Leverette

Leaflet accompanying the packaging: patient information

Leverette, 0.150 mg + 0.030 mg, coated tablets
Levonorgestrel + Ethinylestradiol

You should carefully read the contents of the leaflet before using 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.
• If you have any doubts, you should consult a doctor or pharmacist.
• 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception
• They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more
• You should be vigilant and consult a doctor if the patient suspects that blood clot symptoms have occurred (see below "Blood clots")

Table of contents of the leaflet

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

1. What is Leverette and what is it used for

• Leverette is a contraceptive pill used to prevent pregnancy.

Each of the 21 yellow tablets contains a small amount of two different female hormones: levonorgestrel and ethinylestradiol.
7 white tablets do not contain active ingredients and are called placebo tablets.
Contraceptive pills containing two hormones are called "combined" pills.

2. Important information before taking Leverette

General notes

Before starting to take Leverette, you should read the information about blood clots (thrombosis) in section 2. It is especially important to read about the symptoms of blood clots (see section 2 "Blood clots").
Before you can start taking Leverette, your doctor will ask you a few questions about your health and the health of your close relatives. Your doctor will also measure your blood pressure and may perform other tests.
This patient leaflet describes several situations in which you should stop taking Leverette or in which the effectiveness of Leverette may be reduced.
In such situations, you should not have sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other barrier methods.
You should also not use the calendar method or the temperature measurement method during this time.
These methods may be ineffective because Leverette affects the monthly changes in body temperature and cervical mucus.

Leverette, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

When not to take Leverette:

You should not take Leverette if you have any of the conditions listed below. If you have any of the conditions listed below, you should inform your doctor. Your doctor will discuss with you which other method of preventing pregnancy will be more suitable.

• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if you know you have a blood clotting disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you need to have surgery or will be immobilized for a long time (see "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (temporary stroke symptoms);
• if you have any of the following diseases, which may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage
• very high blood pressure;
• very high levels of fats in the blood (cholesterol or triglycerides).
• hyperhomocysteinemia
• if you have (or have had in the past) a type of migraine called "migraine with aura";
• if you have (or have had in the past) liver disease and liver function has not yet returned to normal;
• if you have (or have had in the past) liver cancer;
• if you have (or have had in the past) breast cancer or cancer of the genital organs;
• if you have any unexplained vaginal bleeding;
• if you are allergic to ethinylestradiol or levonorgestrel or any of the other ingredients of this medicine (listed in section 6). This may cause itching, rash, or swelling;
• if you have hepatitis C and are taking antiviral medicines containing ombitasvir, paritaprevir, and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also "Leverette and other medicines").

Warnings and precautions

When should you contact your doctor?
You should contact your doctor immediately

• if you notice any of the possible signs of a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), lung (pulmonary embolism), heart attack, or stroke (see below "Blood clots").

In order to describe the symptoms of these serious side effects, see "How to recognize a blood clot".

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

Before starting to take Leverette, you should contact your doctor. In certain situations, you should be particularly careful when taking Leverette or any other combined hormonal contraceptive, and you may need to be regularly examined by your doctor. If these symptoms occur or worsen while taking Leverette, you should also tell your doctor.

• if a close relative has had breast cancer;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you have depression; Some women taking hormonal contraceptives, including Leverette, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, you should contact your doctor as soon as possible for further medical advice.
• if you have Crohn's disease or ulcerative colitis (a chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a genetic disorder of red blood cells);
• if you have been told you have high levels of fats in the blood (hypertriglyceridemia) or have a family history of this condition. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you need to have surgery or will be immobilized for a long time (see "Blood clots");
• if you have just given birth, you are at a higher risk of blood clots. You should contact your doctor to find out how soon you can start taking Leverette after giving birth.
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see "Leverette and other medicines");
• if you have a disease that first occurred during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disease called porphyria,

a skin rash with blisters during pregnancy (pregnancy pemphigoid), a nervous system disease that causes uncontrolled body movements (Sydenham's chorea);

• if you have (or have had in the past) chloasma (skin discoloration, especially on the face and neck, also known as "pregnancy spots"). In this case, you should avoid direct exposure to sunlight and ultraviolet radiation.
• if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives that may cause difficulty breathing, you should contact your doctor immediately. Products containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Leverette, is associated with an increased risk of blood clots, compared to not using them. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur

• in veins (also known as "venous thromboembolism" or "deep vein thrombosis")
• in arteries (also known as "arterial thromboembolism" or "arterial occlusion"). Not all blood clots may disappear completely after treatment. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

It should be remembered that the overall risk of developing harmful blood clots due to Leverette is small.

HOW TO RECOGNIZE A BLOOD CLOT

You should contact your doctor immediately if you notice any of the following symptoms.

BLOOD CLOTS IN VEINS

What can happen if blood clots form in veins?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thromboembolism). However, these side effects are rare. They most often occur in the first year of using combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot moves from the leg and settles in the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in veins highest?

The risk of forming blood clots in veins is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, although it is always higher compared to not using combined hormonal contraceptives.
If the patient stops taking Leverette, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots?

The risk depends on the natural risk of developing venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of blood clots in the legs or lungs associated with Leverette is small.

• During a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• During a year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• The risk of blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots", below).

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with Leverette is small, but some factors can increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) over 30 kg/m2);
• if someone in the patient's immediate family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years old). In this case, the patient may have a hereditary blood clotting disorder;
• if the patient needs to have surgery or will be immobilized for a long time due to injury or illness, or has a leg in a cast. It may be necessary to stop taking Leverette for a few weeks before surgery or immobilization. If the patient needs to stop taking Leverette, they should ask their doctor when they can resume taking the medicine;
• with age (especially over 35 years old);
• if the patient has recently given birth

The risk of blood clots increases with the number of risk factors present in the patient.
Air travel (over 4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell the doctor if any of these risk factors are present, even if the patient is not sure. The doctor may decide to stop the patient from taking Leverette.
The patient should inform their doctor if any of the above conditions change while taking Leverette, e.g., if someone in their immediate family is diagnosed with a blood clot without a known cause or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in arteries?

Similarly to blood clots in veins, blood clots in arteries can cause serious consequences, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is essential to note that the risk of heart attack or stroke associated with Leverette is very small, but it may increase:

• with age (over about 35 years old);
• if the patient smokes. While taking a hormonal contraceptive like Leverette, it is recommended to quit smoking. If the patient is unable to quit smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the patient's immediate family has had a heart attack or stroke at a young age (under 50 years old). In this case, the patient may also be at higher risk of having a heart attack or stroke;
• if the patient or someone in their immediate family has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, arrhythmia, called atrial fibrillation)
• if the patient has diabetes.

If the patient has more than one of the above conditions or if any of them are particularly severe, the risk of blood clots may be even higher.
The patient should inform their doctor if any of the above conditions change while taking Leverette, e.g., if they start smoking, someone in their immediate family is diagnosed with a blood clot without a known cause, or if they gain significant weight.

Leverette and cancer

In women taking combined contraceptives, breast cancer has been slightly more common, but it is not known if this is caused by the medicines. It is possible, for example, that more tumors are detected in women taking contraceptives because they are examined by their doctors more often. The frequency of breast cancer decreases gradually after stopping combined hormonal contraceptives.
It is essential to regularly examine your breasts and contact your doctor if you find any lumps.
In women taking combined contraceptives, rare cases of benign liver tumors and even rarer cases of malignant liver tumors have been reported.
The patient should contact their doctor if they experience severe abdominal pain.
Breast cancer has been slightly more common in women taking combined oral contraceptives for an extended period than in women who have not taken them; however, it is not known what the significance of other factors is, such as sexual behavior and other factors, such as human papillomavirus (HPV) infection.

Irregular bleeding

During the first few months of taking Leverette, unexpected bleeding (outside of the week of taking placebo tablets) may occur. If bleeding occurs for longer than the first few months or if it occurs after several months, the patient should contact their doctor, who will determine the cause.

What to do if bleeding does not occur during the placebo tablet period

If the patient has taken all the tablets correctly, has not vomited, or has not had severe diarrhea, and has not taken any other medicines, it is unlikely that they are pregnant. If two consecutive bleedings do not occur, the patient may be pregnant. In this case, they should contact their doctor immediately. Before starting the next pack of Leverette, the patient should make sure they are not pregnant.

Leverette and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including herbal preparations. The patient should also inform any other doctor or dentist prescribing another medicine (or pharmacist) that they are taking Leverette. They may say whether the patient should use additional contraceptive methods (e.g., condoms) and for how long.
The patient should not take Leverette if they have hepatitis C and are taking antiviral medicines containing ombitasvir, paritaprevir, and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as these medicines may cause elevated liver enzyme test results (increased alanine aminotransferase activity). The doctor will recommend a different type of contraception before starting these medicines.
The patient can resume taking Leverette about 2 weeks after finishing the treatment. See the section "When not to take Leverette".
Some medicines may affect the level of Leverette in the blood, which may make it less effective in preventing pregnancy or may cause unexpected bleeding.

• This applies to medicines used to treat:
• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine);
• tuberculosis (e.g., rifampicin);
• HIV or hepatitis C virus infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)
• fungal infections (griseofulvin, ketoconazole);
• arthritis, degenerative joint disease (etoricoxib)
• pulmonary hypertension (bosentan);
• herbal preparations containing St. John's Wort (Hypericum perforatum).
• Leverette may affect the action of other medicines, such as:
• medicines containing cyclosporin;
• antiepileptic medicines, lamotrigine (this may lead to an increased frequency of seizures);
• theophylline (a medicine used to treat respiratory disorders);
• tizanidine (a medicine used to treat muscle pain and/or muscle spasms).

Taking Leverette with food and drink

Leverette can be taken with or without food, with a small amount of water if necessary.

Lab tests

If a blood test is necessary, the patient should tell their doctor or laboratory staff that they are taking a contraceptive, as oral contraceptives may affect the results of some tests.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

Pregnant women should not take Leverette. If the patient becomes pregnant while taking Leverette, they should stop taking the medicine immediately and contact their doctor. If the patient plans to become pregnant, they can stop taking Leverette at any time (see also "Stopping Leverette").

Breastfeeding

During breastfeeding, Leverette is not usually recommended. If the patient wants to take a contraceptive while breastfeeding, they should consult their doctor.

Driving and using machines

There is no information to suggest that taking Leverette affects the ability to drive or use machines.

Leverette contains lactose.

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking Leverette.

3. How to take Leverette

This medicine should always be taken as directed by the doctor. If the patient is unsure, they should contact their doctor or pharmacist.
The patient should remember to take the tablets according to the dosing schedule, as missing a tablet may reduce the effectiveness of the medicine.

How and when to take Leverette

Each pack contains 28 tablets: 21 yellow tablets containing active ingredients and 7 white placebo tablets.
The tablets in Leverette are arranged in order.
The patient should take one Leverette tablet every day, with a small amount of water if necessary. The tablets should be taken at the same time every day.
The patient should not confuse the tablets:they should take the yellow tablets for the first 21 days, followed by the white tablets for the next 7 days. A new pack should be started immediately (21 yellow, followed by 7 white tablets). There should be no break between packs.
Due to the differences in tablet composition, it is essential to start taking the tablets from the first tablet at the top left, and then take the tablets every day in the direction of the arrows on the pack.

Preparing the pack

To help remember the day of tablet intake, each Leverette pack comes with 7 self-adhesive strips with the days of the week printed on them. The patient should choose a strip that starts with the day of the week they want to start taking the tablets. For example, if they want to start taking the tablets on a Wednesday, they should use the strip that starts with "Wed".
The sticker should be stuck to the top of the pack, where it says "Place the day-of-the-week sticker here". This way, the first chosen day of the week will be above the first tablet, and the patient can check if they have taken the correct tablet for the day. The arrows show the order in which the tablets should be taken.
During the 7 days of taking the white placebo tablets (placebo period), bleeding (withdrawal bleeding) should occur. This bleeding usually starts on the 2nd or 3rd day after taking the last yellow active tablet. After taking the last white tablet, the patient should start a new pack, regardless of whether the bleeding has stopped or is still ongoing. This means that the patient should start new packs on the same day of the week, and the bleeding should occur on the same days every month.
Taking Leverette according to these instructions will also protect against pregnancy during the 7 days of taking the placebo tablets.

When to start taking Leverette

• If the patient did not use any hormonal contraceptives in the previous monthThe patient should start taking Leverette on the first day of their period (i.e., the first day of menstruation). Starting Leverette on the first day of menstruation provides immediate protection against pregnancy. The patient can also start taking Leverette on days 2-5 of their cycle, but in this case, they should use additional contraceptive methods (e.g., condoms) for the first 7 days.
• Switching from a combined hormonal contraceptive, vaginal ring, or transdermal patchThe patient can start taking Leverette the next day after taking the last active tablet (last tablet containing active ingredients) of their previous combined oral contraceptive, or at the latest, on the day after the usual break during which they do not take tablets or take placebo tablets (last tablet not containing active ingredients) of their previous combined contraceptive. When switching from a combined transdermal patch or vaginal ring, the patient should follow their doctor's advice.
• Switching from a progestogen-only contraceptive (mini-pill, injection, implant, or intrauterine system releasing progestogen)The patient can switch from a mini-pill at any time (in the case of an implant or intrauterine system, on the day of its removal, and in the case of an injection, on the day of the next scheduled injection), but in all these cases, the patient should use additional contraceptive methods (e.g., condoms) for the first 7 days of taking Leverette.
• After a miscarriageThe patient should follow their doctor's advice.
• After childbirthThe patient can start taking Leverette between 21 and 28 days after giving birth. If they start later than 28 days, they should use a barrier method (e.g., condoms) for the first 7 days of taking Leverette. If the patient has had sexual intercourse after giving birth and before starting Leverette again, they should first make sure they are not pregnant or wait for their first period.
• While breastfeedingIf the patient is breastfeeding and wants to start taking Leverette again after giving birth, they should read the section "Pregnancy and breastfeeding".

If the patient is unsure when to start taking Leverette, they should ask their doctor.

What to do if the patient takes more Leverette than they should

There are no reports that taking too many Leverette tablets has caused serious harmful effects.
If the patient takes a large number of tablets at once, they may experience nausea or vomiting. In young girls, vaginal bleeding may occur.
If the patient has taken too many Leverette tablets or realizes that a child has swallowed some tablets, they should contact their doctor or pharmacist.

What to do if the patient forgets to take Leverette

The tablets in the 4th row of the pack are placebo tablets. If the patient misses one of these tablets, the contraceptive effectiveness of Leverette is maintained. The patient should discard the missed placebo tablet.
If the patient misses a yellow active tablet (tablets in the 1st, 2nd, or 3rd row), they should follow these instructions:

• If less than 12 hourshave passed since missing the tablet, the contraceptive protection is not reduced. The patient should take the tablet as soon as they remember and take the next tablets at the usual time (even if this means taking two tablets on the same day). In this case, no additional contraceptive method is required.
• If more than 12 hourshave passed since missing the tablet, the contraceptive protection may be reduced. The more tablets the patient misses, the higher the risk of pregnancy.

The patient should follow these rules if they miss a tablet:

• If the patient misses more than one tablet in a packThey should contact their doctor.
• If the patient misses one tablet in the 1st weekThey should take the missed tablet as soon as they remember, even if this means taking two tablets at the same time. The patient should take the next tablets at the usual time and use additional barrier methods (e.g., condoms)for the next 7 days. If the patient had sexual intercourse in the week before missing the tablet, there is a risk of pregnancy. In this case, the patient should contact their doctor.
• If the patient misses one tablet in the 2nd weekThey should take the missed tablet as soon as they remember, even if this means taking two tablets at the same time. The patient should take the next tablets at the usual time. The contraceptive protection is not reduced, and there is no need to use additional contraceptive methods.
• If the patient misses one tablet in the 3rd weekThere are two options to choose from:
• 1. The patient should take the missed tablet as soon as they remember, even if this means taking two tablets at the same time. The patient should take the next tablets at the usual time. Instead of taking the placebo tablets, the patient should start a new pack immediately.

It is likely that the patient will experience bleeding at the end of the second pack, but they may also experience spotting or bleeding while taking the tablets from the second pack.

• 2. The patient can stop taking the active tablets from the current pack and start taking the placebo tablets ( the patient should note the day they missed the tablet). If the patient wants to start a new pack on the day they usually start, they should take the placebo tablets for less than 7 days.

If the patient follows one of the above recommendations, the contraceptive protection will be maintained.

• If the patient misses any tablets from the current pack and does not experience bleeding during the placebo tablet period, it may mean that they are pregnant. In this case, before starting the next pack, the patient should consult their doctor.

Missed more
than 1
tablet
Consult a doctor
Yes
Was there sexual intercourse
in the week before missing
the tablet?
In the 1st week
No

• Take the missed tablet
• Use a barrier method (condom) for the next 7 days and
• Finish the current pack

Missed only
1 tablet
(taken after
12 hours)

• Take the missed tablet
• Finish the current pack

In the 2nd week

• Take the missed tablet and
• Finish the pack
• Do not take the placebo tablets, and start a new pack immediately

In the 3rd week
Or

• Stop taking the tablets from the current pack immediately
• Start taking the placebo tablets (for no more than 7 days, including the day the tablet was missed)
• Then start a new pack

What to do if the patient experiences vomiting or severe diarrhea

If the patient vomits or has severe diarrhea within 3-4 hours of taking a tablet, there is a risk that the active ingredients in the tablet may not have been fully absorbed into the body. The situation is almost the same as if the patient had missed a tablet. After vomiting or diarrhea, the patient should take another tablet from a spare pack as soon as possible. If possible, the patient should take the tablet within 12 hours of the usual time of taking the tablet. If this is not possible, or if more than 12 hours have passed, the patient should follow the instructions in the section "If you forget to take Leverette".

Delaying withdrawal bleeding: what you need to know

Although it is not recommended, it is possible to delay a period by starting a new pack of Leverette immediately, instead of taking the white placebo tablets.
The patient may experience spotting or bleeding while taking the tablets from the second pack.
After taking all the tablets from the second pack, the patient can start a new pack as usual.
Before deciding to delay a period, the patient should consult their doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If any side effects occur, especially severe and persistent ones, or changes in health that the patient considers related to the use of Leverette, she should consult a doctor.

Severe side effects

You should immediately contact a doctor if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives that may cause difficulty breathing (see also "Warnings and precautions"). All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). To get detailed information about the different risk factors associated with the use of combined hormonal contraceptives, you should read section 2 "Important information before taking Leverette". Below is a list of side effects associated with the use of Leverette: Common side effects(may occur in 1 to 10 women):

• nausea;
• abdominal pain;
• weight gain;
• headache;
• depressed mood;
• mood changes;
• breast pain;
• breast tenderness.

Uncommon side effects(may occur in 1 to 100 women):

• vomiting;
• diarrhea;
• fluid retention;
• migraine;
• decreased libido;
• breast enlargement;
• rash;
• hives.

Rare side effects(may occur in 1 to 1000 women):

• intolerance to contact lenses;
• hypersensitivity;
• weight loss;
• increased libido;
• breast discharge;
• vaginal discharge;
• skin disorders: erythema nodosum (characterized by painful red nodules on the skin);
• skin disorders: erythema multiforme (rash with redness resembling target lesions or wounds);
• harmful blood clots in a vein or artery, for example:
• in the leg or foot (e.g., deep vein thrombosis);
• in the lungs (e.g., pulmonary embolism);
• heart attack;
• stroke;
• mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack;
• blood clots in the liver, stomach/intestine, kidneys, or eye.

The likelihood of developing blood clots may be higher if the patient has any other risk factors that increase this risk (see section 2 for more information about risk factors for developing blood clots and symptoms of blood clots). In women taking oral contraceptives, the following serious side effects have been reported more frequently, but it is not known whether this is caused by the treatment (see section 2 "Warnings and precautions").

• increased blood pressure
• liver tumors or breast cancer

The following diseases have also been associated with the use of combined hormonal contraceptives: Crohn's disease, ulcerative colitis, epilepsy, endometriosis, porphyria (a metabolic disorder that causes abdominal pain and mental disorders), systemic lupus erythematosus (a condition in which the body destroys its own organs and tissues), herpes during late pregnancy, Sydenham's chorea (rapid, uncontrolled movements and tremors), hemolytic-uremic syndrome (a disease that occurs as a result of diarrhea caused by E. coli infection), liver disorders with jaundice, gallbladder disease, or the formation of gallstones. In women with hereditary angioedema, oral contraceptives containing estrogens may trigger or worsen the symptoms of angioedema (see section 2 "Warnings and precautions").

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309; Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Leverette

The medicine should be stored out of sight and reach of children. Do not store above 30°C. Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month. Batch number: "Lot". Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Leverette contains

The Leverette blister pack contains 21 yellow active tablets in the 1st, 2nd, and 3rd rows of the blister and 7 white placebo tablets in the 4th row of the blister. The active substances are levonorgestrel and ethinylestradiol. Each film-coated tablet contains 0.150 mg of levonorgestrel and 0.030 mg of ethinylestradiol. The other ingredients are: Core:lactose monohydrate, povidone K30, crospovidone type A, magnesium stearate Coating:polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).

Placebo film-coated tablets (white):

Core:lactose, povidone K30, magnesium stearate Coating:polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc

What Leverette looks like and contents of the pack

Each blister contains 21 yellow film-coated tablets and 7 white film-coated tablets. The active tablets are yellow, round, 6 mm in diameter, and approximately 4 mm thick. The placebo tablets are white, round, 6 mm in diameter, and approximately 3-4 mm thick. Leverette is available in packs containing 1, 3, 6, or 13 blisters, each with 28 tablets (21 active tablets + 7 placebo tablets). Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Exeltis Poland Sp. z o.o. ul. Szamocka 8 01-748 Warsaw

Manufacturer:

Laboratorios León Farma, S.A. C/ La Vallina s/n, Pol. Ind. Navatejera, 24008 Navatejera -León Spain

This medicinal product is registered in the Member States of the European Economic Area under the following names:

Netherlands: Levonorgestrel/Ethinylestradiol Chemical Farma 150/30 microgram Filmomhulde tabletten Austria: Melleva 150 Mikrogramm / 30 Mikrogramm Filmtabletten Hungary: Missee 0,15 mg/0,03 mg filmtabletta Czech Republic: Leverette 0,15 mg/0,03 mg potahované tablety Slovakia: Leverette 0,15/0,03 mg filmom obalené tablety Estonia: Leverette Lithuania: Leverette 0.03 mg plėvele dengtos tabletės Latvia: Leverette 0.03 mg apvalkotās tabletes Spain: Levesia Diario 0,15 mg/0,03 mg comprimidos recubiertos con película EFG Poland: Leverette Germany Asumate 30/21+7 0.15mg/0.03mg Filmtabletten Belgium Asterluna Continu 30 0,15 mg/0,03 mg filmomhulde tabletten / comprimés pelliculés / Filmtabletten Luxembourg Asterluna Continu 30 0,15 mg/0,03 mg comprimés pelliculés Finland Leverette 150 mikrog/30 mikrog kalvopäällysteiset tabletit Italy Extrelis Sweden Leverette Date of last revision of the leaflet:24.10.2022