KELSEE 2 mg /0.02 Mg Таблетки С Пролонгированным Высвобождением

Содержание инструкции

1. KELSEE 2 mg/0.02 mg prolonged-release tablets
   1. Cos'è KELSEE e a cosa serve
   2. Cosa deve sapere prima di prendere KELSEE
   3. How to take KELSEE
   4. Possible side effects
   5. How to store KELSEE
   6. Contents of the pack and other information

KELSEE 2 mg/0.02 mg prolonged-release tablets

dienogest / ethinylestradiol

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

1. Cos'è KELSEE e a cosa serve

KELSEE è una pillola contraccettiva orale combinata e viene utilizzato per prevenire gravidanze.
Ognuna delle 24 compresse di colore bianco pallido contiene una piccola quantità di due differenti
ormoni femminili, chiamati dienogest ed etinilestradiolo. Le 4 compresse verdi non contengono
sostanze attive e vengono chiamate compresse placebo.
Le pillole contraccettive che contengono due ormoni vengono chiamate “pillole combinate”.

2. Cosa deve sapere prima di prendere KELSEE

Note generali
Prima di iniziare a utilizzare KELSEE deve leggere le informazioni sui coaguli sanguigni nel
paragrafo 2. È particolarmente importante che legga i sintomi di un coagulo sanguigno – vedere
paragrafo 2 “Coaguli sanguigni”.
Prima di poter iniziare a prendere KELSEE, il medico le farà alcune domande sulla sua storia
sanitaria personale e su quella dei suoi parenti stretti. Il medico le misurerà anche la pressione del
sangue e, a seconda della sua situazione personale, potrà anche eseguire altri esami.
prendere KELSEE o in cui l’efficacia di KELSEE può essere ridotta. In questi casi non deve avere
rapporti sessuali oppure deve usare precauzioni contraccettive aggiuntive non ormonali come i
preservativi o un altro metodo di barriera. Non usi il metodo del calendario o quello della
misurazione della temperatura. Questi metodi possono essere inaffidabili perché KELSEE altera i
cambiamenti mensili della temperatura corporea e del muco del collo dell’utero.

KELSEE, come altri contraccettivi ormonali, non protegge contro le infezioni da HIV (AIDS)
o contro altre malattie a trasmissione sessuale.
Se prende la pillola, il medico le chiederà di sottoporsi a controlli regolari. Normalmente, deve
consultare il suo medico almeno una volta all'anno.

Non prendaKELSEE
Non prenda KELSEE 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.

Non prendaKELSEE se lei:

• è allergica all’etinilestradiolo, al dienogest o ad uno qualsiasi degli altri componenti di questo medicinale (elencati al paragrafo 6);
• ha (o ha mai avuto) un coagulo sanguigno in un vaso della gamba (trombosi venosa profonda, TVP), del polmone (embolia polmonare, EP) o di altri organi;
• 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;
• deve sottoporsi a un’operazione o se starà coricata per un lungo periodo (vedere paragrafo 2 “Coaguli sanguigni”);
• ha mai avuto un attacco cardiaco o un ictus;
• 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);
• 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
• ha (o ha mai avuto) un tipo di emicrania chiamata “emicrania con aura”;
• ha (o ha mai avuto) una grave malattia epatica, a meno che i suoi test epatici del sangue siano tornati normali;
• ha (o ha mai avuto) un tumore epatico benigno o maligno;
• ha (o ha mai avuto) o sospetta di avere un cancro dipendente da ormoni sessuali (per es. della mammella o dell’endometrio);
• manifesta sanguinamento vaginale senza alcuna causa;
• ha l’epatite C e sta assumendo medicinali contenenti ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir o sofosbuvir/velpatasvir/voxilaprevir (vedere il paragrafo 2 “Altri medicinali e KELSEE”).

Se manifesta una di queste condizioni mentre sta prendendo KELSEE, deve interrompere
immediatamente l’assunzione e contattare il medico. Nel frattempo, deve usare un altro metodo di
contraccezione non ormonale. Per ulteriori informazioni vedere anche il paragrafo “Avvertenze e
precauzioni”.

Avvertenze e precauzioni
Si rivolga al medico o al farmacista prima di prendere KELSEE.

Quando fare particolare attenzione con KELSEE
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 “Coaguli sanguigni” [trombosi]).

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.
In alcune situazioni, è necessaria particolare attenzione quando prende KELSEE o qualsiasi altra
pillola combinata e potrebbe essere necessario che venga regolarmente controllata dal medico.
Se questa condizione compare o peggiora mentre sta usando KELSEE, deve anche informare il
medico se lei:

• ha la malattia di Crohn o la colite ulcerosa (malattia intestinale infiammatoria cronica);
• ha il lupus eritematoso sistemico (LES, una malattia che colpisce il sistema di difese naturali);
• ha la sindrome emolitica uremica (SEU, un disturbo della coagulazione del sangue che causa insufficienza renale);
• ha l'anemia falciforme (una malattia ereditaria dei globuli rossi);
• 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);
• deve sottoporsi a un’operazione o se starà coricata per un lungo periodo (vedere paragrafo 2 “Coaguli sanguigni”);
• ha appena partorito, il suo rischio di sviluppare coaguli sanguigni è maggiore. Chieda al medico quanto tempo dopo il parto può iniziare a prendere KELSEE;
• ha un’infiammazione alle vene poste sotto la pelle (tromboflebite superficiale);
• ha le vene varicose;
• ha difetti della valvola cardiaca o disturbi del ritmo cardiaco;
• ci sono casi di cancro al seno in parenti stretti;
• ha malattie del fegato o della cistifellea o calcoli biliari;
• ha ittero o prurito dovuto alla congestione biliare;
• ha colorazione a chiazze, giallo-brunastra della pelle, soprattutto sul viso (cloasma), o se l'ha manifestata durante una gravidanza precedente; in questo caso bisogna evitare la forte luce solare e i raggi UV;
• ha alcuni problemi nella formazione dell’emoglobina (porfiria);
• soffre di depressione;
• soffre di epilessia;
• ha il ballo di san Vito (corea di Sydenham);
• ha avuto eruzione cutanea con vesciche durante una gravidanza precedente (herpes gestationis);
• ha perdita dell'udito dell'orecchio interno (perdita dell'udito correlata all'otosclerosi);
• manifesta sintomi dell’angioedema come gonfiore del viso, della lingua e/o della gola e/o difficoltà di deglutizione o orticaria con potenziale difficoltà respiratorie, contatti immediatamente il medico. I prodotti contenenti estrogeni possono provocare o peggiorare i sintomi dell’angioedema ereditario e acquisito.

Non esiti a chiedere consiglio al medico o al farmacista se ha qualsiasi dubbio sull'uso di KELSEE.

COAGULI SANGUIGNI
L’uso di un contraccettivo ormonale combinato come KELSEE 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
KELSEE 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 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 Trombosi venosa profonda
• 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

Sintomi che si verificano più frequentemente in un occhio:

• perdita immediata della vista o
• offuscamento indolore della vista che può progredire a perdita della vista Trombosi della vena retinica (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; Ictus

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). Tuttavia, questi effetti collaterali 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 un 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 KELSEE il rischio di sviluppare un coagulo sanguigno torna ai
livelli normali entro poche settimane.

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

• Out of 10,000 women who do not use any combined hormonal contraception and who 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, noretisterone or norgestimate, about 5-7 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains dienogest and ethinylestradiol like KELSEE, between approximately 8 and 11 women will develop a TEV in a year.

The risk of a blood clot forming depends on your medical history (see below “Factors
that increase the risk of a blood clot forming”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with KELSEE 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 of yours has had a blood clot in a leg, in the lung or in another organ at a young age (under about 50 years). In this case you may have an inherited blood clotting disorder;
• if you need to undergo surgery or if you need to stay in bed for a long period due to an injury or illness or if you have a leg in plaster. You may need to stop taking KELSEE a few weeks before the operation or during the time you are less mobile. If you need to stop taking KELSEE ask your doctor when you can start taking it again.
• as you get older (especially over 35 years);
• if you have recently given birth.

The risk of developing a blood clot increases when you have more than one of these
conditions.
Air travel (lasting > 4 hours) can temporarily increase the risk of developing a
blood clot, especially if you have some of the other factors listed.
It is important that you tell your doctor if any of these conditions apply to you, even
if you are not sure. Your doctor may decide to stop you from taking KELSEE.
If any of the above conditions change while you are using KELSEE, for example if a
close relative develops a 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 KELSEE is
very low but it can increase:

• as you get older (over 35 years)
• if you smoke.When you use a combined hormonal contraceptive like KELSEE it is advisable that you 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 contraception
• 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 a heart problem (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 severe, the risk of
developing a blood clot may be even higher.
If any of the above conditions change while you are using KELSEE, for example if you start
to smoke, if a close relative develops a thrombosis for no known reason or if you gain a lot of
weight, contact your doctor.

KELSEE and cancer
Breast cancer has been detected with slightly more frequency in women who use
the combined pill, but it has not been established whether this is due to the pill. It is possible that these
women were simply examined more thoroughly and more frequently, which
means that breast cancer was diagnosed earlier. The incidence of breast cancer
gradually decreases when the use of combined hormonal contraceptives is stopped. It is
important that you regularly check your breasts and must contact your doctor if you feel any
lumps.
In women who use the combined pill for a relatively long period, studies have
reported cases of cervical cancers. At present it is not known whether this is caused by the pill or is
linked to sexual behaviour (for example more frequent changes of partner) and other factors.
Rarely, benign liver tumors have been reported in women taking the pill and even more
rarely malignant liver tumors. See your doctor if you experience unusual severe abdominal pain.

Psychiatric disorders
Some women who use hormonal contraceptives including KELSEE have reported depression or
low mood. Depression can be severe and sometimes can lead to suicidal thoughts. If you
experience changes in mood and depressive symptoms, see your doctor as soon as possible for
further medical advice.

Bleeding between periods
During the first few months of using KELSEE, you may experience unexpected bleeding
(bleeding not coinciding with the days of taking the placebo tablets). If these
bleedings persist for more than a few months, or if they start after several months, your doctor must
investigate the cause.

What you should do if no bleeding occurs on the days of taking the placebo tablets
If you have taken all the white active tablets 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 you have missed two consecutive cycles, then you may be pregnant. Contact your doctor immediately.
Do not start the next blister until you are sure you are not pregnant.

Other medicines and KELSEE
Always tell your doctor what medicines or herbal products you are already using, including
any medicines obtained without a prescription. Tell your doctor or dentist who
prescribe other medicines (or the pharmacist) that you are taking KELSEE. They can tell you if
you need to take additional contraceptive precautions (for example a condom) and, if so, for
how long.
Some medicines

• can affect the levels of KELSEE in the blood
• can make it less effective in preventing pregnancy
• can cause unexpected bleeding.

These include:

• medicines used for the treatment of:
• HIV and hepatitis C infections (called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)
• epilepsy (for example phenobarbital, phenytoin, primidone, carbamazepine, oxcarbazepine, topiramate or felbamate)
• tuberculosis (for example rifampicin)
• fungal infections (griseofulvin, imidazole antifungals, for example itraconazole, voriconazole, fluconazole)
• bacterial infections (macrolide antibiotics, for example clarithromycin, erythromycin)
• some heart conditions, high blood pressure (calcium channel blockers, for example verapamil, diltiazem)
• arthritis, osteoarthritis (etoricoxib)
• the herbal remedy St John's Wort, which is used to treat certain types of depression.

KELSEE can affect the effectof other medicines, for example

• lamotrigine
• cyclosporine
• theophylline
• tizanidine

Do not use KELSEE if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir and
sofosbuvir/velpatasvir/voxilaprevir because these medicines can cause increased values in
blood tests on liver function (increased liver enzyme values ALT). Your doctor will prescribe you another type of contraception before starting treatment with these
medicines. KELSEE can be restarted approximately 2 weeks after the end of this
treatment. See section “Do not use KELSEE”.
Ask your doctor or pharmacist for advice before taking any medicine.
Interactions with laboratory tests
The use of KELSEE can affect the results of some tests, including liver function, adrenal cortex, kidney and thyroid values, and also the amount of some proteins present
in the blood, such as proteins that affect the metabolism of lipids (fats), carbohydrates, blood
coagulation and fibrinolysis. However, such changes generally fall within the normal range.

Pregnancy and breastfeeding
Pregnancy
KELSEE should not be taken during pregnancy. You should not be pregnant before starting to
take KELSEE. If you become pregnant while taking KELSEE, you should immediately
stop taking it and contact your doctor.
Breastfeeding
It is not recommended to take KELSEE if you are breastfeeding.
If you want to breastfeed, your doctor will advise you on a suitable method of contraception.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
No effects on the ability to drive and use machines have been observed.

KELSEE contains lactose
Each white active tablet of KELSEE contains 19 mg of lactose (as lactose monohydrate). Each
green placebo tablet contains 56 mg of lactose (as lactose monohydrate).
If you have been diagnosed with an intolerance to certain sugars, contact your doctor before taking
this medicine.

3. How to take KELSEE

Take this medicine always exactly as your doctor or pharmacist has told you. If
you have doubts, ask your doctor or pharmacist.
Each blister contains 28 tablets. Take one tablet of KELSEE every day at the same time for 28
consecutive days strictly following the direction indicated by the arrows as follows: take one
white active tablet each day for the first 24 days and then one green placebo tablet each
day for the last 4 days.
After taking the last tablet, continue to take KELSEE the next day starting another
blister without any interval between blisters. You will always start a new blister on the same day of the
week. Because there are no interruptions in taking the medicine, it is important that you have
the next blister ready before you finish one.
To help you keep track, there are 7 stickers showing the 7 days of the week for each blister of
KELSEE. Choose the weekly sticker that starts with the day you start taking the tablets.
For example, if you start on Wednesday, use the sticker that starts with “WED”. Apply the
weekly sticker on the KELSEE blister, where you can read “Apply day sticker here”. This way
there will be a day indicated above each tablet and you can see if you have taken a certain pill. The
arrows indicate the order in which you must take the pills.
During the 4 days in which you take the green placebo 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 white active tablet of KELSEE. After taking the last
green tablet, you must start the next blister, whether the bleeding has ended or is
still continuing. This means that you must start each blister on the same day of the week and that
the withdrawal bleeding must start on the same day each month.
If you use KELSEE in this way, you will be protected from pregnancy even during the 4 days in which you take the
placebo tablets.
Note the instructions in section 3 “If you forget to take KELSEE” to maintain
the contraceptive effect.

Method and route of administration
Swallow each tablet with a small amount of water if necessary. It does not matter if
you take the tablets with or without food.

When you can start taking KELSEE
If you have not used any hormonal contraception during the previous month
Start taking KELSEE on the first day of your cycle (i.e. the first day of your period). If you start
taking KELSEE 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 you must also use
additional protective measures (for example, a condom) for the first 7 days.

If you are switching from a combined hormonal contraceptive or from a vaginal or patch
contraceptive combination
You can start KELSEE 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 pill-free days
of the previous pill (or after the last inactive tablet of the previous pill).
If you are switching from a vaginal ring or a patch, you should preferably start
taking it on the day of removal of the last ring or patch of the cycle, but at the latest on the day
on which the next application would have taken place.

If you were using 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 be 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.

If you start KELSEE after a pregnancy termination in the first trimester
You can normally start immediately, but before doing so you must follow your
doctor's advice.

If you start KELSEE after having a baby or aftera pregnancy termination in the
second trimester
You can start KELSEE between 21 and 28 days after delivery or after the pregnancy termination. If
you start later, you must use an additional barrier contraceptive method during the first seven days
of taking the pill. If you have had sexual intercourse before starting to take KELSEE, make sure you are not
pregnant or wait until your next menstrual period.
Take this medicine always exactly as your doctor or pharmacist has told you. If
you have doubts, ask your doctor or pharmacist.

Duration of use
Your doctor will tell you how long you should take this pill.

If you take more KELSEE than you should
No serious harmful effects have been reported after taking too many KELSEE tablets. If
you take more tablets at the same time, the symptoms that may occur are nausea, vomiting and
slight vaginal bleeding.

If you forget to take KELSEE
If you forget to take a white active tablet(tablets 1-24 of your blister), you must
behave as follows:

• If you realise you have forgotten a white tablet within 24 hours of the time younormally take the tablet, protection against pregnancy is not reduced. Take the tablet as soon as you remember and continue taking the tablets at the usual time.
• If you realise you have forgotten a white tablet more than 24 hours after the time younormally take it, protection against pregnancy may be reduced. The more tablets you have forgotten, the greater the risk of pregnancy.

The risk of incomplete protection against pregnancy is greater if you forget a
white tablet at the beginning or end of the blister. Therefore, you must follow these
rules:

• More than one tablet forgotten in this blisterContact your doctor.
• One tablet forgotten on 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. Then continue taking the tablets at the usual time and use additional precautions, such as a condom, for the next 7 days. If you have had sexual intercourse in the previous week, you should consider the possibility of pregnancy. In this case, ask your doctor for advice.
• One tablet forgotten on 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. Then continue taking the tablets at the usual time. If you have taken the tablets correctly for the 7 days before the forgotten tablet, contraceptive protection is not reduced and no further precautions are necessary.
• One tablet forgotten on days 15 - 24 (third or fourth row)You can choose between the following options without having to use additional contraception, provided you have taken the pill correctly for the 7 days before forgetting the tablet. Otherwise, you should follow the first of these two options and use additional protective measures for 7 days.
• 1. Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at the usual time. Instead of taking the green 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 green placebo tablets - 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 white active tablets and immediately start taking the 4 green placebo tablets (note the day on which you forgot the tablet before taking the placebo tablets). If you want to start a new blister on the day you usually start, take the placebo tablets for less than 4 days.

If you follow one of these two recommendations, you will remain protected from pregnancy.

• If you have forgotten any of the tablets in a blister, and you do not have bleeding on the placebo days, it is possible that you are pregnant. You should consult your doctor before starting the next blister.

If you have forgotten one or more green tablets, you are still protected provided that no more than
4 days pass between the last white tablet of the current blister and the first white tablet of the next
blister.

What to do in case of severe vomiting or diarrhoea
If you vomit or have severe diarrhoea, there is a risk that the active ingredient in the pill has not
been completely absorbed by the body; the situation is almost the same as forgetting a
tablet. In these cases, you must use an additional contraceptive method, ask your doctor for advice.
If you vomit or have severe diarrhoea within 3-4 hours after taking a white active tablet of
KELSEE, you must take another white tablet from another blister as soon as possible. If possible, take it
within 24 hours of the usual time you take the pill. No additional contraceptive precautions are necessary.
If this is not possible or if 24 hours have passed, you must follow the
instructions in the previous paragraph “If you forget to take KELSEE”.

Delaying your period: what you should know
Although it is not recommended, you can postpone your period by not taking the green
placebo tablets from the fourth row and going straight to a new blister of KELSEE and finishing it. You
may have some light bleeding or spotting while using the tablets
of this second blister. Finish this second blister by taking the 4 green tablets from the fourth
row. Then start the next blister.

You can ask your doctor for advice before deciding to delay your period.
Changing the day of the week on which your period starts: what you should know
If you take the tablets following the instructions, your period will start during the days in which
you take the placebo tablets. If you need to change this day, reduce the number of days in which you take
the placebo tablets – when you take the green placebo tablets– (but never increase it, 4 is the
maximum!). For example, if you start taking the placebo tablets on Friday, and want to change this
to Tuesday (3 days earlier), you must start a new blister 3 days earlier. You may not have any bleeding during these days. You may then have some light bleeding or spotting.

If you are not sure how to proceed, consult your doctor.
If you stop taking KELSEE
You can stop taking KELSEE at any time. From the day of interruption you are no longer
protected from pregnancy.
If you have any questions about using this medicine, ask your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any side effect, especially if severe or persistent, or if you notice any change in your
health that you think may be due to KELSEE, inform your doctor or pharmacist.
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 taking KELSEE”.

Serious side effects
Serious reactions related to the use of the pill, as well as the associated symptoms, are described in the
sections: “What you need to know before taking KELSEE”, “Blood clots”, “KELSEE and cancer”.
if necessary.
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 section 2. “Warnings and precautions”).

Other possible side effects
The following side effects, listed by frequency, have been observed in clinical studies with
KELSEE:

Common side effects(may affect up to 1 in 10 people):

• vaginal infections, including fungal infections of the vulva and vagina and bacterial vaginosis
• changes in sexual desire, mood swings
• headache
• nausea, abdominal pain
• acne
• breast discomfort or pain, painful menstrual periods, abnormal bleeding between regular menstrual periods
• weight gain, increased levels of the hormone that stimulates the thyroid and triglycerides in the blood

Uncommon side effects(may affect up to 1 in 100 people):

• urinary tract infections, presence of bacteria in the urine (bacteriuria)
• hypothyroidism (reduced thyroid function)
• changes in appetite, including increased or decreased appetite, elevated blood glucose levels
• depressed mood, depression, anxiety, mental disorders (including mental impairment, borderline personality disorder and panic attacks), sleep disorders (such as insomnia or drowsiness)
• dizziness, migraine
• high blood pressure (hypertension)
• harmful blood clots in a leg or in the veins of the foot (deep vein thrombosis)
• tense abdomen
• vomiting, diarrhea, flatulence
• hair loss (alopecia)
• itching, skin irritation (dermatitis), rash
• increased sweating (hyperhidrosis)
• pain in arms and legs
• absent menstruation, abnormal vaginal bleeding, changes in menstruation, pelvic pain, ovarian cysts, vaginal discharge and vulvovaginal discomfort, including itching or dryness, vulvovaginal inflammation, cervical dysplasia (abnormal growth of cells on the surface of the cervix), pain/spasms during sexual intercourse (dyspareunia)
• fatigue (tiredness)
• swelling
• weight loss
• altered blood test results: elevated blood levels of creatine phosphokinase, cholesterol, liver enzymes.

Rare side effects(may affect up to 1 in 1000 people):

• inflammation of the tympanic membrane, which can cause hearing disturbance and ear pain (otitis media)
• genital herpes
• benign breast tumor (fibroadenoma of the breast)
• low number of leukocytes (white blood cells) in the blood.
• hyperthyroidism (increased thyroid activity)
• fluid retention, lipid imbalance in the blood (dyslipidemia)
• perception of altered taste (dysgeusia)
• partial loss of tactile sensation (hypoesthesia)
• a burning or tingling sensation that is usually felt in the hands, arms, legs or feet, but can also occur in other parts of the body (paresthesia)
• itchy eyes, visual disturbances
• vertigo
• fast heartbeat (palpitations)
• changes in blood pressure
• bruise (a collection of blood outside the blood vessels under the skin)
• hot flashes
• venous disorders including spider veins and varicose veins
• painful blood clots in a vein or an artery, for example: in a leg or foot (i.e. venous thrombosis) or in a lung (i.e. pulmonary embolism)
• nosebleeds (epistaxis)
• indigestion (dyspepsia)
• constipation
• gastroesophageal reflux
• sensitive teeth (dental hyperesthesia)
• skin disorders, dry skin, hives, chloasma (brown-golden pigmented patches)
• joint pain (arthralgia)
• altered urine tests: presence of red blood cells and white blood cells in the urine
• irregular thickening of the endometrium
• genital discomfort
• feeling of general malaise
• altered blood test results: increased levels in the blood of lactate dehydrogenase, potassium, prolactin, fibrin D-dimer
• abnormal blood pressure.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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 KELSEE

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 and on the blister after
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Keep the blister in the outer packaging to protect the medicine from light.
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. Contents of the pack and other information

What KELSEE contains
White tablet:

• The active ingredients are dienogest and ethinylestradiol.
• The other ingredients are: Tablet core:lactose monohydrate, hypromellose (E 464), povidone, magnesium stearate (E 470b). Film coating:partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), macrogol (E 1521), talc (E 553b).

Green tablet:

• It does not contain any active ingredients.
• The other ingredients are: Tablet core:lactose monohydrate, corn starch, povidone, colloidal silicon dioxide, magnesium stearate (E 470b). Film coating:hypromellosa (E 464), triacetin (E 1518), polysorbate 80, titanium dioxide (E 171), indigotine aluminium lake, yellow iron oxide.

Description of the appearance of KELSEE and contents of the pack
KELSEE is in the form of prolonged-release tablets.
Each pack contains 1, 3, 6 or 13 blisters, each containing 28 tablets (24 white
active tablets and 4 green inactive tablets).
Not all pack sizes may be marketed.

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
24193 Villaquilambre, León
Spain