FEDRA 0.075 MG/0.02 MG Coated tablet

Зміст інструкції

1. Fedra 0.075 mg + 0.02 mg coated tablets
   1. Cos’è Fedra e a cosa serve
   2. Cosa deve sapere prima di prendere Fedra
   3. How to take Fedra
   4. How to store Fedra
   5. Contents of the pack and other information

Fedra 0.075 mg + 0.02 mg coated tablets

gestodene + ethinylestradiol

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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible methods of contraception, if 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;
• Pay attention and see 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 you take Fedra
• 3. How to take Fedra
• 4. Possible side effects
• 5. How to store Fedra
• 6. Contents of the pack and other information

1. Cos’è Fedra e a cosa serve

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

2. Cosa deve sapere prima di prendere Fedra

General notes
Before starting to take Fedra, read the information on blood clots in the paragraph
“Blood clots”. It is particularly important that you read the symptoms of a blood clot
(see paragraph “Blood clots”).
Before starting or restarting taking Fedra, it is advisable to have a thorough medical
examination. It is also advisable to have periodic check-ups, at least once a year,
during the use of the product. The frequency and type of visit will be established by the doctor and
will be aimed in particular at controlling blood pressure, a breast examination,
abdominal and general gynecological examination including a Pap test and related blood tests.

Like all contraceptive pills, Fedra does not protect against infection with HIV
(AIDS) or any other sexually transmitted disease.
Fedra is prescribed for personal use and should not be available to more people
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. The doctor will discuss
with you other methods of birth control that may be more suitable for your case.

• if you are allergic to the active ingredients gestodene and ethinylestradiol or to any of the other components of this medicine (listed in paragraph 6);
• if you have (or have ever had) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lung (pulmonary embolism, PE) or in other organs;
• if you know you have a disorder that affects blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies;
• if you are going to have surgery or if you will be bedridden for a long period (see paragraph “Blood clots”);
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or a transient ischemic attack (TIA - symptoms of a temporary stroke);
• if you have one of the following diseases, which may increase the risk of blood clots forming in the arteries:
• severe diabetes with damage to blood vessels,
• 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 cancer or cancer of the genital organs;
• if you have (or have ever had) benign or malignant liver tumor;
• if you have unexplained vaginal bleeding;
• if you are (or suspect you are) pregnant;
• if you have eye diseases of vascular origin;
• in combination with Ritonavir (antiviral medicine).

If any of these conditions appear for the first time during use of the product,
stop taking it immediately and consult your doctor. In the meantime, use non-hormonal
contraceptive methods. See also “General notes”.
Do not take Fedra if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir and dasabuvir (see also the paragraph “Other medicines and
Fedra”).

Warnings and precautions
When to be particularly careful with Fedra
When should you contact a doctor?
Contact a doctor urgently

• if you notice possible signs of a blood clot that may indicate you have a blood clot in the leg (deep vein thrombosis), a blood clot 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 side effects, go to the paragraph “How
to recognize a blood clot”.
the use of the product or in which the effectiveness of the product may be reduced.
In such situations, do not have sexual intercourse or use additional non-hormonal
contraceptive precautions such as a condom or other barrier method.
Do not use the rhythm and basal temperature methods, which may be unreliable, as
the pill alters the normal changes in temperature and cervical mucus that occur
during the menstrual cycle.

Precautions
In the presence of any of the conditions listed below, the use of a combined pill
may require close monitoring by the doctor. Tell your doctor about the presence of any of the
conditions below before starting to take Fedra. The doctor may recommend a completely
different method of contraception (non-hormonal).

Tell your doctor if any of the following applies to you.
If this condition appears or worsens while you are using Fedra, tell your doctor:
smoking;
diabetes;
overweight;
high blood pressure;
heart valve defects or some heart rhythm disorders;
superficial phlebitis (vein inflammation);
varicose veins;
history of thrombosis, heart attack or stroke (even in close relatives);
migraine (headache on one side);
depression;
epilepsy (see “Other medicines and Fedra”);
history of high levels of cholesterol and triglycerides (fats) in the blood (even in close
relatives);
lumps in the breast;
family history of breast cancer;
liver or gallbladder disease;
porphyria (a blood metabolic abnormality);
if you suffer from or have suffered from cloasma (skin patches with a brownish-yellow
pigmentation, especially on the face). In this case, avoid prolonged exposure to the sun or
ultraviolet rays;

if you have suffered from herpes gestationis(an autoimmune skin disease involving
women during pregnancy or in the immediate postpartum period);
some pathological conditions characterized by resistance to Activated Protein C,
hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency,
antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant), which
predispose to the onset of venous or arterial thrombosis;
Sydenham's chorea (a central nervous system disorder);
hearing loss from otosclerosis;
if you have hereditary angioedema, estrogen-containing products may induce or
worsen the symptoms of angioedema. If you notice symptoms of angioedema such as swelling
of the face, tongue and/or pharynx and/or difficulty swallowing or hives with difficulty
breathing, immediately inform your doctor.
if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
if you have systemic lupus erythematosus (SLE, a disease that affects the body's defense
system);
if you have hemolytic uremic syndrome (HUS, a blood clotting disorder that
causes kidney failure);
if you have sickle cell anemia (an inherited red blood cell disease);
if you have high levels of fats in the blood (hypertriglyceridemia) or a family history
positive for this condition. Hypertriglyceridemia has been associated with an increased risk
of developing pancreatitis (inflammation of the pancreas);
if you are going to have surgery or if you will be bedridden for a long period (see
paragraph “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 the veins under the skin (superficial thrombophlebitis);
if you have varicose veins.
If any of the above conditions appear for the first time, recur or worsen
during the use of the pill, consult your doctor.
Do not take preparations based on Hypericum perforatum at the same time as medicines
containing oral contraceptives, digoxin, theophylline, carbamazepine, phenobarbital, phenytoin due to the risk of a
decrease in plasma levels and a decrease in the therapeutic efficacy of oral contraceptives, digoxin, theophylline, carbamazepine, phenobarbital, phenytoin (see paragraph
“Other medicines and Fedra”).

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

BLOOD CLOTS
The use of a combined hormonal contraceptive like Fedra causes an increased risk of
developing a blood clot compared to not using it. In rare cases, a blood clot can
block blood vessels and cause serious problems.
Blood clots can develop

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

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

Healing from blood clots is not always complete. Rarely, serious long-term effects can occur, or, very rarely, such effects can 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
Contact a doctor immediately if you notice any of the following signs or symptoms.
Do you have any of these signs? What are you likely to suffer from?
Swelling in one leg or along a vein in the leg or
foot, especially if accompanied by:

• pain or tenderness in the leg that can only be felt when standing or walking;
• increased feeling of warmth in the affected leg;
• change in the color of the skin of the leg, such as paleness, redness or blueness. Deep vein thrombosis
• sudden shortness of breath or rapid breathing and Pulmonary embolism

unexplained;

• sudden cough with possible blood emission;
• severe chest pain that may increase when breathing deeply;
• severe dizziness or vertigo;
• rapid or irregular heartbeat;
• severe stomach pain. If you are not sure, inform the doctor as some of these symptoms such as cough or shortness of breath can be mistaken for a milder condition such as a respiratory infection (e.g. a “common cold”).

Symptoms that occur more frequently in one eye:

• sudden loss of vision or
• painless blurred vision that may progress to vision loss. Retinal vein thrombosis (blood clot in the eye)
• pain, discomfort, feeling of pressure or heaviness in the chest;
• feeling of tightness, indigestion or suffocation;

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

• The use of combined hormonal contraceptives has been linked to an increased risk of blood clots in the veins (venous thrombosis). However, these side effects are rare. In most cases, they occur in the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• Very rarely, the clot can 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 first use a combined hormonal contraceptive. The risk may also be
higher if you restart a combined hormonal contraceptive (the same
medicine or a different medicine) after a break of 4 or more weeks.
After the first year, the risk decreases but is still 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.

• Out of 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone or norgestimate, about 5-7 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive containing gestodene, such as Fedra, about 9-12 will develop a blood clot in a year.
• The risk of a blood clot forming depends on your medical history (see below “Factors that increase the risk of 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 some conditions increase it.
Your risk is higher:

• if you are strongly overweight (body mass index or BMI greater than 30 kg/m²);
• if a close relative has had a blood clot in a leg, lung or other organ at a young age (under about 50 years). In this case you may have an inherited blood clotting disorder;
• if you need to undergo surgery or if you need to be bedridden for a long period due to an injury or illness or if you have a leg in a cast. You may need to stop taking Fedra a few weeks before surgery or during the period when you are less mobile. 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 of age);
• if you have given birth less than a few weeks ago.

The risk of developing a blood clot increases when you have more than one of these conditions.
Air travel (duration >4 hours) can temporarily increase the risk of a blood clot forming, especially if you have some of the other risk factors listed.

It is important that you tell your doctor if any of these conditions apply to you, even if you are not sure. Your doctor may decide to stop you from taking Fedra.
If any of the conditions above change while you are using Fedra, for example if a close relative develops a thrombosis for no known reason or if you gain a lot of 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 can cause 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 can increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Fedra it is advisable
• to quit smoking. If you cannot quit smoking and you are over 35 years old, your doctor may advise you to use 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 about 50 years). In this case you may also be at high 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 (valve 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 conditions above change while you are using Fedra, for example if
you start smoking, if a close relative develops a thrombosis for no known reason or if you increase
a lot of weight, contact your doctor.

Cancers
Diagnoses of breast cancer are slightly more frequent in women who use the pill
compared to those of the same age who do not use it. The slight increase in the number of breast cancer diagnoses gradually disappears within 10 years of stopping
treatment. It is not known whether the difference is due to the pill.
This increase may be due to earlier diagnosis, as women are visited
more frequently, to the biological effect of the pill or to both factors. Breast cancer,
diagnosed in women who take the pill tends to be clinically less advanced
compared to that diagnosed in women who do not use it.

Rarely, benign liver tumors and even more rarely malignant liver tumors have been reported in women who take the pill. Such tumors can cause internal bleeding. Consult
your doctor immediately if you experience severe abdominal pain.
Cervical cancer has been reported to be more frequent in women who use
the pill for a long time. This may not be due to the pill, but to sexual behavior and
other factors called from time to time in the genesis of cancers in general.
The tumors mentioned above can be life-threatening or fatal.

When should you see a doctor
Seek urgent medical attention

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

For a description of the symptoms of these serious side effects, see the section “How
to recognize a blood clot”.

Periodic checks
While using the pill, your doctor will ask you to attend periodic check-up visits, in
generally every year.

Consult your doctor as soon as possible:
if you notice any change in your state of health, particularly in relation to what
particularly attention with Fedra”. Do not forget the references to close relatives);
if you feel a lump in your breast;
if you need to use other medicines (see also “Other medicines and Fedra”);

Stop taking the tablets and consult your doctor immediately if you notice possible signs
of thrombosis:
sudden onset cough;
severe chest pain that may radiate to the left arm;
sudden shortness of breath;
unusual, severe, prolonged headache or migraine;
partial or total loss of vision or double vision;
slurred speech or inability to speak;
sudden changes in hearing, smell and taste;
dizziness or fainting;
weakness or numbness of any part of the body;
severe abdominal pain;
severe pain or swelling of a leg.
The situations and symptoms above are illustrated and explained in more detail in other paragraphs of

Children and adolescents

The safety and efficacy of Fedrain children and adolescents under 18 years of age
have not been established. No data are available.
Patients with hepatic impairment (liver)
Do not take Fedraif you suffer from liver disease. See “Do not take Fedra” and “Warnings and
precautions”.
Patients with renal impairment (kidneys)

Fedrahas not been specifically studied in patients with reduced renal function.

Other medicines and Fedra
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines, including those available without a prescription.
Some medicines may influence the levels of Fedra in the blood and prevent effective
action of the pill. These include:

• primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate (used for the treatment of epilepsy),
• rifampicin (used for the treatment of tuberculosis) and rifabutin,
• protease inhibitors and non-nucleoside reverse transcriptase inhibitors, for example ritonavir and nevirapine (used for the treatment of infections such as HIV and hepatitis C),
• griseofulvin (used for the treatment of other infections),
• azole antifungals, such as itraconazole, voriconazole, fluconazole (used for the treatment of fungal infections)
• macrolide antibiotics such as clarithromycin, erythromycin (used for the treatment of bacterial infections)
• calcium channel blockers such as verapamil and diltiazem (used for the treatment of some heart conditions and high blood pressure)
• etoricoxib (arthritis, osteoarthritis)
• modafinil and flunarizine.
• Fedra may interfere with the mechanism of action of other medicines, for example
• medicines containing ciclosporin
• the anti-epileptic lamotrigine
• melatonin (a hormone)
• midazolam (sedative)
• theophylline (used to dilate the airways),
• tizanidine (used to dilate muscles).
• omeprazole Preparations containing Hypericum perforatumshould not be administered simultaneously with oral contraceptives, as this may result in a loss of contraceptive efficacy. Unwanted pregnancies and resumption of the menstrual cycle have been reported following the induction of enzymes responsible for drug metabolism by preparations containing Hypericum perforatum. The induction effect can persist for at least 2 weeks after discontinuation of treatment with products containing Hypericum perforatum(see “Fedra with food and drinks”). Always inform the doctor who prescribes the pill about the medicines you are already taking, and also inform all other doctors or dentists who prescribe you other medicines that you are

using Fedra, so that they can establish whether and for how long additional contraceptive methods are necessary.
The use of the pill may affect the results of some blood tests, but such changes are generally within the normal range. For this reason, it is advisable to inform the doctor who requested 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 and dasabuvir, as this may cause increases in the results of
the blood test for liver function (increased liver enzyme ALT). Your doctor will
prescribe you another type of contraceptive before starting treatment with these medicines.
Fedra can be resumed approximately 2 weeks after completion of this treatment. See the
section “Do not take Fedra”.

Fedra with food and drinks
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 a loss of contraceptive efficacy (see “Other medicines and Fedra”).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice 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 operating machinery
No effects on the ability to drive and operate machinery have been observed.

Fedra contains lactose monohydrate and sucrose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

3. How to take Fedra

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

Combined oral contraceptives, when taken correctly, have a failure rate of
1% per year. The failure rate increases when pills are forgotten or not taken correctly.

START OF THE FIRST PACK
No hormonal contraception in the previous month
Start taking Fedra on the first day of your cycle, i.e. the first day of your period,
taking the tablet marked with that day of the week. For example, if
your period starts on a Friday, take the pill marked with Friday. Then continue
in the order indicated by the arrows. You can also start between the second and fifth day of your cycle,
but in this case use an additional contraceptive method (barrier method) for the first seven
days of taking the tablets in the first cycle.

Switching from another combined pill, vaginal ring, or patch
You can start taking Fedra the day after the last pill of your previous contraceptive
(i.e. without observing any interval). If the pack of your previous contraceptive
also contains inactive pills, you can take Fedra the day after the last inactive pill

active(if in doubt, ask your doctor). You can also start later, but no later than
the day after the pill-free interval (or the day after the last inactive pill) of your previous contraceptive. If you have used a vaginal ring or a patch,
you should start taking Fedra preferably on the day the last ring or
patch of a cycle is removed, or at the latest, when the next application should be made.
If you follow these instructions, you do not need to use an additional contraceptive method.

Switching from a progestin-only pill (mini-pill)
You can stop taking the mini-pill any day and start taking Fedra the next day, at the same time. However, for the first seven days of taking the tablets, use
an additional contraceptive method (barrier method) when you have sexual intercourse.

Switching from an injectable contraceptive, implant, or progestin-releasing intrauterine system (IUS)
Start taking Fedra on the day you are due to have your next injection, or the day the
implant is removed. However, for the first seven days of taking the tablets, use a
additional contraceptive method (barrier method) when you have sexual intercourse.

After childbirth
The start of taking the pill after childbirth must be decided by your doctor. He/she
will decide whether to start treatment between the 21st and 28th day, or later. In
the latter case, it is advisable to use an additional barrier method for the first 7 days of
taking the tablets. However, if you have had sexual intercourse in the meantime, before
actually starting to take the pill, rule out pregnancy or wait for the first period to appear.
If you are breastfeeding and want to take Fedra, talk to your doctor first (see “Pregnancy and
breastfeeding”).

After a spontaneous or induced abortion
Follow your doctor’s instructions.

If you take more Fedra than you should
There are no reports of serious adverse effects in case of taking more tablets
at the same time. In such a case, nausea, vomiting or vaginal bleeding may occur.
Even girls who have not yet had their period, but who have accidentally taken
this medicine may experience such bleeding.
In case of accidental ingestion/intake of an excessive dose of Fedra, immediately inform
your doctor or go to the nearest hospital.

If you forget to take Fedra
If less than 12 hourshave passed since the usual time of taking, the reliability of the pill is
preserved. Take the forgotten tablet as soon as you remember and continue as usual.

Ifmore than 12 hourshave passed since the usual time of taking, the reliability of the pill
may be reduced. The more tablets you forget to take consecutively,
the greater the risk that the contraceptive effect is reduced. The risk of pregnancy is
particularly high if you forget pills at the beginning and end of the pack. Follow
the instructions below (see also the diagram below).

More than one tablet forgotten in a pack
Consult your doctor.

One tablet forgotten during the first week
Take the 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 have had sexual intercourse in the week before the omission, it is possible
that you have become pregnant. Inform your doctor immediately.

One tablet forgotten during the second week
Take the forgotten tablet as soon as you remember (even if this means taking two
tablets at the same time) and continue as usual. The reliability of the pill is
preserved. You do not need to take additional contraceptive precautions.

One tablet forgotten during the third week
You can choose one of the following alternatives, without the need for additional contraceptive
precautions.

• 1. Take the forgotten tablet as soon as you remember (even if this means taking two tablets simultaneously) and continue as usual. Start the new pack as soon as you have finished the current one, withoutan interval between the two packs. You may experience breakthrough bleeding or spotting during the use of this second pack. or
• 2. Stop taking the tablets of the pack in use, observe an interval of 7 days or less ( including the day the pill was forgotten) and continue with a new pack. If you choose this alternative, you can start the new pack on the same day of the week as you usually do. If you forget to take one or more tablets and your period does not occur during the first pill-free interval, it is possible that you have become pregnant. Consult your doctor before starting the new pack.

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


had intercourse in the week before the omission?

no


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

or

• interrupt the pack in use
• observe a pill-free interval (no more than 7 days including the one in which the pill was forgotten)
• continue with a new pack

In case of gastrointestinal disorders (e.g. vomiting and/or diarrhea)
If you experience vomiting or severe diarrhea within 3-4 hours of taking Fedra, it is possible that the
active ingredient has not been completely absorbed. It is as if the tablet had been
forgotten. Therefore, follow the instructions given for forgotten tablets.

Delayed menstruation: what you need to know
Even if not recommended, you can delay your period by continuing with a new
pack of Fedra without observing the 7-day interval. During the use of this second
pack, you may experience breakthrough bleeding or spotting. Continue with the next pack
after the usual 7-day interval.

Ask your doctor for advice before deciding to delay your period.
Change of the start day of menstruation: what you need to know
If you take the tablets according to the instructions, your period will start approximately on the same
day of the week. If you need to change that day, you can shorten ( never lengthen)the normal
break between two consecutive packs. For example, if your period usually starts on
Friday and you want it to start on Tuesday (3 days earlier), you will have to start the next pack
3 days earlier. If you make the break between two cycles too short (e.g. 3 days or
less), you may not have a period during that interval. In this case, you may
experience breakthrough bleeding or spotting during the next cycle of treatment.

Contact your doctor if you have doubts about how to proceed.
In case of unexpected bleeding
With all oral contraceptives, you may experience vaginal bleeding between periods in the first few months of taking them. Usually irregular bleeding disappears once
the body gets used to the pill (usually after about 3 cycles of taking). Consult your
doctor if this bleeding persists, becomes heavy or recurs at intervals.
In case of missed period
If you have taken all the tablets correctly, you have not experienced vomiting or taken
other medicines, it is very unlikely that you have become pregnant. Continue using
the medicine as usual.
If your period does not occur for two consecutive times, it is possible that you have
become pregnant. Consult your doctor immediately. Do not start the new pack
until your doctor has ruled out pregnancy.

If you stop taking Fedra
You can stop taking Fedra at any time. If you do not want to become pregnant, consult
your doctor about other methods of contraception.
If you want to stop taking Fedra because you want to become pregnant, talk to your doctor. In this
case, it is generally advisable to wait until your periods return to be
regular before trying to conceive.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone
experiences them.

If you experience any side effects, especially if they are serious or persistent, or if
any change occurs in your health that you think may be due to Fedra,
tell your doctor.
A greater risk of developing blood clots in the veins(venous thromboembolism (VTE)) or

blood clots in the arteries(arterial thromboembolism (ATE)) is present in all women who
take combined hormonal contraceptives. 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 related symptoms, are described in
the section “When to be particularly careful with Fedra”. For more information, read
these sections and consult your doctor immediately.

Other undesirable effects
The following undesirable effects have been reported in women using the pill:

• tension, pain and secretions of the breast;
• headache, migraine (unilateral headache);
• changes in sexual desire, depressed mood;
• intolerance to contact lenses;
• nausea, vomiting and feeling unwell;
• changes in vaginal secretions;
• skin (cutaneous) reactions;
• fluid retention;
• changes in body weight;
• hypersensitivity reactions;
• oligomenorrhea (increase in the time interval between one menstruation and the next), amenorrhea (absence of menstruation);
• 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 symptoms similar to those of a stroke, known as a transient ischemic attack (TIA),
• blood clots in the liver, stomach/intestine, kidneys or eye.

The possibility of developing a blood clot may be higher if you have any other condition that increases this risk (see paragraph 2 for more information on conditions that increase the risk of blood clots and the symptoms of a blood clot).
In women with hereditary angioedema (a rare hereditary disease characterized by the appearance of swelling [edema] of the skin, mucous membranes and internal organs), exogenous estrogens (hormone replacement therapy) may induce or worsen the symptoms of angioedema.
undesirable effects.

Reporting of undesirable effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through

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 which is stated on the packaging (blister,
outer package) after “Exp.” The expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C.
Store in the original packaging to protect the medicine from light.
Store all medicines correctly.
Do not use the product if you notice a change in colour or crumbling of the tablet, or in
the presence of any other visible sign of deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Fedra contains
The active ingredients are: gestodene and ethinylestradiol. Each coated tablet contains 0.075 mg of
gestodene and 0.02 mg of ethinylestradiol.
The other ingredients are: lactose monohydrate, corn starch, povidone 25, talc, magnesium
stearate, sucrose, povidone 90, macrogol 6.000, calcium carbonate, ethylene glycol monostearate (wax E).

Description of the appearance of Fedra and contents of the pack
Coated tablets for oral use.
The product is packaged in calendar blisters containing 21 coated tablets.

Marketing Authorisation Holder
Bayer S.p.A. - Viale Certosa, 130 - 20156 Milan (MI)

Manufacturer

• Bayer AG, Muellerstrasse 170-178, D-13353, Berlin (Germany)
• Delpharm Lille SAS, Parc d'Activités Roubaix-Est, 22 Rue de Toufflers, CS 50070, 59452 Lys- Lez-Lannoy, France