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 brand names of the same medicinal product.
Important information regarding combined hormonal contraceptives

• When used correctly, they represent one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of venous and arterial blood clots, particularly during the first year of use or after restarting following an interval of 4 weeks or more.
• Be vigilant and consult a doctor if the user suspects symptoms of blood clots (see section 2. "BLOOD CLOTS").

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

• Keep this leaflet for future reference.
• If in doubt, consult a doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If the user experiences any adverse reactions, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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 remarks
Before starting to take Midiana, you should read the information about blood clots (thrombosis) in section 2. It is especially important to become familiar with the symptoms of blood clots (see section 2. “BLOOD CLOTS”).
Before starting 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 situation, may carry out 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 cases, 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 monitoring methods. These methods may be unreliable because Midiana alters the 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 any of these conditions apply to you, inform your doctor. Your doctor will discuss with you which alternative method of contraception may 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 your legs (deep vein thrombosis), lungs (pulmonary embolism), or 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 are undergoing 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 currently 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 (renal 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 medicines 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 Midiana, discuss it with your doctor or pharmacist.

When to contact your doctor?
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), lungs (pulmonary embolism), heart attack, or stroke (see section below “BLOOD CLOTS”). For a description of symptoms of these serious adverse events, see “HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS”.

Tell your doctor if you have any of the following conditions.
Special caution may be needed when using Midiana or any other combined oral contraceptive, and regular check-ups by your doctor may be necessary. Inform your doctor before starting Midiana if you have any of the following conditions.
If any of these symptoms develop 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 urticaria potentially associated with breathing difficulties, seek immediate medical attention. Medicinal products containing estrogens may induce or exacerbate 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 discoloration, especially on the face or neck, known as chloasma (melasma). In this case, 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 affecting the body’s natural defence system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridaemia) or have a positive family history of this condition. Hypertriglyceridaemia 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 for advice on 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 hormonal contraception. In rare cases, a blood clot can block a blood vessel and cause serious problems.
Blood clots can occur:

• in veins (referred to below as “venous thrombosis” or “venous thromboembolic disease”)
• in arteries (referred to below as “arterial thrombosis” or “arterial thromboembolic events”).

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 attention if you experience any of the following symptoms.

Do you experience any of these symptoms?
Likely reason for your symptoms?

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

• 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 bluish discoloration.

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

• sudden cough without obvious cause, possibly accompanied by coughing up blood;

• sharp chest pain, which may worsen on deep breathing;

• severe dizziness or vertigo;

• rapid or irregular heartbeat;

• severe stomach pain.

If you are unsure, consult your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for milder conditions such as respiratory tract infection (e.g. cold).

Symptoms most commonly affecting one eye:
Retinal vein thrombosis (blood clot in the eye)

• sudden vision loss or

• painless visual disturbances, which may progress to vision loss.

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

• squeezing or fullness in the chest, arm, or below the breastbone

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

• The use of combined hormonal contraceptives is associated with an increased risk of venous blood clots (venous thrombosis). Although these adverse events are rare, they most commonly occur 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 clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of venous blood clots the highest?
The risk of developing venous blood clots 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 another 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 blood clots returns to normal within a few weeks.

What factors influence the risk of venous blood clots?
The risk depends on the individual's natural risk of developing 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 one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In one 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 developing blood clots depends on the individual's medical history (see "Factors that increase the risk of blood clots" below).

Factors increasing the risk of venous blood clots
The risk of developing 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 family member of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years). In this case, the patient may have an inherited clotting disorder;
• 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 periods of immobility. If the patient must stop taking Midiana, consult the doctor about when it is safe to restart;
• with increasing age (particularly 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, especially if the patient has another risk factor present.
It is important to inform the doctor if any of these risk factors apply to the patient, even if uncertain. The doctor may decide to discontinue Midiana.
Inform the doctor if any of the above conditions change during treatment with Midiana, for example, if a close family member develops thrombosis without a known cause, or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots can lead to 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 Midiana is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Midiana, smoking should be avoided. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member 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 family member has high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valvular heart disease, cardiac arrhythmia such 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 arterial blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Midiana, for example, if the patient starts smoking, a close family member develops thrombosis without a known cause, or if the patient 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, more cancers may be detected in women using combined oral contraceptives because they are examined more frequently by doctors. 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 lumps.
Benign liver tumours have been reported rarely in women using oral contraceptives, and malignant liver tumours have been reported very rarely. If the patient experiences 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, contact the doctor as soon as possible for further medical advice.

Intermenstrual 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 of use, contact the 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 diarrhoea, and the patient has not taken any other medicines, the likelihood of pregnancy is very low.
If 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 tablets until pregnancy has been ruled out.

Midiana and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use.
The patient should also inform other doctors or dentists prescribing other medicines that she is using Midiana. The doctor will advise whether additional contraceptive methods (e.g. condoms) are needed, and for how long.
Midiana should not be used in patients with hepatitis C who are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause abnormal liver function test results (increased alanine aminotransferase enzyme activity). Before starting these treatments, the doctor will prescribe another type of contraception. Midiana may be restarted approximately 2 weeks after completing the above-mentioned treatment. See section “When not to use Midiana”.
Some medicines may affect 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 (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as nevirapine, ritonavir, efavirenz) or other infections (griseofulvin),
• pulmonary hypertension (bosentan),
• fungal infections (e.g. griseofulvin, ketoconazole),
• symptomatic treatment of osteoarthritis (etoricoxib),
• herbal product 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 consult her doctor first.

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

• cyclosporine (a medicine used to prevent rejection of transplanted organs),
• the antiepileptic drug 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, inform the doctor or laboratory staff that the patient 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 plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Midiana must not be used during pregnancy. If the patient becomes pregnant while taking Midiana, she must stop taking it immediately and contact her doctor.
If the patient wishes to become pregnant, she may stop taking 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 use oral contraceptives while breastfeeding, she should contact her doctor.
Before taking any medicine, consult a doctor or pharmacist.
Driving and operating machinery
There are no data indicating an effect of Midiana on the ability to drive or operate machinery.
Midiana contains monohydrate lactose and soy lecithin
Midiana contains 48.17 mg of monohydrate lactose. In case of intolerance to certain sugars, consult a doctor before using this medicine.
Midiana contains 0.070 mg of soy lecithin. If the patient is allergic to soy or peanuts, she should not take this medicine.

3. How to use Midiana

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Midiana should be taken daily for 21 days.
Each Midiana blister pack contains 21 tablets, each marked with a day of the week (see "Translation of symbols indicating days of the week next to each tablet on the primary packaging" at the end of this leaflet).

• Take one tablet at the same time every 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 daily until all 21 tablets have been consumed.
• Swallow the tablet whole, with water if necessary. Do not chew the tablets.

Seven days without tablets
After taking all 21 tablets from the blister, there follows 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 the following Saturday.
Within a few days after taking the last tablet from the blister, a withdrawal bleed similar to menstruation should occur. This bleeding may still be ongoing when it is time to start the next blister.
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 on time.

When to start the next blister
The next pack of Midiana should be started after the 7-day break, even if bleeding has not yet stopped. Always start a new blister on schedule.
During this 7-day break, a withdrawal bleed should occur. Bleeding usually begins 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 continues.

When to start the first blister

• If the patient has not used any hormonal contraceptive in the previous month: Begin taking Midiana on the first day of the menstrual cycle (i.e., the first day of menstruation). If Midiana is started on the first day of menstruation, immediate protection against pregnancy is provided. Starting between days 2 and 5 of the cycle is also possible, 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 or from a combined hormonal vaginal system or transdermal patch: Begin taking Midiana the day after the last active tablet (the last tablet containing active ingredients) of the previous contraceptive, but no later than the day after the tablet-free interval ends (or after the last inactive tablet of the previous contraceptive). When switching from a combined hormonal vaginal system or transdermal patch, follow the doctor's advice.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen): Switching can occur at any time from the progestogen-only pill (on the day of removal of the 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: Following a miscarriage or abortion during the first three months of pregnancy, a doctor may recommend starting Midiana immediately. This provides contraceptive protection starting with the first tablet.
• After childbirth: Midiana may be started between day 21 and day 28 after delivery. If treatment begins later than day 28, a barrier method (e.g., condom) should be used for the first 7 days of taking Midiana. If sexual intercourse occurred after childbirth and before restarting Midiana, pregnancy should first be ruled out or the patient should wait until the next menstrual bleeding occurs.
• If the patient is breastfeeding and wishes to start Midiana after childbirth: Refer to the section "Breast-feeding".

If the patient is unsure when to start taking the medicine, she should consult a doctor.
Taking more Midiana than recommended
No severe adverse effects have been observed after taking an excessive amount of Midiana tablets.
Taking several tablets at once may cause symptoms such as nausea, vomiting, or vaginal bleeding. In young girls before the onset of the first menstruation, accidental intake of this medicine may also cause vaginal bleeding.
If too many Midiana tablets are taken or if a child accidentally ingests the medicine, consult a doctor or pharmacist immediately.

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 remembered, and take the next tablet at the usual time.
• If more than 12 hours have passed since the scheduled time, 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 pack. Therefore, follow these guidelines (see also the flowchart below):

• More than one tablet missed from one pack: Consult a doctor.
• One tablet missed in Week 1: Take the missed tablet as soon as remembered, even if this means taking two tablets at the same time. Continue taking the remaining tablets at the usual time and use additional contraception, such as a condom, for the next 7 days. If the patient had sexual intercourse in the week before missing the tablet, pregnancy may have occurred. In this case, consult a doctor.
• One tablet missed in Week 2: Take the missed tablet as soon as remembered, even if this means taking two tablets simultaneously. Continue taking the remaining tablets at the usual time. Contraceptive protection is not reduced, and no additional contraception is needed. However, if more than one tablet has been missed, use additional barrier methods (e.g., condom) for 7 days.
• One tablet missed in Week 3: Either of the following two options may be used:
  1. Take the missed tablet as soon as remembered, 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 immediately start the next pack after finishing the current one. Withdrawal bleeding will most likely occur at the end of the second pack, but spotting or breakthrough bleeding may occur during the second pack.
  2. Alternatively, stop taking tablets and proceed directly to 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 one of the above recommendations is followed, contraceptive protection will be maintained.

• If any tablet from the pack was missed and no withdrawal bleeding occurs during the first tablet-free week, this may indicate that the patient is pregnant. In this case, consult a doctor before starting the next pack.

Missed tablets from the same blister
Yes
Did sexual intercourse occur in the
previous week?
No

• Take the missed tablet
• Use a barrier method (condom) for the next 7 days
• Finish taking all tablets in the blister

Missed 1 tablet
(taken with - Take the missed tablet and
in Week 2
delay >12 hours) - Finish taking tablets from the blister

• Take the missed tablet
• Finish taking tablets from the blister
• Do not take a 7-day break between packs
• Immediately start taking tablets from the next blister in Week 3
• Immediately stop taking tablets from the blister
• Begin the tablet-free interval (no longer than 7 days, including the day the tablet was missed)
• Then start taking tablets from the next blister

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 time of taking the tablet. If this is not possible or if more than 12 hours have passed, follow the advice given in the section "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 Midiana blister, and taking all tablets from this pack. Spotting or breakthrough bleeding may occur during the second pack. The next pack should then be started after the usual 7-day tablet-free interval.
Before deciding to delay the withdrawal bleed, consult a doctor.

Changing the day of the withdrawal bleed: what you should know
If the patient takes the tablets as directed, bleeding will occur during the 7-day tablet-free interval. If the patient wishes to change this day, she may do so by shortening (but never extending—the maximum is 7 days) the tablet-free interval. For example, if the 7-day tablet-free interval normally starts on Friday, and the patient wishes to change it to Tuesday (3 days earlier), she should start the new blister 3 days earlier than usual. Bleeding may not occur during this time, but spotting or breakthrough bleeding may occur.
If the patient is unsure how to proceed, she should consult a doctor.

Stopping Midiana
Midiana may be discontinued at any time. If the patient does not wish to become pregnant, consult a doctor about other effective methods of birth control.
If the patient wishes to become pregnant, stop taking Midiana and wait for the onset of menstruation. This makes it easier to calculate the expected date of delivery.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone will experience them. If any adverse reactions occur, especially severe and persistent ones, or any changes in health that the patient considers related to the use of Midiana, medical advice should be sought.

Serious adverse reactions
Seek immediate medical advice if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty in swallowing, or urticaria potentially associated with breathing difficulties (see also section "Warnings and precautions").

All women using combined hormonal contraceptives have an increased risk of developing venous blood clots (venous thromboembolic disease) 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 women)

• 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 women):

• Changes in libido (interest in sex)
• 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 women):

• Allergic reactions (hypersensitivity)
• Asthma
• Hearing disorders
• Skin disorders such as erythema nodosum (characterized by painful, red skin nodules) or erythema multiforme (characterized 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 patient has 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 not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-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 provide more information on the safety of the medicine.

5. How to store the medicine 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 stated 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. This will help protect the environment.

6. Contents of the pack and other information

What Midiana contains

• The active substances are drospirenone and ethinylestradiol. Each coated tablet contains 3 mg drospirenone and 0.03 mg ethinylestradiol.
• Other components of the medicine are: monohydrate lactose, pregelatinized starch, corn starch, povidone K 25, magnesium stearate. Coating Opadry II White 85G18490: polyvinyl alcohol, titanium dioxide (E 171), talc (E 553b), macrogol 3350, soy lecithin.

What Midiana looks like and contents of the pack
Round, biconvex coated tablet, white or almost white, with the imprint
"G63" on one side.
Midiana is packed in PVC/PVDC/Aluminium blisters containing 21 coated tablets.
Blisters are placed in cardboard boxes together with the package leaflet and a cardboard sachet for storing
the blisters, included with each package.
Pack sizes:
21 coated tablets
3 x 21 coated tablets
For more detailed information about the medicine, 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation number in Portugal, country of export: 5282124
Parallel Import Authorisation number: 195/16
Translation of the weekday symbols printed next to each tablet on the immediate packaging:
Seg - Monday
Ter - Tuesday
Qua - Wednesday
Qui - Thursday
Sex - Friday
Sab - Saturday
Dom - Sunday