DAMSEL 3 mg/2 mg /2 Mg/2 Mg/3 Mg/1 Mg/0 Mg Фильм-Coated Таблетки

Содержание инструкции

1. Damsel film-coated tablets
   1. Cos’è Damsel e a cosa serve
   2. Cosa ha bisogno di sapere prima di prendere Damsel
   3. How to take Damsel
   4. Possible side effects
   5. How to store Damsel
   6. Package Contents and Other Information

Damsel film-coated tablets

Estradiol valerate/Dienogest
Generic medicine

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

1. Cos’è Damsel e a cosa serve

• Damsel è una pillola contraccettiva e serve per prevenire la gravidanza.
• Ogni compressa attiva colorata contiene una piccola quantità di ormoni femminili, estradiolo valerato o estradiolo valerato combinato con dienogest.
• Le 2 compresse bianche non contengono alcun principio attivo e sono chiamate compresse inattive.
• Le pillole contraccettive che contengono due ormoni sono chiamate “pillole combinate”.

2. Cosa ha bisogno di sapere prima di prendere Damsel

Note generali
Prima di iniziare a usare Damsel 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 Damsel, il medico le farà alcune domande riguardo alla sua storia personale di
salute e a quella dei suoi familiari. Il medico le misurerà anche la pressione arteriosa e, in base alla
sua situazione personale, potrà anche effettuare altri esami.
Damsel o in cui l’affidabilità di Damsel può risultare diminuita. In tali situazioni non deve avere
rapporti sessuali oppure deve adottare misure contraccettive aggiuntive non ormonali, ad esempio
usare il profilattico o un altro metodo di barriera. Non usi il metodo del ritmo o il metodo della
temperatura basale. Tali metodi possono risultare inaffidabili, in quanto Damsel altera le variazioni
mensili della temperatura corporea e del muco cervicale.

Damsel, 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 Damsel
Non usi Damsel 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 prenda Damsel:

• se ha (o ha mai avuto) un coagulo sanguignoin 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 sanguigni”);
• 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:
• diabetegrave 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 mai avuto) una malattia del fegatoe la funzione del suo fegato è ancora anormale;
• se ha (o ha mai avuto) un tumore del fegato;
• se ha (o ha mai avuto) un cancro o sospetta di avere un cancro della mammella o degliorgani 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 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”.

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

• se un parente stretto ha o ha avuto un cancro della mammella;
• se ha una patologia 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 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 Damsel;
• 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 Damsel”);
• 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 Damsel 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 Damsel.

Informazioni supplementari per categorie particolari di pazienti
Utilizzo nei bambini:
L’uso di Damsel non è indicato nelle donne che non hanno ancora avuto il loro primo flusso mestruale.

COAGULI SANGUIGNI
L’uso di un contraccettivo ormonale combinato come Damsel 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 pericoloso associato a
Damsel 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: o dolore o sensibilità alla gamba che può essere avvertito solo in piedi o camminando; o maggiore sensazione di calore nella gamba colpita; o variazione del colore della pelle della gamba, come pallore, colorazione rossastra o bluastra. Trombosi venosa profonda
• mancanza di respiro improvvisa e inspiegabile o respirazione accelerata;
• 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

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 rispetto al non utilizzo di un
contraccettivo ormonale combinato.
Quando si interrompe l’assunzione di Damsel, il rischio di sviluppare un coagulo sanguigno torna ai
livelli normali entro alcune settimane.

Qual è il rischio di sviluppare un coagulo sanguigno?
Il rischio dipende dal suo rischio naturale di TEV e dal tipo di contraccettivo ormonale combinato che
sta assumendo.
Il rischio globale di sviluppare un coagulo sanguigno nella gamba o nel polmone (TVP o EP) con
Damsel è basso.

• Su 10 000 donne che non usano alcun contraccettivo ormonale combinato e che non sono incinta, circa 2 svilupperanno un coagulo sanguigno in un anno.
• Su 10 000 donne che usano un contraccettivo ormonale combinato contenente levonorgestrel, noretisterone o norgestimato, circa 5-7 svilupperanno un coagulo sanguigno in un anno.
• Il rischio di sviluppare un coagulo sanguigno con Damsel è circa lo stesso degli altri contraccettivi ormonali combinati compresi i contraccettivi contenenti levonorgestrel.
• Il rischio che si formi un coagulo sanguigno dipende dalla sua anamnesi medica (vedere sotto “Fattori che aumentano il rischio di formazione di un coagulo sanguigno”).

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

• 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, in the lung or in another organ at a young age (e.g., 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 a cast. It may be necessary to stop taking Damsel a few weeks before the operation or during the time when you are less mobile. If you have to stop taking Damsel, 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 Damsel.
If any of the above conditions change while you are using Damsel, 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 Damsel is very
low but can increase:

• as you get older (over 35 years);
• if you smoke. When using a combined hormonal contraceptive like Damsel it is advisable that you 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 severe, the risk of
developing a blood clot may be even higher.
If any of the above conditions change while you are using Damsel, 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.

Damsel 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 cancers are discovered in women who use the combined pill because they are visited more
often. The risk of breast cancer decreases gradually after stopping
combined hormonal contraception. It is important that you regularly check your breasts and must
contact your doctor if you feel any lump.
In women who use 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 a

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 Estradiol valerate/Dienogest have reported
depression or depressed mood. Depression can be severe and sometimes can lead to suicidal thoughts.
If you experience changes in mood and depressive symptoms, seek medical advice as soon as possible.
for further medical advice.

Breakthrough bleeding
During the first few months of taking Damsel, unexpected bleeding may occur. Usually the
bleeding starts on day 26, the day you take the second brown tablet, or
in the following days. The information provided by diaries kept by women during a clinical study with
Estradiol valerate/Dienogest 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 occur after a few months, the doctor must investigate the cause.

What to do if your period does not occur on day 26 or in the following days
The information provided by diaries kept by women during a clinical study with Estradiol
valerate/Dienogest 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 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 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 have ruled out pregnancy.

Other medicines and Damsel
Always inform your doctor about the medicines or herbal products you are already taking. Inform
also any other doctor or dentist who prescribes you other medicines (or the pharmacist from whom you have
received the medicine) that you are taking Damsel. They can tell you if you need to take
further contraceptive measures (for example a condom) and, if so, for how long.
Some medicines

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

These include:
o 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);
• Hepatitis C virus (HCV) (as a combination regimen with ombitasvir/paritaprevir/ritonavir with or without dasabuvir, and glecaprevir/pibrentasvir regimen) can cause increases in liver function test results (increased liver enzyme ALT) in women using COCs containing ethinylestradiol. Damsel contains estradiol instead of ethinylestradiol. It is not known whether an increase in liver enzyme ALT can occur when using Damsel with this combination regimen against HCV. Your doctor will give you the necessary instructions;
• fungal infections (e.g. griseofulvin, ketoconazole); or the herbal preparation based on St. John's wort.

Damsel can affect the effectof other medicines, for example:
o medicines containing ciclosporin;
o the antiepileptic lamotrigine (this can cause an increase in the frequency of seizures
epileptic).

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

pharmacist can tell you if you need to take additional protective measures while taking

Damsel together with other medicines.

Damsel with food
Damsel can be taken with or without food.

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

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

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

pregnancy or breastfeeding.

Driving and using machines
There is no reason to believe that Damsel affects the ability to drive vehicles or operate
machinery.

Damsel contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact your doctor before
taking Damsel.

3. How to take Damsel

Each blister contains 26 active colored tablets and 2 inactive white tablets.
Take one Damsel tablet every day. You can take the tablets with or without food, but you must
take them at about the same time each day.

Pack Preparation
To help you to respect the correct sequence, the tablets are marked on the aluminum side with
a number and an arrow indicating the order of intake. Start with tablet number 1 and follow the
direction of the arrow on the blister until you have taken all 28 tablets.
Usually, the so-called withdrawal bleeding begins when you are taking the second
brown tablet or the white tablets, and may not yet have ended before you start the next
blister. Some women still have their period even after they have already taken the first
tablets of the new blister.
Start the next blister without interruption, i.e. the day after you have finished the current blister, even if the
menstruation has not yet ended.
If you use Damsel in this way, the contraceptive action is guaranteed even during the 2 days when you are
taking the inactive tablets.

When you can start the first blister

• If you have not used a hormonal contraceptive in the previous month.Start taking Damsel on the first day of your cycle (the first day of your menstruation).
• Switching from another combined hormonal contraceptive pill, or a combined vaginal contraceptive ring, or patch.Start taking Damsel the day after the last active tablet (the last tablet containing the active ingredients) of the previous pill. When switching from a vaginal contraceptive ring or patch, start using Damsel 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, intrauterine system).You can switch any day from the progestin-only pill (from an implant or IUS on the day of its removal, from the injectable when the next injection would be due), but in all these cases you must adopt additional contraceptive measures (e.g. a condom) for the first 9 dayswhile using Damsel.
• After an abortion.Follow your doctor's advice.
• After childbirth.You can start taking Damsel between 21st and 28th dayafter delivery. If you start taking it later than the 28th day, use a barrier method (e.g. a condom) during the first 9 daysof taking Damsel. If, after childbirth, you have had intercourse before starting to take Damsel, you should rule out pregnancy or wait for your next period. If you want to start taking Damsel after pregnancy and are breastfeeding, read the paragraph “Pregnancy and breastfeeding”. Ask your doctor for advice if you are unsure when to start.

If you take more Damsel than you should
There are no reports of serious adverse effects if you take more Damsel tablets.
In the event of taking several tablets at once, you may experience nausea or vomiting. Young
girls may experience vaginal bleeding.
If you have taken too many Damsel tablets, or discover that a tablet has been taken by a
child, seek immediate medical or pharmaceutical advice.

If you forget to take Damsel
Inactive tablets: if you forget a white tablet (the two tablets at the end of the blister), you do not need to
take it later as it does not contain any active ingredient. However, it is
important to discard the forgotten white tablet(s) 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 when oneactive tablet is forgotten, you must
adopt additional contraceptive measures, such as a barrier method like a condom.

Take the tablets following the instructions below. For details see also the
"pill forgotten diagram".

• 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 next tablets at the usual time.
• If the delay in taking a tablet is more than 12 hours, contraceptive protection may be reduced. Depending on the day of the cycle when the forgetfulness occurred, you must adopt additional contraceptive measures, such as a barrier method like a condom. For detailssee also the "pill forgotten diagram".
• More than one tablet forgotten in a blister.Contact your doctor.

Do not take more than 2 active tablets in one day.
If you have forgotten to start a new blister, or if you have forgotten one or more tablets during days
3-9of the blister, there is a risk that you are 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 forget
(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
"forgotten pills diagram".
If you have forgotten any of the active tablets in a blister and have not had your period at the
end of the blister, you may be pregnant. Contact your doctor before starting the next blister.

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

What to do in case of severe vomiting or diarrhea
If you vomit within 3-4 hours of taking an active tablet, or in case of severe diarrhea, it is possible
that the active ingredients of the pill are not completely absorbed by your body.
The situation is therefore comparable to that which occurs when you forget to take a
tablet. After vomiting or severe diarrhea, take the next tablet as soon as possible. If
possible within 12 hours of 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 Damsel”. If
you do not want to change your usual taking pattern, take the corresponding tablet from
another blister.

If you stop taking Damsel
You can stop taking Damsel 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 Damsel and wait for a menstrual period before trying to conceive.
You will then be able to calculate the estimated due date more accurately.

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Damsel can cause side effects, although not everybody gets them.
If you experience any side effect, especially if severe or persistent, or if you experience any
change in your health that you think could be due to Damsel, inform your doctor.
A higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots
in the arteries (arterial thromboembolism (ATE)) is present in all women who take
combined hormonal contraceptives. For more detailed information on the different risks associated
with taking combined hormonal contraceptives, see section 2 “What you need to know before you
use Damsel”.

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

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

Common side effects (may affect between 1 and 10 users out of 100)

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

Uncommon side effects (may affect between 1 and 10 users out of 1,000)

• 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 between 1 and 10 users out of 10,000)

• candida infection, oral herpes, pelvic inflammatory disease, a vascular eye disease resembling 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
• dangerous blood clots in a vein or an artery, for example: in a leg or foot (DVT) or in a lung (PE) or heart attack or stroke or mini-stroke or temporary stroke-like symptoms, known as a transient ischemic 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).
• constipation, dry mouth, indigestion, heartburn
• liver nodules (focal nodular hyperplasia), chronic inflammation of the gallbladder
• allergic skin reactions, yellow-brown spots (cloasma) and other pigmentation disorders, male-pattern hair growth, 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 cysts, nipple discharge, polyp of the cervix, redness of the cervix, bleeding during intercourse, spontaneous milk secretion from the breast, genital discharge

swollen
lymph nodes

• asthma, difficulty breathing, nosebleeds
• chest pain, fatigue and general feeling of unwellness, fever
• Abnormal cervical smear (Pap test)

Further information (taken from diaries kept by women during a clinical study with estradiol
valerate/dienogest) on the possible side effects “irregular menstruation (heavy
irregular bleeding)” and “absence of menstruation” are reported in the sections “Intermenstrual
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 Damsel and are listed below (see also the sections “When you must not take
Damsel”, “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 contraceptive pills 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 effect, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Damsel

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 pack after “EXP”. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 Damsel Contains
The active ingredients are estradiol valerate, or estradiol valerate combined with dienogest.
Each blister (28 film-coated tablets) of Damsel contains 26 active tablets in 4 different colors
in rows 1, 2, 3 and 4 as well as 2 white inactive tablets in row 4.
Composition of colored tablets containing one or two active ingredients:
2 dark yellow tablets containing each 3 mg of estradiol valerate
5 pink 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 brown tablets containing each 1 mg of estradiol valerate
Composition of the white inactive tablets:
These tablets do not contain any active ingredient.
Other excipients of the colored active tablets are:
Tablet core: lactose monohydrate, corn starch, pregelatinized corn starch, povidone
(E1201), anhydrous colloidal silica, magnesium stearate (E572).
Tablet coating: hypromellose (E464), macrogol 6000, iron oxide red (E172), titanium
dioxide (E 171), talc (E553b), iron oxide yellow (E172).
The excipients of the white inactive tablets are:
Tablet core: lactose monohydrate, microcrystalline cellulose, magnesium stearate (E572).
Tablet coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171),
macrogol 3350, talc (E553b).

Description of the appearance of Damsel and contents of the pack
The tablets of Damsel are film-coated tablets; the tablet core is coated with
a coating.
Each blister (28 film-coated tablets) contains 2 dark yellow tablets in the 1st row, 5
pink tablets in the 1st row, 17 light yellow tablets in the 2nd, 3rd and 4th rows, 2 brown
tablets in the 4th row and 2 white inactive tablets in the 4th row.
The active dark yellow tablet is a round, biconvex, film-coated tablet, imprinted
with "L" on one side.
The active pink tablet is a round, biconvex, film-coated tablet, imprinted "L" on
one side.
The active light yellow tablet is a round, biconvex, film-coated tablet, imprinted
with "L" on one side.
The active brown tablet is a round, biconvex, film-coated tablet, imprinted "L"
on one side.
The inactive white tablet is a round, biconvex, film-coated tablet, imprinted "PL"
on one side.
Damsel is available in packs of 1, 3 or 6 blisters, each containing 28 tablets.
A cardboard box is included for storing the blister.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
S.F. GROUP S.r.l.
Via Tiburtina, 1143
00156 Rome, Italy

Manufacturers
Cyndea Pharma S.L.
Avenida Agreda 31
Polígono Industrial Emiliano Revilla Sanz
Ólvega, Soria
42110 Spain

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Sweden:Rubinia

Italy:Damsel