Midiana

Package leaflet: Information for the user

MIDIANA

3 mg/0.03 mg film-coated tablets
Drospirenone/ethinylestradiol
Equivalent medicinal product

Important things to know 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 forming in the 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 may have symptoms of a blood clot (see section 2 “Blood clots”).

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Midiana is and what it is used for

• Midiana is a contraceptive pill and is used to prevent pregnancy.
• Each tablet contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.
• Contraceptive pills that contain two hormones are called "combined" pills.

2. What you should know before taking Midiana

General information
Before starting Midiana, you must read the information about blood clots in section 2.
It is particularly important that you read about the symptoms of a blood clot (see section 2 "Blood clots").
Before you can start taking Midiana, your doctor will ask you some questions about your medical history and that of your close relatives. In addition, your doctor will measure your blood pressure and, depending on your specific case, may carry out other examinations.
This patient leaflet describes various situations in which you must stop taking Midiana, or in which the contraceptive reliability of Midiana may be reduced. In such situations, you must abstain from sexual intercourse, or use additional non-hormonal contraceptive precautions, for example, use a condom or another barrier method. Do not use rhythm or temperature-based methods. These methods may be unreliable because Midiana alters the monthly variations in body temperature and vaginal mucus.
Like other hormonal contraceptives, Midiana does not protect against HIV (AIDS) infection or other sexually transmitted diseases.

Do not take Midiana
Do not take Midiana 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 birth control methods that might be more suitable for your case.

• If you have (or have had) a blood clot in a vein 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 due to undergo surgery or will be bedridden for a long period (see section "Blood clots");
• if you have ever had a heart attack or stroke;
• if you have (or have had) angina pectoris (a condition causing severe chest pain that may be an early sign of heart attack) or transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following conditions, which could increase the risk of forming clots in the arteries:
• 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 hyperhomocysteinaemia;
• if you have (or have had) a type of migraine called "migraine with aura";
• if you have (or have had) a liver disease and your liver function has not yet returned to normal;
• if your kidneys do not work properly (renal failure);
• if you have (or have had) a liver tumour;
• if you have (or have had) cancer of the breast or genital organs, even if only suspected;
• if you have unexplained vaginal bleeding;
• if you are allergic to ethinylestradiol or drospirenone or to any of the other ingredients of this medicine (listed in section 6). This may cause itching, rash, or swelling.
• Midiana contains soya lecithin. If you are allergic to peanuts or soya, do not use this medicine.

Do not use Midiana 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 Midiana").

Children and adolescents
Midiana is not intended for use in female patients whose menstrual cycle has not yet begun.

Warnings and precautions
Talk to your doctor or pharmacist before taking Midiana.

When should you contact a doctor?
Contact a doctor urgently:

• if you notice signs of a possible 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 side effects, see section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you.
In some situations, you must be especially careful when using Midiana or any other combined oral contraceptive, and your doctor should examine you at regular intervals. If any of these conditions appear or worsen while you are using Midiana, inform your doctor.

• if you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with potential breathing difficulties, contact your doctor immediately. Products containing oestrogens may cause or worsen symptoms of hereditary or acquired angioedema;
• if you have a close relative who has ever had breast cancer;
• if you have a liver or gallbladder disease;
• if you have diabetes;
• if you suffer from depression or mood changes;
• if you have epilepsy (see section "Other medicines and Midiana");
• if you have had a condition for the first time during pregnancy or with previous use of sex hormones (e.g. hearing loss, a blood disorder called porphyria, yellowing of the skin or eyes (jaundice), generalised itching, blistering rash during pregnancy (herpes gestationis), a nerve disorder causing sudden involuntary movements (Sydenham’s chorea));
• if you have ever had chloasma (skin pigmentation, especially on the face or neck, known as "pregnancy mask"). If so, avoid sunlight or direct ultraviolet light;
• 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 defence system);
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited red blood cell disorder);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are due to undergo surgery or will be bedridden for a long period (see section 2 "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 Midiana;
• if you have inflammation of veins under the skin (superficial thrombophlebitis);
• if you have varicose veins.

BLOOD CLOTS
Using a combined hormonal contraceptive like Midiana 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, serious long-term effects may occur, or very rarely, these effects may be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with Midiana 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 suffering from?

• swelling in one leg or along a vein in the leg or foot, especially if accompanied by:
  Deep vein thrombosis

• pain or tenderness in the leg, felt only when standing or walking

• increased warmth in the affected leg

• change in skin colour of the leg, such as paleness, reddish or bluish discolouration.

• sudden and unexplained shortness of breath or rapid breathing;
  Pulmonary embolism

• sudden cough without an obvious cause, possibly with coughing up 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 an eye:
Retinal vein thrombosis
(blood clot in the eye)

• sudden loss of vision or

• painless blurring of vision that may progress to loss of vision.

• chest pain, discomfort, pressure, or heaviness;
  Heart attack

• squeezing or fullness sensation in the chest, arm, or under the breastbone;

• feeling of fullness, indigestion, or choking;

• discomfort in the upper body spreading to back, jaw, throat, arms, or stomach;

• sweating, nausea, vomiting, or dizziness;

• extreme weakness, anxiety, or shortness of breath;

• rapid or irregular heartbeat.

• sudden numbness or weakness of the face, arm, or leg, especially on one side of the body;
  Stroke

• sudden confusion, difficulty speaking or understanding;

• sudden difficulty seeing with one or both eyes;

• sudden difficulty walking, dizziness, loss of balance or coordination;

• sudden severe or prolonged headache with no known cause;

• loss of consciousness or fainting with or without seizures.

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 of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same or a different medicine) 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 Midiana, 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 (venous thromboembolism) 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 Midiana 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 drospirenone, such as Midiana, about 9–12 will develop a blood clot in one year.
• The likelihood 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 Midiana 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 may have an inherited blood clotting disorder.
• if you are due to undergo surgery or need to remain bedridden for a long time due to injury or illness, or if you have a plaster cast on your leg. You may need to stop taking Midiana several weeks before surgery or during periods of reduced mobility. If you need to stop taking Midiana, 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 if you have more than one of these conditions.
Air travel (lasting >4 hours) may temporarily increase the risk of blood clots, particularly if you have other listed 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 your use of Midiana.
If any of the above conditions change while you are using Midiana, for example if a close relative develops a 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?
As with blood clots in a vein, clots in an artery can cause serious problems, for example, they can 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 Midiana is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Midiana, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years of age, 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 have an increased risk of heart attack or stroke.
• if you or a close relative have high levels of fat 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 Midiana, 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.

Midiana and cancer
A slightly increased number of breast cancer cases has been observed in women using combined oral contraceptives, but it is not known whether this is due to the treatment. For example, breast tumors may be detected more frequently in women taking combined pills because they undergo medical check-ups more regularly. The risk of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important to perform regular breast examinations and contact your doctor if you notice any lumps.
In rare cases, benign liver tumors have been reported among users of combined oral contraceptives, and even more rarely, malignant liver tumors. Contact your doctor if you experience unusually severe abdominal pain.

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

Bleeding between periods
During the first few months of taking Midiana, you may experience unexpected bleeding (at times other than during the pill-free week).
If such bleeding occurs for more than a few months, or if it starts after several months of regular use, contact your doctor for appropriate evaluation.

What to do if you do not have bleeding during the seven-day pill-free interval
If you have taken all the pills correctly, have not vomited, have not had severe diarrhoea, and have not taken other medicines, it is very unlikely that you are pregnant.
If you do not have bleeding for two consecutive months, you may be pregnant. Contact your doctor immediately.
Start the next pack of pills only if you are certain you are not pregnant.

Other medicines and Midiana
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Also inform any other doctors or dentists who prescribe medicines for you (or your pharmacist) that you are using Midiana. They will advise you whether additional contraceptive precautions (e.g. a condom) are needed, for how long, or whether the use of another medicine you require should be adjusted.
Do not use Midiana if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or
sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause increases in liver function blood test results (elevated liver enzyme ALT).
Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
Midiana may be resumed approximately 2 weeks after completing this treatment. See section “Do not use Midiana”.
Some medicines may affect Midiana levels in the blood and may reduce its effectiveness in preventing pregnancy, or may cause unexpected bleeding. These include:

• medicines used to treat
  • epilepsy (e.g. barbiturates, carbamazepine, phenytoin, primidone, felbamate, oxcarbazepine, topiramate)
  • tuberculosis (e.g. rifampicin)
  • HIV and hepatitis C virus infections (so-called protease inhibitors or non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)
  • high blood pressure in the blood vessels of the lungs (bosentan)
  • fungal infections (e.g. griseofulvin, ketoconazole)
  • symptomatic treatment of osteoarthritis (etoricoxib)
• the herbal remedy St. John’s wort (Hypericum perforatum). If you wish to use herbal products containing St. John’s wort while using Midiana, you must first consult your doctor.

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

• cyclosporine (a medicine used to prevent tissue rejection after organ transplantation)
• the antiepileptic lamotrigine (this may lead to an increased frequency of seizures)
• tizanidine (a medicine used to treat muscle spasticity)
• theophylline (a medicine used to treat asthma).

Consult your doctor or pharmacist before taking any medicine.

Midiana with food and drinks
Midiana may be taken with or without food, and if necessary, with a small amount of water.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take Midiana if you are pregnant. If you become pregnant while taking Midiana, stop taking it immediately and contact your doctor. If you wish to become pregnant, you may stop taking Midiana at any time (see also "If you wish to stop taking Midiana").

Consult your doctor or pharmacist before taking any medicine.

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

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
There is no information suggesting that the use of Midiana affects the ability to drive or operate machinery.

Midiana contains lactose and soybean lecithin
Midiana contains 48.17 mg of monohydrated lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Midiana also contains 0.070 mg of soybean lecithin. If you are allergic to peanuts or soy, do not use this medicine.

3. How to take Midiana

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take one tablet of Midiana every day, if necessary with a small amount of water. You may take the tablets with or without food, but you must take them at approximately the same time each day.
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 one tablet marked “WED”. Follow the direction of the arrow on the pack until you have taken all 21 tablets.
Then, do not take any more tablets for 7 days. During these 7 days without tablets (also called the “tablet-free” or “interruption” week), you should experience a withdrawal bleed. This so-called “withdrawal bleeding” usually starts on the 2nd or 3rd day after starting the tablet-free week.
On the 8th day after taking the last Midiana tablet (i.e., after the 7-day interruption week), start the next pack, even if you are still bleeding. This means that each pack must be started on the same day of the week, and withdrawal bleeding should occur during the same days every month.
If you take Midiana as directed, you will be protected against pregnancy even during the 7 days when you do not take tablets.

When can you start the first pack?

• If you have not used a hormonal contraceptive in the previous month Start taking Midiana on the first day of your cycle (i.e., the first day of your menstrual period). If Midiana is started on the first day of your period, you will be immediately protected against pregnancy. It is also possible to start between the 2nd and 5th day of the 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, vaginal ring, or combined contraceptive patch You may start Midiana preferably the day after taking the last active tablet (i.e., the last tablet containing active ingredients) of your previous contraceptive, but no later than the day after the end of the tablet-free interval of your previous contraceptive (or after the last inactive tablet of your previous contraceptive). If switching from a vaginal ring or a combined transdermal patch, follow your doctor’s advice.

• Switching from a progestogen-only method (progestogen-only pill, progestogen-only injection or implant, or progestogen-releasing IUD)
  You may switch at any time from progestogen-only pills (in the case of an implant or IUD: on the day of removal; in the case of an injectable method: on the day scheduled for the next injection), but in all these cases, you must use additional contraceptive precautions (e.g., a condom) during the first 7 days of tablet intake.

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

• After childbirth You may start taking Midiana between 21 and 28 days after delivery. If you start later than 28 days after delivery, use a so-called barrier method (e.g., a condom) for the first 7 days of taking Midiana. If you have had sexual intercourse after delivery and before starting (or restarting) Midiana, you must first exclude the possibility of pregnancy, or wait until your next menstrual period.

• If you are breastfeeding and wish to start taking Midiana Read the section “Breast-feeding”.

If you have any doubts about when to start, consult your doctor.
If you take more Midiana than you should
No serious consequences have been reported following the ingestion of an excessive number of Midiana tablets.
If many tablets are taken at the same time, symptoms such as nausea or vomiting may occur, or vaginal bleeding may appear.
Even young girls who have not yet started menstruating but have accidentally taken the medicine may experience such bleeding.
If you have taken an excessive number of Midiana tablets, or if you find that a child has taken them, consult your doctor or pharmacist.

If you forget to take Midiana

• If a tablet is taken less than 12 hours late, contraceptive protection is not reduced. Take the missed tablet as soon as you remember and continue taking the following tablets at your usual time.
• If a tablet is taken more than 12 hours late, contraceptive effectiveness may be reduced. The greater the number of missed tablets, the higher the risk of pregnancy.

The risk of partial loss of contraceptive protection is greater if a tablet is missed at the beginning or end of a pack. Therefore, follow the rules below (see also the scheme below):

• If you miss more than one tablet in this pack Inform your doctor.

• If you miss a tablet during the first week Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets as usual and use additional precautions for the next 7 days—e.g., a condom. If you had sexual intercourse during the week before missing the tablet, pregnancy may have occurred. In this case, inform your doctor.

• If you miss a tablet during the second week Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets as usual. Contraceptive protection is not reduced, and no additional precautions are necessary. If you miss more than one tablet, use a so-called barrier method, e.g., a condom, for 7 days.

• If you miss a tablet during the third week 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 tablets as usual. Instead of having a 7-day tablet-free interval, start the next pack immediately after finishing the last tablet of the current pack.

You will most likely have a menstrual period at the end of the second pack, but light bleeding or spotting similar to menstruation may occur during the intake of the second pack.

2. You may also stop taking tablets from the current pack and go directly to the tablet-free interval (note the day on which you missed the tablet). If you wish to start a new pack on your usual day, you may shorten the tablet-free interval to less than 7 days.

By following either of these two recommendations, you will remain protected against pregnancy.
If one or more tablets from a pack have been missed and you do not have a withdrawal bleed during the first tablet-free interval, pregnancy may have occurred. Contact your doctor before starting the next pack.

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

Delaying your period: what you need to know
Although not recommended, it is possible to delay your period by skipping the 7-day tablet-free interval and immediately starting a new pack of Midiana, taking all the tablets in it. You may experience light bleeding or spotting during the use of the second pack. After the usual 7-day tablet-free interval, start the next pack.
It is advisable to consult your doctor before deciding to delay your period.

Changing the first day of your period: what you need to know
If tablets are taken as directed, your period will start during the 7-day tablet-free interval. If you wish to change this day, shorten the tablet-free interval—but never extend it: 7 days is the maximum. For example, if your 7-day tablet-free interval starts on Friday and you wish to change it to Tuesday (3 days earlier), start the new pack 3 days earlier than usual. If the tablet-free interval is very short (e.g., 3 days or less), you may not have any bleeding during this time. There is a possibility of light bleeding or spotting.
If you have any doubts about what to do, consult your doctor.

If you stop taking Midiana
You may stop taking Midiana at any time. If you wish to avoid pregnancy, ask your doctor for advice on other reliable contraceptive methods.
If you wish to become pregnant, stop taking Midiana and wait for a menstrual period before trying to conceive. This will make it easier to calculate the expected date of delivery.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think could be due to Midiana, inform your doctor.

Serious side effects
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 potential breathing difficulties (see also section “Warnings and precautions”).

An increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) exists in all women taking combined hormonal contraceptives. For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before taking Midiana”.

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

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

• menstrual disorders, bleeding between periods, breast tenderness, breast pain
• headache, depression
• migraine
• nausea
• thick, whitish vaginal discharge, vaginal yeast infection

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

• breast enlargement, changes in sex drive
• high blood pressure, low blood pressure
• vomiting, diarrhoea
• acne, rash, severe itching, hair loss (alopecia)
• vaginal infection
• fluid retention, weight changes

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

• allergic reactions (hypersensitivity), asthma
• breast discharge
• hearing impairment
• skin disorders known as nodular erythema (characterized by painful red skin nodules), or erythema multiforme (characterized by skin rash with redness or sores resembling a target)
• 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 stroke, 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).

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

5. How to store Midiana

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and outer carton after Exp.. The expiry date refers to the last day of that month.
Store below 30 °C. Keep in the original packaging to protect the medicine from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Midiana contains

• The active substances are 3 mg of drospirenone and 0.03 mg of ethinylestradiol in each tablet.
• The other components are: Tablet core: monohydrate lactose, pregelatinized corn starch, corn starch, povidone K-25, magnesium stearate. Film coating: polyvinyl alcohol, titanium dioxide (E171), talc (E553b), macrogol 3350, lecithin (soy).

Description of the appearance of Midiana and package contents
Film-coated tablet, white or almost white, round, biconvex. Markings imprinted on one side: “G63”, no markings on the other side.
Midiana 3 mg/0.03 mg film-coated tablets are packaged in PVC/PVDC/Al blisters with a calendar.
The blisters are individually placed in a carton; each carton contains a leaflet and a pouch for storage.
Pack sizes:
21 film-coated tablets
3x21 film-coated tablets
6x21 film-coated tablets
13x21 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Gedeon Richter Plc
Gyömrői út 19-21
1103 Budapest
Hungary

Manufacturer
Gedeon Richter Plc
Gyömrői út 19-21
1103 Budapest
Hungary

This medicinal product is authorized in the European Economic Area countries under the
following names:
Hungary: Seelar
Italy: Midiana