GRACIAL Coated tablet

Содержание инструкции

1. Gracial tablets
   1. COSA DEVE SAPERE PRIMA DI PRENDERE GRACIAL
   2. POSSIBLE SIDE EFFECTS
   3. HOW TO STORE GRACIAL
   4. PACKAGE CONTENTS AND OTHER INFORMATION

Gracial tablets

Desogestrel/Ethinylestradiol

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

• They are one of the most reliable reversible methods of contraception, if used correctly.
• They slightly increase the risk of blood clots forming in veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
• Pay attention and see a doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

Read this leaflet carefully before using this medicine as it contains
important information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to other people, 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.

Contents of this leaflet:

1. What Gracial is and what it is used for

2. What you need to know before you take Gracial

3. How to take Gracial

4. Possible side effects

5. How to store Gracial

6. Contents of the pack and other information

1. WHAT GRACIAL IS AND WHAT IT IS USED FOR

Composition and type of pill
Gracial is a combined oral contraceptive, also known as the pill. Each tablet contains a
small amount of two different female hormones. These are desogestrel (a progestin)
and ethinylestradiol (an estrogen).
Considering the low concentration of hormones, Gracial is considered a low-dose
oral contraceptive. Because the hormones are present in different dosages in the blue tablets
than in the white tablets, Gracial is considered a biphasic combined oral contraceptive.

Why to use Gracial
Gracial is used for the prevention of pregnancy.
When used correctly (without forgetting any tablets), the possibility of pregnancy is
very low.
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2. COSA DEVE SAPERE PRIMA DI PRENDERE GRACIAL

Note generali
Prima di iniziare a usare Gracial 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”).

Non usi Gracial
Non usi Gracial 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.

• se ha (o ha mai avuto) un coagulo sanguigno in un vaso della gamba (trombosi venosa profonda, TVP), del polmone (embolia polmonare, EP) o di altri organi;
• se sa di avere un disturbo che colpisce la coagulazione del sangue, come carenza di proteina C, carenza di proteina S, carenza di antitrombina-III, fattore V di Leiden o anticorpi antifosfolipidi;
• se deve sottoporsi a un’operazione o se starà coricata per un lungo periodo (vedere paragrafo “Coaguli sanguigni”);
• se ha mai avuto un attacco cardiaco o un ictus;
• se ha (o ha mai avuto) un’angina pectoris (una condizione che causa un forte dolore al torace e che può rappresentare un primo segno di attacco cardiaco) o un attacco ischemico transitorio (TIA - sintomi di ictus temporaneo);
• se ha una delle seguenti malattie, che potrebbe aumentare il rischio che si formino coaguli nelle arterie:
• diabete grave con lesione dei vasi sanguigni
• pressione arteriosa molto alta
• livello molto alto di grassi (colesterolo o trigliceridi) nel sangue
• una malattia nota come iperomocisteinemia
• se ha (o ha mai avuto) un tipo di emicrania chiamata “emicrania con aura”;
• se presenta o ha sofferto in passato di pancreatite (infiammazione del pancreas) associata a livelli elevati di grassi nel sangue;
• se presenta ittero (ingiallimento della pelle) o soffre di grave malattia epatica;
• se presenta o ha sofferto in passato di un tipo di cancro che si accresce sotto l’influenza di ormoni sessuali (quale tumore della mammella o degli organi genitali);
• se presenta o ha sofferto in passato di tumori del fegato;
• se presenta sanguinamento vaginale di origine sconosciuta;
• se presenta iperplasia endometriale (crescita anormale del rivestimento interno dell’utero);
• se è incinta o sospetta di essere incinta;
• se è allergica ai principi attivi o ad uno qualsiasi dei componenti di Gracial.

Se una qualunque di queste condizioni compare per la prima volta durante l’uso della pillola, ne
sospenda immediatamente l’assunzione ed informi il medico. Nel frattempo faccia uso di metodi
contraccettivi non ormonali. Vedere anche paragrafo “Note generali”.
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Non usi Gracial se ha l'epatite C e sta prendendo medicinali contenenti
ombitasvir/paritaprevir/ritonavir e dasabuvir o glecaprevir/pibrentasvir (vedere anche il
paragrafo Altri medicinali e Gracial).

Quando fare particolarmente attenzione con Gracial
Note generali
l’assunzione della pillola o nelle quali può verificarsi una riduzione dell’efficacia della pillola. In
queste situazioni non deve avere rapporti sessuali o deve adottare precauzioni contraccettive
aggiuntive non ormonali, quali l’uso del profilattico o di altro metodo di barriera. Non usare i
metodi del ritmo o della temperatura basale. Questi metodi possono risultare non affidabili
poiché la pillola altera le normali modificazioni della temperatura e del muco cervicale che si
verificano durante il ciclo mestruale.
Quando deve rivolgersi a un medico?
Si rivolga urgentemente a un medico

• se osserva segni possibili di un coagulo sanguigno che possono indicare che soffre di un coagulo sanguigno nella gamba (trombosi venosa profonda), di un coagulo sanguigno nel polmone (embolia polmonare), di un attacco cardiaco o di un ictus (vedere il paragrafo seguente “Coagulo sanguigno (trombosi)”). Per una descrizione dei sintomi di questi gravi effetti indesiderati vada al paragrafo “Come riconoscere un coagulo sanguigno”.

Gracial, così come tutte le pillole contraccettive, non protegge nei confronti dell’infezione da
HIV (AIDS) o di qualunque altra malattia a trasmissione sessuale.
Gracial non deve essere normalmente utilizzato per posticipare una mestruazione. Tuttavia, se in
casi eccezionali fosse necessario posticipare una mestruazione, contatti il proprio medico.

Informi il medico se una qualsiasi delle seguenti condizioni si applica al suo caso.
Se questa condizione compare o peggiora mentre sta usando Gracial deve informare il medico.

• Se manifesta sintomi di angioedema quali gonfiore di viso, lingua e/o gola e/o difficoltà di deglutizione o orticaria con possibile difficoltà di respirazione, contatti immediatamente il medico. I prodotti contenenti estrogeni possono causare o peggiorare i sintomi dell’angioedema ereditario o acquisito.
• se fuma;
• se ha il diabete;
• se è sovrappeso;
• se ha la pressione sanguigna alta;
• se ha un disturbo della valvola cardiaca o alcuni disturbi del ritmo cardiaco;
• se ha un’infiammazione delle vene poste sotto la pelle (tromboflebite superficiale);
• se ha le vene varicose;
• se ha precedenti nei familiari prossimi di trombosi, attacco cardiaco o ictus;
• se soffre di emicrania;
• se soffre di depressione;
• se soffre di epilessia;

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• se ha malattie epatiche o della colecisti;
• se ha la malattia di Crohn o la colite ulcerosa (malattia intestinale infiammatoria cronica);
• se ha il lupus eritematoso sistemico (LES; una malattia che colpisce il sistema di difese naturali);
• se ha la sindrome emolitica uremica (SEU, un disturbo della coagulazione del sangue che causa insufficienza renale);
• se ha l’anemia falciforme (una malattia ereditaria dei globuli rossi);
• se ha 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 Gracial;
• se qualcuno dei suoi familiari prossimi ha avuto un tumore della mammella;
• se ha disturbi che sono comparsi per la prima volta o si sono aggravati in corso di gravidanza o a seguito di precedente terapia con ormoni sessuali (ad es. perdita dell’udito, una malattia chiamata porfiria, una malattia della pelle denominata herpes gestationis, una malattia denominata Corea di Sydenham);
• se ha o ha mai avuto il cloasma (chiazze sulla pelle a pigmentazione bruno-giallognola, in particolare sul viso). In tal caso evitare l’eccessiva esposizione al sole o ai raggi ultravioletti.

Disturbi psichiatrici
Alcune donne che usano contraccettivi ormonali tra cui Gracial hanno segnalato depressione o
umore depresso. La depressione può essere grave e a volte può portare a pensieri suicidari. Se si
verificano cambiamenti d’umore e sintomi depressivi, si rivolga al più presto al medico per
ricevere ulteriori consigli medici.
In caso di prima comparsa, recidiva o peggioramento di una qualunque delle suddette condizioni
durante l’uso della pillola, consulti il medico.

Pillola e trombosi
COAGULI SANGUIGNI
L’uso di un contraccettivo ormonale combinato come Gracial 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.
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È importante ricordare che il rischio globale di un coagulo sanguigno dannoso associato a
Gracial è basso.
COME RICONOSCERE UN COAGULO SANGUIGNO
Si rivolga immediatamente a un medico se nota uno qualsiasi dei seguenti segni o sintomi.
Presenta uno di questi segni? Di cosa soffre
probabilmente?

• gonfiore a una gamba o lungo una vena della gamba o del piede, specialmente se accompagnato da:
• dolore o sensibilità alla gamba che può essere Trombosi venosa profonda

avvertito solo in piedi o camminando

• maggiore sensazione di calore nella gamba colpita
• variazione del colore della pelle della gamba, come pallore, colorazione rossastra o bluastra
• mancanza di respiro o respirazione accelerata improvvisi e inspiegabili;
• tosse improvvisa senza una causa evidente, con possibile emissione di sangue;
• dolore acuto al torace che può aumentare quando si respira profondamente;
• stordimento grave o capogiri;
• battito cardiaco accelerato o irregolare;
• forte dolore allo stomaco.

Se non è sicura, informi il medico in quanto alcuni di
questi sintomi come la tosse o la mancanza di respiro
possono essere scambiati per una condizione più lieve
come un’infezione delle vie respiratorie (ad es. un
“comune raffreddore”).
Embolia polmonare
Sintomi che si verificano più frequentemente in un
occhio:

• perdita immediata della vista o
• offuscamento indolore della vista che può progredire a perdita della vista Trombosi della vena retinica (coagulo sanguigno nell’occhio)
• dolore, fastidio, sensazione di pressione o di pesantezza al torace;
• sensazione di schiacciamento o di pienezza al torace, a un braccio o sotto lo sterno;
• sensazione di pienezza, indigestione o soffocamento;
• fastidio alla parte superiore del corpo, che si irradia a schiena, mascella, gola, braccia e stomaco;
• sudorazione, nausea, vomito o capogiri;
• estrema debolezza, ansia o mancanza di respiro;
• battiti cardiaci accelerati o irregolari. Attacco cardiaco
• intorpidimento o debolezza improvvisa del viso, di un Ictus 5 di 18

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 Gracial, il rischio di sviluppare un coagulo sanguigno torna
ai livelli normali entro alcune settimane.
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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
Gracial è basso.

• Su 10.000 donne che non usano alcun contraccettivo ormonale combinato e che non sono incinta, circa 2 svilupperanno un coagulo sanguigno in un anno.
• Su 10.000 donne che usano un contraccettivo ormonale combinato contenente levonorgestrel, noretisterone o norgestimato, circa 5-7 svilupperanno un coagulo sanguigno in un anno.
• Su 10.000 donne che usano un contraccettivo ormonale combinato contenente desogestrel, come Gracial, circa 9-12 svilupperanno un coagulo sanguigno in un anno.
• Il rischio che si formi un coagulo sanguigno dipende dalla sua anamnesi medica (vedere sotto “Fattori che aumentano il rischio di formazione di un coagulo sanguigno”).

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

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

• as you get older (over 35 years);
• if you smoke. When using a combined hormonal contraceptive like Gracial, it is advisable to quit smoking. If you cannot quit smoking and you are over 35 years old, your doctor may advise you to use a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under about 50 years). In this case you may also be at high risk of heart attack or stroke;
• if you, or a close relative, 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 Gracial, 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.
Very rarely, thrombosis can cause serious permanent disability or may be fatal.

Pill and cancer
Breast cancer is diagnosed slightly more frequently in women who use the pill compared to those who do not. This slight increase in risk gradually disappears within 10 years of stopping use of the pill. It is not known whether the pill is the cause of this difference. This may be due to the fact that women are visited by the doctor much more often and therefore cancer of the breast is likely to be diagnosed earlier.
In women who use the pill, benign and, even more rarely, malignant liver tumors have been observed. These tumors can cause internal bleeding.
Contact your doctor immediately if you experience any severe abdominal pain.
Cervical cancer is caused by a human papillomavirus (HPV) infection. It is more common in women who use the pill for a long time. It is not known whether this is due to the use of hormonal contraceptives or sexual behavior or other factors (such as improved cervical screening).

Other medicines and Gracial
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines or herbal remedies, including those available without a prescription. This will allow them to tell you whether and for how long you need to use additional contraceptive methods.
Some medicines can affect the levels of Gracial in the blood and make it less effective in preventing pregnancyor cause unexpected bleeding.
These include medicines for the treatment of

• epilepsy and narcolepsy (e.g., primidone, hydantoins, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate, modafinil);
• tuberculosis (e.g., rifampicin, rifabutin);
• HIV or Hepatitis C infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz) and/or combinations with medicines against hepatitis C virus (HCV) (e.g. boceprevir, telaprevir) or other infections (griseofulvin);
• high blood pressure in the blood vessels of the lungs (bosentan) and St. John's wort preparations (Hypericum perforatum), used especially for the treatment of depression. The pill can also interfere with the activity of other medicines (e.g. cyclosporine and lamotrigine).

The simultaneous administration of strong CYP3A4 enzyme inhibitors (e.g. ketoconazole, itraconazole, clarithromycin) or moderate CYP3A4 enzyme inhibitors (e.g. fluconazole, diltiazem, erythromycin) may increase blood concentrations of estrogens or progestogens, including etonogestrel, the active metabolite of desogestrel.
Do not use Gracial if you suffer from Hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir as this may cause increases in blood test results for liver function (increased liver enzyme ALT).
Your doctor will prescribe another type of contraceptive before starting treatment with these medicines.
Gracial can be started again about 2 weeks after the end of this treatment. See section “Do not use Gracial”.
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Laboratory tests
If you need a blood test, tell your doctor or the laboratory that you are taking the pill, as oral contraceptives can affect the results of some blood tests.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Gracial must not be used by women who are pregnant or suspect they are pregnant. If you suspect you are pregnant while taking Gracial, you should stop taking it immediately and contact your doctor as soon as possible.

Breastfeeding
The use of Gracial is not recommended during breastfeeding. If you wish to take the pill while breastfeeding, you should consult your doctor.

Driving and operating machinery
Gracial does not affect the ability to drive or operate machinery.

Gracial contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this medicine.

When to contact your doctor
Periodic checks
While using the pill, your doctor will ask you to attend periodic check-up visits. In general, you should have a check-up at least once a year.

Contact your doctor as soon as possible if:

• you notice any change in your health, especially with regard to

“What you need to know before using Gracial”. Do not forget changes in the health of your close relatives);

• you feel a lump in your breast;
• you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives together with difficulty breathing;
• you need to use other medicines (see also section “Other medicines and Gracial”);
• you need to be immobilized or undergo surgery (inform your doctor at least four weeks before);
• you experience heavy and unusual vaginal bleeding;
• you forgot to take the tablets during the first week of the pack and had sexual intercourse in the 7 days before;
• you have severe diarrhea;
• you have not had your period for two consecutive cycles or suspect you are pregnant (do not start 10 of 18

a new pack without first consulting your doctor).

Stop taking the tablets and see your doctor immediately if you notice possible signs of thrombosis such as:

• unusual cough;
• severe chest pain that may radiate to the left arm;
• shortness of breath;
• unusual, severe or prolonged headache or a migraine attack;
• partial or total loss of vision or double vision;
• slurred speech or inability to speak;
• sudden changes in hearing, smell and taste;
• dizziness or fainting;
• weakness or numbness of any part of the body;
• severe abdominal pain;
• severe pain or swelling in a leg.

Use in children and adolescents
There are no clinical data on efficacy and safety in children and adolescents under 18 years of age.

3HOW TO TAKE GRACIAL
When and how to take the tablets
Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, ask your doctor or pharmacist.
The pack of Gracial contains 22 tablets: 7 blue tablets (marked with numbers 1-

• 7) and 15 white tablets (marked with numbers 8-22). Take one tablet every day at about the same time, if necessary with a little water. Each time you start a new pack of Gracial, always start with the blue tablet number 1 in the top left corner of the blister. Mark the day of the week you start taking the pill by indenting the aluminum foil of the corresponding cell. This way you can easily check that the tablets have been taken correctly. Follow the direction of the arrows until all 22 tablets have been used up. First take all the blue tablets, then all the white ones. Do not take pills for 6 days afterwards. Your period should occur during these 6 days (withdrawal bleeding). It usually starts 2-3 days after taking the last Gracial tablet. Start the new pack on the seventh day, even if your period has not yet ended. This way you will always start the new pack on the same day of the week and the withdrawal bleeding will occur approximately on the same days of the week each month.

How to start the first pack of Gracial
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• If you have not used any hormonal contraceptive pill in the previous month.Start taking Gracial on the first day of your cycle, that is, the first day of your period. Gracial is effective immediately. You therefore do not need additional contraceptive methods.

You can also start between the second and fifth day of your cycle, but in this case you must use an
additional contraceptive method (barrier method) for the first 7 days of taking the
tablets in the first cycle.

• Switching from another combined hormonal contraceptive (from combined oral contraceptive pill, vaginal contraceptive ring or transdermal patch)You can start taking Gracial the day after the last pill of the previous contraceptive (that is, without observing any pill-free interval). If the previous contraceptive pack also contains inactive tablets, you can take Gracial the day after taking the last active tablet (in case of doubt, ask your doctor or pharmacist). You can also start later, but no later than the day after the pill-free interval (or the day after the last inactive tablet) of the previous contraceptive. If you use a vaginal ring or a transdermal patch, it is preferable to start taking Gracial on the same day as removing the ring or patch. You can also start, at the latest, on the day scheduled for the next application of the ring or patch.

If you have used the pill, patch or ring consistently and correctly and if you are sure you are not
pregnant, you can also stop taking the pill or remove the ring or patch on
any day and start using Gracial immediately.
If you follow these instructions, you do not need to use additional contraceptive methods.

• Switching from a progestin-only pill (mini-pill)You can stop taking the mini-pill on any day and start taking Gracial the next day, at the same time. However, if you have sexual intercourse, use an additional contraceptive method (barrier method) for the first 7 days of taking Gracial.
• Switching from a progestin-only injectable contraceptive or implant or from a progestin-releasing intrauterine device (IUS)You can start taking Gracial when the next injection is due or on the day the implant or IUS is removed. However, if you have sexual intercourse, use an additional contraceptive method (barrier method) for the first 7 days of taking Gracial.
• After childbirthAfter having a baby, your doctor may tell you to wait until your first normal menstrual period before starting to use Gracial. Sometimes it is possible to start even earlier. Your doctor will give you instructions. If you are breastfeeding and want to use Gracial, talk to your doctor first.
• After a spontaneous or induced abortionYour doctor will give you instructions.

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If you have taken too many Gracial tablets (overdose)
No serious adverse effects have been reported after taking many Gracial tablets at once.
If you have taken more tablets at the same time, you may experience nausea, vomiting or
vaginal bleeding.

If you discover that a child has taken Gracial, contact your doctor for instructions.

WHAT TO DO IF…
…you forget to take the tablets
If less than 12 hourshave passed since the usual time of taking, the reliability of the pill is
maintained. Take the forgotten tablet as soon as you remember and then take the
tablets subsequently as usual.
If more than 12 hourshave passed since the usual time of taking, the reliability of the pill may
be reduced. The more tablets you forget to take consecutively,
the greater the risk that the contraceptive effect is reduced.
The risk of pregnancy is particularly high if you forget pills at the beginning and end
of the pack. Therefore, you must follow the instructions below (see also the
scheme below).

If you have forgotten to take more than one tablet from a pack
Contact your doctor for instructions.

If you have forgotten 1 tablet during the first week
Take the tablet as soon as you remember (even if this means taking two tablets
at the same time) and continue as usual. Use additional contraceptive methods (barrier method) for the next 7 days.
If you had sexual intercourse in the week before forgetting, there is a possibility
that you may have become pregnant. Contact your doctor immediately.

If you have forgotten 1 tablet during the second week
Take the forgotten tablet as soon as you remember (even if this means taking two
tablets at the same time) and continue as usual. The contraceptive safety
of the pill is maintained. No further contraceptive measures are necessary.

If you have forgotten 1 tablet during the third week (8 days)
You can choose one of the following alternatives, without the need for additional contraceptive
precautions.

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

Or

• 2. Stop taking the tablets from the pack in use, and observe an interval of 6 days or less ( including the day the tablet was forgotten) and continue with a new pack. If you choose this alternative, you can start the new pack on the same day of the week as you usually start. 13 of 18

If you have forgotten to take one or more tablets from a pack and your period does not occur during the first pill-free interval, it is possible that you have become
pregnant. In this case, you should contact your doctor before starting the new pack.

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…….if you suffer from gastrointestinal disorders (such as vomiting or severe diarrhea)
If you vomit or have severe diarrhea, the active ingredients of the Gracial tablet may not be
completely absorbed. If you vomit within 3-4 hours of taking the tablet, this is a
similar situation to a forgotten tablet. You must follow the instructions provided for
forgotten tablets. In case of severe diarrhea, contact your doctor.

.......if you want to postpone the day your period starts
You can postpone the start of your period if you start taking the white tablets from a
new pack of Gracial immediately after finishing the pack in use. You can
continue with the new pack for as long as you want, up to the end of the second
pack (maximum 15 days). When you want your period to start, stop
taking the tablets. During the use of the second pack, you may experience some
breakthrough bleeding or spotting during the taking of the tablets. Start the next pack
after the usual 6-day pill-free interval.

.......if you want to change the day your period starts
If you take the tablets correctly, you will have your period approximately on the same day every
4 weeks. If you want to change this day, you should only shorten (never lengthen) the next
period of the pill-free interval. For example, if your period usually appears on
Friday and you want it to appear on Tuesday in the future (3 days earlier), you must
start the next pack 3 days earlier than usual. If you shorten your pill-free interval by a lot (for example, 3 days or less), you may not have bleeding during
that interval. You may have breakthrough bleeding or spotting during the use of the
next pack.

……if you have unexpected bleeding
With all oral contraceptives, in the first few months of taking, you may have irregular vaginal
bleeding (spotting or breakthrough bleeding) between periods. You may need to use sanitary pads; but you must continue to take the tablets normally.
Usually irregular bleeding disappears once the body gets used to
the pill (usually after about 3 months). Consult your doctor if the bleeding persists, becomes
heavy or recurs at intervals.

……if your period is missed
If you have taken all the tablets correctly and have not vomited or taken any other
medicines, it is very unlikely that you have become pregnant. Continue to take
Gracial as usual.
If your period does not occur for two consecutive times, it is possible that you have become
pregnant. Contact your doctor immediately. Do not start the new pack of Gracial until
your doctor has ruled out pregnancy .

If you want to stop using Gracial
You can stop taking Gracial at any time. If you still want to avoid a
pregnancy, consult your doctor for advice on other methods of birth control.
If you want to stop taking Gracial to become pregnant, you should wait for
the appearance of a natural period before starting to try to conceive. This will help
you determine when the baby will be born.
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4. POSSIBLE SIDE EFFECTS

Like all medicines, Gracial can cause side effects, although not everybody gets them.
If you experience any side effect, especially if severe or persistent, or if any change in your
health occurs that you think could be due to Gracial, 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 taking Gracial”.
As with all COCs, changes in vaginal bleeding characteristics may occur, especially during the first
few months of treatment. These changes may include changes in frequency (absent, reduced,
more frequent or continuous), intensity (reduced or increased) or duration of bleeding.
Serious reactions associated with the use of the pill and related symptoms are described in the
sections “The pill and thrombosis” and “The pill and cancer”.
Serious side effects
Contact your doctor immediately if you experience any of the following symptoms of
angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with
possible difficulty breathing (see also “Warnings and precautions”).
The following side effects have been observed in women using the pill:
Common (may affect more than 1 in 100 women):

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

Not common (may affect more than 1 in 1,000 women and less than 1 in 100 women):

• fluid retention
• decreased libido
• migraine
• vomiting, diarrhea
• skin reactions, urticaria
• breast enlargement.

Rare (may affect less than 1 in 1,000 women):

• harmful blood clots in a vein or an artery, for example: o in a leg or foot (DVT)

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o in a lung (PE)
o heart attack
o stroke
o mini-stroke or temporary symptoms similar to those of a stroke, known as a transient
ischemic attack (TIA)
o blood clots in the liver, stomach/intestine, kidneys or eye.
The possibility of developing a blood clot may be higher if you have any other condition that
increases this risk (see section 2 for more information on conditions that increase the risk of
blood clots and the symptoms of a blood clot).

• hypersensitivity reactions
• increased libido
• intolerance to contact lenses
• erythema nodosum, erythema multiforme (skin diseases)
• breast secretion, vaginal secretion
• weight loss.

Following the instructions contained in the package leaflet reduces the risk of side
effects.

Reporting of side effects
If you get any side effects, 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 http://
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 GRACIAL

Do not use this medicine after the expiry date which is reported on the pack after Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C. Do not freeze. Store in the original packaging to protect the medicine from light and moisture.
Do not use this medicine if there are changes in the colour of the tablets, crumbling of the tablets or any other visible sign of deterioration.
Keep this medicine out of the sight and reach of children.
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.
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6. PACKAGE CONTENTS AND OTHER INFORMATION

What Gracial contains
The active ingredients are:
blue tablets: desogestrel (0.025 mg) and ethinylestradiol (0.040 mg)
white tablets: desogestrel (0.125 mg) and ethinylestradiol (0.030 mg)
The other ingredients are:
blue tablets: anhydrous colloidal silica, lactose monohydrate, potato starch,
povidone, stearic acid, alpha-tocopherol and indigotin (E132);
white tablets: anhydrous colloidal silica, lactose monohydrate, potato starch,
povidone, stearic acid and alpha-tocopherol.

Description of the appearance of Gracial and package contents
Gracial is available in packs of 1 and 3 blisters of 22 tablets (7 blue tablets and
15 white tablets), inserted in an aluminum pouch and packaged in a carton.
The tablets are biconvex, round and have a diameter of 6 mm. Each tablet is
identified with TR8 (white tablet) or TR9 (blue tablet) on one side and are smooth on the other
side.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24
Ireland
Tel: 0039 0687502429

Manufacturer:
Organon (Ireland) Ltd, Drynam Road, PO BOX 2857, Swords, Dublin (Ireland)

Alternative manufacturer for packaging and final control
Cyndea Pharma, S.L, Polígono Industrial Emiliano Revilla Sanz, Avenida de Ágreda, 31 Ólvega
42110 (Soria), Spain
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