LUCILLE Фильм-coated таблетки

Содержание инструкции

1. What Lucille is and what it is used for
2. Cosa deve sapere prima di usare Lucille
3. How to use Lucille
4. Possible side effects
5. How to store Lucille
6. Package Contents and Other Information

Lucille, film-coated tablets
Desogestrel/Ethinylestradiol

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 a doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

Read this leaflet carefully before using 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Lucille is and what it is used for
• 2. What you need to know before you use Lucille

When to contact your doctor

• 3. How to use Lucille
• 4. Possible side effects
• 5. How to store Lucille
• 6. Contents of the pack and other information

1. What Lucille is and what it is used for

Composition and type of Pill
Lucille is a combined oral contraceptive (“the combined pill”). Each tablet contains a
small amount of two different female hormones. These are desogestrel (a progestin) and
ethinylestradiol (an estrogen). Due to its low hormone content, Lucille is considered a
low-dose oral contraceptive. Because the two hormones are used at different dosages in the
tablets of three different colors, Lucille is considered a triphasic oral contraceptive.

Why use Lucille?
Lucille is used for the prevention of pregnancy.
When used correctly (without forgetting to take the tablets), the possibility of pregnancy
is very low.

2. Cosa deve sapere prima di usare Lucille

Note generali
Prima di iniziare a usare Lucille 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”).
della pillola o nelle quali l’affidabilità della pillola può essere ridotta. In queste situazioni dovrà
rinunciare ad avere rapporti sessuali oppure adottare misure anticoncezionali aggiuntive non ormonali,
ad es. un profilattico o un altro metodo di barriera. Non usi metodi basati sui ritmi biologici o sulla
temperatura. Questi metodi possono essere inefficaci perché la pillola modifica le variazioni della
temperatura corporea e del muco cervicale che si verificano normalmente durante il ciclo mestruale.

Lucille, come tutte le pillole contraccettive, non protegge dall’infezione da HIV (AIDS) o da altre
malattie a trasmissione sessuale.
Lucille è stato prescritto soltanto per lei. Non lo dia ad altre persone.
Lucille di norma non deve essere usato per posticipare una mestruazione. Tuttavia, qualora in casi
eccezionali avesse la necessità di posticipare una mestruazione, contatti il medico.

Non usi Lucille
Non usi Lucille se presenta una delle condizioni elencate sotto. Se presenta una qualsiasi delle
condizioni elencate sotto, si rivolga al medico. Il medico discuterà con lei degli altri metodi di
controllo delle nascite che potrebbero essere più adatti al suo caso. Vedere anche paragrafo
“Avvertenze e precauzioni”.
profonda, TVP), del polmone (embolia polmonare, EP) o di altri organi;

• 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 mai avuto un attacco cardiaco o un ictus;
• se ha (o ha mai avuto) un’angina pectoris (una condizione che causa un forte dolore al torace e che può rappresentare un primo segno di 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 arteriosa molto alta
• livello molto alto di grassi (colesterolo o trigliceridi) nel sangue
• una malattia nota come iperomocisteinemia
• se ha (o ha mai avuto) un tipo di emicrania chiamata “emicrania con aura”;
• se ha o ha mai avuto una pancreatite (un’infiammazione del pancreas) associata a livelli elevati di sostanze grasse nel sangue;
• se ha ittero (ingiallimento della cute) o ha (ha avuto) una grave malattia epatica e il fegato ancora non funziona normalmente;
• se ha o ha mai avuto un cancro che può accrescersi sotto l’influenza di ormoni sessuali (ad es. della mammella o degli organi genitali);
• se ha o ha mai avuto un tumore epatico;
• se ha un qualsiasi tipo di sanguinamento vaginale di origine sconosciuta;
• se ha iperplasia endometriale (crescita anormale del rivestimento interno dell’utero);
• se è in corso una gravidanza o se sospetta una gravidanza;
• se è allergica al desogestrel o all’etinilestradiolo, o ad uno qualsiasi degli altri componenti di questo medicinale (elencati al paragrafo 6);
• se ha l'epatite C e sta prendendo medicinali contenenti ombitasvir/paritaprevir/ritonavir e dasabuvir o glecaprevir/pibrentasvir o sofosbuvir/velpatasvir/voxilaprevir (vedere anche il paragrafo Altri medicinali e Lucille).

Se una qualunque di queste condizioni compare per la prima volta durante l’uso della pillola,
sospenderne immediatamente l’uso e consultare il medico. Nel frattempo usare metodi contraccettivi
non ormonali. Vedere anche “Note generali” sopra.

Avvertenze e precauzioni
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 (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 (trombosi)”). Per una descrizione dei sintomi di questi gravi effetti indesiderati vada al paragrafo “Come riconoscere un coagulo sanguigno”.

Si rivolga al medico o al farmacista prima di usare Lucille.

Informi il medico se una qualsiasi delle seguenti condizioni si applica al suo caso.
Se questa condizione compare o peggiora mentre sta usando Lucille deve informare il medico.
Se nota sintomi di angioedema quali gonfiore di viso, lingua e/o gola e/o difficoltà di deglutizione
o orticaria con possibile difficoltà di respirazione, contatti immediatamente un medico. I prodotti
contenenti estrogeni possono causare o peggiorare i sintomi dell’angioedema ereditario o
acquisito.
se fuma;
se ha il diabete;
se è sovrappeso;
se ha la pressione sanguigna alta;
se ha un disturbo della valvola cardiaca o alcuni disturbi del ritmo cardiaco;
se ha un’infiammazione alle vene poste sotto la pelle (tromboflebite superficiale);
se ha le vene varicose;
se ha precedenti, nei familiari prossimi, di trombosi, attacco cardiaco o ictus;
se soffre di emicrania;
se soffre di epilessia;
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 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 Lucille;
se qualcuno dei suoi familiari prossimi ha avuto un tumore della mammella;
se ha malattie epatiche o della colecisti;
se ha la malattia di Crohn o la colite ulcerosa (malattia intestinale infiammatoria cronica);
se ha il lupus eritematoso sistemico (LES, una malattia che colpisce il sistema di difese naturali);
se ha la sindrome emolitica uremica (SEU, un disturbo della coagulazione del sangue che causa
insufficienza renale);
se ha l’anemia falciforme (una malattia ereditaria dei globuli rossi);
se ha disturbi che sono comparsi per la prima volta o si sono aggravati in corso di gravidanza o di
precedente uso di ormoni sessuali (ad es., perdita dell’udito, una malattia chiamata porfiria, una
malattia della pelle denominata herpes gestationis, una malattia denominata corea di Sydenham);
se ha o ha mai avuto il cloasma (chiazze sulla pelle a pigmentazione bruno-giallognola, in
particolare sul viso). In tal caso, evitare l’eccessiva esposizione al sole o ai raggi ultravioletti.
Disturbi psichiatrici
Alcune donne che usano contraccettivi ormonali tra cui Lucille hanno segnalato depressione o umore
depresso. La depressione può essere grave e a volte può portare a pensieri suicidari. Se si verificano
cambiamenti d’umore e sintomi depressivi, si rivolga al più presto al medico per ricevere ulteriori
consigli medici.
In caso di prima comparsa, recidiva o peggioramento di una qualunque delle suddette condizioni
durante l’uso della pillola, si deve consultare il medico.

Pillola e Trombosi
COAGULI SANGUIGNI
L’uso di un contraccettivo ormonale combinato come Lucille 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
Lucille 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:
• dolore o sensibilità alla gamba che può essere avvertito Trombosi venosa profonda

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 improvvisi e inspiegabili;
• 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.

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”).
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 si interrompe l’assunzione di Lucille, il rischio di sviluppare un coagulo sanguigno torna ai
livelli normali entro alcune 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
Lucille è basso.

• Su 10.000 donne che non usano alcun contraccettivo ormonale combinato e che non sono incinta, 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.
• Su 10.000 donne che usano un contraccettivo ormonale combinato contenente desogestrel, come Lucille, circa 9-12 svilupperanno un coagulo sanguigno in un anno.
• Il rischio che si formi un coagulo sanguigno dipende dalla sua anamnesi medica (vedere sotto “Fattori che aumentano il rischio di formazione 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 Lucille is low but some conditions cause an
increase. Your risk is higher:

• if you are severely overweight (body mass index or BMI greater than 30 kg/m²);
• if a close relative has had a blood clot in the leg, lung, or another organ at a young age (under about 50 years). In this case you may have an inherited blood clotting disorder;
• if you are going to have surgery or if you need to lie down 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 Lucille a few weeks before surgery or during the time you are less mobile. If you need to stop taking Lucille, 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 (duration >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 Lucille.
If any of the above conditions change while you are using Lucille, 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 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 Lucille is very
low but can increase:

• as you get older (over 35 years);
• if you smoke. When using a combined hormonal contraceptive like Lucille 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 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, has high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have 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 Lucille, 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.

Pill and Cancer
Breast cancer has been diagnosed slightly more frequently in women who use the Pill
compared to women of the same age who do not use it. This slight increase in the number of breast cancer diagnoses gradually disappears within 10 years of stopping use of the
Pill. It is not known whether the Pill is the cause of this difference. It may be that women have been
visited more frequently, so that breast cancer has been detected earlier.
In women taking the Pill, benign liver tumors and even more rarely malignant liver tumors have been reported. These tumors can cause internal bleeding. Consult
your doctor immediately in case of severe abdominal pain.
Cervical cancer is caused by Human Papilloma Virus infection. It has been reported that
it occurs more frequently in women who use the Pill for a long time. It is not known if
this is due to the use of hormonal contraceptives or to sexual behavior and other factors (such as
better cervical screening).

Children and adolescents
No clinical data are available on efficacy and safety in adolescents under 18
years of age.

Other medicines and Lucille
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Some medicines

• can affect the levels of Lucille in the blood
• can make it less effective in preventing pregnancy
• cause unexpected bleeding. These include medicines used for the treatment of:
• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g. Rifampicin, rifabutin);
• HIV or Hepatitis C infections (known as protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as e.g. ritonavir, nelfinavir, nevirapine, efavirenz) and/or combinations with medicines against hepatitis C virus (HCV) (e.g. boceprevir, telaprevir) or other infections (griseofulvin, rifabutin);
• fungal infections (griseofulvin, ketoconazole);
• arthritis, osteoarthritis (etoricoxib);
• high blood pressure in the blood vessels of the lungs (bosentan);
• herbal preparations containing St. John's wort (Hypericum Perforatum), used especially for the treatment of depressed mood.

Lucille can also affect the effect of other medicines (e.g., ciclosporin, the antiepileptic
lamotrigine – this could lead to an increase in the frequency of seizures).
Also inform all other doctors or dentists who prescribe other medicines (or the pharmacist) of the
fact that you are using Lucille, so that they can say whether and for how long you need to use
additional contraceptive methods.
Do not use Lucille if you suffer from Hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or
sofosbuvir/velpatasvir/voxilaprevir as this can cause increases in blood tests for
liver function (increased liver enzyme ALT).
Your doctor will prescribe another type of contraceptive before starting treatment with these
medicines.
Lucille can be started again about 2 weeks after the end of this treatment. See
paragraph “Do not use Lucille”.
Laboratory tests
If you are undergoing blood or urine tests, tell the healthcare staff that you
are using Lucille, as it may affect the results of some tests.

Pregnancy and breastfeeding

Pregnancy
Lucille must not be used in case of confirmed or suspected pregnancy. If you suspect a
pregnancy while taking Lucille, you should consult your doctor as soon as possible.

Breastfeeding
Lucille is not generally recommended during breastfeeding. If you want to use the Pill
during breastfeeding, ask your doctor’s advice.

Driving and operating machinery
No effects have been observed.

Lucille contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

When to contact your doctor?
Periodic checks
While using the Pill, your doctor will ask you to come for periodic check-up visits. Generally
you should have a check-up every year.

Contact your doctor as soon as possible if:

• you observe possible signs of a blood clot which may mean you have a blood clot in the leg (deep vein thrombosis), a blood clot in the lungs (pulmonary embolism), a heart attack or a stroke (see BLOOD CLOTS in the paragraph above). For a description of the symptoms of these serious side effects see “HOW TO RECOGNIZE A BLOOD CLOT”.
• you notice any change in your health status, especially regarding the

sub-paragraph “Do not use”; do not forget the references to changes in the health status of
close family members);

• you feel a lump in your breast;
• you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives together with difficulty breathing;
• you need to use other medicines (see also paragraph 2.”Other medicines and Lucille”);
• you are immobilized or need to undergo surgery (consult your doctor at least four weeks before);
• you have heavy and unusual vaginal bleeding;
• you have forgotten to take tablets during the first week of the pack and have had sexual intercourse in the seven days before;
• you have severe diarrhea;
• you have not had your period for two times in a row or suspect you are pregnant (do not start a new pack until you have consulted your doctor).

3. How to use Lucille

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

When and how to use the tablets
The Lucille pack contains 21 tablets: 7 yellow tablets (numbered 1 to 7), 7 red tablets (numbered 8 to 14) and 7 white tablets (numbered 15 to 21).
The tablet must be taken every day at the same time, if necessary with a little water. Each time you start a new pack of Lucille, you must take the yellow tablet marked with the number 1, in the top left of the blister. Choose from the seven stickers with the days of the week the one corresponding to the day you start taking Lucille. Stick the sticker with the day on the blister, just above the row of yellow tablets. This way you can easily check if you have taken the tablet for the day. Follow the direction of the arrows until all 21 tablets have been taken, first the yellow ones, then the red ones and finally the white ones. For the next 7 days, you must not take any tablets. During these 7 days, you should experience vaginal bleeding (withdrawal bleeding). This usually starts 2-3 days after the last Lucille tablet. Start the new pack on the eighth day, even if the withdrawal bleeding is still ongoing. This means that the new packs will always be started on the same day of the week and that the withdrawal bleeding will appear around the same days each month.

Starting the first pack of Lucille

• When no hormonal contraceptive has been used in the previous month. Start taking Lucille on the first day of your cycle, i.e. the first day of your menstrual bleeding. Lucille is immediately effective and you do not need to use an additional contraceptive method. You can also start between the 2nd and 5th day of your cycle, but in this case you must make sure to also use an additional contraceptive method (barrier method) for the first 7 days of taking the tablets in the first cycle.
• Switching from another combined hormonal contraceptive (combined oral contraceptive pill (COC), vaginal ring or transdermal patch).You can start taking Lucille the day after taking the last tablet from the previous contraceptive pack (i.e. without any pill-free interval). If the previous contraceptive pack also contains inactive tablets, you can take Lucille the day after taking the last activetablet (in case of doubt, ask your doctor or pharmacist). You can also start later, but no later than the day after the pill-free interval of the previous contraceptive (or the day after the last inactive tablet of the previous contraceptive). If you are switching from a vaginal ring or a transdermal patch, you should start using Lucille preferably on the day the ring or patch is removed, or at the latest, on the day you would have started using a new ring or patch.

If you have been using the Pill, the patch or the ring consistently and correctly and if you are sure you are not pregnant, you can also stop taking the Pill or removing the ring or the patch at any time and start using Lucille immediately.
If you follow these instructions, you do not need to use any additional contraceptive method.

• Switching from a progestin-only pill (minipill).You can stop the minipill at any time and start taking Lucille the next day, at the same time. However, if you have sexual intercourse, make sure to also use an additional contraceptive method (barrier method) for the first 7 days of taking Lucille.
• Switching from a contraceptive injection or an implant or an intrauterine device (IUD) based on progestin only.Start using Lucille on the day you would have had the next injection or the day the implant or device is removed. However, if you have sexual intercourse, make sure to also use an additional contraceptive method (barrier method) for the first 7 days of taking Lucille.
• After childbirth.After childbirth, your doctor may tell you to wait until after your first normal menstrual period before starting to take Lucille. Sometimes it is possible to start earlier. Follow your doctor's recommendations. If you are breastfeeding and want to take Lucille, you should talk to your doctor first.
• After a spontaneous or induced abortion.Follow your doctor's recommendations.

If you use more Lucille than you should
No serious adverse effects have been reported from taking too many Lucille tablets at once.
If more Lucille tablets have been taken at once, you may experience nausea, vomiting or vaginal bleeding. If a child has taken Lucille, consult a doctor.

If you forget to use Lucille

• If less than 12 hourshave passed since the usual time of taking, the effectiveness of the Pill is preserved. Take the forgotten tablet as soon as you remember it and take the subsequent tablets as usual.
• If more than 12 hourshave passed since the usual time of taking, the effectiveness of the Pill may be reduced. The more tablets you forget to take consecutively, the greater the risk that the contraceptive effect is reduced. The risk of pregnancy is particularly high if you forget the yellow tablets at the beginning of the pack or the white tablets at the end of the pack. Therefore, follow the instructions below (see also the scheme below).

More than one forgotten tablet in a pack
Consult your doctor.

1 forgotten tablet during the first week (yellow tablets)
Take the tablet as soon as you remember it (even if this means taking two tablets at the same time) and take the subsequent tablets as usual. Use additional contraceptive methods (barrier method) for the next 7 days.
If you have had sexual intercourse in the week before the forgetfulness, there is a possibility that a pregnancy has occurred. Inform your doctor immediately.

1 forgotten tablet during the second week (red tablets)
Take the forgotten tablet as soon as you remember it (even if this means taking two tablets at the same time) and take the subsequent tablets as usual.
The effectiveness of the Pill is preserved. No additional contraceptive precautions are necessary.

1 forgotten tablet during the third week (white tablets)
You can choose one of the following alternatives, without the need for additional contraceptive precautions.

• 1. Take the forgotten tablet as soon as you remember it (even if this means taking two tablets at the same time) and take the subsequent tablets as usual. Start the new pack as soon as you have finished the current one, without an interval between the two packs. You may not experience withdrawal bleeding until the end of the second pack, but you may experience spotting or breakthrough bleeding during the days of taking the tablets.

Or

• 2. Stop taking the tablets from the pack in use, observe a pill-free interval of 7 days or less (including the day the pill was forgotten) and then start with a new pack. If you choose this alternative, you can start the new pack on the same day of the week as usual.

If you have forgotten to take tablets from a pack and, during the first normal pill-free interval, you do not have your period, it is possible that a pregnancy has occurred. Consult your doctor before starting the new pack.

If you suffer from gastrointestinal disorders (e.g. vomiting, severe diarrhea)
If you experience vomiting or severe diarrhea, it is possible that the active ingredients of the Lucille tablet have not been completely absorbed. If vomiting occurs within 3-4 hours of taking a tablet, it is as if the tablet has been forgotten. You should therefore follow the instructions given in case of forgotten tablets. In case of severe diarrhea, consult your doctor.

If you want to change the day of the start of your period
If you take the tablets correctly, your period will occur around the same day every 4 weeks. If you want to move the onset of this menstruation, you must shorten (never prolong) the next pill-free interval. For example, if your period usually occurs on Friday and you want it to start on Tuesday (3 days earlier), you must start the next pack 3 days earlier than usual. If you make the period of the pill-free interval very short (for example 3 days or less), the bleeding may not occur during the interval. You may have breakthrough bleeding or spotting during the taking of the tablets of the next pack.

If you have unexpected vaginal bleeding
With all Pills, you may experience irregular vaginal bleeding (spotting or breakthrough bleeding) between periods during the first few months of taking them. A sanitary pad may be needed, but you should still continue taking the tablets as usual. Irregular vaginal bleeding usually disappears once the body has adjusted to the Pill (usually after about 3 months).
Consult your doctor if the bleeding persists, becomes heavy or recurs.

If you have not had your period
If you have taken all the tablets correctly and have not experienced vomiting or taken other medicines, then it is very unlikely that a pregnancy has occurred. Continue using Lucille as usual.
If your period does not occur for two months in a row, it is possible that a pregnancy has occurred. Consult your doctor immediately. Do not start the new pack of Lucille until your doctor has ruled out pregnancy.

If you want to stop using Lucille
You can stop using Lucille whenever you want. If you do not want to become pregnant, consult your doctor about other methods of birth control.
If you stop using Lucille because you want to become pregnant, you should wait to have a spontaneous period before trying to conceive. This helps to calculate when the baby will be born.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lucille 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 Lucille, inform
your doctor.

A higher 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 using Lucille”. Other serious reactions seen with the Pill are described in section 2
“Warnings and precautions”
Serious side effects
Contact your doctor immediately if you notice any of the following symptoms of angioedema:
swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with possible
difficulty breathing (see also “Warnings and precautions”).
Common: may affect more than 1 in 10 women

• depressed mood, mood changes
• headache
• nausea, abdominal pain
• breast pain, breast tenderness
• weight gain.

Not common: may affect more than 1 in 100 women

• fluid retention
• decreased libido
• migraine
• vomiting, diarrhoea
• skin rash, urticaria
• breast enlargement.

Rare: may affect more than 1 in 1,000 women

• 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 a transient ischaemic 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).
• hypersensitivity reactions
• increased libido
• intolerance to contact lenses
• erythema nodosum, erythema multiforme (these are skin diseases)
• nipple discharge, vaginal discharge
• weight loss.

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

5. How to store Lucille

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 package or blister.
Store at a temperature below 30°C. Store in the original package.
Do not use this medicine if you notice, for example, changes in the colour of the tablet,
crumbling of the tablet or any other visible sign of deterioration.
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 Lucille Contains
The active ingredients are:
yellow tablets: desogestrel (0.050 mg) and ethinylestradiol (0.035 mg)
red tablets: desogestrel (0.100 mg) and ethinylestradiol (0.030 mg)
white tablets: desogestrel (0.150 mg) and ethinylestradiol (0.030 mg).
The other ingredients are:
tablet core:
all-rac-alpha-tocopherol;
lactose monohydrate;
potato starch;
povidone;
anhydrous colloidal silica;
stearic acid.
coating:
yellow, red and white tablets:
hypromellose;
macrogol 400;
talc;
titanium dioxide (E171).
yellow tablets:
yellow iron oxide (E172).
red tablets:
red iron oxide (E172).

Description of the Appearance of Lucille and Package Contents
Lucille is available in packs of 1, 3 and 6 strips of 21 tablets (7 yellow, 7 red and
7 white tablets), packaged in a cardboard box.
The tablets are biconvex, round and 5 mm in diameter. The tablets have “VR
4” (yellow tablets), “VR 2” (red tablets), “TR 5” (white tablets) imprinted on one side and are smooth
on the other side.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24, Ireland
Tel: 0039 0687502429

Manufacturer
N.V. Organon, PO Box 20, 5340 BH, Kloosterstraat 6, Oss, Netherlands

Alternative Manufacturer for Packaging and Final Control
Cyndea Pharma, S.L, Polígono Industrial Emiliano Revilla Sanz, Avenida de Ágreda, 31 Ólvega
42110 (Soria), Spain
This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Czech Republic/Finland/Greece/Portugal: Laurina
Germany: Novial
Italy: LUCILLE