Stediril 30

Leaflet accompanying the packaging: patient information

Stediril 30, 150 micrograms + 30 micrograms, sugar-coated tablets

Levonorgestrel + ethinylestradiol

You should read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same.
• If any of the side effects get worse or if you notice any side effects not mentioned in the leaflet, you should tell your doctor or pharmacist.

Table of contents of the leaflet:

• 1. What is Stediril 30 and what is it used for
• 2. Important information before taking Stediril 30
• 3. How to take Stediril 30
• 4. Possible side effects
• 5. How to store Stediril 30
• 6. Package contents and other information

1. What is Stediril 30 and what is it used for

Stediril 30 is available in the form of a combined oral contraceptive tablet ("Tablet") for use in order to prevent pregnancy.
The medicine contains two types of female sex hormones: estrogen and progestogen. These hormones prevent pregnancy by acting in three ways: they prevent the release of the egg from the ovaries; they thicken the mucus in the cervix, making it difficult for sperm to penetrate the uterus; they prevent the thickening of the uterine lining so that a fertilized egg cannot develop in it.
Stediril 30 should be taken daily for 21 days (1 tablet), after which there is a 7-day break from taking the tablet.

Benefits of taking the Tablet:

• it is one of the most reliable, reversible contraceptive methods, if used correctly,
• it does not require interrupting sexual intercourse,
• it usually makes menstrual periods more regular, more scarce and less painful,
• it may alleviate premenstrual symptoms.

Stediril 30 does not protect against sexually transmitted infections, such as chlamydia or HIV. Only condoms protect against these infections.

Stediril 30 should be taken according to the recommendations in order to prevent pregnancy.

2. Important information before taking Stediril 30

It is essential to understand the benefits and risks associated with taking the Tablet before starting to take it or deciding to continue it. Although the Tablet is suitable for most healthy women, it is not suitable for all of them.
You should inform your doctor if you have any diseases or risk factors mentioned in this leaflet.

Before taking the Tablet

The doctor will ask a few questions about your health and the health of your close relatives and measure your blood pressure.
The doctor should also perform other tests, such as a breast examination.

While taking the Tablet

• You should regularly visit your doctor, usually when a new prescription is needed.
• You should regularly visit your doctor for a cervical smear test.
• Once a month, you should examine your breasts and nipples - you should inform your doctor if you notice or feel any changes, such as lumps or depressions in the skin.
• If you need to have a blood test, you should inform your doctor that you are taking the Tablet, as it may affect the results of some tests.
• If surgery is planned, you should inform your doctor. It may be necessary to stop taking the Tablet 4-6 weeks before the operation. This will reduce the risk of blood clots (see "Tablet and thrombosis"). The doctor will inform you when you can resume taking the Tablet.

When not to take Stediril 30

Taking Stediril 30 will pose a risk to your health:

• If you are allergic to levonorgestrel, ethinylestradiol or any of the other ingredients of this medicine (listed in section 6)
• If you are pregnant or suspect you are pregnant
• If you have hormone-dependent cancer - such as some breast, endometrial or ovarian cancers
• If you have unexplained vaginal bleeding
• If you or your close relatives have ever had problems with blood circulation, including blood clots (thrombosis) in the legs (deep vein thrombosis), lungs (pulmonary embolism), heart (heart attack), brain (stroke) or other parts of the body
• If you have high blood pressure that is not controlled by medication
• If you have irregular heart rhythm (arrhythmia) or heart valve problems caused by blood clotting problems
• If you have headaches with neurological symptoms (aura)
• If you have diabetes with blood vessel problems
• If you have a disease that increases the risk of blood clots (thrombosis - see "Tablet and thrombosis")
• If you have ever had pancreatitis associated with high blood lipid levels (high cholesterol or triglycerides)
• If you have ever had severe liver disease
• You should not take Stediril 30 if you have hepatitis C and are taking antiviral medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir or sofosbuvir with velpatasvir and voxilaprevir (see also "Stediril 30 and other medicines").

If you have any of the above conditions or if they occur for the first time while taking Stediril 30, you should contact your doctor as soon as possible. Do not take Stediril 30.

You should tell your doctor if you have any of the following conditions.

If these symptoms occur or worsen while taking Stediril 30, you should also tell your doctor.

• If symptoms of angioedema occur, such as swelling of the face, tongue and (or) throat, and (or) difficulty swallowing or hives, which can cause difficulty breathing, you should contact your doctor immediately. Products containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.

A serious risk factor or multiple risk factors for venous or arterial thrombosis may also be a contraindication (see "Warnings and precautions, Tablet and thrombosis").

Warnings and precautions

Tablet and smoking

Women taking the Tablet are strongly advised to quit smoking.
Smoking increases the risk of serious side effects from the heart and circulatory system. This risk increases with age and the number of cigarettes smoked and is significant in women over 35 years old.

Tablet and thrombosis

The Tablet may slightly increase the risk of blood clots (called thrombosis), especially in the first year of use.
A blood clot in a leg vein - deep vein thrombosis - is not always serious. However, if it moves from the veins to the lungs, it can cause chest pain, shortness of breath, collapse or even death. This condition is called pulmonary embolism and is very rare.
The risk of blood clots is only slightly increased by taking the Tablet.

• Within one year, out of 100,000 women who do not take the Tablet and are not pregnant, about 5 of them will develop a blood clot.
• Within one year, out of 100,000 women who take the Tablet, such as Stediril 30, about 20 of them will develop a blood clot.
• Within one year, out of 100,000 pregnant women, about 60 of them will develop a blood clot.

The risk of blood clots in the veins increases further:

• with age,
• in the case of significant overweight,
• if you or your close relatives have ever had blood clots,
• in the case of prolonged immobilization due to surgery, injury or illness,
• in the case of one or more miscarriages,
• after recent childbirth or abortion after the first three months of pregnancy. You should inform your doctor if any of these risk factors occur in you. Taking the Tablet may further increase this risk, so Stediril 30 may not be suitable.

Symptoms of a blood clot include:

• painful swelling of the leg,
• sudden chest pain,
• difficulty breathing. You should contact your doctor as soon as possible. Do not take Stediril 30 until your doctor allows it. In the meantime, you should use other methods of contraception, such as condoms.

Blood clots can also form in the blood vessels of the heart (causing a heart attack) or brain (causing a stroke) in rare cases. In young, healthy women, the risk of a heart attack or stroke is extremely low.
The risk of a heart attack or stroke increases further:

• if you smoke,
• if you have high blood pressure,
• if you have been diagnosed with high blood lipid levels (cholesterol or triglycerides),
• if you are significantly overweight,
• with age,
• if you have irregular heart rhythm (atrial fibrillation),
• if you or your close relatives have had a heart attack or stroke at a young age,
• if you have migraines,
• if you have been diagnosed with diabetes. You should inform your doctor if any of these risk factors occur in you. Taking the Tablet may further increase this risk, so Stediril 30 may not be suitable.

Symptoms of a heart attack or stroke include:

• sudden severe chest pain that may radiate to the left arm,
• sudden weakness or numbness of one side or part of the body,
• the onset of migraines for the first time or worsening of migraines,
• any sudden changes in vision (such as loss of vision or visual disturbances),
• dizziness, fainting, collapse or seizures. You should contact your doctor as soon as possible. Do not take Stediril 30 until your doctor allows it. In the meantime, you should use other methods of contraception, such as condoms.

Surgery and immobilization
You should stop taking the Tablet 4 weeks before planned surgery and 2 weeks after surgery that increases the risk of thrombosis, or during prolonged immobilization. You should discuss taking the Tablet with your doctor in such situations.
Childbirth, abortion or miscarriage
After childbirth, there is an increased risk of blood clots. You should not start taking the Tablet earlier than 28 days after childbirth if you are breastfeeding.
The same applies to abortion or miscarriage after the first three months of pregnancy.

Tablet and cancer

Taking the Tablet for a long time reduces the risk of ovarian and endometrial cancer. However, it appears to slightly increase the risk of cervical cancer- although this may be due to sexual behavior rather than taking the tablet. The most important risk factor for cervical cancer is persistent human papillomavirus infection.
All women should have regular cervical smears.
If you have or have had breast cancerin the past, you should not take the Tablet.
The Tablet slightly increases the risk of breast cancer. This risk increases with the duration of taking the Tablet, but decreases within 10 years of stopping it.
Breast cancer rarely occurs in women under 40, so the risk of additional breast cancer cases in women currently or recently taking the Tablet is small.
The risk of breast cancer is higher:

• the older the woman is,
• if a close relative has had breast cancer (mother, sister or grandmother),
• in the case of significant overweight,
• in the case of giving birth at an older age or if you have never given birth. You should report to your doctor as soon as possible if you notice any changes in your breasts, such as skin dimpling, changes in the nipples or other lumps that can be seen or felt.

Very rarely, taking the Tablet has also been associated with certain types of liver cancerin women taking the medicine for a long time.

Tablet and liver disease

Taking the Tablet has also been rarely associated with liver disease, such as jaundice and non-cancerous liver tumors.
Early diagnosis of liver cell damage allows for prompt withdrawal of the medicine, which reduces the harmful effect of the medicine on the liver. If liver cell damage is diagnosed, you should stop taking the Tablet, use other methods of contraception and consult your doctor.
It may be that the Tablet cannot be used until liver function disorders have subsided.
If you experience severe abdominal pain or yellowing of the skin or eyes (jaundice), you should contact your doctor as soon as possible. It may be necessary to stop taking Stediril 30.

Tablet and vision

When wearing contact lenses, discomfort or even intolerance may occur while taking the Tablet. If more serious eye problems occur, you should stop taking the Tablet and consult your doctor immediately.

High blood pressure

While taking the tablet, high blood pressure may occur. If you have ever had high blood pressure problems, you may need to use another method of contraception. If your doctor prescribes the Tablet, you should have your blood pressure checked regularly and stop taking the Tablet and use another method of contraception if it increases significantly (see also "Do not take Stediril 30 if you have any of the following conditions").

Migraine and headache

If you experience migraines or headaches, in a form that has not occurred before, the Tablet may not be suitable. In this case, you should stop taking the Tablet and consult your doctor.

Immune reactions

The Tablet may cause or worsen symptoms of angioedema (sudden swelling of tissues in some cases causing difficulty breathing, swallowing and hives).
The increased risk occurs if you or your relatives have ever had angioedema. You should consult your doctor.

Tablet and carbohydrate and lipid metabolism

If you have ever had problems with glucose tolerance or diabetes, you should tell your doctor, as close monitoring of you may be required (see also "Do not take Stediril 30 if you have any of the following conditions").
In a small number of women, changes in blood lipid levels may occur while taking the Tablet. You should inform your doctor, who may consider using non-hormonal contraception.
If you are being treated for high lipid levels, regular check-ups will be required while taking the Tablet.

Vaginal bleeding

Irregular vaginal bleeding may occur (unexpected bleeding outside the weekly break, when you are not taking the medicine) or spotting, especially during the first three months of taking the Tablet. A reliable assessment of irregular bleeding is possible only after an adaptation period of about three cycles. If these forms of bleeding persist or recur, you should consult your doctor to rule out non-hormonal causes, such as pregnancy or certain diseases. If necessary, your doctor may prescribe another Tablet (see also "Vaginal bleeding should not last long").
If you have previously had amenorrhea or irregular periods, these conditions may recur while taking the Tablet.
In the case of amenorrhea during taking the Tablet, see also "Missing a dose of Stediril 30".

Psychiatric disorders

Some women taking hormonal contraceptives, including Stediril 30, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, you should contact your doctor as soon as possible for further medical advice.
Women with a history of depression should be closely monitored and if severe symptoms of recurring depression occur, you should stop taking the product. It may turn out that the tablet is not suitable and another type of contraception will be needed.

Medical examinations

Before prescribing the Tablet for the first time, your doctor will take a complete medical history, including family history, and perform a physical examination. You should regularly visit your doctor for a cervical smear test.
The next visit should take place after three months from the start of taking the Tablet. Once a year, you should visit your doctor for a check-up, which will be the same as the first one.
While taking the Tablet, in patients who have had chloasma in the past, brown spots on the face (chloasma) may occur. Patients prone to chloasma should avoid sun exposure and ultraviolet radiation.

Children and postmenopausal women

Stediril 30 is intended for use only in women of reproductive age. It should not be used by children or postmenopausal women.

Stediril 30 and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. You should also check the leaflets of all medicines you are taking to see if they can be used with hormonal contraception.
Some medicines may make Stediril 30 less effective in preventing pregnancy, for example:

• medicines used to treat constipation (laxatives),
• certain medicines used to treat epilepsy,
• certain medicines used to treat tuberculosis,
• certain medicines used to treat HIV (AIDS),
• certain antifungal medicines,
• certain sedatives (called "barbiturates"),
• certain anti-inflammatory medicines,
• St. John's wort (a herbal medicine),
• atorvastatin (a medicine that lowers blood lipid levels),
• vitamin C or paracetamol,
• theophylline (a medicine used to treat asthma),
• cyclosporin.

If it is necessary to take one of these medicines, it may turn out that Stediril 30 is not suitable and there is a need to use additional contraception for a certain period. Your doctor or pharmacist will inform you if this is necessary and for how long.
Stediril 30 may also affect the action of other medicines. Therefore, it is very important to tell your doctor if you are taking the Tablet with other medicines.
Taking a medicine called troleandomycin while taking the Tablet increases the risk of liver function disorders (reduced bile secretion by the liver).
Taking a medicine called flunaryzine while taking the Tablet may sometimes cause milk production in the breasts of women who have not recently given birth.
You should not take Stediril 30 if you have hepatitis C and are taking antiviral medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir or sofosbuvir with velpatasvir and voxilaprevir, as these medicines may cause elevated liver function test results (increased activity of the liver enzyme ALT).
Your doctor will suggest another type of contraception before starting these medicines.
You can resume taking Stediril 30 about 2 weeks after finishing the treatment. See "When not to take Stediril 30".

Stediril 30 with food and drink

There are no special recommendations for taking Stediril 30 with food and drink.

Pregnancy, breastfeeding and fertility

In pregnancy and during breastfeeding or if you suspect you are pregnant, or if you plan to become pregnant, you should consult your doctor before taking this medicine.
You should not take Stediril 30 during pregnancy. If you suspect you are pregnant, you should have a pregnancy test done before stopping Stediril 30.
There is no evidence that Stediril 30 causes harm to the fetus if it is taken inadvertently during use, but if pregnancy is confirmed, you should stop taking Stediril 30.
Stediril 30 is not recommended during breastfeeding. You should discuss another method of contraception with your doctor. Breastfeeding does not protect against pregnancy.

Stediril 30 contains lactose and sucrose

Stediril 30 contains lactose and sucrose. You should inform your doctor before starting to take the medicine if you have an intolerance to some sugars.

3. How to take Stediril 30

3.1 How to take Stediril 30

This medicine should always be taken according to the doctor's instructions. If you have any doubts, you should consult your doctor.
Stediril 30 should be taken daily for 21 days.
Stediril 30 is available in blisters containing 21 tablets. Each tablet is marked with the day of the week.

• Tablets should be taken daily at approximately the same time.
• You should start taking the tablet marked with the correct day of the week.
• Tablets should be taken in the direction of the arrows indicated on the packaging. You should take one tablet daily until all 21 tablets have been taken.
• Tablets should be swallowed whole, if necessary with a glass of water. They should not be chewed.

Then there is a 7-day break from taking the tablets
After taking all 21 tablets from the blister, there is a 7-day break from taking the tablets. If the last tablet from the first pack was taken on a Friday, the first tablet from the next pack should be taken on the following Saturday.
Within a few days of taking the last tablet from the blister, withdrawal bleeding will occur, similar to a menstrual period. This bleeding may not have stopped before starting the next pack of tablets.
There is no need to use additional contraception during these 7 tablet-free days, as long as the tablets are taken correctly and the next pack is started on time.
Then you should start the next pack
After the 7 tablet-free days, you should start the next blister of Stediril 30 - even if the bleeding has not stopped. You should always start a new blister on time.
As long as the tablets are taken correctly, each subsequent pack will always start on the same day of the week.

3.2 How to start taking Stediril 30

First use or starting the Tablet after a break
You should start taking Stediril 30 on the first day of your next menstrual period. Starting in this way provides immediate contraceptive protection.
It is acceptable to start taking Stediril 30 between the 2nd and 7th day of your menstrual period (e.g. starting on a Sunday). You should use additional methods of contraception, such as condoms, until you have taken the first seven tablets correctly.
Switching from another contraceptive to Stediril 30

• If you were previously taking a medicine containing 21 tablets: you should start taking Stediril 30 the next day after finishing the previous pack. Contraceptive protection is immediate. Bleeding will occur only after completing the first blister of Stediril 30.
• If you were previously taking a medicine containing 28 tablets: you should start taking Stediril 30 the next day after finishing the active tablets. Contraceptive protection is immediate. Bleeding will occur only after completing the first blister of Stediril 30.
• If you were previously using a progestogen-only contraceptive(progestogen-only tablets, subdermal implant, intrauterine device, injection):
• progestogen-only tablet: you can stop taking progestogen-only tablets on any day and start taking Stediril 30 the next day
• implant or intrauterine device: you should start taking Stediril 30 on the same day that the implant or intrauterine device is removed.
• injection: you should start taking tablets on the day of the planned next injection. You should use additional methods of contraception, such as condoms, until you have taken the first seven tablets correctly.

Starting Stediril 30 after a miscarriage or abortion
If the miscarriage or abortion occurred within the first three monthsof pregnancy, your doctor may inform you that you can start taking Stediril 30 immediately. This means that you will have immediate contraceptive protection.
If the miscarriage or abortion occurred after the third monthof pregnancy, you can start taking Stediril 30 after 28 days. It is recommended to use additional methods of contraception, such as condoms, during the first 7 days of taking the medicine. If you have had sexual intercourse, you should rule out pregnancy or wait for your next menstrual period to occur.
Contraception after childbirth
You can start taking Stediril 30 after 28 days from a normal, uncomplicated childbirth, if you are not breastfeeding and are fully recovered. It is recommended to use additional methods of contraception during the first 7 days of taking Stediril 30.
If you have had sexual intercourse, you should rule out pregnancy or wait for your first menstrual period after childbirth or abortion to occur.
Your doctor will provide further information on contraception.

3.3 Taking more than the recommended dose of Stediril 30

It is unlikely that taking more than one tablet will cause side effects, but you should talk to your doctor as soon as possible.

3.4 Missing a dose of Stediril 30

If you miss a tablet, you should follow the instructions below.
If it has been less than 12 hourssince you missed the tablet, you should take the missed tablet as soon as possible. You should take the next tablets at the usual time. Contraceptive protection has not been reduced.
If it has been more than 12 hourssince you missed the tablet or if you have missed two or more active tablets, contraceptive protection may be reduced. Therefore, you should take only the last missed tablet as soon as possible, which may mean taking two tablets on the same day. Previously missed tablets should be left in the blister and you should continue taking the tablets as usual. You should also use additional methods of contraception, such as condoms, for the next seven days.
You should follow the rules below:

• If you missed one or more tablets in the first week of taking the blister (days 1-7) and you have had sexual intercourse, there is a risk of pregnancy. You should contact your doctor or pharmacist as soon as possible.
• If you took the last tablet after the seven days during which you should have used additional contraception, you should have a 7-day break before starting the next blister.
• If you took the last tablet before the end of these seven days, during which you should have used additional contraception, you should start the next pack the next day. Until you finish the second blister, you will usually not have withdrawal bleeding.

If you forgot to take any of the tablets from the blister and did not have withdrawal bleeding during the tablet-free period, it may mean that you are pregnant. Before starting the tablets from the next blister, you should contact your doctor or pharmacist or have a pregnancy test.
If you started a new blister late, you may not be protected against pregnancy. If you have had sexual intercourse, you should consult your doctor or pharmacist. You should also use additional methods of contraception, such as condoms, for seven days.

3.5 What to do if you vomit or have diarrhea

If you vomit or have severe diarrhea, the hormones from the tablet may not have been fully absorbed. You should continue taking the tablets at the usual time. You should use additional contraception, such as condoms, during the illness and for the next seven days after recovery. If it has been more than 12 hours, you should follow the instructions from the "Missing a dose of Stediril 30" section.
You should contact your doctor if gastrointestinal disturbances do not subside or worsen. Your doctor may recommend another method of contraception.

3.6 Delaying withdrawal bleeding - can I be pregnant?

Occasionally, withdrawal bleeding may not occur. This may mean that you are pregnant, but it is unlikely if the tablets have been taken correctly. If there is a risk of pregnancy (e.g. due to missing a tablet or taking other medicines) before starting the next pack, you should have a pregnancy test. If it turns out that you are pregnant, you should stop taking Stediril 30 and consult your doctor.

3.7 How to delay withdrawal bleeding

If you want to delay the time of withdrawal bleeding, you should skip the 7-day break and immediately start taking tablets from a new pack of Stediril 30. You can delay withdrawal bleeding for any length of time, up to the time you take all the tablets from the new pack. During this time, you may experience irregular bleeding or spotting.
You should resume regular taking of Stediril 30 after the usual 7-day break.
If you have any further questions about taking this medicine, you should talk to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe side effects

You should contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and (or) throat, and (or) difficulty swallowing or hives, which can cause difficulty breathing (see also "Warnings and precautions").
Like all medicines, Stediril 30 may cause allergic reactions (hypersensitivity). These reactions may include, in very rare cases, hives, sudden swelling of tissues and severe reactions from the respiratory and circulatory systems, such as: decreased blood pressure, dizziness, nausea and difficulty breathing. If you notice any symptoms of an allergic reaction, you should stop taking Stediril 30 immediately and consult your doctor or go to the nearest hospital.
Severe side effects related to taking the contraceptive tablet have been described in section 2, "Tablet and thrombosis" and "Tablet and cancer". If you need further information, you should read these sections.

Other possible side effects:

Very common (occurring in more than 1 in 10 women):

• headache, including migraine (if it is severe or unusual, or prolonged, you should contact your doctor as soon as possible)
• bleeding and spotting between menstrual periods during the first few months (although it usually subsides when the body gets used to Stediril 30) - see "Vaginal bleeding should not last long".

Common (occurring in 1 to 10 in 100 women):

• weight change (increase or decrease)
• mood changes, including depression, changes in libido (sex drive)
• nervousness or dizziness
• breast pain, breast tenderness, breast enlargement, nipple discharge, change in menstrual bleeding, change in vaginal discharge, amenorrhea, painful menstrual periods
• vaginitis, including yeast infection (candidiasis)
• stomach problems, such as nausea, vomiting, abdominal pain
• acne
• fluid retention, edema (e.g. swelling of the ankles or feet) caused by fluid accumulated in the tissues.

Uncommon (occurring in 1 to 10 in 1,000 women):

• change in blood lipid levels (lipids in the blood), including hypertriglyceridemia, change in appetite (increase or decrease)
• increased blood pressure
• stomach cramps, bloating, diarrhea
• skin rash, brown irregular spots on the skin (melanoderma/chloasma), which may persist, excessive hair growth (hirsutism), excessive hair loss (alopecia).

Rare (occurring in 1 to 10 in 10,000 women):

• severe allergic reactions, including very rare cases of hives, sudden swelling of tissues (angioedema) and severe reactions from the respiratory and circulatory systems, such as: decreased blood pressure, dizziness, nausea and difficulty breathing
• decreased folate levels in the blood, glucose intolerance
• intolerance to contact lenses
• jaundice (cholestatic jaundice)
• inflammation of fat cells under the skin (erythema nodosum)
• leucorrhoea.

Very rare (occurring in less than 1 in 10,000 women):

• worsening of systemic lupus erythematosus (a chronic autoimmune disorder)
• worsening of porphyria (a disorder due to the lack of certain enzymes)
• worsening of chorea (a movement disorder)
• inflammation of the optic nerve, blood clots in the retinal blood vessels
• worsening of varicose veins (varicose veins)
• pancreatitis, inflammation of the large intestine due to reduced blood flow to the intestine (ischemic colitis)
• gallbladder disease, including gallstones
• erythema multiforme (a skin disease)
• hemolytic-uremic syndrome (a kidney disease)
• hepatocellular carcinoma (liver cancer)

Stediril 30 may also cause inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis) and liver cell damage with an unknown frequency, which cannot be determined from the available data.
You should inform your doctor or pharmacist if you suspect that any side effect may be caused by Stediril 30. If any of your existing disorders worsen while taking Stediril 30, you should also inform your doctor or pharmacist.

Vaginal bleeding should not last long

In some women, unexpected vaginal bleeding may occur while taking Stediril 30, especially during the first few months. Usually, this bleeding is not a cause for concern and will subside after a day or two. You should take Stediril 30 as usual. The problem should subside after taking a few initial blisters of the medicine.
Unexpected bleeding may also occur if the tablets are not taken regularly, so you should try to take the tablets daily at the same time. Unexpected bleeding may also be caused by taking other medicines.
You should consult your doctor if bleeding or spotting:

• lasts longer than a few first months
• starts after a few months of taking Stediril 30
• continues even after stopping Stediril 30.

5. How to store Stediril 30

The medicinal product should be stored out of sight and reach of children. Do not use this medicinal product after the expiry date stated on the blister or carton after (EXP). The expiry date refers to the last day of the given month. Do not store above 25°C. Store in the original package. Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Stediril 30 contains

• The active substances of the medicinal product are levonorgestrel and ethinylestradiol. Each coated tablet contains 150 micrograms of levonorgestrel and 30 micrograms of ethinylestradiol.
• The other ingredients are: The tablet core contains: lactose monohydrate, maize starch, povidone K 25, magnesium stearate, talc, and purified water. The tablet coating contains: sucrose, macrogol 6000, calcium carbonate, talc, povidone K 90, purified water. Glazing agents: white wax, carnauba wax, talc.

What Stediril 30 looks like and what the pack contains

Coated tablets
The tablets are white, shiny, coated with a smooth surface.
Each blister of Stediril 30 contains 21 white tablets.
PVC/Aluminium foil blister in an aluminium sachet with silica gel as a desiccant, in a cardboard box.
PVC/Aluminium foil blister in a cardboard box.
Each pack of Stediril 30 contains 1x21 or 3x21 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer

Haupt Pharma Muenster GmbH
Schleebrueggenkamp 15
48159 Muenster
Germany
Pfizer Ireland Pharmaceuticals Unlimited Company
Little Connell, Newbridge
Co. Kildare
W12 HX57
IrelandPfizer Polska Sp. z o.o.
tel. 22 335 61 00

Date of last update of the leaflet: 06/2025