Yasmin

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the outer packaging in a foreign language!
Yasmin
0.03 mg + 3 mg, coated tablets
Ethinylestradiolum + Drospirenonum
Important information regarding combined hormonal contraceptives

• When used correctly, they are one of the most reliable, reversible methods of contraception
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting following a break of 4 weeks or more
• Be vigilant and consult a doctor if you suspect symptoms of blood clots (see section 2 "Blood clots")

Please read this leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
• If any side effects worsen or if any side effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Yasmin is and what it is used for
2. What you need to know before taking Yasmin
   When not to use Yasmin
   Warnings and precautions
   Blood clots
   Yasmin and cancer
   Yasmin and other medicines
   Pregnancy
   Breast-feeding
   Driving and operating machinery
   Yasmin contains lactose
3. How to take Yasmin
   When to start the first blister pack
   Taking more than the recommended dose of Yasmin
   Missing a dose of Yasmin
   Stopping Yasmin
   What to do in the following situations:
   • occurrence of gastrointestinal disturbances (vomiting)
   • intention to delay the withdrawal bleed
   • intention to change the day of withdrawal bleed to another day of the week
   • occurrence of unexpected bleeding
   • absence of withdrawal bleed
4. Possible side effects
5. How to store Yasmin
6. Contents of the pack and other information

1. What Yasmin is and what it is used for

Yasmin is a combined oral contraceptive. Each coated tablet contains two different hormones: ethinylestradiol (an oestrogen) and drospirenone (a progestogen).
When Yasmin is taken according to the recommendations in this leaflet, the likelihood of becoming pregnant is very low.
Please note that Yasmin, like other combined oral contraceptives, does not protect against infection with HIV (AIDS) or sexually transmitted diseases.
Indications
Prevention of pregnancy.

2. Important information before using Yasmin

General information
Before starting to take Yasmin, you should read the information about blood clots (thrombosis) in section 2. It is particularly important to be aware of the symptoms of blood clots (see section 2 "Blood clots").
Each year, approximately 1 in 100 women who correctly use combined oral contraceptive medicines become pregnant. This number may increase if tablets are missed or taken incorrectly.

When not to use Yasmin
Do not take Yasmin if you have any of the conditions listed below.
If you have any of the conditions listed below, you must inform your doctor.
Your doctor will discuss with you which alternative method of contraception may be more suitable.

• if you are allergic to ethinylestradiol or drospirenone, or any of the other ingredients of this medicine Yasmin (listed in section 6). Symptoms may include itching, rash, or swelling;
• if you currently have (or have ever had) a blood clot in the deep leg veins (deep vein thrombosis), in the lungs (pulmonary embolism), or in another organ;
• if you know you have a disorder affecting blood clotting—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you are undergoing surgery or will be immobile for a long time (see section "Blood clots");
• if you have (or have had in the past) angina pectoris (a condition causing severe chest pain and may be the first sign of heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have had a heart attack or stroke;
• if you currently have (or have had in the past) a type of migraine called "migraine with aura";
• if you have any of the following conditions that may increase the risk of arterial blood clots:
• severe diabetes with blood vessel damage;
• very high blood pressure;
• very high levels of fats in the blood (cholesterol or triglycerides);
• a condition called hyperhomocysteinemia;
• if you have had or currently have severe liver disease (until liver function tests return to normal);
• if you have severe or acute kidney failure;
• if you have had or currently have benign or malignant liver tumours;
• if you currently have or have had hormone-dependent cancer (e.g. breast cancer or genital organ cancer);
• if you have unexplained vaginal bleeding;
• if you are pregnant or suspect you may be pregnant.

If any of the symptoms listed above occur for the first time while taking Yasmin, stop taking the medicine immediately and consult your doctor. During this time, use non-hormonal methods of contraception (see also "General information").
Do not take Yasmin if you have hepatitis C and are taking antiviral medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir (see also section "Yasmin and other medicines").

Additional information for special populations
Children and adolescents
Yasmin is not intended for use in girls whose menstrual cycles have not yet begun.

Women of advanced age
Yasmin is not intended for use after menopause.

Women with liver function disorders
Do not take Yasmin if you suffer from liver disease. See also sections "When not to use Yasmin" and "Warnings and precautions".

Women with kidney function disorders
Do not take Yasmin if you suffer from kidney failure or acute kidney failure. See also sections "When not to use Yasmin" and "Warnings and precautions".

Warnings and precautions
When to contact your doctor
Seek immediate medical advice

• if you notice possible symptoms of blood clots, which may indicate that you have a blood clot in your leg (deep vein thrombosis), in your lungs (pulmonary embolism), a heart attack, or a stroke (see section below "Blood clots (thrombosis)").

For a description of the symptoms of these serious adverse effects, see "How to recognize the occurrence of blood clots".

Tell your doctor if you have any of the following conditions.
If you take oral contraceptives while having any of the conditions listed below, special and regular medical monitoring is required. If any of these conditions develop or worsen during treatment with Yasmin, you should also inform your doctor.

• if you smoke,
• if you have diabetes,
• if you are obese,
• if you have high blood pressure,
• if you have heart valve disorders or heart rhythm disorders,
• if you have superficial thrombophlebitis (inflammation of veins under the skin),
• if you have varicose veins,
• if there is a family history of thrombosis, myocardial infarction, or stroke,
• if you have migraines,
• if you have epilepsy (see "Yasmin and other medicines"),
• if you have hypertriglyceridemia (elevated blood fat levels) or a positive family history of this condition. Hypertriglyceridemia is associated with an increased risk of pancreatitis,
• if you require surgery or will be immobile for a long time (see section 2 "Blood clots"),
• if you have recently given birth, as you are at increased risk of blood clots. Consult your doctor for advice on how soon you can start taking Yasmin after childbirth,
• if you have a family history of breast cancer,
• if you have liver or gallbladder disease,
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel diseases),
• if you have systemic lupus erythematosus (a disease affecting the body’s natural immune system),
• if you have haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure),
• if you have sickle cell anaemia (an inherited disorder of red blood cells),
• if you have a condition that first occurred or worsened during pregnancy or previous use of steroid hormones (e.g. hearing loss, herpes gestationis, Sydenham’s chorea),
• if you have or have ever had skin pigmentation disorders (yellow-brown skin patches, so-called chloasma), in which case you should avoid excessive exposure to sunlight or ultraviolet radiation. If any of the above symptoms occur for the first time, recur, or worsen during treatment with Yasmin, contact your doctor.

BLOOD CLOTS
Thrombosis refers to the formation of blood clots that may block blood vessels. Thrombosis sometimes occurs in the deep veins of the legs (deep vein thrombosis). If a clot fragment detaches from its site of origin, it may block arteries in the lungs, causing a pulmonary embolism. Deep vein thrombosis is rare; it may occur even without taking medication, for example during pregnancy.
The use of combined hormonal contraceptives such as Yasmin is associated with an increased risk of blood clots compared to not using such therapy.
In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

• in veins (referred to as "venous thrombosis" or "venous thromboembolic disease")

• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic events").

• Complete recovery after a blood clot is not always possible. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.

It should be remembered that the overall risk of harmful blood clots associated with the use of Yasmin is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical attention if you experience any of the following symptoms.
Are you experiencing any of these symptoms? What might be the likely cause?

• swelling of the legs and/or swelling along a vein in the leg or foot, especially if accompanied by:
• pain or tenderness in the leg, which may occur only when standing or walking,
• increased warmth in the affected leg,
• change in skin colour of the leg, such as pallor, redness, or blueness.

Pulmonary embolism

• sudden unexplained shortness of breath or rapid breathing;
• sudden cough without apparent cause, possibly accompanied by coughing up blood;
• sudden sharp chest pain, which may worsen on deep breathing;
• severe dizziness or vertigo;
• rapid or irregular heartbeat;
• severe stomach pain.

If you are unsure, consult your doctor, as some of these symptoms, such as cough or shallow breathing, may be mistaken for milder conditions such as respiratory tract infection (e.g. cold).

Symptoms usually occur in one eye: Retinal vein thrombosis (blood clot in the eye)

• sudden loss of vision or
• painless visual disturbances, which may progress to vision loss

BLOOD CLOTS IN VEINS
What can happen if blood clots form in veins

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thrombosis). Although these adverse events are rare, they most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When the risk of blood clots in veins is highest
The risk of blood clots in veins is greatest during the first year of first-time use of combined hormonal contraceptives. The risk may also be higher when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than in women who do not use combined hormonal contraceptives.
If a woman stops taking Yasmin, the risk of blood clots returns to normal within a few weeks.

What determines the risk of blood clots in veins
The risk depends on a woman's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of blood clots in the legs or lungs associated with the use of Yasmin is low.

• Among 10,000 women who are not using combined hormonal contraceptives and who are not pregnant, about 2 will develop blood clots in a year.
• Among 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop blood clots in a year.
• Among 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Yasmin, about 9 to 12 will develop blood clots in a year.
• The risk of blood clots depends on the individual medical history of the woman (see "Factors that increase the risk of blood clots in veins", below)

Factors increasing the risk of blood clots in veins
The risk of blood clots associated with the use of Yasmin is small, but certain factors may increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) above 30 kg/m²);
• if a close relative of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In such cases, the patient may have an inherited clotting disorder;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue Yasmin several weeks before surgery or immobilization. If the patient must stop taking Yasmin, ask the doctor when it is safe to resume taking the medication.
• with increasing age (especially over 35 years);
• if the patient has given birth within the past few weeks;
• the risk of blood clots increases with the number of risk factors present in the patient.

Air travel (>4 hours) may temporarily increase the risk of blood clots, particularly if the patient has another risk factor listed above.
Inform the doctor if any of the listed risk factors apply to the patient, even if uncertain. The doctor may decide to discontinue Yasmin.
Inform the doctor if any of the above conditions change during treatment with Yasmin, for example, if a close relative is diagnosed with unexplained thrombosis or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES
What can happen if blood clots form in arteries
As with venous blood clots, arterial clots can lead to serious consequences, such as heart attack or stroke.

Factors increasing the risk of arterial blood clots
It should be emphasized that the risk of heart attack or stroke associated with the use of Yasmin is very low, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Yasmin, smoking should be discontinued. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under 50 years). In such cases, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close relative has high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valvular heart disease, arrhythmia such as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Yasmin, for example, if the patient starts smoking, a close relative is diagnosed with unexplained thrombosis, or if the patient gains significant weight.
If symptoms suggestive of thrombosis occur, stop taking the tablets and consult a doctor immediately (see also "When to contact the doctor").

Yasmin and cancer
Breast cancer occurs slightly more frequently in women taking oral contraceptives than in women of the same age who do not use them. It is not known whether this difference is solely due to the use of hormonal contraceptives. It may also be due to the fact that women using hormonal contraception are examined more frequently, leading to earlier detection of breast cancer. The difference in breast cancer incidence gradually decreases and disappears within 10 years after stopping oral contraceptives.
Rare cases of benign and, even more rarely, malignant liver tumours have been reported in women using combined oral contraceptives, which in some cases led to life-threatening intra-abdominal bleeding. If severe upper abdominal pain occurs, inform the doctor as soon as possible.
There have been reports of increased incidence of cervical cancer in women who have used oral contraceptives for a long time. However, this association may not be related to taking the pills, but rather to sexual behaviour or other factors.

Psychiatric disorders
Some women using hormonal contraceptives, including Yasmin, have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts.
If mood changes or symptoms of depression occur, contact the doctor as soon as possible for further medical advice.

Yasmin and other medicines
Some medicines may:

• affect the blood concentration of Yasmin;
• reduce its effectiveness in preventing pregnancy;
• cause unexpected bleeding.

These include medicines used to treat:

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine);
• tuberculosis (e.g., rifampicin);
• HIV and hepatitis C virus infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);
• fungal infections (e.g., griseofulvin, ketoconazole);
• arthritis and osteoarthritis (etoricoxib);
• pulmonary hypertension (bosentan);
• herbal products containing St. John's wort (Hypericum perforatum).

Yasmin may also affect the action of other medicines, for example:

• those containing cyclosporine;
• antiepileptic lamotrigine (may lead to increased frequency of seizures);
• theophylline (used for breathing problems);
• tizanidine (used to treat muscle pain and/or muscle spasms).

Do not use Yasmin if the patient has hepatitis C and is taking antiviral medicines containing ombitasvir, paritaprevir, ritonavir, and dasabuvir, as this may lead to elevated liver function test results (increased levels of liver enzyme ALT). The doctor will recommend another type of contraception before starting these medicines. Yasmin may be resumed approximately 2 weeks after stopping treatment. See section "When not to take Yasmin".
Before taking any medicine, consult a doctor or pharmacist.
Always inform your doctor about any medicines or herbal products you are currently taking.
Also inform any other doctor, including a dentist or pharmacist, who prescribes another medicine, that you are using Yasmin. They will advise whether additional contraceptive methods (e.g., condoms) are needed and, if so, for how long.

Pregnancy
Before taking any medicine, consult a doctor or pharmacist.
Yasmin is not recommended during pregnancy or if pregnancy is suspected. If pregnancy is suspected, consult a doctor immediately.

Breast-feeding
Before taking any medicine, consult a doctor or pharmacist.
Yasmin is not recommended during breast-feeding.

Driving and operating machinery
No influence of Yasmin on the ability to drive or operate machinery has been observed.

When to contact the doctor
Contact the doctor immediately if:

• you notice any worrying changes in your health, especially any of the symptoms listed above as requiring special caution;
• there have been cases of thrombosis, myocardial infarction, or stroke in close relatives;
• a breast lump is detected;
• you plan to take other medicines (see also "Yasmin and other medicines");
• immobilization or planned surgery is expected (inform the doctor at least 4 weeks in advance);
• heavy vaginal bleeding occurs;
• tablets are missed in the first week of the cycle (each first week in consecutive months of Yasmin use), and intercourse occurred in the preceding 7 days;
• acute diarrhoea occurs;
• no withdrawal bleeding occurs in two consecutive months or pregnancy is suspected (do not start the next pack without consulting a doctor).

The situations and symptoms listed above are described in more detail in other sections of this leaflet.

Yasmin contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

3. How to use Yasmin

Yasmin must always be taken exactly as directed by your doctor. If you have any doubts, you should
contact your doctor again.
Yasmin, like other oral contraceptives, does not protect against infection with the HIV virus (AIDS)
or sexually transmitted diseases.

When to start the first blister pack

• If you are taking Yasmin for the first time or restarting after a break, take the first tablet on the first day of your cycle, i.e. on the day menstrual bleeding starts.
• In other cases, follow the instructions under the headings: “If you previously used another combined oral contraceptive”, “If you previously used only progestogen-only contraceptives”, “After childbirth”, or “After a natural or induced abortion”.
• Take the tablet marked with the corresponding day of the week first. For example, if your period starts on a Wednesday, take the tablet marked “Wed” first. Then continue taking the tablets in the order indicated on the blister.

Taking Yasmin for the first time

• After taking the first tablet, continue taking one tablet daily for the next 21 days. Take the tablets in the direction of the arrows on the packaging.
• Tablets should be taken every day at the same time.
• Swallow the tablets whole, with water if necessary.

7-day break from Yasmin
After finishing the pack (21 tablets), no tablets are taken for the next 7 days.
During this break, withdrawal bleeding usually begins. It typically occurs on the 2nd or 3rd day
after taking the last tablet. Start taking tablets from the next pack after the 7-day break.
During the 7-day break, no additional contraceptive methods are required, provided the tablets
have been taken according to the recommended schedule and the next pack is started after 7 days.

Starting the next pack of Yasmin
Start the next pack after the 7-day break. Each new pack will begin on the same day of the week as the previous one, making it easy to remember when to start a new pack. Start taking tablets from the next pack after the 7-day break, even if withdrawal bleeding is still ongoing.

If you previously used another combined oral contraceptive, a combined contraceptive vaginal system, or a transdermal system

If you previously used another combined oral contraceptive for 21 days
After taking all 21 tablets from the previous combined oral contraceptive pack, take a 7-day break, then start Yasmin. Take the first Yasmin tablet marked with the appropriate day of the week, and follow the instructions under “Taking Yasmin for the first time”.
If you start Yasmin this way, contraceptive protection will be maintained.
Withdrawal bleeding may not occur before completing the first Yasmin pack, but this is not a cause for concern. Spotting or light bleeding may occur during tablet-taking days, but this is also not a cause for concern.

If you previously used another combined oral contraceptive for 28 days
If you used a 28-day combined oral contraceptive, start Yasmin the day after taking the last tablet of the previous contraceptive. Take the first Yasmin tablet marked with the appropriate day of the week, then follow the instructions under “Taking Yasmin for the first time”.
If you follow these instructions, additional contraceptive methods are not required. Withdrawal bleeding may not occur before completing the first Yasmin pack, but this is not a cause for concern. Spotting or light bleeding may occur during tablet-taking days, but this is also not a concern.

If you used a vaginal contraceptive system or a transdermal system, start Yasmin on the day of removal, but no later than the day the next system would have been applied.

If you previously used only progestogen-only contraceptives

If you previously used a progestogen-only pill (mini-pill)
You may stop taking the mini-pill at any time and start taking Yasmin instead, at the same time of day. If you have sexual intercourse during the first 7 days of taking Yasmin, use additional contraceptive methods (mechanical methods) simultaneously.

If you previously used progestogen-only contraception as an injection, implant, or intrauterine system
Start Yasmin on the day the next injection would have been due, or on the day of implant or system removal. If you have sexual intercourse during the first 7 days of taking Yasmin, use additional contraceptive methods (mechanical methods) simultaneously.

After childbirth, natural or induced abortion

After a first-trimester abortion
You may start Yasmin immediately. In this case, additional contraceptive methods are not required.

After childbirth or second-trimester abortion
Start taking Yasmin between days 21 and 28 after childbirth or second-trimester abortion. If starting later, use additional mechanical contraception for the first 7 days of tablet-taking. If you had intercourse before starting the combined oral contraceptive, ensure you are not pregnant, or wait until the first natural menstrual period occurs.

Taking more than the recommended dose of Yasmin
Nausea, vomiting, or vaginal bleeding may occur. Such bleeding may even occur in girls who have not yet started menstruating but accidentally took the drug.
There are no reports of serious adverse effects after taking multiple Yasmin tablets at once. If you took more than the recommended dose, or someone else did, inform your doctor.

Stopping Yasmin
You may discontinue the drug at any time. Your doctor will then suggest alternative contraceptive methods. If you stop taking Yasmin because you wish to become pregnant, wait until the next natural menstrual period occurs. This will help determine the expected date of delivery.

Missed dose of Yasmin
If less than 12 hours have passed since you missed a tablet, the contraceptive effectiveness of Yasmin is maintained. Take the missed tablet as soon as possible and take the next tablet at the usual time.

If more than 12 hours have passed since the missed tablet, or if more than one tablet was missed, the contraceptive effectiveness of Yasmin may be reduced. Therefore, you must use additional contraceptive methods. The more consecutive tablets missed, the greater the risk of reduced contraceptive effectiveness.

More than one tablet missed from the pack
Contact your doctor.

One tablet missed in the 1st week of the current pack
Take the missed tablet as soon as possible (even if this means taking two tablets at the same time), and continue taking the next tablets at the usual time. Use additional contraceptive methods (mechanical methods) for the next 7 days.
If you had sexual intercourse in the week before missing the tablet, pregnancy may have occurred. Inform your doctor immediately.

One tablet missed in the 2nd week of the current pack
Take the missed tablet as soon as possible (even if this means taking two tablets at the same time), and continue taking the next tablets at the usual time. The contraceptive effectiveness of Yasmin is maintained, and additional contraceptive methods are not required.
However, if you previously made dosing errors or missed more than one tablet, use additional (mechanical) contraception for 7 days.

One tablet missed in the 3rd week of the current pack
You may choose one of the following options without needing additional contraceptive methods, provided you took the tablets correctly during the 7 days before the missed dose. Otherwise, follow the first of the two options below and use additional contraception for the next 7 days.

1. Take the missed tablet as soon as possible (even if this means taking two tablets at the same time), and continue taking the next tablets at the usual time. Start the next pack immediately after finishing the current one, i.e. without a 7-day break. Withdrawal bleeding will occur after finishing the second pack, but spotting or bleeding may occur during tablet-taking days.

2. Alternatively, stop taking tablets from the current pack, take a 7-day or shorter break (including the day the tablet was missed), then continue with tablets from the next pack.

If you missed tablets and no withdrawal bleeding occurs during the first break, you may be pregnant. Contact your doctor before starting the next pack.

Guidelines for missed tablets

• Gastrointestinal disturbances (vomiting)
  If vomiting occurs, the active ingredients in Yasmin may not be fully absorbed. If vomiting occurs within 3 to 4 hours of taking the tablet, follow the instructions for missed tablets. If you have severe gastrointestinal disturbances, use additional contraceptive methods.

• Delaying withdrawal bleeding
  To delay withdrawal bleeding, start the next pack immediately after finishing the current one, without a 7-day break. You may continue taking tablets until the pack is finished. If you wish to have bleeding, simply stop taking tablets. Spotting or light bleeding may occur during the use of the next pack. Start the following pack after a 7-day break.

• Changing the day of withdrawal bleeding to another day of the week
  If you take tablets as directed, bleeding occurs approximately every 4 weeks on the same day. To change the bleeding day to another day of the week, shorten the next tablet-free interval by the number of days you wish to shift the bleeding. For example, if bleeding usually starts on Fridays and you want it to start on Tuesdays (3 days earlier), start the new pack 3 days earlier than usual. If the tablet-free interval is very short (e.g. 3 days or less), withdrawal bleeding may not occur. Spotting or light bleeding may occur during the next pack.

• Unexpected bleeding
  During the first few months of taking Yasmin, irregular vaginal bleeding (spotting or intermenstrual bleeding) may occur. Continue taking the tablets as scheduled. Irregular bleeding usually resolves after 3 cycles of Yasmin use. If bleeding persists, becomes heavy, or recurs, inform your doctor.

• Absence of withdrawal bleeding
  If all tablets were taken on time, there were no episodes of vomiting or severe diarrhoea, and no other medications were taken concurrently, the likelihood of pregnancy is very low. Continue taking Yasmin.

If withdrawal bleeding does not occur in two consecutive months, pregnancy is possible. Contact your doctor immediately. Do not start the next pack of Yasmin until your doctor has ruled out pregnancy.

If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicinal product, Yasmin may cause adverse effects, although not everyone experiences them.
If any adverse effects occur, particularly severe and persistent ones, or changes in health status which the patient considers to be related to the use of Yasmin, medical advice should be sought from a doctor.
All women taking combined hormonal contraceptives have an increased risk of venous blood clots (venous thromboembolic disease) or arterial blood clots (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before taking Yasmin".
Serious adverse effects
Serious adverse effects associated with taking Yasmin and their accompanying symptoms are described in the following sections of this leaflet: "Blood clots" and "Yasmin and cancer". Please read these sections carefully to obtain additional information and consult your doctor immediately if necessary.
Other possible adverse effects
The symptoms listed below have been reported by patients taking Yasmin, although they may not necessarily have been caused by the medicine.
Common (affects more than 1 in 100 people and less than 1 in 10 people):

• nausea,
• abdominal pain,
• migraine,
• weight gain,
• headache, mood changes, depressive mood,
• menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness,
• vaginal discharge, candidiasis (fungal infection).

Uncommon (affects more than 1 in 1,000 people and less than 1 in 100 people):

• vomiting, diarrhoea,
• high blood pressure, low blood pressure,
• migraine,
• decreased libido, breast enlargement, changes in libido,
• vaginal inflammation,
• acne, eczema (rash), itching, hair loss, rash, urticaria,
• fluid retention, changes in body weight.

Rare (affects less than 1 in 1,000 people):

• hypersensitivity reactions, asthma,
• contact lens intolerance,
• hearing impairment,
• weight loss,
• increased libido,
• vaginal discharge,
• galactorrhea (milk secretion from breasts),
• nodular erythema, erythema multiforme.
• harmful blood clots in a vein or artery, for example:
  o in the leg or foot (e.g. deep vein thrombosis)
  o in the lungs (e.g. pulmonary embolism)
  o heart attack
  o stroke
  o mini-stroke or transient ischaemic attack (TIA)
  o blood clots in the liver, stomach and intestines, kidneys or eye

The likelihood of developing blood clots may be higher if the patient has other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clot formation).
In women with hereditary angioedema, exogenous estrogens may cause the onset or worsening of symptoms.
Other adverse effects may occur in some individuals during treatment with Yasmin.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Yasmin

Keep the medicine out of the sight and reach of children.
Store below 30°C. Keep in the original packaging.
Do not use after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Each coated tablet contains 0.03 mg ethinylestradiol and 3 mg drospirenone.
Excipients:
Tablet core:
monohydrate lactose
corn starch
pregelatinized corn starch
povidone K 25
magnesium stearate
Coating:
hypromellose
macrogol 6000
talc
titanium dioxide (E 171)
yellow iron oxide (E172)
What Yasmin looks like and contents of the pack
The pack contains PVC/Al blisters of 21 or 63 coated tablets in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Netherlands, country of export:
Bayer B.V.
Energieweg 1
3641 RT Mijdrecht
The Netherlands
Manufacturer
Bayer AG
Müllerstrasse 178
13353 Berlin
Germany
Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. k.
Działkowa 56
02-234 Warszawa
SHIRAZ PRODUCTIONS Sp. z o.o.
Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
Beskidzka 190
91-610 Łódź
Number of marketing authorisation in the Netherlands, country of export: RVG 23827
Number of parallel import authorisation: 431/22
Translation of the day-of-the-week symbols on the immediate packaging:
MA – Monday
DI – Tuesday
WO – Wednesday
DO – Thursday
VR – Friday
ZA – Saturday
ZO – Sunday