YASMIN Фильм-coated таблетки

Содержание инструкции

1. Yasmin 0.03 mg / 3 mg film-coated tablets
   1. Cos’è Yasmin e a cosa serve
   2. Cosa deve sapere prima di prendere Yasmin
   3. How to take Yasmin
   4. Possible side effects
   5. How to store Yasmin
   6. Contents of the pack and other information

Yasmin 0.03 mg / 3 mg film-coated tablets

Ethinylestradiol / Drospirenone

Read this leaflet carefully before you start taking this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may be harmful for them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. See section 4.

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

• They are one of the most reliable reversible methods of contraception, when 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 you restart 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 Yasmin is and what it is used for
• 2. What you need to know before you take Yasmin When you must not use Yasmin Warnings and precautions Blood clots Yasmin and cancer Psychiatric disorders Breakthrough bleeding What to do if you do not have a withdrawal bleed Other medicines and Yasmin Yasmin with food and drink Laboratory tests Pregnancy and breastfeeding Driving and using machines Yasmin contains lactose
• 3. How to take Yasmin When can you start the first blister? If you take more Yasmin than you should If you forget to take Yasmin What to do if you vomit or have severe diarrhoea How to delay your period: what you need to know

How to change the day your period starts: what you need to know
If you stop taking Yasmin

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

1. Cos’è Yasmin e a cosa serve

• Yasmin è una pillola contraccettiva e serve per prevenire la gravidanza.
• Ogni compressa contiene una piccola quantità di due diversi ormoni femminili, il drospirenone e l’etinilestradiolo.
• Le pillole contraccettive che contengono due ormoni sono chiamate pillole “combinate”.

2. Cosa deve sapere prima di prendere Yasmin

Note generali
Prima di iniziare a usare Yasmin 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 prendere Yasmin, il medico le farà alcune domande sulla sua storia personale di salute e quella dei
suoi familiari. Il medico inoltre le misurerà la pressione e, in base alla sua situazione personale, potrà anche
effettuare altri esami.
In questo foglio vengono descritte varie situazioni nelle quali deve sospendere Yasmin o nelle quali la
sicurezza di Yasmin può risultare diminuita. In tali situazioni è necessario astenersi da rapporti sessuali
oppure adottare misure contraccettive aggiuntive non ormonali, come il profilattico o un altro metodo di
barriera. Non usi il metodo del ritmo o della temperatura basale. Infatti tali metodi possono essere
inaffidabili, in quanto Yasmin altera le variazioni mensili della temperatura corporea e del muco cervicale.

Yasmin, come tutti i contraccettivi ormonali, non offre alcuna protezione nei confronti dell’infezione
da HIV (AIDS) o di altre malattie a trasmissione sessuale.
Quando non deve usare Yasmin
Non usi Yasmin 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.

Non usi Yasmin

• Se ha (o ha mai avuto) un coagulo di sangue in un vaso sanguigno della gamba (trombosi venosa 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: o diabete grave con lesione dei vasi sanguigni

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

• Se ha (o ha mai avuto) un tipo di emicrania chiamata “emicrania con aura”;
• se ha (o ha mai avuto) una malattia del fegato e la funzionalità del fegato è ancora anormale
• se i suoi reni non funzionano bene (insufficienza renale)
• se ha (o ha mai avuto) un tumore del fegato
• se ha (o ha mai avuto) o si sospetta che abbia un cancro della mammella o degli organi genitali
• se ha sanguinamenti vaginali non spiegabili
• se è allergica all’etinilestradiolo o al drospirenone o ad uno qualsiasi degli altri componenti di questo medicinale (elencati al paragrafo 6). Questa condizione può causare prurito, eruzioni cutanee o gonfiore.

Non usi Yasmin se ha l’epatite C e se sta assumendo medicinali contenenti ombitasvir/paritaprevir/ritonavir
e dasabuvir (vedere anche il paragrafo “Altri medicinali e Yasmin”).

Informazioni aggiuntive su popolazioni particolari

Bambini ed adolescenti
Yasmin non è indicato in donne il cui ciclo mestruale non è ancora iniziato.

Pazienti anziane
Yasmin non è indicato dopo la menopausa.

Donne con compromissione del fegato
Non prenda Yasmin se soffre di malattie del fegato. Vedere anche i paragrafi ‘Non prendere Yasmin” e
‘Avvertenze e precauzioni’.

Pazienti con compromissione renale
Non prenda Yasmin se soffre di insufficienza renale o insufficienza renale acuta. Vedere anche i paragrafi
‘Non prendere Yasmin” e ‘Avvertenze e precauzioni’.

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

Si rivolga al medico prima di prendere Yasmin.

Informi il medico se una qualsiasi delle seguenti condizioni si applica al suo caso.
In alcune situazioni deve fare particolare attenzione mentre usa Yasmin o qualsiasi altra pillola combinata,
ed è possibile che il medico debba visitarla regolarmente. Se questa condizione compare o peggiora mentre
sta usando Yasmin, deve informare il medico.

• se un parente stretto ha o ha avuto un cancro della mammella
• se ha una malattia del fegato o della colecisti

• se ha il diabete
• se soffre di depressione
• 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 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 Yasmin;
• se ha un’infiammazione alle vene poste sotto la pelle (tromboflebite superficiale);
• se ha le vene varicose.
• se soffre di epilessia (vedere “Altri medicinali e Yasmin”)
• se ha una malattia che è comparsa per la prima volta durante la gravidanza o in corso di un precedente uso di steroidi sessuali (per esempio, perdita dell’udito, una malattia del sangue chiamata porfiria, eruzione cutanea con vescicole durante la gravidanza (herpes gravidico), una malattia dei nervi che causa movimenti improvvisi del corpo (Corea di Sydenham)
• se ha o ha mai avuto cloasma (scolorimento della pelle, specialmente del viso o del collo, noto come “maschera gravidica”). In tal caso eviti l’esposizione diretta alla luce solare o ai raggi ultravioletti
• se soffre di angioedema ereditario, i medicinali contenenti estrogeni possono provocarne o peggiorarne i sintomi. Se accusa sintomi di angioedema, come gonfiore del viso, della lingua e/o della gola e/o difficoltà a deglutire o orticaria con difficoltà di respirazione, si rivolga immediatamente al medico.

COAGULI SANGUIGNI
L’uso di un contraccettivo ormonale combinato come Yasmin causa un aumento del rischio di sviluppare un

coagulo sanguignorispetto 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 Yasmin èbasso.

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

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 Yasmin, il rischio di sviluppare un coagulo sanguigno torna ai livelli
normali entro alcune 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 Yasmin 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, noretisterone or noregestimate, about 5-7 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as Yasmin, about 9-12 will develop a blood clot 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”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Yasmin is low but some conditions cause an
increase. Your risk is greater:

• if you are strongly 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, lung or other 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 a cast. You may need to stop taking Yasmin a few weeks before surgery or during the time you are less mobile. If you need to stop taking Yasmin, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years of age);
• 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 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 Yasmin. If any of the above conditions change while you are using Yasmin, 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 Yasmin is very low
but may increase:

• as you get older (over 35 years of age);
• if you smoke.When you use a combined hormonal contraceptive like Yasmin 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 contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative of yours has had a heart attack or stroke at a young age (under about 50 years). In this case you may also be at high risk of heart attack or stroke;
• if you, or a close relative, have high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have 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 severe, the risk of developing a blood clot may be even higher. If any of the above conditions change while you are using Yasmin, for example if you start smoking, if a close relative develops thrombosis for no known reason or if you gain a lot of weight, contact your doctor.

Yasmin and cancer
Breast cancer is observed with a slightly higher frequency in women who use combined pills,
but it is not known whether this is due to the treatment. For example, it is possible that in women who
use the pill, a greater number of tumors are diagnosed because they undergo more
frequent medical checks. The occurrence of breast cancer decreases gradually after
stopping combined hormonal contraception. It is important that you regularly check your
breast and contact your doctor if you feel any lump.
In women who use the pill, benign liver tumors have been observed in rare cases, and even
more rarely, malignant liver tumors. Contact your doctor if you experience unusually severe abdominal pain.

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

Breakthrough bleeding
During the first few months of taking Yasmin, you may experience unexpected bleeding (bleeding outside of the
pill-free week). If this bleeding occurs for more than a few months, or
starts after a few months, your doctor should check what is wrong.

What to do if your period does not occur during the pill-free week
If you have taken all the tablets correctly, you have not had vomiting or severe diarrhea and you have not taken any other
medicines, it is highly unlikely that you are pregnant.
If your period does not occur for two consecutive times, 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 Yasmin
Always tell your doctor if you are taking any medicines or herbal products. Tell any other doctor
or dentist who prescribes another medicine to you (or pharmacist) that you are taking Yasmin. They
may tell you that you need to use additional contraceptive measures (for example a condom) and, if so,
for how long or whether the use of another medicine you need should be changed.
Some medicines

• affect the levels of Yasmin in the blood
• may make it less effective in preventing pregnancy
• may cause unexpected bleeding. These include:
• medicines for the treatment of: o epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine) o tuberculosis (e.g. rifampicin) o HIV and Hepatitis C virus infection (ritonavir, nevirapine, efavirenz known as protease inhibitors and non-nucleoside reverse transcriptase inhibitors) o fungal infections (griseofulvin, ketoconazole) o arthritis, osteoarthritis (etoricoxib) o high blood pressure in the arteries of the lungs (bosentan) o St. John's wort, herbal remedy

Yasmin can affect the effect of other medicines, for example:

• medicines containing cyclosporine
• the antiepileptic 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 Yasmin if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir as this may cause increases in blood test results of liver function (increased liver enzyme ALT). Your doctor will prescribe you another type of contraceptive before starting treatment with these medicines. Yasmin can be resumed about 2 weeks after completion of this treatment. See the section “Do not use Yasmin”.

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

Yasmin with food and drink
Yasmin can be taken with or without food, if necessary with some water.

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

Pregnancy

If you are pregnant do not take Yasmin. If you become pregnant while taking Yasmin, stop it
immediately and contact your doctor. If you want to become pregnant, you can stop taking Yasmin at
any time (see also “If you stop taking Yasmin”).

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

Breast-feeding
The use of Yasmin is generally not recommended during breast-feeding. If you want to take the pill during
breast-feeding, you should consult your doctor.

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

Driving and operating machinery
There is no evidence to suggest that Yasmin affects the ability to drive or operate
machinery.

Yasmin contains lactose
If you are intolerant to some sugars, contact your doctor before taking Yasmin.

3. How to take Yasmin

Take one Yasmin tablet every day, if necessary with a little water. You can take the tablets
with or without food, but you must take them at about the same time each day.
The blister pack contains 21 film-coated tablets. Next to each tablet is printed the day of the
week on which it should be taken. If, for example, you start on Wednesday, take the tablet next to the
word WED. Follow the direction of the arrows on the blister pack until you have taken all 21 tablets.
Then do not take any tablets for 7 days. During these 7 days (so-called pill-free week)
your menstrual period should occur. This is called “withdrawal bleeding” and generally starts
on the second or third day of the pill-free week.
Start a new blister on the eighth day after the last Yasmin tablet (i.e. after the 7-day break),
regardless of whether your period has stopped or not. This means that you must start each
new Yasmin blister on the same day of the week and also your periods will start each month
on the same day.
Taking Yasmin as indicated above, you are protected from pregnancy even during the 7 days when you do not take the
tablets.

When can you start the first blister?

• If you have not used a hormonal contraceptive in the month before.Start taking Yasmin on the first day of your cycle (i.e. the first day of your menstrual period). If you start on the first day of your period, the contraceptive effect is immediate. You can also start taking Yasmin between the 2nd and 5th day of your cycle, but in this case you should use additional contraceptive measures (e.g. a condom) for the first 7 days.
• Switching from a combined hormonal contraceptive, a combined vaginal contraceptive ring ora patch.Start taking Yasmin preferably on the day after the last active tablet (the last tablet containing the active ingredients) of your previous pill, or at the latest on the day after the pill-free interval

free from the pill (or after the last inactive tablet of your previous pill). When switching from a combined
vaginal contraceptive ring or a patch, follow your doctor’s advice.

• Switching from a progestin-only method (progestin-only pill, injection,implant or progestin-releasing intrauterine system (IUS)).You can switch to the pill on any day from the progestin-only pill (from an implant or IUS on the day of its removal, from an injectable when you are due to have the next injection), but in all these cases use additional contraceptive measures (e.g. a condom) for the first 7 days of taking the tablets.
• After an abortionFollow your doctor’s advice.
• After childbirthYou can start taking Yasmin between 21 and 28 days after childbirth. If you start later than 28 days, use a barrier method (e.g. a condom) during the first 7 days of taking Yasmin. If, after childbirth, you have had intercourse before starting (or restarting) taking Yasmin, make sure you are not pregnant or wait for your period.
• If you are breastfeeding and want to start (or restart) taking YasminRead the section “Breast-feeding”. Ask your doctor for advice if you are not sure when to start

If you take more Yasmin than you should
There have been no reports of serious harmful effects following the taking of too many Yasmin tablets. If
you take several tablets at once, you may experience nausea or vomiting or vaginal bleeding.
Girls who have not yet had their periods, but who have accidentally taken this
medicine may also experience such bleeding.
If you have taken too many Yasmin tablets, or discover that some tablets have been taken by a child, seek
immediate medical or pharmaceutical advice.

If you forget to take Yasmin

• If the delay in taking a tablet is less than 12 hours, your contraceptive protection is not reduced. Take the tablet as soon as you remember and then take the subsequent tablets as usual.
• If the delay in taking a tablet is more than 12 hours, your contraceptive protection may be reduced. The more tablets you have forgotten, the higher the risk of becoming pregnant. The risk of incomplete contraceptive protection is greatest if you forget a tablet at the beginning or end of the blister. Therefore, you must follow the instructions below (see also the diagram below):
• More than one tablet forgotten in this packConsult your doctor.
• One tablet forgotten in the first weekTake 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 contraceptivemeasuresfor the next 7 days, for example a condom. If you have had sexual intercourse in the week before the forgotten tablet, you may be pregnant. In this case, consult your doctor.
• One tablet forgotten in the second week

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. The contraceptive safety
of the pill is maintained and therefore no additional precautions are necessary.

• One tablet forgotten in the third weekYou can choose between two options:
• 1. you can take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at the usual time. Skip the pill-free interval and start the next blister immediately. You are likely not to have a period until the end of the second blister or you may have some spotting or breakthrough bleeding during the second blister;
• 2. you can also stop taking the tablets of the current cycle and go straight to a 7-day break (including the day the tablet was forgotten). If you want to start the next blister on your usual day, observe an interval of less than 7days.

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

• If you have forgotten any of the tablets in the blister and your period does not occur during the first pill-free interval, you may be pregnant. Consult your doctor before starting a new blister.

What to do in case of vomiting or severe diarrhoea

If you vomit within 3-4 hours of taking a tablet or have severe diarrhoea, it is possible that the active ingredients
of the pill have not been completely absorbed by your body. The situation is comparable to that
which occurs when you forget to take a tablet. After vomiting or diarrhoea, take another
tablet from a reserve pack as soon as possible. If possible, take it within 12 hoursof the usual
time of taking the tablets. If this is not possible, or if 12 hours have already passed, you must follow the
instructions in the section “If you forget to take Yasmin”.

How to delay your period: what you should know
Although it is not recommended, you can delay your period by continuing with a new blister of Yasmin
instead of observing the 7-day break. During the use of this second blister, you may experience some spotting
or breakthrough bleeding. Continue with the next blister after the usual 7-day break.

You can ask your doctor for advice before deciding to delay your period.
How to change the day your period starts: what you should know
If you take the tablets according to the instructions, your period will start in the pill-free week. If
you need to change the day it starts, shorten the normal break between two packs (but never prolong it -

7 days is the maximum!). For example, if the break normally starts on Friday and you want to move it to
Tuesday (3 days earlier), start the next blister 3 days earlier. If you make the break between
cycles very short (e.g. 3 days or less), you may not have any bleeding during this interval.
Subsequently, you may experience some spotting or breakthrough bleeding.

Ask your doctor for advice if you are not sure what to do.
If you stop taking Yasmin
You can stop taking Yasmin at any time. If you still want to avoid pregnancy, you should
consult your doctor for advice on other safe methods of birth control. If you want to
become pregnant, stop taking Yasmin and wait for your period before trying to conceive. This will
allow you to calculate the expected date of delivery more easily.

If you have any questions about using 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 Yasmin, tell 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 you use
Yasmin”.
The following side effects have been associated with the use of Yasmin.

Common side effects(may affect between 1 and 10 women in 100)

• menstrual disorders, breakthrough bleeding, breast pain, breast tenderness
• headache, depressed mood
• migraine
• nausea
• thick, white vaginal discharge, candidiasis. Uncommon side effects(may affect between 1 and 10 women in 1000)

• breast enlargement, changes in libido
• high blood pressure, low blood pressure
• vomiting, diarrhoea
• acne, rash, intense itching, hair loss (alopecia)
• vaginal infection
• fluid retention, body weight changes. Rare side effects(may affect between 1 and 10 women in 10,000)
• allergic reactions (hypersensitivity), asthma
• nipple secretion
• hearing impairment
• skin diseases such as erythema nodosum (characterised by reddish and painful skin nodules) or erythema multiforme (characterised by a rash with target-like or ulcerated lesions).
• 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)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 Yasmin

Keep this medicine out of sight and reach of children.
Do not store at a temperature above 30°C. Store in the original package.

Expiry date
Do not use this medicine after the expiry date stated on the pack after “Do not use after:” or ”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
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Yasmin contains

• The active ingredients are drospirenone and ethinylestradiol. Each tablet contains 3 milligrams of drospirenone and 0.030 milligrams of ethinylestradiol.

• The excipients are: lactose monohydrate, corn starch, pregelatinized corn starch, povidone K25, magnesium stearate, hypromellose, macrogol 6,000, talc, titanium dioxide (E171), yellow iron oxide (E172).

Description of the appearance of Yasmin and contents of the pack

• Each Yasmin blister contains 21 light yellow film-coated tablets.
• Yasmin tablets are film-coated; the tablet core is coated. The tablets are light yellow, round, with convex faces, one of which is imprinted with the letters “DO” in a regular hexagon.
• Yasmin is available in packs of 1, 3, 6 and 13 blisters, each containing 21 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Bayer S.p.A. - Viale Certosa, 130 - 20156 - Milan.

Manufacturer
Bayer AG 13342 Berlin - Germany.
This medicinal product is authorised in the Member States of the European Economic Area under the following
names:

• Austria, Belgium, Croatia, Denmark, Finland, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, United Kingdom: Yasmin
• France: Jasmine