PRACTIL 0.15 mg/0.03 mg Таблетки

Содержание инструкции

1. Practil 0,15 mg + 0,03 mg tablets
   1. What is Practil and what is it used for
   2. Cosa deve sapere prima di prendere Practil
   3. How to take Practil
   4. Possible side effects
   5. How to store Practil
   6. Contents of the pack and other information

Practil 0,15 mg + 0,03 mg 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 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 any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Practil and what is it used for

Composition and type of pill
Practil is a combined oral contraceptive pill to be taken by mouth. Each tablet contains a
small amount of two different female hormones. These are desogestrel (a progestin) and
ethinylestradiol (an estrogen).
Due to the low hormone content, Practil is considered a low-dose oral contraceptive. Because all the tablets in the pack contain the same hormones in the same
dosage, Practil is considered a single-phase combined oral contraceptive.

Why use Practil
Practil is used to prevent pregnancy.
When used correctly (without forgetting any tablets) the chance of pregnancy is very
low.

2. Cosa deve sapere prima di prendere Practil

Note generali
Prima di iniziare a prendere Practil 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 prenda Practil
Non prenda Practil 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
contraccettivi che potrebbero essere più adatti al suo caso.

• se è allergico ai principi attivi o ad uno qualsiasi degli altri componenti di questo medicinale (elencati al paragrafo 6);
• 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 “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 soffre o ha sofferto in passato di pancreatite (un’infiammazione del pancreas) associata a livelli elevati di sostanze grasse nel sangue;
• se soffre di ittero (ingiallimento della pelle) o di una grave malattia epatica (del fegato);
• se ha o ha mai avuto un cancro che può accrescersi sotto l’influenza di ormoni sessuali (ad esempio della mammella o degli organi genitali);
• se ha o ha mai avuto un tumore epatico;
• se ha un qualsiasi tipo di sanguinamento vaginale di origine sconosciuta;
• se ha iperplasia endometriale (crescita anormale del rivestimento interno dell’utero);
• se è in gravidanza o sospetta di essere in gravidanza;
• se ha l’epatite C e se sta assumendo medicinali contenenti ombitasvir/paritaprevir/ritonavir e dasabuvir o glecaprevir/pibrentasvir (vedere anche paragrafo “Altri medicinali e Practil”).

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”.

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

Note generali
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 preservativo o di altro metodo di barriera. Non usi 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 “Coaguli sanguigni (trombosi)”).

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

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

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

• 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;
• 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 Practil;
• 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 esempio 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.

In caso di prima comparsa, o di ricomparsa 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 Practil causa un aumento del rischio di
sviluppare un coagulo sanguigno rispetto al non utilizzo. In rari casi un coagulo sanguigno può
bloccare i vasi sanguigni e causare problemi gravi.
I coaguli sanguigni possono svilupparsi

• nelle vene (condizione chiamata “trombosi venosa”, “tromboembolia venosa” o TEV)
• nelle arterie (condizione chiamata “trombosi arteriosa”, “tromboembolia arteriosa” o TEA).

La guarigione dai coaguli sanguigni non è sempre completa. Raramente, si possono verificare effetti
gravi di lunga durata o, molto raramente, tali effetti possono essere fatali.

È importante ricordare che il rischio globale di un coagulo sanguigno dannoso associato a
Practil è basso.
COME RICONOSCERE UN COAGULO SANGUIGNO
Si rivolga immediatamente a un medico se nota uno qualsiasi dei seguenti segni o sintomi.
Presenta uno di questi segni? Di cosa soffre
probabilmente?

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

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 braccio o di una gamba, soprattutto su un lato del corpo;
• improvvisa confusione, difficoltà a parlare o a comprendere;
• improvvisa difficoltà a vedere con uno o con entrambi gli occhi;
• improvvisa difficoltà a camminare, capogiri, perdita dell’equilibrio o della coordinazione;
• improvvisa emicrania, grave o prolungata, senza causa Ictus

COAGULI SANGUIGNI IN UNA VENA
Cosa può accadere se si forma un coagulo sanguigno in una vena?

• L’uso di contraccettivi ormonali combinati è stato correlato a un aumento del rischio di formazione di coaguli sanguigni nelle vene (trombosi venosa). 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 Practil, 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
Practil è basso.

• Su 10.000 donne che non usano alcun contraccettivo ormonale combinato e che non sono in gravidanza, 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 Practil, 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 sviluppare un coagulo sanguigno”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Practil 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 (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 Practil a few weeks before surgery or during the period when you are less mobile. If you need to stop taking Practil, 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 conditions of this
type.
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 Practil.
If any of the above conditions change while you are using Practil, 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 a stroke.

Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of Practil is very
low but may increase:

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

If you have more than one of these conditions or if one of them is particularly severe, the risk of
developing a blood clot may be even higher.
If any of the above conditions change while you are using Practil, 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 with a slightly higher frequency in women
who use the pill compared to those who do not use it. This slight increase in risk disappears
gradually within 10 years after 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
much more often and therefore breast cancer is likely to be diagnosed earlier.
In women who use the pill, benign liver tumors 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
frequent 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 better control of the
cervix).

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

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

Other medicines and Practil
Always inform your doctor about any medicines or herbal products you are already using. Also inform
all other doctors or dentists (or the pharmacist) who prescribe other medicines that you are
taking Practil, so that they can tell you if you need to use additional contraceptive precautions (for example a condom) and, if so, for how long, or if the use of another medicine you need must be changed.
Do not use Practil if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir as these products can
cause increases in blood test values for liver function (increased liver enzymes ALT).
The doctor will prescribe you another type of contraceptive before starting treatment with these
medicines.
Practil can be resumed approximately 2 weeks after the end of this treatment. See
section “Do not take Practil”.
Some medicines

• can affect the blood levels of Practil
• can determine a decrease in contraceptive efficacy
• can cause unexpected bleedingThese include medicines used for the treatment:
• of epilepsy (e.g., primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate);
• of tuberculosis (e.g., rifampicin, rifabutin);
• of HIV infection (e.g., ritonavir, nelfinavir, nevirapine, efavirenz);
• of hepatitis C virus infection (e.g., boceprevir, telaprevir);
• of other infectious diseases (e.g., griseofulvin);
• of high blood pressure in the blood vessels of the lungs (bosentan);
• of depressed mood (St. John's wort herbal remedy).

If you are taking medicines or herbal products that may lead to a reduction
in the effectiveness of Practil, you must also use a barrier method of contraception. Because the effect of other
medicines on Practil can last up to 28 days after their discontinuation, an
additional barrier method of contraception must be used for the entire period.
Practil can influencethe effect ofother medicines, e.g.

• medicines containing cyclosporine
• the antiepileptic lamotrigine (this can lead to an increase in the frequency of seizures).

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
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Practil must not be used by pregnant women or women who suspect they are pregnant. If you suspect
you are pregnant while taking Practil, you should stop treatment immediately and
contact your doctor as soon as possible.

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

Driving and using machines
Practil does not affect the ability to drive vehicles or use machines.

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

When to contact your doctor
Periodic checks
During the use of 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 status, in particular with regard to

“What you need to know before taking Practil”. Do not forget changes in the health status 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 Practil”);
• you need to be immobilized or undergo surgery (inform your doctor at least 4 weeks before);
• you experience heavy and unusual vaginal bleeding;
• during the first week you forgot to take the tablets contained in the pack and had sexual intercourse in the seven days before;
• you suffer from severe diarrhea;
• you have not had your period for two consecutive cycles or suspect you are pregnant (do not start a new pack without first consulting your doctor).

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

• unusual cough;
• severe chest pain that may spread 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.

3. How to take Practil

Take this medicine always exactly as your doctor or pharmacist has told you. If
you have doubts, ask your doctor or pharmacist.

When and how to take the tablets
The Practil pack contains 21 tablets, all marked with the day of the week on which each one must be taken.
Take one tablet every day at about the same time, if necessary with a little water. Follow the
direction of the arrows until all 21 tablets have been taken.
Do not take pills for the next 7 days.
Your period should occur during these 7 days (withdrawal bleeding). In
general, it starts 2-3 days after taking the last Practil tablet.
Start the new pack on the eighth day, even if your period has not yet started. By
doing so, 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.

Use in children and adolescents
Clinical data on efficacy and safety in adolescents under 18 years of
age are not available.

How to start the first pack of Practil

• If you have not used any hormonal contraceptive pill in the previous month.Start taking Practil on the first day of your cycle, i.e. the first day of your period, taking the tablet marked with that day of the week. Then continue in the order indicated by the arrows. Practil is effective immediately. You therefore do not need any 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 (combined oral contraceptive pill, vaginal contraceptive ring or transdermal patch)You can start taking Practil the day after the last pill of the previous contraceptive (i.e. without observing any pill-free interval). If the previous contraceptive pack also contains inactive pills, you can take Practil the day after taking the last active pill (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 pill) of the previous contraceptive. If you use a vaginal ring or a transdermal patch, it is preferable to start taking Practil on the same day as removing the ring or patch. You can start, at the latest, also on the day scheduled for the next application of the ring or patch.

If you have used the pill, patch or ring 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 Practil 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 the mini-pill on any day and start taking Practil 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 Practil.
• Switching from a progestin-only injectable contraceptive or implant orfrom a progestin-releasing intrauterine device (IUS)You can start taking Practil 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 Practil.
• After childbirthAfter having a baby, your doctor may tell you to wait until your first normal menstrual period before starting to use Practil. Sometimes it is possible to start even earlier. Your doctor will give you instructions. If you are breastfeeding and want to use Practil, talk to your doctor first.
• After a spontaneous or induced abortionYour doctor will give you instructions.

If you take more Practil than you should
No serious harmful effects have been reported after taking many Practil 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 takenPractil, contact your doctor for instructions.

If you forget to take Practil
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
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 the pills at the beginning and end of
the pack. Therefore, you must follow the instructions below (see also the diagram
below).

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

If you forgot 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 methods) for the next 7 days.
If you had sexual intercourse in the week before the missed dose, there is a possibility that you
have become pregnant. Contact your doctor immediately.

If you forgot 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 forgot 1 tablet during the third week
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 the new pack as soon as you have finished the current one, withoutan 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, observe an interval of 7 days or less ( including the day the pill was forgotten) and then 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 do. If you forget to take one or more tablets from a pack and your period does not occur in the first pill-free interval, you may be pregnant. In this case, you should contact your doctor before starting the new pack.

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

.......if you want to postpone the start of your period
You can postpone the start of your period if you start taking the tablets from a new
pack of Practil immediately after finishing the pack in use. You can continue with the
new pack as long as you want, up to the end of the second pack. When you want
your period to start, stop taking the tablets. During the use of the second
pack, you may experience breakthrough bleeding or spotting while taking the
tablets.

.......if you want to change the start day of your period
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 must only shorten (never lengthen) the next
period of the pill-free interval. For example, if your period usually comes
on Friday and you want it to come 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 considerably (for
example 3 days or less), you may not have bleeding during that interval. You may have
breakthrough bleeding or spotting while using the next pack.

……if you have unexpected bleeding
With all oral contraceptives, in the first months of taking, you may experience irregular vaginal
bleeding (spotting or breakthrough bleeding) between periods. You may need to use
pads, but you must continue to take the tablets normally. Irregular bleeding usually 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 does not occur
If you have taken all the tablets correctly and have not vomited or taken other medicines, it is
very unlikely that you have become pregnant. Continue taking Practil as
usual.
If your period does not occur for two consecutive times, you may be pregnant. Contact your doctor immediately. Do not start the new pack of Practil until the
doctor has ruled out pregnancy.

If you stop taking Practil
If you have any questions about using this medicine, ask your doctor or pharmacist.
You can stop taking Practil at any time. If you still want to avoid pregnancy,
ask your doctor for advice on other methods of birth control.
If you want to stop taking Practil to become pregnant, you should wait for
your next natural period before trying to conceive. This will help you
determine when the baby is due.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think might be due to Practil, 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 Practil”.
Serious reactions associated with the use of the pill and related symptoms are described in the sections “Pill and
thrombosis” and “Pill and cancer”.
Common (may affect up to 1 in 10 people):

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

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

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

Rare (may affect more than 1 in 1,000 people):

• harmful blood clots in a vein or an artery, for example: o in a leg or foot (DVT) o in the lung (PE) o heart attack o stroke o mini-stroke o 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)
• nipple discharge, vaginal discharge
• weight loss.

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform
your doctor or pharmacist. You can also report side effects directly through the national
reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

1. How to store Practil

Keep this medicine out of the sight and reach of children.
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 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 use this medicine if you notice changes in the colour of the tablets, crumbling of the
tablets or any other visible sign of deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Practil contains

• The active ingredients are: desogestrel (0.150 mg) and ethinylestradiol (0.030 mg).
• The other ingredients are: anhydrous colloidal silica, lactose monohydrate, potato starch, povidone, stearic acid, alpha-tocopherol.

Description of the appearance of Practil and contents of the pack
Practil is available in 1 blister of 21 tablets packaged in a carton.
The tablets are biconvex, round and with a diameter of 6 mm and identified with TR5 on one side and
Organon* on the other side.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Roma

Manufacturer
N.V. Organon, Kloosterstraat 6, 5349 AB Oss, Netherlands