household waste or wastewater.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

Equivalent of Ginette 35 found in:

A-Z Index: