Lasca

Italy
Brand name Lasca
Form tablets, film-coated
Active substance / Dosage
ETHINYLESTRADIOL
LEVONORGESTREL
Prescription type Prescription only
ATC code
G03AA07
Registration number 044473
Manufacturer EXELTIS ITALIA S.R.L.

Table of Contents

Package leaflet: Information for the user

Lasca, 100 micrograms / 20 micrograms, film-coated tablets

Levonorgestrel / Ethinylestradiol
Equivalent medicinal product
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 other people, even if they have the same symptoms as you, because it could be harmful.
  • If you experience any side effect, 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 among the most reliable reversible methods of contraception, when used correctly.
  • They slightly increase the risk of 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 may have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of this leaflet

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

1. What Lasca is and what it is used for

  • Lasca is a contraceptive pill used to prevent pregnancy.
  • Each tablet contains a small amount of two different female hormones, called levonorgestrel and ethinylestradiol.
  • Contraceptive pills containing two hormones are known as "combined pills". Lasca is referred to as a "low-dose" contraceptive pill because it contains only a small amount of hormones.

2. What you should know before taking Lasca

General notes
Before starting to use Lasca, 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 starting to use Lasca, your doctor will ask you some questions about your personal medical history and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out further examinations.
This leaflet describes various situations in which you must stop using Lasca, or where the effectiveness of Lasca may be reduced. In such cases, you must either avoid sexual intercourse or use additional non-hormonal contraceptive precautions, such as a condom or another barrier method. Do not use methods such as rhythm or basal body temperature. These methods may be unreliable because Lasca alters the monthly changes in body temperature and cervical mucus.
Lasca, like other hormonal contraceptives, does not protect against HIV (AIDS) and other sexually transmitted infections.
While using this medicine, you should see your doctor regularly, at least twice a year.
If you experience unusual symptoms, such as unexplained pain in the chest, abdomen, or legs, you must consult your doctor immediately.

Do not use Lasca

  • if you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), or other organs;
  • if you have, or have ever had, a heart attack or stroke;
  • 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 due to undergo surgery or will be bedridden for a prolonged period (see section "Blood clots");
  • if you have (or have ever had) a disease that may indicate a future heart attack (e.g. angina pectoris, which causes severe chest pain) or stroke (e.g. transient ischaemic attack without lasting effects);
  • if you have any of the following conditions that could increase the risk of forming clots in the arteries:
    o 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 hyperhomocysteinemia
  • if you have (or have ever had) a certain type of migraine (with so-called focal neurological symptoms);
  • Do not use Lasca if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also section "Other medicines and Lasca");
  • if you have (or have ever had) inflammation of the pancreas (pancreatitis);
  • if you have (or have ever had) a liver disease and liver function has not yet returned to normal;
  • if you have (or have ever had) a liver tumour;
  • if you have (or have ever had) or are suspected of having breast cancer or a genital organ tumour;
  • if you have any unexplained vaginal bleeding;
  • if you have stopped menstruating, possibly due to exercise or diet;
  • if you are allergic to levonorgestrel or ethinylestradiol, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lasca

  • if a close relative has or has had breast cancer;
  • if you have liver or gallbladder disease;
  • if you suffer from diabetes;
  • if you suffer from depression;
  • if you are due 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 childbirth you can start taking Lasca;
  • if you have inflammation of the veins near the skin surface (superficial thrombophlebitis);
  • if you have varicose veins;
  • if you have Crohn's disease or an inflammatory bowel disease (ulcerative colitis);
  • if you have a blood disorder called HUS (haemolytic uraemic syndrome) that causes kidney damage;
  • if you have a blood disorder called sickle cell anaemia;
  • if you suffer from epilepsy (see section "Other medicines and Lasca");
  • if you have an autoimmune disease called SLE (systemic lupus erythematosus);
  • if you have a condition that first appeared during pregnancy or previous use of sex hormones (e.g. hearing loss, a blood disorder called porphyria, blistering rash during pregnancy (herpes gestationis), a nervous system disorder causing sudden jerky movements (Sydenham's chorea));
  • if you have or have had chloasma (skin pigmentation, especially on the face or neck, known as "pregnancy mask"). In this case, avoid direct sunlight or ultraviolet light;
  • if you have hereditary angioedema, products containing oestrogens may trigger or worsen your symptoms. You must contact your doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives together with breathing difficulties.

When should you contact a doctor?
Seek urgent medical advice

  • if you notice any possible signs of a blood clot which may indicate that you have a blood clot in the leg (i.e., deep vein thrombosis), in the lung (i.e., 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, see section "How to recognize a blood clot".

BLOOD CLOTS
Using a combined hormonal contraceptive like Lasca 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, and very rarely, these effects can be fatal. It is important to remember that the overall risk of a harmful blood clot associated with Lasca is low.

HOW TO RECOGNIZE A BLOOD CLOT
Contact your doctor immediately if you notice any of the following signs or symptoms.

What condition do you have?
Do you have any of these signs?
Likely diagnosis?

  • Swelling in one leg or along a vein in the leg or foot, especially if accompanied by:

    • pain or tenderness in the leg, felt only when standing or walking
    • increased warmth in the affected leg
    • change in skin colour of the leg, such as paleness, redness, or bluish discolouration
      → Deep vein thrombosis

  • Sudden and unexplained shortness of breath or rapid breathing
    → Pulmonary embolism


  • sudden cough without an obvious cause, possibly with coughing up blood;
    - sharp chest pain that may worsen when breathing deeply;
    - severe dizziness or lightheadedness;
    - rapid or irregular heartbeat;
    - severe stomach pain.
    If you are unsure, tell 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 infection (e.g. a "common cold").
Symptoms occurring more frequently in one eye:
 sudden loss of vision or
 painless blurring of vision that may progress to loss of vision		Retinal vein thrombosis (blood clot in the eye)
  • pain, discomfort, pressure or heaviness in the chest;
    - squeezing or fullness in the chest, in one arm or under the sternum;
    - feeling of fullness, indigestion or suffocation;
    - discomfort in the upper body spreading 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;
    - sudden confusion, difficulty speaking or understanding;
    - sudden trouble seeing with one or both eyes;
    - sudden difficulty walking, dizziness, loss of balance or coordination;
    - sudden severe or prolonged headache with no known cause;
    - loss of consciousness or fainting, with or without seizures.
    Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.
Stroke
  • swelling and pale blue discoloration of a limb;
    - severe abdominal pain (acute abdomen)
Blood clots blocking other blood vessels

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 the 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 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 Lasca, 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 individual baseline risk of venous thromboembolism (VTE) 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 Lasca 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.
  • The likelihood of developing a blood clot depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).
Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill/patch/ring and who are not pregnantAbout 2 women out of 10,000
Women using a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimateAbout 5-7 women out of 10,000
Women using LascaAbout 5-7 women out of 10,000

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Lasca 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 (for example, under approximately 50 years). In this case, you may have an inherited blood clotting disorder;
  • if you are due to undergo surgery or if you need to remain bedridden for a long period due to injury or illness, or if you have a leg in plaster. You may need to stop taking Lasca several weeks before surgery or during periods of reduced mobility. If you need to stop taking Lasca, 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.

Your risk of developing a blood clot increases if you have more than one of these conditions. Air travel (lasting over 4 hours) may temporarily increase the risk of blood clots forming, especially if you have any of the other risk factors listed. 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 you from taking Lasca. If any of the above conditions change while you are using Lasca—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 cause 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 Lasca is very low, but it may increase:

  • with increasing age (over 35 years);
  • if you smoke. When using a combined hormonal contraceptive such as Lasca, it is advisable to stop smoking. If you are unable to 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, your risk of developing a blood clot may be even higher.
If any of the above conditions change while you are using Lasca—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.

Lasca and cancer
Breast cancer has been observed slightly more frequently in women using combined pills, but it is not known whether this is caused by the treatment. For example, it is possible that more cancers are detected in women taking combined pills because they undergo medical check-ups more frequently.
The occurrence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important that you regularly check your breasts 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 the pill. Contact your doctor if you experience unusually severe abdominal pain.
Cervical cancer has been reported in long-term users, but it is unclear whether sexual behavior or other factors, such as human papillomavirus (HPV), contribute to this.

Psychiatric disorders
Some women using hormonal contraceptives, including Lasca, 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.

Bleeding between menstrual cycles
During the first few months of taking Lasca, you may experience unexpected bleeding (bleeding outside the tablet-free week). If this bleeding lasts for more than a few months, or if it starts after several months, your doctor should investigate the cause.

What to do if you do not have bleeding during the tablet-free week
If you have taken all tablets correctly, have not vomited or had severe diarrhea, and have not taken other medications, it is highly unlikely that you are pregnant.
If the expected bleeding does not occur for two consecutive cycles, you may be pregnant. Contact your doctor immediately. Do not start the next blister pack until you are certain you are not pregnant.

Other medicines and Lasca
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. They will advise you whether you need to take additional contraceptive precautions (for example, condoms) and, if so, for how long.
Some medicines can affect the levels of Lasca in your blood and make it less effective in preventing pregnancy, or may cause unexpected bleeding. These include:

  • medicines used to treat epilepsy (for example, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, or felbamate), tuberculosis (for example, rifampicin), HIV infections (for example, ritonavir, nelfinavir, efavirenz), fungal infections (for example, griseofulvin), arthritis, osteoarthritis (etoricoxib), or high blood pressure in the blood vessels of the lungs (bosentan);
  • the herbal remedy St. John’s wort.

Lasca can affect the effectiveness of other medicines, for example:

  • medicines containing cyclosporine;
  • the antiepileptic lamotrigine (this may lead to increased frequency of seizures);
  • theophylline (used to treat respiratory problems);
  • tizanidine (used to treat muscle pain and/or cramps).

Troleandomycin may increase the risk of intrahepatic cholestasis when administered concurrently with combined oral contraceptives.

  • Do not use Lasca if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, as this could cause increases in liver function blood tests (elevated ALT transaminases). Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines. Lasca may be restarted approximately 2 weeks after completing this treatment. See the section “Do not use Lasca”.

Ask your doctor or pharmacist for advice before taking any medicine.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

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

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

Pregnancy
You must not take Lasca if you are pregnant. If you become pregnant while using Lasca, stop taking it immediately and consult your doctor. If you wish to become pregnant, you may stop taking Lasca at any time (see also the section “If you stop taking Lasca”).

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

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

Lasca contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
The coating of Lasca contains Allura Red AC aluminium lake (E129) and soy lecithin, which may cause allergic reactions. Do not use this medicine if you are allergic to peanuts or soy.

3. How to take Lasca

Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Take the first tablet from one of the sections marked with the corresponding day of the week (for example, “MON” for Monday), following the direction of the arrow indicated on the blister.
Take the tablets every day at approximately the same time. You may take Lasca with or without food, if necessary with a small amount of water.
Take one tablet daily for 21 consecutive days. Start a new blister after a 7-day tablet-free interval; during this interval, withdrawal bleeding (a menstrual period) usually occurs.
Withdrawal bleeding, which resembles a menstrual period, will usually begin two or three days after taking the last tablet and may not be finished before starting the next blister.
If you use Lasca in this way, you will be protected against pregnancy even during the 7 days when you do not take any tablets.

When to start the first blister

  • If you have not used a hormonal contraceptive in the previous month: Start taking Lasca on the first day of your cycle (i.e. the first day of menstruation). If you start taking Lasca on the first day of your period, contraceptive protection begins immediately. You may also start between the second and fifth day of your cycle, but in this case you must use additional contraceptive precautions (e.g. a condom) for the first 7 days.
  • Switching from another combined hormonal contraceptive, vaginal ring, or patch: You should preferably start Lasca 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 of your previous pill (or the day after the last inactive tablet of your previous pill). When switching from a combined hormonal contraceptive, vaginal ring, or patch, follow your doctor’s advice.
  • Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine device releasing progestogen - IUD): You may switch on any day from the progestogen-only pill (from an implant or IUD on the day of its 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 a spontaneous or induced abortion: Follow your doctor’s advice.
  • After childbirth: You may start Lasca between 21 and 28 days after delivery. If you start taking it later than day 28, use a barrier contraceptive method (e.g. a condom) during the first seven days of taking Lasca. If you have had sexual intercourse after childbirth before starting (or restarting) Lasca, ensure you are not pregnant or wait until your next menstrual cycle.
  • If you are breastfeeding and wish to start (or restart) taking Lasca after childbirth: Read the section on “Breast-feeding”.

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

If you take more Lasca than you should

There have been no reports of serious harmful effects from taking too many Lasca tablets. If you take several tablets at once, you may experience symptoms such as nausea or vomiting. Young girls may have vaginal bleeding.
If you have taken too many Lasca tablets or discover that a child has taken some, consult your doctor or pharmacist.

If you forget to take Lasca

  • If you are less than 12 hours late in taking a tablet, 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 you are more than 12 hours late in taking a tablet, the contraceptive effect may be reduced. The more tablets you forget, the higher the risk that protection against pregnancy is reduced.

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

  • If you have missed more than one tablet in this blister: 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 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, you may be pregnant. In this case, contact your doctor.
  • 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 tablets at your usual time. The contraceptive effect of this medicine is not reduced, and you do not need to take additional precautions.
  • If you missed one tablet between days 15-21 (third row): 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 tablets at your usual time. Instead of starting the tablet-free interval, start the next blister immediately. You will most likely have a menstrual period at the end of the second blister, but you may experience light bleeding or spotting during the intake of tablets in the second blister.
    2. You may also stop taking tablets in the current blister and immediately start the 7-day tablet-free interval (note the day on which you missed the tablet). If you wish to start a new blister on the day you usually start, reduce the tablet-free interval to less than 7 days.

If you follow either of these two recommendations, you will continue to be protected against pregnancy.

  • If you have missed any tablet in a blister and do not have bleeding during the first days of the tablet-free interval, you may be pregnant. You must consult your doctor before starting the next blister.

Missed more than 1 tablet in 1 blister?
Ask your doctor for advice.

Yes
Did you have sexual intercourse in the week
before you forgot?
No
Take the missed tablet
Use a barrier method (condom) for the next 7
days, and finish the blister
Only 1 tablet
Take the missed tablet
missed
Finish the blister
(taken more than 12 hours late)
Take the missed tablet and
Finish the blister
Instead of the usual 7-day break
Start the next blister
or
Immediately stop the current blister
Start the 7-day tablet-free interval (not exceeding 7
days, including the missed tablet)
Then start the next blister

What to do if you vomit or have severe diarrhoea

If you vomit within 3-4 hours of taking a 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 similar to missing a tablet. After vomiting or severe diarrhoea, take another tablet from a spare blister as soon as possible. If possible, take it within 12 hours of your usual time of taking the tablet. If this is not possible or if more than 12 hours have passed, follow the advice given in the section “If you forget to take Lasca”.

How to delay your menstrual period: what you need to know

Although not recommended, you can delay your menstrual period by moving directly to a new blister of Lasca and completing it, instead of taking the tablet-free interval. You may experience light bleeding or spotting during the use of tablets in this second blister. After the usual 7-day tablet-free interval, start the next blister.
You may consult your doctor before deciding to delay your menstrual period.

How to change the first day of your menstrual period: what you need to know

If you take the tablets as instructed, your menstrual period will occur during the tablet-free week. If you wish to change this day, reduce the number of days in the tablet-free interval (but never extend it – 7 days is the maximum!). For example, if your tablet-free interval usually starts on Friday and you wish to change it to Tuesday (3 days earlier), you should start a new blister 3 days earlier than usual. If you significantly shorten the tablet-free interval (e.g. to 3 days or fewer), you may not have any bleeding during these days. You may then experience light bleeding or spotting.
If you are unsure how to proceed, consult your doctor.

If you stop taking Lasca

You may stop taking Lasca at any time. If you do not wish to become pregnant, consult your doctor about other reliable contraceptive methods. If you wish to become pregnant, stop taking Lasca and wait for a menstrual period before planning a pregnancy. This will make it easier to calculate the expected date of delivery.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
An increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) exists 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 should know before taking Lasca".
Below is a list of side effects that have been associated with the use of Lasca.
Common (may affect up to 1 in 10 women):

  • mood changes, depression
  • headache
  • nausea, abdominal pain (stomach ache)
  • breast pain or tenderness
  • weight gain
  • skin rash

Uncommon (may affect up to 1 in 100 women):

  • decreased interest in sex
  • migraine
  • vomiting, diarrhoea
  • raised or itchy skin rash
  • swollen breasts
  • fluid retention

Rare (may affect up to 1 in 1,000 women):

  • intolerance to contact lenses
  • allergic reactions
  • increased interest in sex
  • vaginal or breast discharge
  • red, painful lumps on the skin (nodular erythema)
  • rash with redness or sores with target-shaped lesions (erythema multiforme)
  • weight loss

The following serious adverse reactions have been reported slightly more frequently in women using contraceptive pills (see section 2: What you should know before taking Lasca?):

  • venous or arterial blood clots
  • increased blood pressure
  • liver tumours or breast carcinoma
  • disturbances in liver function
  • harmful blood clots in a vein or an 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/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).
The following conditions may occur or worsen with combined oral contraceptives: Crohn's disease, ulcerative colitis, epilepsy, migraine, endometriosis, porphyria (a metabolic disorder causing abdominal pain and mental disturbances), systemic lupus erythematosus (a condition in which the body attacks and damages its own organs and tissues), herpes during late pregnancy, Sydenham's chorea (rapid involuntary movements or jerking movements), haemolytic uraemic syndrome (a condition occurring after E.coli-induced diarrhoea), liver problems associated with jaundice, gallbladder disorders or gallstone formation.
In women with hereditary angioedema (sudden swelling of the skin, mucous membranes, internal organs or brain), the oestrogens present in contraceptive pills may induce or worsen angioedema symptoms.
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 www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lasca

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton and on the blister after "EXP".
The expiry date refers to the last day of that month.
Levonorgestrel/Ethinylestradiol poses a risk to the aquatic environment. 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 Lasca contains
The active substances are 100 micrograms of levonorgestrel and 20 micrograms of ethinylestradiol.
Each tablet contains 100 micrograms of levonorgestrel and 20 micrograms of ethinylestradiol. The
other components (excipients) are: anhydrous lactose, povidone K-30 (E1201), magnesium stearate (E470b),
and a coating system [partially hydrolysed polyvinyl alcohol (E1203), talc (E553b),
titanium dioxide (E171), macrogol 3350, Allura Red AC aluminium lake (E129), lecithin (E322),
red iron oxide (E172) and indigo carmine aluminium lake (E132)].
Description of the appearance of Lasca and contents of the pack

  • Each film-coated tablet is pink and round, with a diameter of approximately 5.7 mm.
  • Lasca is available in blisters of 21 tablets in 3 rows.
  • Packs contain 1, 3, 6 or 13 blisters, each blister containing 21 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Exeltis Italia S.r.l.
Via Lombardia, 2/A
20068 Peschiera Borromeo (MI)
Italy
Manufacturer
Laboratorios León Farma, S.A.
C/ La Vallina s/n. Polígono Industrial Navatejera,
Villaquilambre, 24008 León
Spain
This medicinal product is authorised in the European Economic Area Member States under the
following names:
Belgium: Levesialle 20 0.02 mg /0.10 mg filmomhulde tabletten / comprimés pelliculés /
Denmark: Filmtabletten
France: Mirabella
Italy: Asterluna 100 micrograms/20 micrograms, coated tablet
Luxembourg: Lasca
: Levesialle 20 0.02 mg /0.10 mg comprimés pelliculés
Portugal: Levesialle
Spain: Levesialle 0.10 mg/0.02 mg comprimidos recubiertos con película EFG

Package leaflet: Information for the user

Lasca, 100 micrograms / 20 micrograms, film-coated tablets

Levonorgestrel / Ethinylestradiol
Equivalent 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 may be harmful.
  • If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. 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 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 contact your doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of this leaflet

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

1. What Lasca is and what it is used for

  • Lasca is a contraceptive pill used to prevent pregnancy.
  • Each pink tablet contains a small amount of two different female hormones, called levonorgestrel and ethinylestradiol.
  • The white tablets do not contain any active ingredients and are also called placebo tablets.
  • Contraceptive pills containing two hormones are called "combined pills". Lasca is referred to as a "low-dose" contraceptive pill because it contains only a small amount of hormones.

2. What you should know before taking Lasca

General information
Before starting to use Lasca, 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 starting Lasca, your doctor will ask you some questions about your personal medical history and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out additional tests.
This leaflet describes several situations in which you must stop using Lasca, or in which the effectiveness of Lasca may be reduced. In such cases, you must either avoid sexual intercourse or use additional non-hormonal contraceptive precautions, such as using a condom or another barrier method. Do not use methods such as rhythm or basal body temperature. These methods may be unreliable because Lasca alters the monthly changes in body temperature and cervical mucus.
Lasca, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or other sexually transmitted diseases.
While using this medicine, you should see your doctor regularly, at least twice a year.
If you experience unusual symptoms such as unexplained pain in the chest, abdomen, or legs, you must consult your doctor immediately.

Do not use Lasca

  • if you have (or have ever had) a blood clot in a blood vessel in your leg (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), or other organs;
  • if you have, or have ever had, a heart attack or stroke;
  • 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 due to undergo surgery or will be bedridden for a prolonged period (see section “Blood clots”);
  • if you have (or have ever had) a disease that may indicate a future risk of heart attack (e.g., angina pectoris, which causes severe chest pain) or stroke (e.g., transient ischemic attack without lasting effects);
  • if you have (or have ever had) any of the following conditions that could increase the risk of forming clots in the arteries:
    • 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 certain type of migraine (with so-called focal neurological symptoms);
  • Do not use Lasca if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also section “Other medicines and Lasca”);
  • if you have (or have ever had) inflammation of the pancreas (pancreatitis);
  • if you have (or have ever had) a liver disease and liver function has not yet returned to normal;
  • if you have (or have ever had) a liver tumour;
  • if you have (or have ever had) or are suspected of having breast cancer or a genital organ tumour;
  • if you have any unexplained vaginal bleeding;
  • if you have stopped menstruating, possibly due to exercise or diet;
  • if you are allergic to levonorgestrel or ethinylestradiol, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lasca

  • if a close relative has or has had breast cancer;
  • if you have a liver or gallbladder disease;
  • if you have diabetes;
  • if you suffer from depression;
  • if you are due 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 childbirth you can start taking Lasca;
  • if you have inflammation of veins near the skin surface (superficial thrombophlebitis);
  • if you have varicose veins;
  • if you have Crohn’s disease or an inflammatory bowel disease (ulcerative colitis);
  • if you have a blood disorder called HUS (haemolytic uraemic syndrome) that causes kidney damage;
  • if you have a blood disorder called sickle cell anaemia;
  • if you suffer from epilepsy (see section “Other medicines and Lasca”);
  • if you have an autoimmune disease called SLE (systemic lupus erythematosus);
  • if you have had a condition that first appeared during pregnancy or a previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering rash during pregnancy (herpes gestationis), a nervous system disorder causing sudden involuntary movements of the body (Sydenham’s chorea));
  • if you have or have had chloasma (skin pigmentation, especially on the face or neck, also known as "pregnancy mask"). In this case, avoid direct sunlight or ultraviolet light;
  • if you have hereditary angioedema, products containing estrogens may trigger or worsen symptoms. You must contact your doctor immediately if you develop symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives together with breathing difficulties.

When should you contact a doctor?
Contact a doctor urgently

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

For a description of the symptoms of these serious side effects, go to the section “How to recognize a blood clot”.

BLOOD CLOTS
Using a combined hormonal contraceptive like Lasca 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, and very rarely, these effects can be fatal. It is important to remember that the overall risk of a harmful blood clot associated with Lasca is low.

HOW TO RECOGNIZE A BLOOD CLOT
Contact a doctor immediately if you notice any of the following signs or symptoms.
What condition do you have?
Do you have any of these signs?
Likely?
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,
reddish or bluish discoloration
  • 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 with deep breathing; -severe dizziness or lightheadedness; -rapid or irregular heartbeat; -severe stomach (abdominal) 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").
Pulmonary embolism
Symptoms occurring more frequently in one eye: sudden loss of vision or painless blurring of vision that may progress to vision lossRetinal vein thrombosis (blood clot in the eye)
  • chest pain, discomfort, pressure, or heaviness -crushing sensation or fullness in the chest, in one arm, or under the breastbone; -feeling of fullness, indigestion, or choking; -discomfort in the upper body spreading 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; -sudden confusion, difficulty speaking or understanding; -sudden trouble seeing with one or both eyes; -sudden difficulty walking, dizziness, loss of balance or coordination; -sudden severe or prolonged headache with no known cause; -loss of consciousness or fainting with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.
Stroke
  • swelling and pale blue discoloration of a limb; -severe stomach (abdominal) pain (acute abdomen)
Blood clots blocking other blood vessels

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 first-time use of a combined hormonal contraceptive. The risk may also be higher if you restart taking 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 if you were not using a combined hormonal contraceptive.
When you stop taking Lasca, 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 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 Lasca 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.
  • The likelihood of a blood clot forming depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).
Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill/patch/ring and who are not pregnantAbout 2 women in 10,000
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimateAbout 5-7 women in 10,000
Women who use LascaAbout 5-7 women in 10,000

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Lasca 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 (for example, under about 50 years). In this case, you might have an inherited blood clotting disorder;
  • if you are due to undergo surgery or need to remain bedridden for a long period due to injury or illness, or if you have a leg in plaster. You may need to stop taking Lasca several weeks before surgery or during periods of reduced mobility. If you need to stop taking Lasca, 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 over 4 hours) may temporarily increase the risk of blood clots, especially if you have some of the other risk factors listed. 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 Lasca. If any of the above conditions change while you are using Lasca—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 cause 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 Lasca is very low, but it may increase:

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

Lasca and cancer
Breast cancer has been observed slightly more frequently in women using combined pills, but it is not known whether this is caused by the treatment. For example, more cancers may be detected in women taking combined pills because they undergo medical examinations more often.
The occurrence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important that you regularly check your breasts and consult 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 the pill. Contact your doctor if you have unusually severe abdominal pain.
Cervical cancer has been reported in long-term users, but it is unclear whether sexual behavior or other factors, such as human papillomavirus (HPV), contribute to this.

Psychiatric disorders
Some women using hormonal contraceptives, including Lasca, 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, consult your doctor as soon as possible for further medical advice.

Bleeding between menstrual cycles
During the first few months of taking Lasca, you may experience unexpected bleeding (bleeding outside the placebo tablet week). If this bleeding lasts for more than a few months, or if it starts after several months, your doctor should investigate the cause.

What to do if you do not have bleeding during the placebo tablet days
If you have taken all the active pink tablets correctly, have not had severe vomiting or diarrhea, and have not taken other medicines, it is highly unlikely that you are pregnant.
If the expected bleeding does not occur for two consecutive cycles, you may be pregnant. Consult your doctor immediately. Do not start the next blister pack until you are certain you are not pregnant.

Other medicines and Lasca
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines. They will advise you whether you need to take additional contraceptive precautions (for example, condoms) and, if so, for how long.
Some medicines can affect the levels of Lasca in your blood and make it less effective in preventing pregnancy, or may cause unexpected bleeding. These include:

  • medicines used to treat epilepsy (for example, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, or felbamate) or tuberculosis (for example, rifampicin) or arthritis, osteoarthritis (etoricoxib) or HIV infections (for example, ritonavir, nelfinavir, efavirenz) or fungal infections (for example, griseofulvin) or high blood pressure in the blood vessels of the lungs (bosentan);
  • the herbal remedy St. John’s wort.

Lasca can affect the effectiveness of other medicines, for example:

  • medicines containing cyclosporine;
  • the antiepileptic lamotrigine (this may lead to increased frequency of seizures);
  • theophylline (used to treat respiratory problems);
  • tizanidine (used to treat muscle pain and/or cramps).

Troleandomycin may increase the risk of intrahepatic cholestasis when administered concurrently with combined oral contraceptives.

  • Do not use Lasca if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, as this could cause increases in liver function blood tests (elevated ALT transaminases). Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines. Lasca can be restarted approximately 2 weeks after completing this treatment. See the section “Do not use Lasca”.

Ask your doctor or pharmacist for advice before taking any medicine.
Inform your doctor or pharmacist if you are using, have recently used, or may use any other medicine.

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

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

Pregnancy
You must not take Lasca if you are pregnant. If you become pregnant while using Lasca, stop taking it immediately and consult your doctor. If you wish to become pregnant, you may stop taking Lasca at any time (see also the section “If you stop treatment with Lasca”).

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

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

Lasca contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
The coating of Lasca contains Allura Red AC aluminium lake (E129) and soy lecithin, which may cause allergic reactions. Do not use this medicine if you are allergic to peanuts or soy.

3. How to take Lasca

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

If you were using another contraceptive before starting Lasca, 28 tablets, you may be aware that most contraceptives contain 21 tablets. With these contraceptives, you take one tablet daily for 21 days, followed by a week without tablets (tablet-free interval). The regimen for Lasca, 28 tablets, is different. After taking the 21 pink tablets, you must continue with the 7 placebo tablets; therefore, there is no tablet-free interval, but a week of "placebo" (the week during which you take the placebo tablets in the fourth row). Since you take one tablet every day and there is no tablet-free interval between packs, taking the tablets becomes a habit, reducing the risk of forgetting a dose.

The two different colored tablets of Lasca, 28 tablets, are arranged in a specific order. One pack contains 28 tablets.
Take one Lasca tablet every day. You may take Lasca with or without food, if necessary with a small amount of water. Take the tablets every day at approximately the same time.

Do not confuse the tablets: take one pink tablet once daily for the first 21 days, then one white tablet once daily for the last 7 days. Immediately start a new blister pack (21 pink tablets followed by 7 white tablets). Therefore, there is no tablet-free interval between two blister packs.

Due to the different composition of the tablets, you must start with the first tablet in the top left corner (near the label “START”) and take one tablet every day. Follow the direction of the arrows on the blister pack for the correct sequence.

To help you remember to take your tablet, each Lasca pack provides, for each blister, a weekly sticker label containing 7 day labels with the days of the week printed on them. Choose the weekly sticker that starts with the day you begin taking the tablets. For example, if you start on Wednesday, use the weekly sticker starting with “WED”.

Apply the weekly sticker along the top edge of the blister pack where it says “Apply weekly label here”.

Now, each tablet has a day marked above it, so you can see whether you have already taken a particular tablet. The arrows indicate the order in which you should take the tablets.

During the 7 days when you take the white placebo tablets (the placebo days), you should experience bleeding (so-called withdrawal bleeding). This usually starts on the second or third day after taking the last pink active tablet. After taking the last white tablet, you must start the next blister pack, whether or not the bleeding has stopped.

This means you must start each new blister pack on the same day of the week, and the withdrawal bleeding should begin on the same day every month.

If you use Lasca in this way, you will be protected against pregnancy even during the 7 days when you take the white placebo tablets.

When to start the first blister pack

  • If you have not used a hormonal contraceptive in the previous month: Start taking Lasca on the first day of your cycle (i.e., the first day of your menstrual period). If you start taking Lasca on the first day of your period, contraceptive protection begins immediately. You may also start between the second and fifth day of your cycle, but in this case you must use additional contraceptive precautions (e.g., a condom) for the first 7 days.

  • Switching from another combined hormonal contraceptive, vaginal ring, or patch: You may start Lasca preferably 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 tablet-free interval of your previous pill ends (or the day after the last placebo tablet, the last tablet without active ingredient of your previous pill). When switching from a combined hormonal contraceptive, vaginal ring, or patch, follow your doctor’s advice.

  • Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine device releasing progestogen – IUD): You may switch on any day from the progestogen-only pill (from an implant or IUD 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 miscarriage or induced abortion: Follow your doctor’s advice.

  • After giving birth: You may start Lasca between 21 and 28 days after delivery. If you start taking it later than day 28, use a barrier contraceptive method (e.g., a condom) during the first seven days of taking Lasca. If you have had sexual intercourse after giving birth and before starting (or restarting) Lasca, ensure you are not pregnant or wait until your next menstrual period.

  • If you are breastfeeding and wish to start (or restart) taking Lasca after giving birth: Read the section on “Breast-feeding”.

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

If you take more Lasca than you should

There are no reports of serious harmful effects from taking too many Lasca tablets. If you take several tablets at once, you may experience symptoms such as nausea or vomiting. Young girls may experience vaginal bleeding.

If you have taken too many Lasca tablets or discover that a child has taken some, consult your doctor or pharmacist.

If you forget to take Lasca

The tablets in the fourth row of the blister are placebo tablets. If you forget to take one of these tablets, it does not affect the reliability of Lasca. Discard the forgotten placebo tablet.

If you forget to take an active pink tablet (tablets in the first, second, or third row), follow these instructions:

  • If you are less than 12 hours late in taking a tablet, contraceptive protection is not reduced. Take the missed tablet as soon as possible and continue taking the following tablets at your usual time.

  • If you are more than 12 hours late in taking a tablet, contraceptive effectiveness may be reduced. The greater the number of tablets you have forgotten, the higher the risk that contraceptive protection is reduced. The risk of incomplete protection is greater if you forget a pink tablet at the beginning (first row) or end (third row) of the pack. Therefore, follow the rules below (see also the diagram later):

  • If you have missed more than one tablet in this pack: Contact 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 for the next 7 days, e.g., a condom. If you had sexual intercourse in the week before you forgot the tablet, be aware that there is a risk of pregnancy. In this case, contact 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. The contraceptive effect of this medicine is not reduced, and you do not need to take additional precautions.

  • If you missed a tablet between days 15–21 (third row): 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 of this blister pack, discard them and start the next blister pack immediately (your starting day will be different). You will most likely have a menstrual period at the end of the second blister pack—during the intake of the white placebo tablets—but you may experience light bleeding or spotting during the intake of the tablets in the second blister pack.

    2. You may also stop taking the active pink tablets in the blister pack and immediately start taking the white placebo tablets (before taking the placebo tablets, note the day on which you missed the tablet). Then continue with the next blister pack. If you wish to start a new blister pack on your usual starting day, reduce the placebo tablet period to fewer than 7 days.

If you follow either of these two recommendations, you will continue to have contraceptive protection.

  • If you have forgotten any tablet in a blister pack and do not have bleeding during the first placebo days, you may be pregnant. You should consult your doctor before starting the next blister pack.

More than 1 pink tablet missed in 1 blister
Ask your doctor for advice

Yes
Did you have sexual intercourse in the week
before you forgot?
No
Take the missed tablet
Use a barrier method (condom) for the next 7
days, and finish the blister
Only 1 pink tablet
Take the missed tablet
missed
Finish the blister
(taken more than 12 hours late)
Take the missed tablet and
Finish taking the pink tablets
Discard the 7 white tablets
Start the next blister
or
Immediately stop taking the
pink tablets
Go directly to the 7 white tablets
Then start the next blister

What to do in case of vomiting or severe diarrhoea

If you vomit within 3–4 hours after taking an active pink tablet or if you 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 similar to forgetting a tablet. After vomiting or severe diarrhoea, take another pink tablet from a spare blister pack as soon as possible. If possible, take it within 12 hours of your usual time of taking the tablet. If this is not possible or if more than 12 hours have passed, follow the advice given in the section “If you forget to take Lasca”.

How to delay your menstrual period: what you need to know

Although not recommended, you can postpone your menstrual period by not taking the white placebo tablets and instead starting directly with a new blister pack of Lasca and completing it. You may experience light bleeding or spotting while taking the tablets in this second blister pack. Complete this second blister pack by taking the 7 white tablets from the fourth row. Then start a new blister pack.

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

How to change the first day of your menstrual period: what you need to know

If you take the tablets as instructed, your menstrual period will start during the days you take the placebo tablets. If you wish to change this day, reduce the number of days you take the placebo tablets—while taking the white placebo tablets—but never increase it—7 is the maximum! For example, if you usually start the placebo tablets on Friday and wish to change it to Tuesday (3 days earlier), you should start a new blister pack 3 days earlier than usual. You may not have any bleeding during these days. You may then experience light bleeding or spotting.

If you are unsure how to proceed, consult your doctor.

If you stop taking Lasca

You may stop taking Lasca at any time. If you do not wish to become pregnant, consult your doctor about other reliable contraceptive methods. If you wish to become pregnant, stop taking Lasca and wait for a menstrual period before planning a pregnancy. This will make it easier to calculate your expected date of delivery.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
An increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) exists in all women who take 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 Lasca”.
Below is a list of side effects that have been associated with the use of Lasca.
Common (may affect up to 1 in 10 women):

  • mood changes, depression
  • headache
  • nausea, abdominal pain (stomach ache)
  • breast tenderness or pain
  • weight gain
  • skin rash

Uncommon (may affect up to 1 in 100 women):

  • decreased interest in sex
  • migraine
  • vomiting, diarrhoea
  • raised or itchy skin rashes
  • swollen breasts
  • fluid retention

Rare (may affect up to 1 in 1,000 women):

  • intolerance to contact lenses
  • allergic reactions
  • increased interest in sex
  • vaginal or breast discharge
  • red, painful lumps on the skin (erythema nodosum)
  • rash with redness or sores with target-shaped lesions (erythema multiforme)
  • weight loss

The following serious adverse reactions have been reported slightly more frequently in women using contraceptive pills (see section 2: What you need to know before taking Lasca):

  • venous or arterial blood clots
  • increased blood pressure
  • liver tumours or breast cancer
  • disturbances in liver function
  • harmful blood clots in a vein or an 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).
The following conditions may occur or worsen with combined oral contraceptives: Crohn’s disease, ulcerative colitis, epilepsy, migraine, endometriosis, porphyria (a metabolic disorder causing abdominal pain and mental disturbances), systemic lupus erythematosus (a condition in which the body attacks and damages its own organs and tissues), herpes in late pregnancy, Sydenham's chorea (rapid involuntary movements or jerky motions), haemolytic uraemic syndrome (a condition occurring after E.coli-induced diarrhoea), liver problems associated with jaundice, gallbladder disorders or gallstone formation.
In women with hereditary angioedema, estrogens present in contraceptive pills may induce or worsen symptoms of angioedema.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lasca

Keep this medicine out of the sight and reach of children.
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.
This medicine does not require any special storage conditions.
Levonorgestrel/Ethinylestradiol poses a risk to the aquatic environment. 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 Lasca contains
The active substances are 100 micrograms of levonorgestrel and 20 micrograms of ethinylestradiol.
Lasca tablets are of two colours:

  • Each pink tablet contains 100 micrograms of levonorgestrel and 20 micrograms of ethinylestradiol. The other components (excipients) are: anhydrous lactose, povidone K-30 (E1201), magnesium stearate (E470b), and a pink film coating [partially hydrolysed polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), macrogol 3350, Allura Red AC aluminium lake (E129), lecithin (E322), red iron oxide (E172), and indigo carmine aluminium lake (E132)].
  • Each white tablet (inactive tablet or placebo tablet) contains only excipients (and therefore no active substances), which are: anhydrous lactose, povidone K-30 (E1201), magnesium stearate (E470b), and a white film coating [partially hydrolysed polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), macrogol 3350].

Description of the appearance of Lasca and contents of the pack
The active tablets are pink, round, and approximately 5.7 mm in diameter.
The placebo tablets are white, round, and approximately 5.7 mm in diameter.
Each blister contains 21 pink film-coated active tablets in the first, second, and third rows of the blister and 7 white film-coated placebo tablets in the fourth row.
Lasca is available in packs containing 1, 3, 6, or 13 blisters of 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Exeltis Italia S.r.l.
Via Lombardia, 2/A
20068 Peschiera Borromeo (MI)
Italy

Manufacturer
Laboratorios León Farma, S.A.
C/ La Vallina s/n. Polígono Industrial Navatejera,
Villaquilambre, 24008 León
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium: Levesialle Continu 20 0.02 mg/0.10 mg filmomhulde tabletten / comprimés pelliculés
Denmark: Filmtabletten
Finland: Mirabella 28
France: Mirabella 100 mikrog/20 mikrog kalvopäällysteiset tabletit
Italy: Asterluna Continu 100 microgrammes/20 microgrammes, comprimé pelliculé
Luxembourg: Lasca
Norway: Levesialle Continu 20 0.02 mg/0.10 mg comprimés pelliculés
Portugal: Mirabella
Spain: Levesialle Diario 0.10 mg/0.02 mg comprimidos recubiertos con película EFG
Sweden: Levesia
Germany: Asumate 20 /21+7 0.10 mg/ 0.02 mg Filmtabletten