Miranova

Package leaflet: Information for the user

Miranova 0.1 mg + 0.02 mg coated tablets

levonorgestrel + ethinylestradiol
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives (COCs):

• They are one of the most reliable reversible contraceptive methods when used correctly;
• They slightly increase the risk of blood clots forming in the veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks;
• Be alert and contact your doctor if you think you have symptoms of a blood clot (see section “Blood clots”).

Contents of this leaflet:

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

1. What Miranova is and what it is used for

Miranova is a combined hormonal contraceptive (CHC) used to prevent pregnancy.
Each tablet contains a small amount of two female hormones, levonorgestrel and ethinylestradiol.
Contraceptive pills containing two hormones are known as "combined pills".
Miranova is referred to as a "low-dose" oral contraceptive because it contains only a small amount of hormones.

2. What you should know before taking Miranova

General information
Before starting Miranova, you must read the information about blood clots in the section "Blood clots". It is particularly important that you read about the symptoms of a blood clot (see section "Blood clots").
Before starting or restarting Miranova, a thorough medical examination is recommended, and pregnancy must be ruled out. Additionally, periodic check-ups—at least once a year—are advisable while using this medicine. The frequency and type of examination will be determined by your doctor and will particularly include monitoring of blood pressure and other checks.

This patient leaflet describes certain situations in which you should stop taking the medicine or in which its effectiveness may be reduced. In such situations, you must not have sexual intercourse or must use additional non-hormonal contraceptive precautions, such as using a condom or another barrier method. Do not use rhythm methods or basal body temperature methods, as they may be unreliable because the pill alters the normal changes in body temperature and cervical mucus that occur during the menstrual cycle.
Like all contraceptive pills, Miranova does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
Do not use Miranova
Do not use Miranova if you have any of the conditions listed below. If you have any of the conditions listed below, consult your doctor. Your doctor will discuss with you other birth control methods that might be more suitable for your case.

• if you are allergic to levonorgestrel, ethinylestradiol, or any of the other ingredients of this medicine (listed in section 6);
• if you have (or have ever had) a blood clot in a vein of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;
• if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are scheduled for surgery or will be immobile for a prolonged period (see section "Blood clots");
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain that may be an early sign of heart attack) or transient ischemic attack (TIA—temporary stroke-like symptoms);
• if you have one of the following conditions, which may increase the risk of developing blood clots in the arteries:
  o severe diabetes with blood vessel damage,
  o very high blood pressure,
  o very high levels of fats (cholesterol or triglycerides) in the blood,
  o a condition known as hyperhomocysteinemia (elevated levels of homocysteine in the blood);
• if you have (or have ever had) a type of migraine called "migraine with aura";
• if you have vascular diseases of the eye;
• if you have or have previously had a severe liver disease and liver function has not yet returned to normal;
• if you have or have previously had breast or genital organ cancer;
• if you have or have previously had benign or malignant liver tumors;
• if you have vaginal bleeding of unknown origin;
• if your periods have stopped for unknown reasons;
• if you are or suspect you are pregnant.

Do not use Miranova if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (also see section "Other medicines and Miranova").
Warnings and precautions
Talk to your doctor or pharmacist before taking Miranova.

When to be especially careful with Miranova
When should you contact a doctor?
Seek urgent medical advice if:

• you notice signs suggestive of a blood clot, which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack, or a stroke (see the following section "Blood clot (thrombosis)"). For a description of the symptoms of these serious side effects, refer to the section "How to recognize a blood clot". The use of combined oral contraceptives may require close medical supervision if any of the following conditions apply. Inform your doctor if any of the conditions listed below apply to you before starting Miranova. Your doctor may recommend a different (non-hormonal) method of contraception.

Inform your doctor if any of the following conditions apply to you.
If any of these conditions develop or worsen while you are taking Miranova, inform your doctor.

• smoking;
• diabetes;
• obesity (severe overweight);
• hypertension (high blood pressure);
• heart valve defects or certain heart rhythm disorders;
• if a family member (sibling or parent), especially at a relatively young age (i.e., before age 50), has experienced venous thromboembolism (formation of a thrombus or embolus in a vein);
• varicose veins;
• migraine (headache);
• depression;
• epilepsy (see "Other medicines and Miranova");
• history of high cholesterol and triglyceride (fats) levels in the blood (also in close family members);
• family history of breast cancer;
• liver or gallbladder diseases;
• porphyria (a metabolic blood disorder);
• if you have or have previously had chloasma (yellow-brown skin patches, especially on the face). In this case, avoid prolonged exposure to sunlight or ultraviolet rays;
• if you have had herpes gestationis (an autoimmune skin disease affecting women during or immediately after pregnancy);
• hyperhomocysteinemia (elevated homocysteine in the blood, predisposing to venous thrombosis);
• Sydenham's chorea (a disorder of the central nervous system);
• hearing loss due to otosclerosis.
• if you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with possible breathing difficulties, contact your doctor immediately. Medicines containing estrogens may trigger or worsen symptoms of hereditary or acquired angioedema.
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE, a disease affecting the body's natural defense system);
• if you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing impaired kidney function);
• if you have sickle cell anemia (a hereditary red blood cell disorder);
• if you have high levels of fats in the blood (hypertriglyceridemia) or a positive family history for this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);

• if you are scheduled for surgery or will be immobile for a prolonged period (see section "Blood clots");
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking Miranova.

If any of the above conditions appear for the first time, recur, or worsen during use of the pill, consult your doctor.
BLOOD CLOTS
Using a combined hormonal contraceptive such as Miranova increases the risk of developing a blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop:

• in veins (a condition called "venous thrombosis", "venous thromboembolism", or VTE)
• in arteries (a condition called "arterial thrombosis", "arterial thromboembolism", or ATE).

Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, these effects can be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with Miranova is low.
HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical advice if you notice any of the following signs or symptoms.
Do you have any of these signs? What might you be suffering from?
Deep vein thrombosis
Swelling in one leg or along a vein in the leg or foot, especially if accompanied by:

• pain or tenderness in the leg, which may only be felt when standing or walking
• increased warmth in the affected leg
• change in skin color of the leg, such as paleness, redness, or bluish discoloration.

Pulmonary embolism
Sudden and unexplained shortness of breath or rapid breathing;

• sudden cough without an obvious cause, possibly with coughing up blood;
• sharp chest pain that may worsen when breathing deeply;
• severe dizziness or lightheadedness;
• rapid or irregular heartbeat;
• severe abdominal pain

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

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots forming in veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same or a different medicine) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not using a combined hormonal contraceptive.
When you stop taking Miranova, the risk of developing a blood clot returns to normal levels within a few weeks.

What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE (venous thromboembolism) and the type of combined hormonal contraceptive you are taking.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Miranova is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, such as Miranova, about 5–7 will develop a blood clot in one year.
• The likelihood of a blood clot forming depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Miranova is low, but certain conditions can increase it. Your risk is higher:

• if you are very overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in a leg, lung, or another organ at a young age (under approximately 50 years). In this case, you may have an inherited blood clotting disorder;
• if you are due to undergo surgery or need to remain lying down for a prolonged period due to injury, illness, or if you have a leg in plaster. You may need to stop taking Miranova several weeks before surgery or during periods of reduced mobility. If you need to stop taking Miranova, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years);
• if you gave birth less than a few weeks ago.

The risk of developing a blood clot increases when you have more than one of these conditions.

Air travel (lasting more than 4 hours) may temporarily increase the risk of blood clot formation, especially if you have some of the other risk factors listed above.
It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to have you stop taking Miranova.
If any of the above conditions change while you are using Miranova—for example, if a close relative develops thrombosis without a known cause or if you gain significant weight—contact your doctor.
BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems—for example, they may lead to a heart attack or stroke.
Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of Miranova is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Miranova, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke;
• if you or a close relative have high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valve defects, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions, or if one is particularly severe, the risk of developing a blood clot may be even higher.
If any of the above conditions change while you are using Miranova—for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.
Tumours
Breast cancer diagnoses are slightly more frequent in women using the pill compared to women of the same age who do not use it. The slight increase in breast cancer diagnoses gradually disappears over the 10 years following discontinuation of treatment. It is not known whether this difference is due to the pill.
This increase could be due to earlier diagnosis (because women are examined more frequently), to the biological effect of the pill, or to a combination of both factors. Breast cancer diagnosed in women taking the pill tends to be clinically less advanced than in women who do not use it.
Benign liver tumours have been reported rarely in women taking the pill, and malignant liver tumours even more rarely. Such tumours may cause internal bleeding. Consult your doctor immediately if you experience severe abdominal pain.
Cervical cancer has been reported to be more frequent in women who use the pill for long periods. This may not be due to the pill itself, but rather to sexual behaviour and other factors that are often involved in the development of tumours in general.
Psychiatric disorders

Some women using hormonal contraceptives have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor.
In case of unexpected bleeding
With all oral contraceptives, vaginal bleeding between periods may occur during the first few months of use. If such bleeding persists for more than 3 months or begins after several months, contact your doctor for an evaluation.
Consult your doctor if such bleeding persists, becomes heavy, or recurs at intervals.
What to do if you do not have bleeding during the pill-free interval
If all tablets have been taken correctly, with no vomiting or use of other medications, it is very unlikely that you are pregnant. Continue taking the medicine as usual.
If you miss two consecutive periods, pregnancy may have occurred.
Consult your doctor immediately. Do not start a new pack until your doctor has ruled out pregnancy.

Regular check-ups
While using the pill, your doctor will recommend periodic check-ups, at least once a year.
Consult your doctor as soon as possible if:
you notice any change in your health status, particularly related to what is reported in this leaflet (see also “Do not use Miranova” and “Warnings and precautions”. Do not forget to consider family history);
you detect a lump in your breast;
you need to take other medicines (see also “Other medicines and Miranova”);
you are immobilized or need to undergo surgery (consult your doctor at least four weeks in advance);
you have severe and unusual vaginal bleeding;
you forgot to take tablets in the first week of use and had sexual intercourse in the seven days before the missed dose;
you miss two consecutive menstrual cycles or suspect pregnancy; do not start a new pack without your doctor’s approval.
Stop taking the tablets and consult your doctor immediately if you notice possible signs of thrombosis:
sudden onset of coughing;
severe chest pain that may radiate to the left arm;
sudden shortness of breath;
unusual, severe, or prolonged headache or migraine attack;
partial or complete loss of vision or double vision;
slurred speech or inability to speak;
sudden changes in hearing, smell, or taste;
dizziness or fainting;
sudden weakness or numbness in any part of the body;
severe abdominal pain;
severe pain or swelling in one leg.
The situations and symptoms listed above are described and explained in greater detail in other sections of this patient information leaflet.
Children and adolescents
Miranova is indicated only after menarche (first menstrual period).
Elderly population:
Miranova is not indicated after menopause.
Impaired liver function
Miranova is contraindicated in women with severe liver disease. See “Do not use Miranova”.
Impaired kidney function
Miranova has not been specifically studied in patients with reduced kidney function.
Other medicines and Miranova
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. If your dentist or any other doctor prescribes other medicines, inform them that you are using Miranova, so they can determine whether and for how long additional contraceptive methods are needed.
Some medicines may:

• affect blood levels of Miranova,
• prevent the pill from effectively preventing pregnancy,
• cause unexpected bleeding.

These include:

• metoclopramide (used to treat nausea and vomiting),
• primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate (used to treat epilepsy),
• rifampicin and rifabutin (used to treat tuberculosis),
• ritonavir, nevirapine, and efavirenz (used to treat HIV and hepatitis C infections),
• modafinil (used to treat excessive sleepiness) and flunarizine (used to prevent headaches),
• griseofulvin, itraconazole, voriconazole, and fluconazole (used to treat fungal infections),
• clarithromycin, erythromycin, and troleandomycin (antibiotics used to treat bacterial infections),
• verapamil and diltiazem (used to treat certain heart conditions and high blood pressure),
• etoricoxib (used to treat arthritis and osteoarthritis),
• bosentan (used for high blood pressure in the pulmonary arteries),
• products containing St. John’s wort (Hypericum perforatum) used to treat depression.

Miranova may interfere with the action of other medicines, such as:

• medicines containing cyclosporine (used to prevent transplant rejection),
• lamotrigine (used to treat epilepsy, a condition causing loss of consciousness and violent involuntary muscle contractions),
• melatonin (used to treat insomnia),
• midazolam (a medicine that induces sleep),
• theophylline (used to dilate the airways),
• tizanidine (used to relax muscles).

Laboratory tests
Use of the pill may affect the results of certain blood tests, but these changes generally remain within the normal range. Therefore, it is important to inform the doctor requesting the tests that you are taking the pill.
Do not use Miranova if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause increases in liver function blood test results (elevated liver enzyme ALT). Your doctor will prescribe another type of contraceptive before you start treatment with these medicines. Miranova may be resumed approximately 2 weeks after completion of this treatment. See section “Do not use Miranova”.
Miranova with food and drinks
Do not take Miranova with grapefruit juice.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use Miranova if you are pregnant or suspect pregnancy.
If you become pregnant while using Miranova, stop taking the medicine immediately.
Miranova is not recommended during breastfeeding.
Small amounts of contraceptive steroids and/or their metabolites may be excreted in breast milk. These amounts may affect the infant.

Driving and using machines
Miranova does not affect or affects negligibly the ability to drive or use machines.
Miranova contains lactose and sucrose
This medicine contains lactose and sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Miranova

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The Miranova pack contains 21 tablets, each marked with the day of the week on which it should be taken. Take the tablet at approximately the same time every day, if necessary with a little water. Follow the direction of the arrows until all 21 tablets are used. Do not take any tablets during the following 7 days, during which menstruation (withdrawal bleeding) should occur, usually starting 2–3 days after taking the last Miranova tablet. Begin the new pack on the eighth day, even if menstruation has not yet finished. By doing so, you will always start the new pack on the same day of the week, and withdrawal bleeding will occur approximately on the same days each month.
If tablets are missed or not taken correctly, combined oral contraceptives may lose their effectiveness.

Starting the first pack
No hormonal contraceptive used in the previous month
Begin taking Miranova on the first day of your cycle (i.e., the first day of menstruation), taking the tablet marked with that day of the week. For example, if menstruation starts on Friday, take the tablet marked Friday. Then continue in the order indicated by the arrows. Alternatively, you may start between the second and fifth day of the cycle, but in this case, use an additional contraceptive method (barrier method) for the first seven days of tablet intake in the first cycle.

Switching from another combined oral contraceptive, vaginal ring, or contraceptive patch
You may start taking Miranova the day after the last active tablet of your previous contraceptive (i.e., without any interval). If the previous pack contains inactive tablets, start Miranova the day after the last active tablet (in case of doubt, consult your doctor). You may also start later, but not later than the day after the tablet-free interval (or the day after the last inactive tablet) of the previous contraceptive. If you have used a vaginal ring or patch, start Miranova preferably on the day of removal of the last ring or patch of a cycle, or at the latest when the next application would have been due.

Switching from a progestogen-only pill (mini-pill)
You may stop the mini-pill on any day and start taking Miranova the next day at the same time. However, during the first seven days of tablet intake, use an additional contraceptive method (barrier method) when having sexual intercourse.

Switching from an injectable or implant contraceptive or from a progestogen-releasing intrauterine system (IUS)
Start using Miranova on the day your next injection is due or on the day the implant is removed. However, during the first seven days of tablet intake, use an additional contraceptive method (barrier method) when having sexual intercourse.

After childbirth
The timing of starting the pill after childbirth should be determined by your doctor. He or she will decide whether to start treatment between day 21 and day 28 or later. In the latter case, it is advisable to use an additional barrier method during the first 7 days of tablet intake. However, if you have had sexual intercourse in the meantime, exclude pregnancy or wait for the onset of the first menstruation before starting the pill.
If you are breastfeeding and wish to take Miranova, speak to your doctor first (see “Pregnancy and breastfeeding”).

After spontaneous or induced abortion
Follow your doctor’s instructions.

If you take more Miranova than you should
No serious adverse effects have been reported after taking several tablets at once. In such cases, nausea, vomiting, or vaginal bleeding may occur. Even girls who have not yet had their first menstruation but have accidentally taken this medicine may experience such bleeding.
In case of accidental ingestion/overdose of Miranova, contact your doctor immediately or go to the nearest hospital.

If you forget to take Miranova
If less than 12 hours have passed since the usual time of intake, the reliability of the pill is maintained. Take the missed tablet as soon as you remember and continue as usual.
If more than 12 hours have passed since the usual time of intake, the reliability of the pill may be reduced. The greater the number of consecutive tablets missed, the higher the risk that contraceptive protection is reduced. The risk of pregnancy is particularly high if tablets are missed at the beginning or end of the pack. Follow the instructions below (see also the flowchart that follows).

More than one tablet missed in a pack
Consult your doctor.

One tablet missed during the first week
Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and continue as usual. Use additional contraceptive methods (barrier method) for the next 7 days.
If you had sexual intercourse during the week before the missed tablet, pregnancy may have occurred. Inform your doctor immediately.

One tablet missed during the second week
Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and continue as usual. The reliability of the pill is maintained. No additional contraceptive precautions are necessary.

One tablet missed during the third week
You may choose one of the following alternatives, without needing additional contraceptive precautions.

1. Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and continue as usual. Start the new pack immediately after finishing the current one, without any tablet-free interval. Withdrawal bleeding may not occur until the end of the second pack, but you may experience intermenstrual bleeding (spotting) during tablet intake. or
2. Stop taking tablets from the current pack, observe a tablet-free interval of 7 days or less ( including the day the tablet was missed ), and then continue with a new pack. If you choose this option, you can always start the new pack on the same day of the week as you usually do.

If you forget to take one or more tablets and do not have your period during the first tablet-free interval, pregnancy may have occurred. Consult your doctor before starting the new pack.

more than one tablet missed in a cycle → consult your doctor
↑
did you have sexual intercourse in the week before the missed tablet?
↓
no
↓

• take the missed tablet
• use additional contraceptive precautions for 7 days
• finish the pack

only one tablet missed (more than 12 hours late)
second week →

• take the missed tablet
• finish the pack

third week →

• take the missed tablet
• finish the pack
• do not observe the tablet-free interval
• continue with the new pack

or

• stop the current pack
• observe a tablet-free interval (no more than 7 days, including the day the tablet was missed)
• continue with a new pack

In case of gastrointestinal disturbances (e.g., vomiting and/or diarrhoea)
If you vomit or have severe diarrhoea within 3–4 hours after taking Miranova, the active ingredient may not have been completely absorbed. This is similar to missing a tablet. Follow the instructions for missed tablets.

Delaying menstruation: what you should know
Although not recommended, it is possible to delay menstruation by starting a new pack of Miranova immediately without observing the 7-day tablet-free interval. During the use of this second pack, breakthrough bleeding or spotting may occur. Continue with the next pack after the usual 7-day interval.
Consult your doctor before deciding to delay menstruation.

Changing the day of onset of menstruation: what you should know
If you take the tablets as instructed, menstruation will begin approximately on the same day of the week. If you wish to change this day, you may shorten ( but never extend ) the usual break between two consecutive packs. For example, if your period usually starts on Friday and you wish it to start on Tuesday (3 days earlier), you should start the next pack 3 days earlier. If the break between two cycles is made too short (e.g., 3 days or less), menstruation may not occur during that interval. In such cases, you may experience breakthrough bleeding or spotting during the next treatment cycle.
Consult your doctor if you have any doubts about how to proceed.

If you stop taking Miranova
You may stop using Miranova at any time. If you do not wish to become pregnant, consult your doctor about other methods of birth control.
If you wish to stop using Miranova because you want to become pregnant, talk to your doctor. In this case, it is generally advisable to wait until menstruation returns to a regular pattern before trying to conceive.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Serious side effects

An increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) exists in all women taking combined hormonal contraceptives. For more detailed information on the different risks associated with taking combined hormonal contraceptives, see "Warnings and precautions".

Contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible difficulty breathing (see also section "Warnings and precautions").

The following side effects have been reported with the use of Miranova:

Common (may affect up to 1 in 10 people)

• nausea,
• abdominal pain,
• weight gain,

• headache,
• mood changes, depression,
• breast tenderness,
• breast pain.

Uncommon (may affect up to 1 in 100 people)

• vomiting,
• diarrhoea,
• fluid retention,
• migraine (unilateral headache),
• decreased sexual desire,
• breast enlargement,
• skin reactions (rash, urticaria).

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

• intolerance to contact lenses,
• hypersensitivity reactions (allergy),
• weight loss,
• increased sexual desire,
• breast discharge,
• vaginal discharge,
• skin disorders (nodular erythema, erythema multiforme),
• harmful blood clots in a vein or artery, for example: in a leg or foot (DVT), in a lung (PE), heart attack, stroke, mini-stroke or temporary stroke-like symptoms known as transient ischaemic attack (TIA), or blood clots in the liver, stomach/intestines, kidneys or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section "Warnings and precautions" for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

Frequency not known (cannot be estimated from the available data)

• exacerbation of symptoms of hereditary and acquired angioedema

The following conditions have been associated with combined oral contraception:

inflammatory bowel diseases (Crohn’s disease and ulcerative colitis), porphyria (a rare blood disorder), systemic lupus erythematosus (an autoimmune disease affecting multiple organs), gestational herpes (a skin rash affecting pregnant women or women after childbirth), Sydenham’s chorea (rapid, involuntary movements caused by an autoimmune disease), haemolytic uraemic syndrome (a disease causing blood clot formation), liver problems.

Reporting of side effects

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

5. How to store Miranova

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging (blister, box) after "EXP." The expiry date refers to the last day of that month. The expiry date applies to the product in its original, undamaged packaging stored under recommended conditions.
Do not use the medicine if you notice any change in colour or crumbling of the tablet, or if there are any other visible signs of deterioration.
Store below 30°C. Keep in the original packaging to protect the medicine from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Miranova contains

• The active substances are: levonorgestrel and ethinylestradiol. Each coated tablet contains 0.1 mg of levonorgestrel and 0.02 mg of ethinylestradiol.
• The other components are: lactose monohydrate, corn starch, pregelatinized starch, povidone 25, magnesium stearate, sucrose, povidone 90, macrogol 6000, calcium carbonate, talc, glycerol 85%, titanium dioxide, iron oxide red (E172), iron oxide yellow (E172), ethylene glycol ester of montanic acid (E wax).

Description of the appearance of Miranova and package contents
Coated tablets for oral use.
The product is packaged in calendar blisters containing 21 tablets.
Marketing Authorization Holder
Bayer S.p.A. - Viale Certosa, 130 - 20156 Milan (MI)
Manufacturer
Bayer AG, Muellerstrasse 170-178, D-13353; Berlin (Germany).
Bayer Weimar GmbH und Co. KG, Dobereinerstrasse 20, 99427 Weimar (Germany).