Midiana

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Midiana(Aranka)

3 mg + 0.03 mg, coated tablets

Drospirenonum + Ethinylestradiolum
Midiana and Aranka are different trade names for the same medicine.

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• To a small extent, they increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
• Caution should be exercised and a doctor should be consulted if the patient suspects that symptoms of blood clots have occurred (see section 2 "Blood clots").

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be passed on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Midiana and what is it used for
• 2. Important information before using Midiana
• 3. How to use Midiana
• 4. Possible side effects
• 5. How to store Midiana
• 6. Contents of the package and other information

1. What is Midiana and what is it used for

• Midiana is a contraceptive pill 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 contraceptive pills.

2. Important information before using Midiana

General notes

Before starting to take Midiana, you should read the information about blood clots (thrombosis) in section 2. It is especially important to read about the symptoms of blood clots (see section 2 "Blood clots").
Before you can start using Midiana, your doctor will ask you a few questions about your health and the health of your close relatives. Your doctor will also measure your blood pressure and, depending on the individual case, may also perform some other tests.
This leaflet describes several situations in which you should stop using Midiana or in which the effectiveness of Midiana may be reduced. In such situations, you should either not have sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. You should not use the observation method or the temperature measurement method. These methods may be unreliable because Midiana modifies the monthly changes in body temperature and cervical mucus.

Midiana, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

When not to use Midiana

You should not use Midiana if you have any of the conditions listed below. If you have any of the conditions listed below, you should inform your doctor. Your doctor will discuss with you which other contraceptive method will be more suitable for you.

• 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), lungs (pulmonary embolism), or other organs.
• if you know that you have blood clotting disorders - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• if you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots").
• if you have had a heart attack or stroke.
• if you have (or have had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (transient stroke symptoms).
• if you have any of the following diseases, which may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fats in the blood (cholesterol or triglycerides),
• a disease 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 disorders still persist.
• if you have kidney function disorders (kidney failure).
• if you have (or have had in the past) liver tumors.
• if you have (or have had in the past) or suspect breast cancer or genital cancer.
• if you have any unexplained vaginal bleeding.
• Midiana contains soy lecithin. If you are allergic to peanuts or soy, you should not take this medicine.

You should not use Midiana in patients with hepatitis C and taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Midiana and 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 to use Midiana, you should discuss it with your doctor or pharmacist.
When should you contact your doctor?
You should contact your doctor immediately

• if you notice any symptoms of blood clots, which may indicate that you have blood clots in your leg (deep vein thrombosis), blood clots in your lungs (pulmonary embolism), a heart attack, or a stroke (see below "Blood clots (thrombosis)"). To get a description of these serious side effects, see "How to recognize blood clots".

You should tell your doctor if you have any of the following conditions.In certain situations, you should be particularly careful when using Midiana or any other combined contraceptive pill. You may also need to be regularly examined by your doctor. If any of the following conditions occur, you should inform your doctor before starting to use Midiana.
If these symptoms occur or worsen while using Midiana, you should also tell your doctor.
If you have:

• 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, you should contact your doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary and acquired angioedema;
• a close relative who has ever had breast cancer;
• liver or gallbladder disease;
• diabetes;
• depression or mood changes;
• epilepsy (see "Midiana and other medicines");
• a disease that first appeared during pregnancy or while using sex hormones (e.g., hearing loss, a blood disease called porphyria, jaundice, itching all over the body, or a skin rash with blisters during pregnancy);
• or if you have ever had discoloration of the skin, especially on the face or neck, called chloasma. In this case, you should avoid direct exposure to sunlight or ultraviolet radiation;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a hereditary disease of red blood cells);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if you have recently given birth, you are at increased risk of blood clots. You should consult your doctor to find out how soon you can start taking Midiana after giving birth;
• if you have superficial thrombophlebitis (blood clots in the veins under the skin);
• if you have varicose veins.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Midiana, is associated with an increased risk of blood clots, compared to when no therapy is used. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur

• -in veins (also called "venous thromboembolism" or "deep vein thrombosis")
• -in arteries (also called "arterial thromboembolism" or "arterial thrombosis").

Not everyone recovers fully from a blood clot. In rare cases, the effects of a blood clot can be long-term or, very rarely, fatal.

It is important to remember that the overall risk of harmful blood clots caused by Midiana is small.

HOW TO RECOGNIZE BLOOD CLOTS

You should contact your doctor immediately if you notice any of the following symptoms.
Does the patient experience any of these symptoms?
Why is the patient likely to suffer

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking
• increased temperature in the affected leg
• change in skin color of the leg, such as pallor, redness, or cyanosis Deep vein thrombosis

BLOOD CLOTS IN VEINS

What can happen if blood clots form in a vein?

• -The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). Although these side effects are rare, they can occur. Most often, they occur in the first year of using combined hormonal contraceptives.
• -If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• -If a blood clot moves from the leg and settles in the lungs, it can cause a pulmonary embolism.
• -In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in a vein highest?

The risk of forming blood clots in a vein is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher compared to when combined hormonal contraceptives are not used.
If you stop using Midiana, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of blood clots in the legs or lungs associated with Midiana is small.

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

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with Midiana is small, but some factors can increase this risk. The risk is higher:

• -if you have a high body mass index (BMI) (over 30 kg/m);
• -if someone in your immediate family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years old). In this case, you may have a hereditary blood clotting disorder;
• -if you need to have surgery or will be immobilized for a long time due to injury or illness, or have a leg in a cast. It may be necessary to stop using Midiana for a few weeks before surgery or immobilization. If you need to stop using Midiana, you should ask your doctor when you can resume using it;
• -with age (especially over 35 years old);
• -if you have recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Air travel (over 4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor.
It is essential to tell your doctor if any of these risk factors occur in you, even if you are not sure. Your doctor may decide to stop using Midiana.
You should inform your doctor if any of the above conditions change while using Midiana, e.g., if someone in your immediate family is diagnosed with a blood clot without a known cause or if you gain weight significantly.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in an artery?

Similarly to blood clots in veins, blood clots in arteries can cause serious consequences, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is essential to note that the risk of a heart attack or stroke associated with Midiana is very small, but it may increase:

• -with age (over about 35 years old);
• -if you smoke. While using a hormonal contraceptive like Midiana, it is recommended to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may recommend using a different type of contraception;
• -if you are overweight;
• -if you have high blood pressure;
• -if someone in your immediate family has had a heart attack or stroke at a young age (under 50 years old). In this case, you may also be at increased risk of having a heart attack or stroke;
• -if you or someone in your immediate family has high levels of fats in the blood (cholesterol or triglycerides);
• -if you have migraines, especially migraines with aura;
• -if you have heart disease (valve damage, arrhythmia called atrial fibrillation);
• -if you have diabetes.

If you have more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher.
You should inform your doctor if any of the above conditions change while using Midiana, e.g., if you start smoking, someone in your immediate family is diagnosed with a blood clot without a known cause, or if you gain weight significantly.

Midiana and cancer

Breast cancer occurs slightly more often in women who use combined contraceptive pills, but it is not known if this is caused by their use. For example, it may be that more tumors are detected in women who use combined contraceptive pills because they are examined by doctors more often. The risk of breast cancer gradually decreases after stopping the use of combined hormonal contraceptives. You should regularly examine your breasts and contact your doctor if you feel any lump.
Women who use contraceptive pills have rarely reported benign liver tumors, and even more rarely, malignant liver tumors. If you feel severe abdominal pain, you should contact your doctor.

Psychiatric disorders

Some women who use hormonal contraceptives, including Midiana, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, you should contact your doctor as soon as possible for further medical advice.

Irregular bleeding

During the first few months of using Midiana, you may experience unexpected bleeding (bleeding outside the 7-day break from taking pills). If such bleeding persists for longer than a few months or starts after a few months, you should contact your doctor to investigate the cause.

What to do if you do not experience withdrawal bleeding during the 7-day break without taking pills

If you have taken all the pills correctly, have not vomited, or have not had severe diarrhea, and you have not taken any other medicines, the likelihood of pregnancy is very low.
If you do not experience the expected withdrawal bleeding twice in a row, you may be pregnant. You should contact your doctor immediately. You should not start the next pack of Midiana until you are sure you are not pregnant.

Midiana and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should also inform other doctors or your dentist who prescribe other medicines that you are taking Midiana. Your doctor will inform you if there is a need to use additional contraceptive methods (e.g., condoms) and if so, for how long.
Do not take Midiana if you have hepatitis C and 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 activity).
Before starting to take these medicines, your doctor will prescribe a different contraceptive method.
You can resume taking Midiana after about 2 weeks from the end of the above-mentioned treatment. See section "When not to use Midiana".
Certain medicines may affect the level of Midiana in your blood 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 or hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as nevirapine, ritonavir, efavirenz) or other infections (griseofulvin),
• high blood pressure in the blood vessels of the lungs (bosentan),
• fungal infections (e.g., griseofulvin, ketoconazole),
• symptomatic treatment of osteoarthritis (etoricoxib),
• a herbal product containing St. John's Wort (Hypericum perforatum). If you want to use herbal products containing St. John's Wort while taking Midiana, you should consult your doctor first.

Midiana may affect the effectiveness of other medicines, such as:

• cyclosporin (a medicine used to prevent rejection of transplanted organs),
• an antiepileptic medicine
• lamotrigine (may increase the frequency of seizures),
• tizanidine (a medicine used to treat muscle spasticity),
• theophylline (a medicine used to treat asthma).

Before taking any medicine, you should consult your doctor or pharmacist.

Midiana with food and drink

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

Lab tests

If a blood test is necessary, you should tell your doctor or laboratory staff that you are taking contraceptive pills, as hormonal contraceptives may affect the results of some tests.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
Women who are pregnant should not take Midiana. If you become pregnant while using Midiana, you should stop taking it immediately and contact your doctor.
If you want to become pregnant, you can stop taking Midiana at any time (see also "Stopping Midiana").
Before taking any medicine, you should consult your doctor or pharmacist.
Breastfeeding
Midiana is not recommended for use during breastfeeding. If you want to take contraceptive pills while breastfeeding, you should contact your doctor.
Before taking any medicine, you should consult your doctor or pharmacist.

Driving and using machines

There is no data on the effect of Midiana on the ability to drive and use machines.

Midiana contains lactose and soy lecithin

Midiana contains 48.17 mg of lactose monohydrate. If you have intolerance to some sugars, you should consult your doctor before taking this medicine.
Midiana contains 0.070 mg of soy lecithin. If you are allergic to soy or peanuts, you should not take this medicine.

3. How to use Midiana

This medicine should always be taken as directed by your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.

Midiana should be taken every day for 21 days.

Each blister pack of Midiana contains 21 tablets, each marked with a day of the week.

• You should take a tablet at the same time every day.
• You should start taking the tablets from the tablet marked with the corresponding day of the week.
• You should move in the direction of the arrows on the blister pack. You should take one tablet every day until all 21 tablets have been taken.
• The tablet should be swallowed whole, if necessary with water. You should not chew the tablets.

Seven days without taking pills

After taking all 21 tablets from the blister pack, there is a 7-day period without taking pills. So, if the last tablet from one pack is taken on a Friday, the first tablet from the next pack can be taken on the Saturday of the following week.
During the 7 days without taking pills, withdrawal bleeding should occur, similar to a menstrual period. This bleeding may not have stopped by the time the next pack of pills is started.

When to start the next pack

You should start taking the pills from the next pack of Midiana after a 7-day break without taking pills, even if the bleeding has not stopped. You should always start a new pack on time.

When can you start the first pack

• If you have not used a hormonal contraceptive in the previous month.You should start using Midiana on the first day of your cycle (i.e., the first day of your menstrual period). If you start using Midiana on the first day of your menstrual period, you are immediately protected against pregnancy. You can also start using Midiana on days 2-5 of your cycle, but in this case, you will need to use an additional contraceptive method (e.g., condoms) for the first 7 days.
• Switching from another combined hormonal contraceptive or a combined hormonal contraceptive vaginal ring or patchYou can start using Midiana the next day after taking the last active pill (the last pill containing active substances) of your previous contraceptive, but no later than the day after the end of the break in taking pills from your previous contraceptive (or after the last inactive pill of your previous contraceptive). When switching from a combined hormonal contraceptive vaginal ring or patch, you should follow your doctor's advice.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen)

You can switch from a progestogen-only pill on any day, from an implant or intrauterine system on the day of its removal, or from an injection when the next injection is scheduled. In these cases, you should always use an additional contraceptive method (e.g., condoms) for the first 7 days of using Midiana.

• After a miscarriage or abortionAfter a miscarriage or abortion in the first three months of pregnancy, your doctor may advise you to start taking Midiana immediately. This means that contraceptive protection occurs after taking the first pill.
• After childbirthYou can start taking Midiana from 21 to 28 days after giving birth. If you start taking Midiana later than 28 days, you should use a mechanical method (e.g., condoms) for the first 7 days of taking Midiana. If you have had sexual intercourse after giving birth before resuming Midiana, you should first make sure you are not pregnant or wait for your next menstrual period.
• If you are breastfeeding and want to start taking Midiana after giving birthYou should read the section "Breastfeeding".

If you are unsure when to start taking Midiana, you should consult your doctor.

What to do if you take more Midiana than you should

No serious harmful effects have been observed after taking too many Midiana pills.
Taking several pills at once may cause nausea or vomiting or vaginal bleeding. Also, in young girls before their first menstrual period, vaginal bleeding may occur if they accidentally take this medicine.
If you take too many Midiana pills or if a child accidentally takes Midiana, you should consult your doctor or pharmacist.

What to do if you forget to take Midiana

• If it has been less than 12 hourssince the scheduled time for taking the pill, contraceptive protection is not reduced. You should take the pill as soon as you remember and take the next pill at the usual time.
• If it has been more than 12 hourssince the scheduled time for taking the pill, contraceptive protection may be reduced. The more pills that are missed, the higher the risk of becoming pregnant.

The risk of reduced contraceptive protection is highest when pills are missed at the beginning or end of the pack. Therefore, you should follow these rules (see also the scheme below):

• You have missed more than one pill from one packYou should contact your doctor.
• -You have missed one pill in the 1st weekYou should take the pill as soon as you remember and take the next pill at the usual time, even if this means taking two pills at the same time. You should use additional protection, such as condoms, for the next 7 days. If you have had sexual intercourse in the week before missing the pill, you may be pregnant. In this case, you should contact your doctor.
• -You have missed one pill in the 2nd weekYou should take the pill as soon as you remember and take the next pill at the usual time, even if this means taking two pills at the same time. You should take the next pills at the usual time. Contraceptive protection is not reduced, and you do not need to use additional protection. If you have missed taking a pill, you should use additional mechanical contraceptive methods, such as condoms, for 7 days.
• -You have missed one pill in the 3rd weekYou can follow one of the two instructions below:
• 1. You should take the missed pill as soon as you remember, even if this means taking two pills at the same time. You should take the next pills at the usual time. You should skip the 7-day break without taking pills and start the next pack of Midiana immediately. You will probably experience bleeding at the end of the second pack, but you may also experience spotting or bleeding similar to a menstrual period while taking the pills from the second pack.
• 2. You can also stop taking the pills and go directly to the break without taking pills (you should note the day you missed the pill so that the number of days without taking pills does not exceed the maximum of 7 days).If you want to start the next pack on the day you usually start taking the pills, the break without taking pills should be shorter than 7 days

If you follow one of the above instructions, contraceptive protection will be maintained.

• If you have missed taking any of the pills from the pack and do not experience withdrawal bleeding during the first week without taking pills, you may be pregnant. In this case, you should contact your doctor before starting the next pack.

What to do if you experience vomiting or severe diarrhea

If you vomit or experience severe diarrhea within 3-4 hours after taking a pill, there is a risk that the active substances from the pill may not have been fully absorbed into your body. The situation is similar to missing a pill. After vomiting or diarrhea, you should take another pill from the reserve pack as soon as possible. If possible, you should take it within 12 hoursof the usual time for taking the pill. If this is not possible or more than 12 hours have passed, you should follow the instructions given in the section "If you forget to take Midiana".
Delaying the start of withdrawal bleeding: what you need to knowAlthough it is not recommended, it is possible to delay the start of withdrawal bleeding by skipping the 7-day break without taking pills and starting the next pack of Midiana immediately. While taking the pills from the second pack, you may experience spotting or bleeding similar to a menstrual period. You should start the next packafter the usual 7-day break without taking pills.
Before deciding to delay the start of withdrawal bleeding, you should consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any side effects, especially severe or persistent ones, or changes in your health that you think may be related to the use of Midiana, you should consult a doctor.
Severe side effects
You should 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 potentially with difficulty breathing (see also the section "Warnings and precautions").
In all women using combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). For detailed information on the different risk factors associated with the use of combined hormonal contraceptives, you should refer to section 2 "Important information before taking Midiana".
Below is a list of side effects that are associated with the use of drospirenone and ethinylestradiol.

Common side effects (may occur in up to 1 in 10 patients)

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

Uncommon side effects (may occur in up to 1 in 100 patients):

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

Rare side effects may occur in up to 1 in 1,000 patients):

• Allergic reactions (hypersensitivity),
• Asthma,
• Hearing disorders,
• Skin disorders, such as erythema multiforme (characterized by the occurrence of painful, red nodules on the skin) or erythema nodosum (characterized by a rash in the form of round redness 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 stroke symptoms, known as a transient ischemic attack,
• Blood clots in the liver, stomach/intestine, kidneys, or eye. The likelihood of blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clots).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Midiana

The medicine should be stored 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 in a temperature below 30°C. Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Midiana contains

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

What Midiana looks like and what the pack contains

Round, biconvex, film-coated tablet, white or almost white in color, with "G63" embossed on one side.
Midiana, 3 mg + 0.03 mg, is packaged in PVC/PVDC/Aluminum blisters, in a cardboard box.
A cardboard sleeve is included in the packaging, in which the blister should be placed.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the 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

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Marketing authorization number in Portugal, the country of export: 5282124, 5282132
Parallel import authorization number: 9/19
Translation of the symbols of the days of the week on the packaging:

Seg

• Monday

Ter

• Tuesday

Qua

• Wednesday

Qui

• Thursday

Sex

• Friday

Sab

• Saturday Dom- Sunday

Date of revision of the leaflet: 05.01.2024

[Information about the trademark]