Visofid

Italy
Brand name Visofid
Form tablets, film-coated
Active substance / Dosage
CYPROTERONE ACETATE
ETHINYLESTRADIOL
Prescription type Prescription only – non-repeatable
ATC code
G03HB01
Registration number 035368
Manufacturer FIDIA FARMACEUTICI S.P.A.

Table of Contents

Package leaflet: Information for the patient

VISOFID 2 mg + 0,035 mg film-coated tablets

Cyproterone acetate + ethinylestradiol
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

The use of VISOFID is restricted to cases where treatment of the androgen-dependent conditions described in the indications is required. Although due to its composition VISOFID also has a contraceptive effect, it must not be used for this purpose. Therefore, after complete resolution of the conditions for which the medicine was prescribed, continued use of VISOFID for contraceptive purposes alone is not recommended.
This patient information leaflet includes all information regarding combined oral contraceptives.
Patients being treated with VISOFID must not use other hormonal contraceptives, as this would expose the patient to excessive hormone doses without any need for effective contraceptive protection.

Contents of this leaflet

  1. What VISOFID is and what it is used for
  2. What you need to know before taking VISOFID
  3. How to take VISOFID
  4. Possible side effects
  5. How to store VISOFID
  6. Contents of the pack and other information

1. What VISOFID is and what it is used for

VISOFID is used for the treatment of skin disorders such as acne, excessively oily skin, and excessive hair growth in women of reproductive age. Due to its contraceptive properties, the medicine should only be prescribed if the physician considers treatment with a hormonal contraceptive (oral contraceptive pill) to be appropriate.
You should take VISOFID only if your skin condition has not improved with other acne treatments, including topical therapies and antibiotics.
Although VISOFID also has contraceptive effects, it must not be prescribed for this purpose; its use should be reserved solely for cases where treatment of the above-mentioned androgen-dependent disorders is necessary.
It is recommended that treatment be discontinued after three to four cycles following complete resolution of the conditions for which the medicine was prescribed, and that VISOFID not be continued solely for contraceptive purposes.
Further treatment cycles with VISOFID may be administered if the androgen-dependent pathological conditions should recur.

2. What you should know before taking VISOFID

General information
VISOFID contains the progestogen cyproterone acetate and the oestrogen ethinylestradiol, and is administered for twenty-one days in monthly cycles. Therefore, it is essentially similar to a combined oral contraceptive.
This patient information leaflet describes certain situations in which you must stop taking the medicine or in which its effectiveness may be reduced. In such situations, contraceptive protection is also lost; therefore, if you wish to avoid pregnancy, you must abstain from sexual intercourse or use additional non-hormonal contraceptive precautions such as condoms or other barrier methods.
Do not use rhythm or basal body temperature methods, which may be unreliable, since combined oestrogen-progestogen preparations such as VISOFID alter the normal variations in body temperature and cervical mucus that occur during the menstrual cycle.
Before starting or restarting VISOFID, a thorough medical examination is recommended.
In addition, periodic check-ups during treatment with this medicine are advisable. The frequency and type of examination will be determined by your doctor and will particularly include monitoring of blood pressure, breast and abdominal examination, gynaecological examination, Pap test, and appropriate blood tests.
Like all oral contraceptives, VISOFID does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
VISOFID is prescribed for personal use only and should not be shared among multiple individuals.

Do not use VISOFID
Inform your doctor before starting VISOFID if any of the following conditions apply to you.
In such cases, your doctor may prescribe a different treatment:

  • if you are using another hormonal contraceptive;
  • if you have (or have had in the past) a blood clot in a leg (thrombosis), in the lungs (pulmonary embolism), or in another part of the body;
  • if you have (or have had in the past) a disease that may indicate a future risk of heart attack (e.g. angina pectoris, causing severe chest pain) or a "mini-stroke" (transient ischaemic attack);
  • if you have (or have had in the past) a heart attack or stroke;
  • if you have a disease that may increase the risk of forming a blood clot in the arteries. This occurs in the following conditions:
    • diabetes with blood vessel involvement,
    • very high blood pressure,
    • very high levels of fats (lipids) in the blood (cholesterol or triglycerides);
  • if you have blood clotting disorders (e.g. Protein C deficiency);
  • if you have (or have had in the past) migraine with visual disturbances;
  • if you are allergic to cyproterone acetate, ethinylestradiol, or any of the other ingredients of this medicine (listed in section 6);
  • if you suffer from cardiovascular disorders: coronary heart disease, valvular heart disease, or rhythm disorders that may lead to thrombus formation;
  • if you suffer from sickle cell anaemia (an inherited red blood cell disorder);
  • if you have or have had jaundice (yellowing of the skin) or severe liver disease;
  • if you have or have had breast or genital organ cancer;
  • if you have or have had benign or malignant liver tumours;
  • if you have meningioma or have previously been diagnosed with meningioma (a generally benign tumour of the tissue layer between the brain and the skull);
  • if you have vaginal bleeding of unknown origin;
  • if you are or suspect you are pregnant;
  • if you are breastfeeding (see "Pregnancy and breastfeeding");
  • if you have suffered from herpes gestationis (an autoimmune skin disease affecting women during pregnancy or immediately after childbirth);
  • if you have experienced hearing loss due to otosclerosis during a previous pregnancy;
  • if you are a young woman with an unstable menstrual cycle;
  • if you have eye problems of vascular origin.

If any of these conditions occurs for the first time while using the medicine, stop taking it immediately and consult your doctor.
VISOFID must not be used in men.
Do not use VISOFID if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also section “Other medicines and VISOFID”).

Warnings and precautions
Talk to your doctor or pharmacist before using VISOFID.
The effectiveness of VISOFID may be reduced if you forget to take tablets, or if you experience vomiting and/or diarrhoea (see “How to use VISOFID”), or if you take other medicines at the same time (see “Other medicines and VISOFID”).

When to contact your doctor
Stop taking the tablets and contact your doctor immediately if you notice possible signs of a blood clot. Symptoms are described in section 2 “ Blood clots (thrombosis) ”.

Reasons requiring immediate discontinuation of treatment with VISOFID:

  1. new onset or worsening of migraines, or increased frequency of unusually severe headaches;
  2. sudden disturbances in vision or hearing, or other sensory disturbances;
  3. first symptoms of thrombophlebitis or thromboembolic symptoms (formation of blood clots in blood vessels) (e.g. unusual pain or swelling in the legs, sharp pain during breathing or unexplained cough). Feeling of chest pain and tightness;
  4. six weeks before a major surgical procedure (e.g. abdominal, orthopaedic), including surgery on the lower limbs and sclerotherapy of varicose veins, and throughout any period of immobilisation, such as after accidents or surgery. Treatment with VISOFID may be resumed two weeks after full recovery of ambulation. In case of emergency surgery, preventive antithrombotic treatment (e.g. subcutaneous administration of heparin) should be considered;
  5. onset of jaundice (yellowish discoloration of the skin, mucous membranes, and whites of the eyes), hepatitis, or generalized itching;
  6. increased frequency of epileptic seizures;
  7. significant increase in blood pressure;
  8. onset of severe depression;
  9. severe pain in the upper abdomen or liver enlargement;
  10. worsening of conditions known to deteriorate during use of oral contraceptives or during pregnancy;
  11. pregnancy is a reason for immediate discontinuation of treatment, as a slight increase in the risk of fetal malformations cannot be excluded.

If any of the following conditions apply, use of VISOFID may require close medical monitoring. You must inform your doctor if you have any of the following conditions before starting VISOFID:

  • smoking;
  • diabetes;
  • overweight;
  • hypertension (high blood pressure);
  • heart valve disorders or certain cardiac rhythm disorders;
  • superficial phlebitis (venous inflammation);
  • varicose veins;
  • history of thrombosis, heart attack, or stroke (even among close relatives);
  • migraine (one-sided headache);
  • depression;
  • epilepsy;
  • history of elevated cholesterol and triglyceride (fat) levels in the blood (even among close relatives);
  • breast lumps;
  • family history (even among close relatives) of breast cancer;
  • liver or gallbladder disease;
  • Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
  • systemic lupus erythematosus (SLE, a disease affecting the skin of the entire body);
  • haemolytic-uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
  • sickle cell anaemia (an inherited red blood cell disorder);
  • porphyria (a metabolic blood disorder);
  • chloasma (brownish-yellow skin patches, particularly on the face). In this case, avoid prolonged exposure to sunlight or ultraviolet rays;
  • fluid retention;
  • reduced folate levels;
  • history of herpes gestationis (an autoimmune skin disease affecting women during pregnancy or immediately after childbirth);
  • certain pathological conditions such as resistance to activated Protein C, hyperhomocysteinaemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant), which predispose to venous or arterial thrombosis;
  • Sydenham's chorea (a central nervous system disorder);
  • hearing loss due to otosclerosis;
  • hereditary angioedema. Contact your doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue or throat, and/or difficulty swallowing, or hives, together with breathing difficulties. Medicinal products containing oestrogens may induce or worsen symptoms of angioedema.

If any of the above conditions appears for the first time, recurs, or worsens during use of VISOFID, consult your doctor.
Do not take St. John’s wort (Hypericum perforatum) preparations, as the effectiveness of medicines containing oral contraceptives may be reduced (see “Other medicines and VISOFID”). The use of VISOFID may affect the results of certain blood tests. Inform the doctor who ordered the tests that you are taking this medicine.
VISOFID is also an oral contraceptive. Together with your doctor, you should consider all aspects related to the safe use of hormonal oral contraceptives.

Blood clots (thrombosis)
Taking VISOFID may slightly increase the risk of developing a blood clot (thrombosis). The likelihood of forming a blood clot is only slightly higher in women taking VISOFID compared to women who do not take VISOFID or any other oral contraceptive.
Thrombosis does not always resolve and may be fatal in 1–2% of cases.

Blood clots in a vein
A blood clot in a vein (venous thrombosis) may block the vein. This may occur in the veins of the legs, lungs (pulmonary embolism), or any other organ.
The use of a combined oral contraceptive increases the risk of developing a blood clot compared to women who do not use any combined oral contraceptive. The risk of developing a venous blood clot is highest during the first year of use. This risk is lower than the risk of developing a clot during pregnancy. In users of combined oral contraceptives, the risk of venous blood clots increases further:

  • with increasing age;
  • if you smoke.
    It is strongly recommended that you stop smoking if you use a hormonal contraceptive such as VISOFID, especially if you are over 35 years of age;
  • if a close relative had a blood clot in the legs, lungs, or elsewhere at a young age;
  • if you are overweight;
  • if you are undergoing surgery, need to remain bedridden due to an accident or illness, or have a leg in a cast.

In these cases, it is important to inform your doctor that you are using VISOFID so that treatment can be interrupted. Your doctor may advise you to stop using VISOFID several weeks before surgery or during periods of reduced mobility. Your doctor will also advise you when you can resume taking VISOFID once you are mobile again.

Blood clots in an artery
A clot in an artery can cause serious problems. For example, a clot in an artery of the heart can cause a heart attack, while in the brain it can cause a stroke.
The use of a combined oral contraceptive has been associated with an increased risk of arterial clots. The risk increases further:

  • with increasing age;
  • if you smoke.
    It is strongly recommended that you stop smoking if you use a hormonal contraceptive such as VISOFID, especially if you are over 35 years of age;
  • if you are overweight;
  • if you have high blood pressure;
  • if a close relative had a heart attack or stroke at a young age;
  • if you have high levels of fats (lipids) in the blood (cholesterol or triglycerides);
  • if you suffer from migraine;
  • if you have a heart condition (valvular heart disease, rhythm disorders).

Arterial thromboembolic events may be life-threatening or fatal.

Symptoms of blood clots
Stop taking the tablets and contact your doctor immediately if you notice possible signs of a blood clot, such as:

  • sudden, unexplained cough;
  • severe chest pain, possibly radiating to the left arm;
  • shortness of breath;
  • any unusual, severe, or persistent headache, or worsening of migraine;
  • partial or complete blindness, or double vision;
  • difficulty or inability to speak;
  • sudden changes in hearing, smell, or taste;
  • dizziness or fainting;
  • weakness or numbness in any part of the body;
  • severe abdominal pain;
  • severe pain or swelling in one leg.

After a blood clot forms, recovery is not always complete. Severe and permanent disabilities may rarely occur, and the clot may even be fatal. The risk of blood clots is increased immediately after childbirth; therefore, you should ask your doctor how long you should wait after delivery before starting VISOFID.

If you have a combination of risk factors or a more severe manifestation of a single risk factor, your potential risk of thrombosis may be greater than the simple cumulative risk of the individual factors.
VISOFID must not be prescribed if the benefit-risk assessment is unfavourable (see “Do not use VISOFID”).

Tumours
Breast cancer diagnoses are slightly more frequent in women using combined oral oestrogen-progestogen preparations compared to women of the same age who do not use them. The slight increase in breast cancer diagnoses gradually disappears within ten years after stopping treatment.
It is not known whether this difference is due to the combined oestrogen-progestogen preparation.
This increase may be due to earlier diagnosis (because women are examined more frequently), the biological effect of the combined oestrogen-progestogen preparation, or both. Breast cancers diagnosed in women using combined oral oestrogen-progestogen preparations tend to be less clinically advanced than those diagnosed in non-users.
Benign liver tumours have been reported rarely, and malignant liver tumours even more rarely, in women using combined oral oestrogen-progestogen preparations. These tumours may cause internal bleeding. Contact your doctor immediately if you experience severe abdominal pain. Such tumours may be life-threatening or fatal.
Cervical cancer has been reported to be more frequent in women using combined oral oestrogen-progestogen preparations for a long time. This may not be due to the combined oestrogen-progestogen preparation itself, but rather to sexual behaviour and other factors involved in tumour development.
An increased risk of a benign brain tumour (meningioma) has been reported with high doses (equal to or greater than 25 mg) of cyproterone acetate. If you have been diagnosed with meningioma, your doctor will discontinue treatment with all medicines containing cyproterone, including VISOFID, as a precautionary measure (see section “Do not use VISOFID”).

Psychiatric disorders
Some women using hormonal contraceptives, including VISOFID, have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or depressive symptoms, consult your doctor as soon as possible for further medical advice.

Regular check-ups
During use of VISOFID, your doctor will ask you to attend regular check-up visits.

Contact your doctor as soon as possible if:

  • you notice any change in your health status, particularly related to what is described in this leaflet (see also “Do not use VISOFID” and “Warnings and precautions”). Do not forget to mention family history);
  • you detect a breast lump;
  • you need to take other medicines (see also “Other medicines and VISOFID”);
  • you are immobilised or need to undergo surgery (consult your doctor at least four weeks in advance);
  • you experience heavy or unusual vaginal bleeding;
  • you missed tablets in the first week of use and had sexual intercourse within the seven days before the missed dose;
  • you do not have menstrual periods for two consecutive cycles or suspect pregnancy; do not start a new pack without your doctor’s approval.

Children and adolescents
VISOFID is indicated only after menarche (the onset of the first menstrual period).

Elderly women
VISOFID is not indicated after menopause (cessation of menstrual periods).

Women with impaired liver function
Do not use VISOFID in case of severe liver disease. See also section “Warnings and precautions”.

Women with impaired kidney function
Inform your doctor if you have kidney problems.

Other medicines and VISOFID
Always inform your doctor if you are taking medicines or herbal products. Inform any other doctor or dentist who prescribes you a medicine (or your pharmacist) that you are taking VISOFID. They will advise you whether you need additional contraceptive measures (e.g. condoms), and for how long, or whether the use of another medicine you may need should be adjusted.
Some medicines:

  • affect the levels of VISOFID in the blood and
  • may make it less effective in preventing pregnancy, or
  • may cause unexpected bleeding.
    These include medicines for the treatment of:
  • epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
  • tuberculosis (e.g. rifampicin)
  • HIV infection and hepatitis C virus (ritonavir, nevirapine, efavirenz, known as protease inhibitors and non-nucleoside reverse transcriptase inhibitors)
  • fungal infections (e.g. griseofulvin, ketoconazole)
  • arthritis, osteoarthritis (etoricoxib)
  • high blood pressure in the pulmonary arteries (bosentan)
  • St. John’s wort (herbal remedy)

VISOFID may affect the action of other medicines, for example:

  • medicines containing cyclosporine
  • the antiepileptic lamotrigine (this may lead to increased frequency of epileptic seizures)
  • theophylline (used to treat respiratory problems)
  • tizanidine (used to treat muscle pain and/or muscle cramps)

Do not use VISOFID if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, as this may cause increases in liver function blood test results (elevated liver enzyme ALT). Your doctor will prescribe another type of contraceptive before starting treatment with these medicines.
VISOFID may be resumed approximately 2 weeks after completing this treatment. See section “Do not use VISOFID”.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use VISOFID during confirmed or suspected pregnancy.
VISOFID is not recommended during breastfeeding.

Driving and using machines
No effects on the ability to drive or use machines have been observed.

VISOFID contains lactose and sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

VISOFID contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How to take VISOFID

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Due to its composition being similar to that of combined oral contraceptives, VISOFID inhibits ovulation and therefore prevents conception. Consequently, you should not use other hormonal contraceptives, as this would expose you to excessive hormone doses without any need for effective contraceptive treatment. For the same reason, if you wish to become pregnant, you must not take VISOFID.

VISOFID must be taken regularly, as irregular intake may lead to intermenstrual bleeding and loss of contraceptive effectiveness.

Take the tablets with some liquid every day at approximately the same time, following the order indicated on the packaging.

Starting the first pack
Begin taking VISOFID on the first day of your menstrual cycle, using the tablet marked with the corresponding day of the week; for example, a tablet marked "Friday" if your menstruation starts on Friday. Then follow the days in sequence, taking one tablet daily without chewing, at the same time each day, preferably in the evening, until all tablets are used. The pack contains 21 tablets.

Subsequent treatment cycles
After finishing the 21 tablets, stop taking the tablets for 7 days, during which withdrawal bleeding (menstruation) should begin. Resume treatment on the eighth day, even if bleeding continues. In this way, you will start the new pack on the same day of the week as the previous one.

Duration of use
Your doctor will tell you how long you should take VISOFID.
The duration of treatment depends on the severity of your condition; normally, treatment should continue for many months.

If symptoms recur weeks or months after stopping treatment, consult your doctor, who may recommend restarting treatment with VISOFID. When restarting VISOFID (after a pill-free interval of 4 weeks or more), you should consider an increased risk of venous thromboembolism (see also "Warnings and precautions").

Special situations

Switching from another oral contraceptive to VISOFID
Start taking VISOFID on the first day of menstruation following the last active tablet of the previous oral contraceptive, then follow the instructions above.

Taking VISOFID after childbirth or after an abortion
Normally, after childbirth or an abortion, VISOFID should only be prescribed after the completion of the first normal menstrual cycle.

However, if immediate and reliable contraceptive protection is medically required, treatment with VISOFID may be started within the twelfth day (but not earlier than the seventh day) after childbirth, or no later than the fifth day after an abortion.

When administering oral estrogen-progestogen combinations in the period immediately following childbirth or abortion, it is necessary to consider the increased risk of thromboembolic disease.

If you are breastfeeding and wish to take VISOFID, speak to your doctor first.

Absence of withdrawal bleeding (menstruation)
In rare cases, if withdrawal bleeding does not occur, pregnancy must be ruled out before continuing treatment with VISOFID. If pregnancy is confirmed, treatment must be immediately discontinued.

Management of irregular bleeding
Occasionally, light bleeding (spotting) or intermenstrual bleeding may occur, particularly during the first three months of use; this usually resolves spontaneously. Continue taking VISOFID even if irregular bleeding occurs. If bleeding persists or recurs, medical evaluation is advised to exclude organic causes and the possible need for curettage. This also applies to cases of light bleeding that recur at irregular intervals over several consecutive cycles or that occur for the first time after prolonged use of VISOFID.

In case of vomiting or diarrhoea
If vomiting or diarrhoea occurs within 3 to 4 hours after taking the tablet, the active ingredients may not be adequately absorbed. Continue your regular daily intake, but use additional contraceptive measures for the remainder of the cycle to prevent pregnancy, which would necessitate immediate discontinuation of treatment.

If you take more VISOFID than you should
There are no reports of serious adverse effects following the ingestion of multiple tablets at once. In such cases, nausea, vomiting, or vaginal bleeding may occur. Even girls who have not yet had their first menstruation may experience vaginal bleeding if they accidentally take this medicine.

In case of accidental ingestion or overdose of VISOFID, contact your doctor immediately or go to the nearest hospital.

If you forget to take VISOFID
If you forget to take a VISOFID tablet at the usual time, take it within the next twelve hours. If more than thirty-six hours have passed since the last tablet was taken, the contraceptive protection of VISOFID is no longer assured. In this case, discard the missed tablet and continue your regular daily intake, but use additional contraceptive precautions for the remainder of the cycle to avoid pregnancy, which would require immediate discontinuation of treatment.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you experience any side effect, especially if it is severe and persistent, or if you notice any change in your health status that you think may be due to VISOFID, please inform your doctor.
An increased risk of developing blood clots in the veins (venous thromboembolism, VTE) or blood clots in the arteries (arterial thromboembolism, ATE) exists in all women taking combined hormonal contraceptives. For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you should know before using VISOFID”.

The following is a list of side effects that have been reported with the use of VISOFID:

Common side effects: may affect up to 1 in 10 people

  • nausea, abdominal pain,
  • changes in body weight (weight gain)
  • headache
  • mood changes
  • breast pain

Uncommon side effects: may affect up to 1 in 100 people

  • vomiting, diarrhoea,
  • fluid retention
  • breast hypertrophy (breast enlargement, possibly causing breast tenderness)
  • skin reactions, urticaria
  • migraine (one-sided headache)
  • decreased sexual desire

Rare side effects: may affect up to 1 in 1,000 people

  • intolerance to contact lenses
  • hypersensitivity reactions (allergy)
  • changes in body weight (weight loss)
  • increased sexual desire
  • vaginal discharge
  • breast discharge
  • nodular erythema, erythema multiforme or polymorphous erythema
  • thromboembolism

Frequency not known

  • increase in blood pressure

Serious side effects
The following serious side effects associated with the use of oestrogen-progestogen combinations, and their related symptoms, are described in the section “Warnings and precautions” under “Blood clots (thrombosis)” and “Tumours”:

  • hypertension
  • hypertriglyceridaemia
  • diabetes
  • liver tumours (benign and malignant)
  • liver problems
  • chloasma
  • angioedema
  • jaundice and/or pruritus due to cholestasis, gallstone formation, porphyria, systemic lupus erythematosus, haemolytic-uraemic syndrome, Sydenham's chorea, herpes gestationis, hearing loss due to otosclerosis, Crohn's disease, ulcerative colitis, cervical cancer.

For further information, please read these sections and consult your doctor immediately.
If you suffer from hereditary angioedema, medicines containing certain female sex hormones (oestrogens) may induce or worsen angioedema symptoms (see section “Warnings and precautions”).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VISOFID

Keep this medicine out of the sight and reach of children.
Do not store above 25 °C.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”. The expiry date refers to the last day of that month.
The stated expiry date refers to the medicine kept in its original, undamaged packaging and stored correctly.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What VISOFID contains

  • The active substances are cyproterone acetate and ethinylestradiol. Each coated tablet contains: 2 mg of cyproterone acetate and 0.035 mg of ethinylestradiol.
  • The other components are Tablet core: lactose, microcrystalline cellulose, povidone, sodium croscarmellose, magnesium stearate. Tablet coating: Opadry white: hypromellose, titanium dioxide (E 171), polyethylene glycol 400, indigotine (E 132); Opadry Buff: hypromellose, titanium dioxide (E 171), polyethylene glycol 400, iron oxides (E 172); quinoline yellow (E 104); Opaglos 6000 white: shellac, yellow carnauba wax, white wax; sucrose.

Description of the appearance of VISOFID and package contents
VISOFID is available as coated tablets.
Each pack contains 21 round, biconvex, smooth-surfaced tablets, pale yellow in colour, packed in a thermoformed blister made of polyvinyl chloride film and an aluminium foil, sealed by heat sealing. A 21-day calendar is printed on the blister.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (PD)
Manufacturer
Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A
35031 Abano Terme (PD)