Mycyclamen

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Mycyclamen 0.02 mg/3 mg film-coated tablets

ethinylestradiol/drospirenone
Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives:

• They are one of the most reliable reversible contraceptive methods when used correctly.
• They slightly increase the risk of blood clots forming in 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 may have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of this leaflet

1. What Mycyclamen is and what it is used for
2. What you need to know before taking Mycyclamen
   • When you must not use Mycyclamen
   • Warnings and precautions
   • Blood clots
   • Mycyclamen and cancer
   • Bleeding between periods
   • What to do if no bleeding occurs during the placebo tablet days
   • Other medicines and Mycyclamen
   • Laboratory tests
   • Pregnancy and breastfeeding
   • Driving and using machines
   • Mycyclamen contains lactose
3. How to take Mycyclamen
   • Preparing the blister pack
   • When you can start the first blister pack
   • If you take more Mycyclamen than you should
   • If you forget to take Mycyclamen
   • What to do if you vomit or have severe diarrhoea
   • Delayed menstrual period: what you need to know
   • Change in the first day of your menstrual period: what you need to know
   • If you stop treatment with Mycyclamen
4. Possible side effects
5. How to store Mycyclamen
6. Contents of the pack and other information

1. What Mycyclamen is and what it is used for

• Mycyclamen is a contraceptive pill used to prevent pregnancy.
• Each of the 24 pink tablets contains a small amount of two different female hormones, namely ethinylestradiol and drospirenone.
• The 4 white tablets do not contain any active ingredients and are referred to as "placebo tablets".
• Contraceptive pills that contain two hormones are known as "combined" pills.

2. What you should know before taking Mycyclamen

General information
Before starting to use Mycyclamen, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 "Blood clots").
Before you start taking Mycyclamen, your doctor will ask you some questions about your personal and family medical history. In addition, your doctor will measure your blood pressure and, depending on your individual condition, may carry out other examinations.
This patient information leaflet describes various situations in which you must stop taking Mycyclamen or in which the safety of Mycyclamen may be reduced. In such situations, you must not have sexual intercourse or must use additional non-hormonal contraceptive measures, e.g. use a condom or other barrier methods. Do not use rhythm or temperature-based methods. These methods may not be reliable because Mycyclamen alters the monthly fluctuations in body temperature and cervical mucus.
Mycyclamen, like other hormonal contraceptives, does not protect against HIV (AIDS) or other sexually transmitted infections.

When you must not use Mycyclamen
Do not use Mycyclamen 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 individual case.

• if you have (or have ever had) a blood clot in a blood vessel in your leg (deep vein thrombosis, DVT), in your lung (pulmonary embolism, PE), or in other organs;
• if you have ever had a heart attack or a stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain that may be an early sign of a heart attack) or a transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following diseases, which may increase the risk of blood clots forming in the arteries:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats (cholesterol or triglycerides) in the blood
  • a condition known as hyperhomocysteinaemia
• 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 have (or have ever had) a type of migraine called "migraine with aura";
• if you have (or have ever had) a liver disease and liver function has not yet returned to normal;
• if your kidneys are not working properly (renal insufficiency);
• if you have (or have ever had) a liver tumour;
• if you have (or have ever had) or if it is suspected that you have cancer of the breast or genital organs;
• if you have unexplained vaginal bleeding;
• if you are due to undergo surgery or will be bedridden for a prolonged period (see section 2 "Blood clots");
• if you are allergic to ethinylestradiol or drospirenone, or to any of the other ingredients of this medicine (listed in section 6). This condition may manifest as itching, rash, or swelling;
• Do not use Mycyclamen if you have hepatitis C or if you are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (also see section "Other medicines and Mycyclamen").

Children and adolescents
Mycyclamen is not intended for use in women whose menstrual cycles have not yet started.
Elderly women
Mycyclamen is not intended for use after menopause.
Women with hepatic impairment
Do not take Mycyclamen if you suffer from liver disease (see sections "Do not take Mycyclamen" and "Warnings and precautions").
Women with renal impairment
Do not take Mycyclamen if you suffer from poorly functioning kidneys or acute renal failure (see sections "Do not take Mycyclamen" and "Warnings and precautions").

Warnings and precautions
When should you contact a doctor?
Seek immediate medical attention if:

• you notice possible signs of a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), in your 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, see the section "How to recognize a blood clot".
In certain situations, you must exercise particular caution when using Mycyclamen or any other combined oral contraceptive, and it may be necessary for you to be regularly monitored by your doctor.
Inform your doctor if any of the following conditions occur or worsen while you are using Mycyclamen:

• if a close relative has or has ever had breast cancer
• if you have cancer
• if you have a liver or gallbladder disease
• if you have other kidney problems or are taking medicines that increase potassium levels in the blood
• if you have diabetes
• if you suffer from depression
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease)
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure)
• if you have sickle cell anaemia (an inherited red blood cell disorder)
• if you suffer from epilepsy (see section "Other medicines and Mycyclamen")
• if you have systemic lupus erythematosus (SLE, a disease affecting the body's natural defence system)
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas)
• if you are due to undergo surgery or will be bedridden for a prolonged period (see section 2 "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 Mycyclamen
• if you have inflammation of veins under the skin (superficial thrombophlebitis)
• if you have varicose veins
• if you have a condition that first appeared during pregnancy or during previous use of sex hormones (e.g. hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (herpes gestationis), a nervous disorder causing sudden involuntary movements of the body (Sydenham's chorea))
• if during treatment you develop high blood pressure that is not controlled by medication
• if you have or have ever had brownish-yellow patches of pigmentation (chloasma), known as "pregnancy mask", particularly on the face. In this case, avoid direct exposure to sunlight or ultraviolet radiation while taking this medicine
• 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 a doctor immediately. Medicinal products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

Blood clots
Using a combined hormonal contraceptive such as Mycyclamen 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, such effects may be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with Mycyclamen is low.

How to recognize a blood clot
Seek immediate medical attention if you notice any of the following signs or symptoms.
Do you have any of these signs? What might you be suffering from?

• 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 colour of the leg, such as paleness, redness, or bluish discoloration
• sudden and unexplained shortness of breath or rapid breathing
• sudden cough without an obvious cause, possibly with

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 developing blood clots 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 Mycyclamen, 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 Mycyclamen 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, about 5–7 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as Mycyclamen, about 9–12 will develop a blood clot in one year.
• The likelihood of developing a blood clot 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 Mycyclamen is low, but certain conditions can increase this risk. 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 scheduled for surgery or need to remain bedridden for a prolonged period due to injury, illness, or if you have a leg in plaster. You may need to stop taking Mycyclamen several weeks before surgery or during periods of reduced mobility. If you need to stop taking Mycyclamen, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years);
• if you have given 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 >4 hours) may temporarily increase the risk of blood clot formation, especially if you have some of the other risk factors listed.
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 stop your use of Mycyclamen.
If any of the above conditions change while you are using Mycyclamen—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 can 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 Mycyclamen is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Mycyclamen, it is advisable to stop smoking. If you cannot 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 (valvular defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions, or if one of them 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 Mycyclamen—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.

Mycyclamen and cancer
Breast cancer has been observed slightly more frequently in women using "combined pills," but it is not known whether this is caused by the treatment. For example, it is possible that more tumors are diagnosed in women using "combined pills" because they undergo more frequent medical check-ups. The occurrence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important to regularly examine your breasts and contact your doctor if you feel any lumps.
Rarely, benign liver tumors and, even more rarely, malignant liver tumors have been reported in women using the pill. Contact your doctor if you experience unusual abdominal pain or severe abdominal swelling (which may be due to liver enlargement).

Bleeding between periods
During the first few months of taking Mycyclamen, unexpected bleeding (bleeding outside the placebo tablet days) may occur. If this bleeding continues for more than a few months or starts after several months, your doctor should investigate the cause.

What to do if bleeding does not occur during the placebo tablet days
If you have taken all the pink tablets correctly, have not vomited or had severe diarrhea, and have not taken other medicines, it is very unlikely that you are pregnant.
If the expected bleeding does not occur for two consecutive cycles, you may be pregnant. Contact your doctor immediately. Do not start the next blister pack until you are sure you are not pregnant.

Psychiatric disorders
Some women using hormonal contraceptives, including Mycyclamen, have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or depressive symptoms, consult your doctor as soon as possible for further medical advice.

Other medicines and Mycyclamen
Inform your doctor about any medicines or herbal remedies you are taking, have recently taken, or might take. Also inform any other doctor or dentist who prescribes medicines (or your pharmacist) that you are taking Mycyclamen. They will advise you whether you need additional contraceptive precautions (e.g., condom) and for how long, or whether the use of another medicine you need should be adjusted.
Do not use Mycyclamen if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this may lead to increased results in blood tests assessing liver function (increase in liver enzyme ALT levels).
Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
You may restart taking Mycyclamen approximately 2 weeks after completing the treatment (see section “When not to use Mycyclamen”).

Some medicines affect the blood levels of Mycyclamen and may reduce its effectiveness in preventing pregnancy or may cause unexpected bleeding. These include:

• medicines used to treat epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbamazepine, felbamate, topiramate) or tuberculosis (e.g., rifampicin) or HIV and hepatitis C infections (medicines called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz) or fungal infections (griseofulvin, ketoconazole) or arthritis, osteoarthritis (etoricoxib) or high blood pressure in the lung vessels (bosentan);
• the herbal preparation St. John’s wort.

If you are taking any of the above medicines together with Mycyclamen, you must use additional contraceptive precautions (for example, use of a condom) during and for 28 days after the treatment.
Mycyclamen may affect the effect of other medicines, for example:

• medicines containing cyclosporine;
• the antiepileptic lamotrigine (this may lead to increased frequency of seizures);
• theophylline (used to treat respiratory problems);
• tizanidine (used to treat muscle pain and/or muscle cramps).

Your doctor may monitor your blood potassium levels if you are taking certain medicines for heart conditions (e.g., diuretics).

Laboratory tests
If you require a blood test, inform your doctor or laboratory staff that you are taking the pill, as hormonal contraceptives can alter the results of certain tests.

Pregnancy and breastfeeding
Pregnancy
Do not take Mycyclamen if you are pregnant. If you become pregnant while taking Mycyclamen, stop taking it immediately and inform your doctor. If you wish to become pregnant, you can stop taking Mycyclamen at any time (see “If you stop treatment with Mycyclamen”).

Breastfeeding
The use of Mycyclamen is generally not recommended for women who are breastfeeding. If you wish to take the pill while breastfeeding, contact your doctor.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
There is no evidence to suggest that the use of Mycyclamen affects the ability to drive vehicles or operate machinery.

Mycyclamen contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Mycyclamen

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Each blister contains 24 pink active tablets and 4 white placebo tablets.
The two differently coloured tablets of Mycyclamen are arranged in order. One blister contains 28
tablets.
Take one tablet of Mycyclamen every day, with a small amount of water if necessary. You may
take the tablets with or without food, but you must take them at approximately the same time each day.
Do not confuse the tablets: take one pink tablet for the first 24 days, followed by one white tablet for the last 4 days. After this, immediately start a new blister (24 pink tablets followed by 4 white tablets). Therefore, there is no break between two blisters.
Due to the different composition of the tablets, start with the first tablet in the top left corner and take one tablet each day. Follow the direction of the arrow on the blister for the correct order.
Blister preparation
To help you follow the correct order, there are 7 labels, each showing one of the 7 days of the week, for each Mycyclamen blister. Choose the label corresponding to the day you start taking the tablets. For example, if you start on Wednesday, use the weekly label marked “WED”.
Stick the appropriate label to the upper left corner of the blister at the position marked “Start”. This way, each tablet will have a day marked above it, so you can see whether you have taken a particular tablet. The arrows indicate the order in which you should take the tablets.
During the 4 days when you take the white placebo tablets (the placebo days), you should experience menstruation (called “withdrawal bleeding”). This usually starts on the 2nd or 3rd day after the last active pink tablet of Mycyclamen. After taking the last white tablet, start the next blister immediately, even if your menstruation has not yet ended. This means you must start each blister on the same day of the week, and the withdrawal bleeding should occur every month on the same days.
If you use Mycyclamen in this way, you will be protected from pregnancy even during the 4 days when you take the placebo tablets.
When can you start the first blister?

• If you have not used any contraceptive in the previous month Start taking Mycyclamen on the first day of your cycle (i.e. the first day of your menstruation). If you start taking Mycyclamen on the first day of menstruation, you will be immediately protected against pregnancy. You may also start between day 2 and day 5 of your cycle, but you must use additional contraceptive precautions (e.g. a condom) for the first 7 days.
• Switching from another combined hormonal contraceptive or from a combined contraceptive in the form of a vaginal ring or patch Start taking Mycyclamen preferably the day after the last active tablet (the last tablet containing active ingredients) of your previous pill, or at the latest the day after the end of the pill-free interval (or after the last inactive tablet of your previous pill). When switching from a combined contraceptive in the form of a vaginal ring or patch, follow your doctor’s advice.
• Switching from a progestogen-only method (progestogen-only pills, injection, implant, or intrauterine system releasing progestogen - IUD) You may switch on any day from the progestogen-only pill (from an implant or IUD on the day of its removal, from an injectable when your next injection is due), but in all these cases you must use additional contraceptive precautions (e.g. a condom) for the first 7 days of tablet intake.
• After an abortion or termination of pregnancy Follow your doctor’s advice.
• After childbirth After childbirth, you may start taking Mycyclamen between 21 and 28 days postpartum. If you start more than 28 days after childbirth, you must use a so-called barrier contraceptive method (e.g. a condom) for the first 7 days of taking Mycyclamen. If you have had sexual intercourse after childbirth before starting Mycyclamen, you must first ensure that you are not pregnant, otherwise wait until your next menstruation.
• If you are breastfeeding and wish to start (or restart) using Mycyclamen after childbirth Read the section “Breast-feeding”.

If you are unsure, ask your doctor when to start.
If you take more Mycyclamen than you should
There are no reports of serious or life-threatening consequences from taking too many Mycyclamen tablets.
If you have taken several tablets at once, you may experience symptoms such as nausea, vomiting, or vaginal bleeding. Even girls who have not yet had their first menstrual period but who have accidentally taken this medicine may experience such bleeding.
If you have taken too many Mycyclamen tablets or if you find that a child has ingested them, contact your doctor or pharmacist for advice.
If you forget to take Mycyclamen
The last 4 tablets in the fourth row of the blister are placebo tablets. If you forget to take one of these tablets, this will have no effect on the effectiveness of Mycyclamen. Discard the forgotten placebo tablets.
If you forget an active pink tablet (tablets 1–24 of the blister), do the following:

• If you are less than 24 hours late in taking a tablet, your protection against pregnancy is not reduced. Take the missed tablet as soon as you remember, then take the next tablet at the usual time.
• If you are more than 24 hours late in taking a tablet, your protection against pregnancy may be reduced. The greater the number of tablets missed, the higher the risk of pregnancy.

The risk of incomplete protection against pregnancy is higher if you miss a pink tablet at the beginning or end of the blister. Therefore, follow the rules below (see the diagram below):

• More than one tablet missed in the blister

Contact your doctor.

• One tablet missed on days 1–7 (first row)

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Take the following tablets as scheduled and use additional precautions for the next 7 days, for example a condom. If you had sexual intercourse in the week before missing the tablet, consider that there may be a risk of pregnancy. In this case, contact your doctor.

• One tablet missed on days 8–14 (second row)

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Take the following tablets as scheduled. Protection against pregnancy is not reduced and no additional precautions are needed.

• One tablet missed on days 15–24 (third or fourth row)

You have two options:

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Take the following tablets as scheduled. Instead of taking the white placebo tablets of this blister, discard them and immediately start the next blister (your starting day will be different). Your menstruation will most likely occur at the end of the second blister, during the intake of the white placebo tablets, but spotting or bleeding may occur during the second blister.
2. You may also stop taking the active pink tablets and go directly to the 4 white placebo tablets (before taking the placebo tablets, note the day on which you forgot to take the tablet). If you wish to start a new blister on your usual starting day, take the placebo tablets for fewer than 4 days.

If you follow either of these two recommendations, you will remain protected against pregnancy.

• If you have missed any tablet from a blister and do not have a menstrual period during the placebo days, this may mean you are pregnant. You must contact your doctor before starting the next blister.

The following diagram describes what to do if you forget to take tablets
What to do in case of vomiting or severe diarrhoea
If you vomit within 3–4 hours after taking an active pink tablet or if you have severe diarrhoea, there is a risk that the active ingredients of the tablet are not fully absorbed by your body. In this case, you may need to use additional protection (such as a condom) to avoid pregnancy. The situation is similar to missing a tablet. After vomiting or diarrhoea, take another pink tablet from a spare blister as soon as possible: if possible, take it within 12 hours of your usual pill-taking time. If this is not possible or if more than 12 hours have passed, follow the advice given in the section “If you forget to take Mycyclamen”.
Delayed menstrual period: what you should know
Although not recommended, it is possible to delay your menstrual period by not taking the white placebo tablets of the 4th row and immediately starting a new blister of Mycyclamen until it is finished. Light spotting or menstrual-like bleeding may occur during the use of the second blister. Finish this second blister, including the 4 white tablets of the fourth row. Then start the next blister.
You must consult your doctor before deciding to delay your menstrual period.
Changing the first day of your menstrual period: what you should know
If you take the tablets as instructed, your menstrual period will begin during the placebo days. If you wish to change the starting day, you may shorten (but never lengthen – 4 days is the maximum!) the placebo days when taking the white placebo tablets. For example, if your period starts on Friday during the placebo tablets and you wish to shift it to Tuesday (3 days earlier), you should start the new blister 3 days earlier than usual. It may happen that you do not have any bleeding during this period. Light spotting or menstrual-like bleeding may occur.
If you are unsure how to proceed, contact your doctor for advice.
If you stop taking Mycyclamen
You may stop taking Mycyclamen at any time. If you do not wish to become pregnant, ask your doctor for advice on other reliable methods of birth control. If you wish to become pregnant, stop taking Mycyclamen and wait for one menstrual cycle before trying to conceive. This will make it easier to calculate your due date.
If you have further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think could be due to Mycyclamen, inform your doctor.
All women taking combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 "What you need to know before taking Mycyclamen".
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 breathing difficulties (see also section "Warnings and precautions").
If any of the following side effects occur, you may need urgent medical attention. Stop taking Mycyclamen and contact a doctor or go immediately to the nearest hospital.
Rare (may affect up to 1 in 1,000 women):

• inflammation of the gallbladder
• hypersensitivity (allergic reactions with signs such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives accompanied by breathing difficulties)
• dangerous blood clots in a vein or artery, for example:
• in a leg or foot (i.e. deep vein thrombosis (DVT))
• in a lung (e.g. pulmonary embolism)
• heart attack
• stroke
• mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA)
• blood clots in the liver, stomach/intestine, kidneys or eyes.

The likelihood of developing a blood clot may be higher if you have any other condition that increases the risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of blood clots).
Conditions that may occur or worsen during pregnancy or with previous use of the pill include:

• systemic lupus erythematosus (SLE, a disease affecting the immune system)
• inflammation of the colon or other parts of the intestine (with signs such as bloody diarrhoea, pain on defecation, abdominal pain) (Crohn’s disease and ulcerative colitis)
• epilepsy
• uterine fibroids (non-cancerous tumours that can develop within the muscular tissue of the uterus)
• blood pigment disorder (porphyria)
• blistering rash (herpes gestationis) during pregnancy
• Sydenham’s chorea (a nerve disorder characterised by sudden, involuntary movements of the body)
• blood disorders causing kidney damage (haemolytic uraemic syndrome with signs such as reduced urine production, blood in the urine, reduced red blood cells, nausea, vomiting, confusion and diarrhoea)
• yellowing of the skin or whites of the eyes due to blockage of the bile duct (cholestatic jaundice).

Additionally, breast cancer has been observed (see section 2 “Mycyclamen and cancer”), as well as non-cancerous (benign) and cancerous (malignant) liver tumours (with signs such as abdominal swelling, weight loss, abnormal liver function tests detectable in blood tests), and chloasma (brownish-yellow pigmented patches on the skin, particularly on the face, so-called “melasma” or “pregnancy mask”, which may be permanent, especially in women who previously had chloasma during pregnancy).
Other possible side effects
Common (may affect up to 1 in 10 women):

• mood changes
• headache
• nausea
• breast pain, menstrual disorders such as irregular periods, absence of periods

Uncommon (may affect up to 1 in 100 women):

• depression, nervousness, sleep disturbances
• dizziness, tingling sensations
• migraine, varicose veins, increased blood pressure
• stomach pain, vomiting, indigestion, flatulence, stomach inflammation, diarrhoea
• acne, itching, skin rash
• pain, for example in the back, limbs, muscle cramps
• vaginal fungal infection, pelvic pain, breast enlargement, benign breast nodules, uterine/vaginal bleeding (which usually stops if treatment is continued), vaginal discharge, hot flushes, inflammation of the vagina (vaginitis), menstrual disorders, painful periods, reduced menstruation, very heavy periods, vaginal dryness, abnormal Pap smear, reduced interest in sex
• lack of energy, increased sweating, fluid retention (with signs such as swelling of the face and limbs)
• weight gain.

Rare (may affect up to 1 in 1,000 women):

• candidiasis (fungal infection)
• anaemia, increased number of platelets in the blood
• allergic reaction
• hormonal disorders (endocrine)
• increased appetite, loss of appetite, abnormally high potassium levels in the blood, abnormally low sodium levels in the blood
• failure to achieve orgasm, insomnia
• dizziness, tremor
• eye disorders, for example eyelid inflammation, dry eyes
• abnormally rapid heartbeat
• vein inflammation, nosebleeds, fainting
• abdominal swelling, intestinal disorders, bloated feeling, stomach hernia, fungal infection of the mouth, constipation, dry mouth
• pain in the bile ducts or gallbladder
• eczema, hair loss, acneiform skin inflammation, dry skin, skin inflammation with nodule formation, excessive hair growth, skin disorders, stretch marks, skin inflammation, photosensitive skin inflammation, skin nodules
• painful or difficult sexual intercourse, vaginal inflammation (vulvovaginitis), bleeding after intercourse, breakthrough bleeding, breast cysts, increased breast cells (hyperplasia), abnormal growth of the mucosal surface of the cervix, contraction or atrophy of the uterine lining, ovarian cysts, uterine enlargement
• general feeling of malaise
• weight loss.

Not known (frequency cannot be estimated from the available data):

• erythema multiforme (skin rash with target-like lesions or ulcers).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may 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 Mycyclamen

Keep this medicine out of the sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date which is stated on the blister and carton after “Do not use after” or “EXP”. The expiry date refers to the last day of that month.
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 Mycyclamen contains
The active substances are ethinylestradiol and drospirenone.
Each pink film-coated active tablet contains 0.02 milligrams of ethinylestradiol and 3 milligrams of drospirenone.
The white film-coated tablet does not contain any active substances.

The other components are:
Pink film-coated active tablets: monohydrate lactose, pregelatinized starch (maize), povidone (E1201), croscarmellose sodium, polysorbate 80, magnesium stearate (E572), polyvinyl alcohol, titanium dioxide (E171), macrogol, talc (E553b), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
White film-coated inactive tablets: anhydrous lactose, povidone (E1201), magnesium stearate (E572), partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol, talc (E553b).

Description of the appearance of Mycyclamen and package contents

• Each Mycyclamen blister pack contains 24 round, film-coated pink tablets in rows 1, 2, 3 and 4, and 4 white placebo tablets, film-coated, in row 4.
• Mycyclamen tablets, both pink and white, are film-coated. The tablet core is coated.
• Mycyclamen is available in cardboard boxes containing 1, 3, 6 or 13 blisters, each blister containing 28 tablets (24+4).

Not all pack sizes may be marketed.

Marketing Authorization Holder
Exeltis Italia S.r.l.
Via Lombardia, 2/A
20068 Peschiera Borromeo (MI)
Italy

Manufacturers
Laboratorios León Farma, S.A.
C/ La Vallina s/n, Pol. Ind. Navatejera.
24193 - Villaquilambre, León.
Spain
McDermott Laboratories Ltd
35 Baldoyle Industrial Estate, Grange Road
Dublin 13
Ireland
Mylan Hungary Kft
2900 Komárom,
Mylan Pharma Utca 1
Hungary

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium: Marliesviatris 0,02 mg/3 mg filmomhulde tabletten
Italy: Mycyclamen
Netherlands: Ethinylestradiol/Drospirenon Viatris 24+4 0,02 mg/3 mg, filmomhulde tabletten
Portugal: Drosdiol
Spain: Etinilestradiol/Drospirenona Viatris Pharmaceuticals 0,02 mg/3 mg comprimidos recubiertos con pelicula (24+4) EFG