Fedra

Package leaflet: Information for the user

Fedra 0.075 mg + 0.02 mg coated tablets

gestodene + ethinylestradiol
Please read 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives (CHCs):

• They are among the most reliable reversible contraceptive methods when used correctly;
• They slightly increase the risk of blood clots forming in veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks;
• Be alert and contact your doctor if you think you have symptoms of a blood clot (see section “Blood clots”).

Contents of this leaflet:

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

1. What Fedra is and what it is used for

Fedra is a medicine that contains two different female hormones: gestodene (a progestogen) and
ethinylestradiol (an oestrogen), which belong to a group of medicines called oestrogen-progestogen combinations, fixed combinations.
This medicine is a combined hormonal contraceptive (COC) used to prevent pregnancy.

2. What you should know before taking Fedra

General information
Before starting to take Fedra, you must read the information about blood clots in the section
"Blood clots". It is particularly important that you read about the symptoms of a blood clot
(see section "Blood clots").
Before starting or restarting Fedra, a thorough medical examination is recommended. In addition, periodic check-up examinations should be carried out at least once a year while using this product. The frequency and type of examination will be determined by your doctor and will particularly include monitoring of blood pressure, breast and abdominal examination, general gynecological examination including a Pap test, and appropriate blood tests.

Like all contraceptive pills, Fedra does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
Fedra is prescribed for personal use only and should not be shared among multiple users simultaneously.
Do not take Fedra
Do not take Fedra if you have any of the conditions listed below.
If you have any of the conditions listed below, consult your doctor. Your doctor will discuss with you other methods of birth control that may be more suitable for your individual case.

• if you are allergic to the active substances gestodene and ethinylestradiol or to any of the other ingredients of this medicine (listed in section 6);
• if you have (or have ever had) a blood clot in a blood vessel of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;
• if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are scheduled for surgery or will be bedridden for a prolonged period (see section "Blood clots");
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain that may be an early sign of heart attack) or transient ischemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following conditions, which may increase the risk of arterial clots:
• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fats (cholesterol or triglycerides) in the blood,
• a condition known as hyperhomocysteinemia;
• if you have (or have ever had) a type of migraine called "migraine with aura";
• if you have (or have ever had) jaundice (yellowing of the skin) or severe liver disease;
• if you have (or have ever had) breast or genital organ cancer;
• if you have (or have ever had) benign or malignant liver tumour;
• if you have vaginal bleeding of unknown origin;
• if you are (or suspect you may be) pregnant;
• if you have vascular eye diseases;
• in combination with Ritonavir (an antiviral medicine).

If any of these conditions occurs for the first time while using the product,
stop taking it immediately and consult your doctor. In the meantime, use non-hormonal contraceptive methods. See also “General information”.
Do not use Fedra if you have hepatitis C and are taking medications containing
ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or
sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Fedra”).

Warnings and precautions
When to be especially careful with Fedra
When should you contact a doctor?
Seek urgent medical advice

• if you notice possible signs of a blood clot, which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack, or a stroke (see the following section "Blood clots").

For a description of the symptoms of these serious adverse effects, refer to the section “How to recognize a blood clot”.
This patient information leaflet describes certain situations in which you should stop taking the product or in which its effectiveness may be reduced. In such situations, you must avoid 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, as the pill alters the normal variations in body temperature and cervical mucus that occur during the menstrual cycle.
Precautions
If any of the following conditions apply, the use of a combined oral contraceptive may require close medical supervision. Inform your doctor if you have any of the conditions listed below before starting Fedra. Your doctor may recommend a completely different (non-hormonal) method of contraception.
Inform your doctor if any of the following conditions apply to you.
If any of these conditions develops or worsens while you are using Fedra, inform your doctor:
smoking;
diabetes;
overweight;
hypertension;
heart valve disorders or certain heart rhythm disorders;
superficial phlebitis (vein inflammation);
varicose veins;
personal or family history of thrombosis, heart attack, or stroke (even in close relatives);
migraine (one-sided headache);
depression;
epilepsy (see “Other medicines and Fedra”);
personal or family history of high cholesterol and triglycerides (fats) in the blood;
breast lumps;
family history of breast cancer;
liver or gallbladder disease;
porphyria (a metabolic blood disorder);
if you suffer or have suffered from chloasma (brownish-yellow patches on the skin, particularly on the face). In this case, avoid prolonged exposure to sunlight or ultraviolet radiation;

if you have suffered from herpes gestationis (an autoimmune skin condition affecting women during pregnancy or immediately after childbirth);
certain medical conditions associated with resistance to Activated Protein C, hyperhomocysteinemia, 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 disorder of the central nervous system);
hearing loss due to otosclerosis;
If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible breathing difficulties, inform your doctor immediately. Medicines containing estrogens may induce or worsen symptoms of hereditary or acquired angioedema;
if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
if you have systemic lupus erythematosus (SLE, a disease affecting the body's natural defense system);
if you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure);
if you have sickle cell anemia (an inherited red blood cell disorder);
if you have high levels of fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
if you are scheduled for surgery or will be bedridden for a prolonged period (see section “Blood clots”);
if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking Fedra;
if you have inflammation of veins under the skin (superficial thrombophlebitis);
if you have varicose veins.
If any of the above conditions appears for the first time, recurs, or worsens during use of the pill, consult your doctor.
Do not take preparations containing Hypericum perforatum (St. John's wort) concurrently with medicines containing oral contraceptives, digoxin, theophylline, carbamazepine, phenobarbital, or phenytoin due to the risk of decreased plasma levels and reduced therapeutic efficacy of oral contraceptives, digoxin, theophylline, carbamazepine, phenobarbital, and phenytoin (see section “Other medicines and Fedra”).
Psychiatric disorders
Some women using hormonal contraceptives, including Fedra, 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, contact your doctor as soon as possible for further medical advice.
BLOOD CLOTS
Using a combined hormonal contraceptive such as Fedra increases the risk of developing a blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop

• in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)

• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, such effects may be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with
Fedra is low.
HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical attention if you notice any of the following signs or symptoms.
Do you have one of these signs? What might you be suffering from?
Deep vein thrombosis
Swelling in one leg or along a vein in the leg or foot, especially if accompanied by:

• pain or tenderness in the leg, which may only be felt when standing or walking;
• increased warmth in the affected leg;
• change in skin color of the leg, such as paleness, redness, or bluish discoloration.

Pulmonary embolism

• sudden unexplained shortness of breath or rapid breathing;
• sudden cough without an obvious cause, possibly with coughing up of blood;
• sharp chest pain that may worsen when breathing deeply;
• severe dizziness or lightheadedness;
• rapid or irregular heartbeat;
• severe stomach pain.

If you are unsure, inform your doctor, as some of these
symptoms, such as cough or shortness of breath, may be mistaken for a milder condition such as a respiratory tract infection (e.g., a "common cold").
Symptoms occurring more frequently in one eye: Retinal vein thrombosis

• sudden loss of vision or (blood clot
• painless blurring of vision that may progress to loss of vision in the eye).

Heart attack

• pain, discomfort, pressure, or heaviness in the chest;
• crushing or fullness sensation in the chest, in one arm, or under the sternum;

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of developing blood clots in veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it can cause a pulmonary embolism.
• Very rarely, a clot may form in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year in which
you take a combined hormonal contraceptive for the first time. The risk may also be
higher if you restart taking a combined hormonal contraceptive (the same
medication or a different one) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not
using a combined hormonal contraceptive.

When you stop taking Fedra, the risk of developing a blood clot returns to
normal levels within a few weeks.
What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive
you are taking.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with
Fedra is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing gestodene, such as Fedra, about 9–12 will develop a blood clot in one year.
• The risk of developing a blood clot depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Fedra is low, but certain conditions can increase it. Your risk is higher:

• if you are very overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in a leg, lung, or another organ at a young age (under approximately 50 years). In this case, you might have an inherited blood clotting disorder;
• if you are due to undergo surgery or need to remain bedridden for a prolonged period due to injury, illness, or if you have a plaster cast on your leg. You may need to stop taking Fedra several weeks before surgery or during periods of reduced mobility. If you need to stop taking Fedra, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years);
• if you have given birth within the last few weeks.

The risk of developing a blood clot increases when you have more than one of these conditions.
Air travel (lasting >4 hours) may temporarily increase the risk of blood clot formation, particularly if you have other risk factors listed above.

It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to stop your use of Fedra.
If any of the above conditions change while you are using Fedra—for example, if a close relative develops thrombosis without a known cause or if you gain significant weight—contact your doctor.
BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems—for example, they may lead to a heart attack or stroke.
Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of Fedra is very low but may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Fedra, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also be at increased risk of heart attack or stroke;
• if you or a close relative have high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions or if one of them is particularly severe, the risk of developing a blood clot may be even higher.
If any of the above conditions change while you are using Fedra—for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.
Tumours
Breast cancer diagnoses are slightly more frequent in women using the pill compared to women of the same age who do not use it. The slight increase in breast cancer diagnoses gradually disappears within 10 years after stopping treatment. It is not known whether this difference is due to the pill.
This increase could be due to earlier diagnosis, as women are examined more frequently, to the biological effect of the pill, or to a combination of both factors. Breast cancer diagnosed in women taking the pill tends to be less clinically advanced than in women who do not use it.

Benign liver tumours have been reported rarely in women taking the pill, and malignant liver tumours even more rarely. Such tumours can cause internal bleeding. Consult your doctor immediately if you experience severe abdominal pain.
It has been reported that cervical cancer (cervix) is more frequent in women who use the pill for a long time. This may not be due to the pill itself, but rather to sexual behaviour and other factors implicated in the development of tumours in general.
The tumours mentioned above can be life-threatening or fatal.
When to contact a doctor
Seek urgent medical advice

• if you notice possible signs of a blood clot, which may indicate you have a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack, or a stroke (see the following section "Blood clot (thrombosis)").

For a description of symptoms of these serious side effects, refer to the section “How to recognize a blood clot”.
Regular check-ups
While using the pill, your doctor will ask you to attend periodic check-ups, usually once a year.
Consult your doctor as soon as possible :
if you notice any change in your health status, particularly related to what is reported in this patient information leaflet (see also “Do not take Fedra” and “When to be particularly careful with Fedra”. Do not forget references to close family members);
if you feel a lump in your breast;
if you need to take other medicines (see also “Other medicines and Fedra”);
if you are immobilized or need to undergo surgery (consult your doctor at least four weeks beforehand);
if you have unusually heavy vaginal bleeding;
if you missed taking tablets in the first week of use and had sexual intercourse in the seven days before the missed tablets;
if you do not have periods for two consecutive cycles or if you suspect pregnancy, do not start a new pack without your doctor’s approval.
Stop taking the tablets and consult your doctor immediately if you notice possible signs of thrombosis:
sudden onset of coughing;
severe chest pain that may radiate to the left arm;
sudden shortness of breath;
unusual, severe, or prolonged headache or migraine attack;
partial or complete loss of vision or double vision;
slurred speech 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.
The situations and symptoms listed above are described and explained in greater detail in other sections of this patient information leaflet.
Children and adolescents

The safety and efficacy of Fedra in children and adolescents under 18 years of age have not been established. No data are available.
Patients with hepatic impairment (liver)
Do not take Fedra if you suffer from liver disease. See “Do not take Fedra” and “Warnings and precautions”.
Patients with renal impairment (kidneys)
Fedra has not been specifically studied in patients with reduced kidney function.
Other medicines and Fedra
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Some medicines can affect the levels of Fedra in the blood and reduce the effectiveness of the pill. These include:

• primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate (used to treat epilepsy),
• rifampicin (used to treat tuberculosis) and rifabutin,
• protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir and nevirapine (used to treat infections such as HIV and hepatitis C),
• griseofulvin (used to treat other infections),
• azole antifungals, such as itraconazole, voriconazole, fluconazole (used to treat fungal infections),
• macrolide antibiotics, such as clarithromycin, erythromycin (used to treat bacterial infections),
• calcium channel blockers, such as verapamil and diltiazem (used to treat certain heart conditions and high blood pressure),
• etoricoxib (arthritis, osteoarthritis),
• modafinil and flunarizine.

Fedra may interfere with the action of other medicines, such as those containing cyclosporine or lamotrigine (antiepileptic), melatonin (a hormone), midazolam (a sedative), theophylline (used to dilate airways), tizanidine (used to relax muscles), or omeprazole.

Preparations containing Hypericum perforatum should not be taken at the same time as oral contraceptives, as contraceptive effectiveness may be lost. Unintended pregnancies and resumption of menstrual bleeding have been reported due to enzyme induction affecting drug metabolism caused by Hypericum perforatum preparations. The enzyme-inducing effect may persist for at least 2 weeks after stopping treatment with Hypericum perforatum-containing products (see “Fedra with food and drink”).
Always inform the doctor prescribing the pill about any medicines you are currently taking, and also inform any other doctors or dentists prescribing other medicines that you are

using Fedra, so they can determine whether and for how long additional contraceptive methods are needed.
The use of the pill may affect the results of certain blood tests, but these changes are generally within the normal range. Therefore, it is advisable to inform the doctor requesting the tests that you are taking the pill.
Do not take Fedra if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these products 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. Fedra can be resumed approximately 2 weeks after completing this treatment. See the section “Do not take Fedra”.
Fedra with food and drink
Fedra should not be taken with grapefruit juice.
During the use of oral contraceptives, do not take preparations containing St. John’s wort (Hypericum perforatum). Concurrent use may lead to loss of contraceptive effectiveness (see “Other medicines and Fedra”).
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Fedra if you are pregnant or suspect you are pregnant.
Fedra is not recommended during breastfeeding.
Driving and using machines
No effects on the ability to drive or use machines have been observed.
Fedra contains lactose monohydrate and sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Fedra

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The Fedra pack contains 21 tablets, each marked with the day of the week on which it should be taken. Take one tablet at approximately the same time every day, with a little water if necessary. Follow the direction of the arrows until all 21 tablets have been used. Do not take any tablets during the following 7 days, during which withdrawal bleeding (menstruation) should occur, usually starting 2–3 days after taking the last tablet of Fedra. Start the new pack on the eighth day, even if your menstrual bleeding has not yet stopped. By doing so, you will always start the new pack on the same day of the week, and withdrawal bleeding will occur approximately on the same days each month.

Combined oral contraceptives, when taken correctly, have a failure rate of 1% per year. The failure rate increases if tablets are missed or not taken correctly.
STARTING THE FIRST PACK
No hormonal contraception used in the previous month
Begin taking Fedra on the first day of your cycle, i.e., the first day of menstruation, taking the tablet marked with that day of the week. For example, if your period starts on Friday, take the tablet marked Friday. Then continue in the order indicated by the arrows. You may alternatively start between the second and fifth day of the cycle, but in this case use an additional contraceptive method (barrier method) for the first seven days of tablet intake in the first cycle.
Switching from another combined oral contraceptive, vaginal ring, or contraceptive patch
You may start taking Fedra the day after the last active tablet of your previous contraceptive (i.e., without any interval). If the previous pack contains inactive tablets, start Fedra the day after the last active tablet (in case of doubt, consult your doctor). You may also start later, but not later than the day after the pill-free interval (or the day after the last inactive tablet) of the previous contraceptive. If you have used a vaginal ring or patch, start taking Fedra preferably on the day of removal of the last ring or patch of a cycle, or at the latest, when the next application would have been due.
If you follow these instructions, no additional contraceptive method is needed.
Switching from a progestogen-only pill (mini-pill)
You may stop the mini-pill on any day and start taking Fedra the next day at the same time. However, during the first seven days of tablet intake, use an additional contraceptive method (barrier method) when having sexual intercourse.
Switching from a contraceptive injection, implant, or intrauterine system releasing progestogen (IUS)
Start taking Fedra on the day you are due for your next injection or on the day the implant is removed. However, during the first seven days of tablet intake, use an additional contraceptive method (barrier method) when having sexual intercourse.
After childbirth
The timing of starting the pill after childbirth should be determined by your doctor. He or she will decide whether to start treatment between days 21 and 28 postpartum, or later. In the latter case, an additional barrier method should be used during the first 7 days of tablet intake. However, if you have had sexual intercourse in the meantime, exclude pregnancy before starting the pill or wait for the onset of the first menstruation.
If you are breastfeeding and wish to take Fedra, speak to your doctor first (see “Pregnancy and breastfeeding”).
After spontaneous or induced abortion
Follow your doctor’s instructions.
If you take more Fedra than you should
There have been no reports of serious adverse effects from taking multiple tablets at once. In such cases, nausea, vomiting, or vaginal bleeding may occur. Even girls who have not yet had their first period but have accidentally taken this medicine may experience such bleeding.
In case of accidental ingestion/overdose of Fedra, contact your doctor immediately or go to the nearest hospital.

If you forget to take Fedra
If less than 12 hours have passed since your usual time of intake, the contraceptive reliability remains intact. Take the missed tablet as soon as you remember, and continue as usual.
If more than 12 hours have passed since your usual time of intake, contraceptive reliability may be reduced. The greater the number of consecutive missed tablets, the higher the risk of reduced contraceptive effect. The risk of pregnancy is particularly high if you miss tablets at the beginning or end of the pack. Follow the instructions below (see also the flowchart that follows).
More than one tablet missed in a pack
Consult your doctor.
One tablet missed during the first week
Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and continue as usual. Use additional contraceptive methods (barrier method) for the next 7 days.
If you had sexual intercourse in the week before the missed tablet, pregnancy may have occurred. Inform your doctor immediately.
One tablet missed during the second week
Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and continue as usual. Contraceptive reliability is maintained. No additional contraceptive precautions are necessary.
One tablet missed during the third week
You may choose one of the following alternatives, without needing additional contraceptive precautions.

1. Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and continue as usual. Start the new pack immediately after finishing the current one, without any interval between packs. Withdrawal bleeding may not occur until after the second pack is completed, but you may experience intermenstrual bleeding (spotting) during tablet intake. or
2. Stop taking tablets from the current pack, observe a pill-free interval of 7 days or less ( including the day the tablet was missed ), and then start a new pack. If you choose this option, you can start the new pack on the same day of the week as usual. If you miss one or more tablets and no withdrawal bleeding occurs during the first pill-free interval, pregnancy may have occurred. Consult your doctor before starting the new pack.

more than one consult your doctor
tablet
missed in a
cycle

yes


did you have intercourse in the week
before the missed tablet?

no


• take the missed tablet
• use additional contraceptive precautions for 7 days
• finish the pack only one tablet missed (more than second ▪ take the missed tablet 12 hours passed) week ▪ finish the pack
• take the missed tablet third ▪ finish the pack week ▪ do not observe the pill-free interval
• continue with the new pack

or

• stop the current pack
• observe a pill-free interval (no more than 7 days, including the day the tablet was missed)
• continue with a new pack

In case of gastrointestinal disturbances (e.g., vomiting and/or diarrhoea)
If you experience vomiting or severe diarrhoea within 3–4 hours of taking Fedra, the active ingredient may not have been completely absorbed. This is similar to missing a tablet. Therefore, follow the instructions for missed tablets.
Delaying menstruation: what you should know
Although not recommended, it is possible to delay menstruation by starting a new pack of Fedra without observing the 7-day interval. Breakthrough bleeding or spotting may occur during the second pack. Continue with the next pack after the usual 7-day interval.
Consult your doctor before deciding to delay menstruation.
Changing the day of menstruation onset: what you should know
If you take the tablets as instructed, your periods will start approximately on the same day of the week. If you wish to change this day, you may shorten ( never lengthen ) the usual 7-day interval between two consecutive packs. For example, if your periods usually start on Friday and you wish them to start on Tuesday (3 days earlier), you should start the next pack 3 days earlier. If the interval between two cycles is too short (e.g., 3 days or less), menstruation may not occur during that interval. In such a case, you may experience breakthrough bleeding or spotting during the next treatment cycle.
Consult your doctor if you have any doubts about how to proceed.
In case of unexpected bleeding
With all oral contraceptives, vaginal bleeding between periods may occur during the first few months of use. Irregular bleeding usually resolves once the body has adjusted to the pill (typically after about 3 cycles). Consult your doctor if such bleeding persists, becomes heavy, or recurs regularly.
If menstruation does not occur
If all tablets have been taken correctly, without vomiting or use of other medications, it is very unlikely that pregnancy has occurred. Continue using the medicine as usual.
If menstruation does not occur for two consecutive cycles, pregnancy may have occurred. Consult your doctor immediately. Do not start a new pack until your doctor has ruled out pregnancy.
If you stop taking Fedra
You may stop using Fedra at any time. If you do not wish to become pregnant, consult your doctor about other methods of contraception.
If you wish to stop using Fedra because you want to become pregnant, speak to your doctor. In general, it is advisable to wait until menstruation becomes regular again before trying to conceive.
If you have any doubts about using this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any side effect, especially if it is severe or persistent, or if you notice any change in your health that you think may be due to Fedra, inform your doctor.
All women taking combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section “When to be particularly careful with Fedra”.
Serious side effects
Serious adverse reactions associated with the use of the pill, and their symptoms, are described in the section “When to be particularly careful with Fedra”. For further information, read these sections and contact your doctor immediately.
Contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible breathing difficulties (see also section “Warnings and precautions”).
Other side effects
The following side effects have been reported in women using the pill:

• breast tenderness, pain, and discharge;
• headache, migraine (one-sided headache);
• changes in sexual desire, depressed mood;
• intolerance to contact lenses;
• nausea, vomiting, and feeling unwell;
• changes in vaginal discharge;
• skin reactions;
• fluid retention;
• changes in body weight;
• hypersensitivity reactions;
• oligomenorrhoea (increased interval between periods), amenorrhoea (absence of periods);
• intermenstrual bleeding;
• harmful blood clots in a vein or artery, for example:
• in a leg or foot (DVT),
• in a lung (PE),
• heart attack,
• stroke,
• mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA),
• blood clots in the liver, stomach/intestine, kidneys, or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).
Following the instructions in this leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may 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 Fedra

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging (blister, box) after "Exp.". The expiry date refers to the last day of that month.
Do not store above 25 °C.
Keep in the original packaging to protect the medicine from light.
Dispose of all medicines properly.
Do not use the product if you notice any change in colour or crumbling of the tablet, or if there are any other visible signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Fedra contains
The active substances are: gestodene and ethinylestradiol. Each coated tablet contains 0.075 mg of
gestodene and 0.02 mg of ethinylestradiol.
The other components are: lactose monohydrate, maize starch, povidone 25, talc, magnesium
stearate, sucrose, povidone 90, macrogol 6000, calcium carbonate, ethylene glycol ester of montanic acid (wax E).
Description of the appearance of Fedra and package contents
Coated tablets for oral use.
The product is packaged in calendar blisters containing 21 coated tablets.
Marketing Authorization Holder
Bayer S.p.A. - Viale Certosa, 130 - 20156 Milan (Italy)
Manufacturer
➢ Bayer AG, Muellerstrasse 170-178, D-13353, Berlin (Germany)