LESTRONETTE 0.10 MG/0.02 MG Фильм-coated таблетки

Содержание инструкции

1. Lestronette 0.10 mg + 0.02 mg film-coated tablets
   1. Cos’è Lestronette e a cosa serve
   2. Cosa deve sapere prima di prendere Lestronette
   3. How to take Lestronette
   4. Possible side effects
   5. How to store Lestronette
   6. Contents of the pack and other information

Lestronette 0.10 mg + 0.02 mg film-coated tablets

levonorgestrel/ethinylestradiol
Generic medicine

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

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

• They are one of the most reliable reversible 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 have symptoms of a blood clot (see section 2 “Blood clots”)

Contents of this leaflet

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

1. Cos’è Lestronette e a cosa serve

• Lestronette è una pillola contraccettiva ed è utilizzata per evitare la gravidanza.
• Ciascuna compressa contiene un piccolo quantitativo di due diversi ormoni femminili, denominati levonorgestrel ed etinilestradiolo.
• Le pillole contraccettive contenenti due ormoni sono dette “pillole combinate”. Lestronette è chiamata pillola contraccettiva a “basso dosaggio” perché contiene solo una piccola quantità di ormoni.

2. Cosa deve sapere prima di prendere Lestronette

Note generali
Prima di iniziare ad usare Lestronette 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 prendere Lestronette, il suo medico le farà alcune domande relative al suo stato di
salute ed allo stato di salute dei suoi parenti più stretti. Il medico le misurerà inoltre la pressione sanguigna
e, in base alla sua personale situazione, le potrà anche prescrivere ulteriori analisi.
Lestronette o nelle quali può verificarsi una riduzione dell’efficacia di Lestronette. In queste situazioni
non deve avere rapporti sessuali o deve adottare precauzioni contraccettive aggiuntive non ormonali, quali
l’uso del profilattico o di altro metodo di barriera. Non usare i metodi del ritmo o della temperatura basale.
Questi metodi possono risultare non affidabili poiché Lestronette altera le normali modificazioni della
temperatura e del muco cervicale che si verificano durante il ciclo mestruale.

Lestronette, come gli altri contraccettivi ormonali, non protegge nei confronti dell’infezione da HIV
(AIDS) né di altre malattie a trasmissione sessuale.
Quando non deve usare Lestronette
Non deve usare Lestronette se presenta una delle condizioni elencate di seguito. Se soffre di una qualsiasi
delle condizioni elencate di seguito, deve informare il medico. Il medico discuterà con lei degli altri metodi
di controllo delle nascite che potrebbero essere più adatti al suo caso.

Non prenda Lestronette

• se è allergica a levonorgestrel, a etinilestradiolo o ad uno qualsiasi degli altri componenti di questo medicinale (elencati al paragrafo 6). Questa condizione può causare prurito, eruzione cutanea o gonfiore;
• se ha, o ha mai avuto, un coagulo di sangue in un vaso sanguigno delle gambe (trombosi venosa profonda, TVP), dei polmoni (embolo polmonare, EP) o in altri organi;
• se sa di avere un disturbo che colpisce la coagulazione del sangue, ad esempio: 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 deve restare coricata per un lungo periodo (vedere paragrafo 2 “Coaguli sanguigni”);
• se ha, o ha mai avuto, un attacco di cuore o un ictus;
• se ha, o ha mai avuto, angina pectoris (una condizione che può causare forte dolore al petto e può essere un primo segno di un attacco cardiaco) o un attacco ischemico transitorio (TIA - sintomi di ictus temporaneo);
• se ha una delle seguenti malattie che potrebbe aumentare il rischio che si formino coaguli nelle arterie:
• diabete grave con lesione dei vasi sanguigni;
• pressione sanguigna molto alta;
• livelli molto elevati di grassi nel sangue (colesterolo e trigliceridi);
• una malattia nota come iperomocisteinemia;
• se soffre o ha mai sofferto di un tipo di emicrania chiamata “emicrania con aura”;
• se soffre o ha mai sofferto di malattia epatica grave e i suoi valori di funzionalità epatica non sono ancora nella norma;
• se soffre o ha mai sofferto di tumori del fegato;
• se ha, ha mai avuto, o si sospetta abbia un cancro alla mammella o agli organi genitali;
• se presenta sanguinamento vaginale di origine sconosciuta;
• se ha smesso di avere le mestruazioni, probabilmente a causa dell'esercizio fisico o della dieta
• se ha l’epatite C e sta assumendo medicinali contenenti ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir o sofosbuvir/velpatasvir/voxilaprevir (vedere anche il paragrafo “Altri medicinali e Lestronette”).

Informazioni aggiuntive su popolazioni speciali

Uso nei bambini
Lestronette non è destinato all'uso nelle donne il cui ciclo mestruale non è ancora iniziato.

Uso nelle donne anziane
Lestronette non è destinato all'uso dopo la menopausa.

Donne con compromissione epatica
Non assuma Lestronette se soffre di malattie epatiche. Vedere anche i paragrafi "Quando non si deve usare
Lestronette" e "Avvertenze e precauzioni".

Donne con compromissione renale
Si rivolga al medico. I dati disponibili non suggeriscono la necessità di modificare l'uso di Lestronette.

Avvertenze e precauzioni
Quando deve rivolgersi ad un medico?
Si rivolga urgentemente ad un medico

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

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

Informi il medico se una qualsiasi delle seguenti condizioni si applica al suo caso.
Consulti il medico prima di prendere Lestronette. In alcune situazioni è necessario che Lei presti particolare
attenzione quando fa uso di Lestronette o di altre pillole combinate. Può essere necessario che il suo medico
la sottoponga a regolari controlli.
Se questa condizione compare o peggiora mentre sta prendendo Lestronette, deve informare il medico:

• Se un familiare di primo grado ha avuto cancro della mammella.
• Se soffre di malattia del fegato o della colescisti.
• Se soffre di diabete.
• Se soffre di depressione.
• Se ha il morbo di Crohn o colite ulcerosa (malattia infiammatoria cronica dell’intestino).
• Se soffre di lupus eritematoso sistemico (LES, una malattia che colpisce il suo sistema immunitario naturale)
• Se soffre di sindrome uremico-emolitica (SUE, un disturbo della coagulazione del sangue che provoca insufficienza renale).
• Se soffre di anemia falciforme (una malattia ereditaria che colpisce i globuli rossi).
• Se ha livelli elevati di grassi nel sangue (ipertrigliceridemia) o un'anamnesi familiare positiva per tale condizione. L’ipertrigliceridemia è stata associata a un maggior rischio di sviluppare pancreatiti (infiammazioni del pancreas).
• Se deve sottoporsi a un’operazione o se deve restare 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 Lestronette.
• Se ha un’infiammazione alle vene poste sotto la pelle (tromboflebite superficiale). Se ha le vene varicose.
• Se soffre di epilessia (veda “Altri medicinali e Lestronette”).
• Se presenta disturbi che sono comparsi la prima volta durante la gravidanza o durante il trattamento con ormoni sessuali (per esempio la perdita dei capelli, una malattia del sangue chiamata porfiria,

un’eruzione cutanea con vesciche che si presenta nel corso della gravidanza (herpes gestazionale) o una
malattia dei nervi che causa improvvisi movimenti del corpo (corea di Sydenham).

• Se ha sofferto di pigmentazione della pelle a chiazze bruno-giallognole (cloasma), chiamate macchie gravidiche, specialmente sul viso. In tal caso eviti l’esposizione diretta alla luce del sole o ai raggi ultravioletti.
• Se nota sintomi di angioedema come gonfiore del viso, della lingua e/o della faringe, e/o difficoltà a deglutire o orticaria con difficoltà di respirazione, contatti immediatamente un medico. I prodotti contenenti estrogeni possono causare o peggiorare i sintomi dell’angioedema ereditario o acquisito.

COAGULI SANGUIGNI
L’uso di un contraccettivo ormonale combinato come Lestronette causa, rispetto al non utilizzo, un aumento
del rischio di sviluppare un coagulo sanguigno. 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 Lestronette è 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: Trombosi venosa profonda
• dolore o sensibilità alla gamba che può essere avvertito solo in piedi 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 inspiegata;
• tosse improvvisa senza una causa evidente, con possibile emissione di sangue;
• dolore acuto al torace che può aumentare quando si respira profondamente;
• stordimento grave o capogiri;
• battito cardiaco accelerato o irregolare;
• forte dolore allo stomaco Embolia polmonare

Se non è sicura, informi il medico in quanto alcuni di questi
sintomi come la tosse o la mancanza di respiro possono essere
scambiati per una condizione più lieve come un’infezione delle
vie respiratorie (ad es. un “comune raffreddore”).
Sintomi che si verificano più frequentemente in un occhio:
Trombosi della vena retinica

• perdita immediata della vista o
• offuscamento indolore della vista che può progredire a perdita della vista (coagulo sanguigno nell’occhio)
• dolore, fastidio, sensazione di pressione o di pesantezza al torace
• sensazione di schiacciamento o di pienezza al torace, a un braccio o sotto lo sterno;
• sensazione di pienezza, indigestione o soffocamento;
• fastidio alla parte superiore del corpo, che si irradia a schiena, mascella, gola, braccia e stomaco;
• sudorazione, nausea, vomito o capogiri;
• estrema debolezza, ansia o mancanza di respiro;
• battiti cardiaci accelerati o irregolari Attacco cardiaco
• intorpidimento o debolezza improvvisa del viso, di un braccio o di una gamba, soprattutto su un lato del corpo;
• improvvisa confusione, difficoltà a parlare o a comprendere;
• improvvisa difficoltà a vedere con uno o con entrambi gli occhi;
• improvvisa difficoltà a camminare, capogiri, perdita dell’equilibrio o della coordinazione;
• improvvisa emicrania, grave o prolungata, senza causa nota;
• perdita di conoscenza o svenimento con o senza convulsioni.

Talvolta i sintomi di ictus possono essere brevi, con un recupero
quasi immediato e completo, ma deve comunque rivolgersi
urgentemente a un medico in quanto potrebbe essere a rischio di
un altro ictus.
Ictus

• gonfiore e colorazione blu pallida di un’estremità;
• forte dolore allo stomaco (addome acuto) Coaguli sanguigni che bloccano altri vasi sanguigni

COAGULI DI SANGUE IN UNA VENA
Cosa può succedere se si forma un coagulo di sangue in una vena?

• L'uso di contraccettivi ormonali combinati è stato collegato a un aumento del rischio di formazione di coaguli di sangue nelle vene (trombosi venosa). Tuttavia, questi effetti collaterali sono rari. Più frequentemente, si verificano nel primo anno di utilizzo di un contraccettivo ormonale combinato.
• Se un coagulo di sangue si forma in una vena della gamba o del piede, può causare una trombosi venosa profonda (TVP).
• Se un coagulo di sangue si sposta dalla gamba e si deposita nel polmone, può causare un'embolia polmonare.
• Molto raramente, un coagulo può formarsi in una vena di un altro organo come l'occhio (trombosi venosa retinica).

Quando è più alto il rischio di sviluppare un coagulo di sangue in una vena?
Il rischio di sviluppare un coagulo di sangue in una vena è più alto durante il primo anno di assunzione di un
contraccettivo ormonale combinato per la prima volta. Il rischio può essere anche più alto se si riprende ad
assumere un contraccettivo ormonale combinato (lo stesso prodotto o un prodotto diverso) dopo una pausa di
4 settimane o più.
Dopo il primo anno, il rischio si riduce, ma è sempre leggermente più alto rispetto a quando non si utilizza un
contraccettivo ormonale combinato.
Quando si interrompe l'assunzione di Lestronette, il rischio di sviluppare un coagulo di sangue torna alla
normalità entro poche settimane.

What is the risk of developing a blood clot?
The risk depends on your natural risk of 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
Lestronette is low.

• Out of 10,000 women who do not use any combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive containing levonorgestrel like Lestronette, about 5-7 will develop a blood clot in a year.
• The risk of having a blood clot will vary depending on your personal medical history (see "Factors that increase the risk of a blood clot" below).

Factors that increase the risk of a blood clot in a vein
The risk of a blood clot with Lestronette is low, but some conditions increase it.
The risk is higher:

• if you are very overweight (body mass index or BMI greater than 30 kg/m)
• if a close family member has had a blood clot in the leg, lung or another organ at a young age (e.g. before the age of 50). In this case you may have an inherited blood clotting disorder
• if you need to have surgery, or if you are inactive for a long period due to an injury or illness, or if you have a leg in a cast. The use of Lestronette may need to be stopped several weeks before surgery or while you are less mobile. If you need to stop using Lestronette, ask your doctor when you can start using it again
• as you get older (especially after the age of 35)
• if you have given birth less than a few weeks ago.

The risk of developing a blood clot increases the more conditions you have.
Air travel (>4 hours) can temporarily increase the risk of a blood clot, especially
if you have some of the other factors listed.
It is important to tell your doctor if any of these conditions apply to you, even if you are not sure.
Your doctor may decide that Lestronette should be stopped.
If any of the above conditions change while you are using Lestronette, for example, a close relative
develops thrombosis for no known reason; or you gain a lot of weight, tell your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like a blood clot in a vein, a clot in an artery can cause serious problems.
For example, it can cause a heart attack or stroke.

Factors that increase the risk of a blood clot in an artery
It is important to note that the risk of a heart attack or stroke resulting from the use of Lestronette is very low, but
it can increase:

• with increasing age (over 35)
• if you smoke. When using a combined hormonal contraceptive like Lestronette, it is recommended to quit smoking. If you cannot quit smoking and you are over 35, your doctor may advise you to use a different type of contraception
• if you are overweight
• if you have high blood pressure
• if a close family member has had a heart attack or stroke at a young age (under about 50). In this case you may also be at higher risk of having a heart attack or stroke
• if you or a close family member have high levels of fats in the blood (cholesterol or triglycerides)
• if you suffer from migraine, especially migraine with aura
• if you have a heart problem (valve disorder, 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 increase even further.
If any of the above conditions change while you are using Lestronette, for example, if you start to
smoke, if a close relative develops thrombosis for no known reason; or you gain a lot of weight, tell your
doctor.

Lestronette and cancer

• Cervical cancer has been reported in women who use contraceptives for a long time, but it is not clear whether this is caused by sexual behavior or other factors such as the human papillomavirus (HPV).
• Breast cancer is diagnosed slightly more frequently in women who use combined pills, but it is not known whether this is due to the treatment. The risk of developing breast cancer decreases after stopping the pills. It is important that you check your breasts regularly and contact your doctor if you notice any lumps.
• Benign (non-cancerous) liver tumors are rare, and malignant (cancerous) liver tumors are even more rarely reported in users of combined pills. Contact your doctor if you have unusually severe stomach pain.

Psychiatric disorders
Some women using hormonal contraceptives including Lestronette 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 periods
During the first few months of taking Lestronette, you may experience unexpected bleeding
(bleeding outside of the pill-free days). If this bleeding occurs for more than three months,
or if it restarts after a few months, your doctor needs to find out what is wrong.

What to do if you do not have bleeding on the pill-free days
If you have taken the pills correctly, you have not had vomiting or severe diarrhea and you have not taken any other
medicines, it is very unlikely that you are pregnant. However, if the expected bleeding does not occur for
two consecutive times, you may be pregnant. Contact your doctor immediately as a pregnancy must be
excluded before continuing the pill. Start the next blister only if you are certain you are not
pregnant.

Other medicines and Lestronette
Tell your doctor if you are taking, have recently taken or might take any other medicines
Also tell any other doctors or dentists who may prescribe you other medicines (or the pharmacist) that
you are taking Lestronette. This way they can tell you whether and for how long you need to use additional contraceptive methods (for example, a condom).

• Some medicines can
• have an influence on the levels of Lestronette in your blood
• reduce its effectiveness in preventing pregnancy or
• cause unexpected bleeding.

These include:
medicines used for the treatment of:

• Intestinal motility (e.g. metoclopramide) epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate or felbamate) tuberculosis (e.g. rifampicin)
• HIV and hepatitis C infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz) fungal infections (griseofulvin)
• arthritis, osteoarthritis (etoricoxib)
• high blood pressure in the blood vessels in the lungs (bosentan)
• St. John's Wort remedies.

The antibiotic troleandomycin may increase the risk of bile retention if taken together with the pill.

• Lestronette can affect the effect of other medicines, for example
• medicines containing ciclosporin
• the anti-epileptic lamotrigine (this may lead to an increase in the frequency of seizures)
• theophylline (used to treat breathing problems)
• tizanidine (used to treat muscle pain and/or muscle cramps). Do not use Lestronette if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, because these products can cause increases in liver function test results (increased liver enzyme ALT). Your doctor will prescribe you another type of contraception before starting treatment with these medicines. Lestronette can be resumed approximately 2 weeks after the end of this treatment. See the paragraph "Do not use Lestronette".

Lestronette with food and drink
Lestronette can be taken with or without food, if necessary with a small amount of water.
Lestronette should not be taken with grapefruit juice.

Diagnostic tests
If you need a blood test, tell your doctor or the laboratory that you are taking the pill, as
oral hormonal contraceptives can alter the results of some tests.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do not take Lestronette if you are pregnant. If you become pregnant while taking Lestronette, stop
Lestronette immediately and contact your doctor. You can stop Lestronette at any time if you want to become pregnant (see also "If you stop taking Lestronette").
Using Lestronette is not recommended during breastfeeding unless advised by your doctor. If
you want to take the pill while breastfeeding, you should consult your doctor.

Driving and using machines
There is no information to suggest that the use of Lestronette may affect the ability to drive and
use machines.

Lestronette contains lactose.
If your doctor has told you that you are intolerant to certain sugars, contact him before taking this medicine.

Lestronette contains Red Aluminium Lake (E 129)
May cause allergic reactions.

3. How to take Lestronette

Take this medicine always exactly as your doctor has told you. If you have doubts consult your
doctor.
Each blister contains 21 tablets. Each tablet is marked with the day of the week on which
it must be taken. For example, if you start taking the tablets on Tuesday, press the tablet through the
foil, corresponding to the blister marked with "MAR". Take the tablets every day
in the order indicated by the arrows.
Take one Lestronette tablet every day for 21 days, if necessary with a little water. You can take
the tablets with or without food, but you should take them every day at about the same time.
Once you have finished all 21 tablets, you will not take any tablets during the next 7 days. The
menstruation (withdrawal bleeding) will start during these 7 days, usually 2-3 days after
taking the last Lestronette tablet.
Start the next blister on the eighth day even if the menstruation continues. In this way you will always
start a new blister on the same day of the week and the withdrawal bleeding will occur at approximately the same
time each month.

When you can start with the first blister

• If you have not used any hormonal contraceptive in the previous month.Start taking Lestronette on the first day of your cycle (the first day of your menstruation). If you start taking Lestronette on this day you are immediately protected against pregnancy. You can also start between the 2nd and 5th day of your cycle, but you must use additional contraceptive methods (for example, a condom) for the first 7 days.
• Switching from another combined hormonal contraceptive, from a vaginal contraceptive ring or from apatchStart taking Lestronette the day after the last active tablet of the previous pill (or after removing the ring or patch) or, at the latest, the day after the usual pill-free interval (without ring, without patch) or the last placebo tablet of the previous hormonal contraceptive.
• Switching from a progestin-only method (oral pill, injection, implant or intrauterine system IUS/IUD)You can switch to Lestronette from the progestin-only pill at any time (from an implant or an IUS/IUD on the same day of removal, while from an injection on the day the next injection is due) but in all these cases you must use an additional contraceptive method (e.g. a condom) for the first 7 days of taking the tablets.
• After an abortion in the first trimesterFollow your doctor's advice.
• After having a baby or an abortion in the second trimesterTake Lestronette between the 21st and 28th day after delivery or abortion in the second trimester. If instead you start after the 28th day, you must use an additional barrier method (for example, a condom) during the first 7 days of taking Lestronette. If you have had sexual intercourse after having a baby, before taking Lestronette (again) you must first make sure you are not pregnant or wait until your next menstruation before taking Lestronette.
• If you are breastfeeding and want to start taking Lestronette again after having a babyRead paragraph 2 “Pregnancy and breastfeeding”.

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

If you take more Lestronette than you should
No serious adverse effects have been reported after taking many Lestronette tablets. If you have taken
more tablets at the same time, you may feel sick, vomit or bleed from the vagina. Also, the
girls who have not yet had their periods but who have accidentally taken this medicine
may experience such bleeding.
If you have taken too many Lestronette tablets or discover that a child has taken some, ask
your doctor or pharmacist for advice.

If you forget to take Lestronette

• If you are less than 12 hours latein taking the tablet, protection against pregnancy is not reduced. Take the pill as soon as you remember and then follow the usual schedule.
• If you are more than 12 hours latein taking the tablet, protection against pregnancy may be reduced. The more tablets you forget, the greater the risk of pregnancy.

In this case, you must follow the rules below:

• taking the tablets should never be interrupted for more than 7 days.
• The effectiveness of Lestronette depends on 7 days of uninterrupted tablet intake.
• If you are more than 12 hours late on days 1 to 7(see also the diagram) Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the subsequent tablets as usual. In addition, use a barrier contraceptive method, such as a condom, for the next 7 days. If you have had sexual intercourse in the 7 days preceding the forgotten tablet, you need to consider the possibility of pregnancy. The more tablets you forget and the closer you get to the regular interval without tablets, the greater the risk of pregnancy. Consult your doctor if this has happened to you.
• If you are more than 12 hours late on days 8 to 14(see also the diagram)

Take the forgotten tablet as soon as you remember, even if this means taking two tablets
at the same time. Then continue taking the subsequent tablets as usual. Provided
you have taken the tablets correctly for the 7 days preceding the first forgotten tablet, you do not
need to use additional contraceptive precautions. If you have not taken the tablets correctly or
you have forgotten more than one tablet, you must use additional contraceptive precautions for the next 7 days.

• If you are more than 12 hours late on days 15 to 21(see also the diagram) The risk of pregnancy increases the closer you get to the 7-day pill-free interval. However, pregnancy can still be prevented by adjusting the dosage. If you follow the following advice, you do not need to use additional contraceptive precautions, provided that all the tablets have been taken correctly in the 7 days preceding the first forgotten tablet. Otherwise, you must follow the first of these two options and also use additional contraceptive precautions for the next 7 days. Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time.
• 1. Then take the remaining tablets as usual. Instead of taking a 7-day break without tablets, continue immediately with the next 21-tablet blister. You will probably not experience withdrawal bleeding until the end of the second blister, but you may experience spotting or breakthrough bleeding during the days of taking the tablets. You can stop taking the tablets from the current blister and take a 7-day break without tablets, including the days on which you forgot to take the tablets, and then continue with the next blister.
• If you forget several tablets and no withdrawal bleeding occurs during the first normal pill-free interval, the possibility of pregnancy should be considered.

What to do in case of vomiting or severe diarrhea
If you vomit within 3-4 hours of taking the tablet, or have severe diarrhea, there is a risk that the active ingredients
of the pill will not be completely absorbed by your body. The situation is almost analogous to that of a
forgotten tablet. In case of vomiting or diarrhea, take another tablet from another blister as soon as
possible. If possible, take it within 12 hours, or when you normally take the pill. If this is not possible, or
if 12 hours have already passed, follow the instructions provided in the paragraph “If you forget to take Lestronette”.

Postponing your period: what you need to know
Although not recommended, you can postpone your period by going straight to a new blister of
Lestronette until you finish it. Spotting (drops or spots of blood) or breakthrough bleeding may occur during the use of the second blister. Once the second blister is finished, a
7-day break without tablets is necessary.

Ask your doctor for advice before deciding to postpone your period.
Changing the first day of your menstrual cycle: what you need to know
If you want to change the day of the start or have your period on another day of the week, you can
shorten the next pill-free interval by as many days as you want. The shorter the interval, the greater
the risk that you will not experience withdrawal bleeding and that you will experience breakthrough bleeding and
spotting during the second pack. Do not prolong the pill-free interval.
.

If you stop taking Lestronette
You can stop taking Lestronette at any time. If you still want to avoid pregnancy,
consult your doctor for advice on other methods of birth control. If you want to become
pregnant, stop taking Lestronette and wait for a period before trying to become pregnant.
You will be able to calculate the presumed 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 everybody gets them.
If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think could be due to Lestronette, tell your doctor.

Serious side effects
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 paragraph 2 “What you need to know before taking Lestronette”.
Contact your doctor immediately if you notice any of the following symptoms of angioedema: swelling of the
face, tongue and/or pharynx and/or difficulty swallowing or hives with possible difficulty breathing
(see also “Warnings and precautions”).
The following is a list of side effects that have been associated with the use of Lestronette.

• Common: may affect up to 1 in 10 women:
• mood changes, depression
• headache
• nausea, abdominal pain
• breast pain or breast tension
• weight gain
• Uncommon: may affect up to 1 in 100 women:
• decreased libido,
• migraine
• vomiting, diarrhoea
• skin rash
• itching or bumps on the skin
• breast enlargement
• fluid retention
• Rare: may affect up to 1 in 1,000 women:
• intolerance to contact lenses
• allergic reactions
• increased libido
• breast or vaginal discharge
• redness or blotches on the skin
• weight loss
• harmful blood clots in a vein or an artery, for example:
• in a leg or foot (DVT),
• in a lung (PE),
• heart attack,
• stroke,
• mini-stroke or temporary symptoms similar to those of a stroke, known as a transient ischaemic attack (TIA),
• 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 paragraph 2 for more information on conditions that increase the risk of blood clots and the symptoms of a blood clot).
• Not known: frequency cannot be estimated from available data: increased liver enzymes (increased transaminases).

The following serious adverse events have been reported with a slightly higher frequency in women who
used the contraceptive pill, but it is not known whether this is caused by the treatment (see paragraph 2 “What
you need to know before taking Lestronette”):

• increased blood pressure
• liver tumors or breast cancer.

The following conditions have been associated with combined oral contraception:
Crohn's disease, ulcerative colitis, porphyria (a metabolic disease that causes abdominal pain and mental
disorders), systemic lupus erythematosus (when the body attacks and damages its own organs and tissues), herpes in
advanced pregnancy, Sydenham's chorea (jerky or rapid and involuntary movements), haemolytic uraemic
syndrome (a condition that occurs after diarrhoea caused by E. coli), liver problems
manifested by jaundice.

Reporting of side effects
If you get any side effect, 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Lestronette

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 30°C.
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 the month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lestronette contains
The active ingredients are levonorgestrel and ethinylestradiol.
Each tablet contains 0.10 mg of levonorgestrel and 0.02 mg of ethinylestradiol.
The other ingredients are: lactose, povidone K-30 (E 1201), magnesium stearate (E 572) and opadry II pink [polyvinyl alcohol, talc (E 553b), titanium dioxide (E 171), polyethylene glycol 3350, red aluminium lake (E 129),
lecithin (E 322), red iron oxide (E 172) and blue aluminium lake (E 132)].

Description of the appearance of Lestronette and contents of the pack

• Each film-coated tablet is pink and round.
• Lestronette is available in strips (blisters) of 21 tablets.
• The packs contain 1, 3 and 6 blisters, each containing 21 tablets. Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Theramex Ireland Limited
Kilmore House, Park Lane, Spencer Dock
Dublin 1, D01 YE64
Ireland

Manufacturer
Merckle GmbH - Ludwig-Merckle Strasse 3, 89143 Blaubeuren (Germany)
Laboratorios Leon Farma S.A., C/La Vallina s/n, Poligono Industrial Navatejera, 24008 Navatejera, Leon
(Spain)

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Germany: Liana-ratiopharm
Italy: Lestronette 0.10 mg+0.02 mg film-coated tablets
Netherlands: Ethinylestradiol/levonorgestrel Teva 0.02/0.1 mg film-coated tablets