CALINDIR 0.03 MG/3 MG Film-coated tablets

Содержание инструкции

1. CALINDIR 0.03 mg/3 mg film-coated tablets
   1. How to take CALINDIR
   2. Cosa deve sapere prima di prendere CALINDIR
   3. How to take CALINDIR
2. CALINDIR make sure you are not pregnant or wait until your next period.
   1. Possible side effects
   2. How to store CALINDIR
   3. Contents of the pack and other information

CALINDIR 0.03 mg/3 mg film-coated tablets

Ethinylestradiol / Drospirenone
Generic medicine

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, 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 when 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 CALINDIR is and what it is used for

2. What you need to know before you take CALINDIR

• When you must not use CALINDIR
• Warnings and precautions
• Blood clots
• Blood clots in a vein
• Blood clots in an artery
• CALINDIR and cancer
• Breakthrough bleeding
• What to do if your period does not occur during the pill-free week
• Other medicines and CALINDIR
• CALINDIR with food and drink
• Laboratory tests
• Pregnancy
• Breast-feeding
• Driving and using machines
• CALINDIR contains lactose

3. How to take CALINDIR

• When can you start the first pack?
• If you take more CALINDIR than you should
• If you forget to take CALINDIR
• What to do in case of vomiting or severe diarrhoea
• How to delay your period: what you need to know
• How to change the day your period starts: what you need to know
• If you want to stop treatment with CALINDIR

4. Possible side effects

5. How to store CALINDIR

6. Contents of the pack and other information

1. What CALINDIR is and what it is used for

• CALINDIR is a contraceptive pill and is used to prevent pregnancy.
• Each tablet contains a small amount of two different female hormones, drospirenone and ethinylestradiol.
• Contraceptive pills that contain two hormones are called “combined” pills.

2. Cosa deve sapere prima di prendere CALINDIR

Note generali
Prima di iniziare a usare CALINDIR 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 che inizi a prendere CALINDIR il medico le farà alcune domande riguardo alla sua
storia personale di salute ed a quella dei suoi familiari. Il medico le misurerà anche la
pressione sanguigna e, a seconda della sua situazione personale, potrà anche eseguire
alcune altre analisi.
l’assunzione di CALINDIR o in cui la sicurezza di CALINDIR può essere ridotta. In queste
situazioni lei non deve avere rapporti sessuali o deve adottare misure contraccettive
aggiuntive non ormonali, ad esempio usare un profilattico o un altro metodo di barriera.
Non usi il metodo del ritmo o della temperatura basale. Questi metodi possono essere
inaffidabili in quanto CALINDIR altera le variazioni mensili della temperatura corporea e
del muco cervicale.

Come gli altri contraccettivi ormonali, CALINDIR non protegge dalle infezioni da HIV
(AIDS) né da altre malattie sessualmente trasmesse.
Quando non deve usare CALINDIR
Non usi CALINDIR se presenta una delle condizioni elencate sotto. Se presenta una qualsiasi
delle condizioni elencate sotto, si rivolga al medico. Il medico discuterà con lei degli altri metodi
di controllo delle nascite che potrebbero essere più adatti al suo caso.

Non usi Calindir:

• 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 ha (o ha mai avuto) una malattia del fegato e la funzione del suo fegato non si è ancora normalizzata;
• se i suoi reni non funzionano bene (insufficienza renale);
• se ha (o ha mai avuto) un tumore al fegato;
• se ha (o ha mai avuto) o se sospetta di avere un tumore alla mammella o agli organi genitali
• se ha sanguinamenti vaginali inspiegabili;
• se è allergica all’etinilestradiolo o al drospirenone o ad uno qualsiasi degli altri componenti di questo medicinale (elencati al paragrafo 6). Ciò può causare prurito, eruzione cutanea o gonfiore.

Non usi CALINDIR se ha l’epatite C e se sta assumendo medicinali contenenti
ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir / pibrentasvir o
sofosbuvir/velpatasvir/voxilaprevir (vedere anche il paragrafo “Altri medicinali e CALINDIR”).

Informazioni aggiuntive su popolazioni particolari

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

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

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

Per una descrizione dei sintomi di questi gravi effetti indesiderati vada al paragrafo
“Come riconoscere un coagulo sanguigno”.
Si rivolga al medico prima di prendere Calindir.

Disturbi psichiatrici
Alcune donne che usano contraccettivi ormonali tra cui CALINDIR 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.

Informi il medico se una qualsiasi delle seguenti condizioni si applica al suo caso.
In alcune situazioni deve fare particolarmente attenzione quando usa CALINDIR o qualsiasi altra
pillola combinata e il medico potrebbe doverla visitare regolarmente. Se una qualsiasi delle
seguenti condizioni la riguarda, informi il medico prima di iniziare a usare CALINDIR . Inoltre, se
una qualsiasi delle seguenti condizioni la riguarda o compare o peggiora mentre sta usando
CALINDIR consulti il medico:

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

COAGULI SANGUIGNI
L’uso di un contraccettivo ormonale combinato come CALINDIR causa un aumento del rischio di
sviluppare un coagulo sanguignorispetto al non utilizzo. In rari casi un coagulo sanguigno può
bloccare i vasi sanguigni e causare problemi gravi.
I coaguli sanguigni possono svilupparsi:

• nelle vene (condizione chiamata “trombosi venosa”, "tromboembolia venosa” o TEV);
• nelle arterie (condizione chiamata “trombosi arteriosa”, “tromboembolia arteriosa” o TEA). La guarigione dai coaguli sanguigni non è sempre completa. Raramente, si possono verificare effetti gravi di lunga durata o, molto raramente, tali effetti possono essere fatali.

È importante ricordare che il rischio globale di un coagulo sanguigno dannoso associato a
CALINDIRè 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 Trombosi venosa del piede, specialmente se accompagnato da: profonda
• dolore o sensibilità alla gamba che può essere 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 Embolia polmonare improvvisa e inspiegata;
• 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”).
Sintomi che si verificano più frequentemente in un
occhio:

• perdita immediata della vista o
• offuscamento indolore della vista che può progredire Trombosi della vena retinica (coagulo sanguigno nell’occhio)

a perdita della vista

• dolore, fastidio, sensazione di pressione o di Attacco cardiaco 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;

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 CALINDIR, 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
CALINDIR 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 drospirenone, come CALINDIR, 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 CALINDIR is low but some conditions increase it.
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 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 lie down 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 CALINDIR a few weeks before surgery or during the period when you are less mobile. If you need to stop taking CALINDIR, 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. Your doctor may decide to stop you from taking CALINDIR.
If any of the above conditions change while you are using CALINDIR, 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 CALINDIR is very low but can increase:

• as you get older (over 35 years);
• if you smoke.When you use a combined hormonal contraceptive like CALINDIR 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 of yours has had a heart attack or stroke at a young age (under about 50 years). In this case you may also be at high risk of heart attack or stroke;
• if you, or a close relative, have high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valve defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions or if one of them is particularly serious, the risk of developing a blood clot may be even higher.
If any of the above conditions change while you are using CALINDIR, 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.

CALINDIR and cancer
Breast cancer has been observed with a slightly higher incidence in women who use combined pills but it is not known whether this is caused by the treatment. For example, it is possible that in women who take combined pills, more tumors are diagnosed because they visit their doctor more frequently. The occurrence of breast cancer decreases gradually after stopping combined hormonal contraceptives. It is important that you check your breasts regularly and contact your doctor if you notice a lump.
In rare cases, benign liver tumors have been observed in those using the pill and in even rarer cases malignant liver tumors. Contact your doctor if you have unusually severe abdominal pain.

Intermenstrual bleeding
During the first few months you take CALINDIR ,you may experience unexpected bleeding (bleeding outside the withdrawal week). If this bleeding continues for more than a few months or if it starts after a few months, your doctor should check what is wrong.

What to do if your period does not occur in the withdrawal week
If you have taken all the tablets correctly, you have not vomited or had severe diarrhea and you have not taken other medicines, it is highly unlikely that you are pregnant.
If your periods do not occur for two consecutive times, you may be pregnant. Contact your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Other medicines and CALINDIR
Always tell your doctor if you are taking any medicines or herbal products that you are already using. Also, tell any other doctor or dentist who prescribes you another medicine (or the pharmacist) that you are using CALINDIR. They may tell you whether you need to use other contraceptive methods (e.g. condoms) and, if so, for how long or whether the use of another medicine you may need should be modified.
Some medicines:

• affect the levels of CALINDIR in the blood
• may make it less effective in preventing pregnancy
• may cause unexpected bleeding

These include:

• medicines used for the treatment of: o epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine) o tuberculosis (e.g., rifampicin) o HIV and hepatitis C virus infections (ritonavir, nevirapine, efavirenz known as protease inhibitors and non-nucleoside reverse transcriptase inhibitors) o other infections (griseofulvin) o high blood pressure in the arteries of the lungs (bosentan)
• the herbal remedy St John's wort

CALINDIR can affect the effect of other medicines, such as:

• medicines containing cyclosporine
• the antiepileptic lamotrigine (potentially leading to an increase in the frequency of seizures)
• theophylline (used to treat breathing problems)
• tizanidine (used to treat muscle pain and/or muscle cramps)

Do not use CALINDIR if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir / pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, as these products can cause increases in liver function test results (increased liver enzyme ALT). Your doctor will prescribe you another type of contraceptive before starting treatment with these medicines.
CALINDIR can be resumed about 2 weeks after the end of this treatment.
See the section “Do not use CALINDIR”.

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

CALINDIR with food and drink
CALINDIR can be taken with or without food, if necessary with a little water.

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

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

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

Breast-feeding
The use of CALINDIR is generally not recommended during breast-feeding. If you want to take the pill while breast-feeding, contact your doctor.

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

Driving and using machines
There is no evidence to suggest that CALINDIR affects the ability to drive or operate machinery.

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

3. How to take CALINDIR

Take this medicine following exactly the instructions of your doctor or
pharmacist. If you have doubts, consult your doctor or pharmacist.
Take one tablet of CALINDIR a day, if necessary with a small amount of water.
You can take the tablets with or without food, but you must take them every day at approximately
the same time.
The pack contains 21 tablets. Next to each tablet, the day of the
week on which you should take it is printed. For example, if you start on Wednesday, take a tablet
with “WED” printed next to it. Follow the direction of the arrow on the pack until you have taken
all 21 tablets.
Then do not take any tablets for 7 days. During these 7 days without tablets
(also called a pill-free week or withdrawal week) your menstruation should begin.
This so-called “withdrawal bleeding” usually starts on the 2nd or 3rd day of the
withdrawal week.
On the 8th day after the last CALINDIR tablet (i.e., after the 7 days of pause), you must start
a new pack, regardless of whether or not your menstruation has stopped. This
means that you must start each pack on the same day of the week and that your menstruation
will occur on the same days of each month.
If you take CALINDIR in this way, you will be protected from pregnancy even during the 7 days in
which you do not take tablets.

When can you start the first pack?

• If you have not used a hormonal contraceptive in the previous monthStart taking CALINDIR on the first day of your cycle (i.e., the first day of your period). If you start taking CALINDIR on the first day of your period, the contraceptive effect is immediate. You can also start taking CALINDIR between the 2nd and 5th day of your cycle, but in this case you must use additional contraceptive measures (e.g., a condom) for the first 7 days.
• Switching from a combined hormonal contraceptive or from a combined contraceptive vaginal ring or patchStart taking CALINDIR preferably the day after the last active tablet (the last tablet containing the active ingredients) of the previous pill, but at the latest the day after the pill-free interval (or after the last inactive tablet of the previous pill). If you previously used a combined contraceptive vaginal ring or patch, follow your doctor’s advice.
• Switching from a progestin-only method (progestin-only pill,injection, implant or progestin-releasing intrauterine system (IUS))You can switch any day from the progestin-only pill (from an implant or IUS on the day of its removal, from an injectable product when the next injection is due) on any day, but in all these cases you must use additional contraceptive measures (e.g., a condom) for the first 7 days of taking the tablets.
• After an abortion

Follow your doctor’s advice.

• After childbirthYou can start taking CALINDIR between 21 and 28 days after childbirth. If you start after 28 days, use a so-called barrier method (e.g., a condom) during the first seven days of taking CALINDIR. If, after giving birth, you have had sexual intercourse before starting (or resuming)

CALINDIR make sure you are not pregnant or wait until your next period.

• If you are breastfeeding and want to start (or restart) taking CALINDIRRead the “Breastfeeding” paragraph.

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

If you take more CALINDIR than you should
No serious harmful effects have been reported related to taking too many CALINDIR tablets.
If you take several tablets at once, you may experience nausea or vomiting or
vaginal bleeding.
Girls who have not yet had their period, but who have accidentally taken
this medicine may also experience such bleeding.
If you have taken too many CALINDIR tablets or if you discover that some tablets have been taken
by a child, seek immediate medical or pharmaceutical advice.

If you forget to take CALINDIR

• If less than 12 hourshave passed since the usual time of taking it, contraceptive protection is not reduced. Take the tablet as soon as you remember and then continue with the tablets at the usual time.
• If more than 12 hourshave passed since the usual time of taking it, contraceptive protection may be reduced. The more tablets you have forgotten, the greater the risk of becoming pregnant.

The risk of incomplete contraceptive protection is greatest if you forget to take a
tablet at the beginning or end of the pack. You should therefore follow the following rules
(see also the diagram below):

• More than one tablet forgotten in a pack

Consult your doctor.

• One tablet forgotten in the first week

Take the forgotten tablet as soon as you remember, even if this means taking
two tablets at the same time. Then continue to take the tablets at the usual
time and use additional contraceptive measures for the next 7 days, such as a
condom.
If you had sexual intercourse in the week before the forgotten tablet, you may be
pregnant. In this case, consult your doctor.

• One tablet forgotten in the second week

Take the forgotten tablet as soon as you remember, even if this means taking
two tablets at the same time. Continue to take the tablets at the usual time.
The contraceptive safety of the pill is maintained and therefore no additional
precautions are necessary.

• One tablet forgotten in the third week

You can choose between two options:

• 1. Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue to take the tablets at the usual time. Instead of starting the pill-free interval, immediately start the next pack.

You will most likely not have a period until the end of the second blister or
you may also have some light bleeding or a period-like bleed during the
second pack.

• 2. You can also stop taking the tablets from the current cycle and go directly to the 7-day pill-free interval (including the day of theforgotten tablet).If you want to start a new pack on the day you usually start it, make the pill-free interval less than 7 days.

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

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

What to do in case of vomiting or severe diarrhea
If you experience vomiting or severe diarrhea within 3-4 hours of taking a tablet, there is a
risk that the active ingredients of the pill have not been completely absorbed by your
body. The situation is comparable to when you forget to take a
tablet. After vomiting or diarrhea, take another tablet from a
reserve pack as soon as possible. If possible, take it within 12 hoursof the time you usually take the
pill. If this is not possible or more than 12 hours have passed, follow the advice given in the
paragraph “ If you forget to take CALINDIR”.
How to delay your period: what you need to know
Although not recommended, you can delay your period by going directly to a new
pack of CALINDIR instead of taking a pill-free interval, and finishing that
pack.
During the use of this second blister, you may have some light bleeding or period-like
bleeding. Continue with the next blister after the usual 7-day interval.

You can ask your doctor for advice before deciding to delay your period.
How to change the day your period starts: what you need to know
If you take the tablets according to the instructions, your period will start during the week
of the pill-free interval. If you need to change the day your period starts, reduce the number of
pill-free days ( but never increase it, 7 days is the maximum!). For example, if you usually
start the pill-free interval on Friday and want to move that day to Tuesday (3 days
earlier) start a new pack 3 days earlier than usual. If you shorten the pill-free
interval significantly (e.g. to 3 days or less) you may not have any
period during those days. You may then experience some light bleeding or period-like
bleeding.

If you are not sure what to do, ask your doctor for advice.
If you stop taking CALINDIR
You can stop taking CALINDIR at any time. If you do not want a
pregnancy, ask your doctor for advice on other safe methods of birth control. If
you want to become pregnant, stop taking CALINDIR and wait for a period before
trying to conceive. You will be able to calculate the expected date of delivery more easily.

If you have any doubts about using CALINDIR, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any side effect, particularly if severe or persistent, or if any change occurs in your health that you think might be due to CALINDIR, inform your doctor.
An increased 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 take CALINDIR”.
The following side effects have been associated with the use of CALINDIR:

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

• menstrual flow disorders, intermenstrual bleeding, breast pain, breast tenderness;
• headache, depressed mood;
• migraine;
• nausea;
• thick, white vaginal discharge, candidiasis.

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

• breast enlargement, changes in libido;
• high blood pressure, low blood pressure;
• vomiting, diarrhoea;
• acne, skin rash, severe itching, hair loss (alopecia);
• vaginal infection;
• fluid retention and changes in body weight
• urticaria.

Rare side effects(may affect up to 1 in 10,000 women):

• allergic reactions (hypersensitivity), asthma
• nipple secretion
• hearing impairment
• skin diseases such as erythema nodosum (characterised by painful, reddish skin nodules) or erythema multiforme (characterised by skin rash with target or ulcer-like lesions).
• harmful blood clots in a vein or an artery, for example: in a leg or foot (DVT) or in the lung (PE) or heart attack or stroke

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

Reporting of side effects
If you get any side 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 CALINDIR

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.

Expiry date
Do not use this medicine after the expiry date which is stated on the packaging after the
phrase “Use by:” or “EXP.”. The expiry date refers to the last day of that
month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Contents of the pack and other information

What CALINDIR contains
The active ingredients are ethinylestradiol 0.03 mg and drospirenone 3 mg.
The other ingredients are:
Tablet core: lactose monohydrate, corn starch, pregelatinized starch (of corn),
crospovidone, povidone K-30, polysorbate 80, magnesium stearate.
Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350,
talc (E553b), yellow iron oxide (E172).

Description of the appearance of CALINDIR and contents of the pack
Yellow, round, film-coated tablets.
CALINDIR is available in packs of 1, 2, 3, 6 and 13 blisters, each containing 21
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz Spa, L.go U.Boccioni, 1, 21040, Origgio (VA), Italy

Manufacturer responsible for batch release
Laboratorios León Farma, S.A., Pol. Ind. Navatejera. C/ La Vallina s/n 24008 - Villaquilambre,
León, Spain
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany