EGINA

Package leaflet: Information for the user

Egina 0.02 mg/3 mg film-coated tablets

Ethinylestradiol/drospirenone
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on 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, pharmacist or nurse. See section 4.

Important information about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible methods of contraception when used correctly.
• They slightly increase the risk of developing blood clots 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 contact your doctor if you think you have symptoms of a blood clot (see section 2, "Blood clots").

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

1. What Egina is and what it is used for

• Egina is a contraceptive pill used to prevent pregnancy.
• Each of the 24 pink tablets contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol.
• The 4 white tablets contain no active ingredients and are also known as placebo tablets.
• Contraceptive pills containing two hormones are called "combined" pills.

2. What you should know before taking Egina

General Notes
Before starting to use Egina, 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 you can start taking Egina, your doctor will ask you some questions about your personal health and that of your closest relatives. Your doctor will also measure your blood pressure and, depending on your personal situation, may carry out some additional tests.
This patient information leaflet describes various situations in which you must stop taking Egina or in which the effectiveness of Egina might be reduced. In these situations, you must not have sexual intercourse or must use additional non-hormonal contraceptive precautions, for example, use a condom or another barrier method. Do not use the rhythm method or basal body temperature method. These methods may be unreliable because Egina alters the monthly variations in body temperature and cervical mucus.
Like other hormonal contraceptives, Egina does not protect against HIV (AIDS) or other sexually transmitted infections.

When not to use Egina
Do not use Egina 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 methods of birth control that might be more suitable for your situation.
Do not use Egina

• if you have (or have ever had) a blood clot in a vein 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, or antiphospholipid antibodies;
• if you are scheduled for 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 that may be an early sign of heart attack) or transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following conditions, which may increase the risk of arterial clots:
  o severe diabetes with blood vessel damage
  o very high blood pressure
  o very high levels of fats (cholesterol or triglycerides) in the blood
  o 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) liver disease and your liver function has not yet returned to normal;
• if your kidneys are not working properly (renal failure);
• if you have (or have ever had) a liver tumour;
• if you have (or have ever had) or suspect you may have a tumour of the breast or genital organs;
• if you have unexplained vaginal bleeding;
• if you are allergic to ethinylestradiol or drospirenone or to any of the other ingredients of this medicine (listed in section 6). This may cause itching, rash, or swelling.

Do not use Egina if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or
sofosbuvir/velpatasvir/voxilaprevir (also see section “Other medicines and Egina”).

Additional information on special populations
Children and adolescents
Egina is not indicated in women whose menstrual cycle has not yet started.
Elderly women
Egina is not indicated after menopause.
Women with impaired liver function
Do not take Egina if you suffer from liver disease. See also the sections "Do not take Egina" and "Warnings and precautions".
Women with impaired kidney function
Do not take Egina if you suffer from poorly functioning kidneys or acute renal failure. See also the sections "Do not take Egina" and "Warnings and precautions".

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

• if you notice possible signs of a blood clot which may indicate that 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 clot (thrombosis)"). For a description of the symptoms of these serious side effects, go 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 exercise particular caution when taking Egina or any other combined hormonal contraceptive, and regular medical check-ups may be necessary.
If any of these conditions develop or worsen while you are using Egina, inform your doctor.

• if a close relative has or has ever had breast cancer;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you are depressed;
• 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 scheduled for 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 Egina;
• if you have inflammation of veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have epilepsy (see “Other medicines and Egina”);
• if you have had a condition for the first time during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering rash during pregnancy (herpes gestationis), a nerve disorder involving sudden involuntary movements (Sydenham’s chorea));
• if you have or have had patchy brown pigmentation (chloasma), so-called “pregnancy mask”, especially on the face. If this applies to you, avoid direct exposure to sunlight or ultraviolet light;
• if symptoms of angioedema occur, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives possibly with breathing difficulties, contact a doctor immediately. Products containing oestrogens may cause or worsen symptoms of hereditary or acquired angioedema.
• Consult your doctor before taking Egina.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Egina 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, serious long-term effects may occur or, very rarely, these effects may be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with Egina is low.

HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical advice if you notice any of the following signs or symptoms.

Do you have one of these signs? What might you have?

• swelling in one leg or along a vein in the leg or foot, especially if accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking – Deep vein thrombosis
• increased warmth in the affected leg
• change in skin colour of the leg, such as paleness, redness, or bluish discolouration
• sudden and unexplained shortness of breath or rapid breathing
• sudden cough without an obvious cause, possibly with coughing up of blood
• sharp chest pain that may worsen when breathing deeply
• severe dizziness or lightheadedness – Pulmonary embolism
• 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 in one eye:
Retinal vein thrombosis (blood clot in the eye)

• sudden loss of vision or

• painless blurring of vision that may progress to loss of vision

• chest pain, discomfort, pressure, or heaviness

• squeezing or fullness in the chest, arm, or under the breastbone

• feeling of fullness, indigestion, or choking

• discomfort in the upper body, radiating to the back, jaw, throat, arms, or stomach

• sweating, nausea, vomiting, or dizziness

• extreme weakness, anxiety, or shortness of breath

• rapid or irregular heartbeat – Heart attack

• sudden numbness or weakness of the face, arm, or leg, especially on one side of the body – Stroke

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
if you restart taking a combined hormonal contraceptive (the same medication or a different one) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not
using a combined hormonal contraceptive.
When you stop taking Egina, 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 VTE (venous thromboembolism) and 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
Egina 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 in a year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in a year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as Egina, about 9–12 will develop a blood clot in a year.
• Your individual risk of developing a blood clot depends on your medical history (see below “Factors that increase the risk of blood clot formation”).

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

• if you are very 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 (under approximately 50 years). In this case, you may have an inherited blood clotting disorder;
• if you are due to undergo surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in plaster. You may need to stop taking Egina several weeks before surgery or during periods of reduced mobility. If you need to stop taking Egina, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years of age);
• 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, particularly if you have other listed risk factors.
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 use of Egina.
If any of the above conditions change while you are using Egina—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 Egina is very low but may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Egina, it is advisable to stop smoking. If you cannot stop smoking and you 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 Egina—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.

Egina and cancer
Breast cancer occurs slightly more frequently in women who use combined oral contraceptives, but it is not known whether this is caused by the treatment. For example, more tumours may be detected in women taking combined pills because they are examined more frequently by their doctor. The occurrence of breast tumours gradually decreases after stopping combined hormonal contraceptives. It is important to regularly check your breasts and contact your doctor if you notice a lump.
In rare cases, benign liver tumours have been reported in users of oral contraceptives, and even more rarely, malignant liver tumours. Contact your doctor if you experience unusual severe abdominal pain.

Psychiatric disorders
Some women using hormonal contraceptives, including Egina, have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or depressive symptoms, consult your doctor as soon as possible for further medical advice.

Intermenstrual bleeding
During the first few months of taking Egina, you may experience unexpected bleeding (bleeding outside the placebo days). If bleeding occurs for more than a few months, or if it starts after several months, your doctor should investigate the cause.

What to do if menstruation does not occur during the placebo days
If you have taken all the active pink tablets correctly, have not vomited or had severe diarrhoea, and have not taken other medicines, it is very unlikely that you are pregnant.
If you miss two consecutive periods, you may be pregnant. Contact your doctor immediately. Start the next pack only if you are certain you are not pregnant.

Other medicines and Egina
Always inform your doctor about any medicines or herbal products you are currently using. Also inform any other doctor or dentist prescribing new medicines (or your pharmacist) that you are taking Egina. They may advise you whether you need to take additional contraceptive precautions (e.g. condoms), and if so, for how long, or whether the dosing regimen of another medicine you need should be changed.
Do not use Egina if you have Hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir/dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these products may cause increased liver function test results (elevated liver enzyme ALT levels).
Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
Egina can generally be restarted approximately 2 weeks after completing treatment. See section “Do not use Egina”.

Some medicines:

• may affect Egina levels in the blood;
• may make it less effective in preventing pregnancy;
• may cause unexpected bleeding. These include:
  • medicines used to treat epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine), tuberculosis (e.g., rifampicin), HIV and Hepatitis C infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz), fungal infections (e.g., griseofulvin, ketoconazole), arthritis, osteoarthritis (etoricoxib), or high blood pressure in the lung blood vessels (bosentan);
  • the herbal remedy St. John’s wort.

Egina may affect the action of other medicines, for example:

• medicines containing cyclosporine;
• the antiepileptic lamotrigine (this may lead to an increased frequency of epileptic seizures);
• theophylline (used to treat respiratory problems);
• tizanidine (used to treat muscle pain and/or muscle cramps).
  Ask your doctor or pharmacist for advice before taking any other medicine.

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take Egina if you are pregnant. If you become pregnant while taking Egina, stop taking it immediately and contact your doctor. If you wish to become pregnant, you may stop taking Egina at any time (see also “If you stop taking Egina”).

Breastfeeding
The use of Egina is generally not recommended during breastfeeding. If you wish to take the pill while breastfeeding, contact your doctor.

Driving and use of machines
There is no information suggesting that the use of Egina affects the ability to drive vehicles or operate machinery.

Egina contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Egina

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Each blister contains 24 pink active tablets and 4 white placebo tablets.
The two differently coloured tablets of Egina are arranged in a specific order. One blister contains 28 tablets.
Take one tablet of Egina daily, if necessary with a small amount of water. You may take the tablets with or without food, but you must take them at approximately the same time each day.
Do not confuse the tablets: take one pink tablet for the first 24 days, followed by one white tablet for the last 4 days. Then immediately start a new blister (24 pink and then 4 white tablets). There is therefore no break between two blisters.
Due to the different composition of the tablets, you must start with the first tablet in the top left corner and take one tablet each day. Follow the direction of the arrows on the blister for the correct order.

Preparing the blister
To help you keep track of your daily pill intake, each blister of Egina comes with 7 adhesive labels, each showing 7 days of the week. Choose the label that starts with the day of the week on which you begin taking the tablets. For example, if you start on Wednesday, use the label starting with "WED".
Apply the weekly label along the upper left edge of the blister where it says "Stick label here". Now each tablet has a day marked above it, allowing you to check whether you have taken a particular tablet. The arrows indicate the order in which the tablets should be taken.

During the 4 days when you take the white placebo tablets (the placebo days), you should experience menstruation (the so-called "withdrawal bleed"). This usually begins on day 2 or 3 after the last active pink tablet of Egina. After taking the last white tablet, you must immediately start the next blister, regardless of whether your menstrual bleeding has ended. This means that you should start each blister on the same day of the week, and the withdrawal bleeding should occur on the same days every month.
If you use Egina in this way, you are protected against pregnancy even during the 4 days when you are taking a placebo tablet.

When can you start the first pack?

• If you have not used a hormonal contraceptive in the previous month Start taking Egina on the first day of your cycle (i.e. the first day of your menstrual period). If you start taking Egina on the first day of your period, protection against pregnancy is immediate. You may also start between day 2 and day 5 of your cycle, but in this case you must use additional contraceptive precautions (e.g. a condom) for the first 7 days.

• Switching from a combined hormonal contraceptive, vaginal ring, or combined contraceptive patch You may start taking Egina preferably the day after the last active tablet (the last tablet containing active ingredients) of your previous pill, or at the latest the day after the end of the pill-free interval (or after the last inactive tablet of the previous pill). When switching from a vaginal ring or a combined contraceptive patch, follow your doctor's advice.

• Switching from a progestogen-only method (progestogen-only pill, contraceptive injection, implant, or progestogen-releasing intrauterine device, IUD) You may switch from a progestogen-only pill on any day (from an implant or IUD on the day of its removal, from an injectable product at the time the next injection would have been due), but in all these cases you must use additional contraceptive precautions (e.g. a condom) for the first 7 days of tablet intake.

• After an abortion Follow your doctor's advice.

• After childbirth You may start taking Egina between day 21 and day 28 after delivery. If you start after day 28, use a so-called barrier method (e.g. a condom) during the first seven days of using Egina.
  If you have had sexual intercourse after childbirth before starting (or restarting) Egina, make sure you are not pregnant or wait until your next menstrual period.

• If you are breastfeeding and wish to start (or restart) taking Egina after childbirth Read the section “Breastfeeding”.

Ask your doctor what to do if you are unsure about when to start.

If you take more Egina than you should
No serious harmful effects have been reported following overdose with Egina tablets.
If you take several tablets at once, you may feel unwell, vomit, or experience vaginal bleeding. Girls who have not yet started menstruating but have accidentally taken this medicine may also experience such bleeding.
If you have taken too many Egina tablets or if you find out that a child has taken some, consult your doctor or pharmacist.

If you forget to take Egina
The last 4 tablets in the 4th row of the blister are placebo tablets. If you forget to take one of these tablets, this will not affect the reliability of Egina. You should discard the forgotten placebo tablet.

If you forget to take a pink active tablet (tablets 1–24 of the blister strip), you must take the following steps:

• • If the delay in taking the tablet is less than 24 hours, protection against pregnancy is not reduced. Take the missed tablet as soon as you remember, then continue taking the following tablets at your usual time.
• If more than 24 hours have passed since your usual time of intake, protection against pregnancy may be reduced. The greater the number of tablets missed, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is greater if you miss a pink tablet at the beginning or end of the pack. Therefore, follow these rules (see also the diagram below):

• If you have missed more than one tablet in this blister, consult your doctor.

• If you missed a tablet between days 1–7 (first row):
  Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time and use additional precautions (e.g. a condom) for the next 7 days. If you had sexual intercourse in the week before the missed tablet, you may be pregnant. In this case, consult your doctor.

• If you missed a tablet between days 8–14 (second row):
  Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Protection against pregnancy is not reduced, and you do not need to take additional precautions.

• If you missed a tablet between days 15–24 (third and fourth rows):
  You have two options:

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Instead of taking the white placebo tablets in this blister, discard them and immediately start the next blister (your starting day will now be different). You will most likely have your period at the end of the second blister – during the intake of the white placebo tablets – but spotting or bleeding may occur during the second blister.
2. You may also stop taking the active pink tablets and go directly to the 4 placebo tablets (before taking the white placebo tablets, note the day on which you missed the tablet). If you wish to start a new blister on your usual day, take the placebo tablets for less than 4 days.

If you follow either of these two recommendations, you will remain protected against pregnancy.

• If you missed a tablet in a blister and do not experience menstrual bleeding during the placebo days, this may indicate that you are pregnant. You must contact your doctor before starting the next blister.

What to do in case of severe vomiting or diarrhoea
If you experience severe vomiting or diarrhoea within 3-4 hours after taking a pink active tablet, there is a risk that the active ingredients in the pill have not been completely absorbed by your body. This is as if you had forgotten to take a tablet. After vomiting or diarrhoea, take another pink tablet as soon as possible from a spare pack. If possible, take it within 24 hours of your usual pill-taking time. If this is not possible or if more than 24 hours have passed, follow the advice given in the section “If you forget to take Egina”.

To delay menstruation: what you should know
Although not recommended, it is possible to delay menstruation by not taking the white placebo tablets from row 4, and instead starting immediately with a new Egina blister pack and completing it. You may experience spotting or menstruation-like bleeding during use of this second blister. After completing this second blister, take the 4 white placebo tablets from row 4, then start the next blister pack.
You may wish to consult your doctor before deciding to delay your period.

Changing the first day of menstruation: what you should know
If you take the tablets as directed, menstruation will begin during the placebo days. If you wish to change this day, you may shorten the number of placebo days (i.e. when you take the white placebo tablets), but never extend them – 4 is the maximum. For example, if you usually start taking placebo tablets on Friday and wish to change it to Tuesday (3 days earlier), you should start the new blister pack 3 days earlier than usual. You may not have any bleeding during this time. Afterwards, spotting or menstruation-like bleeding may occur.
If you are unsure how to proceed, consult your doctor.

If you stop taking Egina
You may stop taking Egina at any time. If you do not wish to become pregnant, consult your doctor about other reliable methods of contraception. If you wish to become pregnant, stop taking Egina and wait for a menstrual period before trying to conceive. This will allow you to calculate the expected delivery date more easily.
If you have any doubts about using Egina, consult your doctor or pharmacist.

4. Possible side effects

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

Women taking combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you should know before taking Egina”.

Contact a doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives potentially accompanied by breathing difficulties (see also section “Warnings and precautions”).

Below is a list of side effects that have been associated with the use of Egina:

• Common side effects (may affect from 1 to 10 women in 100):
  o mood swings, headache, nausea, breast tenderness, or menstrual problems such as irregular periods or absence of periods.

• Uncommon side effects (may affect from 1 to 10 women in 1,000):
  o depression, nervousness, drowsiness or dizziness, “pins and needles” sensations, migraine, varicose veins, increased blood pressure, stomach ache, vomiting, indigestion, flatulence, stomach inflammation, diarrhoea, acne, itching, skin rashes, or general discomfort and pain, such as back pain, limb pain, muscle cramps, vaginal fungal infection, pelvic pain, breast enlargement, benign breast lumps, uterine/vaginal bleeding (which usually resolves during continued treatment), genital discharge, hot flushes, vaginal inflammation (vaginitis), menstrual problems, painful periods, light periods, heavy periods, vaginal dryness, cervical smear abnormalities, loss of libido, lack of energy, increased sweating, fluid retention, or weight gain.

• Rare side effects (may affect from 1 to 10 women in 10,000):
  o candidiasis (a vaginal infection), anaemia, increased number of platelets in the blood, allergic reaction, endocrine disorders, increased appetite, loss of appetite, abnormally high potassium levels in the blood, abnormally low sodium levels in the blood, inability to achieve orgasm, insomnia, vertigo, tremor, eye disorders such as eyelid inflammation, dry eyes, abnormally rapid heartbeat, or harmful blood clots in a vein or an artery, for example:
  o in a leg or foot (DVT),
  o in the lung (PE),
  o heart attack,
  o stroke,
  o mini-stroke,
  o transient ischaemic attack (TIA) – temporary symptoms similar to those of a stroke,
  o blood clots in the liver, stomach/intestines, 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).
  o inflammation of a vein, nosebleeds, fainting,
  o abdominal swelling, intestinal disorder, bloating sensation, hiatus hernia, fungal infection of the mouth, constipation, dry mouth,
  o pain in the bile ducts or gallbladder, gallbladder inflammation,
  o brownish-yellow patches on the skin, eczema, hair loss, acne-like skin inflammation, dry skin, granulomatous skin inflammation, excessive hair growth, skin disorders, stretch marks, skin inflammation, photosensitivity-related skin inflammation, skin nodules,
  o painful or difficult sexual intercourse, vaginal inflammation (vulvovaginitis), bleeding after intercourse, withdrawal bleeding, breast cysts, increased number of breast cells (hyperplasia), malignant breast lumps, abnormal growth of cervical mucosa, reduced endometrial lining, ovarian cysts, uterine enlargement,
  o malaise,
  o weight loss.

The following side effects have also been reported, but their frequency cannot be estimated from the available data: hypersensitivity, erythema multiforme (skin rash with target-like red lesions or sores).

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

5. How to store Egina

Keep this medicine out of the sight and reach of children.
Store below 30 °C.
Do not use this medicine after the expiry date stated on the carton and blister 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Egina contains

• The active substances are: ethinylestradiol and drospirenone. Each pink film-coated active tablet contains 0.02 mg of ethinylestradiol and 3 mg of drospirenone.

The white film-coated tablets do not contain any active substances.

• The other components are:

Pink film-coated active tablets: monohydrate lactose, pregelatinized starch (maize),
povidone (E1201), croscarmellose sodium, polysorbate 80, magnesium stearate (E572).
Polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b), yellow iron oxide (E172),
red iron oxide (E172), black iron oxide (E172).
White film-coated tablets: anhydrous lactose, povidone (E1201), magnesium stearate (E572).
Polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b).

Description of the appearance of Egina and package contents

• Each Egina blister contains 24 pink film-coated active tablets, located in rows 1, 2, 3 and 4 of the blister, and 4 white placebo film-coated tablets in row 4.
• Egina tablets, both pink and white, are film-coated tablets; the tablet core is coated.
• Egina is available in packages containing 1, 3, 6 and 13 blisters, each containing 28 (24 + 4) tablets.

It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
S.F. Group S.r.l.
Via Tiburtina, 1143
00156 - Roma
Italy

Manufacturer
Laboratorios Leon Farma, S.A.
C/ La Vallina, s/n,
Polígono Industrial Navatejera,
Villaquilambre 24193 (León),
SPAIN

This medicinal product is authorized in the European Economic Area countries under the following names:
Portugal Drospera 3mg/0,02mg film-coated tablets
Finland Dizminelle 0.02 mg/3 mg film-coated tablets
Netherlands Ethinylestradiol/Drospirenone Xiromed 0.02 mg/3 mg, film-coated tablets
Spain DROSPIRENONA/ETINILESTRADIOL EXELTIS 3 MG/0.02 MG
FILM-COATED TABLETS EFG
Italy Egina 0.02 mg/3 mg film-coated tablets