Lerna

Package leaflet: Information for the patient

LERNA 0.02 mg/3 mg film-coated tablets

ethinylestradiol/drospirenone
Equivalent 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 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, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods 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 LERNA is and what it is used for
2. What you need to know before you take LERNA
Do not use LERNA
Warnings and precautions
LERNA and venous and arterial thrombosis
LERNA and cancer
Intermenstrual bleeding
What to do if menstruation does not occur during the placebo days
Other medicines and LERNA
Laboratory tests
Pregnancy
Breast-feeding
Driving and use of machines
LERNA contains lactose

3. How to take LERNA

Preparation of the blister
When can you start with the first blister pack?
If you take more LERNA than you should
If you forget to take LERNA
What to do in case of vomiting or severe diarrhoea
Delaying menstruation: what you need to know
Changing the first day of menstruation: what you need to know
If you wish to stop taking LERNA
4. Possible side effects
5. How to store LERNA
6. Contents of the pack and other information
1. What LERNA is and what it is used for

• LERNA is a contraceptive pill and is 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 do not contain active ingredients and are also called placebo tablets.
• Contraceptive pills containing two hormones are called "combined" pills.

2. What you should know before taking LERNA

General Notes
Before starting to use LERNA, you must read the information about blood clots in section 2.
It is particularly important that you read the symptoms of a blood clot – see section 2 “Blood Clots”.
Before you can start taking LERNA, your doctor will ask you questions about your personal medical history and that of your close relatives. Your doctor will measure your blood pressure and, depending on your individual situation, may carry out additional examinations. This leaflet describes various situations in which you should stop treatment with LERNA, or where the safety of LERNA may be reduced. In such cases, you must either abstain from sexual intercourse or use additional non-hormonal contraceptive precautions, for example, use a condom or another barrier method. Do not use the rhythm method or temperature method. These methods may be unreliable because LERNA alters monthly variations in body temperature and cervical mucus.
LERNA, like all other hormonal contraceptives, provides no protection against HIV (AIDS) or other sexually transmitted infections.
Do not use LERNA
Do not use LERNA 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.

• 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, or antiphospholipid antibodies;
• if you are scheduled for surgery or will be confined to bed for a prolonged period (see section 2 “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 ischemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following conditions, which may increase the risk of arterial clots:
  • 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 hyperhomocysteinemia;
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you currently suffer (or have previously suffered) from liver disease and your liver function has not yet returned to normal;
• if your kidneys are not functioning properly (renal failure);
• if you have (or have previously had) a liver tumor;
• if you have (or have previously had) or are suspected of having breast cancer or cancer of the genital organs;
• if you experience vaginal bleeding of unknown origin;
• if you are allergic to ethinylestradiol or drospirenone or to any of the other components of this medicine (listed in section 6). This may manifest as itching, rash, or swelling.
• Do not use LERNA if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Other medicines and LERNA").

Additional Information for Special Populations
Children and adolescents
LERNA is not intended for use in women whose menstrual cycles have not yet started.
Elderly women
LERNA is not intended for use after menopause.
Women with hepatic impairment
Do not take LERNA if you suffer from liver disease (see sections "Do not take LERNA" and "Warnings and precautions").
Women with renal impairment
Do not take LERNA if you suffer from poorly functioning kidneys or acute renal failure (see sections "Do not take LERNA" and "Warnings and precautions").

Warnings and Precautions
When should you contact a doctor?
Seek urgent medical advice if:

• you notice signs suggesting a possible 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 Clots”).
  For a description of symptoms of these serious adverse effects, refer to the section “How to recognize a blood clot”.
  In certain situations, you need to exercise particular caution when taking LERNA or any other combined hormonal contraceptive, and regular medical check-ups may be necessary.
  Inform your doctor if any of the following conditions develop or worsen while you are using LERNA
  Consult your doctor or pharmacist before taking LERNA:

• If a close relative has (or has had) breast cancer;

• if you have cancer;

• if you suffer from liver disease (such as bile duct obstruction that may cause jaundice and symptoms such as itching) or gallbladder disease (such as gallstones);

• if you have other kidney problems (beyond those described in the section “Do not take LERNA”) and are taking medications that increase potassium levels in the blood. Your doctor may monitor your blood potassium levels;

• if you suffer from diabetes;

• if you suffer from depression; some women using hormonal contraceptives, including LERNA, have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor as soon as possible for further medical advice;

• if you suffer from Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);

• if you have systemic lupus erythematosus (SLE, a disease affecting the body’s natural defense system);

• if you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure);

• if you have sickle cell anemia (an inherited red blood cell disorder);

• if you have high levels of fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);

• if you are scheduled for surgery or will be confined to bed 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 childbirth you can start taking LERNA;

• if you have inflammation of veins beneath the skin (superficial thrombophlebitis);

• if you have varicose veins;

• if you suffer from epilepsy (see also “Other medicines and LERNA”);

• if you have a condition that first appeared during pregnancy or during a previous use of sex hormones, for example, hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (herpes gestationis), a nerve disorder characterized by sudden body movements (Sydenham’s chorea);

• if you develop high blood pressure during treatment that is not controlled by medication;

• if you have or have had patchy brown skin discoloration (chloasma), commonly known as “pregnancy mask,” especially on the face. If this affects you, avoid direct exposure to sunlight or ultraviolet light while taking this medicine;

• If you develop symptoms of angioedema such as swelling of the face, tongue, and/or throat and/or difficulty swallowing or hives with potential breathing difficulties, contact a doctor immediately.
  Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
Using a combined hormonal contraceptive such as LERNA 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 TEA).
  Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, these effects can be fatal. It is important to remember that the overall risk of a harmful blood clot associated with LERNA 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 any of these signs? What might you be suffering from?

• 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;

• increased warmth in the affected leg;

• change in skin color of the leg, such as paleness, redness, or bluish discoloration.
  → Deep vein thrombosis

• 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 worsens with deep breathing;

• severe dizziness or lightheadedness;

• rapid or irregular heartbeat;

• severe stomach pain.
  → Pulmonary embolism

Symptoms occurring more frequently in one eye:

• sudden loss of vision;

• painless blurring of vision that may progress to vision loss.
  → Retinal vein thrombosis

• chest pain, discomfort, pressure, or heaviness;

• squeezing sensation or fullness in the chest, arm, or under the sternum;

• feeling of fullness, indigestion, or choking;
  → Heart attack

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. Most cases 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 may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, the 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 or a different product) 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 LERNA, 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 LERNA 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 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 in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as LERNA, about 9–12 will develop a blood clot in one year.
• The likelihood 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 LERNA 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 a 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 scheduled for surgery or need to remain bedridden for a prolonged period due to injury, illness, or if you have a plaster cast on your leg. You may need to stop taking LERNA several weeks before surgery or during periods of reduced mobility. If you need to stop taking LERNA, 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, especially if you have some of the 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 LERNA.
If any of the above conditions change while you are using LERNA—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 LERNA is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as LERNA, 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 fat 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 LERNA—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.

LERNA and cancer
Breast cancer is observed slightly more frequently in women using combined pills, but it is not known whether this is caused by the treatment. For example, more tumors may be detected in users of combined pills because these women undergo medical check-ups more frequently. The occurrence of breast tumors gradually decreases after stopping combined hormonal contraceptives. It is important to examine your breasts regularly and contact your doctor if you feel any lumps.
In rare cases, benign liver tumors and, even more rarely, malignant liver tumors have been reported in women using oral contraceptives. Contact your doctor if you experience unusual severe abdominal pain, abdominal swelling (which may be due to liver enlargement), or if you vomit blood, notice blood in your stool, or have very dark stools, as these could be signs of stomach bleeding.

Intermenstrual bleeding
During the first few months of taking LERNA, unexpected bleeding (bleeding outside the placebo days) may occur. If bleeding persists for more than a few months or 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 experienced vomiting or severe diarrhea, and have not taken other medications, it is highly 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 LERNA
Inform your doctor about any medicines or herbal products you are currently using, have recently used, or might use. Also inform any other doctor or dentist who prescribes a medicine (or your pharmacist) that you are using LERNA. They will advise you whether you need to take additional contraceptive precautions (such as condoms) and for how long.
Do not use LERNA if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these products may cause an increase in liver function blood test values (elevated ALT liver enzyme).
Your doctor will prescribe another type of contraceptive before starting treatment with these medications.
LERNA can be resumed approximately 2 weeks after completing this treatment. See section "Do not use LERNA".

Some medicines may affect blood levels of LERNA and can reduce its effectiveness in preventing pregnancy, or may cause unexpected bleeding. These include:

• medicines used to treat:
  o epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, felbamate, topiramate)
  o tuberculosis (e.g., rifampicin)
  o HIV and hepatitis C infections (medicines called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)
  o other infections (griseofulvin or ketoconazole)
  o arthritis, osteoarthritis (etoricoxib)
  o high blood pressure in the pulmonary arteries (bosentan)
• the herbal remedy St. John’s wort (Hypericum perforatum)

LERNA may affect the action of other medicines, for example:
o medicines containing cyclosporine
o the antiepileptic lamotrigine (this may lead to an increased frequency of epileptic seizures)
o theophylline (used to treat respiratory problems)
o tizanidine (used to treat muscle pain or muscle cramps)
Your doctor may monitor your blood potassium levels if you are taking certain medicines for heart conditions (such as diuretics).

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

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, you must not take LERNA. If you become pregnant while using LERNA, stop taking it immediately and contact your doctor. If you wish to become pregnant, you may stop taking LERNA at any time (see also "If you wish to stop taking LERNA").

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

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

LERNA 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 of sodium (23 mg) per tablet, i.e., essentially "sodium-free."
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking LERNA.

3. How to take LERNA

Take this medicine exactly as directed by your doctor or pharmacist. 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 LERNA are arranged in order. One blister contains 28 tablets.
Take one tablet of LERNA every day, if necessary with a small amount of water. You may take the tablet with or without food, but you should take it every day at approximately the same time.

Do not confuse the tablets: take one pink tablet for the first 24 days, then one white tablet for the last 4 days. You must then immediately start a new blister pack (24 pink and then 4 white tablets). Therefore, there is no break between two blister packs.

Because of the different composition of the tablets, you must start with the first tablet in the top left corner and take the tablets in the correct order each day. Follow the direction of the arrows on the blister pack to ensure proper sequence.

Blister pack preparation
To help you keep track of your daily pill intake, there are 7 adhesive labels, each showing the days of the week, for each LERNA blister pack. 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 beginning with "WED".
Apply the weekly label along the top edge of the blister pack where it says "Place label here", so that the first day appears above the tablet marked "1". Now each tablet has a day indicated above it, allowing you to check whether you have taken a particular tablet. The arrows indicate the order in which to take the tablets.

During the 4 days when you are taking 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 LERNA. After taking the last white tablet, you must start the next blister pack immediately, regardless of whether your bleeding has stopped. This means you should start each new blister pack on the same day of the week, and the withdrawal bleed should occur on the same days every month.

If you use LERNA in this way, you are protected against pregnancy even during the 4 days when you are taking the placebo tablets.

When can you start the first blister pack?

• If you have not used any hormonal contraceptive in the previous month
  Start LERNA on the first day of your regular cycle (i.e., the first day of your menstrual period). If you start LERNA on the first day of your menstrual cycle, you are immediately protected against pregnancy. You may also start between days 2–5 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, a combined vaginal contraceptive ring, or a contraceptive patch
  You should preferably start taking LERNA the day after the last active tablet (the last tablet containing active ingredients) of your previous pill, but no later than the day after the end of the tablet-free interval (or after the last inactive tablet of the previous pill). When switching from a combined vaginal contraceptive ring or a contraceptive patch, follow your doctor’s advice.

• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or progestogen-releasing IUD)
  You may switch at any time from the progestogen-only pill (from an implant or IUD, you should switch on the day of removal; from an injectable, when 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 or termination of pregnancy
  Follow your doctor’s advice.

• After childbirth
  You may start LERNA between day 21 and day 28 after delivery. If you start later than day 28, you must use a barrier method of contraception (e.g., a condom) during the first 7 days of taking LERNA. If you have had sexual intercourse after childbirth before starting (or restarting) LERNA, you must first make sure you are not pregnant, or wait until your next menstrual period.

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

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

If you take more LERNA than you should
There are no reports of serious harmful effects from taking too many LERNA tablets.
If you take several tablets at the same time, you may experience nausea, vomiting, or vaginal bleeding.
Girls who have not yet had their first menstrual period may also experience such bleeding if they accidentally take this medicine.
If you have taken too many LERNA tablets, or if you find that a child has taken any of them, consult your doctor or pharmacist for advice.

If you forget to take LERNA
The last 4 tablets in the 4th row of the blister pack are placebo tablets. If you forget to take one of these tablets, it will not affect the reliability of LERNA. Discard the forgotten placebo tablet.

If you forget to take a pink active tablet (tablets 1–24 of the blister strip), follow the instructions below:

• If the delay in taking a tablet is less than 24 hours, your protection against pregnancy is not reduced. Take the missed tablet as soon as you remember, and then continue taking the following tablets at your usual time.

• If the delay in taking a tablet is more than 24 hours, your protection against pregnancy may be reduced. The greater the number of tablets you have 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 blister pack. Therefore, follow the rules below (see also the chart):

• If you have missed more than one tablet in this blister pack
  Contact your doctor.

• If you missed one 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 for the next 7 days, for example, a condom. If you had sexual intercourse in the week before missing the tablet, contact your doctor, as you may be pregnant.

• If you missed one 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. Your protection against pregnancy is not reduced, and no additional contraceptive precautions are needed.

• If you missed one 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 pack, discard them and immediately start the next blister pack (your starting day will now be different). You will most likely have your period at the end of the second blister pack—during the intake of the white placebo tablets—but breakthrough bleeding or spotting may occur during the second blister pack.
2. You may also choose to stop taking the active pink tablets and go directly to the 4 placebo tablets (including the days when you missed tablets; record the day on which you missed the tablet before taking the white placebo tablets). If you wish to start a new blister pack on your usual day, take the placebo tablets for fewer 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 pack and do not have a withdrawal bleed during the placebo days, this may indicate that you are pregnant. Contact your doctor before starting the next blister pack.

The following diagram shows what to do if you forget to take tablets:

What to do in case of vomiting or severe diarrhoea
If you vomit within 3-4 hours after taking the active pink tablet or have severe diarrhoea, there is a risk
that the active ingredients in the tablet have not been completely absorbed by your body. This situation is almost the same as when you miss a tablet. After vomiting or diarrhoea, you must take another pink tablet from a spare blister pack as soon as possible. If possible, take it within 24 hours of your usual time for taking the pill. If this is not possible or more than 24 hours have passed, follow the advice given in "If you forget to take LERNA".

Delaying menstruation: what you need to 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 blister of LERNA, taking all tablets in that blister. You may experience light bleeding or menstruation-like bleeding during use of this second blister. At the end of this second blister, take the 4 white placebo tablets from row 4. Then start the next blister.

You must consult your doctor before deciding to delay your menstrual period.

Changing the first day of menstruation: what you need to know
If you take the tablets as directed, your period will start during the placebo days. If you wish to change this day, you may reduce the number of placebo days - when you take the white placebo tablets - (but must not increase them - 4 is the maximum!). For example, if you usually start taking the placebo tablets on Friday and wish to change it to Tuesday (3 days earlier), you should start the new blister 3 days earlier than usual. You may not have any bleeding during this time. Afterwards, you may experience light bleeding or menstruation-like bleeding.

Consult your doctor if you are unsure what to do.

If you stop taking LERNA
You may stop taking LERNA at any time. If you do not wish to become pregnant, consult your doctor for advice on other reliable methods of birth control. If you wish to become pregnant, stop taking LERNA and wait for one menstrual cycle before trying to conceive. This will make it easier to calculate the expected date of delivery.

If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 LERNA, inform your doctor.
All 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 LERNA”.

Listed below are the side effects that have been associated with the use of LERNA:

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

• Uncommon side effects (may affect from 1 to 10 users in 1,000):
  o depression, nervousness, drowsiness or dizziness, "pins and needles" or migraine, varicose veins, increased blood pressure or stomach ache, vomiting, indigestion, intestinal gas, stomach inflammation, diarrhoea or acne, itching, rash or aches and pains, for example back pain, limb pain, muscle cramps or vaginal fungal infection, pelvic pain, breast enlargement, benign breast lumps, uterine/vaginal bleeding (which usually disappears with continued treatment), genital discharge, hot flushes, vaginal inflammation (vaginitis), menstrual disorders, painful periods, reduced menstruation, very heavy periods, vaginal dryness, abnormal cervical smear, decreased interest in sex or lack of energy, increased sweating, fluid retention or weight gain

• Rare side effects (may affect from 1 to 10 users in 10,000):
  o candidiasis (a fungal infection) or anaemia, increased number of platelets in the blood
  o allergic reaction
  o hormonal disorder (endocrine)
  o increased appetite, loss of appetite, abnormally high concentration of potassium in the blood, abnormally low concentration of sodium in the blood
  o inability to achieve orgasm, insomnia
  o dizziness, tremor
  o eye disorders, for example eyelid inflammation, dry eyes
  o abnormally rapid heartbeat
  o harmful blood clots in a vein or artery, for example:
  o in a leg or foot (e.g. DVT)
  o in a lung (i.e. PE)
  o heart attack
  o stroke
  o mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA)
  o blood clots in the liver, stomach/intestine, kidneys or eyes
  o vein inflammation, nosebleed, fainting
  o swollen abdomen, intestinal disorders, bloated feeling, stomach hernia, fungal infection of the mouth, constipation, dry mouth
  o bile duct or gallbladder pain, gallbladder inflammation
  o yellow-brown skin patches, eczema, hair loss, acne-like skin inflammation, dry skin, skin inflammation with lumps, excessive hair growth, skin disorders, stretch marks, skin inflammation, photosensitive skin inflammation, skin nodules
  o difficult or painful sexual intercourse, vaginal inflammation (vulvovaginitis), bleeding after intercourse, withdrawal bleeding, breast cysts, increased number of breast cells (hyperplasia), abnormal growth of the cervical mucosa, reduction of the uterine lining, ovarian cysts, uterine enlargement
  o general feeling of being unwell
  o weight loss

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).

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

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 with potential breathing difficulties (see also section “Warnings and precautions”).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://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 LERNA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack/box after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine 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 LERNA 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:
• Tablet core: monohydrate lactose, pregelatinized starch (maize), povidone K-30 (E1201), croscarmellose sodium, polysorbate 80, magnesium stearate (E572).
• Tablet film coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
• White film-coated tablets:
• Tablet core: anhydrous lactose, povidone K-30 (E1201), magnesium stearate (E572).
• Tablet film coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

Description of the appearance of LERNA and contents of the pack

• Each LERNA blister contains 24 pink film-coated active tablets in rows 1, 2, 3 and 4 of the blister and 4 white film-coated placebo tablets in row 4.
• LERNA tablets, both pink and white, are film-coated tablets; the tablet core is coated.
• LERNA is available in packs of 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
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome
Italy
Manufacturer
LABORATORIOS LEON FARMA S.A.
C/La Vallina s/n, Pol. Ind. Navatejera
24193-Villaquilambre, León
SPAIN
This medicinal product is authorized in the European Economic Area countries under the following names:
Netherlands IRADIER 0.02 mg/3 mg fimomhuldetabletten
France Drospirenone/Ethinylestradiol Mylan Pharma Continu 3 mg/0.02 mg, comprimé pelliculé
Spain Etinilestradiol/drospirenona Stada 0.02 mg/3 mg, comprimidos recubiertos con película (24+4) EFG
Germany Georgette-20 24+4 3 mg/0.02 mg Filmtabletten
Czech Republic YOSEFINNE 3 mg/0.02 mg
Italy LERNA
Sweden ESTRELEN 0.02 mg/3 mg filmdragerade tabletter
Poland VIXPO
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