Idilla

Patient Information Leaflet: Information for the User

Idilla film-coated tablets

Estradiol valerate / Dienogest
Generic medicine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods when used correctly.
• They slightly increase the risk of blood clots forming in veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
• Be alert and consult your doctor if you think you are experiencing symptoms of a blood clot (see section 2, “Blood clots”).

Contents of this leaflet

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

1. What Idilla is and what it is used for

• Idilla is a contraceptive pill and is used to prevent pregnancy.
• Each active coloured tablet contains a small amount of female hormones, estradiol valerate or estradiol valerate combined with dienogest.
• The 2 white tablets do not contain any active substance and are called inactive tablets.
• Contraceptive pills that contain two hormones are called "combined pills".

2. What you need to know before taking Idilla

General notes
Before starting to use Idilla, you must read the information about blood clots in section 2. It is
particularly important that you read about the symptoms of a blood clot – see section 2
“Blood clots”.
Before taking Idilla, your doctor will ask you some questions about your personal health history and that of your family members. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out additional tests.
This patient information leaflet describes various situations in which use of Idilla should be discontinued or in which the reliability of Idilla may be reduced. In such cases, you should abstain from sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other barrier methods. Do not use the rhythm method or basal body temperature method. These methods may be unreliable because Idilla alters the monthly fluctuations in body temperature and cervical mucus.
Idilla, like all hormonal contraceptives, does not protect against HIV (AIDS) or other sexually transmitted infections.

When not to take Idilla
Do not use Idilla if you have any of the conditions listed below. If you have any of the conditions listed below, consult your doctor. Your doctor will discuss with you other birth control methods that might be more suitable.
Do not take Idilla:

• if you have (or have ever had) a blood clot in a blood vessel of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;
• if you know you have a disorder affecting blood clotting – such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you are about to undergo surgery or will be bedridden for a prolonged period (see section “Blood clots”);
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain and which may be an early sign of heart attack) or a transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following conditions, which could increase the risk of developing clots in the arteries:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats (cholesterol or triglycerides) in the blood
  • a condition known as hyperhomocysteinaemia
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you have (or have ever had) a liver disease and your liver function is still abnormal;
• if you have (or have ever had) a liver tumour;
• if you have (or have ever had) cancer or suspect you may have cancer of the breast or genital organs;
• if you have unexplained vaginal bleeding;
• if you are allergic (hypersensitive) to estradiol valerate or dienogest or to any of the excipients of this medicine (listed in section 6). This may cause itching, rash, or swelling.

Warnings and precautions
When should you contact a doctor?
Seek urgent medical advice

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

For a description of the symptoms of these serious side effects, refer to the section “How to
recognize a blood clot”.
Inform your doctor if any of the following conditions apply to you.
In certain situations, you need to be especially careful when using Idilla or any other combined oral contraceptive, and your doctor may need to monitor you regularly. If any of these conditions develop or worsen while you are using Idilla, inform your doctor.

• if a close relative has or has ever had breast cancer;
• if you have liver or gallbladder disease;
• if you have jaundice;
• if you have diabetes;
• if you suffer from depression;
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE – a disease affecting the body’s natural defence system);
• if you have haemolytic uraemic syndrome (HUS – a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited red blood cell disorder);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are about to undergo surgery or will be bedridden for a prolonged period (see section 2 “Blood clots”);
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking Idilla;
• if you have inflammation of veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have epilepsy (see section “Other medicines and Idilla”);
• if you have a condition that first appeared during pregnancy or during a previous use of sex hormones, for example, hearing loss, porphyria (a blood disorder), herpes gestationis (blistering skin rash during pregnancy), Sydenham’s chorea (a nerve disorder causing sudden, involuntary movements of the body);
• if you have (or have ever had) patchy yellow-brown skin discoloration, known as “melasma”, especially on the face (chloasma). In this case, avoid direct exposure to sunlight or ultraviolet radiation;
• if you have hereditary or acquired angioedema. Stop taking Idilla and consult your doctor immediately if you notice symptoms such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with breathing difficulties, which are indicative of angioedema. Medicines containing estrogens may induce or worsen symptoms of angioedema;
• if you have heart or kidney failure.

Consult your doctor before taking Idilla.

Additional information for specific patient groups
Use in children
Idilla is not indicated for use in women who have not yet had their first menstrual period.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Idilla increases the risk of developing a blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop

• in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE);
• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, such effects may be fatal.
It is important to remember that the overall risk of a dangerous blood clot associated with
Idilla is low.

HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical attention if you notice any of the following signs or symptoms.
Do you have any of these signs? What might you be suffering from?

• swelling in one leg or along a vein in the leg or foot, Deep vein

• pain or tenderness in the leg, which may only be felt when standing or walking; thrombosis

• increased warmth in the affected leg;

• change in skin colour of the leg, such as paleness, redness, or bluish discolouration.

• sudden unexplained shortness of breath or rapid breathing; Pulmonary

• sudden cough without an obvious cause, possibly with coughing up of blood; embolism

• sharp chest pain that may worsen when breathing deeply;

• severe dizziness or lightheadedness;

• rapid or irregular heartbeat;

• severe stomach pain.

If you are unsure, inform your doctor, as some of these symptoms, such as
cough or shortness of breath, may be mistaken for a milder condition such as a
respiratory tract infection (e.g. a “common cold”).

Symptoms occurring more frequently in one eye: Retinal vein

• sudden loss of vision or thrombosis
• painless blurring of vision that may progress to loss of vision. (blood clot in the eye)

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of developing blood clots in veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it can cause a pulmonary embolism.
• Very rarely, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher when restarting a combined hormonal contraceptive (the same or a different medicine) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than in women who do not use a combined hormonal contraceptive.
When you stop taking Idilla, the risk of developing a blood clot returns to normal levels within a few weeks.

What is the risk of developing a blood clot?
The risk depends on your natural risk of venous thromboembolism (VTE) and on the type of combined hormonal contraceptive you are taking.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Idilla is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot over one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot over one year.
• The risk of developing a blood clot with Idilla is approximately the same as with other combined hormonal contraceptives, including contraceptives containing levonorgestrel.
• The risk of developing a blood clot depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Idilla is low, but certain conditions can increase it. Your risk is higher:

• if you are significantly overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in the leg, lung, or another organ at a young age (e.g., under approximately 50 years). In this case, you might have an inherited blood clotting disorder;
• if you need to undergo surgery or must remain bedridden for a prolonged period due to injury or illness, or if you have a leg in a cast. You may need to stop taking Idilla several weeks before surgery or during periods of reduced mobility. If you need to stop taking Idilla, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years);
• if you have given birth less than a few weeks ago.

The risk of developing a blood clot increases when you have more than one of these conditions.
Air travel (lasting >4 hours) may temporarily increase the risk of blood clot formation, especially if you have some of the other risk factors listed above.
It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to stop your treatment with Idilla.
If any of the above conditions change while you are using Idilla—for example, if a close relative develops thrombosis without a known cause or if you gain significant weight—contact your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems—for example, they can lead to a heart attack or stroke.

Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of Idilla is very low but may increase:

• with increasing age (especially over approximately 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Idilla, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke;
• if you or a close relative have high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions or if one of them is particularly severe, the risk of developing a blood clot may be even higher.
If any of the above conditions change while you are using Idilla—for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.

Idilla and cancer
Breast cancer has been observed slightly more frequently in women using combined oral contraceptives, but it is not known whether this is due to the treatment. For example, it is possible that more tumors are detected in women taking the combined pill because they are examined more frequently. The risk of breast cancer gradually decreases after stopping combined hormonal contraception. It is important that you regularly check your breasts and contact your doctor if you feel any lumps.
In rare cases, benign liver tumors have been observed in women using oral contraceptives, and even more rarely, malignant liver tumors. In isolated cases, these tumors have led to life-threatening internal bleeding. Contact your doctor if you experience severe abdominal pain.
Some studies suggest that long-term use of the pill may increase the risk of developing 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 estradiol valerate/dienogest, have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or symptoms of depression, consult your doctor as soon as possible for further medical advice.

Intermenstrual bleeding
During the first few months of taking Idilla, unexpected bleeding may occur. This bleeding usually starts on day 26, the day you take the second brown tablet, or in the following days. Data from diaries kept by women during a clinical study with estradiol valerate/dienogest show that unexpected bleeding in a given cycle is not uncommon (observed in 10–18% of users). If unexpected bleeding occurs for more than 3 consecutive months, or if it appears after several months, your doctor should investigate the cause.

What to do if menstruation does not occur on day 26 or in the following days
Data from diaries kept by women during a clinical study with estradiol valerate/dienogest show that it is not uncommon for menstruation not to occur on day 26 (observed in approximately 15% of cycles).
If you have taken all tablets correctly, have not experienced vomiting or severe diarrhea, and have not taken other medications, it is highly unlikely that you are pregnant.
If menstruation does not occur for two consecutive cycles, or if you have not taken the tablets correctly, you may be pregnant. Contact your doctor immediately. Do not start the next blister pack until you have confirmed that pregnancy has been ruled out.

Other medicines and Idilla
Always inform your doctor about any medicines or herbal products you are currently taking. Also inform any other doctor or dentist who prescribes you medicines (or the pharmacist providing the medicine) that you are taking Idilla. They can advise you whether you need to use additional contraceptive measures (e.g., condoms) and, if so, for how long.
Some medicines:

• may affect the levels of Idilla in your blood,
• may make it less effective in preventing pregnancy,
• may cause unexpected bleeding.

These include:
o medicines used to treat:

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate),
• tuberculosis (e.g., rifampicin),
• HIV infection and hepatitis C virus (ritonavir, nevirapine, efavirenz, known as protease inhibitors and non-nucleoside reverse transcriptase inhibitors),
• hepatitis C virus (HCV) (such as the combination regimen ombitasvir/paritaprevir/ritonavir with or without dasabuvir, and the regimen glecaprevir/pibrentasvir) may cause an increase in liver function test results (increase in liver enzyme ALT) in women using COCs containing ethinylestradiol. Idilla contains estradiol instead of ethinylestradiol. It is not known whether an increase in liver enzyme ALT may occur when using Idilla with this HCV combination regimen. Your doctor will provide you with necessary instructions,
• fungal infections (e.g., griseofulvin, ketoconazole), or the herbal preparation St. John’s wort.

Idilla may affect the action of other medicines, for example:
o medicines containing cyclosporine,
o the antiepileptic lamotrigine (this may cause an increased frequency of epileptic seizures).
Consult your doctor or pharmacist before taking any medicine. Your doctor or pharmacist can advise you whether you need to take additional protective measures while taking Idilla together with other medicines.

Idilla with food
Idilla can be taken with or without food.

Laboratory tests
If you need a blood test or other laboratory tests, inform your doctor or laboratory staff that you are taking the pill, as oral contraceptives may affect the results of certain tests.

Pregnancy and Breast-feeding
During pregnancy, you must not use Idilla. If you become pregnant while taking Idilla, you must stop treatment immediately and contact your doctor. If you wish to become pregnant, you may stop taking Idilla at any time (see also “If you stop taking Idilla”).
The use of Idilla is generally not recommended during breast-feeding. If you wish to take the pill while breast-feeding, you should consult your doctor.
Consult your doctor or pharmacist before taking any medicine during pregnancy or breast-feeding.

Driving and using machines
There are no reasons to believe that Idilla affects the ability to drive or use machinery.

Idilla contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Idilla

Each blister contains 26 coloured active tablets and 2 white inactive tablets.
Take one tablet of Idilla every day. You may take the tablets with or without food, but you should take them at approximately the same time each day.

Preparing the blister
To help you follow the correct sequence, each pack of Idilla contains 7 adhesive labels with the 7 days of the week.
Choose the weekly label starting with the day on which you begin taking the tablets.
For example, if you start on Wednesday, use the adhesive label beginning with "WED".
Attach the weekly adhesive label along the entire length of the top of the Idilla blister, where it reads "Attach label here", so that the first day is above the tablet marked with the number "1" next to the word "START".
This way, each tablet will have a day marked above it, allowing you to check whether you have taken the pill on any given day. Start with tablet number 1 and follow the direction of the arrow on the blister until all 28 tablets have been taken.

Usually, the so-called withdrawal bleeding starts while you are taking the second brown tablet or the white tablets, and may not yet be finished before you start the next blister. Some women may still be menstruating even after they have already started taking the first tablets of the new blister.

Start the next blister without a break, i.e. the day after finishing the current blister, even if menstruation has not yet ended.
If you use Idilla in this way, contraceptive protection is ensured even during the 2 days when you are taking the inactive tablets.

When to start the first blister

• If you have not used any hormonal contraceptive in the previous month: Start taking Idilla on the first day of your cycle (i.e. the first day of menstruation).
• Switching from another combined oral contraceptive pill, a combined vaginal contraceptive ring, or a contraceptive patch: Start taking Idilla the day after the last active tablet (the last tablet containing active ingredients) of your previous pill. When switching from a combined vaginal contraceptive ring or a patch, start using Idilla on the day of removal, or follow your doctor's advice.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or progestogen-releasing IUS, intrauterine system): You may switch on any day from the progestogen-only pill (or from an implant or IUS on the day of its removal, or from the injectable at the time the next injection would have been due), but in all these cases you must use additional contraceptive measures (e.g. a condom) for the first 9 days of taking Idilla.
• After an abortion: Follow your doctor's advice.
• After childbirth: You may start taking Idilla between the 21st and 28th day after delivery. If you start later than the 28th day, use a barrier method (e.g. a condom) during the first 9 days of taking Idilla. If you have had sexual intercourse after childbirth and before starting Idilla, you must exclude pregnancy or wait for the next menstruation. If you wish to start taking Idilla after pregnancy and are breastfeeding, read the section "Pregnancy and breastfeeding". Ask your doctor for advice if you are unsure about when to start.

If you take more Idilla than you should
There have been no reports of serious harmful effects from taking too many Idilla tablets.
If several tablets are taken at once, you may experience nausea or vomiting. Young girls may have vaginal bleeding.
If you have taken too many Idilla tablets, or if you discover that a child has taken any of the tablets, contact your doctor or pharmacist immediately.

If you forget to take Idilla
Inactive tablets: If you forget a white tablet (the 2 tablets at the end of the blister), you do not need to take them later, as they do not contain any active ingredient. However, it is important that you discard the forgotten white tablet(s) so that the number of days taking inactive tablets does not increase; doing so would increase the risk of pregnancy. Continue taking the next tablet at your usual time.

Active tablets: Depending on the day of the cycle when one active tablet has been forgotten, you must use additional contraceptive measures, such as a barrier method (e.g. a condom).
Take the tablets according to the instructions below. For details, also see the “Missed tablet diagram”.

• If the delay in taking a tablet is less than 12 hours, contraceptive protection is not reduced. Take the tablet as soon as you remember, then continue taking the following tablets at your usual time.
• If the delay in taking a tablet is more than 12 hours, contraceptive protection may be reduced. Depending on the day of the cycle when the tablet was forgotten, you must use additional contraceptive measures, such as a barrier method (e.g. a condom). See also the diagram below.
• More than one tablet forgotten in a blister: Consult your doctor.

Do not take more than two active tablets in one day.
If you forgot to start a new blister, or if you forgot one or more tablets during days 3–9 of the blister, there is a risk of pregnancy (if you had sexual intercourse within the 7 days before forgetting the tablet). In this case, consult your doctor. The greater the number of tablets forgotten (especially those during days 3–24) and the closer the missed tablets are to the inactive tablet phase, the higher the risk that contraceptive protection is reduced. For details, see also the “Missed tablet diagram”.
If you have forgotten any of the active tablets in a blister and do not have your period at the end of the blister, you may be pregnant. Consult your doctor before starting the next blister.

Use in children
No data are available in adolescents under 18 years of age.

What to do in case of vomiting or severe diarrhoea
If you vomit within 3–4 hours after taking an active tablet, or if you have severe diarrhoea, the active ingredients of the tablet may not be completely absorbed by your body.
This situation is therefore similar to that which occurs when you forget to take a tablet. After vomiting or severe diarrhoea, you should take the next tablet as soon as possible, ideally within 12 hours of your usual pill-taking time. If this is not possible, or if more than 12 hours have passed, follow the instructions under “If you forget to take Idilla”.
If you do not wish to change your normal dosing schedule, take the corresponding tablet from another blister.

If you stop taking Idilla
You may stop taking Idilla at any time. If you still wish to avoid pregnancy, consult your doctor for advice on other reliable contraceptive methods. If you wish to become pregnant, stop taking Idilla and wait for one menstrual cycle before trying to conceive. This will allow you to calculate the expected date of delivery more accurately.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Idilla can cause adverse effects, although not everyone experiences them. If you experience any adverse effect, especially if it is severe or persistent, or if you notice any change in your health that you think could be due to Idilla, inform your doctor.

There is an increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) in all women taking combined hormonal contraceptives. For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2, “What you need to know before taking Idilla”.

Serious adverse effects
Serious reactions associated with the use of the pill, along with related symptoms, are described in the following sections: “Blood clots” and “Idilla and cancer”. Please read these sections carefully and consult your doctor immediately if necessary.

Other possible adverse effects
The following adverse effects have been associated with the use of Idilla:

Common adverse effects (may affect between 1 and 10 users in 100)

• headache
• abdominal pain, nausea
• acne
• absence of menstruation, breast tenderness, painful menstruation, irregular menstruation (with heavy, irregular bleeding)
• weight gain

Uncommon adverse effects (may affect between 1 and 10 users in 1,000)

• fungal infection, fungal infection of the vulva and vagina, vaginal infection
• increased appetite
• depression, depressed mood, emotional disturbance, difficulty sleeping, decreased libido, mental disorder, mood swings
• dizziness, migraine
• hot flushes, high blood pressure
• diarrhoea, vomiting
• increased liver enzymes
• hair loss, excessive sweating (hyperhidrosis), itching, rash
• muscle cramps
• breast enlargement, breast nodules, abnormal cell growth in the cervix (cervical dysplasia), dysfunctional genital bleeding, pain during intercourse, fibrocystic mastopathy, heavy menstruation, menstrual disorders, ovarian cyst, pelvic pain, premenstrual syndrome, benign uterine tumour, uterine contractions, uterine/vaginal bleeding including spotting, vaginal discharge, vulvovaginal dryness
• fatigue, irritability, swelling of certain body parts, for example ankles (oedema)
• weight loss, changes in blood pressure

Rare adverse effects (may affect between 1 and 10 users in 10,000)

• candida infection, oral herpes, pelvic inflammatory disease, an eye vascular disease resembling a fungal infection (presumed ocular histoplasmosis syndrome), fungal skin infection (tinea versicolor), urinary tract infection, bacterial inflammation of the vagina
• fluid retention, increase in certain blood fats (triglycerides)
• aggression, anxiety, feeling of unhappiness, increased libido, nervousness, nightmares, restlessness, sleep disturbances, stress
• reduced attention, tingling sensation, vertigo
• intolerance to contact lenses, dry eyes, swollen eyes
• heart attack (myocardial infarction), palpitations
• bleeding from varicose veins, low blood pressure, inflammation of superficial veins, vein pain
• dangerous blood clots in a vein or artery, for example: in a leg or foot (DVT), or in a lung (PE), or heart attack, or stroke, or mini-stroke, or temporary symptoms similar to stroke, known as transient ischaemic attack (TIA), or blood clots in the liver, stomach/intestine, kidneys or eye. The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot)
• constipation, dry mouth, indigestion, heartburn
• liver nodules (focal nodular hyperplasia), chronic inflammation of the gallbladder
• skin allergic reactions, yellowish-brown patches (chloasma) and other pigmentary disorders, growth of hair in a male pattern, excessive hair growth, skin disorders such as: dermatitis and neurodermatitis, dandruff and oily skin (seborrhoea) and other skin disorders
• back pain, jaw pain, feeling of heaviness
• urinary tract pain
• abnormal breakthrough bleeding, benign breast nodules, early-stage breast cancer, breast cysts, breast discharge, cervical polyp, cervical redness, bleeding during intercourse, spontaneous milk secretion from the breast, genital discharge, scanty menstruation, delayed menstruation, rupture of ovarian cyst, foul-smelling vaginal discharge, burning sensation in the vulva and vagina, vulvovaginal discomfort
• swollen lymph nodes
• asthma, breathing difficulties, nosebleeds
• chest pain, tiredness, and general feeling of malaise, fever
• abnormal Pap test (cervical smear)

Additional information (from diaries kept by women during a clinical study with dienogest/estradiol valerate) on the possible adverse effects “irregular menstruation (heavy irregular bleeding)” and “absence of menstruation” is provided in the sections “Intermenstrual bleeding” and “What to do if menstruation does not occur on day 26 or in the following days”.

Description of selected adverse reactions
Adverse reactions with very low frequency or delayed manifestation, considered to be related to those of combined oral contraceptives, may also occur during the use of Idilla and are listed below (see also sections “When not to take Idilla” and “Warnings and precautions”):

• liver tumours (benign or malignant)
• nodular erythema (soft red nodules under the skin), erythema multiforme (skin rash with red spots or lesions)
• hypersensitivity (including symptoms such as rash, urticaria)
• in women with hereditary angioedema (characterized by sudden swelling, for example of the eyes, mouth, throat, etc.), estrogens contained in combined oral contraceptives may trigger or worsen angioedema symptoms.

If liver function is impaired, temporary discontinuation of combined oral contraceptives may be necessary.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store Idilla

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after “Exp”. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Idilla contains
The active substances are estradiol valerate or estradiol valerate combined with dienogest.
Each blister (28 film-coated tablets) of Idilla contains 26 active tablets in 4 different colours in rows 1, 2, 3 and 4, as well as 2 white inactive tablets 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 inactive tablets:
These tablets do not contain any active substance.
Other excipients in the coloured active tablets are:
Tablet core: monohydrate lactose, maize starch, pregelatinized maize starch, povidone (E1201), colloidal anhydrous silica, magnesium stearate (E572).
Tablet coating: hypromellose (E464), macrogol 6000, red iron oxide (E172), titanium dioxide (E171), talc (E553b), yellow iron oxide (E172).
Other excipients in the white inactive tablets are:
Tablet core: monohydrate lactose, microcrystalline cellulose, magnesium stearate (E572).
Tablet coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b).

Description of the appearance of Idilla and contents of the pack
The tablets of Idilla are film-coated tablets; the tablet core is covered with a coating.
Each blister (28 film-coated tablets) contains 2 dark yellow tablets in the 1st row, 5 pink tablets in the 1st row, 17 light yellow tablets in the 2nd, 3rd and 4th rows, 2 brown tablets in the 4th row and 2 white inactive tablets in the 4th row.
The dark yellow active tablet is round, biconvex-faced, film-coated, with "L" printed on one side.
The pink active tablet is round, biconvex-faced, film-coated, with "L" printed on one side.
The light yellow active tablet is round, biconvex-faced, film-coated, with "L" printed on one side.
The brown active tablet is round, biconvex-faced, film-coated, with "L" printed on one side.
The white inactive tablet is round, biconvex-faced, film-coated, with "PL" printed on one side.
Idilla is available in packs of 1, 3 and 6 blisters, each containing 28 tablets.
A cardboard carton for blister storage is included.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Farmitalia S.r.l.
Via Pinciana 25
00198 Roma
Italy

Manufacturer
Cyndea Pharma S.L ,
Polígono Industrial Emiliano Revilla Sanz,
Avenida Ágreda 31, Ólvega (Soria), 42110
Spain.