Visofid

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Medically reviewed

Marina Burgos

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 Visofid

What is Visofid? The Foundational Identity and Mechanism

Property Description
Active ingredient Cyproterone acetate, Ethinyl Estradiol
Form Film-coated tablets
Pharmacological class Combined Oral Contraceptive (COC), Anti-androgenic agent
General purpose Contraception and hormonal balancing
Origin Synthetic steroid combination

What Type of Drug is Visofid? Classification and Form

Visofid is a prescription-only, dual-action, systemic hormonal medication that is clinically recognized for its high efficacy and is classified primarily as a Combined Oral Contraceptive (COC) with distinct anti-androgenic properties. This product is a synthetic steroid combination, presented as film-coated tablets designed for oral administration. The active compounds consist of a combination of estrogen and a progestin with anti-androgenic effects. This fixed-dose combination is utilized for female hormonal contraception, which characterizes the product's role in managing reproductive health.

Composition: Cyproterone, Ethinyl Estradiol and Dual Action

The medication's composition is a fixed-dose combination of two active ingredients: the progestin Cyproterone acetate (CPA) and the estrogen Ethinyl Estradiol (EE). This pairing differentiates it from formulations containing non-anti-androgenic progestins. The combination product utilizes Cyproterone acetate both for its progestogenic role in suppressing ovulation and for its specific function as an anti-androgen agent. Ethinyl Estradiol serves as the synthetic estrogen component, stabilizing the menstrual cycle and enhancing the contraceptive effect.

What is the General Purpose of Visofid?

The general therapeutic purpose of Visofid is to provide highly effective contraception while simultaneously managing physiological states linked to excessive or sensitive responses to male hormones. The two active ingredients work together to ensure reliable pregnancy prevention by altering the reproductive cycle. Furthermore, the strong anti-androgenic action of the Cyproterone acetate component defines the drug's second key purpose: to create hormonal balance by neutralizing the effects of androgens in the body, which is essential to the drug's intended function. This dual mechanism is typically employed for women of reproductive age requiring reliable birth control.

Regulatory References

  1. NIH/NCBI Bookshelf: Oral Contraceptive Pills (including Cyproterone Acetate classification)
  2. WHO Model Lists of Essential Medicines
  3. EMA Referral for Cyproterone- and Ethinylestradiol-Containing Medicines

What side effects are possible with Visofid?

Possible side effects and safety information

The safety profile of Visofid (Cyproterone acetate/Ethinyl Estradiol) is comprehensively documented in official regulatory labeling, classifying potential adverse events by frequency and system involvement.

Serious Adverse Reactions and Vascular Risk

As a combined hormonal agent, the primary serious regulatory concern is the risk of thromboembolic events, which are listed as rare but include deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke. Official documents note that this risk is highest during the first year of use or upon restarting after an extended break. The occurrence of hepatic neoplasms (liver tumours) and Meningioma is also documented; the latter is associated with the long-term use and high cumulative doses of the Cyproterone acetate component.

Common and Uncommon Effects

Adverse reactions that occur more frequently are classified by System-Organ Class. Common effects, meaning they affect more than 1 in 100 but less than 1 in 10 people, include headache, nausea, abdominal pain, and depressed mood. Uncommon effects include vomiting, diarrhea, migraine, and rash. These effects primarily involve the nervous, gastrointestinal, and reproductive systems.

Safety Considerations and Constraints

The official safety framework includes specific constraints and population-based risk modifiers. Use is contraindicated in individuals with a high risk of thrombotic disease or severe hepatic impairment. Furthermore, the risk of serious cardiovascular events is officially heightened by factors like smoking and age over 35. The regulatory constraint prohibits the concomitant use of Visofid with any other hormonal contraceptive due to the resulting increased risk of thromboembolism.

Overdose and Emergency Response

Overdose and when to seek help

This section details the officially documented signs of overdose and the mandated emergency actions for Visofid (Cyproterone acetate / Ethinyl Estradiol), based strictly on governmental regulatory information.

Documented Clinical Manifestations

Acute overdose with this combined hormonal product is associated with specific, typically non-severe clinical signs. The primary manifestations recorded in official regulatory labeling include nausea and vomiting. A characteristic physiological sign related to the hormonal components is withdrawal bleeding, which presents as temporary vaginal bleeding following high exposure. Acute ingestion of large doses is officially classified as not likely to be life-threatening, and no reports of serious, deleterious effects have been noted in regulatory documents.

Feature Regulatory Description
Severity Classification Overdose is not expected to be life-threatening; no serious adverse effects have been reported.
Antidote Availability No specific antidotes are known for this fixed-dose combination of Cyproterone acetate and Ethinyl Estradiol.
Management Focus Treatment is restricted to symptomatic and supportive measures.

Required Emergency Actions

Immediate medical attention must be sought if an acute overdose is suspected or confirmed. Regulators mandate that the individual must contact a poison control center or local emergency services immediately for specialized guidance. Medical procedures following contact may include monitoring of vital signs and, in certain extreme cases of acute ingestion, the consideration of activated charcoal. Urgent medical intervention is required for assessment and supportive care, given the lack of a known antidote and the need to manage acute symptoms.

Therapeutic Uses of Visofid

Visofid is commonly applied in clinical settings that involve certain distressing symptoms related to hormone-driven conditions.

Addressing Severe Acne and Hirsutism

Visofid is commonly used for managing the symptom clusters of severe, persistent acne and moderately severe hirsutism (unwanted hair growth) in women. This approach is considered relevant in clinical scenarios where these skin and hair manifestations are primarily symptoms related to systemic imbalance (androgen sensitivity) and is commonly used in situations where symptoms have been difficult to manage with standard topical or systemic antibiotic therapies. The treatment plays a role in managing the burden of these visible symptoms, which may assist with improving skin appearance and supports general well-being.

The medication helps address symptom clusters that may become intense or disruptive, such as severe inflammatory acne lesions, excessive sebum production (seborrhea), and male-pattern hair growth.

“The medication provides supportive relief when symptoms interfere with routine activities and contributes to easing the overall symptom load.”

Providing Contraception and Cycle Management

Visofid is commonly used to provide reliable pregnancy prevention. It is frequently chosen when patients require this supportive birth control alongside systemic management for an underlying hormonal condition, such as Polycystic Ovary Syndrome (PCOS). In these contexts, the medication assists with maintaining functional stability by supporting the regulation of the rhythm of menstrual cycles, contributing to easing the overall symptom load and contributes to a sense of stability when symptoms are more noticeable.


Quick Fact: Relief for Androgen-Driven Symptoms


Eligibility and Restrictions for Use

Visofid (Cyproterone acetate/Ethinyl Estradiol) is restricted to women of reproductive age (post-menarche). Use is contraindicated for postmenopausal women and before the onset of menstruation. Regulatory documents define clear exclusions for specific high-risk populations.

Eligibility Status Excluded Populations (Selected Examples)
Contraindicated Current or history of venous or arterial thromboembolic events (blood clots, stroke, heart attack).
Known thrombogenic disorders (inherited clotting deficiencies).
Current or history of severe hepatic disease (if function is not normalized) or liver tumors.
Diagnosis or history of Meningioma, or a history of breast cancer.
Pregnancy or Lactation (breast-feeding).
Restricted Use Must not be used simultaneously with any other hormonal contraceptive.
Use requires discontinuation 4 to 6 weeks before major surgery or prolonged immobilization.

This medication must not be used in individuals with severe, uncontrolled diseases such as diabetes mellitus with vascular changes or migraine with focal neurological symptoms. The official labeling defines these rules to strictly limit use to populations for whom the risk profile is considered acceptable under monitored conditions.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Visofid (tretinoin capsules) is subject to several clinically significant drug interactions, primarily involving metabolism and the risk of specific adverse conditions. Due to the potential for severe outcomes, coadministration with several substance categories is explicitly restricted by regulatory bodies.


Restricted or Avoided Combinations

Certain combinations are strongly discouraged due to increased risk of toxicity or altered drug levels:

  • Vitamin A: Concomitant use with Vitamin A is to be avoided, as both are retinoid-related substances, which may lead to cumulative toxicity.
  • Products Known to Cause Intracranial Hypertension: Use with other medicines that can cause increased pressure within the skull (intracranial hypertension) should be avoided to prevent an increased risk of this serious condition.
  • Strong CYP3A Inhibitors: These products interfere with the metabolism of Visofid, which can lead to increased plasma concentrations of the drug and a higher risk of dose-related adverse effects. Coadministration should be avoided.
  • Strong CYP3A Inducers: These products can accelerate the breakdown of Visofid, leading to decreased plasma concentrations, which may reduce its efficacy. Coadministration should also be avoided.
  • Anti-fibrinolytic Agents: Concomitant use may result in an increased risk of thromboembolic events, such as blood clots.

Patients should ensure their healthcare provider is aware of all prescription and non-prescription medicines, supplements, and vitamins being taken to evaluate for potential interactions.

Mechanism of Action

Dual Action on Serotonin Signaling

Visofid affects the central nervous system through dual interaction with two components: it acts on the serotonin transporter protein (SERT) as an inhibitor and on the 5-HT1A receptor as a partial agonist. This Serotonin Partial Agonist and Reuptake Inhibitor (SPARI) mechanism blocks the reuptake of serotonin while also directly modulating 5-HT1A receptor activity, resulting in an elevated concentration of serotonin within the synaptic cleft.


Adaptation of Neural Circuits

The resulting enhanced and modulated serotonergic activity initiates gradual, time-dependent neuroplastic changes within specific neural circuits. This systematic modulation of signaling influences the flow of signals within the targeted pathways, resulting in changes to activity patterns over weeks of sustained interaction. These adaptive, downstream effects on neuronal function modify the overall characteristics of serotonergic system activity at a physiological level.

Dosage and Administration Information

Visofid is a combined hormonal medication prescribed for oral administration as a single coated tablet containing 2.0 mg of Cyproterone acetate and 35 micrograms of Ethinyl Estradiol. The medication is used following a 28-day cyclic regimen, which requires taking one tablet daily for 21 consecutive days, followed by a scheduled 7-day tablet-free interval. The administration protocol involves taking the tablet at about the same time every day to maintain a consistent dosing schedule.

The tablet is swallowed whole with some liquid, and tablets are taken in the order directed by the calendar blister packaging. In the event of a missed dose, the tablet is taken immediately if the delay is less than 12 hours of the usual time; otherwise, specific instructions apply. The concurrent use of this product with any other hormonal contraceptives (such as separate estrogen or progestogen medications) is avoided.

In the context of androgen-driven symptoms, the treatment protocol specifies an initial duration of at least three months before effects are typically assessed. The regimen is typically discontinued 3 to 4 cycles after symptoms have fully resolved. For post-partum patients, the administration rules specify that tablet-taking may commence 21 days after vaginal delivery, provided the patient is fully ambulant and free of puerperal complications.

Recent Clinical Evidence

Research Evidence Overview: What Studies Show About Visofid

This section summarizes the structure of clinical research available for Visofid (Cyproterone acetate/Ethinyl Estradiol), focusing on the types of studies conducted, the populations examined, and the measurements used by researchers, without offering any clinical advice or guidance.


Evidence for Management of Severe Acne and Seborrhea

Visofid was studied in research exploring symptoms of moderate to severe acne and excessive skin oil production, or seborrhea, in women of reproductive age. Research has primarily relied on short-term Randomized Controlled Trials (RCTs) to explore how skin symptoms change over time. Studies focused on outcomes related to skin appearance and managing oil production, using objective tools, such as clinical severity scores and lesion counts, to track changes.

Studies exploring short-term symptom changes typically lasted for a minimum of three to nine menstrual cycles. Trials also monitored certain physiological changes, and trials monitored measured shifts related to certain hormones like SHBG. Findings describe patterns observed in the studies but do not determine whether an individual will respond similarly.

A key area of uncertainty is the limited availability of extensive research on long-term effects; long-term effects are not extensively established, particularly concerning the maintenance of skin appearance or symptom recurrence after study follow-up is complete.


Evidence for Management of Moderately Severe Hirsutism (Excessive Hair Growth)

Visofid was evaluated in research for women experiencing moderately severe hirsutism. The evidence base includes intermediate-to-long-term Randomized Controlled Trials. Researchers monitored outcomes related to physical discomfort by using standardized objective scores, such as the Modified Ferriman-Gallwey Score (mFGS), to quantify hair growth. Studies focusing on this symptom required extended follow-up durations, typically ranging from six to twelve months or longer, to observe any measured shifts.


Evidence for Contraception and Cycle Regulation

Pharmacodynamic studies consistently reported findings related to the suppression of ovulation. Clinical trials tracked the incidence of pregnancy and outcomes related to the regularity of menstrual cycles. However, dedicated, isolated research on its contraceptive function is often placed within the larger evidence base for this class of medicine, rather than being specific to Visofid as an isolated finding.


Key Limitations and Areas for Future Research

Evidence quality varies across studies due to the use of different measurement scales for scoring both acne severity and hirsutism. Furthermore, data for certain groups remain insufficient, as comprehensive information for populations outside of reproductive-age women is limited, indicating that more research is needed to fully characterize the medicine's structure across all potential user groups.

Frequently Asked Questions (FAQ)

Common questions about Visofid (FAQ)

Q: What should I do if I miss a dose of Visofid?

A: If a tablet is missed by 12 hours or more, regulatory guidance suggests that the missed tablet should be skipped, and the usual dosing schedule should be continued at the normal time. The recommended procedure may involve taking two tablets on the same day to return to the correct schedule. Official instructions specify that additional non-hormonal barrier methods, such as condoms, may be needed until 7 consecutive days of active tablets have been taken.

Q: How does Visofid prevent pregnancy?

A: Visofid is a combined hormonal contraceptive that works primarily by suppressing the release of an egg from the ovary, a process called ovulation. Furthermore, the active ingredients alter the lining of the uterus and thicken the mucus in the cervix, which helps to hinder sperm passage and prevent the implantation of a fertilized egg.

Q: What is the primary serious risk associated with Visofid, and when is this risk highest?

A: The primary serious risk associated with combined hormonal agents is the formation of blood clots, known as venous thromboembolism (VTE). Official product information indicates that the excess risk of VTE is highest during the first year a person ever uses this specific combination, or when restarting it after having a break of four weeks or more.

Q: What kind of research has been done on Visofid for acne and excessive hair growth?

A: Studies and official product information indicate that Visofid has been shown to be effective in managing symptoms related to excess male hormones (hyperandrogenism), including severe acne and hirsutism (excessive hair growth). The clinical benefits of the medication are typically observed with continuous use over an extended period, which may be six months or longer.

Q: What does the pill look like (color, shape)?

A: According to the official product information, the active tablets are generally described as yellow, film-coated, and round. They are typically imprinted with specific identifying marks unique to the manufacturer and dosage.

Q: How should I restart Visofid if I am more than 21 days post-partum?

A: For women who do not have risk factors for blood clots, combined hormonal contraceptives may typically be initiated between 21 and 42 days postpartum. If the patient is beyond 42 days postpartum, regulatory guidelines state there are no general restrictions on the use of this medication based solely on the postpartum status.

Q: How quickly will the anti-androgenic effects of Visofid start to work?

A: Studies indicate that the anti-androgenic effects are gradual and not immediate. While treatment begins immediately, noticeable improvement in symptoms like acne and excessive hair growth may require several months of continuous use. Resulting changes are typically assessed after at least three months of treatment.

Q: Are there any warnings regarding sun exposure or light sensitivity with Visofid?

A: Official labeling states that this medication may cause chloasma, which appears as dark patches of skin, usually on the face. Regulatory documents suggest avoiding prolonged sun exposure, sunlamps, and tanning beds. The use of sunscreen and protective clothing is mentioned as a precaution to reduce this risk.

Q: What should I do if I am vomiting or have severe diarrhea after taking a tablet?

A: If vomiting or severe diarrhea occurs within 3 to 4 hours of taking an active tablet, the absorption of the medication may be compromised. Official guidance states that this situation is treated the same way as a missed dose. A new tablet is to be taken from a spare blister pack as soon as possible, with the next tablet taken at the regular scheduled time.

Q: Is there a risk of weight gain with Visofid?

A: According to official product labeling, weight changes (either gain or loss) have been reported as a common adverse reaction associated with the use of the combined hormonal components in this medication.

Q: How do I know when it is time to stop taking Visofid?

A: For the treatment of androgen-driven symptoms, official guidelines suggest that therapy is typically discontinued 3 to 4 menstrual cycles after the symptoms have fully resolved. If a patient wishes to stop taking the tablet for other reasons, it is often recommended to finish the current blister pack before discontinuing.

How should Visofid be stored and disposed of?

How to Store and Dispose of Visofid?

Storing and disposing of Visofid must follow the requirements defined by regulatory authorities to maintain drug stability and ensure safety.

Storage and Handling Requirement Official Instruction
Temperature Store at controlled room temperature, typically 20 C to 25 C (68 F to 77 F).
Protection Keep in the original container, protected from moisture. Do not freeze.
Safety Keep Visofid out of the reach of children.
Disposal Dispose of unused or expired medicine according to federal and local regulations. Utilize drug take-back programs when available. If not available, follow guidelines for safe at-home disposal, such as mixing with undesirable materials before placing in the trash.

These instructions define the authorized storage and disposal methods required for Visofid, ensuring the product's integrity before use and safe elimination when no longer needed.

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

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