Myfreesia

Patient Information Leaflet

Myfreesia 20 micrograms/100 micrograms film-coated tablets

ethinylestradiol and levonorgestrel
Equivalent medicine
Please read this entire leaflet carefully before taking this medicine, as 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, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible methods of contraception when used correctly.
• They slightly increase the risk of blood clots in veins and arteries, particularly during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
• Be vigilant and contact your doctor if you suspect symptoms of a blood clot (see section 2, "Blood clots").

Contents of this leaflet:

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

1. What Myfreesia is and what it is used for

Myfreesia is a contraceptive pill and is used to prevent pregnancy.
Each tablet contains a small amount of two different female hormones, levonorgestrel and
ethinylestradiol.
Contraceptive pills that contain two hormones are known as "combined" pills.

2. What you should know before taking Myfreesia

General information
Before starting to take Myfreesia, you must read the information about blood clots in section 2. It is particularly important to know the symptoms of blood clots – see section 2 “Blood clots”.
Before you can start taking Myfreesia, your doctor will ask you some questions about your health and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your personal situation, may require you to undergo further tests.
This patient leaflet describes certain conditions in which you must stop taking Myfreesia or in which the effectiveness of Myfreesia may be reduced. In such situations, you should either avoid sexual intercourse or use additional non-hormonal contraceptive precautions, such as condoms or other barrier methods. Do not use rhythm or temperature methods. These methods may be unreliable because Myfreesia alters the monthly variations in body temperature and cervical mucus.
Myfreesia, like other hormonal contraceptives, does not protect against HIV (AIDS) or other sexually transmitted infections.

When you should not take Myfreesia
Do not take Myfreesia if you have any of the conditions listed below. If you have any of the conditions listed below, inform your doctor. Your doctor will discuss with you which other method of birth control is most appropriate.
Do not take Myfreesia

• if you have (or have ever had) a blood clot in a blood vessel in your leg (deep vein thrombosis, DVT), in your lung (pulmonary embolism, PE), or in other organs.
• if you know you have a condition affecting blood clotting – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you need surgery or will remain bedridden for a long time (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 and may be an early sign of heart attack) or transient ischemic attack (TIA – symptoms of temporary stroke);
• if you have any of the following conditions that may increase your risk of an arterial blood clot:
  • severe diabetes with blood vessel damage;
  • very high blood pressure;
  • very high levels of fats in the blood (cholesterol or triglycerides);
  • a condition known as hyperhomocysteinemia;
  • if you smoke;
• existing or previous pancreatitis associated with severe hypertriglyceridemia;
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you have (or have ever had) liver disease and your liver function has not yet returned to normal;
• if you have (or have ever had) a liver tumour;
• if you have (or have ever had) or suspect you may have cancer of the breast or genital organs;
• if you have unexplained vaginal bleeding;
• if you are allergic to ethinylestradiol or levonorgestrel, or to any of the other ingredients of this medicine (listed in section 6). This may cause itching, rash, or swelling;
• if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Myfreesia”).

Warnings and precautions
When should you contact your doctor?
Seek immediate medical help if you experience any of the symptoms described below.

For a description of the symptoms of these serious side effects, read “How to recognize a blood clot”.
In certain situations, you should exercise particular caution when using Myfreesia or any other combined oral contraceptive, and your doctor may need to perform regular check-ups.
Inform your doctor if any of the following conditions develop or if you feel worse while taking Myfreesia:
Talk to your doctor or pharmacist before taking Myfreesia

• if any of your close relatives have or have ever had breast cancer;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you have depression;
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have haemolytic uraemic syndrome (HUS – a blood disorder causing kidney damage);
• if you have sickle cell anaemia (an inherited blood disorder affecting red blood cells);
• 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 due to have surgery or will remain bedridden for a long time (see section 2 “Blood clots”);
• if you have recently given birth, as you are at increased risk of blood clots. Ask your doctor how long after delivery you can start taking Myfreesia;
• if you have inflammation of the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you suffer from epilepsy (see “Other medicines and Myfreesia”);
• if you have systemic lupus erythematosus (SLE – a disorder affecting your immune system);
• if you have a condition that first occurred during pregnancy or during previous use of sex hormones (such as hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (herpes gestationis), a nerve disorder causing sudden involuntary movements of the body (Sydenham’s chorea));
• if you have or have ever had chloasma (skin discoloration, especially on the face or neck, also known as “melasma”). If so, avoid direct sunlight or ultraviolet rays while taking this medicine;
• if you notice symptoms of angioedema such as swelling of the face, tongue, and/or throat and/or difficulty swallowing, or hives with breathing difficulties, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Myfreesia increases your 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 (called “venous thrombosis”, “venous thromboembolism” or VTE);
• in arteries (called “arterial thrombosis” or “arterial thromboembolism” or ATE).

Recovery from a blood clot is not always complete. Rarely, it can cause long-term serious effects, and very rarely, it can be fatal.
It is important to remember that the overall risk of a harmful blood clot due to Myfreesia is low.
HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical attention if you notice any of the following signs or symptoms.

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 blood clots in a vein (venous thrombosis). However, this adverse effect is rare. It occurs more frequently 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 or other veins to the lung, it can cause a pulmonary embolism.
• Very rarely, a clot may form in a vein of another organ, such as the eye (retinal venous thrombosis).

When is the risk of developing a blood clot the highest?
The risk of developing a blood clot in a vein is highest during the first year of using a combined hormonal contraceptive. The risk may be higher if you restart taking a combined hormonal contraceptive (the same product 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 Myfreesia, the risk of blood clots returns to normal within a few weeks.

What is the risk of developing a blood clot?
The risk depends on your individual risk of venous thromboembolism (VTE) and on the type of combined hormonal contraceptive you are using.
The overall risk of a blood clot in the leg or lung (DVT or PE) with Myfreesia is very low.

• Among 10,000 women who do not use combined hormonal contraceptives and 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, such as Myfreesia, approximately 5–7 will develop a blood clot in one year.
• Your risk of having a blood clot will vary depending on your personal medical history (see “Factors that increase the risk of blood clots” below).

Factors that increase the risk of blood clot in a vein
The risk of blood clot with Myfreesia is low, but certain conditions increase this risk. Your risk is higher:

• if you are very overweight (body mass index or BMI above 30 kg/m²);
• if one of your close relatives has had a blood clot in the leg, lung, or other organs at a young age (e.g. before age 50). In this case, you may have an inherited blood clotting disorder;
• if you are going to have surgery, or if you will remain bedridden for a prolonged period due to illness or injury, or if you have a plaster cast on your leg. Use of Myfreesia may need to be stopped several weeks before surgery or during your period of reduced mobility. If you need to stop taking Myfreesia, ask your doctor when you can restart it.
• with increasing age (particularly from age 35 onwards);
• if you have recently given birth.

The risk of developing a blood clot increases if you have more than one of the above conditions.
Air travel (4 hours or more) can temporarily increase the risk of blood clot, particularly if you have one of the above risk factors.
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 treatment with Myfreesia.
If any of the above conditions change while you are using Myfreesia, for example, if a close relative has a thrombosis without apparent cause, or if you gain a lot of weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Similarly to a clot in a vein, a clot in an artery can cause serious problems. For example, a heart attack or stroke.

Factors that increase the risk of blood clot in an artery
It is important to note that the risk of heart attack or stroke with use of Myfreesia is very low, but may be increased by:

• increasing age (from age 35 onwards);
• if you smoke. When using a combined hormonal contraceptive such as Myfreesia, it is recommended that you stop smoking. If you are unable to stop smoking and 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 one of your close relatives had a heart attack or stroke at a young age (under 50 years). In this case, you may also have an increased risk of heart attack or stroke;
• if you or a family member have high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraines, especially headaches with aura;
• if you have heart problems (valve disease, rhythm disorder known as atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions, or if some of them are particularly severe, your risk of developing a blood clot increases further.
If any of the above conditions change while you are using Myfreesia, for example, if you start smoking, a family member has a thrombosis without apparent cause, or if you gain a lot of weight, inform your doctor.

Myfreesia and cancer
Breast cancer has been observed slightly more frequently in women using combined oral contraceptives, but it is not known whether this is caused by the treatment. It may be that more cancers are diagnosed in women taking combined pills because they visit their doctor more often. The occurrence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important to regularly check your breasts and inform your doctor if you notice any lumps.
Rarely, benign liver tumours and even more rarely malignant liver tumours have been reported in users of contraceptive pills. Inform your doctor if you experience unusual and severe abdominal pain.

Intermenstrual bleeding
During the first few months of taking Myfreesia, unexpected bleeding (bleeding outside the pill-free week) may occur. If such bleeding occurs for more than three months, or if it starts after several months, your doctor should investigate the cause.

What to do if you do not have a withdrawal bleed during the pill-free week
If you have taken all tablets correctly, have not vomited or had severe diarrhoea, and have not taken any other medicines, it is highly unlikely that you are pregnant.
If the expected withdrawal bleed does not occur for two consecutive cycles, you may be pregnant. Consult your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Psychiatric disorders
Some women using hormonal contraceptives, including Myfreesia, 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.

Other medicines and Myfreesia
Inform your doctor about any medicines or herbal products you are taking or have recently taken, or might take in the future. Also inform any doctor or dentist prescribing other medicines (or your pharmacist) that you are taking Myfreesia. They will advise you whether you need to take additional contraceptive precautions (e.g. condoms), and for how long, or whether the use of another medicine needs to be adjusted.
Do not use Myfreesia 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 increased results in certain liver function tests (elevated liver enzyme ALT).
Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
Myfreesia can be restarted approximately 2 weeks after completing this treatment. See section “Do not take Myfreesia”.

Some medicines:

• may affect blood levels of Myfreesia,
• may make it less effective in preventing pregnancy,
• may cause unexpected bleeding.

These include:

• medicines used to treat:
  • epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, felbamate, topiramate)
  • tuberculosis (e.g., rifampicin)
  • HIV and hepatitis C virus infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)
  • fungal infections (e.g., griseofulvin)
  • arthritis, osteoarthritis (etoricoxib)
  • high blood pressure in the blood vessels of the lungs (bosentan)
  • herbal products such as St. John’s wort (Hypericum perforatum)

Myfreesia may affect the effect of other medicines, such as:

• medicines containing ciclosporin
• the antiepileptic lamotrigine (this could increase the frequency of epileptic seizures)
• theophylline (used for breathing problems)
• tizanidine (used for muscle pain and/or cramps)

Myfreesia with food and drink
Myfreesia can be taken with or without food, with a little water if needed.

Laboratory tests
If you need to have a blood test, inform your doctor or laboratory staff that you are taking the pill, as hormonal contraceptives may affect the results of certain tests.

Pregnancy and breastfeeding
Pregnancy
You must not take Myfreesia if you are pregnant. If you become pregnant while taking Myfreesia, stop taking it immediately and consult your doctor. If you plan to become pregnant, you may stop taking Myfreesia at any time (see “If you stop taking Myfreesia”).

Breastfeeding
The use of Myfreesia is generally not recommended during breastfeeding. If you wish to take the pill while breastfeeding, you must consult your doctor.

Driving and using machines
There is no information available regarding the effects of Myfreesia on the ability to drive vehicles or operate machinery.

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

3. How to take Myfreesia

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Take one Myfreesia tablet every day, if necessary with a small amount of water. You may take
the tablets with or without food, but you must take the tablets every day at approximately the same time.
The pack contains 21 tablets. Next to each tablet, the day of the week on which it should be taken is printed.
For example, if you start on Wednesday, take a tablet marked “WED”. Follow the direction of the arrow on the
pack until all 21 tablets are taken.
Then stop taking the tablets for 7 days. During this 7-day tablet-free interval (also called the break or
interruption week), you should experience bleeding. This “withdrawal bleeding” usually starts on the second or
third day of the tablet-free week.
On the eighth day after taking the last Myfreesia tablet (i.e. after the 7-day tablet-free interval), you must
start the next pack, regardless of whether the bleeding has stopped or not. This means you will start each new
pack on the same day of the week, and withdrawal bleeding should occur on the same days each month.
If you use Myfreesia in this way, you are protected against pregnancy even during the 7 days when you are
not taking a tablet.

When can you start the first pack?

• If you have not used hormonal contraceptives in the past month Start taking Myfreesia on the first day of your cycle (i.e. the first day of your period). If you start taking Myfreesia on the first day of your period, you are immediately protected against pregnancy. You may also start between the second and fifth day of your cycle, but in this case you must use additional contraceptive precautions (e.g. a condom) for the first 7 days.
• Switching from a combined hormonal contraceptive, a combined vaginal contraceptive ring, or a contraceptive patch You should preferably start taking Myfreesia the day after the last active tablet of your previous contraceptive (i.e. the last tablet containing active ingredients), but no later than the day after the usual tablet-free interval of the previous contraceptive (or after the last inactive tablet of the previous pill). If switching from a combined vaginal contraceptive ring or contraceptive patch, follow your doctor’s instructions.
• Switching from a progestogen-only contraceptive (progestogen-only pills, injection, implant, or an intrauterine system releasing progesterone (IUD)) You may switch from progestogen-only pills on any day (from an implant or IUD on the day of its removal, from an injection on the day the next injection would have been given), but in all these cases you must use additional contraceptive precautions (e.g. a condom) during the first 7 days of tablet intake.
• After an abortion Follow your doctor’s advice.
• After childbirth You may start taking Myfreesia between the 21st and 28th day after childbirth. If you start after the 28th day, use a barrier method (e.g. a condom) during the first 7 days of taking Myfreesia. If you have had sexual intercourse after childbirth before starting (again) Myfreesia, make sure you are not pregnant or wait until your next period.
• If you are breastfeeding and want to start (or restart) taking Myfreesia after childbirth, read the section “Breast-feeding”.

Ask your doctor what to do if you are unsure about when to restart.

If you take more Myfreesia than you should
No serious harmful effects have been reported in relation to an overdose of Myfreesia.
If you take several tablets at the same time, you may experience symptoms such as nausea and vomiting.
Adolescents may experience vaginal bleeding.
If you have taken too many Myfreesia tablets or if a child has taken them, consult your doctor or pharmacist.

If you forget to take Myfreesia

• If the delay is less than 12 hours, contraceptive protection is not reduced. Take the missed tablet as soon as you remember, and then continue taking the following tablets at your usual time.
• If the delay is more than 12 hours, contraceptive protection may be reduced. The more tablets you miss, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is greater if you miss a tablet at the beginning or end of the pack. In this case, follow the rules below (see the chart):

• More than one tablet missed in this pack

Consult your doctor.

• One tablet missed in week 1

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the following tablets at your usual time and use additional precautions for the next 7 days, for example, a condom. If you had sexual intercourse in the week before you forgot the tablet, you may be pregnant. In this case, consult your doctor.

• One tablet missed in week 2

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the following tablets at your usual time. Contraceptive protection is not reduced and no additional precautions are needed.

• One tablet missed in week 3

You have two options:

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the following tablets at your usual time. Instead of observing the 7-day break, start the next pack immediately.

You will most likely have a period (withdrawal bleeding) at the end of the second pack, but you may also experience spotting or intermenstrual bleeding during the intake of the second pack.

2. You may also stop the current pack and go directly to the 7-day tablet-free interval ( note the day you missed the tablet ). If you wish to start a new pack on the day you usually start, make the tablet-free interval shorter than 7 days.

If you follow either of these two recommendations, you will remain protected against pregnancy.

• If you have missed any tablet in a pack and do not have bleeding during the tablet-free interval, you may be pregnant. Consult your doctor before starting the next pack.

The following diagram describes what to do if you forget to take one or more tablets:

What to do in case of vomiting or severe diarrhoea
If you vomit within 3–4 hours after taking a tablet or have severe diarrhoea, there is a risk that the active ingredients of the pill are not fully absorbed by your body. This situation is similar to missing a tablet. After an episode of vomiting or severe diarrhoea, take another tablet from a spare pack as soon as possible. If possible, take it within 12 hours or at your usual pill-taking time. If this is not possible or more than 12 hours have passed, follow the advice given in the section “If you forget to take Myfreesia”.

Delaying your period: what you need to know
Although not recommended, you may delay your period by continuing with a new pack of Myfreesia instead of observing the tablet-free interval, and finishing it. You may experience spotting or menstrual-like bleeding during the use of the second pack. After finishing the second pack, observe the usual 7-day tablet-free interval and start the next pack.
You must consult your doctor before deciding to delay your period.

Changing the first day of your period: what you need to know
If you take the tablets as instructed, your period will start during the tablet-free week. If you wish to change this day, reduce the number of tablet-free days ( but never increase it — 7 is the maximum! ). For example, if your tablet-free interval normally starts on Friday and you wish to change it to Tuesday (three days earlier), start a new pack three days earlier than usual. If you make the tablet-free interval too short (e.g. 3 days or fewer), you may not have bleeding during these days. You may then experience spotting or menstrual-like bleeding.
If you are unsure what to do, consult your doctor.

If you stop treatment with Myfreesia
You may stop taking Myfreesia at any time. If you do not wish to become pregnant, consult your doctor about other reliable contraceptive methods. If you wish to become pregnant, stop taking Myfreesia and wait for one menstrual cycle before trying to conceive. This will make it easier to calculate your expected due date.
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 everybody gets them.
If you experience any side effect, especially if it is severe and persistent, or if you notice any change in your health that you think may be due to Myfreesia, consult your doctor.
All women taking combined hormonal contraceptives have an increased risk of blood clots in veins (venous thromboembolism (VTE)) or blood clots in arteries (arterial thromboembolism (ATE)). For detailed information on the different risks associated with the use of combined hormonal contraceptives, see section 2 “What you need to know before taking Myfreesia”.
The following list includes side effects related to the use of Myfreesia.
Serious side effects:
Contact your doctor immediately if you notice 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 possible side effects:
Very common (may affect more than 1 in 10 people):

• headache (including migraine)
• bleeding or spotting between periods

Common (may affect up to 1 in 10 people):

• mood changes, including depression, changes in sex drive (libido)
• vaginal inflammation, including fungal infection (candida)
• nervousness, dizziness, vertigo
• abdominal pain (stomach ache)
• nausea, vomiting, abdominal pain
• fluid retention in tissues (oedema)
• acne
• breast pain, breast tenderness, nipple discharge, changes in vaginal discharge, changes in cervical discharge, painful or irregular periods, absence of periods
• weight gain or weight loss
• inflammation of the vagina, including fungal infections ( candidiasis )

Uncommon (may affect up to 1 in 100 people):

• increased or decreased appetite
• stomach cramps, flatulence, diarrhoea
• skin rash, yellow-brown spots on the skin (chloasma), increased hair growth which may be persistent, hair loss, hives (itching)
• breast enlargement
• increased blood pressure, changes in serum lipid levels, including hypertriglyceridaemia
• reduced ability to metabolize glucose (glucose intolerance)

Rare (may affect up to 1 in 1,000 people):

• yellowing of the skin or whites of the eyes due to obstruction of the bile duct (cholestatic jaundice)
• allergic reactions, including severe reactions with respiratory and circulatory symptoms, painful swelling of the skin and mucous membranes (angioedema)
• intolerance to contact lenses
• harmful blood clots in a vein or an artery, for example: in a leg or foot, or in the lung, or heart attack, or stroke, or mini-stroke, or transient symptoms similar to stroke known as transient ischaemic attack, or blood clots in the liver, stomach/intestine, kidneys or eye
• erythema nodosum (characterized by painful, reddish nodules of the skin), erythema multiforme (severe skin rash)
• decreased serum levels of folic acid (serum levels of folic acid may be reduced by the pill. In case of pregnancy soon after stopping the oral contraceptive, the reduced serum levels of folic acid may be medically relevant)

Very rare (may affect up to 1 in 10,000 people):

• liver cell cancer (with symptoms such as swollen abdomen, weight loss, impaired liver function detectable in blood tests, jaundice)

The likelihood of a blood clot may be increased if you have other conditions that increase this risk (for further information on conditions that increase the risk of a blood clot and symptoms of a blood clot, see section 2).
The following conditions have been associated with the use of combined oral contraceptives:
Not known (frequency cannot be estimated from the available data)

• Inflammation of the optic nerve (optic neuritis), thrombosis in blood vessels of the eye (retinal vascular thrombosis which may cause sudden blurring or loss of vision, either completely or partially in one eye)
• inflammation of the pancreas (pancreatitis) with elevated triglycerides visible in blood tests
• a condition where the large intestine becomes inflamed due to inadequate blood flow; symptoms include stomach pain, diarrhoea, fever and rectal bleeding (ischaemic colitis)
• liver damage (including inflammation of the liver (hepatitis) or liver dysfunction with symptoms such as severe abdominal pain or changes in liver function visible in blood tests)
• a specific type of blood disorder leading to kidney damage (haemolytic uraemic syndrome, with symptoms such as reduced urine output, blood in urine, low red blood cell count, nausea, vomiting, confusion and diarrhoea)
• worsening of a specific autoimmune disease (systemic lupus erythematosus)
• worsening of a metabolic disorder with interruption of haemoglobin production (porphyria)
• worsening of Sydenham's chorea (a nerve disorder causing sudden, involuntary movements of the body)
• inflammation of the colon or other parts of the intestine (with symptoms such as bloody diarrhoea, painful defecation, abdominal pain) (Crohn's disease, ulcerative colitis)
• worsening of varicose veins
• gallbladder disease, including gallstones
• blistering skin rash during pregnancy (herpes gestationis)
• hearing loss, which may also be hereditary (otosclerosis)
• worsening of depression

The oestrogens contained in the pill may trigger or worsen symptoms of angioedema in women who suffer from hereditary angioedema (a condition causing sudden swelling of the skin, mucous membranes, internal organs or brain) (see also section 2 “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. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Myfreesia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Do not use beyond:” or
“EXP:”.
Do not store above 25°C.
Do not dispose of any medicine 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 Myfreesia 20 micrograms/100 micrograms contains:
Active substances:
One film-coated tablet (a "pill") contains 0.02 mg of ethinylestradiol and 0.10 mg of levonorgestrel.
Other components:
Tablet core: lactose monohydrate (see section “Myfreesia contains lactose”), maize starch, gelatin, magnesium stearate.
Tablet coating: hypromellose, macrogol, titanium dioxide (E171).

Description of the appearance of Myfreesia 20 micrograms/100 micrograms and contents of the pack
Myfreesia 20 micrograms/100 micrograms tablets are film-coated, white to off-white, round, and convex.

Myfreesia 20 micrograms/100 micrograms is available in the following pack sizes:
Calendar pack with 1 x 21 film-coated tablets
Calendar pack with 3 x 21 film-coated tablets
Calendar pack with 6 x 21 film-coated tablets
Calendar pack with 13 x 21 film-coated tablets
100 x 21 film-coated tablets (hospital pack)

Not all pack sizes may be marketed.

Marketing Authorization Holder
Exeltis Italia S.r.l.
Via Lombardia, 2/A
20068 Peschiera Borromeo (MI)
Italy

Manufacturers
Pharbil Waltrop GmbH
Im Wirrigen 25
45731 Waltrop
Germany
McDermott Laboratories Ltd. T/A Gerard Laboratories, 35-36 Baldoyle Industrial Estate, Grange Road,
Dublin 13, Ireland