Mytulip

Patient Information Leaflet

Mytulip

2 mg/0.03 mg film-coated tablets
(chlormadinone acetate and ethinylestradiol)
Equivalent medicine
This medicine is under additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as 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 (CHCs):

• 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 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 taking 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 Mytulip is and what it is used for

Mytulip is an oral hormonal contraceptive. Hormonal contraceptives such as Mytulip, which contain two hormones, are also known as "combined hormonal contraceptives" (COC). The 21 tablets in the pack contain the same amount of the two hormones; therefore, Mytulip is also referred to as a "monophasic preparation".
Hormonal contraceptives such as Mytulip do not protect against AIDS (HIV infection) or other sexually transmitted diseases. Only condoms can help in this regard.

2. What you should know before taking Mytulip

Before starting Mytulip, your doctor will perform a general and gynecological examination, rule out pregnancy, and, taking into account contraindications and precautions, decide whether Mytulip is suitable for you.
This examination must be repeated annually during treatment with Mytulip.
General notes
Before starting to use Mytulip, 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”).
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. Your doctor will discuss with you other methods of birth control that may be more suitable for your case.

• If you are allergic to ethinylestradiol, chloromadinone acetate, or any of the other ingredients of this medicine (listed in section 6);
• if you have (or have ever had) a blood clot in a blood vessel of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;
• if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are scheduled for surgery or will be bedridden for a prolonged period (see section “Blood clots”);
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain that may be an early sign of heart attack) or transient ischemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following conditions, which may increase the risk of developing clots 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 hyperhomocysteinemia
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you notice early symptoms or signs of blood clot formation, vein inflammation, or embolism, such as stabbing and transient pain, chest pain, or chest tightness;
• if you have diabetes and your blood sugar levels fluctuate uncontrollably;
• if you have high blood pressure that is difficult to control, or if your blood pressure has increased (values consistently above 140/90 mmHg);
• if you suffer from liver inflammation (e.g., of viral origin) or jaundice and your liver function test results have not yet returned to normal;
• if you have generalized itching or suffer from bile flow disorders, particularly if this occurred during a previous pregnancy or estrogen treatment;
• if bilirubin (a breakdown product of blood pigment) is elevated in your blood, for example due to an inherited 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, an enlarged liver, or 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 if it is suspected that you have, a hormone-dependent malignant tumor, such as breast or uterine cancer;
• if you suffer from severe disorders of lipid metabolism;
• if you suffer from or have suffered from pancreatitis associated with a severe increase in blood lipids (triglycerides);
• if you experience migraine for the first time;
• if you suffer from unusually severe, frequent, or persistent headaches;
• if sudden disturbances in perception (vision or hearing) occur;
• if you experience movement disorders (particularly signs of paralysis);
• if you notice worsening of epileptic seizures;
• if you suffer from severe depression;
• if you suffer from a certain type of hearing loss (otosclerosis) that worsened during a previous pregnancy;
• if you have no menstrual periods for unknown reasons;
• if there is excessive growth of the inner layer of the uterus (endometrial hyperplasia);
• if vaginal bleeding occurs for unknown reasons;
• 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 skull).

Do not take Mytulip if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Mytulip”).
If any of these conditions occur during treatment with Mytulip, stop taking Mytulip 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 section 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 the number of cigarettes smoked. This particularly affects women over 35 years of age. Women over 35 who smoke should use other contraceptive methods.
• If you have high blood pressure, abnormal high levels of lipids in the blood, if you are overweight, or suffer from diabetes (see also section 2 “What you should know before taking Mytulip”). In these cases, the risk of serious adverse effects associated with the use of combined hormonal contraceptives (such as heart attack, embolism, stroke, or liver tumors) is increased.
• If any of the above risk factors apply to you, or if 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 taking Mytulip or stop taking it.

When should you contact a doctor?
Contact a 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 section "Blood clot (thrombosis)"). For a description of the symptoms of these serious adverse effects, see the section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you.
If any of these conditions appear or worsen while you are using Mytulip, inform your doctor.

• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE, a disease affecting the body’s natural defense system);
• if you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have sickle cell anemia (an inherited red blood cell disorder);
• 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 scheduled for 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 Mytulip;
• if you have inflammation of veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• 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. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Mytulip 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 Mytulip is low.
HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical attention if you notice any of the following signs or symptoms.

Does it present any of these signs?	What is it probably 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 color of the leg, such as paleness, redness, or bluish discoloration	Deep vein thrombosis
sudden and unexplained shortness of breath or rapid breathing; • sudden cough without an obvious cause, possibly with coughing up blood; • sharp chest pain that may worsen when breathing deeply; • severe dizziness or lightheadedness; • rapid or irregular heartbeat; • severe stomach pain. If in doubt, consult a doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for a milder condition like a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: • sudden loss of vision or • painless blurring of vision that may progress to vision loss	Retinal vein thrombosis (blood clot in the eye)
chest pain, discomfort, pressure, or heaviness • squeezing sensation or fullness in the chest, in one arm, or under the sternum • feeling of fullness, indigestion, or suffocation • discomfort in the upper body spreading to the back, jaw, throat, arms, or stomach • sweating, nausea, vomiting, or dizziness • extreme weakness, anxiety, or shortness of breath • rapid or irregular heartbeat	Heart attack
sudden numbness or weakness of the face, one arm, or one leg, especially on one side of the	Stroke
body; • sudden confusion, difficulty speaking or understanding speech; • sudden vision problems in one or both eyes; • sudden difficulty walking, dizziness, loss of balance or coordination; • sudden, severe or prolonged headache with no known cause; • loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.
swelling and pale blue discoloration of a limb • severe abdominal pain (acute abdomen)	Blood clots blocking other blood vessels

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 adverse events 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 breaks loose from the leg and travels to 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 when restarting 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 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 individual baseline risk of venous thromboembolism (VTE) and the type of combined hormonal contraceptive you are using. The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Mytulip 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 over 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 over one year.
• Among 10,000 women who use a combined hormonal contraceptive containing cyproterone acetate, such as Mytulip, about 6–9 women will develop a blood clot over one year.
• Your risk of developing a blood clot also depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).

	Risk of developing a blood clot in one year
Women who are not using a combined hormonal pill/bpatch/ring and who are not pregnant	Approximately 2 women out of 10,000
Women using a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	Approximately 5-7 women out of 10,000
Women using Mytulip	Approximately 6-9 women out of 10,000

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 certain conditions can increase it. Your risk is higher:

• if you are significantly overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in the leg, lung, or another organ at a young age (under approximately 50 years). In this case, you may have an inherited blood clotting disorder;
• if you are due to undergo surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in plaster. You may need to stop taking Mytulip several weeks before surgery or during periods of reduced mobility. 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);
• 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 above.
It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to stop your use of Mytulip.
If any of the conditions listed above change while you are using Mytulip, for example if a close relative develops thrombosis without a known cause or if you gain substantial 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 Mytulip is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Mytulip, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years of age, 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 conditions listed above change while you are using Mytulip, for example if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain substantial weight, contact your doctor.

Cancer
Some studies show an increased risk of cervical cancer in women whose cervix has been infected with a specific sexually transmitted virus (human papillomavirus) who take the pill for a long time. However, it is unclear how much this is due to other factors (e.g., differences in number of sexual partners or use of mechanical contraceptive methods).
Studies have reported a slightly higher risk of breast cancer in women currently using combined oral contraceptives (COCs). The increased risk gradually decreases within 10 years after stopping COC treatment, returning to the age-related baseline risk.
Since breast cancer is rare in women under 40 years of age, the excess number of breast cancer diagnoses among women who are or have been using 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 may cause dangerous internal bleeding. If you experience severe stomach pain that does not resolve spontaneously, you should inform your doctor.

Meningiomas
The use of chloromadinone acetate has been linked to the development of a generally benign tumor of the tissue layer between the brain and skull (meningioma). The risk increases especially when used at high doses for a prolonged duration (several years). If you are diagnosed with a meningioma, your doctor will stop treatment with Mytulip (see section “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, or weakness in arms or legs, inform your doctor immediately.

Other diseases
Many women experience a slight increase in blood pressure while taking hormonal contraceptives. If your blood pressure increases significantly during treatment with Mytulip, your doctor will advise you to stop taking Mytulip and may prescribe medication to lower your blood pressure. Once your blood pressure returns to normal, you may resume taking Mytulip.
If you have previously suffered from herpes during pregnancy, a recurrence may occur during use of a hormonal contraceptive.
If you have a lipid metabolism disorder (hypertriglyceridemia) or if this condition runs in your family, there may be an increased risk of pancreatitis.
If you have chronic or acute liver disorders, your doctor may consider it appropriate to discontinue treatment with Mytulip until liver function values return to normal. If you previously experienced jaundice during pregnancy or while taking a hormonal contraceptive and this condition recurs, your doctor will advise you to stop using Mytulip.
If you have diabetes and your blood sugar is under control while taking Mytulip, your doctor will monitor you closely throughout the treatment. It may be necessary to adjust your diabetes treatment.
Brown patches on the skin (chloasma) may uncommonly appear, especially if this condition occurred previously during pregnancy. If you know you are predisposed, you should avoid direct sunlight or ultraviolet light during treatment with Mytulip.

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

Conditions that may be negatively affected
Particular medical monitoring is also required if:

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

Consult your doctor if you have, or have previously had, any of the conditions listed above, or if any of them develop during treatment with Mytulip.

Efficacy
If the contraceptive is not taken regularly, or if you vomit or have diarrhea after taking it (see section 3), or if you are taking certain other medicines at the same time (see section 2), the effectiveness of the contraceptive may be reduced. In very rare cases of metabolic disorders, the effectiveness of the contraceptive may be impaired.
Even when taken correctly, it is not possible to guarantee complete prevention of pregnancy.

Irregular bleeding
Especially during the first few months of taking hormonal contraceptives, irregular bleeding (metrorrhagia/spotting) may occur. If this irregular bleeding continues for three months or reappears after previously regular cycles, please consult your doctor.
The appearance of spotting may also indicate a reduced contraceptive effect. In some cases, withdrawal bleeding may not occur after taking Mytulip for 21 days. If you have taken Mytulip according to the instructions in section 3, it is unlikely that you are pregnant. If Mytulip has not been taken as directed and no withdrawal bleeding occurs, pregnancy must be ruled out before continuing treatment.

Other medicines and Mytulip
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Do not use Mytulip if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these may cause an increase in certain liver function blood tests (elevated liver enzyme ALT).
Your doctor will prescribe another type of contraceptive before starting treatment with these medicines.
Mytulip may be resumed approximately 2 weeks after completion of this treatment. See section “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 to treat 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 motility (e.g., metoclopramide) and activated charcoal may affect the absorption of the active ingredients in Mytulip.

If you are taking a medicine containing one of the active substances listed above (except St. John’s wort) or are starting to take one, you may continue taking Mytulip.
During treatment with these medicines, you must use additional mechanical contraceptive methods (e.g., condoms). If you are taking these medicines, you should also use mechanical contraceptive methods for at least 7 days or up to 28 days after the end of treatment. If long-term treatment with the above-mentioned active substances is required, you should use non-hormonal contraceptive methods. Ask your doctor or pharmacist for advice.
If the concomitant medication continues beyond the end of the tablets in the COC blister pack, you must start the next pack without the usual tablet-free interval.

Inform 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 taken simultaneously.
Please note that the above also applies if you have taken one of these active substances shortly before starting Mytulip therapy.

The administration of Mytulip may affect certain laboratory tests related to liver function, adrenal and thyroid glands, certain blood proteins, carbohydrate metabolism, and blood clotting. Before undergoing a blood test, inform your doctor if you are taking Mytulip.

Pregnancy and breastfeeding
Mytulip is not indicated during pregnancy. If you become pregnant while taking Mytulip, you must stop taking it immediately. However, prior use of Mytulip before pregnancy does not justify termination of pregnancy.
If you take Mytulip, remember that milk production may be reduced and its quality altered. Small amounts of the active ingredients pass into breast milk. Hormonal contraceptives such as Mytulip should only be taken after weaning.

Driving and use of machines
It is not known whether combined hormonal contraceptives have negative effects on the ability to drive or operate machinery.

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

3. How to take Mytulip

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any 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, “Sun” for Sunday), and swallow it whole without chewing. Then take one tablet every day, following the direction of the arrow, preferably at the same time each day, ideally in the evening. If possible, the interval between two tablets should be 24 hours. The day indicators printed on the pack allow you to check each day whether you have already taken the tablet for that specific day.

Take one tablet daily for 21 consecutive days. After this, there will be a 7-day break. Usually, 2–4 days after taking the last tablet, you will experience a withdrawal bleed similar to your menstrual period. After the 7-day break, start taking tablets from a new pack of Mytulip, even if bleeding has not yet stopped.

When can you start taking Mytulip?

If you have not previously used any hormonal contraceptive (during your last menstrual cycle)
Take the first tablet of Mytulip on the first day of your next menstrual cycle.
Contraceptive protection begins on the first day of intake and continues throughout the 7-day break.

If your menstruation has already started, you may take the first tablet between the 2nd and 5th day of your period, regardless of whether bleeding has stopped. However, in this case, you must use additional mechanical contraceptive methods (e.g. condoms) during the first seven days of tablet intake (the "seven-day rule").

If more than 5 days have passed since the start of your menstruation, wait for your next menstrual period to begin taking Mytulip.

If you previously used another combined hormonal contraceptive
Take all tablets from your previous pack as usual. Start taking Mytulip the day after the end of the break period or the period during which you took placebo tablets in your previous combined hormonal contraceptive regimen.

If you previously used a progestogen-only hormonal contraceptive (progestogen-only pill, “POP”)
When using a progestogen-only hormonal contraceptive, withdrawal bleeding similar to menstruation may not occur. Take the first tablet of Mytulip the day after taking your last progestogen-only pill. In this case, additional contraceptive measures must be used for the first seven days.

If you previously used an injectable hormonal contraceptive or an 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 must be used for the first seven days of administration.

If you had a curettage or an abortion during the first three months of pregnancy
After a curettage or abortion, you may start taking Mytulip immediately. In this case, no additional contraceptive method is required.

If you gave birth or had a curettage during the 3rd–6th month of pregnancy
If you are not breastfeeding, you may start taking Mytulip 21–28 days after delivery. You do not need to use any additional mechanical contraceptive method.

However, if more than 28 days have passed since delivery, you must use additional mechanical contraceptive methods for the first seven days.

If you have had sexual intercourse in the meantime, you must exclude pregnancy or wait until your next menstrual period before starting Mytulip.

Remember that you must not take Mytulip if you are breastfeeding (see section “Pregnancy and breastfeeding”).

For how long can you take Mytulip?
You may take Mytulip for as long as desired, provided no health risks arise (see section 2). After stopping Mytulip, the onset of your next menstrual cycle may be delayed by about one week.

What should you do if you vomit or have diarrhoea while taking Mytulip?
If vomiting or diarrhoea occurs within four hours of taking a tablet, the active ingredients of Mytulip may not have been fully absorbed. This situation is similar to missing a tablet. Immediately take another tablet from a new pack. If possible, take the new tablet within 12 hours of the last tablet taken and continue taking Mytulip at the usual time. If this is not possible or more than 12 hours have passed, follow the instructions under “If you forget to take Mytulip” or contact your doctor.

If you take more Mytulip than you should
There is no evidence of severe poisoning symptoms after taking multiple tablets in a single dose. Nausea, vomiting, and especially light vaginal bleeding in younger girls may occur. In such cases, consult your doctor. If necessary, your doctor will monitor 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 as soon as possible within 12 hours. In this case, no additional contraceptive methods are needed, and you may continue taking tablets as usual.

If more than 12 hours have passed, the contraceptive effect of Mytulip is no longer guaranteed. In this case, take the missed tablet immediately and continue taking Mytulip at the usual time. This may mean taking two tablets in one day. During the following seven days, you must use additional mechanical contraceptive methods (e.g. condoms). If during these seven days you finish the tablets in the current pack, immediately start taking tablets from the next pack of Mytulip—i.e., there should be no break between packs (the "seven-day rule").

You may not have a normal withdrawal bleed until the next pack is finished. However, while taking tablets from the new pack, you may experience increased intermenstrual bleeding or spotting.

The more tablets you miss, the higher the risk that contraceptive protection is reduced. If you miss one or more tablets in week 1 and had sexual intercourse in the week before the missed dose, you should be aware that there is a risk of pregnancy. The same applies if you miss one or more tablets and do not experience bleeding during the subsequent treatment-free interval. In these cases, contact your doctor.

Do not take a double dose to make up for a missed dose.

If you wish to delay your menstrual period
Although not recommended, it is possible to delay your menstrual period (withdrawal bleeding) by immediately starting a new pack of Mytulip, skipping the break period, and continuing until the end of the second blister pack.

Spotting (drops or blood stains) or intermenstrual bleeding may occur while taking tablets from the new pack. After the usual 7-day break, continue with the next pack.

Consult your doctor before deciding to delay your menstrual period.

If you wish to change the first day of your menstrual cycle
If you take the tablets as instructed, your menstrual cycle/withdrawal bleeding will start during the week when no tablets are taken. If you wish to change this day, you may do so by shortening the break period (but never lengthening it!). For example, if your tablet-free period usually starts on a Friday and you wish to change it to Tuesday (3 days earlier), start the new pack 3 days earlier than usual. If you shorten the break period significantly (e.g. by 3 days or less), you may not experience any bleeding during this tablet-free interval. Subsequently, you may experience spotting (drops or blood stains) or intermenstrual bleeding.

If you are unsure about how to proceed, consult your doctor.

If you stop treatment with Mytulip
When you stop taking Mytulip, your ovaries quickly resume full activity, and you may become pregnant.

If you have any further 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 everyone will experience them.
If you experience any side effect, especially if it is severe or persistent, or if you notice any change in your health that you think may be due to Mytulip, stop taking Mytulip and contact 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 throat and/or difficulty swallowing, or hives with possible difficulty breathing (see also section “Warnings and precautions”).

Side effects may occur with different frequencies defined as follows:

Uncommon (may affect up to 1 in 100 people)

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

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

• sudden hearing loss
• dizziness and sensation 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 a lung (i.e. PE)
  • heart attack
  • stroke, mini-stroke or temporary symptoms similar to stroke, known as transient ischaemic attack (TIA)
  • blood clots in the liver, stomach/intestines, kidneys or eye.

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

Other possible side effects

Very common (may affect more than 1 in 10 people)

• nausea
• vaginal discharge
• menstrual pain
• absence of menstruation
• intermenstrual 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 disturbances
• 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 ache
• bloating, diarrhoea
• pigmentation disorders, brown spots on the face
• hair loss
• dry skin
• back pain, muscle problems
• breast discharge
• benign breast nodules
• fungal vaginal infections (thrush)
• decreased sexual desire
• tendency to sweat
• changes in blood lipids, including increased triglycerides, observed in 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
• hives, eczema, skin inflammation, itching, worsening of psoriasis
• excessive growth of body and facial hair
• breast enlargement
• inflammation of the vagina
• longer and/or more painful menstruation
• 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 diseases and adverse effects:

• risk of blockage of veins and arteries (see section 2),
• risk of biliary tract diseases (see section 2),
• risk of tumours (e.g. liver tumours, which in isolated cases have caused severe, even fatal, intra-abdominal bleeding; cervical or breast tumours; see section 2),
• worsening of chronic intestinal inflammation (Crohn’s disease, ulcerative colitis; see section 2).
  Read carefully the information in section 2, and if necessary, seek immediate advice from your doctor. If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

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

5. How to store Mytulip

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister pack (calendar pack) after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine 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 Mytulip contains

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

Description of the appearance of Mytulip and package contents
Mytulip tablets are pink, round, film-coated tablets. Mytulip is available in packages
containing 1, 3 or 6 blisters, each blister containing 21 tablets.
Not all pack sizes may be marketed.
Marketing Authorization 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 authorized in the European Economic Area countries under the following
names:
Germany: Lisette 0.03 mg/2 mg Film Tablets
Italy: Mytulip 2 mg/0.03 mg film-coated tablets