MYTULIP 0.03 mg/2 mg Film-coated tablets

Зміст інструкції

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

Mytulip

2 mg/0.03 mg film-coated tablets
(chlormadinone acetate and ethinylestradiol)
Generic medicine
Medicine subject to additional monitoring. This will allow the rapid identification of new
safety information. You can contribute by reporting any adverse effects you experience during
taking this medicine. See section 4 for information on how to report adverse effects.

Important information for you.

• If you have any doubts, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Important things to know about combined hormonal contraceptives (CHCs):

• 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 have symptoms of a blood clot (see section 2 “Blood clots”)

Contents of this leaflet

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

1. What is Mytulip and what is it used for

Mytulip is a hormonal contraceptive to be taken orally. Hormonal contraceptives that, like Mytulip,
contain two hormones are also known as “combined hormonal contraceptives” (CHC). The 21 tablets
in the pack contain the same amount of the two hormones, and therefore Mytulip is also defined
as a “monophasic preparation”.
Hormonal contraceptives like Mytulip do not protect against AIDS (HIV infection) or other sexually transmitted diseases. Only the condom can help in this regard.

2. What you need to know before taking Mytulip

Before starting to take Mytulip, your doctor will perform a general and gynecological examination, exclude
pregnancy and, taking into account the contraindications and precautions, will decide if Mytulip is suitable for you.
This examination must be performed every year during the intake of Mytulip.

General notes
Before starting to use Mytulip, you must 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”).

Do not take Mytulip
Do not use Mytulip 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 are allergic to ethinylestradiol, chlormadinone acetate or any of the other ingredients of this medicine (listed in paragraph 6);
• if you have (or have ever had) a blood clot in a leg vessel (deep vein thrombosis, DVT), in the lung (pulmonary embolism, PE) or other organs;
• 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 are going to have surgery or if you will be bedridden for a long period (see paragraph “Blood clots”);
• 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 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 have (or have ever had) a type of migraine called “migraine with aura”;
• if you notice the first symptoms or signs of a blood clot forming, inflammation of the veins or embolism, such as sharp and fleeting pain, chest pain or a feeling of tightness in the chest;
• if you have diabetes and your blood sugar varies uncontrollably
• if you have high blood pressure, which is difficult to control or have an increase in pressure (values consistently above 140/90 mmHg);
• if you suffer from liver inflammation (e.g. of viral origin) or jaundice and your liver function values have not yet returned to normal;
• if you have itching all over your body or suffer from bile flow disorders, especially if this has occurred on a previous pregnancy or estrogen treatment;
• if the bilirubin (a product of blood pigment degradation) in your blood is elevated, for example due to an innate metabolic disorder (Dubin-Johnson syndrome or Rotor syndrome);
• if you have a liver tumor or have had one in the past;
• if you have severe stomach pain, the liver is enlarged or if you notice signs of intestinal bleeding;
• if porphyria (a disorder of blood pigment metabolism) occurs for the first time or recurs;
• if you have or have had or are suspected of having a hormone-dependent malignant tumor, such as breast or uterine cancer;
• if you suffer from severe lipid metabolism disorders;
• if you suffer or have suffered from pancreatitis associated with a severe increase in blood lipids (triglycerides);
• if you suffer from migraine for the first time;
• if you suffer from unusually severe, frequent or persistent headaches;
• if you experience sudden disturbances in perception (vision or hearing);
• if you have movement disorders (especially signs of paralysis);
• if you notice a worsening of epileptic seizures;
• if you suffer from severe depression;
• if you suffer from a certain type of deafness (otosclerosis) that has worsened during a previous pregnancy;
• if you do not have your period for unknown reasons;
• if you have excessive growth of the inner lining of the uterus (endometrial hyperplasia);
• if you experience vaginal bleeding for any unknown reason;
• if you have a meningioma or have ever been diagnosed with a meningioma (a generally benign tumor of the tissue layer between the brain and the skull).

Do not take Mytulip if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir,
dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also paragraph “Other
medicines and Mytulip”).
If any of these conditions occur during the administration of Mytulip, stop taking it immediately.
You must not take Mytulip or must stop taking it immediately if there is a serious risk or multiple risk factors for blood clotting disorders (see paragraph 2).

Warnings and precautions
Talk to your doctor or pharmacist before taking Mytulip

• If you smoke. Smoking increases the risk of serious cardiovascular side effects when combined with the use of combined hormonal contraceptives. The risk increases with age and with increasing cigarette consumption. This is especially true for women over 35 years of age. Smokers over 35 years of age should use other methods of contraception.
• If you have high blood pressure, abnormally high lipid levels in the blood, if you are overweight or suffer from diabetes (see also paragraph 2 “What you need to know before taking Mytulip”). In these cases, the risk of serious side effects associated with the use of combined hormonal contraceptives (such as heart attack, embolism, stroke or liver tumors) is increased.
• If one of the previous risk factors applies to you, or one of them appears or worsens while you are taking Mytulip. In this case, consult your doctor immediately, who will decide whether you should continue to take Mytulip or stop taking it.

When should you see a doctor?
Seek urgent medical attention

• if you observe possible signs of a blood clot that may indicate that you are suffering from a blood clot in the leg (deep vein thrombosis), a blood clot 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, go to the paragraph “How to recognize a blood clot”.

Tell your doctor if any of the following conditions apply to you.
If this condition occurs or worsens while you are using Mytulip, you should tell your doctor.

• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE, a disease that affects the body's defense system);
• 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 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 if you 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 Mytulip;
• if you have inflammation of the veins in the skin (superficial thrombophlebitis);
• if you have varicose veins
• if you notice symptoms of angioedema such as swelling of the face, tongue and/or pharynx and/or difficulty swallowing or hives with possible difficulty breathing, contact a 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 Mytulip 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 ATE). Healing from blood clots is not always complete. Rarely, serious long-term effects can occur, or, very rarely, these effects can be fatal.

It is important to remember that the overall risk of a harmful blood clot associated with Mytulipis
low.
HOW TO RECOGNIZE A BLOOD CLOT
See a doctor immediately if you notice any of the following signs or symptoms.

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 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 Mytulip, 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 TEV 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
Mytulip is low.

• Out of 10,000 women who do not use any combined hormonal contraceptive and 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 chlormadinone acetate, like Mytulip, about 6-9 women 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 Mytulip is low but some conditions cause an
increase. Your risk is higher:

• if you are severely overweight (body mass index or BMI greater than 30 kg/m²);
• if a close relative of yours has had a blood clot in a leg, lung or another 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. It may be necessary to stop taking Mytulip a few weeks before surgery or during the period when you are less mobile. If you need to stop taking Mytulip, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years of age);
• 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 Mytulip.
If any of the above conditions change while you are using Mytulip, 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 a 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 Mytulip is very low
but may increase:

• as you get older (over 35 years of age);
• if you smoke. When you use a combined hormonal contraceptive like Mytulip it is advisable that you quit smoking. If you cannot quit smoking and you are over 35 years of age, 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 migraines, especially migraines with aura;
• if you have 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 severe, the risk of developing a
blood clot may be even higher.
If any of the above conditions change while you are using Mytulip, for example if you start
smoking, if a close relative develops a thrombosis for no known reason or if you gain a lot of weight,
contact your doctor.

Cancer
Some studies show that there is a risk factor for cervical cancer in women whose cervix
has been infected by a certain sexually transmitted virus (human papillomavirus) who
take the pill for a long time. However, it is not clear how much this is due to other factors
(e.g. differences in the number of sexual partners or the use of mechanical contraceptive methods).
Studies have reported a slightly higher risk of breast cancer in women who are currently
using COCs. The increase in risk gradually decreases within 10 years after stopping
treatment with COCs, until it reaches the risk level related to age.
As breast cancer is rare in women under 40 years of age, the excess number of diagnoses of
breast cancer in patients who use or have used COCs is limited in relation to the overall risk of
breast cancer.
In rare cases, benign liver tumors have been reported with the use of hormonal contraceptives, and even
more rarely malignant liver tumors. These can cause dangerous internal bleeding. In case of intense
stomach pain that does not resolve spontaneously, you should inform your doctor.

Meningiomas
The use of chlormadinone acetate has been linked to the development of a generally benign tumor of the layer
of tissue between the brain and the skull (meningioma). The risk increases especially when it is used at high
doses for a long duration (several years). If you are diagnosed with a meningioma, your doctor
will stop treatment with Mytulip (see paragraph “Do not take Mytulip”). If you notice any symptoms
such as changes in vision (e.g. double or blurred vision), hearing loss or ringing in the ears, loss
of smell, headaches that worsen over time, memory loss, seizures, weakness in the arms
or legs, immediately inform your doctor.

Other diseases
Many women have a slight increase in blood pressure while taking hormonal
contraceptives. If the pressure increases considerably during treatment with Mytulip, your doctor will
advise you to stop taking Mytulip and prescribe a drug to lower your blood pressure.
As soon as the pressure returns to normal values, you can start taking Mytulip again.
If you have suffered from Herpes during a previous pregnancy, a recurrence is possible while using
a hormonal contraceptive.
If you experience an alteration in blood lipid levels (hypertriglyceridemia) or if this condition has
affected someone in your family, there is a possible increase in the risk of pancreatitis.
If you have acute or chronic liver disorders, your doctor may deem it appropriate to discontinue treatment with
Mytulip until liver values return to normal. If you have suffered from jaundice during a previous
pregnancy or while taking a hormonal contraceptive and this condition recurs, your doctor will
advise you to stop using Mytulip.
If you suffer from diabetes and your blood sugar is under controland you are taking Mytulip, your doctor will
monitor you carefully throughout the duration of treatment with Mytulip. You may need to modify your
diabetes treatment.
Not commonly, brown spots may appear on the skin (melasma), especially if the same
condition had already occurred during a previous pregnancy. If you know you are predisposed, you must
avoid direct sunlight or ultraviolet light during treatment with Mytulip.

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

Diseases that may be negatively affected
Particularly careful medical monitoring is also necessary:

• if you suffer from epilepsy;
• if you suffer from multiple sclerosis;
• if you suffer from severe muscle cramps (tetany);
• if you suffer from migraines (see previously in paragraph 2);
• if you suffer from asthma;
• if you have a weak heart or kidneys (see previously in paragraph 2);
• if you suffer from St. Vitus' dance (minor chorea);
• if you are diabetic (see previously in paragraph 2);
• if you have liver disorders (see previously in paragraph 2 “Other diseases”);
• if you suffer from a lipid metabolism disorder (see also paragraph 2);
• if you suffer from immune system disorders (including Systemic Lupus Erythematosus);
• if you are significantly overweight;
• if you have high blood pressure (see previously in paragraph 2);
• if you have endometriosis (the tissue lining the cavity of your uterus, called the endometrium, is located outside this lining layer) (see previously in paragraph 2);
• if you have varicose veins or inflammation of the veins (see previously in paragraph 2);
• if you have blood clotting problems (see previously in paragraph 2);
• if you suffer from a breast disease (mastopathy);
• if you have had benign tumors of the uterus (fibroids);
• if you have had blisters (gestational herpes) in a previous pregnancy;
• if you suffer from depression (see previously in paragraph 2);
• if you suffer from chronic inflammation of the intestine (Crohn's disease, ulcerative colitis).

Consult your doctor if you have, or have had in the past, any of the disorders listed above, or if one appears during
treatment with Mytulip.

Effectiveness
If the contraceptive is not taken regularly, or after taking it you vomit or have diarrhea (see
paragraph 3) or at the same time you are taking certain medications (see paragraph 2), the effect of the contraceptive
may be compromised. In very rare cases of metabolic disorders, the effectiveness of the contraceptive may be
compromised.
Even with correct use of the contraceptive, it is not possible to guarantee total control
of conception.

Irregular bleeding
Particularly in the first few months when you take hormonal contraceptives, irregular bleeding may occur
(metrorrhagia/spotting). If such irregular bleeding continues to occur for three months, or
reappears after previous regular cycles, please consult your doctor.
Also, the appearance of spotting may be indicative of a reduction in the contraceptive effect. In some
cases, withdrawal bleeding may be absent after taking Mytulip for 21 days. If you have taken
Mytulip according to the instructions in paragraph 3, it is unlikely that you are pregnant. If Mytulip has not
been taken as instructed, and no withdrawal bleeding occurs, a
pregnancy should be ruled out before continuing administration.

Other medicines and Mytulip
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those available without a prescription.
Do not use Mytulip if you suffer from hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir,
dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir because these may cause an
increase in the results of some blood tests on liver function (increased liver enzyme
ALT).
Your doctor will prescribe you another type of contraceptive before starting treatment with these medicines.
Mytulip can be resumed approximately 2 weeks after completion of this treatment. See paragraph "
Do not take Mytulip”.
The contraceptive effect of Mytulip may be affected if you take other active substances at the same time.
These include

• medicines for the treatment of epilepsy (such as carbamazepine, primidone, barbiturates, barbexaclone, phenytoin and topiramate),
• rifampicin or rifabutin medicines used for the treatment of tuberculosis,
• medicines used to treat other infections such as griseofulvin, fluconazole and troleandomycin
• modafinil, a medicine used to treat sleep disorders
• some medicines for the treatment of HIV infection (e.g. ritonavir, indinavir),
• vitamin C (ascorbic acid), used to treat a disease called scurvy
• atorvastatin, a medicine used to treat high cholesterol in the blood
• preparations containing St. John's wort ( Hypericum perforatum).
• medicines that stimulate intestinal movement (e.g. metoclopramide) and activated charcoal may affect the absorption of the active substances of Mytulip.

If you are taking a medicine that contains one of the active substances listed above (except for St. John's wort) or are starting to take one, you can continue to take Mytulip.
During treatment with these medicines you should also use mechanical contraceptive methods (e.g.
condoms). If you take these medicines, you should also use mechanical contraceptive methods for at least 7
days or up to 28 days after stopping treatment. If long-term treatment is necessary
with the active substances listed above, you should use non-hormonal contraceptive methods. Ask your
doctor or pharmacist for advice.
If the concomitant administration of the medicine extends beyond the end of the tablets in the blister pack of COC, you should start the next pack without the usual tablet-free interval.
Tell your doctor if you are taking insulin or other medicines to lower blood sugar. The dosage
of these medicines may need to be adjusted.
When using hormonal contraceptives, the excretion of diazepam, cyclosporine, theophylline or prednisolone may
be reduced, resulting in a stronger and prolonged effect of these active substances. The effect
of preparations containing clofibrate, paracetamol, morphine or lorazepam may be reduced if they are
taken at the same time.
Please note that the above also applies if you have taken one of these active substances shortly before starting therapy with Mytulip.
The administration of Mytulip may affect some laboratory tests related to liver, adrenal and thyroid function, of certain blood proteins, carbohydrate metabolism and
blood coagulation. Before undergoing a blood test, tell your doctor if you are taking
Mytulip.

Pregnancy and breastfeeding
Mytulip is not indicated during pregnancy. If you become pregnant while taking Mytulip, you should stop
taking it immediately. The use of Mytulip before a pregnancy, however, does not justify an abortion.
If you take Mytulip you should remember that milk production may be reduced and its quality altered.
Small amounts of the active substances pass into breast milk. Hormonal contraceptives such as Mytulip should
only be taken after stopping breastfeeding.

Driving and operating machinery
It is not known whether combined hormonal contraceptives have adverse effects on the ability to drive vehicles or
operate machinery.

Mytulip contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this
medicine.

3. How to take Mytulip

Take this medicine always exactly as your doctor or pharmacist has told you. If you have doubts
consult your doctor or pharmacist.
For oral use.

How and when to take Mytulip
Take the first tablet from the pack choosing the one marked with the corresponding day of the
week (for example “Dom” for Sunday) and swallow it without chewing. Then take another
tablet every day following the direction of the arrow, if possible at the same time of day,
preferably in the evening. If possible, the interval between two tablets should be 24 hours. The indication of the
days printed on the pack allows you to verify every day if you have already taken the tablet for that
specific day.
Take one tablet a day for 21 consecutive days. After that there will be a 7-day break. Generally
2-4 days after taking the last tablet, withdrawal bleeding will begin, similar to your
menstruation. After 7 days of break, start taking the tablets from the new pack of Mytulip, even
if the bleeding has not yet ended.

When can you start taking Mytulip?
If you have not taken any hormonal contraceptive before (during your last menstrual cycle)
Take the first tablet of Mytulip on the first day of your next menstrual cycle.
Contraception begins on the first day of taking and continues even during the 7-day break.
If your menstruation has already started, take the first tablet from the 2nd to the 5th day of menstruation, both
whether the bleeding has ended or not. However, in this case, you must also use mechanical
contraceptive methods for the first seven days of taking (the seven-day rule).
If your menstruation has started more than 5 days ago, wait for your next period to start taking
Mytulip.
If you have previously taken another combined hormonal contraceptive
Take all the tablets from the old pack as usual. You must start taking Mytulip the
day after the break or the period in which you take the placebo tablets of your previous
combined hormonal contraceptive.
If you have taken a hormonal contraceptive containing only a progestin (progestin-only pill,
“POP”)
When using a hormonal contraceptive containing only a progestin, withdrawal bleeding similar to the menstrual cycle may be absent. Take the first tablet of Mytulip the day
after you took your last progestin-only pill. In this case, additional contraceptive measures will be necessary for the first seven days.
If you have previously used a hormonal injectable contraceptive or a contraceptive implant
Take the first tablet of Mytulip on the day the implant is removed or on the day the next
injection was due. In this case, additional contraceptive measures will be necessary for the first seven
days of administration.
If you have had a curettage or an abortion in the first three months of pregnancy
After curettage or abortion, you can start taking Mytulip immediately. In this case, no other contraceptive method is necessary.
If you have given birth or had a curettage in the 3rd-6th month of pregnancy
If you are not breastfeeding, you can start taking Mytulip, 21-28 days after delivery. You do not need to use any
other mechanical contraceptive method.
However, if 28 days have passed since delivery, for the first seven days, you must use additional
mechanical contraceptive methods.
If you have had sexual intercourse in the meantime, you must rule out pregnancy or wait until your next
menstrual cycle before starting to take Mytulip.
Remember that you should not take Mytulip if you are breastfeeding (see the section “Pregnancy and
breastfeeding”).

How long can you take Mytulip?
You can take Mytulip for as long as you want, as long as there are no risks to your health (see section 2). After stopping taking Mytulip, the start of your next menstrual cycle
may be delayed by about a week.

What should you do if you vomit or have diarrhea while taking Mytulip?
If you experience vomiting or diarrhea within four hours of taking a tablet, it is possible that the active
ingredients of Mytulip have not been completely absorbed. This situation is similar to when you
forget a tablet and must immediately take a new tablet from a new pack. If
possible, take a new tablet within 12 hours of taking the last tablet and continue
to take Mytulip at the same time. If this is not possible or more than 12 hours have passed, follow the
instructions in the section “If you forget to take Mytulip” or contact your doctor.

If you take more Mytulip than you should
There is no evidence that serious signs of poisoning occur after taking many tablets in
one dose. Nausea, vomiting, and, especially in young girls, slight
vaginal bleeding may occur. In these cases, consult your doctor. If necessary, the doctor will check your fluid and electrolyte balance and liver function.

If you forget to take Mytulip
If you forget to take a tablet at the usual time, take it within a maximum of 12 hours. In
this case, no other contraceptive methods are necessary and you can continue taking the tablets as usual.
If more than 12 hourshave passed, the contraceptive effect of Mytulip is no longer guaranteed. In this case, take
the forgotten tablet immediately and continue to take Mytulip at the same time. This may also
mean that you have to take two tablets in one day. In this case, for the next seven
days, you must use additional mechanical contraceptive methods (e.g. condoms). If during these seven
days, you finish the tablets in the pack, immediately start using the tablets from the
next pack of Mytulip, i.e. there must be no break between the two packs (the seven-day
rule).
You will probably not have a normal withdrawal bleeding until the new pack is
finished. However, while using the new pack, you may experience increased intermenstrual bleeding or spotting.
The more tablets you forget, the greater the risk that the contraceptive protection is
reduced. If you forget one or more tablets in week 1 and had intercourse in the week
before the forgetfulness, be aware that there is a risk of pregnancy. The same applies if you forget a
or more tablets and no bleeding occurs in the next period of treatment suspension. In
these cases, contact your doctor.
Do not take a double dose to make up for a forgotten one.

If you want to delay your menstrual cycle
Although not recommended, it is possible to delay your menstrual cycle (withdrawal bleeding) by
immediately starting a new pack of Mytulip, skipping the break and continuing
until the end of the second blister.
Spotting (drops or stains of blood) or breakthrough bleeding may occur while taking
the tablets from the new pack. After the usual 7-day break, continue with the
next pack.
Ask your doctor for advice before deciding to delay your menstrual cycle.

If you want to change the first day of your menstrual cycle
If you take the tablets according to the instructions, your menstrual cycle/withdrawal bleeding will start
in the week in which you do not take any tablets. If you need to change this day, you can do so by shortening
the break (but never lengthening it!). For example, if your tablet break
starts on a Friday and you want to change it to Tuesday (3 days earlier), you must start a new pack 3 days
before usual. If you shorten the break considerably (e.g. 3 days or less), you may
not have any bleeding during this break. Afterwards, you may
experience spotting (drops or stains of blood) or breakthrough bleeding.
If you are not sure how to proceed, ask your doctor for advice.

If you stop taking Mytulip
When you stop taking Mytulip, your ovaries will soon resume their full activity, and you may become
pregnant.
If you have any other questions about 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 everybody 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 may be due to Mytulip, stop taking
Mytulip and inform your doctor or go immediately to the nearest hospital.
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 paragraph “Warnings and precautions”).
Side effects can occur with varying frequencies defined as follows:

Uncommon(may affect up to 1 in 100 people)

• sudden signs of allergy such as skin rash, itching or urticaria, swelling of the face, lips, tongue or other parts of the body, difficulty breathing, wheezing or breathing difficulties

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

• sudden hearing loss
• dizziness and a feeling of “emptiness in the head”, rapid heartbeat, paleness, sweating, restlessness, loss of consciousness (circulatory collapse)
• dangerous blood clots in a vein or artery, for example:
• in a leg or foot (i.e. DVT)
• in the lung (i.e. PE)
• heart attack
• stroke, mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack (TIA)
• blood clots in the liver, stomach/intestines, kidneys or eye.

The possibility of having a blood clot may be greater if you have other conditions that can
increase the risk (see paragraph 2 for more information on conditions that increase the
risk of blood clots and the symptoms of a clot).
An increased risk of blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the
arteries (arterial thromboembolism (ATE)) is present for all women taking combined hormonal contraceptives.
For more detailed information on the different risks associated with the use of combined hormonal
contraceptives, see paragraph 2 “What you need to know before you take Mytulip”.

Other possible side effects
Very common(may affect more than 1 in 10 people)

• nausea
• vaginal discharge
• painful periods
• absence of menstruation
• breakthrough bleeding
• spotting
• headache
• breast pain.

Common(may affect up to 1 in 10 people)

• depression
• irritability, nervousness
• dizziness
• migraine (and/or worsening of these)
• vision disorders
• vomiting
• acne
• abdominal pain
• fatigue
• feeling of heaviness
• fluid retention
• weight gain
• increased blood pressure.

Uncommon(may affect up to 1 in 100 people)

• stomach pain
• feeling of bloating, diarrhea
• skin pigmentation problems, brown spots on the face
• hair loss
• dry skin
• back pain, muscle problems
• breast discharge
• non-cancerous breast lumps
• vaginal fungal infections (thrush)
• decreased libido
• sweating tendency
• changes in blood fats, including increased triglycerides, observed with blood tests.

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

• conjunctivitis
• discomfort when wearing contact lenses,
• ringing in the ears (tinnitus)
• high blood pressure, low blood pressure
• varicose veins,
• urticaria, eczema, skin inflammation, itching, worsening of psoriasis
• excessive hair growth on the body and face,
• breast enlargement,
• inflammation of the vagina
• longer and/or more painful periods
• premenstrual syndrome (physical and emotional problems before the start of menstruation)
• increased appetite.

Very rare(may affect up to 1 in 10,000 people)

• red-purple swellings on the legs and thighs, less commonly on the arms. Joint and muscle pain and fever may also occur (erythema nodosum).

Combined hormonal contraceptives have also been associated with an increased risk of serious illnesses and
side effects:

• risk of obstruction of veins and arteries ( see paragraph 2),
• risk of biliary tract diseases ( see paragraph 2),
• risk of tumors (e.g. liver tumors, which in isolated cases have caused severe bleeding in the abdominal cavity, cervical or breast tumors; see paragraph 2),
• worsening of chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis; seeparagraph 2). Read the information in paragraph 2 carefully, and if necessary, seek immediate medical advice. If any of the side effects worsen, or if you notice the appearance of any side effect not

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. 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 Mytulip

Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package or blister (calendar pack) after EXP. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
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. Contents of the pack and other information

What Mytulip contains

• The active ingredients are ethinylestradiol and chlormadinone acetate. Each film-coated tablet contains 0.03 mg of ethinylestradiol and 2.0 mg of chlormadinone acetate.
• The other ingredients are: lactose monohydrate (see section 2 “Mytulip contains lactose”), corn starch, povidone K30, magnesium stearate, hypromellose, hydroxypropylcellulose, talc, cottonseed oil (hydrogenated), titanium dioxide (E171), red iron oxide (E172).

Description of the appearance of Mytulip and contents of the pack
Mytulip tablets are pink, round, film-coated. Mytulip is available in packs
of 1, 3 and 6 blisters each containing 21 tablets.
Not all pack sizes may be marketed.

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

Manufacturer
McDermott Laboratories t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13,
Ireland
Mylan Hungary Kft, Mylan Utca 1, Komárom, H-2900, Hungary

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Germany: Lisette 0.03 mg/2 mg film-coated tablets
Italy: Mytulip 2 mg/0.03 mg film-coated tablets