LASCA 100 MICROGRAMS/20 MICROGRAMS Film-coated tablets

Зміст інструкції

1. Che cos'è Lasca e a che cosa serve
2. Cosa deve sapere prima di prendere Lasca
3. How to take Lasca
4. Possible side effects
5. How to store Lasca
6. Package Contents and Other Information
7. What Lasca is and what it is used for
8. Cosa deve sapere prima di prendere Lasca
9. How to take Lasca
10. Possible side effects
11. How to store Lasca
12. Package Contents and Other Information

Lasca, 100 micrograms / 20 micrograms, film-coated tablets
Levonorgestrel / Ethinylestradiol
Generic medicine

Read 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

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

• They are one of the most reliable reversible methods of contraception, if 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.
• Pay attention and see 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 you take Lasca
• 3. How to take Lasca
• 4. Possible side effects
• 5. How to store Lasca
• 6. Contents of the pack and other information

1. Che cos'è Lasca e a che cosa serve

• Lasca è una pillola contraccettiva usata per prevenire la gravidanza.
• Ogni compressa contiene una piccola quantità di due differenti ormoni femminili, chiamati levonorgestrel ed etinilestradiolo.
• Le pillole contraccettive che contengono due ormoni sono chiamate "pillole combinate". Lasca è chiamato pillola contraccettiva a “basso dosaggio” perchè contiene solo una piccola quantità

di ormoni.

2. Cosa deve sapere prima di prendere Lasca

Note generali
Prima di iniziare a usare Lasca deve leggere le informazioni sui coaguli sanguigni al paragrafo 2.
È particolarmente importante che legga i sintomi di un coagulo sanguigno (vedere paragrafo 2
“Coaguli sanguigni”).
Prima di iniziare a usare Lasca, il medico le farà alcune domande sulla storia medica personale e su
quella dei suoi parenti stretti. Il medico misurerà anche la sua pressione sanguigna, e, in base alla
sua situazione personale, potrà anche effettuare altri esami.
In questo foglio, sono descritte diverse situazioni in cui deve interrompere l'uso di Lasca, o laddove
l'affidabilità di Lasca può essere ridotta. In tali situazioni, non deve avere rapporti sessuali oppure
deve prendere delle precauzioni contraccettive non ormonali aggiuntive, ad esempio usare un
profilattico o un altro metodo barriera. Non usi metodi come il ritmo o la temperatura basale. Questi
metodi possono essere inaffidabili perché Lasca altera i cambiamenti mensili della temperatura
corporea e del muco cervicale.

Lasca, così come altri contraccettivi ormonali, non protegge dalle infezioni da HIV (AIDS) e da
altre malattie trasmesse sessualmente.
Mentre utilizza questo medicinale deve vedere regolarmente il suo medico, almeno due volte
all’anno.
Se ha sintomi inconsueti, come dolore inspiegabile al torace, all’addome o alle gambe, deve
immediatamente consultare il medico.

Non usi Lasca

• se ha (o ha mai avuto) un coagulo sanguigno in un vaso delle gambe (trombosi venosa profonda, TVP), dei polmoni (embolia polmonare, EP) o di altri organi;
• se ha, o ha mai avuto, un attacco cardiaco o un ictus;
• se sa di avere un disturbo che colpisce la coagulazione del sangue, come carenza di proteina C, carenza di proteina S, carenza di antitrombina-III, fattore V di Leiden o anticorpi antifosfolipidi;
• se deve sottoporsi a un’operazione o se starà coricata per un lungo periodo (vedere paragrafo “Coaguli sanguigni”);
• se ha (o ha mai avuto) una malattia che può essere indicatrice di un attacco cardiaco in futuro (per esempio angina pectoris, che causa un forte dolore al torace) o di un ictus (per esempio un attacco ischemico transitorio senza effetti residui)
• se ha una delle seguenti malattie che potrebbe aumentare il rischio che si formino coaguli nelle arterie: o diabete con lesione dei vasi sanguigni

o pressione arteriosa molto alta
o livello molto alto di grassi (colesterolo o trigliceridi) nel sangue
o una malattia nota come iperomocisteinemia

• se ha (o ha mai avuto) un certo tipo di emicrania (con cosiddetti sintomi neurologici focali)
• Non usi Lasca se ha l’epatite C e sta assumendo medicinali contenenti ombitasvir/paritaprevir/ritonavir e dasabuvir (vedere anche il paragrafo “Altri medicinali e Lasca”).
• se ha (o ha mai avuto) una infiammazione del pancreas (pancreatite)
• se ha (o ha mai avuto) una malattia del fegato e la funzionalità epatica non si è ancora normalizzata
• se ha (o ha mai avuto) un tumore del fegato
• se ha (o ha mai avuto) o se si sospetta che abbia un carcinoma mammario o un tumore degli organi genitali
• se ha qualsiasi inspiegabile sanguinamento dalla vagina
• se ha interrotto le mestruazioni, forse a causa di esercizio fisico o di una dieta
• se è allergica a levonorgestrel o etinilestradiolo, o ad uno qualsiasi degli altri componenti di questo medicinale (elencati al paragrafo 6).

Avvertenze e precauzioni
Si rivolga al medico o il farmacista prima di prendere Lasca

• se un parente stretto ha o ha avuto un carcinoma mammario;
• se ha una malattia del fegato o della cistifellea;
• se soffre di diabete;
• se soffre di depressione;
• se deve sottoporsi a un’operazione o se starà coricata per un lungo periodo (vedere paragrafo 2 “Coaguli sanguigni”).
• se ha appena partorito, il suo rischio di sviluppare coaguli sanguigni è maggiore. Chieda al medico quanto tempo dopo il parto può iniziare a prendere Lasca;
• se ha un’infiammazione alle vene poste sotto la pelle (tromboflebite superficiale);
• se ha le vene varicose;
• se ha il morbo di Crohn o una malattia infiammatoria dell’intestino (colite ulcerosa)
• se ha una malattia del sangue chiamata SEU (sindrome emolitica uremica) che causa danni ai reni
• se ha una malattia del sangue chiamata anemia falciforme
• se soffre di epilessia (vedere il paragrafo “Altri medicinali e Lasca”)
• se ha una malattia del sistema immunitario chiamata LES (lupus eritematoso sistemico)
• se ha una malattia che è comparsa per la prima volta durante la gravidanza o un precedente uso di ormoni sessuali (per esempio, perdita dell'udito, una malattia ematica chiamata porfiria, eruzione cutanea con vesciche durante la gravidanza (herpes gestazionale), una malattia del sistema nervoso che causa movimenti improvvisi del corpo (corea di Sydenham))
• se ha o ha avuto cloasma (una colorazione della pelle, in particolare sul viso o sul collo, nota come "macchie della gravidanza"). In tal caso, eviti la luce solare diretta o la luce

ultravioletta

• se soffre di angioedema ereditario, i prodotti contenenti estrogeni possono causarne o peggiorarne i sintomi. Deve rivolgersi immediatamente al medico se manifesta sintomi di angioedema come viso, lingua e/o gola gonfi e/o difficoltà a deglutire o orticaria insieme a difficoltà respiratorie.

Quando deve rivolgersi a un medico?
Si rivolga urgentemente a un medico

• se osserva segni possibili di un coagulo sanguigno che possono indicare che soffre di un coagulo sanguigno nella gamba (cioè, trombosi venosa profonda), di un coagulo sanguigno nel polmone (cioè, embolia polmonare), di un attacco cardiaco o di un ictus (vedere il paragrafo seguente "Coaguli sanguigni”-trombosi).

Per una descrizione dei sintomi di questi gravi effetti indesiderati vada al paragrafo “Come
riconoscere un coagulo sanguigno”.

COAGULI SANGUIGNI
L’uso di un contraccettivo ormonale combinato come Lasca causa un aumento del rischio di
sviluppare un coagulo sanguigno rispetto al non utilizzo. In rari casi un coagulo sanguigno può
bloccare i vasi sanguigni e causare problemi gravi.
I coaguli sanguigni possono svilupparsi

• nelle vene (condizione chiamata “trombosi venosa”, "tromboembolia venosa” o TEV)
• nelle arterie (condizione chiamata “trombosi arteriosa”, “tromboembolia arteriosa” o TEA). La guarigione dai coaguli sanguigni non è sempre completa. Raramente, si possono verificare effetti gravi di lunga durata o, molto raramente, tali effetti possono essere fatali. È importante ricordare che il rischio globale di un coagulo sanguigno dannoso associato a Lascaè basso.

COME RICONOSCERE UN COAGULO SANGUIGNO
Si rivolga immediatamente a un medico se nota uno qualsiasi dei seguenti segni o sintomi.
Presenta uno di questi segni?
Di cosa soffre
probabilmente?
Gonfiore a una gamba o lungo una vena della gamba o del piede,
specialmente se accompagnato da:

• dolore o sensibilità alla gamba che può essere avvertito solo in piedi Trombosi venosa profonda o camminando
• maggiore sensazione di calore nella gamba colpita
• variazione del colore della pelle della gamba, come pallore, colorazione rossastra o bluastra
• mancanza di respiro o respirazione accelerata improvvisa e inspiegabile; Embolia polmonare

COAGULI SANGUIGNI IN UNA VENA
Cosa può accadere se si forma un coagulo sanguigno in una vena?

• L’uso di contraccettivi ormonali combinati è stato correlato a un aumento del rischio di formazione di coaguli sanguigni nelle vene (trombosi venosa). Questi effetti collaterali, però, sono rari. Nella maggior parte dei casi essi si verificano nel primo anno di utilizzo di un contraccettivo ormonale combinato.
• Se un coagulo sanguigno si forma in una vena della gamba o del piede, può causare una trombosi venosa profonda (TVP).
• Se un coagulo sanguigno si sposta dalla gamba e si colloca nel polmone, può causare un’embolia polmonare.
• Molto raramente il coagulo può formarsi in un altro organo come l’occhio (trombosi della vena retinica).

Quando è massimo il rischio di sviluppare un coagulo sanguigno in una vena?
Il rischio di sviluppare un coagulo sanguigno in una vena è massimo durante il primo anno in cui si
assume per la prima volta un contraccettivo ormonale combinato. Il rischio può essere anche
superiore se si ricomincia ad assumere un contraccettivo ormonale combinato (lo stesso farmaco o
un farmaco diverso) dopo una pausa di 4 o più settimane.
Dopo il primo anno, il rischio si riduce ma è sempre leggermente superiore che se non si stesse
utilizzando un contraccettivo ormonale combinato.
Quando interrompe l’assunzione di Lasca il rischio di sviluppare un coagulo sanguigno torna ai livelli
normali entro poche settimane.

Qual è il rischio di sviluppare un coagulo sanguigno?
Il rischio dipende dal suo rischio naturale di TEV e dal tipo di contraccettivo ormonale combinato che
sta assumendo.
Il rischio globale di sviluppare un coagulo sanguigno nella gamba o nel polmone (TVP o EP) con Lasca
è basso.

• Su 10.000 donne che non usano alcun contraccettivo ormonale combinato e che non sono in gravidanza, circa 2 svilupperanno un coagulo sanguigno in un anno.
• Su 10.000 donne che usano un contraccettivo ormonale combinato contenente levonorgestrel, noretisterone o norgestimato, circa 5-7 svilupperanno un coagulo sanguigno in un anno.
• Il rischio che si formi un coagulo sanguigno dipende dalla sua anamnesi medica (vedere più avanti “Fattori che aumentano il rischio di sviluppare di un coagulo sanguigno”).

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 some conditions cause an
increase. Your risk is higher:

• if you are strongly overweight (body mass index or BMI greater than 30kg/m );
• if a close relative of yours has had a blood clot in a leg, in the lung or in another organ at a young age (for example under about 50 years). In this case you may have an inherited blood clotting disorder;
• if you have to undergo surgery or if you have to stay in bed for a long period due to an injury or illness or if you have a leg in plaster. It may be necessary to stop taking Lasca a few weeks before surgery or during the period when you are less mobile. 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 more than 4 hours) can temporarily increase the risk of a blood clot forming, 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 not sure. The 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 for no known reason or if you gain a lot of 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 a 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 can increase:

• as you get older (over 35 years);
• if you smoke.When you use a combined hormonal contraceptive like Lasca it is advisable that you stop smoking. If you cannot stop smoking and you are over 35 years old, your doctor may advise you to use a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative of yours has had a heart attack or stroke at a young age (under about 50 years). In this case you may also be at high 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 any heart problems (valve 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 serious, 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 to
smoke, if a close relative develops thrombosis for no known reason or if you gain a lot of
weight, contact your doctor.

Lasca and cancer
Breast cancer has been observed with a slightly higher frequency in women who use
combined pills, but it is not known whether this is caused by the treatment. For example, it is possible
that more tumors are detected in women who take combined pills because they have more frequent
medical examinations.
The occurrence of breast tumors gradually decreases after stopping combined hormonal
contraceptives. It is important that you check your breasts regularly and must see your doctor if you feel
any lumps.
In rare cases, benign liver tumors have been reported, and in even rarer cases malignant tumors to the
liver, in women who use 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 the human papillomavirus (HPV), contribute to
this.

Psychiatric disorders
Some women who use hormonal contraceptives including Lasca have reported depression or depressed mood.
Depression can be severe and sometimes can lead to suicidal thoughts. If you experience
mood changes and depressive symptoms, see your doctor as soon as possible for further
medical advice.
Bleeding between menstrual cycles
During the first few months of taking Lasca you may have unexpected bleeding
(bleeding outside the pill-free week). If this bleeding
lasts more than a few months, or if it starts after a few months, your doctor will need to investigate the cause.

What to do if you do not have bleeding during the pill-free week
If you have taken all the pills correctly, you have not had severe vomiting or diarrhea and you have not taken
any other medicines, it is highly unlikely that you are pregnant.
If the expected bleeding does not occur for two consecutive times, you may be pregnant. See
your doctor immediately. Do not start the next blister until you are sure you are not
pregnant.

Other medicines and Lasca
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. They can tell you whether to take any additional contraceptive precautions (for
example condoms) and, if so, for how long.
Some medicines can affect the levels of Lasca in the blood and make it less effective in
preventing pregnancy, or they can 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 HIV infections (for example ritonavir, nelfinavir, efavirenz) or fungal infections (for example griseofulvin) or 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 can lead to an increased frequency of seizures)
• theophylline (used to treat breathing problems)
• tizanidine (used to treat pain and/or muscle cramps).

Troleandomycin may increase the risk of cholestatic jaundice during co-administration 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 may cause increases in blood test results on liver function (increased ALT transaminases). Your doctor will prescribe you another type of contraceptive before starting treatment with these medicines. Taking Lasca can be restarted about 2 weeks after completion of this treatment. See the paragraph “Do not use Lasca”.

Ask your doctor or pharmacist for advice before taking any medicine.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any

other medicine.

Laboratory tests
If you are going to have a blood test, tell your doctor or the people working in the laboratory that you are
taking the pill, because oral contraceptives can affect the results of some tests.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

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

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

Driving and operating machinery
There is no information to suggest that the use of Lasca affects driving or
operating machinery.

Lasca contains lactose
If your doctor has told you that you have an intolerance to some 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 always exactly as described in this leaflet or as your doctor or pharmacist has told you. If you have doubts, ask 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) and follow the direction of the arrow shown on the blister.
Take the tablets every day at about the same time. You can take Lasca with or without food, if necessary with a small amount of water.
Take one tablet a day for 21 consecutive days. Start a new blister after an interval of 7 days without tablets; during this interval, a withdrawal bleed (a period) usually occurs. The withdrawal bleed, which is similar to a period, will start two or three days after you have taken the last tablet and may not have finished before the start of the new blister.
If you use Lasca in this way, you will be protected from pregnancy even during the 7 days when you do not take any tablets.

When you can start with 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 your period). If you start taking Lasca on the first day of your period, contraceptive protection starts immediately. You can also start between the second and fifth day of your cycle, but in this case you must use additional protective measures (for example, a condom) for the first 7 days.
• Switching from another combined hormonal contraceptive, from a vaginal ring or from a patchYou can start Lasca preferably the day after the last active tablet (the last tablet containing active ingredients) of your previous pill, but at the latest the day after the end of the tablet-free days of the previous pill (or the day after the last inactive tablet of the previous pill). When switching from a combined contraceptive ring or patch, follow your doctor's advice.
• Switching from a progestin-only method (progestin-only pill, injection, implant or a progestin-releasing intrauterine device - IUD).You can switch any day from the progestin-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 protective measures (for example, a condom) for the first 7 days of taking the tablet.
• After an abortion, spontaneous or inducedFollow your doctor's advice.
• After having a babyYou can start Lasca between 21 and 28 days after delivery. If you start taking it later than day 28, use a barrier contraceptive method (for example, a condom) during the first seven days of taking Lasca. If, after having a baby, you have had sexual intercourse before starting to take Lasca (or restarting it), make sure you are not pregnant or wait until your next menstrual period.
• If you are breastfeeding and want to start taking Lasca (or restart it) after having a babyRead the paragraph relating to “Breastfeeding”.

Ask your doctor what to do if you are not sure when to start.

If you take more Lasca than you should
There are no reports of serious harmful effects due to taking too many Lasca tablets. If you take several tablets at once, you may have 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, ask for advice from your doctor or pharmacist.

If you forget to take Lasca

• If you are less than 12 hourslate in taking a tablet, contraceptive protection is not reduced. Take the forgotten tablet as soon as you remember and then continue taking the tablets at the usual time.
• If you are more than 12 hourslate in taking a tablet, the contraceptive effect may be reduced. The more tablets you have forgotten, the greater the risk that contraceptive protection is reduced.

The risk of incomplete protection from pregnancy is greater if you forget to take a tablet at the beginning or end of the blister. Therefore, you must follow these rules (see also the diagram below):

• If you have forgotten more than one tablet in this blisterContact your doctor
• If you have forgotten a tablet between days 1-7 (first row)Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the tablets at the usual time and use additional precautionsfor the next 7 days, for example, a condom. If you had intercourse in the week before you forgot to take the tablet, you may be pregnant. In this case, contact your doctor.
• If you have forgotten a tablet between days 8-14 (second row)Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the tablets at the usual time. The contraceptive effect of this medicine is not reduced and you do not need to take further precautions.
• If you have forgotten a tablet between days 15-21 (third row)You can choose between two options:
• 1. Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the tablets at the usual time. Instead of starting the tablet-free interval, start the next blister. You are more likely to have a menstrual period at the end of the second blister, but you may have some light bleeding or spotting during the taking of the tablets

of the second blister.

• 2. You can also stop taking the tablets in the blister and immediately start the 7-day tablet-free interval (note the day on which you forgot the tablet). If you want to start a new blister on the day you usually do, shorten the tablet-free interval to less than 7 days.

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

• If you have forgotten any of the tablets in a blister, and you do not have any bleeding in the first days of the tablet-free interval, it is possible that you are pregnant. You should consult your doctor before starting the next blister. More than 1 tablet forgotten in 1 blister Ask your doctor for advice

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

What to do in case of severe vomiting or diarrhea
If you vomit within 3-4 hours of taking a tablet or if you have severe diarrhea, there is a risk that the active ingredients present in the pill have not been completely absorbed by the body. The situation is almost the same as when you forget a tablet. After vomiting or diarrhea, take another tablet from a reserve blister as soon as possible. If possible, take it within 12 hours of the usual time you take the pill. If this is not possible or if 12 hours have passed, you must follow the advice given in the section "If you forget to take Lasca”.

How to delay your period: what you need to know
Although it is not recommended, you can postpone your period by going directly to a new blister of Lasca and finishing it instead of having the tablet-free interval. You may have some light bleeding or spotting while using the tablets from this second blister. After the usual 7-day tablet-free interval, start the next blister.

You can ask your doctor for advice before deciding to delay your period.
How to change the first day of your period: what you need to know
If you take the tablets as instructed, your period will start during the tablet-free week. If you want to change this day, reduce the number of tablet-free days (but never increase it – 7 is the maximum!). For example, if the tablet-free interval usually starts on Friday, and you want to change it to Tuesday (3 days earlier), you must start a new blister 3 days earlier than usual. If you reduce the tablet-free interval significantly (for example, by 3 days or less) you may not have any bleeding during these days. You may then have some light bleeding or spotting.

If you are unsure how to proceed, consult your doctor.
If you stop taking Lasca
You can stop taking Lasca whenever you want. If you do not want to become pregnant, ask your doctor for advice on other reliable contraceptive methods. If you want to become pregnant, stop taking Lasca and wait for your next period before planning a pregnancy. You will be able to calculate your expected date of delivery more easily.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
A greater risk of developing blood clots in the veins (venous thromboembolism (VTE)) or
blood clots in the arteries (arterial thromboembolism (ATE)) is present 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):

• altered mood, 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 sexual interest
• migraine
• vomiting, diarrhea
• raised bumps or itchy skin
• swollen breasts
• fluid retention

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

• intolerance to contact lenses
• allergic reactions
• increased sexual interest
• vaginal or breast discharge
• red and painful nodules 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 who
use contraceptive pills (see section 2: What you need to know before taking Lasca?)

• venous or arterial blood clots
• increased blood pressure
• liver tumors or breast cancer
• liver function disorders
• harmful blood clots in a vein or an artery, for example: in a leg or foot (DVT) or in the lung (PE) or heart attack or stroke

or mini-stroke or temporary symptoms similar to those of a stroke, known as transient ischemic
attack (TIA) or blood clots in the liver, stomach/intestines, kidneys or eye.
The possibility 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 the
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 that
causes abdominal pain and mental disorders), systemic lupus erythematosus (a condition in which the body
attacks and damages its own organs and tissues), herpes in advanced pregnancy, Sydenham's chorea
(rapid involuntary or jerky movements), hemolytic uremic syndrome (a condition that
occurs after diarrhea caused by E. coli), liver problems that present with jaundice, gallbladder disorders or
formation of gallstones.
In women with hereditary exogenous angioedema (sudden swelling of the skin, mucous membranes, internal organs or the brain), the estrogens present in contraceptive pills
may induce or worsen the symptoms of angioedema.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through 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 which is stated on the package and blister after
“EXP”.
The expiry date refers to the last day of that month.
Levonorgestrel/Etinilestradiolo represents a risk to the aquatic environment. Do not dispose of any
medicine in 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 ingredients are 100 micrograms of levonorgestrel and 20 micrograms of ethinylestradiol.
Each tablet contains 100 micrograms of levonorgestrel and 20 micrograms of ethinylestradiol. The
other ingredients (excipients) are: anhydrous lactose, povidone K-30 (E1201), magnesium stearate (E470b)
and a coating system [polyvinyl alcohol, partially hydrolyzed (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 Lasca and package contents

• 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.
• The 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 Member States of the European Economic Area under the
following denominations:
Belgium:
Denmark:
France:
Italy:
Luxembourg
Levesialle 20 0.02 mg /0.10 mg film-coated tablets / comprimés pelliculés /
Filmtabletten
Mirabella
Asterluna 100 micrograms/20 micrograms, film-coated tablet
Lasca
:
Portugal:
Spain:
Levesialle 20 0.02 mg /0.10 mg comprimés pelliculés
Levesialle
Levesialle 0.10 mg/0.02 mg film-coated tablets EFG

Lasca, 100 micrograms / 20 micrograms, film-coated tablets
Levonorgestrel / Ethinylestradiol
Generic medicine

Read 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, talk to your doctor or pharmacist. See section 4.

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

• They are one of the most reliable reversible methods of contraception, if used correctly.
• They slightly increase the risk of blood clots forming in the veins and arteries, especially during the first month of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
• Pay attention and see 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 you take 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 active ingredients and are also called placebo tablets.
• Contraceptive pills that contain two hormones are called "combined pills". Lasca is called a “low dosage” contraceptive pill because it contains only a small amount of hormones.

2. Cosa deve sapere prima di prendere Lasca

Note generali
Prima di iniziare a usare Lasca deve leggere le informazioni sui coaguli sanguigni al paragrafo 2.
È particolarmente importante che legga i sintomi di un coagulo sanguigno (vedere paragrafo 2
“Coaguli sanguigni”).
Prima di iniziare a usare Lasca, il medico le farà alcune domande sulla storia medica personale e su
quella dei suoi parenti stretti. Il medico misurerà anche la sua pressione sanguigna, e, in base alla
sua situazione personale, potrà anche effettuare altri esami.
In questo foglio, sono descritte diverse situazioni in cui deve interrompere l'uso di Lasca, o laddove
l'affidabilità di Lasca può essere ridotta. In tali situazioni, non deve avere rapporti sessuali oppure
deve prendere delle precauzioni contraccettive non ormonali aggiuntive, ad esempio usare un
profilattico o un altro metodo barriera. Non usi metodi come il ritmo o la temperatura basale. Questi
metodi possono essere inaffidabili perché Lasca altera i cambiamenti mensili della temperatura
corporea e del muco cervicale.

Lasca, così come altri contraccettivi ormonali, non protegge dalle infezioni da HIV (AIDS) e da
altre malattie trasmesse sessualmente.
Mentre utilizza questo medicinale deve vedere regolarmente il suo medico, almeno due volte
all’anno.
Se ha sintomi inconsueti, come dolore inspiegabile al torace, all’addome o alle gambe, deve
immediatamente consultare il medico.

Non usi Lasca

• se ha (o ha mai avuto) un coagulo sanguigno in un vaso delle gambe (trombosi venosa profonda, TVP), dei polmoni (embolia polmonare, EP) o di altri organi;
• se ha, o ha mai avuto, un attacco cardiaco o un ictus;
• se sa di avere un disturbo che colpisce la coagulazione del sangue, come carenza di proteina C, carenza di proteina S, carenza di antitrombina-III, fattore V di Leiden o anticorpi antifosfolipidi;
• se deve sottoporsi a un’operazione o se starà coricata per un lungo periodo (vedere paragrafo “Coaguli sanguigni”);
• se ha (o ha mai avuto) una malattia che può essere indicatrice di un attacco cardiaco in futuro (per esempio angina pectoris, che causa un forte dolore al torace) o di un ictus (per esempio un attacco ischemico transitorio senza effetti residui)
• se ha una delle seguenti malattie che potrebbe aumentare il rischio che si formino coaguli

nelle arterie:
o diabete con lesione dei vasi sanguigni
o pressione arteriosa molto alta
o livello molto alto di grassi (colesterolo o trigliceridi) nel sangue
o una malattia nota come iperomocisteinemia

• se ha (o ha mai avuto) un certo tipo di emicrania (con cosiddetti sintomi neurologici focali)
• Non usi Lasca se ha l’epatite C e sta assumendo medicinali contenenti ombitasvir/paritaprevir/ritonavir e dasabuvir (vedere anche il paragrafo “Altri medicinali e Lasca”).
• se ha (o ha mai avuto) una infiammazione del pancreas (pancreatite)
• se ha (o ha mai avuto) una malattia del fegato e la funzionalità epatica non si è ancora normalizzata
• se ha (o ha mai avuto) un tumore del fegato
• se ha (o ha mai avuto) o se si sospetta che abbia un carcinoma mammario o un tumore degli organi genitali
• se ha qualsiasi inspiegabile sanguinamento dalla vagina
• se ha interrotto le mestruazioni, forse a causa di esercizio fisico o di una dieta
• se è allergica a levonorgestrel o etinilestradiolo, o ad uno qualsiasi degli altri componenti di questo medicinale (elencati al paragrafo 6).

Avvertenze e precauzioni
Si rivolga al medico o il farmacista prima di prendere Lasca

• se un parente stretto ha o ha avuto un carcinoma mammario;
• se ha una malattia del fegato o della cistifellea;
• se soffre di diabete;
• se soffre di depressione;
• se deve sottoporsi a un’operazione o se starà coricata per un lungo periodo (vedere paragrafo 2 “Coaguli sanguigni”).
• se ha appena partorito, il suo rischio di sviluppare coaguli sanguigni è maggiore. Chieda al medico quanto tempo dopo il parto può iniziare a prendere Lasca;
• se ha un’infiammazione alle vene poste sotto la pelle (tromboflebite superficiale);
• se ha le vene varicose;
• se ha il morbo di Crohn o una malattia infiammatoria dell’intestino (colite ulcerosa)
• se ha una malattia del sangue chiamata SEU (sindrome emolitica uremica) che causa danni ai reni
• se ha una malattia del sangue chiamata anemia falciforme
• se soffre di epilessia (vedere il paragrafo “Altri medicinali e Lasca”)
• se ha una malattia del sistema immunitario chiamata LES (lupus eritematoso sistemico)
• se ha una malattia che è comparsa per la prima volta durante la gravidanza o un precedente uso di ormoni sessuali (per esempio, perdita dell'udito, una malattia ematica chiamata porfiria, eruzione cutanea con vesciche durante la gravidanza (herpes gestazionale), una malattia del sistema nervoso che causa movimenti improvvisi del corpo

(corea di Sydenham))

• se ha o ha avuto cloasma (una colorazione della pelle, in particolare sul viso o sul collo, nota come "macchie della gravidanza"). In tal caso, eviti la luce solare diretta o la luce ultravioletta
• se soffre di angioedema ereditario, i prodotti contenenti estrogeni possono causarne o peggiorarne i sintomi. Deve rivolgersi immediatamente al medico se manifesta sintomi di angioedema come viso, lingua e/o gola gonfi e/o difficoltà a deglutire o orticaria insieme a difficoltà respiratorie.

Quando deve rivolgersi a un medico?
Si rivolga urgentemente a un medico

• se osserva segni possibili di un coagulo sanguigno che possono indicare che soffre di un coagulo sanguigno nella gamba (cioè, trombosi venosa profonda), di un coagulo sanguigno nel polmone (cioè, embolia polmonare), di un attacco cardiaco o di un ictus (vedere il paragrafo seguente "Coaguli sanguigni”-trombosi).

Per una descrizione dei sintomi di questi gravi effetti indesiderati vada al paragrafo “Come
riconoscere un coagulo sanguigno”.

COAGULI SANGUIGNI
L’uso di un contraccettivo ormonale combinato come Lasca causa un aumento del rischio di
sviluppare un coagulo sanguigno rispetto al non utilizzo. In rari casi un coagulo sanguigno può
bloccare i vasi sanguigni e causare problemi gravi.
I coaguli sanguigni possono svilupparsi

• nelle vene (condizione chiamata “trombosi venosa”, "tromboembolia venosa” o TEV)
• nelle arterie (condizione chiamata “trombosi arteriosa”, “tromboembolia arteriosa” o TEA). La guarigione dai coaguli sanguigni non è sempre completa. Raramente, si possono verificare effetti gravi di lunga durata o, molto raramente, tali effetti possono essere fatali. È importante ricordare che il rischio globale di un coagulo sanguigno dannoso associato a Lascaè basso.

COME RICONOSCERE UN COAGULO SANGUIGNO
Si rivolga immediatamente a un medico se nota uno qualsiasi dei seguenti segni o sintomi.
Presenta uno di questi segni?
Di cosa soffre
probabilmente?
Gonfiore a una gamba o lungo una vena della gamba o del piede,
specialmente se accompagnato da:

• dolore o sensibilità alla gamba che può essere avvertito solo in piedi Trombosi venosa o camminando profonda
• maggiore sensazione di calore nella gamba colpita
• variazione del colore della pelle della gamba, come pallore,

COAGULI SANGUIGNI IN UNA VENA
Cosa può accadere se si forma un coagulo sanguigno in una vena?

• L’uso di contraccettivi ormonali combinati è stato correlato a un aumento del rischio di formazione di coaguli sanguigni nelle vene (trombosi venosa). Questi effetti collaterali, però, sono rari. Nella maggior parte dei casi essi si verificano nel primo anno di utilizzo di un contraccettivo ormonale combinato.
• Se un coagulo sanguigno si forma in una vena della gamba o del piede, può causare una trombosi venosa profonda (TVP).
• Se un coagulo sanguigno si sposta dalla gamba e si colloca nel polmone, può causare un’embolia polmonare.
• Molto raramente il coagulo può formarsi in un altro organo come l’occhio (trombosi della vena retinica).

Quando è massimo il rischio di sviluppare un coagulo sanguigno in una vena?
Il rischio di sviluppare un coagulo sanguigno in una vena è massimo durante il primo anno in cui si
assume per la prima volta un contraccettivo ormonale combinato. Il rischio può essere anche
superiore se si ricomincia ad assumere un contraccettivo ormonale combinato (lo stesso farmaco o
un farmaco diverso) dopo una pausa di 4 o più settimane.
Dopo il primo anno, il rischio si riduce ma è sempre leggermente superiore che se non si stesse
utilizzando un contraccettivo ormonale combinato.
Quando interrompe l’assunzione di Lasca il rischio di sviluppare un coagulo sanguigno torna ai livelli
normali entro poche settimane.

Qual è il rischio di sviluppare un coagulo sanguigno?
Il rischio dipende dal suo rischio naturale di TEV e dal tipo di contraccettivo ormonale combinato che
sta assumendo.
Il rischio globale di sviluppare un coagulo sanguigno nella gamba o nel polmone (TVP o EP) con Lasca
è basso.

• Su 10.000 donne che non usano alcun contraccettivo ormonale combinato e che non sono in gravidanza, circa 2 svilupperanno un coagulo sanguigno in un anno.
• Su 10.000 donne che usano un contraccettivo ormonale combinato contenente levonorgestrel, noretisterone o norgestimato, circa 5-7 svilupperanno un coagulo sanguigno in un anno.
• Il rischio che si formi un coagulo sanguigno dipende dalla sua anamnesi medica (vedere più avanti “Fattori che aumentano il rischio di sviluppare di un coagulo sanguigno”).

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 some conditions cause an
increase. Your risk is higher:

• if you are strongly overweight (body mass index or BMI greater than 30kg/m );
• if a close relative of yours has had a blood clot in a leg, in the lung or in another organ at a young age (for example, under about 50 years). In this case you may have an inherited blood clotting disorder;
• if you have to undergo surgery or if you have to stay bedridden for a long period due to an injury or illness or if you have a leg in a cast. It may be necessary to stop taking Lasca a few weeks before surgery or during the period when you are less mobile. 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 more than 4 hours) can temporarily increase the risk of a blood clot forming, 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 your case, even if you are not sure. The 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 for no known reason or if you gain a lot of 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 a 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 can increase:

• as you get older (over 35 years);
• if you smoke.When you use a combined hormonal contraceptive like Lasca it is advisable to quit smoking. If you cannot quit smoking and you are over 35 years old, your doctor may advise you to use a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative of yours has had a heart attack or a stroke at a young age (under about 50 years). In this case you may also be at high risk of heart attack or stroke;

• if you, or a close relative, have a high level of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have any heart problems (valve 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 serious, 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 to
smoke, if a close relative develops thrombosis for no known reason or if you gain a lot of
weight, contact your doctor.

Lasca and cancer
Breast cancer has been observed with a slightly higher frequency in women who use
combined pills, but it is not known whether this is caused by the treatment. For example, it is possible
that more tumors are detected in women who take combined pills because they have more frequent
medical examinations.
The occurrence of breast tumors gradually decreases after stopping combined hormonal
contraceptives. It is important that you check your breasts regularly and must see your doctor if you feel
any lump.
In rare cases, benign liver tumors have been reported, and in even rarer cases malignant tumors to the
liver, in women who use 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 the human papillomavirus (HPV), contribute to
this.

Psychiatric disorders
Some women who use hormonal contraceptives including Lasca have reported depression or depressed mood. Depression can be severe and sometimes can lead to suicidal thoughts. If you experience
mood changes and depressive symptoms, see your doctor as soon as possible for further
medical advice.
Breakthrough bleeding
During the first few months of taking Lasca you may have unexpected bleeding
(bleeding outside the placebo pill week). If this bleeding lasts
for more than a few months, or if it starts after a few months, your doctor will need to investigate the cause.

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

Other medicines and Lasca
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. They can tell you whether to take any additional contraceptive precautions (for
example condoms) and, if so, for how long.
Some medicines can affect the levels of Lasca in the blood and make it less effective in
preventing pregnancy, or they can 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 ciclosporin
• the antiepileptic lamotrigine (this can lead to an increased frequency of seizures)
• theophylline (used to treat breathing problems)
• tizanidine (used to treat pain and/or muscle cramps).

Troleandomycin may increase the risk of cholestatic jaundice during concomitant administration 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 may cause increases in blood test results on liver function (increased ALT transaminases). Your doctor will prescribe you another type of contraceptive before starting treatment with these medicines. Taking Lasca can be restarted about 2 weeks after completing this treatment. See the paragraph “Do not use Lasca”.

Ask your doctor or pharmacist for advice before taking any medicine.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any

other medicine.

Laboratory tests
If you are going to have a blood test, tell your doctor or the people working in the laboratory that you
are taking the pill, because oral contraceptives can affect the results of some tests.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

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

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

Drivingandoperatingmachinery
There is no information to suggest that the use of Lasca affects driving or
operating machinery.

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

3. How to take Lasca

Take this medicine always exactly as your doctor or pharmacist has told you. If
you have doubts, consult your doctor or pharmacist.
If you were taking another contraceptive before starting Lasca, 28 tablets, you know that most
contraceptives contain 21 tablets. With these contraceptives you take one tablet for
21 days and then there is a week without taking tablets (tablet-free interval).
The system to follow when using Lasca, 28 tablets, is different. After taking the 21 pink
tablets, you must continue and take the 7 placebo tablets; therefore, there is no tablet-free
interval, but a week of "placebo" (the week in which you take the placebo tablets in the
fourth row). Because you have to take one tablet every day and there is no tablet-free interval
between two packs, taking the tablets becomes a habit and there is therefore less risk of
forgetting to take a tablet.
The two different types of colored tablets of Lasca, 28 tablets, are arranged in order. One
pack contains 28 tablets.
Take one Lasca tablet every day. You can 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 pinktablet once a day for the first 21 days and
then one whitetablet once a day for the last 7 days. Immediately start a new blister
(21 pinktablets and then 7 whitetablets). Therefore, there is no tablet-free interval
between the two blisters.
Due to the different composition of the tablets, it is necessary to start with the first tablet at the
top left (near the “START” label) and take one tablet every day. For the correct sequence,
follow the direction of the arrows on the blister.
To help you remember to take the tablet, each pack of Lasca, for each blister,
provides a sticker containing 7 weekly stickers, each with the days of the week printed on it.
Choose the weekly sticker that starts on the day you start taking the tablets. For
example, if you start on Wednesday, use the weekly sticker that starts with “WED”.
Apply the weekly sticker along the top of the blister where it says “Apply weekly label here”.
Now there is a day indicated above each tablet and you can see if you have already taken a certain tablet.
The arrows indicate the order in which you must take the tablets.
During the 7 days in which you take the whiteplacebo tablets (the placebo days), you should start
bleeding (the so-called withdrawal bleeding). This normally starts on the second or
third day after taking the last pinkactive tablet. After taking the last

whitetablet, you must start the next blister, whether the bleeding has ended or continues.
This means that you must start each blister on the same day of the weekand that the withdrawal
bleeding must start on the same day each month.
If you use Lasca in this way, you will be protected from pregnancy even during the 7 days in which you take the
whiteplacebo tablets.

When you can start with the first blister

• If you have not used a hormone-containing contraceptive in the previous month.Start taking Lasca on the first day of your cycle (i.e. the first day of your period). If you start taking Lasca on the first day of your period, contraceptive protection starts

immediately. You can also start between the second and fifth day of your cycle, but in this
case you must use additional protective measures (for example, a condom) for the first 7 days.

• Switching from another combined hormonal contraceptive, from a vaginal ring or from apatchYou can start Lasca preferably the day after the last active tablet (the last tablet containing active ingredients) of your previous pill, but at the latest the day after the end of the tablet-free days of the previous pill (or the day after the last placebo tablet, the last tablet without active ingredient of the previous pill). When switching from a combined contraceptive ring or patch, follow your doctor's advice.
• Switching from a progestin-only method (progestin-only pill, injection, implantor a progestin-releasing intrauterine device - IUD).You can switch any day from the progestin-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 protective measures (for example, a condom) for the first 7 days of taking the tablet.
• After an abortion, spontaneous or inducedFollow your doctor’s advice.
• After having a babyYou can start Lasca between 21 and 28 days after delivery. If you start taking it later than day 28, use a barrier method of contraception (for example, a condom) for the first seven days of taking Lasca. If, after having a baby, you have had sexual intercourse before starting to take Lasca (or restarting it), make sure you are not pregnant or wait until your next menstrual period.
• If you are breastfeeding and want to start taking Lasca (or restarting it) after having ababyRead the paragraph relating to “Breast-feeding”.

Ask your doctor what to do if you are not sure when to start.

If you take more Lasca than you should
There are no reports of serious harmful effects due to taking too many Lasca tablets. If
you take several tablets at the same time, you may have 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, ask
for advice from your doctor or pharmacist.

If you forget to take Lasca
The tablets in the fourthrow of the blister are the placebo tablets. If you forget to take one
of these tablets, this does not affect the reliability of Lasca. Throw away the forgotten placebo
tablet.
If you forget to take a pink active tablet (tablets in the first, second or third row),
you must behave as follows:

• If you are less than 12 hourslate in taking a tablet, protection against pregnancy is not reduced. Take the forgotten tablet as soon as possible and then continue taking the tablets at the usual time.
• If you are more than 12 hourslate in taking a tablet, the contraceptive effect may be reduced. The more tablets you have forgotten, the greater the risk that protection against pregnancy is reduced. The risk of incomplete protection against pregnancy is greater if you forget to take a pink tablet at the beginning (first row) or at the end (third row) of the blister. Therefore, you must follow the following rules (see also the diagram below):
• If you have forgotten more than one tablet in this blisterContact your doctor
• If you have forgotten a tablet between days 1-7 (first row)Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at the usual time and use additional precautionsfor the next 7 days, for example a condom. If you have had intercourse in the week before you forgot to take the tablet, you should be aware that there is a risk of pregnancy. In this case contact your doctor.
• If you have forgotten a tablet between days 8-14 (second row)Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at the usual time. The contraceptive effect of this medicine is not reduced and you do not need to take further precautions.
• If you have forgotten a tablet between days 15-21 (third row)You can choose between two possibilities:
• 1. Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at the usual time. Instead of taking the white placebo tablets of this blister, throw them away and start the next blister (the starting day will be different). You are more likely to have a menstrual period at the end of the second blister - during the taking of the white placebo tablets - but you may have some light bleeding or menstruation-like bleeding during the taking of the tablets of the second blister.

• 2. You can also stop taking the pink active tablets in the blister and immediately start taking the white placebo tablets (before taking theplacebo tablets, note the day you forgot the tablet). Then continue with the next blister. If you want to start a new blister on the day you usually start, reduce the period of the placebo tablets to less than 7 days.

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

• If you have forgotten any of the tablets in a blister, and you do not have bleeding in the first days of placebo, it is possible that you are pregnant. You must see your doctor before starting the next blister. More than 1 pink tablet forgotten in 1 blister Ask your doctor

Yes
Have you had sexual intercourse in the week
before, before forgetting?
No
Take the forgotten tablet
Use a barrier method (condom) for the 7
following days, and finish the blister
Only 1 pink tablet
forgotten
(taken more than 12 hours after)
Take the forgotten tablet
Finish taking the tablets
Take the forgotten tablet and
Finish taking the pink tablets
Throw away 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 severe vomiting or diarrhea
If you vomit within 3-4 hours of taking a pink active tablet or if you have severe diarrhea, there is a
risk that the active ingredients present in the pill have not been completely absorbed
by the body. The situation is almost the same as when you forget a tablet. After vomiting or
diarrhea, you must take another pink tablet from a reserve blister as soon as possible. If
possible, take it within 12 hours of the usual time you take the pill. If this is not possible or if
12 hours have passed, you must follow the advice given in the paragraph "If you forget to take Lasca”.

How to delay your period: what you need to know
Although it is not recommended, you can postpone your period by not taking the
white placebo tablets and going directly to a new pack of Lasca and finishing it. It is possible that
you have some light bleeding or menstruation-like bleeding while using the tablets of this
second pack. Finish this second pack by taking the 7 white tablets from the fourth row.
Then start a new pack.

You can ask your doctor for advice before deciding to delay your period.
How to change the first day of your menstrual period: what you need to know
If you take the tablets following the instructions, your menstrual period will start during the days in which
you take the placebo tablets. If you want to change this day, reduce the number of days in which
you take the placebo tablets – while taking the white placebo tablets – (but never increase
them – 7 is the maximum!). For example, if you start the placebo tablets on Friday, and you want to change
this to Tuesday (3 days earlier), you must start a new pack 3 days earlier than usual. It is possible
that you have no bleeding during these days. It is possible that you then have some
light bleeding or menstruation-like bleeding.

If you are not sure how to proceed, consult your doctor.
If you stop taking Lasca
You can stop taking Lasca whenever you want. If you do not want to become pregnant, ask your doctor
for advice on other reliable methods of contraception. If you want to become pregnant, stop
taking Lasca and wait for your next menstrual period before planning a pregnancy. You will be able to
calculate the expected date of delivery more easily.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
An increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or
blood clots in the arteries (arterial thromboembolism (ATE)) is present 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):

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

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

• decreased sexual interest
• migraine
• vomiting, diarrhea
• raised, itchy bumps on the skin
• swollen breasts
• fluid retention

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

• intolerance to contact lenses
• allergic reactions
• increased sexual interest
• vaginal or breast discharge
• red and painful nodules on the skin (erythema nodosum)
• rash with redness or blisters with target-shaped lesions (erythema multiforme)
• weight loss

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

• venous or arterial blood clots
• increased blood pressure
• liver tumors or breast cancer
• liver function disorders
• harmful blood clots in a vein or artery, for example: in a leg or foot (DVT) or in the lung (PE)

or heart attack
or stroke
or mini-stroke or temporary stroke-like symptoms, known as a transient ischemic
attack (TIA) or blood clots in the liver, stomach/intestine, kidneys or eye.
The possibility 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
the 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 that
causes abdominal pain and mental disorders), systemic lupus erythematosus (a condition in which the body
attacks and damages its own organs and tissues), herpes in advanced pregnancy, Sydenham’s chorea
(rapid involuntary or jerky movements), hemolytic uremic syndrome (a condition that
occurs after diarrhea caused by E. coli), liver problems that present with jaundice, gallbladder disorders or
gallstone formation.
In women with hereditary exogenous angioedema (sudden swelling of the skin, mucous membranes,
internal organs or brain), the estrogens in contraceptive pills
may induce or worsen the symptoms of angioedema.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through 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 which is stated on the box and blister after
“EXP”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Levonorgestrel/Etinilestradiolo poses a risk to the aquatic environment. Do not dispose of any
medicine in 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 ingredients are 100 micrograms of levonorgestrel and 20 micrograms of ethinylestradiol.
Lasca has 2-color tablets:

• Each pink tablet contains 100 micrograms of levonorgestrel and 20 micrograms of ethinylestradiol. The other ingredients (excipients) are: anhydrous lactose, povidone K-30 (E1201), magnesium stearate (E470b) and a pink film 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)].
• Each white tablet (inactive tablet or placebo tablet) contains only other ingredients (excipients, therefore no active ingredient) which are: anhydrous lactose, povidone K-30 (E1201), magnesium stearate (E470b) and a white film coating system [partially hydrolysed polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), macrogol 3350].

Description of the appearance of Lasca and package contents
The active tablets are pink and round, with a diameter of approximately 5.7 mm.
The placebo tablets are white and round, with a diameter of approximately 5.7 mm.
Each blister contains 21 light 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 with the
following denominations:
Belgium:
Denmark:
Finland:
France:
Italy:
Luxembourg
:
Norway:
Portugal:
Spain:
Sweden:
Germany:
Levesialle Continu 20 0.02 mg/0.10 mg film-coated tablets / comprimés pelliculés /
Filmtabletten
Mirabella 28
Mirabella 100 micrograms/20 micrograms film-coated tablets
Asterluna Continu 100 micrograms/20 micrograms, film-coated tablet
Lasca
Levesialle Continu 20 0.02 mg/0.10 mg comprimés pelliculés
Mirabella
Levesialle 28
Levesialle Diario 0.10 mg/0.02 mg film-coated tablets EFG
Levesia
Asumate 20 /21+7 0.10 mg/ 0.02 mg Filmtabletten