MYCYCLAMEN 0.02 MG/3 MG Film-coated tablets

Зміст інструкції

1. Mycyclamen 0.02 mg/3 mg film-coated tablets
   1. Cos’è Mycyclamen e a cosa serve
   2. Cosa deve sapere prima di prendere Mycyclamen
   3. How to take Mycyclamen
   4. Possible side effects
   5. How to store Mycyclamen
   6. Package Contents and Other Information

Mycyclamen 0.02 mg/3 mg film-coated tablets

ethinylestradiol/drospirenone
Generic medicine

Read this leaflet carefullybeforetaking this medicine because 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 only for you. Do not pass it on to others even if their symptoms are the same as yours, as it could be harmful
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Important things to know about combined hormonal contraceptives:

• They are one of the most reliable reversible methods of contraception, if 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
• Pay attention and see your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”)

Contents of this leaflet

• 1. What is Mycyclamen and what it is used for
• 2. What you need to know before you take Mycyclamen
• When you must not use Mycyclamen
• Warnings and precautions
• Blood clots
• Mycyclamen and cancer
• Bleeding between periods
• What to do if your withdrawal bleeding does not occur 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
• Preparation of the blister
• When you can start with the first blister
• If you take more Mycyclamen than you should
• If you forget to take Mycyclamen
• What to do if you vomit or have severe diarrhoea
• Delay in your period: what you need to know
• Changing the first day of your period: what you need to know
• If you stop taking Mycyclamen
• 4. Possible side effects
• 5. How to store Mycyclamen
• 6. Contents of the pack and other information

1. Cos’è Mycyclamen e a cosa serve

• Mycyclamen is a contraceptive pill and is 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 called “placebo tablets”.
• Contraceptive pills that contain two hormones are called “combined” pills.

2. Cosa deve sapere prima di prendere Mycyclamen

General information
Before starting to use Mycyclamen, read the information on blood clots in paragraph 2. It is
particularly important that you read the symptoms of a blood clot (see paragraph 2 “Blood
clots”).
Before taking Mycyclamen, your doctor will ask you some questions about your personal medical history
and that of your family. In addition, the doctor will measure your blood pressure and, depending on your
personal conditions, may also perform other tests.
Mycyclamen, or in which the safety of Mycyclamen may be reduced. In such situations, you should not
have sexual intercourse or you should take additional non-hormonal contraceptive measures, e.g. use a
condom or other barrier methods. Do not use methods based on the rhythm or temperature. These methods
may not be reliable because Mycyclamen alters the monthly variations in body temperature and
cervical mucus.

Mycyclamen, like other hormonal contraceptives, does not protect against HIV (AIDS) or other
sexually transmitted diseases.
When not to 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. The doctor will discuss with you other methods of birth
control that may be more suitable for your case.

• if you have (or have ever had) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lung (pulmonary embolism, PE) or in other organs;
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris(a condition that causes severe chest pain and may be a first sign of a heart attack) or a transient ischemic attack (TIA - symptoms of a temporary stroke);
• if you have one of the following diseases, which may increase the risk of blood clots forming in the arteries:
• severe diabetes with damage to blood vessels
• very high blood pressure
• very high levels of fats (cholesterol or triglycerides) in the blood
• a disease known as hyperhomocysteinemia
• if you know you have a disorder that affects 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 do not work properly (renal failure);
• if you have (or have ever had) a liver tumor;
• if you have (or have ever had) or suspect you have breast or genital cancer;
• if you have unexplained vaginal bleeding;
• if you are going to have surgery or will be bedridden for a long period (see paragraph 2 “Blood clots”);
• if you are allergic to ethinylestradiol or drospirenone, or to any of the other ingredients of this medicine (listed in paragraph 6). This condition can manifest with itching, rash or swelling;
• Do not use Mycyclamen if you have hepatitis C or are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also paragraph “Other medicines and Mycyclamen”).

Children and adolescents
Mycyclamen is not intended for use in women whose cycle has not yet started.

Elderly women
Mycyclamen is not intended for use after menopause.

Women with hepatic insufficiency
Do not take Mycyclamen if you suffer from a liver disease (see paragraphs “Do not take Mycyclamen”
and “Warnings and precautions”).

Women with renal insufficiency
Do not take Mycyclamen if you suffer from poorly functioning kidneys or acute renal failure (see paragraphs
“Do not take Mycyclamen” and “Warnings and precautions”).

Warnings and precautions
When should you contact a doctor?
Contact your doctor urgently

• if you observe possible signs of a blood clot that may indicate 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 paragraph "Blood clot (thrombosis)").

For a description of the symptoms of these serious side effects, see the paragraph “How to recognize a
blood clot”.
In some situations, you need to be particularly careful when using Mycyclamen or any other combined
pill and may need to be regularly checked by your doctor.

Tell your doctor if any of the following conditions appear 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 hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (an inherited red blood cell disease);
• if you suffer from epilepsy (see paragraph “Other medicines and Mycyclamen ”)
• if you have systemic lupus erythematosus (SLE, a disease that affects the body's defense system);
• if you have high levels of fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are going to have surgery or will be bedridden for a long period (see paragraph 2 “Blood clots”);
• if you have just 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 the veins in the skin (superficial thrombophlebitis);
• if you have varicose veins
• if you have a disease that appeared for the first time during pregnancy or during previous use of sex hormones (e.g. loss of hearing, a blood disease called porphyria, rash with blisters during pregnancy (herpes gestationalis), a nervous disease in which sudden movements of the body appear) (Sydenham's chorea)
• if you have high blood pressure during therapy that is not controlled by medication
• if you have or have ever had brown-golden pigmented patches (chloasma), known as “pregnancy mask”, especially on the face). In this case avoid directexposure to sunlight or ultraviolet rays while taking this medicine
• if you notice symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with possible difficulty breathing, contact your doctor immediately. Products containing estrogens can cause or worsen the symptoms of hereditary and acquired angioedema.

Blood Clots
The use of a combined hormonal contraceptive like Mycyclamen causes an increased risk of
developing a blood clot compared to not using it.
In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop

• in the veins (a condition called “venous thrombosis”, "venous thromboembolism” or VTE)
• in the arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or TEA).

Healing from blood clots is not always complete. Rarely, there may be long-term serious effects or, 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
Contact your doctor immediately if you notice any of the following signs or symptoms.
Do you have any of these signs? What are you likely to suffer from?

• swelling in one leg or along a vein in the leg or foot, especially if accompanied by: Deep vein thrombosis
• pain or sensitivity in the leg that can only be felt when standing or walking
• increased feeling of heat in the affected leg
• change in the color of the skin of the leg, such as paleness, redness or bluishness
• sudden shortness of breath or rapid breathing;
• sudden cough without a clear cause, with Pulmonary embolism

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 in the veins (venous thrombosis). However, these side effects are rare. In

most cases they occur in the first year of use of a combined hormonal contraceptive.
If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).

• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• Very rarely, the clot can 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 you take
a combined hormonal contraceptive for the first time. The risk may also be higher if you
restart a combined hormonal contraceptive (the same medicine or a different medicine)
after a break of 4 or more weeks.
After the first year, the risk decreases but is still 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 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.

• Out of 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone or norgestimate, about 5-7 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as Mycyclamen, about 9-12 will develop a blood clot in a year.
• The risk of a blood clot forming depends on your medical history (see below “Factors that increase the risk of a blood clot forming”).

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 some conditions cause an
increase. Your risk is higher:

• if you are strongly overweight (body mass index or BMI higher than 30 kg/m2);
• if a close relative of yours has had a blood clot in a leg, lung or other organ at a young age (under about 50 years). In this case you may have an inherited blood clotting disorder;
• if you have to undergo surgery or if you have to stay in bed for a long period due to an injury or illness or if you have a leg in plaster. You may need to stop taking

Mycyclamen a few weeks before the operation or during the time when you are less mobile. 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) can temporarily increase the risk of a blood clot
forming, especially if you have some of the other risk factors listed.
It is important that you tell your doctor if any of these conditions apply to you, even if you
are not sure. Your doctor may decide to stop you from taking Mycyclamen.
If any of the above conditions change while you are using Mycyclamen, for example if a
close relative develops a thrombosis for no known reason or if you gain a lot of 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 cause 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 can increase:

• as you get older (over 35 years);
• if you smoke. When you use a combined hormonal contraceptive like Mycyclamen it is advisable that you quit smoking. If you cannot quit smoking and you are over 35 years old, your doctor may advise you to use a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative of yours has had a heart attack or stroke at a young age (under about 50 years). In this case you may also be at high 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 any heart problems (valve 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 serious, 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 to
smoke, if a close relative develops a thrombosis for no known reason or if you gain a lot of weight,
contact your doctor.

Mycyclamen and cancer
Breast cancer has been observed with slightly higher frequency in women who use “combined pills” but it is not known whether this is caused by the treatment. For example, it is possible that a greater number of tumors are diagnosed in women who use “combined pills” because they undergo more frequent medical check-ups. The occurrence of breast cancer becomes gradually less frequent after stopping combined hormonal contraceptives. It is important to check your breasts regularly and
contact your doctor if you feel any lumps.
In rare cases, benign and in even rarer cases, malignant tumors of the liver have been reported in women
who use the pill. Contact your doctor if you experience unusual abdominal pain and intense abdominal swelling (which may be due to enlargement of the liver).

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

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

Psychiatric disorders
Some women who use hormonal contraceptives including Mycyclamen have reported depression or a depressed mood. Depression can be severe and sometimes can lead to suicidal thoughts. If you experience
mood changes and depressive symptoms, seek medical advice as soon as possible.
.

Other medicines and Mycyclamen
Tell your doctor what medicines or herbal remedies you are taking, have recently taken or might
take. Also tell any other doctor or dentist who prescribes you other medicines (or the pharmacist) that
you are taking Mycyclamen. They may tell you whether you need to use additional contraceptive precautions (e.g. a condom) and for how long or whether the use of another medicine you need must be
modified.
Do not use Mycyclamen if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir as this could result in an increase in test results for the evaluation of liver function (increased levels of the liver enzyme ALT).

Your doctor will prescribe you another type of contraceptive before starting therapy with these
medicines.
It is possible to start taking Mycyclamen again about 2 weeks after completing therapy
(see section “When not to use Mycyclamen”).
Some medicines have an influence on the blood levels of Mycyclamen and can reduce its effectiveness in
preventing pregnancy or can cause unexpected bleeding. These include:

• medicines used for the treatment of 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 vessels of the lungs (bosentan)
• herbal preparation St John's Wort

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

• medicines containing ciclosporin
• the antiepileptic lamotrigine (this can lead to a higher frequency of seizures)
• theophylline (used to treat breathing problems)
• tizanidine (used to treat muscle pain and/or muscle cramps).

Your doctor may check your blood potassium levels if you are taking some medicines for
treating heart problems (e.g. diuretics)

Laboratory tests
If you need a blood test, tell your doctor or laboratory personnel that you are taking
the pill, because hormonal contraceptives can alter the results of some tests.

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

Breastfeeding
The use of Mycyclamen is generally not recommended for women who are breastfeeding. If you want to take the pill
while breastfeeding you should contact your doctor.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

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

Mycyclamen contains lactose and sodium
If your doctor has told you that you have an intolerance to some sugars, contact him 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 always exactly as your doctor or pharmacist has told you. If you have
doubts ask your doctor or pharmacist.
Each blister contains 24 active pink tablets and 4 placebo white tablets.
The two tablets of different colors of Mycyclamen are arranged in order. One blister contains 28
tablets.
Take one Mycyclamen tablet every day, if necessary with a small amount of water. You can
take the tablets with a full or empty stomach, but you must take the tablets every day at about the
same time.

Do not confuse the tablets: take a pink tablet for the first 24 days and then a white tablet
for the last 4 days. After that you must immediately start a new blister (24 pink tablets and then 4
white tablets). Therefore, there is no interval between 2 blisters.
Due to the different composition of the tablets you must start with the first tablet at the top left
and take the tablets every day. For the correct order follow the direction of the arrow on the blister.

Blister preparation
To help you follow the correct order there are 7 labels each with the 7 days of the week for each
blister of Mycyclamen. Choose the label corresponding to the day you start taking the tablets. If,
for example, you start on Wednesday, use the weekly label that says “WED”.
Stick the corresponding label in the upper left corner of the blister in the “Start” position. There will
thus be a day indicated above each tablet and you will be able to see if you have taken a certain pill. The
arrows indicate the order in which you must take the pills.
During the 4 days 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 Mycyclamen tablet. After taking the last white tablet, you must start the next blister
even if menstruation has not yet ended. This means that you must start each blister

on the same day of the weekand that the withdrawal bleeding must 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 you take the
placebo tablet.

When can you start with the first blister?

• If you have not used a contraceptive in the previous monthStart 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 your menstruation you will be immediately protected from pregnancy. You can also start between the 2nd and 5th day of your cycle, but you must use additional protective measures (e.g. a condom) for the first 7 days.
• Switching from another combined hormonal contraceptive or from a combined contraceptive inthe form of a vaginal ring or patchStart taking Mycyclamen preferably the day after the last active tablet (the last tablet containing the active ingredients) of the previous pill, or at the latest the day after the pill-free interval (or after the last inactive tablet of the 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 progestin-only method (progestin-only pills, injection,implant or progestin-releasing intrauterine system-IUD)You can switch from the progestin-only pill (from an implant or IUD on the day of its removal, from an injectable when you are due for the next injection) at any time, but in all these cases you must use additional protective measures (e.g. a condom) for the first 7 days of taking the tablets.
• After an abortion or termination of pregnancy.Follow your doctor's advice.
• After giving birth.After giving birth you can start using Mycyclamen between 21 and 28 days after delivery. If you start after more than 28 days, 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 delivery before starting to use Mycyclamen, you must first make sure you are not pregnant, otherwise you must wait until your next menstruation.
• If you are breastfeeding and want to start (or restart) using Mycyclamen afterdeliveryRead the paragraph “Breastfeeding”.

If you are not sure, ask your doctor for advice on when to start.

If you take more Mycyclamen than you should
There are no reports of serious and dangerous consequences of taking too many Mycyclamen
tablets.
If you have taken several tablets at the same time, you may have symptoms of nausea or vomiting or bleeding
from the vagina. 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 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 rowof the blister are placebo tablets. If you forget to take one
of these tablets, this will have no effect on the effectiveness of Mycyclamen. Throw away the forgotten
placebo tablets.
If you have forgotten a pink active tablet (tablets 1-24 of the blister) you must do the following:

• If you are less than 24 hours latein taking a tablet, protection against pregnancy is not reduced. Take the tablet as soon as you remember and then take the next tablet as scheduled at the same time.
• If you are more than 24 hours latein taking a tablet, protection against pregnancy may be reduced. The more tablets you have forgotten, the greater the risk of becoming pregnant.

The risk of incomplete protection from pregnancy is greater if you have forgotten a pink
tablet at the beginning or end of the blister. Therefore, you must follow these rules (see the diagram below):

• More than one tablet forgotten in the blister

Contact your doctor.

• One tablet forgotten on days 1-7 (first row)

Take the forgotten tablet as soon as you remember, even if this means taking 2
tablets at the same time. Take the next tablets as scheduled and use additional
precautionsfor the next 7 days, for example a condom. If you have had sexual intercourse
in the week before forgetting the tablet, you should consider that there is a risk of
pregnancy. In this case contact your doctor.

• One tablet forgotten on days 8-14 (second row)

Take the forgotten tablet as soon as you remember, even if this means
taking 2 tablets at the same time. Take the next tablets as scheduled. The
protection against pregnancy is not reduced and you do not need to take additional precautions.

• One tablet forgotten on days 15-24 (third or fourth row)

You can choose between 2 options

• 1. Take the forgotten tablet as soon as you remember, even if this means taking 2 tablets at the same time. Take the next tablets as scheduled. Instead of taking the white placebo tablets of this blister, throw them away and start directly with the next blister (the start day will be different). You will most likely experience menstruation at the end of the second blister, during the taking of the white placebo tablets, but spotting or bleeding may occur during the second blister.
• 2. You can 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 whichyou forgot to take the tablet).If you want to start a new blister on your usual start day, take the placebo tablets for less than 4 days.

If you follow one of these two recommendations, you will remain protected from pregnancy.

• If you have forgotten any of the tablets in a blister and do not have a menstruation during the placebo days, this may mean that you are pregnant. You should contact your doctor before starting the next blister.

The following diagram describes how to proceed if you have forgotten to take tablets

What to do in case of vomiting or severe diarrhea
If you vomit within 3-4 hours of taking a pink active tablet or if you have severe diarrhea, there is a risk
that the active ingredients of the tablet are not completely absorbed by the body, in which case you may
need to use additional protection (such as a condom) to avoid pregnancy. The
situation is similar to that in case of forgetting a tablet. After vomiting or diarrhea, you should
take as soon as possible, another pink tablet from a reserve blister: if possible take it within

12 hoursof your usual pill-taking time. If this is not possible or if more than 12
hours have passed, you must follow the advice given in the paragraph “If you forget to take Mycyclamen”.

Delay of the menstrual period: what you need to know
Even if not recommended, it is possible to delay your menstrual period by not taking the
white placebo tablets of the 4th row and starting directly with a new blister of Mycyclamen until you finish it.
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 should ask your doctor for advice before deciding to delay your menstrual period.
Change of the first day of your menstrual period: what you need to know
If you take the tablets according to the instructions your menstrual period will start during the placebo days. If
you want to change the start day you can reduce (never increase - 4 days is the maximum!) the placebo days,
when you take the white placebo tablets. For example, if your period with the placebo tablets starts on
Friday and you want to move it to Tuesday (3 days earlier), you must start the new blister 3 days earlier.
You may not have any bleeding during this period. Light
spotting or menstrual-like bleeding may occur.

If you are not sure how to proceed, contact your doctor for advice.
If you stop taking Mycyclamen
You can stop taking Mycyclamen whenever you want. If you do not want to become pregnant, ask
your doctor for advice on other reliable methods of birth control. If you want to become pregnant, stop
taking Mycyclamen and wait for a menstrual cycle before trying to become pregnant. You will be able to
calculate the due date more easily.
If you have any further questions on the use of this medicine ask 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 severe or persistent, or if you notice any change in your health that you think could be due to Mycyclamen, inform your doctor.
A higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) is present in all women who take
combined hormonal contraceptives. For more detailed information on the different risks associated
with taking combined hormonal contraceptives, see section 2 “What you need to know before using
Mycyclamen”.
Contact your doctor immediately if you notice any of the following symptoms of angioedema: swelling of the
face, tongue and/or pharynx and/or difficulty swallowing or urticaria with possible difficulty breathing
(see also the 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 1000 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 urticaria together with difficulty breathing)
• dangerous blood clots in a vein or an 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 symptoms similar to stroke, known as transient ischemic attack (TIA)
• clots in the liver, stomach/intestine, kidneys or eyes.

The likelihood of having a blood clot may be greater if you have any other condition that
increases the risk (see section 2 for more information on conditions that increase the risk of
clots and the 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 diarrhea, pain when defecating, abdominal pain) (Crohn's disease and ulcerative colitis)
• epilepsy
• uterine fibroids (non-cancerous tumor that can develop within the muscle tissue of the uterus)
• blood pigment disorder (porphyria)
• blistering eruption (herpes gestationis) during pregnancy
• Sydenham's chorea (a nerve disease in which sudden body movements appear)
• blood disorders that cause kidney damage (hemolytic uremic syndrome with signs such as decreased urine production, blood in the urine, decreased red blood cells, nausea, vomiting, confusion and diarrhea)
• yellowing of the skin or whites of the eyes due to blockage of the bile duct (cholestatic jaundice).

In addition, breast cancer (see section 2 “Mycyclamen and cancer”) and non-
cancerous (benign) and cancerous (malignant) liver tumors (with signs such as abdominal swelling, weight loss,
abnormal liver function that can be observed with blood tests) and chloasma (brown-gold pigmented patches on the skin, especially on the face, so-called “mask of pregnancy”, which may be
permanent, especially in women who have previously had chloasma during pregnancy) have been observed.

Other possible side effects
Common(may affect up to 1 in 10 women):

• mood swings
• headache
• nausea
• breast pain, menstrual problems, such as irregular periods, missed periods

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

• depression, nervousness, sleep disorders
• dizziness, tingling
• migraine, varicose veins, increased blood pressure
• stomach pain, vomiting, indigestion, gas, stomach inflammation, diarrhea
• acne, itching, 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 with continued treatment), vaginal discharge, hot flashes, inflammation of the vagina (vaginitis), menstrual problems, painful periods, reduced periods, very heavy periods, vaginal dryness, abnormal PAP test, 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)
• anemia, increased number of platelets in the blood
• allergic reaction
• hormonal (endocrine) disorders
• increased appetite, loss of appetite, abnormally high potassium concentration in the blood, abnormally low sodium concentration in the blood
• failure to reach orgasm, insomnia
• vertigo, tremor
• eye disorders, for example inflammation of the eyelids, dry eyes
• abnormally rapid heartbeat
• inflammation of a vein, nosebleeds, fainting
• abdominal enlargement, intestinal disorders, feeling of fullness, 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, sun-sensitive skin inflammation, skin nodules
• difficult or painful sexual intercourse, inflammation of the vagina (vulvovaginitis), bleeding after intercourse, breakthrough bleeding, breast cyst, increased breast cells (hyperplasia), abnormal growth of the cervical mucosa, contraction or atrophy of the uterine lining, ovarian cysts, uterine enlargement
• general feeling of discomfort
• weight loss.

Not known(frequency cannot be estimated based on available data):

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 at a temperature below 30° C.
Do not use this medicine after the expiry date which is stated on the blister and the package after “Do
not use after” or “EXP”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in 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 ingredients 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 ingredients.
The other ingredients are:
Pink film-coated active tablets: lactose monohydrate, pregelatinized starch (corn), povidone
(E1201), sodium croscarmellose, 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 contains 24 round, film-coated tablets, pink in color in the 1st, 2nd, 3rd and 4th rows of the blister and 4 white placebo film-coated tablets in the 4th row.
• The Mycyclamen tablets, both pink and white, are film-coated. The tablet core is coated.
• Mycyclamen is available in packs of 1, 3, 6 and 13 blisters, each containing 28 tablets (24+4).

Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area with the following
names:
Belgium: Marliesviatris 0.02 mg/3 mg film-coated tablets
Italy: Mycyclamen
Netherlands: Ethinylestradiol/Drospirenone Viatris 24+4 0.02 mg/3 mg, film-coated
tablets
Portugal: Drosdiol
Spain: Etinilestradiol/Drospirenona Viatris Pharmaceuticals 0.02 mg/3 mg
film-coated tablets (24+4) EFG