Elliade

Patient Information Leaflet: Information for the User

Elliade, coated tablets
Estradioli valeras + Dienogestum
Please read the entire leaflet carefully before starting to use this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm others, even if their symptoms are similar.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives

• When used correctly, they are among the most reliable, reversible methods of contraception.
• They slightly increase the risk of blood clots in veins and arteries, particularly 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 clot formation (see section 2, "Blood clots").

Contents of the leaflet

1. What Elliade is and what it is used for
2. Before you take 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 Elliade is and what it is used for

• Elliade is a contraceptive tablet used to prevent pregnancy.
• Each coloured tablet contains a small amount of female hormones, specifically: estradiol valerate or estradiol valerate in combination with dienogest.
• The two white tablets do not contain any active substances and are referred to as "placebo".
• Contraceptive tablets containing two hormones are known as "combined oral contraceptives".

2. Important information before using Elliade

General notes
Before starting to take Elliade, you should read the information about blood clots in section 2. It is particularly important to become familiar with the symptoms of blood clots.

• See section 2 "Blood clots".

Before starting to use Elliade, 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, depending on your condition, may carry out other examinations.
This leaflet describes several situations in which you should stop taking Elliade or in which the effectiveness of the medicine may be reduced. In such cases, you should avoid sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. Do not use the rhythm method or temperature method. These methods may be unreliable because Elliade alters the monthly changes in body temperature and cervical mucus.
Elliade, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

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

Do not use Elliade:

• 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 disorders affecting blood clotting – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you require 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 a transient ischaemic attack (temporary stroke-like symptoms, TIA);
• 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 blood lipid levels (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 remains abnormal;
• if you currently have (or have previously had) liver tumour;
• if you currently have (or have previously had) diagnosed or suspected breast cancer or genital organ cancer;
• if you have any unexplained vaginal bleeding;
• if you are allergic (hypersensitive) 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 your doctor
You should contact your doctor immediately:

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

For a description of the symptoms of these serious adverse effects, see "How to recognize the occurrence of blood clots".

Tell your doctor if you have any of the following conditions.
Special caution may be needed when using Elliade or any combined oral contraceptive, and regular medical check-ups may be necessary. You should also inform your doctor if any of these conditions develop or worsen during treatment with Elliade:

• family history of breast cancer;
• liver or gallbladder disease;
• jaundice;
• diabetes;
• depression;
• Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• systemic lupus erythematosus (SLE – a disease affecting the body's natural defense system);
• haemolytic uraemic syndrome (HUS – a blood clotting disorder leading to kidney failure);
• sickle cell anaemia (an inherited disorder of red blood cells);
• high blood lipid levels (hypertriglyceridaemia) or a positive family history of this condition. Hypertriglyceridaemia is associated with an increased risk of 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 Elliade;
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see "Elliade and other medicines");
• if you have a condition that first occurred during pregnancy or previous use of sex hormones, such as hearing loss, porphyria (a blood disorder), herpes gestationis (blistering skin rash during pregnancy), Sydenham's chorea (a nervous system disorder with involuntary body movements);
• if you have chloasma (brownish pigmentation patches, sometimes called "pregnancy mask", especially on the face). In this case, avoid direct exposure to sunlight or ultraviolet radiation;
• if you have hereditary or acquired angioedema. Stop taking Elliade and contact your doctor immediately if you experience symptoms such as swelling of the face, tongue, and/or throat and/or difficulty swallowing, or hives combined with breathing difficulties, which suggest angioedema. Products containing estrogens may cause or worsen angioedema symptoms;
• if you have heart or kidney failure.

You should consult your doctor before using Elliade.

Additional information on specific patient groups
Use in children
Elliade is not intended for use in girls before the onset of their first menstrual period.

BLOOD CLOTS
Using combined hormonal contraceptives such as Elliade is associated with an increased risk of blood clots compared to not using such medicines.
In rare cases, a blood clot can block a blood vessel and cause serious complications.
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").

Recovery from a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
It is important to remember that the overall risk of harmful blood clots caused by using Elliade is low.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Contact your doctor immediately if you experience any of the following symptoms.

| Do you experience any of these symptoms? | Possible cause | |---|---| | Swelling of the leg or swelling along a vein in the leg or foot, especially if accompanied by: | Deep vein thrombosis | | Pain or tenderness in the leg, which may occur only when standing or walking; | | | Increased warmth in the affected leg; | | | Change in skin colour of the leg, e.g. pallor, redness, or blueness; | | | Sudden unexplained shortness of breath or rapid breathing; | Pulmonary embolism | | Sudden cough without obvious cause, possibly accompanied by coughing up blood; | | | Sharp chest pain, which may worsen with deep breathing; | | | Severe dizziness or vertigo; | | | Rapid or irregular heartbeat; | | | Severe abdominal pain; | |

If you are unsure, contact your doctor, as some of these symptoms, such as cough or breathlessness, may be mistaken for milder conditions such as respiratory tract infection (e.g. cold).

Symptoms most commonly affecting one eye: Retinal vein thrombosis (blood clot in the eye)

• sudden loss of vision, or
• painless visual disturbances, which may progress to vision loss;

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 venous blood clots (venous thrombosis). Although 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 venous blood clots highest?
The risk of venous blood clots is highest during the first year of first-time use of combined hormonal contraceptives. The risk may also be increased 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 woman stops taking Elliade, the risk of blood clots returns to normal within a few weeks.

What determines the risk of 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 blood clots in the legs or lungs associated with the use of Elliade is low.

• In one year, about 2 out of 10,000 women who are not using combined hormonal contraceptives and are not pregnant will develop blood clots.
• In one 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 blood clots associated with the use of Elliade is approximately the same as the risk associated with other combined hormonal contraceptives, including those containing levonorgestrel.
• The risk of blood clots depends on the woman's individual medical history (see "Factors that increase the risk of blood clots" below).

Factors increasing the risk of blood clots in veins
The risk of blood clots associated with the use of Elliade is small, but certain 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 relative of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years of age). In such cases, 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 a cast. It may be necessary to discontinue Elliade several weeks before surgery or during immobilization. If the patient must stop taking Elliade, ask the doctor when it is safe to resume the medication.
• with increasing age (particularly over 35 years);
• if the patient has recently given birth (within the last few weeks).

The risk of 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, especially if the patient has another risk factor listed above.
Inform the doctor if any of the listed factors apply to the patient, even if uncertain. The doctor may decide to discontinue Elliade.
Inform the doctor if any of the above conditions change during treatment with Elliade, for example, if a close relative is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES
What can happen if blood clots form in arteries
As with venous blood clots, arterial clots can lead to serious consequences, such as heart attack or stroke.

Factors increasing the risk of blood clots in arteries
It should be emphasized that the risk of heart attack or stroke associated with the use of Elliade is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Elliade, 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 a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under 50 years). In such cases, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close relative has high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valve disorder, heart rhythm disorder such 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 blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Elliade, for example, if the patient starts smoking, a close relative is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Elliade and cancer
In women using combined hormonal contraceptives, breast cancer is observed slightly more frequently, but it is not known whether this is caused by taking the pill. For example, the higher detection rate of tumors in women using combined oral contraceptives may result from the fact that these women are examined more frequently by doctors. The risk of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important to regularly examine the breasts and contact the doctor if any lump is detected.

In women using oral contraceptives, benign liver tumors have been reported rarely, and malignant liver tumors even more rarely. In isolated cases, these tumors have led to life-threatening internal bleeding. If the patient experiences unusual, severe abdominal pain, contact the doctor immediately.

Some studies suggest that long-term use of oral contraceptives increases the risk of cervical cancer. However, it is unclear to what extent sexual behavior or other factors, such as human papillomavirus (HPV), contribute to this risk.

Psychiatric disorders
Some women using 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 or symptoms of depression occur, contact the doctor as soon as possible for further medical advice.

Intermenstrual bleeding
During the first few months of taking Elliade, unexpected bleeding may occur. Bleeding usually starts on day 26, i.e., on the day of taking the second brown tablet, or within the following few days. Data from diaries kept by women participating in clinical trials of a drug containing estradiol valerate and dienogest indicate that such bleeding occurred not infrequently during a cycle (reported by 10–18% of women). If unexpected bleeding persists for more than three consecutive months, or if it starts after several months of regular use, the doctor should determine its cause.

What to do if no withdrawal bleeding occurs on day 26 or within the following days
Data from diaries kept by women in clinical trials of a drug containing estradiol valerate and dienogest indicate that withdrawal bleeding did not occur after day 26 not infrequently (observed in 15% of cycles).
If all tablets were taken correctly, without vomiting or severe diarrhea, and no other medications were taken, the likelihood of pregnancy is low.
If the expected bleeding does not occur for two consecutive cycles, or if tablets were taken incorrectly, this may indicate pregnancy. Contact the doctor immediately.
Do not start the next pack until pregnancy has been ruled out.

Elliade and other medicines
Always inform the doctor prescribing Elliade about any other medicines or herbal products the patient is currently taking. Similarly, inform any other doctor, including a dentist, or pharmacist prescribing or dispensing another medicine that Elliade is being used. They will advise whether additional contraceptive methods (e.g. condoms) are needed, and if so, for how long.

Some medicines may:

• affect the blood concentration of Elliade,
• cause it to be 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 infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);

• hepatitis C virus (HCV) (e.g. combination regimens containing ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir) may cause increased liver function parameters in blood laboratory tests (elevated liver enzyme AlAT activity) in women using combined hormonal contraceptives containing ethinylestradiol. Elliade contains estradiol instead of ethinylestradiol.
  It is not known whether increased AlAT liver enzyme activity may occur when Elliade is used concomitantly with such treatment regimens;

• fungal infections (griseofulvin, ketoconazole);

• herbal products containing St. John's wort (Hypericum perforatum).

Elliade may affect the action of other medicines, e.g.:

• those containing cyclosporine;
• antiepileptic drugs – lamotrigine (this may lead to increased frequency of seizures).

Before taking any medicine, consult a doctor or pharmacist. The doctor or pharmacist may recommend using additional contraceptive measures while taking another medicine simultaneously with Elliade.

Elliade with food and drink
Elliade can be taken with or without food.

Laboratory tests
If blood tests or other laboratory tests are required, inform the doctor or laboratory staff that Elliade is being taken, as oral contraceptives may affect the results of certain tests.

Pregnancy, breastfeeding, and effect on fertility
Elliade must not be used during pregnancy. If the patient becomes pregnant while taking Elliade, she should stop taking it immediately and contact her doctor. If the patient wishes to become pregnant, she may stop taking Elliade at any time (see also "Discontinuation of Elliade").

Elliade is generally not recommended during breastfeeding. If the patient wishes to take Elliade while breastfeeding, she should consult her doctor.

Before taking any medicine, consult a doctor or pharmacist if the patient is pregnant or breastfeeding.

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

Elliade contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, she should contact her doctor before taking Elliade.

3. How to use Elliade

Each blister contains 26 coloured tablets containing active substances and 2 white placebo tablets.
One tablet of Elliade should be taken every day. Tablets may be taken with or without food, but they should be taken at approximately the same time each day.

Preparing the blister
To assist tracking, the tablets are marked on the aluminium side with numbers and an arrow indicating the order of intake. Start with tablet number 1 and follow the direction of the arrow on the blister until all 28 tablets have been taken.

Withdrawal bleeding usually begins when taking the second brown or white tablet and may not stop before starting the next blister.
In some women, bleeding continues after starting the first tablets of a new blister.
Begin the next blister the day after finishing the current one, without interruption, even if bleeding has not stopped.

If Elliade is used as described above, contraceptive protection continues throughout the 2 days when placebo tablets are taken.

When can you start with the first blister?

• If no hormonal contraceptive product has been used in the previous month: Start taking Elliade on the first day of the cycle (i.e. the first day of menstrual bleeding).
• Switching from another combined hormonal contraceptive or from a combined contraceptive vaginal system or transdermal system: Start taking Elliade the day after taking the last tablet (last tablet containing active substances) of the previous contraceptive product. When switching from a combined contraceptive vaginal system or transdermal system, start taking Elliade on the day of removal, or as directed by your doctor.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen IUS): Switching from a progestogen-only pill can be done on any day (from an implant or intrauterine system on the day of removal, or from an injectable form on the day the next injection is due); however, in all cases, additional contraceptive precautions (e.g. condoms) must be used for the first 9 days of taking Elliade.
• After miscarriage: Follow your doctor's advice.
• After childbirth: Elliade may be started between day 21 and day 28 after childbirth. If starting later than day 28, a barrier method (e.g. condoms) must be used for the first 9 days of taking Elliade. If a woman has had sexual intercourse after childbirth before starting Elliade, she should ensure she is not pregnant or wait until the next menstrual bleeding occurs. If a woman wishes to start taking Elliade after childbirth and is breastfeeding, please read the section "Pregnancy and breastfeeding". If in doubt about when to start taking Elliade, consult your doctor.

Taking more than the recommended dose of Elliade
There have been no reports of serious harmful effects from taking too many Elliade tablets.
If several tablets containing active substances are taken at once, nausea or vomiting may occur.
Young girls may experience vaginal bleeding.
If too many tablets of Elliade have been taken or if a child has accidentally swallowed any tablets, contact your doctor or pharmacist for advice.

Missed dose of Elliade
Tablets not containing active substance: If a white tablet (the two tablets at the end of the blister) is missed, it does not need to be taken later, as these tablets do not contain any active substances. However, it is important to discard the missed white tablet(s) to avoid unintentionally extending the number of days on which inactive tablets are taken, which could increase the risk of pregnancy. Take the next tablet at the usual time.

Tablets containing active substance: Depending on the day of the cycle when one active tablet was missed, it may be necessary to use additional contraceptive methods, such as a barrier method (e.g. condom).
Tablets should be taken according to the rules below. See also the detailed information provided in the "Missed tablet management chart".

• If less than 12 hours have passed since the usual time of taking the tablet, contraceptive protection is not reduced. Take the tablet as soon as possible, then continue taking subsequent tablets at the usual time.
• If more than 12 hours have passed since the usual time of taking the tablet, contraceptive protection may be reduced. Depending on the day of the cycle when one tablet was missed, additional contraceptive precautions (e.g. condom) should be used. See also the detailed information in the "Missed tablet management chart".
• More than one tablet from the pack has been missed: Contact your doctor.

Do not take more than 2 tablets containing active substances in one day.
If a woman forgets to start taking tablets from a new blister, or forgets to take one or more tablets between days 3 and 9 of the blister, there is a risk of pregnancy (if intercourse occurred during the seven days before the missed tablet). In such a case, contact your doctor. The greater the number of tablets missed (especially between days 3 and 24) and the closer the missed tablets are to the phase of taking inactive tablets, the higher the risk of reduced contraceptive protection. See also the detailed information in the "Missed tablet management chart".

If any active tablet was missed during the cycle and no bleeding occurs during the use of the tablets at the end of the pack, this may indicate that the woman is pregnant. In such a case, contact your doctor before starting the next pack.

YES
NO

Use in children and adolescents
There are no data on use in children and adolescents under 18 years of age.

What to do if vomiting or severe diarrhoea occurs
If vomiting occurs within 3 to 4 hours after taking an active tablet or if severe diarrhoea occurs, there is a risk that the active substances from the tablet have not been completely absorbed.
This situation is very similar to missing a tablet. After vomiting or diarrhoea, take another tablet as soon as possible. It should be taken, if possible, within 12 hours of the usual time of tablet intake. If this is not possible, or if more than 12 hours have passed, follow the instructions given in the section "Missed dose of Elliade". If a woman wishes to maintain her established tablet-taking schedule, she should take the appropriate tablet from another blister.

Stopping use of Elliade
Elliade may be discontinued at any time. If pregnancy is not desired, consult your doctor about other effective methods of birth control. If pregnancy is desired, stop taking Elliade and wait for a menstrual period before trying to conceive. This makes it easier to calculate the expected date of delivery.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
If any adverse effects occur, especially severe or persistent ones, or any changes in health that the patient considers related to the use of Elliade, medical advice should be sought from a physician.

All women taking combined hormonal contraceptives have an increased risk of blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before using Elliade".

Serious adverse effects
Serious reactions related to the use of the tablets, as well as associated symptoms, are described in the following sections: "Blood clots" and "Elliade and cancer". Please read these sections carefully and consult your doctor if necessary.

Other possible adverse effects
The following adverse effects have been reported in connection with the use of Elliade:

Common adverse effects (occur in 1 to 10 users out of 100):

• headache;
• abdominal pain, vomiting;
• acne;
• absence of menstruation, breast tenderness, painful menstruation, irregular bleeding (increased irregular bleeding);
• weight gain.

Uncommon adverse effects (occur in 1 to 10 users out of 1,000):

• fungal infections, fungal infection of the vulva and vagina, vaginal infection;
• increased appetite;
• depression, low mood, emotional disturbances, difficulty sleeping, decreased interest in sexual activity, psychiatric disorders, mood swings;
• dizziness, migraine;
• hot flushes, high blood pressure;
• diarrhoea, vomiting;
• increased liver enzyme activity;
• excessive hair loss, excessive sweating, itching, rash;
• muscle cramps;
• breast enlargement, breast nodules, cervical dysplasia (abnormal cervical cell growth), menstrual disorders, painful sexual intercourse, fibrocystic breast changes, heavy menstruation, abnormal menstruation, ovarian cyst, pelvic pain, premenstrual syndrome, endometrial hyperplasia, uterine cramps, vaginal bleeding including spotting, vaginal discharge, dryness of the vulva and vagina;
• fatigue, irritability, swelling of certain body parts, e.g. ankles;
• weight loss, changes in blood pressure.

Rare adverse effects (occur in 1 to 10 users out of 10,000):

• candidiasis, cold sores, pelvic inflammatory disease, eye vessel disease resembling fungal infection (presumed ocular histoplasmosis syndrome), fungal skin infections (pityriasis versicolor), urinary tract infection, bacterial vaginosis;
• fluid retention, increased blood triglyceride levels;
• aggression, anxiety, feeling of unhappiness, increased interest in sexual activity, nightmares, nervousness, psychomotor agitation, sleep disorders, tension;
• difficulty concentrating, tingling sensation, dizziness;
• intolerance to contact lenses, dry eye syndrome, eye swelling;
• heart attack, palpitations;
• bleeding from varicose veins, low blood pressure, superficial thrombophlebitis, vein pain;
• harmful blood clots in a vein or artery, for example:
  o in the leg or foot (e.g. deep vein thrombosis),
  o in the lungs (e.g. pulmonary embolism),
  o heart attack,
  o stroke,
  o mini-stroke or transient stroke-like symptoms known as transient ischaemic attack (TIA),
  o blood clots in the liver, stomach and/or intestines, kidneys or eye.
  The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clots).
• constipation, dry mouth, dyspepsia, heartburn;
• liver nodules (focal nodular hyperplasia), chronic cholecystitis;
• skin allergic reactions, golden-brown pigmentation spots (chloasma) and other pigmentary disorders, hirsutism (male-pattern hair growth), excessive hair growth, skin inflammation and neurodermatitis, dandruff and oily skin (seborrhoea) and other skin changes;
• back pain (lower back), jaw pain, feeling of heaviness;
• urinary tract pain;
• unscheduled bleeding, benign breast tumours, early-stage breast cancer, breast cysts, nipple discharge, cervical polyps, cervical redness, bleeding during sexual intercourse, unexpected lactation, genital discharge, lighter periods, delayed menstruation, ovarian cyst rupture, burning sensation in the vagina, unpleasant vaginal odour, vulvar and vaginal discomfort;
• enlarged lymph nodes;
• asthma, breathing difficulties, nosebleeds;
• chest pain, feeling of fatigue and general malaise, fever;
• abnormal cervical smear.

Additional information (from diaries kept by women participating in a clinical trial with dienogest/estradiol valerate) regarding possible adverse effects such as irregular bleeding (increased irregular bleeding) and absence of menstruation is provided in the sections: "Intermenstrual bleeding" and "What to do if no bleeding occurs on day 26 or during several consecutive days".

Description of selected adverse effects
Adverse effects occurring very rarely, or those with delayed onset, which may be related to the use of combined oral contraceptives and may occur during the use of Elliade, are listed below (see also sections "When not to use Elliade" and "Warnings and precautions"):

• liver tumours (benign and malignant);
• erythema nodosum (tender red nodules under the skin), erythema multiforme (skin rash with red spots or sores);
• hypersensitivity reactions (including symptoms such as rash, urticaria);
• in women with hereditary angioedema (characterized by sudden swelling, e.g. of the eyes, face, throat, etc.), estrogens in combined oral contraceptive tablets may trigger or worsen symptoms of this condition.

In the case of impaired liver function, discontinuation of combined oral contraceptive tablets may be necessary.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Elliade

Keep this medicine out of the sight and reach of children.
No special storage instructions apply to this medicine.
Do not use this medicine after the expiry date stated on the carton and blister pack following
EXP. The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Elliade contains
The active substances in Elliade are estradiol valerate or estradiol valerate in combination with dienogest.
Each blister pack (28 coated tablets) of Elliade contains 26 active tablets in 4 different colours arranged in rows 1, 2, 3 and 4, and 2 white placebo tablets without active substances in row 4.

Composition of the coloured 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.

Composition of the white placebo tablets (without active substances):
These tablets do not contain any active substances.

Other ingredients in the coloured active tablets:
Tablet core: monohydrate lactose; maize starch; pregelatinized maize starch; povidone K25; colloidal anhydrous silica; magnesium stearate.
Tablet coating: hypromellose; polyethylene glycol 6000; iron oxide red (E172); titanium dioxide (E171); talc; iron oxide yellow (E172).

Other ingredients in the white placebo tablets:
Tablet core: monohydrate lactose; microcrystalline cellulose; magnesium stearate.
Tablet coating: partially hydrolysed polyvinyl alcohol; titanium dioxide (E171); polyethylene glycol 3350; talc.

What Elliade looks like and contents of the pack
Elliade tablets are film-coated tablets; the tablet core is covered with a coating.
Each blister (28 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 active tablet is a round, biconvex, film-coated tablet marked with "L" on one side.
The pink active tablet is a round, biconvex, film-coated tablet marked with "L" on one side.
The light yellow active tablet is a round, biconvex, film-coated tablet marked with "L" on one side.
The brown active tablet is a round, biconvex, film-coated tablet marked with "L" on one side.
The white placebo tablet is a round, biconvex, film-coated tablet marked with "PL" on one side.

Elliade is available in packs containing 1, 3 or 6 blisters, each blister containing 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
tel. +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 authorised in the Member States of the European Economic Area under the following names:
Poland: Elliade
Sweden: Qleyla