Midiana

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
Midiana (Aranka)
3 mg + 0,03 mg, coated tablets
Drospirenone + Ethinylestradiol
Midiana and Aranka are different trade names for the same medicinal product.
Important information about combined oral contraceptives

• When used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of venous and arterial blood clots, especially during the first year of use or after restarting following a break of 4 weeks or more.
• Be vigilant and consult your doctor if you suspect symptoms of blood clots (see section 2 "Blood clots").

Please read this leaflet carefully before using the medicine, as it contains important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Midiana is and what it is used for
2. What you need to know before taking 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 tablet used to prevent pregnancy.
• Each tablet contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.
• Contraceptive tablets containing two hormones are known as combined oral contraceptives.

2. Important information before using Midiana

General notes
Before starting treatment with Midiana, you should read the information regarding
blood clots (thrombosis) in section 2. It is particularly important to become familiar with the symptoms
of blood clots (see section 2 "Blood clots").
Before you can start using Midiana, your doctor will ask you several questions about
your health and that of your close relatives. Your doctor will also measure your blood pressure and, depending on
your individual case, may perform certain other examinations.
This leaflet describes several situations in which you should stop using Midiana
or when the effectiveness of Midiana may be reduced. In such situations, you should either
avoid sexual intercourse or use additional non-hormonal contraceptive methods,
such as condoms or other mechanical methods. Do not use fertility awareness-based methods or temperature methods. These methods may be unreliable because Midiana alters monthly changes in body temperature and cervical mucus.
Midiana, like other hormonal contraceptives, does not protect against infection with
HIV (AIDS) or other sexually transmitted diseases.

When not to use Midiana
Do not use Midiana 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 contraception would be more suitable.

• if you are allergic to drospirenone and ethinylestradiol or any of the other ingredients of this medicine (listed in section 6). This may cause itching, rash, or swelling.
• if you currently have (or have ever had) a blood clot in the blood vessels of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs.
• if you know you have blood clotting disorders—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies.
• if you require surgery or will be immobile for a prolonged period (see section "Blood clots").
• if you have had a heart attack or stroke.
• if you have (or have had in the past) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms).
• if you have any of the following conditions that may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage,
  • very high blood pressure,
  • very high levels of fats in the blood (cholesterol or triglycerides),
  • a condition called hyperhomocysteinemia.
• if you have (or have had in the past) a type of migraine called "migraine with aura".
• if you have (or have had in the past) liver disease and liver function abnormalities persist.
• if you have kidney function disorders (kidney failure).
• if you have (or have had in the past) liver tumours.
• if you have (or have had in the past) or are suspected of having breast cancer or genital organ cancer.
• if you have any unexplained vaginal bleeding.
• Midiana contains soya lecithin. If you are allergic to peanuts or soya, you should not take this medicine.

Do not use Midiana in patients with hepatitis C who are taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Midiana with other medicines").

Children and adolescents
Midiana is not indicated for use in patients who have not yet had their first menstrual period.

Warnings and precautions
Before starting treatment with Midiana, you should discuss this with your doctor or pharmacist.

When should you contact your doctor?
You should seek immediate medical advice if:

• you notice possible symptoms of blood clots, which may indicate you have a blood clot in your leg (deep vein thrombosis), in your lungs (pulmonary embolism), a heart attack, or a stroke (see section below "Blood clots (thrombosis)"). For a description of symptoms of these serious adverse reactions, see "How to recognize the occurrence of blood clots".

You should inform your doctor if you have any of the following conditions. In
certain situations, special caution is required when using Midiana or any other combined oral contraceptive. Regular medical check-ups may also be necessary. If you have any of the following conditions, inform your doctor before starting Midiana.
If any of these symptoms appear or worsen during treatment with Midiana, you should also inform your doctor.

If you have:

• symptoms of angioedema, such as swelling of the face, tongue, and (or) throat and (or) difficulty swallowing or hives potentially with breathing difficulties, seek immediate medical attention. Medicinal products containing estrogens may induce or worsen symptoms of hereditary or acquired angioedema;
• a close relative who has ever had breast cancer;
• liver or gallbladder disease;
• diabetes;
• depression or mood changes;
• epilepsy (see "Midiana with other medicines");
• a condition that first occurred during pregnancy or previous use of sex hormones (e.g. hearing loss, a blood disorder called porphyria, yellowing of the skin or eyes (jaundice), itching of the whole body, blistering skin rash during pregnancy (pemphigoid gestationis), a nervous system disorder with involuntary body movements (Sydenham's chorea));
• or if you have ever had skin pigmentation changes, especially on the face or neck, known as chloasma (melasma). In this case, avoid direct exposure to sunlight or ultraviolet radiation;
• Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• systemic lupus erythematosus (a disease affecting the body's natural defence system);
• hemolytic uremic syndrome (a blood clotting disorder causing kidney failure);
• sickle cell anemia (a hereditary disorder of red blood cells);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have a positive family history of this condition. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• if you have recently given birth, as you are at increased risk of blood clots. Consult your doctor to find out how soon after delivery you can start taking Midiana;
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins.

BLOOD CLOTS
Using combined hormonal contraceptives such as Midiana is associated with an increased risk of blood clots compared to not using such therapy. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

• in veins (referred to as "venous thrombosis" or "venous thromboembolic disease")
• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic disorders").

Recovery from a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots caused by using Midiana is low.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you experience any of the following symptoms.

Do you experience any of these symptoms? Why might
you be suffering?

• swelling of the leg or swelling along a vein in the leg or foot, especially if accompanied by:
  • pain or tenderness in the leg, which may occur only when standing or walking
  • increased warmth in the affected leg
  • change in skin colour of the leg, such as pallor, redness, or blueness

BLOOD CLOTS IN VEINS
What can happen if blood clots form in veins?

• The use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in veins (venous thrombosis). Although these adverse events are rare, they occur most frequently during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a blood clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of first-time use of combined hormonal contraceptives. The risk may also be higher when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher compared to not using combined hormonal contraceptives at all.
If a patient stops taking Midiana, the risk of developing blood clots returns to normal within a few weeks.

What factors influence the risk of developing blood clots in veins?
The risk depends on the individual's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive being used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Midiana is low.

• In the course of one year, approximately 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In the course of one year, approximately 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In the course of one year, approximately 9–12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Midiana, will develop blood clots.
• The risk of developing blood clots depends on the individual's medical history (see "Factors that increase the risk of developing blood clots" below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Midiana is small, but certain factors may increase this risk. The risk is higher:

• if the patient is overweight (body mass index (BMI) above 30 kg/m²);
• if a close relative of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years of age). In this case, the patient may have inherited clotting disorders;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to discontinue Midiana several weeks before surgery or immobilization. If the patient must stop taking Midiana, she should consult her doctor about when she can resume taking the medicine;
• with increasing age (especially over 35 years);
• if the patient has recently given birth (within the last few weeks).

The risk of developing blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots, particularly if the patient has another risk factor listed above.
It is important to inform the doctor if any of the listed factors apply to the patient, even if uncertain. The doctor may decide to discontinue Midiana.
The patient should inform the doctor if any of the above conditions change during treatment with Midiana, for example, if a close relative is diagnosed with thrombosis of unknown cause or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in the arteries?
As with venous blood clots, arterial clots may cause serious consequences such as heart attack or stroke.

Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with the use of Midiana is very small, but may increase:

• with age (above approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Midiana, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close relative has high levels of blood fats (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valve disorder, heart rhythm disorder known as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of blood clots may be further increased.
The patient should inform the doctor if any of the above conditions change during treatment with Midiana, for example, if she starts smoking, if a close relative is diagnosed with thrombosis of unknown cause, or if she gains significant weight.

Midiana and cancer
Breast cancer occurs slightly more frequently in women using combined oral contraceptives, but it is not known whether this is caused by their use. For example, it may be that more cancers are detected in women using combined oral contraceptives because they undergo more frequent medical examinations. The risk of breast cancer gradually decreases after stopping combined hormonal contraceptives. Women should regularly examine their breasts and contact their doctor if they detect any lump.
Benign liver tumors have been reported, rarely, in women using oral contraceptives, and malignant liver tumors even more rarely. If the patient experiences an unusual, severe abdominal pain, she should contact her doctor.

Psychiatric disorders
Some women using hormonal contraceptives, including Midiana, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, the patient should contact her doctor as soon as possible for further medical advice.

Breakthrough bleeding
During the first few months of using Midiana, unexpected bleeding (bleeding outside the 7-day tablet-free interval) may occur. If such bleeding persists for longer than a few months, or if it starts after several months, the patient should contact her doctor to investigate the cause.

What to do if withdrawal bleeding does not occur during the 7-day tablet-free interval
If all tablets have been taken correctly, without vomiting or severe diarrhea, and the patient has not taken any other medicines, the likelihood of pregnancy is very low.
If the expected withdrawal bleeding does not occur consecutively for two cycles, the patient may be pregnant. She should contact her doctor immediately. The patient should not start the next pack of Midiana until pregnancy has been ruled out.

Midiana and other medicines
The patient should inform her doctor or pharmacist about all medicines currently or recently taken, as well as any medicines she plans to take.
She should also inform other doctors or her dentist, who may prescribe other medicines, that she is using Midiana. The doctor will advise whether additional contraceptive methods (e.g., condoms) are needed and, if so, for how long.
Midiana must not be used in patients with hepatitis C who are taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these products may cause abnormal liver function test results (increased liver enzyme AlAT activity).
Before starting these medications, the doctor will prescribe another type of contraception.
Midiana may be restarted approximately 2 weeks after completion of the above-mentioned treatment. See section "When not to use Midiana."
Some medicines may affect the blood levels of Midiana and may reduce its effectiveness in preventing pregnancy or cause unexpected bleeding. These include medicines used to treat:

• epilepsy (e.g., barbiturates, carbamazepine, phenytoin, primidone, felbamate, oxcarbazepine, topiramate),
• tuberculosis (e.g., rifampicin),
• HIV infection and hepatitis C (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as nevirapine, ritonavir, efavirenz), or other infections (griseofulvin),
• high blood pressure in the lung blood vessels (bosentan),
• fungal infections (e.g., griseofulvin, ketoconazole),
• symptomatic treatment of osteoarthritis (etoricoxib),
• herbal products containing St John’s wort (Hypericum perforatum). If the patient wishes to use herbal products containing St John’s wort while taking Midiana, she should first consult her doctor.

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

• cyclosporine (a medicine used to prevent rejection of transplanted tissue after organ transplantation),
• antiepileptic medicines,
• lamotrigine (seizure frequency may increase),
• tizanidine (a medicine used to treat muscle spasticity),
• theophylline (a medicine used to treat asthma).

Before taking any medicine, consult a doctor or pharmacist.
Midiana with food and drink
Midiana may be taken with or without food, and if necessary, with a small amount of water.

Laboratory tests
If blood tests are required, the patient should inform the doctor or laboratory staff that she is taking oral contraceptives, as hormonal contraceptives may affect the results of certain tests.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Midiana must not be taken during pregnancy. If the patient becomes pregnant while taking Midiana, she must stop immediately and contact her doctor.
If the patient wishes to become pregnant, she may discontinue Midiana at any time (see also "Discontinuation of Midiana").

Before taking any medicine, consult a doctor or pharmacist.

Breastfeeding
Midiana is generally not recommended during breastfeeding. If the patient wishes to take oral contraceptives while breastfeeding, she should consult her doctor.

Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines
There is no data indicating an effect of Midiana on the ability to drive or operate machinery.

Midiana contains lactose and soya lecithin
Midiana contains 48.17 mg of monohydrate lactose. If the patient has intolerance to certain sugars, she should consult her doctor before taking this medicine.
Midiana contains 0.070 mg of soya lecithin. If the patient is allergic to soya or peanuts, she should not take this medicine.

3. How to take Midiana

This medicine should always be taken exactly as instructed by your doctor or pharmacist. In case of
doubt, consult your doctor or pharmacist.
Midiana tablets should be taken daily for 21 days.
Each blister pack of Midiana contains 21 tablets, each marked with a day of the week.

• Take one tablet at the same time each day.
• Start with the tablet marked with the appropriate day of the week.
• Follow the direction of the arrows on the blister. Take one tablet each day until all 21 tablets have been taken.
• Swallow the tablet whole, with water if needed. Do not chew the tablets.

Seven days without tablets
After taking all 21 tablets from the blister pack, there is a 7-day period during which no tablets are
taken. Therefore, if the last tablet from one pack was taken on Friday, the first tablet from the next
pack can be taken on Saturday of the following week.
Within a few days after taking the last tablet from the blister, a withdrawal bleed similar to a menstrual
period should occur. This bleeding may not have finished by the time it is time to start the next blister
pack.
There is no need to use additional contraceptive methods during these 7 days without tablets, provided
the patient has taken the tablets correctly and starts the next blister pack on time.
When to start the next blister pack
The next pack of Midiana tablets should be started after the 7-day break without tablets, even if
bleeding has not yet stopped. Always start a new blister pack on time.
During this 7-day break, when no tablets are taken, a withdrawal bleed should occur. Bleeding usually
starts on the 2nd or 3rd day after the last tablet of Midiana is taken. The next pack should be started
the day after the 7-day break, even if bleeding is still ongoing.
When to start the first blister pack

• If the patient has not used a hormonal contraceptive in the previous month: Start taking Midiana on the first day of the menstrual cycle (i.e., the first day of menstruation). If the patient starts taking Midiana on the first day of her period, immediate protection against pregnancy is provided. Alternatively, the tablet may be started on days 2–5 of the cycle, but in this case, an additional contraceptive method (e.g., condom) must be used for the first 7 days.

• Switching from another combined hormonal contraceptive, combined contraceptive vaginal system, or transdermal patch: Start taking Midiana the day after the last active tablet (the last tablet containing active substances) of the previous contraceptive, but no later than the day after the tablet-free interval of the previous contraceptive ends (or after the last inactive tablet of the previous contraceptive). When switching from a combined contraceptive vaginal system or transdermal patch, follow your doctor’s advice.

• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen):
  Switching can occur on any day from a progestogen-only pill (on the day of removal of an implant or intrauterine system, or on the day of the next scheduled injection). In such cases, an additional contraceptive method (e.g., condom) must always be used for the first 7 days of taking Midiana tablets.

• After miscarriage or abortion: After a miscarriage or abortion during the first three months of pregnancy, your doctor may advise starting Midiana immediately. This means contraceptive protection begins with the first tablet taken.

• After childbirth: Midiana can be started between 21 and 28 days after delivery. If treatment begins later than 28 days after delivery, a barrier method (e.g., condom) should be used for the first 7 days of taking Midiana. If the patient has had sexual intercourse after childbirth and before restarting Midiana, pregnancy should first be ruled out, or the patient should wait until the next menstrual bleed occurs.

• If the patient is breastfeeding and wishes to start taking Midiana after childbirth: Please read section “Breastfeeding”.

If the patient is unsure when to start taking the medicine, she should consult her doctor.
Taking more Midiana tablets than recommended
No severe harmful side effects have been observed after taking too many Midiana tablets.
Taking several tablets at once may cause symptoms such as nausea or vomiting, or vaginal bleeding. In young girls before the onset of the first menstrual period, accidental intake of this medicine may also cause vaginal bleeding.
If too many Midiana tablets have been taken or if a child has taken the medicine, consult a doctor or pharmacist.
Missed dose of Midiana

• If less than 12 hours have passed since the scheduled time of taking the tablet, contraceptive protection is not reduced. Take the missed tablet as soon as you remember, and take the next tablet at the usual time.
• If more than 12 hours have passed since the scheduled time of taking the tablet, contraceptive protection may be reduced. The greater the number of missed tablets, the higher the risk of pregnancy.

The risk of inadequate contraceptive protection is greatest when tablets are missed at the beginning or end of the blister pack. Therefore, follow the rules below (see also the chart below):

• More than one tablet missed from one pack: Contact 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 remaining tablets at the usual time and use additional protection, such as a condom, for the next 7 days. If the patient had sexual intercourse in the week before missing the tablet, she may be pregnant. In this case, contact 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 remaining tablets at the usual time. Contraceptive protection is not reduced and no additional protection is needed. However, if more than one tablet has been missed, use additional barrier contraceptive methods, such as condoms, for 7 days.
• One tablet missed in Week 3: Either of the two following options may be used:
  1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the remaining tablets at the usual time. Skip the 7-day tablet-free interval and start the next pack immediately after finishing the current one. Bleeding will most likely occur at the end of the second pack, but light spotting or menstrual-like bleeding may occur during the second pack.
  2. Alternatively, stop taking tablets and go directly into the tablet-free interval (note the day the tablet was missed so that the total number of days without tablets does not exceed 7 days). If the patient wishes to start the next pack on the day she usually starts, the tablet-free interval should be shorter than 7 days.

If either of the above recommendations is followed, contraceptive protection will be maintained.

• If the patient has missed any tablets from the pack and no bleeding occurs during the first week of the tablet-free interval, this may indicate that the patient is pregnant. In this case, contact your doctor before starting the next pack.

What to do if vomiting or severe diarrhoea occurs
If vomiting or severe diarrhoea occurs within 3–4 hours after taking a tablet, there is a risk that the active substances have not been completely absorbed. 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 it within 12 hours of the usual tablet-taking time. If this is not possible or if more than 12 hours have passed, follow the instructions under “Missed dose of Midiana”.
Delaying the withdrawal bleed: what you should know
Although not recommended, it is possible to delay the withdrawal bleed by skipping the 7-day tablet-free interval, immediately starting a new blister pack of Midiana, and taking all tablets from this pack. Spotting or menstrual-like bleeding may occur during the second pack. The next pack should be started after the usual 7-day tablet-free interval.
Before deciding to delay the withdrawal bleed, consult your doctor.
Changing the first day of the withdrawal bleed: what you should know
If the patient takes the tablets as directed, bleeding will start during the 7-day tablet-free interval. If the patient wishes to change this day, she may do so by shortening (but never lengthening—the maximum is 7 days!) the tablet-free interval. For example, if the 7-day tablet-free interval usually starts on Friday, and the patient wishes to change it to Tuesday (3 days earlier), she should start the new blister pack 3 days earlier than usual. Bleeding may not occur during this time, but spotting or menstrual-like bleeding may occur.
If the patient is unsure how to proceed, she should consult her doctor.
Stopping treatment with Midiana
Treatment with Midiana can be stopped at any time. If the patient does not wish to become pregnant, she should consult her doctor about other effective methods of birth control.
If the patient wishes to become pregnant, stop taking Midiana and wait for a menstrual period. This makes it easier to calculate the expected date of delivery.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone. If any adverse reactions occur, especially severe and persistent ones, or any changes in health which the user considers to be related to the use of Midiana, medical advice should be sought.

Serious adverse reactions

Seek immediate medical attention if the user experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria potentially accompanied by breathing difficulties (see also section "Warnings and precautions").

All women using combined hormonal contraceptives have an increased risk of venous blood clots (venous thromboembolic disorders) or arterial blood clots (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, refer to section 2, "Important information before taking Midiana".

Below is a list of adverse reactions associated with the use of drospirenone and ethinylestradiol.

Common adverse reactions (may occur in up to 1 in 10 users)

• Depressed mood,
• Headache, migraine,
• Nausea,
• Menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness, thick, white vaginal discharge, fungal vaginal infection.

Uncommon adverse reactions (may occur in up to 1 in 100 users):

• Changes in libido (sexual interest),
• High blood pressure, low blood pressure,
• Vomiting, diarrhoea,
• Acne, severe itching, skin rash, hair loss (alopecia),
• Breast enlargement, vaginal infection,
• Fluid retention, changes in body weight.

Rare adverse reactions (may occur in up to 1 in 1,000 users):

• Allergic reactions (hypersensitivity),
• Asthma,
• Hearing disorders,
• Skin disorders such as erythema nodosum (characterised by painful, red nodules on the skin) or erythema multiforme (characterised by circular red patches or sores),
• Breast discharge,
• Harmful blood clots in a vein or artery, for example:
• In the leg or foot (e.g. deep vein thrombosis),
• In the lungs (e.g. pulmonary embolism),
• Heart attack,
• Stroke, mini-stroke or transient ischaemic attack (TIA),
• Blood clots in the liver, stomach/intestines, kidneys or eye. The likelihood of developing blood clots may be higher if the user has any other risk factors (see section 2 for further information on factors increasing the risk of blood clots and symptoms of blood clots).

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Midiana

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Store below 30°C. Keep in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Midiana contains

• The active substances in this medicinal product are drospirenone and ethinylestradiol. One tablet contains 3 mg of drospirenone and 0.03 mg of ethinylestradiol.
• Other components of the medicine are:
  Tablet core: monohydrate lactose, pregelatinized corn starch, corn starch, povidone K 25, magnesium stearate.
  Tablet coating: polyvinyl alcohol, titanium dioxide (E171), talc (E 553b), macrogol 3350, soybean lecithin.

What the medicine looks like and contents of the pack
A round, biconvex, film-coated tablet, white or almost white, with the imprint
"G63" on one side.
Midiana 3 mg + 0.03 mg is packed in PVC/PVDC/Aluminium blisters, placed in a cardboard
box.
A cardboard sachet is included in the package, in which the blister should be stored.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Portugal, country of export:
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary

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

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
Poland
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Poland
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Poland

Number of Marketing Authorisation in Portugal, country of export: 5282124
Number of Parallel Import Authorisation: 9/19

Translation of the symbols for days of the week printed next to each tablet on the immediate packaging:
Seg – Monday
Ter – Tuesday
Qua – Wednesday
Qui – Thursday
Sex – Friday
Sab – Saturday
Dom – Sunday