Midiana

Patient Information Leaflet

Warning! Keep this leaflet! Information on the outer packaging is in a foreign language.
Midiana (Aranka)
3 mg + 0,03 mg, coated tablets
Drospirenonum + Ethinylestradiolum
Midiana and Aranka are different brand names for the same medicine.
Important information about combined hormonal contraceptives

• When used correctly, they are one of the most reliable reversible methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, particularly 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 a blood clot (see section 2. "Blood clots").

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

• Keep this leaflet so that you can read it again if necessary.
• If you have any further 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.

Contents of this leaflet

1. What Midiana is and what it is used for
2. Important information 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 to take Midiana, you should read the information about blood clots (thrombosis) in section 2. It is particularly important to be aware of 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 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 measurement methods. These methods may be unreliable because Midiana modifies monthly changes in body temperature and cervical mucus.
Midiana, like other hormonal contraceptives, does not protect against infection with the HIV virus (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 your legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs.
• if you know you have disorders affecting blood clotting—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 long time (see section "Blood clots").
• if you have had a heart attack or stroke.
• if you suffer (or have suffered in the past) from 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 suffer from any of the following diseases which 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 (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 soybean lecithin. If you are allergic to peanuts or soy, 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 to use Midiana, discuss this with your doctor or pharmacist.

When should you contact your doctor?
You should contact your doctor immediately:

• if you notice possible symptoms of blood clots, which may indicate that 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"). For a description of the symptoms of these serious adverse effects, see "How to recognize the occurrence of blood clots".

Tell your doctor if you have any of the following conditions.
Special caution may be required when using Midiana or any other combined oral contraceptive, and regular medical check-ups may be necessary. If you have any of the conditions listed below, 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 urticaria potentially associated with breathing difficulties, you should contact your doctor immediately. 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 disease that first occurred during pregnancy or during 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 (pruritus), blistering skin rash during pregnancy (pemphigoid gestationis), a neurological disorder with involuntary body movements (Sydenham's chorea);
• or if you have ever had skin pigmentation, 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 natural immune system);
• if you have hemolytic uremic syndrome (a blood clotting disorder causing kidney failure);
• if you have sickle cell anemia (an inherited disorder of red blood cells);
• if you have been diagnosed with high blood fat levels (hypertriglyceridemia) or have a positive family history for this condition. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a long time (see section 2 "Blood clots");
• if you have recently given birth, as you are then 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 complications.
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 after 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 small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Contact your doctor immediately if you experience any of the following symptoms.

Are you experiencing any of these symptoms? Likely reason
for your condition?

• swelling of the leg or swelling along a vein in the leg or foot, Deep vein thrombosis 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, e.g. paleness, redness,
  or blueness.

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

• sudden cough without obvious cause, which may be associated with coughing up blood;

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

• severe dizziness or vertigo;

• rapid or irregular heartbeat;

• severe stomach pain.

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

Symptoms most commonly occur in one eye: Retinal vein thrombosis

• sudden loss of vision or (blood clot in the eye)

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

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

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

• feeling of fullness, indigestion, or choking;

• discomfort in the lower body radiating to the back, jaw, throat, arm, or stomach;

• sweating, nausea, vomiting, or dizziness;

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

• 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 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 developing blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of taking combined hormonal contraceptives for the first time. 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 than in women who do not use combined hormonal contraceptives.
If a woman 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 natural risk of developing venous thromboembolic disease and the type of combined hormonal contraceptive 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, about 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, about 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, 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 in veins depends on the individual's medical history (see "Factors increasing the risk of developing blood clots in veins" and "Factors increasing the risk of developing blood clots in arteries" below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Midiana is low, however,
some factors may increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) above 30 kg/m²);
• if a close relative of the patient has been diagnosed with 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 immobilised for a prolonged period due to injury, illness or has a leg in plaster. It may be necessary to stop taking Midiana several weeks before surgery or immobilisation. If the patient needs to stop taking Midiana, ask the doctor when it is safe to restart;
• with increasing age (particularly over 35 years);
• if the patient has 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 the listed 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, e.g. if a close relative is diagnosed with unexplained thrombosis 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 can lead to serious consequences, such as heart attack or stroke.

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

• with age (over approximately 35 years);

• if the patient smokes. When 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 of age, the doctor may recommend using a different type of
  contraceptive;

• 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 blood fat levels (cholesterol or triglycerides);

• if the patient suffers from migraines, particularly migraines with aura;

• if the patient has heart disease (valve problems, heart rhythm disorders 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 blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Midiana, e.g. if the patient starts smoking, a close relative is diagnosed with unexplained thrombosis, 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, it may be that more cancers are 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. Regular breast examinations are recommended, and the patient should contact her doctor if she detects any lump.

Rarely, benign liver tumours and, even more rarely, malignant liver tumours have been reported in women using oral contraceptives. 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, contact the doctor as soon as possible for further medical advice.

Breakthrough bleeding
During the first few months of using Midiana, unexpected bleeding (occurring outside the seven-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 seven-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 or recently taken, as well as any medicines the patient plans to take.
The patient should also inform other doctors or dentists prescribing 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.

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, as these products may cause abnormal liver function test results (increased liver enzyme activity, AlAT).
Before starting these medicines, the doctor will prescribe a different 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),
  ‐ high blood pressure in the pulmonary arteries (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 consult her doctor first.

Midiana may affect the effectiveness of other medicines, e.g.:
‐ cyclosporine (a medicine used to prevent rejection of transplanted tissue after organ transplantation),
‐ the antiepileptic drug lamotrigine (seizures 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 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 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 soybean 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 soybean lecithin. If the patient is allergic to soy or peanuts, she should not take this medicine.

3. How to take Midiana

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are
unsure, consult your doctor or pharmacist.
Midiana tablets should be taken daily for 21 days.
Each Midiana blister pack contains 21 tablets, each marked with a day of the week.

• Take one tablet at the same time each day.
• Begin taking tablets from 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 necessary. Do not chew the tablets.

Seven days without tablets
After taking all 21 tablets from the blister pack, 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 a
menstrual period should occur. This bleeding may not have ended when 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 continues. Always start a new blister pack on time.
During this 7-day tablet-free interval, a withdrawal bleed (so-called withdrawal bleeding) should
occur. Bleeding usually begins on the 2nd or 3rd day after the last tablet of Midiana has been taken.
The next pack should be started the day after the 7-day tablet-free interval, even if bleeding has not
yet stopped.
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, she is immediately protected against pregnancy. Alternatively, treatment 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 or from a combined contraceptive vaginal system or transdermal patch. Start taking Midiana the day after taking 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 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. Following a miscarriage or abortion in the first three months of pregnancy, your doctor may advise starting Midiana immediately. This means contraceptive protection begins with the first tablet.
• After childbirth. Midiana may be started between day 21 and day 28 after delivery. If treatment starts later than day 28, a barrier method (e.g., condom) must 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 wait until the next menstrual bleeding occurs.
• If the patient is breastfeeding and wishes to start taking Midiana after childbirth, refer to 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 adverse 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 menstruation, accidental intake of this medicine may also
cause vaginal bleeding.
If too many Midiana tablets have been taken or if a child has taken Midiana, 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 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 pack. Therefore, follow the rules below (see also the flowchart below):

• More than one tablet missed from one pack: Consult your doctor.
• One tablet missed in Week 1: Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the following tablets at 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 the missed tablet, she may be pregnant. In this case, consult your doctor.
• One tablet missed in Week 2: Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the following tablets at 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 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, after taking the last tablet, immediately start the next pack. Withdrawal 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 proceed directly to the tablet-free interval (note the day the tablet was missed so that the total tablet-free interval does not exceed 7 days). If the patient wishes to start the new 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 the patient has missed any tablet from the pack and no withdrawal bleeding occurs during the first week of the tablet-free interval, this may indicate that she is pregnant. In this case, consult your doctor before starting the next pack.

Missed several
tablets from the same pack? → Consult your doctor
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 pack

Missed 1 tablet

• Take the missed tablet and (taken late in Week 2 - Finish taking tablets in the pack more than 12 hours late)
• Take the missed tablet
• Finish taking tablets in the pack
• Do not take a 7-day break between packs
• Immediately start taking tablets from the next pack

or
in Week 3

• Immediately stop taking tablets from the current pack
• Begin the tablet-free interval (no longer than 7 days, including the day the tablet was missed)
• Then start taking tablets from 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 your usual tablet-taking time. If this is not possible or 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 Midiana blister pack, and taking all tablets from this pack.
During the second pack, spotting or menstrual-like bleeding may occur. The next pack should then
be started after the usual 7-day tablet-free interval.
Before deciding to delay the withdrawal bleed, consult your 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 lengthening—7 days
is the maximum!) 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 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,
consult your 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

Serious adverse effects
Seek immediate medical attention if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty 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 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 effects associated with the use of drospirenone and ethinylestradiol.

Common adverse effects (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 effects (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 effects (may occur in up to 1 in 1000 women):

• Allergic reactions (hypersensitivity),
• Asthma,
• Hearing disorders,
• Skin disorders such as erythema nodosum (characterised by painful red skin nodules) or erythema multiforme (characterised by circular red patches or sores),
• Galactorrhoea (milk secretion from breasts),
• Harmful blood clots in veins or arteries, 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 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 effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects helps to provide more information on the safety of the medicine.

5. How to store Midiana

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Midiana contains

• The active substances in Midiana are drospirenone and ethinylestradiol. One 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
A 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.
The blisters are placed in a cardboard box containing the patient leaflet and a cardboard sachet in
which the blister should be placed.
Pack sizes:
1x21 coated tablets
3x21 coated tablets
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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw
Marketing Authorisation Number in Portugal, country of export: 5282132
Parallel Import Authorisation Number: 829/15
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.