KLAIRA Фильм-coated таблетки

Содержание инструкции

1. KLAIRA film-coated tablets
   1. What is Klaira and what is it used for
   2. Cosa ha bisogno di sapere prima di prendere Klaira
   3. How to take Klaira
   4. Possible side effects
   5. How to store Klaira
   6. Package Contents and Other Information

KLAIRA film-coated tablets

Estradiol valerate / Dienogest

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 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 Klaira is and what it is used for
• 2. What you need to know before you take Klaira ➢ When you must not take Klaira ➢ Warnings and precautions ➢ Blood clots ➢ Klaira and cancer ➢ Psychiatric disorders ➢ Breakthrough bleeding ➢ What to do if your period does not arrive on day 26 or in the following days ➢ Other medicines and Klaira ➢ Klaira with food and drink ➢ Laboratory tests ➢ Pregnancy and breastfeeding ➢ Driving and using machines ➢ Klaira contains lactose
• 3. How to take Klaira ➢ Preparing the pack ➢ When to start your first pack ➢ If you take more Klaira than you should ➢ If you forget to take Klaira ➢ Use in children ➢ What to do if you have severe vomiting or diarrhoea ➢ If you stop taking Klaira
• 4. Possible side effects
• 5. How to store Klaira

• 6. Contents of the pack and other information

1. What is Klaira and what is it used for

• Klaira is a contraceptive pill and is used to prevent pregnancy.
• Klaira is used for the treatment of heavy menstrual bleeding (not caused by uterine diseases) in women who wish to use oral contraception.
• Each active colored tablet contains a small amount of female hormones, estradiol valerate or estradiol valerate combined with dienogest.
• The 2 white tablets do not contain any active ingredient and are called inactive tablets.
• Contraceptive pills that contain two hormones are also called “combined pills”.

2. Cosa ha bisogno di sapere prima di prendere Klaira

Note generali
Prima di iniziare a usare Klaira deve leggere le informazioni sui coaguli di sangue al paragrafo 2. È
particolarmente importante che legga i sintomi di un coagulo di sangue (vedere paragrafo 2 “Coaguli di
sangue”).
Prima di prendere Klaira, il medico le farà alcune domande riguardo alla sua storia personale di salute e a
quella dei suoi familiari. Il medico inoltre le misurerà la pressione arteriosa e, in base alla sua situazione
personale, potrà anche effettuare altri esami.
cui l’affidabilità di Klaira può risultare diminuita. In tali situazioni è necessario astenersi da rapporti sessuali
oppure adottare misure contraccettive aggiuntive non ormonali, quali il profilattico o altri metodi di barriera.
Non usare il metodo del ritmo o il metodo della temperatura basale. Infatti tali metodi possono risultare
inaffidabili, in quanto Klaira altera le variazioni mensili della temperatura corporea e del muco cervicale.

Klaira, come tutti i contraccettivi ormonali, non offre alcuna protezione contro l’infezione da HIV
(AIDS) o da altre malattie a trasmissione sessuale.
Quando non deve prendere Klaira
Non usi Klaira 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 prenda Klaira:

• se ha (o ha mai avuto) un coagulo di sanguein un vaso 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 di sangue”);
• se ha mai avuto un attacco cardiacoo 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 arteriosamolto 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 emicraniachiamata “emicrania con aura”;
• se ha (o ha avuto) una malattia del fegatoe la funzione del suo fegato è ancora anormale;
• se ha (o ha avuto) un tumore del fegato;
• se ha (o ha avuto) un cancro o sospetta di avere un cancro della mammella o degli organi genitali;
• se presenta sanguinamenti vaginali non spiegabili;
• se è allergica(ipersensibile) all’estradiolo valerato o al dienogest o a uno qualsiasi degli eccipienti di questo medicinale (elencati al paragrafo 6). Questo può provocare prurito, eruzione cutanea o gonfiore .

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

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

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

Informi il medico se una qualsiasi delle seguenti condizioni si applica al suo caso.
In alcune situazioni deve fare particolare attenzione quando usa Klaira o qualsiasi altro contraccettivo orale
combinato, e può essere necessario che il medico la visiti regolarmente. Se questa condizione compare o
peggiora mentre sta usando Klaira deve informare il medico:

• se un parente stretto ha o ha avuto un cancro della mammella
• se ha una malattia del fegato o della cistifellea
• se ha ittero
• 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 di sangue”);
• se ha appena partorito, il suo rischio di sviluppare coaguli di sangue è maggiore. Chieda al medico quanto tempo dopo il parto può iniziare a prendere Klaira;
• se ha un’infiammazione alle vene poste sotto la pelle (tromboflebite superficiale);
• se ha le vene varicose.
• se ha epilessia (vedere paragrafo “Altri medicinali e Klaira”)
• se ha una malattia che è apparsa per la prima volta durante la gravidanza o durante un precedente uso di ormoni sessuali, per esempio perdita dell’udito, porfiria (una malattia del sangue), herpes gestationis (eruzione cutanea con vescicole durante la gravidanza), corea di Sydenham (una malattia dei nervi nella quale si verificano improvvisi movimenti del corpo)
• se ha (o ha avuto) pigmentazione a chiazze giallo-brune, note come “maschera gravidica”, specialmente sul viso (cloasma). In tal caso eviti l’esposizione diretta alla luce solare o ai raggi ultravioletti
• se soffre di angioedema ereditario o acquisito. Interrompa l’assunzione di Klaira e consulti immediatamente il medico se nota sintomi come gonfiore del viso, lingua e/o faringe e/o difficoltà a deglutire o orticaria con difficoltà di respirazione, che sono indicativi di un angioedema. I medicinali contenenti estrogeni possono indurre o aggravare i sintomi dell’angioedema
• se ha insufficienza cardiaca o renale.

Consulti il medico prima di assumere Klaira.

Informazioni supplementari per categorie particolari di pazienti

Utilizzo nei bambini:
L’uso di Klaira non è indicato nelle donne che non hanno ancora avuto il loro primo flusso mestruale
(menarca).

COAGULI DI SANGUE
L’uso di un contraccettivo ormonale combinato come Klaira causa un aumento del rischio di sviluppare un
coagulo di sangue rispetto al non utilizzo. In rari casi un coagulo di sangue può bloccare i vasi sanguigni e
causare problemi gravi.
I coaguli di sangue 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 di sangue 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 di sangue dannoso associato a Klaira è basso.
COME RICONOSCERE UN COAGULO DI SANGUE
Si rivolga immediatamente a un medico se nota uno qualsiasi dei seguenti segni o sintomi.

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

• L’uso di contraccettivi ormonali combinati è stato correlato a un aumento del rischio di formazione di coaguli di sangue 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 di sangue si forma in una vena della gamba o del piede, può causare una trombosi venosa profonda (TVP).
• Se un coagulo di sangue si sposta dalla gamba e si 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 di sangue in una vena?
Il rischio di sviluppare un coagulo di sangue 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 Klaira, il rischio di sviluppare un coagulo di sangue torna ai livelli
normali entro alcune settimane.

Qual è il rischio di sviluppare un coagulo di sangue?
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 di sangue nella gamba o nel polmone (TVP o EP) con Klaira è
basso.

• Su 10.000 donne che non usano alcun contraccettivo ormonale combinato e che non sono incinta, circa 2 svilupperanno un coagulo di sangue in un anno.
• Su 10.000 donne che usano un contraccettivo ormonale combinato contenente levonorgestrel, noretisterone o norgestimato, circa 5-7 svilupperanno un coagulo di sangue in un anno.
• Il rischio di sviluppare un coagulo di sangue con Klaira è circa lo stesso degli altri contraccettivi ormonali combinati compresi i contraccettivi contenenti levonorgestrel.

• Il rischio che si formi un coagulo di sangue dipende dalla sua anamnesi medica (vedere sotto “Fattori che aumentano il rischio di formazione di un coagulo di sangue”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Klaira 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 have to undergo surgery or if you have to stay in bed for a long period due to an injury or illness or if you have a leg in plaster. It may be necessary to stop taking Klaira a few weeks before surgery or during the time when you are less mobile. If you need to stop taking Klaira, 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 Klaira.
If any of the above conditions change while you are using Klaira, 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 Klaira is very low
but can increase:

• as you get older (over 35 years);
• if you smoke. When using a combined hormonal contraceptive like Klaira it is advisable to stop smoking. If you cannot stop smoking and you are over 35 years old, your doctor may advise you to use a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative of yours has had a heart attack or stroke at a young age (under about 50 years). In this case you may also be at high risk of heart attack or stroke;
• if you, or a close relative, have high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have 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 Klaira, 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.

Klaira and cancer
Breast cancerhas been observed with a slightly higher frequency in women who use
the combined pill, but it is not known whether this is due to the treatment. For example, it is possible that more tumors are discovered in women who use the combined pill because they are visited more often. The risk of
breast cancer gradually decreases after stopping combined hormonal contraception.
It is important that you check your breasts regularly and must contact your doctor if you feel any lump.
In women using the pill, benign liver tumorshave been observed in rare cases, and even more rarely

malignant liver tumors. In isolated cases, these tumors have led to life-threatening internal bleeding.
Contact your doctor if you experience particularly severe abdominal pain.
Some studies suggest that long-term use of the pill increases the risk of developing cervical
cancer. However, it is not clear to what extent sexual behavior or other factors such as the human papillomavirus (HPV) increase this risk.

Psychiatric disorders
Some women who use hormonal contraceptives including Klaira 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, seek medical advice as soon as possible.
medically.

Intermenstrual bleeding
During the first few months of taking Klaira, unexpected bleeding may occur. Usually the
bleeding starts on day 26, the day you take the second dark red tablet, or in the
following days. Information provided by diaries kept by women during a clinical study with Klaira
shows that it is not uncommon to have unexpected bleeding in a given cycle (10-18% of users). If you
experience unexpected bleeding for more than 3 consecutive months, or if these appear after a few months, the
doctor must investigate the cause.

What to do if menstruation does not occur on day 26 or in the following days
Information provided by diaries kept by women during a clinical study with Klaira shows that it is
not uncommon for menstruation not to occur on day 26 (observed in about 15% of cycles).
If you have taken all the tablets correctly, you have not vomited or had severe diarrhea and you have not taken any other
medicines, it is highly unlikely that you are pregnant.
If menstruation does not occur for two consecutive times or if you have not taken the tablets
correctly, you may be pregnant. Contact your doctor immediately. Do not start the next pack until
you are sure you have ruled out pregnancy.

Other medicines and Klaira
Always inform your doctor or pharmacist if you are taking or have recently taken any other medicines
or herbal remedies, including those available without a prescription. Also inform any other doctor or
dentist who prescribes you other medicines (or the pharmacist) that you are taking Klaira. They may tell you if you
need to take additional contraceptive measures (for example a condom) and, if so, for how long.
Some medicines

• affect the levels of Klaira in the blood
• may make it less effective in preventing pregnancy
• may 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),
• HIV and Hepatitis C virus infection (ritonavir, nevirapine, efavirenz known as protease inhibitors and non-nucleoside reverse transcriptase inhibitors)
• combination regimens against the Hepatitis C virus (HCV) consisting of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir can cause increases in blood test results concerning liver function (increased liver enzyme ALT) in women using COCs containing ethinylestradiol. Klaira contains estradiol instead of ethinylestradiol. It is not known whether an increase in liver enzyme ALT can occur when using Klaira with this combination regimen against HCV. Your doctor will give you the necessary instructions.
• fungal infections (e.g. griseofulvin, ketoconazole)
• St. John's wort herb (Hypericum Perforatum)
• Klaira may affect the effectof other medicines, for example:
• medicines containing cyclosporine,
• the antiepileptic lamotrigine (this may cause an increase in the frequency of seizures). Ask your doctor or pharmacist before taking any medicine. Your doctor or pharmacistcan tell you if you need to take additional protective measures while taking Klaira together withother medicines.

Klaira with food and drink
Klaira can be taken with or without food, if necessary with a small amount of water.

Laboratory tests
If you need a blood test or other laboratory tests, inform your doctor or laboratory staff that you are taking the pill, because oral contraceptives can affect the results of some
tests.

Pregnancy and breastfeeding
In the event of pregnancy during the use of Klaira, you should stop the
treatment immediately and contact your doctor. If you want to become pregnant, you can stop taking
Klaira at any time (see also "If you stop taking Klaira").
The use of Klaira is generally not recommended during breastfeeding. If you want to take the pill during
breastfeeding, you should consult your doctor.

Ask your doctor or pharmacist before taking any medicine during pregnancy or

breastfeeding.

Driving and operating machinery
There is no reason to believe that Klaira affects the ability to drive vehicles or operate machinery.

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

3. How to take Klaira

Each pack contains 26 coloured active tablets and 2 white inactive tablets.
Take one Klaira tablet each day, with a small amount of liquid if necessary. You can take the tablets with or without food, but you must take them at about the same time each day.

Preparing the pack
To help you to keep to the correct sequence, each pack of Klaira contains 7 self-adhesive labels with the 7 days of the week.
Choose the adhesive label for the week starting with the day you start taking the tablets. For example, if you start on Wednesday, use the adhesive label starting with “WED”.
Attach the adhesive label for the week along the entire length of the top of the Klaira pack where it says “Put the adhesive label here”, so that the first day is above the tablet marked with the number “1”.
This way there is a day shown above each tablet and you can check whether you have taken the pill on a given day. Follow the direction of the arrow on the pack until all 28 tablets have been taken.
Usually your period, also called withdrawal bleeding, starts when you are taking the second dark red tablet or the white tablets, and it may not have finished before you start the next pack. Some women still have their period even after they have already taken the first tablets from the new pack.
Start the next pack without a break, i.e. the day after you have finished the current pack, even if your period has not yet finished. This means you must start the next pack on the same day of the week and your period should occur on the same days each month.
If you use Klaira in this way, contraceptive action is guaranteed even during the 2 days when you are taking the inactive tablets.

When you can start the first pack

• If you have not used a hormonal contraceptive in the previous month.Start taking Klaira on the first day of your cycle (the first day of your period).
• Switching from another combined oral contraceptive pill, or from a vaginal ring, or patch, combined contraceptive.Start taking Klaira the day after the last active tablet (the last tablet containing the active ingredients) of the previous pill. When switching from a contraceptive vaginal ring or patch, start using Klaira on the day of removal or follow your doctor’s advice.
• Switching from a progestin-only method (progestin-only pill, injection, implant or progestin-releasing IUS).You can switch to Klaira on any day from the progestin-only pill (from an implant or IUS 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 contraceptive measures (e.g. a condom) for the first 9 days when using Klaira.
• After an abortion.Follow your doctor’s advice.
• After childbirth.You can start taking Klaira between 21st and 28th dayafter childbirth. If you start taking it later than the 28th day, use a barrier method (e.g. a condom) during the first 9 daysof taking Klaira. If, after childbirth, you have had intercourse before starting to take Klaira, you must rule out pregnancy or wait for your next period. If you want to start taking Klaira after pregnancy and are breastfeeding, read the paragraph “Pregnancy and breastfeeding”.

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

If you take more Klaira than you should
There are no reports of serious harmful effects if you take more Klaira tablets.
If you take several tablets at once, you may experience nausea or vomiting. Young girls may experience vaginal bleeding.

If you have taken too many KLAIRA tablets, or if a child has taken some of your tablets

seek immediate medical advice or contact your pharmacist.

If you forget to take Klaira
Inactive tablets: if you forget a white tablet (the two tablets at the end of the pack), you do not need to take it later as it does not contain any active ingredient. However, it is important that you discard the forgotten white tablet so that you are sure that the number of days of taking the inactive tablets has not increased; this would increase the risk of pregnancy. Continue with the next tablet at the usual time.

Active tablets: depending on the day of the cycle, as indicated on the calendar pack you are using, if oneactive tablet is forgotten, you must use additional contraceptive measures, such as a barrier method like a condom. Take the tablets following the instructions below. For details, see also the diagram below:

• If the delay in taking a tablet is less than 12 hours, contraceptive protection is not reduced. Take the tablet as soon as you remember and then take the subsequent tablets as planned.
• If the delay in taking a tablet is more than 12 hours, contraceptive protection may be reduced. Depending on the day of the cycle, as indicated on the calendar pack you are using, you must use additional contraceptive measures, such as a barrier method like a condom. See also the diagram below.
• More than one tablet forgotten in a packContact your doctor.

Do not take more than two active tablets in one day.
If you have forgotten to start a new pack, or if you have forgotten one or more tablets during the days 3-9of the pack, there is a risk that you may be pregnant (if you have had sexual intercourse in the 7 days before forgetting the tablet). In this case, contact your doctor. The more tablets you have forgotten (especially those in days 3-24) and the closer the forgetfulness is to the phase of the inactive tablets, the greater the risk that contraceptive protection is reduced. For details, see also the diagram below.
If you have forgotten any of the active tablets in a pack and have not had your period at the end of the pack, you may be pregnant. Contact your doctor before starting the next pack.

Use in children
No data are available in adolescents under 18 years of age.

What to do if you experience severe vomiting or diarrhoea
If you vomit within 3-4 hours of taking an active tablet, or in case of severe diarrhoea, it is possible that the active ingredients of the pill are not absorbed completely by your body.
The situation is therefore comparable to that which occurs when you forget to take a tablet.
After vomiting or severe diarrhoea, take the next tablet as soon as possible. If possible within 12 hoursof the usual time of taking the pill. If this is not possible, or if 12 hours have already passed, you must follow the instructions in “If you forget to take Klaira”. If you do not want to change your usual dosing schedule, take the corresponding tablet from another pack.

If you stop taking Klaira
You can stop taking Klaira at any time. If you still want to avoid pregnancy, consult your doctor for advice on other safe contraceptive methods. If you want to become pregnant, stop taking Klaira and wait for a menstrual period before trying to conceive. This will allow you to calculate the expected date of delivery more accurately.

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

4. Possible side effects

Like all medicines, Klaira can cause side effects, although not everybody gets them. If you experience any side effect, particularly if it is serious or persistent, or if you notice any change in your health that you think might be due to Klaira, 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 using Klaira”.

Serious side effects
Serious reactions associated with the use of the pill, as well as related symptoms, are described in the following paragraphs: “Blood clots” and “Klaira and cancer”. Read these paragraphs carefully and consult your doctor immediately if necessary.

Other possible side effects
The following side effects have been associated with the use of Klaira:

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

• headache
• abdominal pain, nausea
• acne
• absence of menstruation, breast discomfort, painful periods, irregular periods (with heavy irregular bleeding)
• weight increase.

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

• fungal infection, fungal infection of the vulva and vagina, vaginal infection
• increased appetite
• depression, depressed mood, emotional disturbance, difficulty sleeping, decreased libido, mental disorder, mood swings
• dizziness, migraine
• hot flushes, high blood pressure
• diarrhoea, vomiting
• increased liver enzymes
• hair loss, excessive sweating (hyperhidrosis), itching, rash
• muscle cramps
• breast enlargement, breast nodules, abnormal cell growth in the cervix (cervical dysplasia), dysfunctional genital bleeding, pain during intercourse, fibrocystic breast disease, heavy menstrual bleeding, menstrual disorders, ovarian cyst, pelvic pain, premenstrual syndrome, benign uterine tumor, uterine contractions, uterine/vaginal bleeding including spotting, vaginal discharge, vulvovaginal dryness
• fatigue, irritability, swelling of some parts of the body, for example the ankles (edema)
• weight loss, changes in blood pressure.

Rare side effects (may affect up to 1 in 1,000 users)

• candida infection, oral herpes, pelvic inflammatory disease, a vascular eye disease that resembles a fungal infection (presumed ocular histoplasmosis syndrome), a fungal skin infection (tinea versicolor), urinary tract infection, bacterial inflammation of the vagina
• fluid retention, increase in certain blood fats (triglycerides)
• aggression, anxiety, feeling of unhappiness, increased libido, nervousness, nightmares, restlessness, sleep disorders, stress
• reduced attention, sensation of “tingling”, vertigo
• intolerance to contact lenses, dry eyes, swollen eyes
• heart attack (myocardial infarction), palpitations
• bleeding from a varicose vein, low blood pressure, inflammation of superficial veins, pain in the veins
• harmful blood clots in a vein or in an artery, for example:
• in a leg or foot (DVT)
• in a lung (PE)
• heart attack
• stroke
• mini-stroke or temporary symptoms similar to those of a stroke, known as a transient ischemic attack (TIA)
• blood clots in the liver, stomach/intestine, kidneys or eye. The possibility of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and the symptoms of a blood clot).
• constipation, dry mouth, indigestion, heartburn
• liver nodules (focal nodular hyperplasia), chronic inflammation of the gallbladder
• allergic skin reactions, yellow-brown spots (cloasma) and other skin pigmentation disorders, hirsutism, excessive hair growth, skin conditions such as: dermatitis and neurodermatitis, dandruff and oily skin (seborrhoea) and other skin conditions
• back pain, jaw pain, feeling of heaviness
• pain in the urinary tract
• abnormal bleeding from interruption, benign breast nodules, early-stage breast cancer, breast cyst, nipple discharge, polyp of the cervix, redness of the cervix, bleeding during intercourse, spontaneous milk secretion from the breast, genital secretion, scanty menstruation, delayed menstruation, rupture of ovarian cyst, foul-smelling vaginal discharge, vulvar and vaginal burning sensation, vulvovaginal discomfort
• enlarged lymph nodes,
• asthma, difficulty breathing, nosebleeds
• chest pain, fatigue and general feeling of being unwell, fever
• Abnormal cervical smear (Pap test)

Further information (taken from diaries kept by women during a clinical study with Klaira) on the possible side effects “irregular periods (with heavy irregular bleeding)” and “absence of menstruation” are reported in the sections “Breakthrough bleeding” and “What to do if your period does not occur on day 26 or thereafter”.
Description of selected adverse reactions
Adverse reactions that have a very low frequency or that have a delayed manifestation and that are considered to be linked to those of combined oral contraceptives, may also occur during the use of Klaira and are listed below (see also the sections “When not to take Klaira”, “Warnings and precautions”):

• Liver tumors (benign or malignant)
• Erythema nodosum (soft red nodules under the skin), erythema multiforme (skin rash with red spots or lesions)
• Hypersensitivity (including symptoms such as rash, urticaria)
• In women with hereditary angioedema (characterized by sudden swelling, for example of the eyes, mouth, throat, etc.) the estrogens contained in combined oral contraceptives may cause or worsen the symptoms of angioedema. If liver function is impaired, it may be necessary to temporarily discontinue the use of combined contraceptive pills.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 Klaira

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is stated on the packaging after “EXP”. The expiry date
refers to the last day of that month.
Medicines should not be disposed of via 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 Klaira contains
The active ingredients are estradiol valerate, or estradiol valerate combined with dienogest.
One pack (28 film-coated tablets) of Klaira contains 26 active tablets of 4 different colours,
in the 1st, 2nd, 3rd and 4th rows and 2 white inactive tablets in the 4th row.
Composition of the coloured tablets containing one or two active ingredients:
➢ 2 dark yellow tablets containing each 3 mg of estradiol valerate,
➢ 5 red tablets containing each 2 mg of estradiol valerate and 2 mg of dienogest,
➢ 17 light yellow tablets containing each 2 mg of estradiol valerate and 3 mg of dienogest,
➢ 2 dark red tablets containing each 1 mg of estradiol valerate.
Composition of the white inactive tablets:
These tablets do not contain any active ingredient.
The excipients of the coloured tablets containing the active ingredients are:
Tablet core: lactose monohydrate, corn starch, pregelatinized corn starch, povidone K25
(E1201), magnesium stearate (E572).
Tablet coating: hypromellose type 2910 (E464), macrogol 6000, talc (E553b), titanium dioxide
(E 171), red iron oxide (E172) and/or yellow iron oxide (E172).
The excipients of the white inactive tablets are:
Tablet core: lactose monohydrate, corn starch, povidone K25 (E1201), magnesium stearate
(E572).
Tablet coating: hypromellose type 2910 (E464), talc (E553b), titanium dioxide (E171).

Description of the appearance of Klaira and contents of the pack
The tablets of Klaira are film-coated tablets; the tablet core is covered with a
coating.
One pack (28 film-coated tablets) of Klaira contains 2 dark yellow tablets in the 1st row, 5
red tablets in the 1st row, 17 light yellow tablets in the 2nd, 3rd and 4th rows, 2 dark red tablets in the
4th row and 2 white inactive tablets in the 4th row.
The dark yellow tablet is round, with biconvex faces, one of which is imprinted with the letters “DD”
within a regular hexagon.
The red tablet is round, with biconvex faces, one of which is imprinted with the letters “DJ” within a
regular hexagon.
The light yellow tablet is round, with biconvex faces, one of which is imprinted with the letters “DH”
within a regular hexagon.
The dark red tablet is round, with biconvex faces, one of which is imprinted with the letters “DN” within a
regular hexagon.
The white (inactive) tablet is round, with biconvex faces, one of which is imprinted with the letters
“DT” within a regular hexagon.
Klaira is available in packs of 1, 3 and 6 blisters, each containing 28 tablets.
Not all pack sizes may be marketed.

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

Manufacturers
➢ Bayer Weimar GmbH und Co. KG, 99427 Weimar – Germany
➢ 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, Cyprus, Czech Republic, Germany, Denmark, Estonia, Greece, Spain,
Finland, France, Ireland, Iceland, Latvia, Luxembourg, Lithuania, Malta, Netherlands, Norway,
Poland, Portugal, Romania, Sweden, Slovenia, Slovakia, Hungary: QLAIRA/Qlaira.
➢ Italy: Klaira.