Leverette

Package leaflet: information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Leverette, 0.150 mg + 0.030 mg, coated tablets
Levonorgestrelum + Ethinylestradiolum
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Important information regarding combined oral contraceptives

• When 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 during the first year of use or after restarting following a break of 4 weeks or more.
• Be vigilant and consult your doctor if you suspect symptoms of blood clots (see section 2, "Blood clots").

Leaflet contents

1. What Leverette is and what it is 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 Leverette is and what it is used for

• Leverette is a contraceptive tablet used to prevent pregnancy.

Each of the 21 yellow tablets contains a small amount of two different female hormones:
levonorgestrel and ethinylestradiol.
The 7 white tablets contain no active substance and are referred to as placebo tablets.
Contraceptive tablets containing two hormones are known as "combined" tablets.

2. Important information before using Leverette

General information
Before starting to take Leverette, you should read the information about blood clots (thrombosis) in section 2. It is particularly important to become familiar with the symptoms of blood clots (see section 2, "Blood clots").
Before you can start taking Leverette, your doctor will ask you several questions about your health and that of your close relatives. Your doctor will also measure your blood pressure and may perform additional tests as appropriate.
This patient leaflet describes several situations in which you should stop taking Leverette or when the effectiveness of Leverette may be reduced.
In such situations, you should avoid sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other barrier methods.
During this time, you should not use the calendar method or temperature-based methods. These methods may be ineffective because Leverette affects monthly body temperature changes and cervical mucus patterns.
Leverette, like other hormonal contraceptives, does not protect against infection with HIV (AIDS) or other sexually transmitted diseases.

When not to use Leverette:
Do not take Leverette if you have any of the conditions listed below. If you have any of these conditions, inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable.

• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know you have a condition affecting blood clotting—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you are undergoing surgery or will be immobile for a prolonged period (see section "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have previously had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following conditions that may increase the risk of arterial blood clots:
• severe diabetes with blood vessel damage
• very high blood pressure
• very high levels of fats in the blood (cholesterol or triglycerides)
• a condition called hyperhomocysteinemia
• if you currently have (or have previously had) a type of migraine called "migraine with aura";
• if you currently have (or have previously had) liver disease and liver function has not returned to normal;
• if you currently have (or have previously had) liver tumour;
• if you currently have (or have previously had) or are suspected of having 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 with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section "Leverette with other medicines").

Warnings and precautions
When should you contact your doctor?
You should contact your doctor immediately

• if you notice possible symptoms of blood clots, which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lungs (pulmonary embolism), a heart attack, or stroke (see section below "Blood clots").
  For a description of the symptoms of these serious adverse effects, see "How to recognize blood clots".

Tell your doctor if you have any of the following conditions.
Before starting to take Leverette, you should consult your doctor. In certain situations, particular caution is required when taking Leverette or any other combined hormonal contraceptive, and regular medical check-ups may be necessary. If any of these symptoms develop or worsen during treatment with Leverette, you should also inform your doctor.

• if a close relative has or has ever had breast cancer;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you have depression; Some women using hormonal contraceptives, including Leverette, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact your doctor as soon as possible for further medical advice;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (a disease affecting the body's natural defence system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2, "Blood clots");
• if you have recently given birth, as you are at increased risk of blood clots. Consult your doctor to find out how soon after delivery you can start taking Leverette;
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see "Leverette with other medicines");
• if you have a condition that first occurred during pregnancy or previous use of sex hormones (e.g. hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (pemphigoid gestationis), a nervous system disorder causing uncontrolled body movements (Sydenham's chorea));
• if you have or have ever had chloasma (skin pigmentation, especially on the face and neck, also known as "melasma" or "pregnancy mask"). In this case, 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 breathing difficulties, contact your doctor immediately. Products containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.

BLOOD CLOTS
Using combined hormonal contraceptives such as Leverette is associated with an increased risk of blood clots compared to not using hormonal contraception. In rare cases, a blood clot may block a blood vessel and cause serious health problems.
Blood clots may occur

• in veins (referred to as "venous thrombosis" or "venous thromboembolic disease")
• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic events").
  Full recovery from a blood clot is not always possible. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal. Remember that the overall risk of harmful blood clots caused by taking Leverette is small.

HOW TO RECOGNIZE BLOOD CLOTS
Contact your doctor immediately if you notice any of the following symptoms.

BLOOD CLOTS IN VEINS
What can happen if blood clots develop in a vein?

• The use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in veins (venous thrombosis). However, these adverse events are rare. They most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

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

What factors influence the risk of developing blood clots?
The risk depends on the individual's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Leverette is low.

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

Factors increasing the risk of venous blood clots
The risk of developing blood clots associated with the use of Leverette is low, however
some factors may increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member of the patient has been diagnosed with blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years). In such case, the patient may have an inherited clotting disorder;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to discontinue Leverette several weeks before surgery or immobilization. If the patient must stop taking Leverette, ask the doctor when it is safe to resume taking the medicine;
• with increasing age (especially over 35 years);
• if the patient has given birth within the last few weeks.

The risk of developing blood clots increases with the number of risk factors present in the
patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots,
particularly if the patient has another risk factor listed above.
It is important to inform the doctor if any of the listed factors apply to the patient,
even if uncertain. The doctor may decide to discontinue the use of Leverette.
Inform the doctor if any of the above conditions change during treatment with Leverette, e.g. if a close family member is diagnosed with unexplained thrombosis or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots can cause serious consequences, such as heart attack or stroke.

Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with the use of Leverette is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Leverette, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years of age, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years). In such case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valve damage, heart rhythm disorder known as 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 developing blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Leverette, e.g. if the patient starts smoking, a close family member is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Leverette and cancer
Breast cancer has been observed slightly more frequently in women using combined hormonal contraceptives, but it is not known whether this is caused by the use of these medicines. It is possible, for example, that more cancers are detected in women using contraceptives because they visit their doctor more frequently. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives.
It is important to regularly examine the breasts and contact the doctor if any lumps are detected.
Benign liver tumours have been observed rarely, and malignant liver tumours very rarely, in women using combined hormonal contraceptives.
Contact the doctor if the patient experiences severe abdominal pain.
Cervical cancer has been observed slightly more frequently in women using combined oral contraceptives long-term compared to women who did not use these contraceptives; however, the significance of additional factors such as sexual behaviour and others, such as infection with human papillomavirus (HPV), is not known.

Breakthrough bleeding
During the first few months of using Leverette, unexpected bleeding (outside the placebo tablet week) may occur. If bleeding persists beyond the first few months or occurs after several months of use, consult a doctor to determine the cause.

What to do if withdrawal bleeding does not occur during the placebo tablet week
If the patient has taken all tablets correctly, has not vomited or had severe diarrhoea, and has not taken any other medicines, it is unlikely that she is pregnant.
If two consecutive withdrawal bleeds are missed, the patient may be pregnant. In such case, contact the doctor immediately. Before starting the next blister pack, confirm that the patient is not pregnant.

Leverette and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use, including herbal preparations. Also inform any other doctor or dentist prescribing another medicine (or a pharmacist) that the patient is using Leverette. They may advise using additional contraceptive methods (e.g. condoms), and if so, for how long.
Do not use Leverette if the patient has hepatitis C and is 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 liver enzyme AlAT activity). The doctor will recommend another type of contraception before starting these medicines.
Leverette may be resumed approximately 2 weeks after stopping the treatment. See section "When not to use Leverette".
Some medicines may affect the blood levels of Leverette, which may reduce its effectiveness in preventing pregnancy or may cause unexpected bleeding.

• This includes 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, osteoarthritis (etoricoxib);
• pulmonary hypertension (bosentan);
• herbal preparations containing St John's wort (Hypericum perforatum).
• Leverette may affect the action of other medicines, for example:
• medicines containing cyclosporine;
• antiepileptic medicines, lamotrigine (this may lead to increased frequency of seizures);
• theophylline (a medicine used to treat breathing disorders);
• tizanidine (a medicine used to treat muscle pain and/or muscle spasms).

Taking Leverette with food and drink
Leverette may be taken with or without food, and if necessary, with a small amount of water.

Laboratory tests
If a blood test is required, inform the doctor or laboratory staff that the patient is taking a contraceptive, as oral contraceptives may affect the results of certain tests.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Leverette must not be used during pregnancy. If the patient becomes pregnant while taking Leverette, she should stop taking the medicine immediately and contact her doctor. If the patient plans to become pregnant, she may stop taking Leverette at any time (see also "Stopping use of Leverette").

Breastfeeding
Leverette is generally not recommended during breastfeeding. If the patient wishes to use a contraceptive during breastfeeding, she should consult her doctor.

Driving and operating machinery
There is no information suggesting that Leverette affects the ability to drive or operate machinery.

Leverette contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.

3. How to use Leverette

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The patient should remember to take the tablets according to the prescribed schedule, as missing a tablet may reduce the effectiveness of the medicine.

How and when should Leverette be taken?
Each blister contains 28 tablets: 21 yellow active tablets and 7 white placebo tablets.
The two differently coloured tablets in the Leverette pack are arranged in a specific order.
Take one tablet of Leverette daily, with a small amount of water if needed. Tablets should be taken at the same time each day.

Do not confuse the tablets: take the yellow tablets for the first 21 days, followed by the white placebo tablets for the next 7 days. A new blister pack should be started immediately (21 yellow tablets, then 7 white tablets). Therefore, do not take a break between two blister packs.

Due to the different composition of the tablets, it is essential to start from the first tablet at the top left corner and take the tablets each day in the direction indicated by the arrows on the blister.

Preparing the blister pack
To help remember which day the tablet should be taken, each Leverette blister pack includes 7 adhesive strips printed with the abbreviations of the days of the week. Choose the strip that starts with the day of the week on which tablet intake begins.
For example, if tablet intake starts on Wednesday, use the strip beginning with "Śr." (abbreviation for Wednesday in Polish).

Stick the label at the top of the blister pack in the area marked "Kleepsu koht-Vieta uzlīmei-Čia priklijuokite žymeklį", which means "Place for the label". In this way, the first selected day of the week will be positioned above the first tablet.
This ensures that each tablet is clearly associated with a specific day of the week, allowing you to verify whether the correct tablet was taken each day. The arrows indicate the order of tablet intake.

During the 7 days of taking the white placebo tablets (the placebo period), bleeding (so-called withdrawal bleeding) should occur. This bleeding usually starts on the 2nd or 3rd day after taking the last active yellow tablet. After taking the last white placebo tablet, start the next blister pack immediately, regardless of whether bleeding has stopped or is still ongoing. This means that new packs should always be started on the same day of the week, and withdrawal bleeding should occur on approximately the same days each month.

Taking Leverette exactly as instructed ensures contraceptive protection also during the 7 days of taking placebo tablets.

When to start taking Leverette

• If the patient has not previously used any hormonal contraceptives: Begin taking Leverette on the first day of the menstrual cycle (i.e., the first day of menstruation). Starting on the first day of menstruation ensures immediate protection against pregnancy. Alternatively, you may start between days 2 and 5 of the cycle, but in this case, additional contraceptive methods (e.g., condoms) must be used for the first 7 days.

• Switching from a combined hormonal contraceptive, vaginal contraceptive system, or transdermal patch: Begin taking Leverette the day after taking the last active tablet (the last tablet containing active ingredients) of the previous combined oral contraceptive, or no later than the day following the usual tablet-free or placebo period of the previous combined contraceptive. If switching from a combined vaginal contraceptive system or transdermal patch, follow your doctor’s advice.

• Switching from a progestogen-only contraceptive (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen): You may switch to Leverette at any time (in case of an implant or intrauterine system – on the day of removal; in case of an injection – on the day of the next scheduled injection), but in all these cases, additional contraceptive methods (e.g., condoms) must be used for the first 7 days of taking Leverette.

• After miscarriage: Follow your doctor’s instructions.

• After childbirth: Begin taking Leverette between days 21 and 28 after delivery. If starting later than day 28, use a barrier method (e.g., condoms) for the first 7 days of taking Leverette. If the patient has had sexual intercourse after delivery and before (re)starting Leverette, pregnancy should first be ruled out or wait until the next menstrual period.

• During breastfeeding: If the patient is breastfeeding and wishes to start (or restart) taking Leverette after childbirth, refer to the section "Pregnancy and breastfeeding".

If the patient is unsure when to start taking Leverette, consult a doctor.

Taking more than the recommended dose of Leverette
There are no reports that taking too many Leverette tablets causes serious harmful effects.
However, taking a large number of tablets at once may cause nausea or vomiting. In young girls, vaginal bleeding may occur.
If a patient has taken too many Leverette tablets or if a child has swallowed several tablets, contact a doctor or pharmacist immediately.

Missed dose of Leverette
The tablets in the 4th row of the blister are placebo tablets. If a patient misses one of these, the contraceptive effectiveness of Leverette remains unchanged. Discard the missed placebo tablet.

If a patient misses a yellow active tablet (from the 1st, 2nd, or 3rd row), follow the instructions below:

• If less than 12 hours have passed since the missed tablet, contraceptive protection is not reduced. Take the missed tablet as soon as you remember, even if this means taking two tablets on the same day. Continue taking the following tablets at the usual time. In this case, no additional contraceptive method is required.

• If more than 12 hours have passed since the missed tablet, contraceptive protection may be reduced. The more tablets missed, the higher the risk of pregnancy.

Follow the instructions below if a tablet is missed:

• More than one tablet missed in a pack: Contact your doctor.

• One tablet missed in Week 1: Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the remaining tablets at the usual time and use additional barrier contraceptive methods (e.g., condoms) for the next 7 days. If you had sexual intercourse in the week before missing the tablet, there is a risk of pregnancy. In this case, consult your doctor.

• One tablet missed in Week 2: Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the remaining tablets at the usual time. Contraceptive protection is not reduced, and no additional contraceptive method is required.

• One tablet missed in Week 3: Two options are available:

  1. Take the missed tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the remaining tablets at the usual time. Instead of taking the placebo tablets, start the next blister pack immediately.
     Withdrawal bleeding will most likely occur at the end of the second blister pack, but spotting or bleeding may occur during the second pack.

  2. Alternatively, stop taking the active yellow tablets from the current blister pack and immediately start taking the white placebo tablets (note the day on which the tablet was missed). If the patient wishes to start the new pack on the usual day of the week, the placebo period will be shorter than 7 days.

  If either of the above options is followed correctly, contraceptive protection will be maintained.

• If any tablet in the current pack is missed and no withdrawal bleeding occurs during the placebo period, this may indicate that the patient is pregnant. In this case, consult a doctor before starting the next blister pack.

What to do if vomiting or severe diarrhoea occurs
If vomiting or severe diarrhoea occurs within 3–4 hours after taking a tablet, there is a risk that the active ingredients have not been fully absorbed. This situation is similar to missing a tablet. After vomiting or diarrhoea, take another tablet from a spare blister pack as soon as possible. If possible, take the tablet within 12 hours of the usual time. If this is not possible, or if more than 12 hours have passed, follow the instructions under "Missed dose of Leverette".

Delayed withdrawal bleeding: what you should know
Although not recommended, it is possible to delay menstruation by starting a new blister pack of Leverette immediately, instead of taking the white placebo tablets.
Spotting or breakthrough bleeding may occur during the second pack.
After completing all tablets in the second pack, start the next pack as usual.
Before deciding to delay menstruation, consult your doctor.

Changing the day of withdrawal bleeding: what you should know
If the patient takes the tablets as directed, menstruation will begin during the week of taking the placebo tablets. If a change in this day is required, shorten (but never extend – 7 days is the maximum duration of the placebo period!) the placebo tablet intake. For example, if the placebo period usually starts on Friday and you wish to change it to Tuesday (3 days earlier), start the new blister pack 3 days earlier than usual. If the placebo period is significantly shortened (e.g., to 3 days or less), withdrawal bleeding may not occur during this time. Instead, light bleeding or spotting may occur.
If in doubt, consult your doctor.

Stopping treatment with Leverette
The patient may stop taking Leverette at any time. If pregnancy is not desired, consult a doctor about other effective contraceptive methods.
If the patient plans to become pregnant, stop taking the tablets and wait until the next menstrual period before trying to conceive. This makes it easier to calculate the expected delivery date.

For any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If any adverse effects occur, especially severe and persistent ones, or changes in health which the patient considers to be related to the use of Leverette, medical advice should be sought.
Serious adverse effects
Seek immediate medical advice 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, which may cause difficulty breathing (see also section 2, "Warnings and precautions").
All women using combined hormonal contraceptives have an increased risk of venous blood clots (venous thromboembolic disease) or arterial blood clots (arterial thromboembolic disorders). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, refer to section 2, "Important information before taking Leverette".
Below is a list of adverse effects associated with the use of Leverette:
Common adverse effects (may occur in 1 to 10 women out of 100):

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

Uncommon adverse effects (may occur in 1 to 100 women out of 1000):

• vomiting;
• diarrhoea;
• fluid retention;
• migraine;
• decreased libido;
• breast enlargement;
• rash;
• urticaria.

Rare adverse effects (may occur in 1 to 1000 women out of 10,000):

• intolerance to contact lenses;
• hypersensitivity;
• weight loss;
• increased libido;
• breast discharge;
• vaginal discharge;
• skin disorders: nodular erythema (characterized by painful red nodules on the skin);
• skin disorders: erythema multiforme (a rash with redness resembling bullseyes or target lesions);
• 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 ischaemic attack (TIA);
• blood clots in the liver, stomach/intestines, kidneys or eye.

The likelihood of developing blood clots may be higher if the patient has any other factors that increase this risk (see section 2 for further information on factors increasing the risk of blood clots and symptoms of blood clots).
The following serious adverse effects have been reported more frequently in women taking contraceptive tablets, although it is not known whether they are caused by the treatment (see section 2, "Warnings and precautions"):

• increased blood pressure
• liver tumours or breast cancer.

The following conditions have also been associated with the use of combined hormonal contraceptives:
Crohn's disease, ulcerative colitis, epilepsy, endometriosis, porphyria (a metabolic disorder causing abdominal pain and psychiatric disturbances), systemic lupus erythematosus (a condition in which the body attacks its own organs and tissues), herpes gestationis (a late-pregnancy skin condition), Sydenham's chorea (rapid, uncontrolled movements and tremors), haemolytic-uraemic syndrome (a disease occurring after diarrhoea caused by E. coli infection), liver disorders manifesting as jaundice, gallbladder disease or gallstone formation.
In women with hereditary angioedema, contraceptive tablets containing estrogens may trigger or worsen symptoms of angioedema (see section 2, "Warnings and precautions").
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Leverette

Keep this medicine out of the sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Leverette contains
Each Leverette blister pack contains 21 yellow coated tablets with active substances 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 coated (yellow) tablet contains 0.150 mg levonorgestrel and 0.030 mg ethinylestradiol.
Other ingredients are:
Core: monohydrate lactose, povidone K 30, crospovidone type A, magnesium stearate
Coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172).
Placebo coated tablets (white):
Core: lactose, povidone K 30, magnesium stearate
Coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc.

What Leverette looks like and contents of the pack
Each blister contains 21 yellow coated tablets and 7 white coated tablets.
The active tablets are yellow, round, with a diameter of 6 mm and a thickness of approximately 4 mm.
The placebo tablets are white, round, with a diameter of 6 mm and a thickness of approximately 3–4 mm.
Leverette is available in packs containing 1, 3, 6 or 13 blisters, each containing 28 tablets (21 tablets containing active substances + 7 placebo tablets), and including a set of 7 self-adhesive labels with abbreviations of the days of the week, arranged differently depending on the day the patient starts taking the tablets.

For more detailed information, please contact the responsible party or the parallel importer.

Responsible party in Latvia, country of export:
UAB Exeltis Baltics
Antano Tumėno g. 4
LT-01110 Vilnius
Lithuania

Manufacturer:
Laboratorios León Farma, S.A.
Polígono Industrial Navatejera, La Vallina S/N
24008 Navatejera (Leon)
Spain

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing authorization number in Latvia, country of export: 13-0261
Parallel import authorization number: 309/25