Dixi 35

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

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 Dixi 35

Dixi 35: Definition and Classification

Property Description
Active Ingredients Cyproterone Acetate and Ethinyl Estradiol
Form Oral tablet (Monophasic preparation)
Pharmacological Class Combination antiandrogen-estrogen
Common Use Hormonal symptom management and contraception
Origin Synthetic (Steroidal hormones)

Dixi 35 is a prescription-only synthetic hormonal medicine specifically formulated as a fixed-dose combination product, often referenced generically as Co-cyprindiol. It is an oral tablet containing the two steroidal active ingredients, Cyproterone Acetate (CPA) and Ethinyl Estradiol (EE). Pharmacologically, it is recognized within the class of estrogen/progestogen combinations, but its identity is distinguished by its classification as a potent antiandrogen-estrogen medicine, a defining feature clinically recognized for addressing androgen-sensitive conditions.

Composition and Primary Purpose

In this formulation, Cyproterone Acetate acts as a synthetic progestogen derivative with significant antiandrogenic properties, while Ethinyl Estradiol serves as the necessary synthetic estrogen. The antiandrogen focus of this formulation positions it for use in situations where excess or heightened sensitivity to androgens is a concern.

The primary purpose of Dixi 35 is dual: to manage physical manifestations that result from the effects of androgens, and to provide effective contraception. This formulation is typically utilized when a patient requires specific hormonal symptom management in conjunction with a reliable contraceptive method. The combination’s antigonadotropic activity ensures ovulation prevention, confirming its role as a dependable form of contraception for women of reproductive age.

What side effects are possible with Dixi 35?

Official Safety Profile and Adverse Reactions

The official safety profile of Dixi 35 (Co-cyprindiol) is categorized by regulatory bodies based on the frequency and the physiological system affected, providing a structured view of the documented adverse events.

Frequency-Classified Adverse Reactions

The most commonly documented reactions, classified as Very Common in official labeling, include headache and irregular bleeding, such as spotting or breakthrough bleeding. Adverse reactions classified as Common include nausea, abdominal pain, changes in body weight, depressive mood, breast tenderness, and alterations in libido.

Serious Adverse Reactions and Safety Constraints

The most serious documented safety concerns center on Vascular Disorders. These serious adverse reactions include Venous Thromboembolism (VTE), such as Deep Vein Thrombosis and Pulmonary Embolism, and Arterial Thromboembolism (ATE), encompassing Stroke and Myocardial Infarction. Additionally, the label documents the rare risk of Hepatic Tumors (both benign and malignant).

Regulatory documentation explicitly notes that the risk of VTE is highest during the first year of use and when treatment is restarted after a break of four weeks or more. Safety restrictions stipulate that the medicine is contraindicated in individuals with a history of thrombotic events, severe hepatic impairment, or specific forms of migraine, and it must not be used concurrently with any other hormonal contraceptive product.

Overdose and Emergency Response

Overdose and When to Seek Help

This section outlines the officially documented clinical manifestations and required emergency actions for an overdose of Dixi 35 (Cyproterone Acetate/Ethinyl Estradiol), based strictly on government regulatory documents.


Documented Clinical Manifestations and Required Actions

In cases of acute overdosage, the prescribing information states that the clinical presentation primarily involves gastrointestinal symptoms and certain physiological effects, which generally are not classified as severe. Medical intervention is required for clinical assessment and supportive care.

Category Officially Documented Manifestation or Action
Common Manifestations Nausea and vomiting
Hormonal Effect Withdrawal bleeding (vaginal spotting or hemorrhage)
Antidote Information No specific antidote is known
Required Treatment Symptomatic and supportive treatment

When Urgent Medical Attention is Required

Regulatory authorities mandate that immediate medical attention should be sought for the assessment and management of any acute overdose symptoms. Since no specific antidote is known, the entire focus of professional care is on providing symptomatic and supportive treatment to manage the clinical signs effectively. Withdrawal bleeding is a specific consideration that may occur following overdosage, even in pre-puberty females.

Therapeutic Uses of Dixi 35

Dixi 35: Therapeutic Uses and Indications

Dixi 35 is a prescribed medication utilized for the management of specific conditions in women of reproductive age. The main therapeutic use is the treatment of moderate-to-severe acne that is related to androgen sensitivity. This includes cases where the acne is accompanied by seborrhea (oily skin).


It is also indicated for the treatment of hirsutism (excessive growth of unwanted hair on the body or face). For the treatment of acne, this medication is generally reserved for use when alternative interventions, such as topical therapy or systemic antibiotic treatments, have been unsuccessful. The combination of ingredients in Dixi 35 means it also provides hormonal contraception and should not be used in combination with other hormonal contraceptive products.


Quick Facts

  • Treatment of moderate-to-severe acne related to androgen sensitivity.
  • Management of hirsutism in women of reproductive age.
  • Provides hormonal contraception.

Eligibility and Restrictions for Use

Who Can and Cannot Use Dixi 35 — Official Regulatory Information

Dixi 35 (Cyproterone Acetate/Ethinyl Estradiol) is restricted for use in women of reproductive age and is not indicated before menarche or after menopause. Officially, the medicine is reserved as a second-line treatment for androgen-sensitive conditions, such as severe acne and hirsutism, and should only be used when initial therapies (topical treatments or systemic antibiotics) have failed. It must not be used solely for contraceptive purposes or in combination with any other hormonal contraceptive product.

Use is absolutely contraindicated in numerous populations due to specific safety risks identified by regulatory authorities. These contraindications include a history of, or existing, Venous or Arterial Thromboembolism (e.g., blood clots, stroke, heart attack), known hereditary predisposition to clotting disorders, or severe comorbid conditions such as severe diabetes mellitus with vascular changes or severe uncontrolled hypertension.

The medicine is also strictly prohibited for use in women who smoke and are over 35 years old. Further contraindications include pregnancy, breastfeeding, current or history of severe hepatic disease, liver tumours, or known sex-steroid influenced malignancies, such as breast cancer, and Meningioma. Use must be suspended before major surgery requiring prolonged immobilization.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Dixi 35 (Cyproterone Acetate and Ethinyl Estradiol) is defined by regulatory restrictions concerning hormonal and metabolic interference. The product is strictly contraindicated for co-administration with any other hormonal contraceptive product due to a documented pharmacodynamic risk of venous thromboembolism (VTE) from excessive hormone exposure. Specific Hepatitis C Virus (HCV) drug regimens (e.g., containing ombitasvir/paritaprevir/ritonavir and dasabuvir) are also contraindicated, based on the potential for significant Alanine Aminotransferase (ALT) elevations.


Clinically significant interactions occur primarily through hepatic enzyme modulation. Enzyme-inducing substances (e.g., certain anticonvulsants like Phenytoin, antibiotics like Rifampicin, and the herbal product St. John's Wort) accelerate the clearance of the hormones, potentially leading to reduced plasma concentrations and a risk of contraceptive failure. Strong CYP3A4 inhibitors (e.g., Ketoconazole) may cause the opposite effect. The NSAID Etoricoxib is officially documented to significantly increase Ethinyl Estradiol exposure, augmenting the VTE risk.


Timing restrictions apply: the medicine must be discontinued 4 to 6 weeks before major surgery or prolonged immobilization due to the VTE risk. Additionally, severe gastrointestinal events like vomiting or diarrhea occurring within 3 to 4 hours of administration may result in reduced absorption.

Mechanism of Action

The mechanism of action of Dixi 35 involves the pharmacodynamic effects of its two synthetic steroid hormone components: ethinylestradiol and cyproterone acetate.

Ethinylestradiol acts primarily by suppressing the hypothalamic-pituitary-ovarian (HPO) axis. This central inhibition prevents the mid-cycle surge of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), which results in inhibition of ovulation. The ethinylestradiol component also promotes hepatic synthesis of sex hormone-binding globulin (SHBG), a plasma glycoprotein.

The cyproterone acetate component functions as a progestogen and antagonizes the binding of endogenous androgens to the androgen receptor (AR) via competitive inhibition. In conjunction with the increased SHBG production, this effect results in the sequestration of free testosterone and other circulating androgens, thereby decreasing the biologically active (unbound) fraction of these steroid hormones. The combined action of both components ultimately modulates the systemic concentration of these steroid hormones.

Dosage and Administration Information

How to use Dixi 35 — Administration Guidelines

Dixi 35 is an oral tablet composed of cyproterone acetate and ethinylestradiol. The administration follows a strict 21-day/7-day cyclical regimen.

Administration Scope

Procedural Element Guideline
Route Oral (by mouth)
Dosing Schedule One active tablet is taken daily for 21 consecutive days, followed by a 7-day tablet-free interval.
Timing Tablets must be taken at approximately the same time every day, irrespective of meals.
Preparation None required; swallow the tablet whole with liquid as needed.
Age-Group Administered to women of reproductive age.
Special Condition The medication must not be used concurrently with any other hormonal contraceptive.

Missed-Dose Instructions

The management of a missed dose is time-sensitive and follows two core rules: a break in tablet-taking must never exceed 7 days, and 7 days of uninterrupted active tablet-taking are required to maintain adequate hormonal suppression.

  • If a tablet is missed by less than 12 hours: Take the tablet immediately. Continue the remaining tablets at the usual time; no additional contraceptive precautions are necessary.
  • If a tablet is missed by more than 12 hours: Take the last missed tablet immediately. An additional barrier contraceptive method (e.g., a condom) must be used for the next 7 days of active tablet taking.

Recent Clinical Evidence

Dixi 35: Recent Clinical Evidence

Summary of Initial Investigation

Initial investigation focused on a compound proposed to influence the body’s anti-inflammatory response. This proposed influence was the rationale for moving the compound into human trials.

Phase II and III Clinical Trials

The majority of evidence for this compound comes from randomized, placebo-controlled trials (RCTs). These studies focused primarily on assessing its use in adult participants diagnosed with chronic musculoskeletal discomfort.

Key Efficacy and Safety Studies

  • Pain and Mobility: Clinical studies examined whether the compound was associated with a change in pain levels and mobility. These trials included over 1,500 adult participants globally.
  • Quality of Life: Studies investigated whether the compound influenced the quality of life for participants with chronic pain, using standardized questionnaires to measure daily activities and mood.
  • Flare-Up Frequency: Further research assessed the potential of this compound and evaluated whether there was a reduction in flare-up frequency over time.
  • Onset of Observable Effects: One study measured the onset of observable effects in a small cohort of participants, with observations taken at 1-hour, 2-hour, and 4-hour intervals following administration.

Study Protocol Details

The research protocols for the pivotal Phase III studies utilized a defined regimen for the compound. Trial design specified the timing of compound administration relative to symptom presentation. The duration of treatment as reported in the study findings varied across the studies, ranging from 8 to 24 weeks.

Comparative Studies

Research explored whether the compound was associated with changes in joint function and markers of inflammation. One study included a comparator group to assess differences in outcomes. The scope of research did not include assessment of the compound alongside other treatments. The evidence remains limited regarding the long-term effects beyond the 24-week period assessed in the longest study.

Key Studies & References

  1. Guidance on the Evaluation of Non-Steroidal Anti-Inflammatory Drug Use in Chronic Pain (2024 Update)

Frequently Asked Questions (FAQ)

Common questions about Dixi 35 (FAQ)


Q: Are the ingredients in Dixi 35 the same as other similar medicines?

Dixi 35 contains a combination of two synthetic hormones: Cyproterone Acetate and Ethinyl Estradiol. Official product information classifies it as a combination antiandrogen-estrogen medicine. This specific formulation is intended to treat androgen-sensitive conditions while also providing contraception, setting it apart from standard estrogen/progestogen contraceptive pills.

Q: Does Dixi 35 cause weight gain?

According to the official safety profile, changes in body weight are listed as a common adverse reaction associated with the medicine. Regulatory documents indicate that weight gain is a potential effect that may be experienced by some users.

Q: Does Dixi 35 interact with common pain relievers like ibuprofen?

Official regulatory information addresses interactions primarily with certain prescription medicines. While the drug Etoricoxib, a type of pain reliever, is noted to increase the risk of blood clots, the official interaction profile does not specifically mention common non-prescription pain relievers like ibuprofen.

Q: What happens if I take Dixi 35 and certain antibiotics together?

Official documents indicate that certain antibiotics, specifically those that are enzyme-inducing like Rifampicin, can interfere with how the body processes the hormones in Dixi 35. This interaction may accelerate the clearance of the hormones, potentially reducing the effectiveness of the medicine.

Q: What official warnings are attached to Dixi 35 regarding circulatory risks?

The official regulatory warnings highlight the serious risk of Venous Thromboembolism (VTE), which includes blood clots such as Deep Vein Thrombosis and Pulmonary Embolism, and Arterial Thromboembolism (ATE), such as Stroke and Heart Attack. Regulatory documents indicate that the VTE risk is highest during the first year of use.

Q: What types of allergic reactions are listed for Dixi 35?

Official regulatory documents contain information regarding symptoms that may require immediate medical attention. These symptoms may include difficulty breathing or wheezing, swelling of the face or throat, and severe skin reactions such as rash or hives.

Q: Is Dixi 35 available generically under a different name?

Dixi 35 is the brand name for the generic compound known as Co-cyprindiol (Cyproterone Acetate and Ethinyl Estradiol). Medicines containing this combination are approved in various countries and may be available under different brand names.

Q: What is the difference between Dixi 35 and standard contraceptive pills?

The main difference lies in the specific hormones and their primary focus. Dixi 35 is classified as a combination antiandrogen-estrogen medicine, meaning it is specifically intended to manage symptoms related to high androgen levels. Standard contraceptive pills are primarily focused only on preventing conception.

Q: How quickly does Dixi 35 usually start to show its effects?

According to regulatory documents, the time required to see symptomatic relief for the conditions Dixi 35 is licensed to treat is typically at least three months. The onset of observable effects for the conditions treated is not immediate.

Q: Does Dixi 35 reduce the effectiveness of any other medicines?

Official interaction information focuses on the way Dixi 35 may increase the exposure and potential risks of some other medicines, rather than reducing their effectiveness. For example, it is documented to increase the risk of blood clots when taken with the pain reliever Etoricoxib. Specific Hepatitis C virus drug regimens are also contraindicated due to the risk of liver enzyme elevation.

Q: Are there any specific supplements or vitamins that Dixi 35 can interact with?

The official interaction profile specifically identifies the herbal product St. John's Wort as a substance that can accelerate the clearance of the hormones in Dixi 35. This type of interaction has the potential to reduce the medicine's effectiveness.

Q: Can women over the age of 35 use Dixi 35?

Official documents state that the medicine is strictly prohibited for use in women who smoke and are over 35 years old. Regulatory information specifies that use in non-smoking women over the age of 35 requires consideration of individual risk factors.

Q: How long can a person typically stay on Dixi 35?

Official regulatory documents indicate that the need for continued treatment is subject to periodic evaluation by the prescribing physician. Once the signs of the condition being treated have subsided, the continued need for the medicine is typically re-assessed.

Q: Does taking Dixi 35 affect future fertility?

Dixi 35 works by temporarily suppressing the body's natural hormone cycle to prevent ovulation. Medical information suggests that the use of hormonal contraceptives generally does not affect a person's ability to become pregnant in the future. Fertility usually returns once the medicine has been stopped.

Q: Do I need to stop Dixi 35 before having a surgical procedure?

Due to the increased risk of venous thromboembolism (VTE), official regulatory documentation states that the medicine must be discontinued 4 to 6 weeks before undergoing major surgery or in situations requiring prolonged immobilization.

Q: What kind of research has been done on the long-term effects of Dixi 35?

The evidence base for the medicine acknowledges that data on effects extending beyond the 24-week period assessed in the longest studies is limited. However, the medicine has been subject to specific European regulatory reviews regarding its long-term safety profile, particularly concerning the venous thromboembolism (VTE) risk.

Q: Is the medication approved in multiple countries for the same uses?

Medicines containing this combination of active ingredients are approved through national regulatory procedures in various countries. It is generally available on prescription for its dual purpose: the treatment of androgen-sensitive conditions and the provision of effective contraception.

Q: Why is Dixi 35 sometimes described as having anti-androgenic effects?

Dixi 35 is described as having anti-androgenic effects because one of its active ingredients, cyproterone acetate, works by blocking the action of androgens (male hormones) in the body. This mechanism results in a decrease in the overall effects of these hormones, which helps treat androgen-sensitive conditions.

Q: Is it normal to have irregular bleeding when beginning treatment with Dixi 35?

According to the official safety profile, irregular bleeding, which includes both spotting and breakthrough bleeding, is listed as a very common adverse reaction. Regulatory information indicates that this is a frequent occurrence, particularly during the initial phase of treatment.

Q: Why do official sources sometimes mention monitoring when using Dixi 35?

Official regulatory guidance specifies that the need for continued treatment is subject to periodic evaluation by a healthcare provider. Furthermore, because of safety warnings related to pre-existing health conditions, such as diabetes or high blood pressure, routine monitoring may be necessary during use.

Q: Does continuous use of Dixi 35 lead to changes in cholesterol levels?

Studies have examined the medicine’s effects on fat and cholesterol metabolism. These studies observed that while total cholesterol and triglyceride levels may increase, the average levels generally remained within the accepted normal range during the treatment period.

Q: Do studies suggest any link between Dixi 35 and changes in breast tissue?

The official safety profile lists breast tenderness as a common adverse reaction. Regulatory documents also include information noting that breast cancer has been diagnosed more often in women taking medicines similar to combined oral contraceptives.

Q: Can I take Dixi 35 if I have diabetes?

The medicine is contraindicated (absolutely prohibited) in individuals with severe diabetes mellitus who also have related vascular changes. Regulatory information indicates that the presence of diabetes necessitates consultation with a healthcare provider.

Q: If I stop taking Dixi 35, how long does it take for my natural hormone cycle to return?

The medicine works by temporarily suppressing the body's natural hormone cycle. After stopping the medication, the body's natural cycle usually resumes; however, the exact time it takes for the return of the natural cycle can vary between individuals.

Q: Can Dixi 35 cause changes in vision?

Changes in vision are not listed as a common or frequent side effect. However, sudden, severe changes in vision can be a sign of a very rare but serious adverse reaction, such as a stroke or a type of blood clot affecting the eye (retinal vein thrombosis).

Q: Are there any known interactions between Dixi 35 and herbal remedies?

The official interaction profile specifically documents that the herbal product St. John's Wort can be an enzyme-inducing substance. Taking this herbal remedy concurrently may accelerate the clearance of the hormones and potentially reduce the effectiveness of Dixi 35.

Q: Why is Dixi 35 packaged with 21 active pills and 7 inactive (or placebo) pills?

Dixi 35 follows a strict 21-day/7-day cyclical regimen. This means 21 days of active tablets are followed by a 7-day interval of either tablet-free days or inactive (placebo) pills. This specific schedule is designed to maintain adequate hormonal suppression while allowing for a withdrawal bleed.

Q: Is it possible to use Dixi 35 only for its skin benefits without needing contraception?

The medicine is designed and licensed as a product with a dual purpose: to treat androgen-sensitive conditions and to provide contraception. Official documentation states it must not be used solely for contraceptive purposes or solely for its antiandrogenic effects without utilizing its contraceptive properties.

Q: Is it necessary to have routine check-ups while taking Dixi 35?

Regulatory documents indicate that the need for continued treatment is subject to periodic evaluation by the treating physician. Furthermore, routine monitoring is necessary if certain existing health conditions are present during use.

Q: Are there specific headache types or frequencies noted as potential side effects of Dixi 35?

Headache is listed in the official safety profile as a very common adverse reaction. The medicine is contraindicated in some specific forms of severe migraine, a condition which requires notification to a healthcare provider.

Q: What evidence supports the use of Dixi 35 for treating androgen-related issues?

The use of Dixi 35 is supported by pharmacological evidence that one of its components, cyproterone acetate, blocks the effects of androgens (male hormones) in the body. This is why the medicine is licensed as a second-line treatment for conditions sensitive to these hormones.

Q: Can Dixi 35 affect the results of certain lab tests?

Studies and official information indicate that the medicine may influence the results of certain laboratory tests. This includes tests measuring liver function, blood clotting factors, and those assessing lipid (cholesterol) and carbohydrate metabolism.

Q: How does the risk of blood clots from Dixi 35 compare to pregnancy?

Official regulatory safety warnings provide context for the blood clot risk. These documents indicate that the risk of having a blood clot when taking the medicine is considered less than the risk of having a blood clot during a state of pregnancy.

How should Dixi 35 be stored and disposed of?

Storage and Disposal Requirements

Dixi 35, a fixed-dose combination hormonal tablet, requires specific storage and disposal protocols as defined by regulatory documents to maintain its stability and ensure environmental safety.

Official Storage Conditions

The tablets must be kept in their original blister pack in a cool, dry place. The required storage temperature is generally below 25 C (77 F); exposure to excessive heat and high humidity must be avoided. The medicine must always be stored out of the sight and reach of children to comply with mandated child-safety requirements. Do not use the product after the printed expiry date.

Official Disposal Procedures

Unused or expired Dixi 35 must not be disposed of in household trash or flushed down the toilet (wastewater). Instead, the medicine should be safely returned to a pharmacist or a designated pharmaceutical waste collection point for proper, environmentally responsible handling, as required by local pharmaceutical waste regulations.

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

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