Elliade

Leaflet accompanying the packaging: information for the user

Elliade, film-coated tablets

Estradiol valerate + Dienogest

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any 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.
• Care should be taken and the doctor consulted if the patient suspects that blood clot symptoms have occurred (see section 2 "Blood clots").

Table of contents of the leaflet

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

1. What is Elliade and what is it used for

• Elliade is a contraceptive pill used to prevent pregnancy.
• Each colored tablet contains a small amount of female hormones, namely estradiol valerate or estradiol valerate in combination with dienogest.
• The two white tablets do not contain active substances and are referred to as "placebo".
• Contraceptive pills that contain two hormones are called "combined pills".

2. Important information before taking Elliade

General notes

Before starting to take Elliade, the information about blood clots in section 2 should be read. It is especially important to read about the symptoms of blood clots.

• See section 2 "Blood clots".

Before starting to take Elliade, the doctor will ask a few questions about the patient's health and the health of their close relatives. The doctor will also measure blood pressure and, depending on the patient's condition, may perform other tests.

This leaflet describes several situations in which the use of Elliade should be stopped or in which the reliability of the medicine may be reduced. In such situations, the patient should refrain from sexual intercourse or use additional, non-hormonal contraceptive measures, such as condoms or other mechanical methods. The calendar method or temperature measurement method should not be used. These methods may be unreliable because Elliade modifies the monthly changes in body temperature and cervical mucus.

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

When not to take Elliade

Elliade should not be taken if the patient has any of the conditions listed below. If the patient has any of the conditions listed below, they should inform their doctor. The doctor will discuss with the patient which other contraceptive measure will be more suitable.

Do not take Elliade:

• if the patient currently has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if the patient knows they have blood coagulation disorders - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient is about to have surgery or will be immobilized for a long time (see section "Blood clots").
• if the patient has had a heart attack or stroke;
• if the patient has (or has had) 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, ang. TIA - temporary stroke symptoms);
• if the patient has 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 (a disease of the blood);
• if the patient currently has (or has had) a type of migraine called "migraine with aura";
• if the patient currently has (or has had) liver disease, and liver function is still impaired;
• if the patient currently has (or has had) liver cancer;
• if the patient currently has (or has had) diagnosed or suspected breast or genital cancer;
• if the patient has any unexplained vaginal bleeding;
• if the patient has been diagnosed with hypersensitivity (allergy) to estradiol valerate or dienogest, or any of the other ingredients of the medicine (listed in section 6). This may cause itching, rash, or swelling.

Warnings and precautions

When to contact a doctor

The doctor should be contacted immediately

• if the patient notices any possible symptoms of a blood clot, which may indicate that the patient has a blood clot in the leg (deep vein thrombosis), blood clot in the lungs (pulmonary embolism), heart attack, or stroke (see section below "Blood clots").

In order to get a description of the serious side effects listed, see "How to recognize the formation of blood clots".

The doctor should be told if the patient has any of the following conditions.

In certain situations, special care should be taken when taking Elliade or any other combined contraceptive pill; regular medical check-ups may also be necessary. If these symptoms occur or worsen while taking Elliade, the doctor should also be told if:

• there is a history of breast cancer in the patient's close family;
• the patient has liver or gallbladder disease;
• the patient has jaundice;
• the patient has diabetes;
• the patient has depression;
• the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• the patient has systemic lupus erythematosus (SLE - a disease that affects the body's natural defense system);
• the patient has hemolytic uremic syndrome (HUS - a blood clotting disorder that causes kidney failure);
• the patient has sickle cell anemia (a hereditary disease of red blood cells);
• the patient has been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or has a family history of this disease. Hypertriglyceridemia is associated with an increased risk of pancreatitis;
• the patient is about to have surgery or will be immobilized for a long time (see section 2 "Blood clots").
• the patient has recently given birth, in which case she is at increased risk of blood clots. The doctor should be consulted for information on how soon it is possible to start taking Elliade after giving birth.
• the patient has superficial thrombophlebitis (blood clots in the veins under the skin).
• the patient has varicose veins.
• the patient has epilepsy (see "Elliade and other medicines");
• the patient has a disease that first appeared during pregnancy or while taking sex hormones, such as hearing loss, porphyria (a blood disease), herpes gestationis (a skin rash that occurs during pregnancy), Sydenham's chorea (a nervous system disease that causes involuntary body movements);
• the patient has chloasma (golden-brown pigment spots, so-called pregnancy spots, especially on the face). In this case, direct exposure to sunlight or ultraviolet radiation should be avoided;
• the patient has hereditary or acquired angioedema. The patient should stop taking Elliade and consult a doctor immediately if symptoms such as facial swelling, tongue and/or throat swelling, and difficulty swallowing or breathing occur, which may indicate angioedema. Estrogen-containing products may cause or worsen angioedema symptoms;
• the patient has heart or kidney failure.

The doctor should be consulted before taking Elliade.

Additional information for special patient groups

Use in children

Elliade is not intended for use in girls before their first menstrual period.

BLOOD CLOTS

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

Blood clots can form:

• in the veins (also called "venous thromboembolism" or "venous thrombotic events");
• in the arteries (also called "arterial thromboembolism" or "arterial thrombotic events").

Not everyone who has a blood clot will fully recover. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

It is essential to remember that the overall risk of harmful blood clots caused by taking Elliade is small.

HOW TO RECOGNIZE THE FORMATION OF BLOOD CLOTS

The doctor should be contacted immediately if any of the following symptoms are noticed.

Why is the patient likely to be sick?

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by: Deep vein thrombosis
• pain or tenderness in the leg, which may only be felt when standing or walking;
• increased temperature in the affected leg;
• change in skin color of the leg, such as pallor, redness, or cyanosis;
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat.
• severe abdominal pain;

If the patient is unsure, they should contact their doctor, as some of these symptoms, such as coughing or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g., a cold).

PULMONARY EMBOLISM

Symptoms usually occur in one eye:

• sudden loss of vision or
• painless vision disturbances, which may progress to loss of vision; Retinal vein thrombosis (blood clot in the eye)

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 the veins (venous thromboembolism). Although these side effects are rare, they can occur, especially in the first year of use.
• If blood clots form in the veins of the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot breaks loose from the leg and lodges 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 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, but it is always higher compared to not using combined hormonal contraceptives. If the patient stops taking Elliade, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots

The risk of blood clots associated with taking Elliade 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 close 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, is immobilized for a long time due to injury or illness, or has a leg in a cast. It may be necessary to stop taking Elliade for a few weeks before surgery or immobilization. If the patient needs to stop taking Elliade, 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.

Traveling by air (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.

The doctor should be told if any of these risk factors are present, even if the patient is unsure. The doctor may decide to stop the patient from taking Elliade.

The doctor should be told if any of the above conditions change while taking Elliade, for example, if someone in the patient's close 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 should be emphasized that the risk of heart attack or stroke associated with taking Elliade is very small, but it may increase:

• with age (over approximately 35 years old);
• if the patient smokes.While taking a hormonal contraceptive like Elliade, 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 close 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 increased risk of heart attack or stroke;
• if the patient or someone in their close 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 severe, the risk of blood clots may be even higher.

The doctor should be told if any of the above conditions change while taking Elliade, for example, if the patient starts smoking, someone in their close family is diagnosed with a blood clot without a known cause, or if the patient gains significant weight.

Elliade and cancer

Women taking combined contraceptives have a slightly higher incidence of breast cancer, but it is not known if this is caused by the pill. For example, the higher detection of tumors in women taking combined contraceptives may be due to the fact that these women are more frequently examined by doctors. The risk of breast cancer decreases gradually after stopping combined hormonal contraceptives. It is essential to regularly examine the breasts and consult a doctor if any lump is felt.

Women taking contraceptive pills have been reported to have: rarely - benign liver tumors, and even more rarely - malignant liver tumors. In individual cases, these tumors have led to life-threatening internal bleeding. If a patient experiences unusual, severe abdominal pain, they should consult a doctor.

Some studies suggest that long-term use of contraceptive pills increases the risk of cervical cancer. However, it is not clear to what extent sexual behavior or other factors, such as the human papillomavirus (HPV), increase this risk.

Psychiatric disorders

Some women taking hormonal contraceptives, including those containing estradiol valerate and dienogest, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, the patient should consult their doctor as soon as possible for further medical advice.

Irregular bleeding

During the first few months of taking Elliade, unexpected bleeding may occur. Usually, bleeding starts on the 26th day, i.e., on the day of taking the second brown tablet, or within a few subsequent days. According to the diaries kept by women participating in the clinical trial of the medicine containing estradiol valerate and dienogest, such bleeding occurred frequently (reported by 10-18% of women). If unexpected bleeding occurs for longer than 3 months in a row or starts after several months, the doctor should determine the cause.

What to do if bleeding does not occur on the 26th day or within a few subsequent days

According to the diaries kept by women participating in the clinical trial of the medicine containing estradiol valerate and dienogest, bleeding did not occur on the 26th day in many cases (found in 15% of cycles).

If all tablets were taken correctly, there was no vomiting or severe diarrhea, and no other medicines were taken, the likelihood of pregnancy is low.

If the expected bleeding does not occur twice in a row or if the tablets were not taken correctly, it may indicate pregnancy. The doctor should be contacted immediately.

The next pack should not be started until it is certain that the patient is not pregnant.

Elliade and other medicines

The doctor prescribing Elliade should always be told what medicines or herbal products the patient is already taking. Similarly, any other doctor, including a dentist prescribing another medicine, or a pharmacist dispensing a medicine, should be told that the patient is taking Elliade. They will provide information on whether additional contraceptive measures are needed (e.g., condoms) and, if so, for how long.

Some medicines may:

• affect the level of Elliade in the blood,
• make it less effective in preventing pregnancy,
• cause unexpected bleeding.

This applies to medicines:

• used to treat:
• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g., rifampicin);
• HIV and hepatitis C virus (HCV) infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz);
• hepatitis C (e.g., treatment regimens using ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin, or using glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir) may increase liver function test results in the blood (increased liver enzyme activity ALT) in women taking combined hormonal contraceptives containing ethinyl estradiol. Elliade contains estradiol instead of ethinyl estradiol.

It is not known whether increased liver enzyme activity ALT can occur when taking Elliade with such a treatment regimen;

• used to treat fungal infections (griseofulvin, ketoconazole);
• herbal products containing St. John's wort (Hypericum perforatum).

Elliade may affect the actionof other medicines, such as:

• those containing cyclosporin;
• antiepileptic drugs - lamotrigine (which may lead to an increased frequency of seizures).

Before taking any medicine, the patient should consult their doctor or pharmacist. The doctor or pharmacist will provide information on whether additional contraceptive measures are needed (e.g., condoms) and, if so, for how long.

Elliade with food and drink

Elliade can be taken with or without food.

Lab tests

If blood tests or other lab tests need to be performed, the doctor or lab staff should be told that the patient is taking Elliade, as oral contraceptives may affect the results of some tests.

Pregnancy, breastfeeding, and fertility

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

It is generally not recommended to take Elliade while breastfeeding. If the patient wants to take Elliade while breastfeeding, they should consult their doctor.

Before taking any medicine, the patient should consult their doctor or pharmacist if they are pregnant or breastfeeding.

Driving and using machines

There is no information suggesting that taking Elliade affects the ability to drive or operate machinery.

Elliade contains lactose

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

3. How to take Elliade

Each blister pack contains 26 colored tablets containing active substances and 2 white placebo tablets.

One Elliade tablet should be taken every day. The tablets can be taken with or without food, but they should be taken at approximately the same time every day.

Preparing the blister pack

To make it easier to follow, the tablets are marked with a number and an arrow indicating the order of taking. Start with tablet 1 and follow the direction of the arrow on the blister pack until all 28 tablets have been taken.

Usually, the so-called withdrawal bleeding starts when taking the second brown or white tablet and may not end before starting the next blister pack.

In some women, bleeding may still occur when starting a new blister pack.

Start the next blister pack without interruption, i.e., the next day after finishing the current pack, even if bleeding has not stopped.

If Elliade is taken in the above manner, protection against pregnancy is maintained during the 2 days when taking the placebo tablets.

When can the first blister pack be started?

• If no hormonal contraceptive product was used in the previous month.Elliade should be started on the first day of the cycle (i.e., on the first day of menstrual bleeding).
• Switching from another combined hormonal contraceptive or a combined hormonal contraceptive vaginal ring or patch.Elliade should be started on the day after taking the last tablet (last active tablet) of the previous contraceptive product. When switching from a combined hormonal contraceptive vaginal ring or patch, Elliade should be started on the day the ring or patch is removed or as advised by the doctor.
• Switching from a progestogen-only method (mini-pill, injection, implant, or intrauterine system releasing progestogen IUS).The switch from a mini-pill can be made on any day (from an implant or intrauterine system on the day of its removal, or from injections on the day of the scheduled next injection), but in all cases, additional contraceptive measures (e.g., condoms) should be used for the first 9 daysof taking Elliade.
• After a miscarriage.The doctor's advice should be followed.
• After childbirthAfter giving birth, Elliade can be started between 21 and 28 daysafter delivery. If started later than 28 days, a mechanical method (e.g., condoms) should be used for the first 9 daysof taking Elliade. If the patient has had sexual intercourse after giving birth before starting to take Elliade, they should make sure they are not pregnant or wait for their next menstrual period. If the patient wants to start taking Elliade after giving birth and is breastfeeding, they should read the section "Pregnancy and breastfeeding". If the patient is unsure when to start taking Elliade, they should consult their doctor.

What to do if more than the recommended dose of Elliade is taken

There are no reports of serious harmful effects from taking too many Elliade tablets at once.

If several active tablets are taken at the same time, nausea or vomiting may occur. Young girls may experience vaginal bleeding.

If too many Elliade tablets are taken or if it is noticed that a child has swallowed them, the patient should contact their doctor or pharmacist for advice.

What to do if a dose of Elliade is missed

Placebo tablets:If the patient forgets to take a white tablet (2 tablets at the end of the blister pack), they do not need to take it later, as these tablets do not contain any active substances. However, it is essential to discard the missed white tablet (missed white tablets) to avoid accidentally increasing the number of days when taking placebo tablets, which could increase the risk of pregnancy. The next tablet should be taken at the usual time.

Active tablets:Depending on the day of the cycle when an active tablet is missed, additional contraceptive measures may be necessary, such as a mechanical method (e.g., condoms).

The tablets should be taken according to the following rules. See also the detailed information presented in the "Procedure in case of a missed tablet" section.

• If less than 12 hourshave passed since the scheduled time of taking the tablet, the protection against pregnancy is not reduced. The tablet should be taken as soon as possible, and subsequent tablets should be taken at the usual time.
• If more than 12 hourshave passed since the scheduled time of taking the tablet, the protection against pregnancy may be reduced. Depending on the day of the cycle when the tablet was missed, additional contraceptive measures (e.g., condoms) should be used. See also the detailed information presented in the "Procedure in case of a missed tablet" section.
• More than one tablet has been missed from the packThe patient should contact their doctor.

Do not take more than 2 active tablets on the same day.

If the patient forgets to start taking tablets from a new pack, or if they forget to take one or more tablets between days 3 and 9of the pack, there is a risk that they may be pregnant (if they had sexual intercourse during the 7 days before missing the tablet). In this case, the patient should contact their doctor. The more tablets that are missed (especially between days 3 and 24), and the closer it is to the phase of taking placebo tablets, the higher the risk of reduced protection against pregnancy. See also the detailed information presented in the "Procedure in case of a missed tablet" section.

If a tablet is missed while taking active tablets and bleeding does not occur during the placebo tablet phase, it may indicate that the patient is pregnant. In this case, the patient should contact their doctor before starting the next pack.

What to do if vomiting or severe diarrhea occur

If vomiting occurs within 3 to 4 hours of taking an active tablet or if severe diarrhea occurs, there is a risk that the active substances from the tablet may not have been fully absorbed into the body.

This situation is very similar to missing a tablet. After vomiting or diarrhea, the patient should take another tablet as soon as possible. The patient should try to take it 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 rules outlined in the "What to do if a dose of Elliade is missed" section.

Stopping Elliade

Taking Elliade can be stopped at any time. If the patient does not want to become pregnant, they should consult their doctor about other effective contraceptive methods. If the patient wants to become pregnant, they can stop taking Elliade and wait for their menstrual period before trying to conceive. This way, it will be easier to calculate the expected time of delivery.

In case of doubts about taking Elliade, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Elliade can cause side effects, although not everybody gets them. If any side effects occur, especially severe or persistent ones, or changes in health that the patient thinks are related to taking Elliade, they should consult their doctor.

All women taking combined hormonal contraceptives are at increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). For detailed information on the various risk factors associated with taking combined hormonal contraceptives, see section 2 "Important information before taking Elliade".

Severe side effects

Severe reactions related to taking the tablets, as well as related symptoms, are described in the following sections: "Blood clots" and "Elliade and cancer". These sections should be read carefully, and if necessary, the doctor should be consulted.

5. How to store the drug Elliade

The drug should be stored out of sight and out of reach of children.
There are no special recommendations for storing the drug.
Do not use this drug after the expiration date stated on the packaging and on the blister after EXP. The expiration date means the last day of the given month.
The entry on the packaging after the abbreviation EXP means the expiration date, and after the abbreviation Lot means the batch number.
Drugs should not be thrown into the sewage system or household waste containers. You should ask your pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Package contents and other information

What the drug Elliade contains

The active substances of the drug are estradiol valerate or estradiol valerate in combination with dienogest.
Each blister (28 film-coated tablets) of the drug Elliade contains 26 tablets with active substances in 4 different colors in rows 1, 2, 3, and 4, and 2 white tablets without active substances (placebo) in row 4.
The composition of the colored tablets containing one or two active substances:
2 dark yellow tablets, each containing 3 mg of estradiol valerate.
5 pink tablets, each containing 2 mg of estradiol valerate and 2 mg of dienogest.
17 light yellow tablets, each containing 2 mg of estradiol valerate and 3 mg of dienogest.
2 brown tablets, each containing 1 mg of estradiol valerate.
The composition of the white tablets without active substances (placebo):
These tablets do not contain any active substances.
Other ingredients of the colored tablets with active substances are:
Tablet core: lactose monohydrate; corn starch; pregelatinized corn starch; povidone K25; colloidal silica anhydrous; magnesium stearate.
Tablet coating: hypromellose; macrogol 6000; iron oxide red (E172); titanium dioxide (E171); talc; iron oxide yellow (E172).
Other ingredients of the white tablets without active substances are:
Tablet core: lactose monohydrate; microcrystalline cellulose; magnesium stearate.
Tablet coating: partially hydrolyzed polyvinyl alcohol; titanium dioxide (E171); macrogol 3350; talc.

What the drug Elliade looks like and what the packaging contains

The tablets of the drug Elliade are film-coated; the tablet core is coated with a coating.
Each blister (28 film-coated tablets) contains 2 dark yellow tablets in row 1, 5 pink tablets in row 1, 17 light yellow tablets in rows 2, 3, and 4, 2 brown tablets in row 4, and 2 white tablets in row 4.
The dark yellow tablet with active substance is a round, biconvex, film-coated tablet marked with "L" on one side.
The pink tablet with active substances is a round, biconvex, film-coated tablet marked with "L" on one side.
The light yellow tablet with active substances is a round, biconvex, film-coated tablet marked with "L" on one side.
The brown tablet with active substance is a round, biconvex, film-coated tablet marked with "L" on one side.
The white tablet without active substances is a round, biconvex, film-coated tablet marked with "PL" on one side.
The drug Elliade is available in packages of 1, 3, or 6 blisters, each containing 28 tablets.
Not all package sizes may be on the market.

Marketing authorization holder

Polpharma S.A.
Pelplińska 19
83-200 Starogard Gdański
Phone: +48 22 364 61 01

Manufacturer

Cyndea Pharma, S.L.
Polígono Industrial Emiliano
Revilla Sanz
Avenida Agreda 31
42110 Ólvega, Soria
Spain

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

Poland: Elliade
Sweden: Qleyla
Date of last revision of the leaflet:March 2025