Yasmin

Package leaflet: Information for the user

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Yasmin
0.03 mg + 3 mg, coated tablets
Ethinylestradiolum + Drospirenonum
Please read the entire leaflet carefully before use, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Important information regarding combined oral 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 your doctor if you suspect symptoms of blood clots (see section 2 "Blood clots").

Table of contents of the leaflet:

1. What Yasmin is and what it is used for
2. Important information before taking Yasmin
   When not to use Yasmin
   Warnings and precautions
   BLOOD CLOTS
   Yasmin and cancer
   Psychiatric disorders
   Intermenstrual bleeding
   What to do if no withdrawal bleeding occurs
   Yasmin and other medicines
   Yasmin with food and drink
   Laboratory tests
   Pregnancy
   Breast-feeding
   Driving and operating machinery
   Yasmin contains monohydrate lactose
3. How to take Yasmin
   When can you start the first blister pack?
   Taking more Yasmin than you should
   Missing a dose of Yasmin
   What to do if you vomit or have severe diarrhoea
   Delayed onset of withdrawal bleeding: what you should know
   Changing the first day of withdrawal bleeding: what you should know
   Stopping Yasmin
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 contraceptive tablet used to prevent pregnancy.
• Each coated tablet contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol.
• Contraceptive tablets containing two hormones are known as "combined" pills.

2. Important information before using Yasmin

General notes
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”).
Before starting Yasmin, your doctor will ask you several questions about your health
and that of your close relatives. Your doctor will also measure your blood pressure and, if necessary,
perform other examinations.
This leaflet describes several situations in which you should stop taking Yasmin
or when the effectiveness of Yasmin may be reduced. In such cases, you should either
avoid sexual intercourse or use additional non-hormonal contraceptive methods,
such as condoms or other mechanical methods. Do not use the calendar method or
temperature-based methods. These methods may be unreliable because Yasmin affects
monthly body temperature changes and cervical mucus patterns.
Yasmin, like other hormonal contraceptives, does not protect against infection
with HIV (AIDS) or other sexually transmitted diseases.

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

Do not use Yasmin:

• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know you have blood clotting disorders—such as 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 prolonged period (see section “Blood clots”);
• if you have had a heart attack or stroke;
• if you have (or have had in the past) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following conditions that may increase the risk of arterial clot:
  • 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 currently have or have previously had a type of migraine called “migraine with aura”;
• if you currently have or have previously had severe liver disease and liver function remains abnormal;
• if you have kidney function disorders (kidney failure);
• if you have previously had or currently have liver tumours;
• if you have previously had or currently have breast or genital organ cancer, or if such cancer is suspected;
• if you have unexplained vaginal bleeding;
• if you are allergic to ethinylestradiol or drospirenone, or any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, rash, or swelling. Do not take Yasmin if you have hepatitis C and are taking medicinal products containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section “Yasmin with other medicines”).

Additional information for specific populations
Children and adolescents
Yasmin is not intended for use in girls who have not yet started menstruating.

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

Women with liver function disorders
Do not take Yasmin if you have 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 have kidney failure or acute kidney failure. See also sections “When not to use Yasmin” and “Warnings and precautions”.

Warnings and precautions
When should you contact your doctor?
You should contact your doctor immediately

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

For a description of symptoms of these serious adverse events, see “How to recognize the development of blood clots”.

Tell your doctor if you have any of the following conditions.
You should discuss these with your doctor before starting Yasmin. In certain situations,
special caution is required when using Yasmin or any other combined hormonal contraceptive,
and regular medical check-ups may be necessary. If any of these conditions appear or worsen during treatment with Yasmin, inform your doctor.

• if you have a family history of breast cancer;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you have depression;
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure);
• if you have sickle cell anaemia (a hereditary disorder of red blood cells);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of pancreatitis;
• if you are undergoing surgery or will be immobile for a prolonged period (see section 2 “Blood clots”);
• if you have recently given birth, as you are at increased risk of blood clots. Consult your doctor about when it is safe to start taking Yasmin after childbirth;
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see “Yasmin with other medicines”);
• if you have systemic lupus erythematosus (a disease affecting the body’s natural defence system);
• if you have a condition that first appeared during pregnancy or previous use of sex hormones [e.g. hearing loss, porphyria (a blood disorder), herpes gestationis (skin rash with blisters during pregnancy), Sydenham’s chorea (a nervous system disorder causing sudden involuntary movements)];
• if you have developed or have previously had skin pigmentation changes (yellow-brown discoloration, so-called chloasma), in which case you should avoid excessive exposure to sunlight or ultraviolet radiation;
• if you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives, which may cause breathing difficulties, seek immediate medical attention. Medicinal products containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.

BLOOD CLOTS
Using combined hormonal contraceptives such as Yasmin is associated with an increased risk of blood clots compared to not using such medication.
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”).

Recovery from a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots associated with taking Yasmin is low.

HOW TO RECOGNIZE THE DEVELOPMENT 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 in one leg 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,
  • skin discoloration of the leg, such as pallor, redness, or blueness.

• Sudden unexplained shortness of breath or rapid breathing;

• Sudden coughing without an obvious cause, possibly with coughing up blood;

• Sharp chest pain, which may worsen with 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 shortness of breath, may be mistaken for milder conditions such as respiratory tract infections (e.g. cold).

Symptoms most commonly affecting one eye:

• Sudden vision loss or

• Painless visual disturbances, which may progress to vision loss.
  (Retinal vein thrombosis – blood clot in the eye)

• Chest pain, discomfort, pressure, heaviness;

• Sensation of tightness, fullness, or squeezing in the chest, arm, or below the breastbone;

• Feeling of fullness, indigestion, or choking;

• Discomfort in the upper body radiating to the back, jaw, throat, arm, or stomach;

• Sweating, nausea, vomiting, or dizziness;

• Extreme weakness, anxiety, or shortness of breath;

• Rapid or irregular heartbeat.
  (Myocardial infarction – heart attack)

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

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the 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 is the risk of blood clots in veins the highest?
The risk of blood clots in veins is greatest during the first year of taking combined hormonal contraceptives for the first time. 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 compared to not using combined hormonal contraceptives.
If a woman stops taking Yasmin, the risk of blood clots returns to normal within a few weeks.

What does the risk of blood clots in veins depend on?
The risk depends on the 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.

• In the course of one year, about 2 out of 10,000 women who are not using combined hormonal contraceptives and are not pregnant will develop blood clots.
• In the course of one year, about 5–7 out of 10,000 women who are using combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In the course of one year, about 9–12 out of 10,000 women who are using combined hormonal contraceptives containing drospirenone, such as Yasmin, will develop blood clots.
• The risk of blood clots in veins depends on the individual woman's medical history (see "Factors increasing the risk of venous blood clots" 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 has significant overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member of the patient has been diagnosed with blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years). In this case, 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, the doctor should be consulted regarding when it is safe to resume treatment.
• with increasing age (especially over 35 years);
• if the patient has recently given birth (within the past few weeks).

The risk of venous 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, especially if the patient has another risk factor listed above.
The doctor should be informed if any of the listed factors apply to the patient, even if there is uncertainty. The doctor may decide to discontinue Yasmin.
The doctor should be informed if any of the above conditions change during treatment with Yasmin, for example, if a close family member is diagnosed with unexplained thrombosis or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
Similar to 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 small, 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 another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valve disorder, heart rhythm disorder 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.
The doctor should be informed if any of the above conditions change during treatment with Yasmin, for example, if the patient starts smoking, a close family member is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Yasmin and cancer
Breast cancer occurs slightly more frequently in women using combined oral contraceptives, but it is not known whether this is caused by the use of hormonal contraceptives. For example, more cancers may be detected in women using combined contraceptives because they are examined more frequently by doctors. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important to examine the breasts regularly and contact a doctor if any lumps are detected.
Rare cases of benign or, even more rarely, malignant liver tumors have been reported in women using combined oral contraceptives, which may lead to life-threatening intra-abdominal bleeding. If severe upper abdominal pain occurs, the doctor should be contacted immediately.

Psychiatric disorders
Some women using hormonal contraceptives, including Yasmin, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, medical advice should be sought immediately.

Intermenstrual bleeding
During the first few months of taking Yasmin, unexpected bleeding (bleeding outside the pill-free week) may occur. If such bleeding persists for longer than a few months, or if it starts after several months, the doctor should investigate the cause.

What to do if no withdrawal bleeding occurs
If all tablets have been taken correctly, without vomiting or severe diarrhoea, and no other medications have been taken, the likelihood of pregnancy is very low.
If expected withdrawal bleeding does not occur twice in succession, this may indicate pregnancy. The doctor should be contacted immediately. The next blister pack should not be started until pregnancy has been ruled out.

Yasmin and other medicines
Always inform your doctor about any medicines or herbal products you are currently taking. You should also inform any other doctor, including a dentist, or pharmacist prescribing another medicine that you are using Yasmin. They may advise whether additional contraceptive methods (e.g. condoms) are needed, for how long, or whether another necessary medicine should be adjusted.

Some medicines may:

• affect the blood concentration of Yasmin,
• cause reduced effectiveness in preventing pregnancy,
• cause unexpected bleeding.

This applies to medicines used in the treatment of:

• 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, osteoarthritis (etoricoxib)
• pulmonary hypertension (bosentan)
• herbal products containing St John's wort ( Hypericum perforatum )

Yasmin may 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).

Yasmin should not be used in patients with hepatitis C and taking medicinal products containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as they may cause elevated liver function test results (increased levels of the liver enzyme AlAT).
The doctor will recommend another type of contraception before starting treatment with these medicines.
Yasmin may be resumed approximately 2 weeks after completing treatment. See section "When not to use Yasmin".
Before taking any medicine, consult a doctor or pharmacist.

Yasmin with food and drink
Yasmin may be taken independently of meals. If necessary, it can be taken with a small amount of water.

Laboratory tests
If a blood test is required, inform the doctor or laboratory staff that you are taking Yasmin, as oral contraceptives may affect the results of certain tests.

Pregnancy
Yasmin must not be used during pregnancy. If the patient becomes pregnant while taking Yasmin, treatment should be stopped immediately and the doctor contacted.
If the patient wishes to become pregnant, she may discontinue Yasmin at any time (see also "Discontinuing Yasmin").
Before taking any medicine, consult a doctor or pharmacist.

Breast-feeding
Yasmin is not recommended during breast-feeding. If the patient wishes to take Yasmin while breast-feeding, she should consult her doctor.
Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines
There is no information suggesting that Yasmin affects the ability to drive or operate machinery.

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

3. How to take Yasmin

Take one Yasmin tablet every day, with a small amount of water if needed. Tablets may be taken with or without food, but they should be taken daily at approximately the same time.

The blister pack contains 21 coated tablets. Next to each tablet is printed the day of the week on which it should be taken. For example, if you start on Wednesday, take the tablet marked "WED" next to it (see: "Translation of the day-of-the-week symbols next to each tablet on the primary packaging" at the end of this leaflet and on the sachet). Move in the direction of the arrow on the blister pack until all 21 tablets have been taken.

After this, do not take any tablets for 7 days. During this 7-day break (also called the "tablet-free week"), withdrawal bleeding usually occurs. This so-called "withdrawal bleed" typically starts on the 2nd or 3rd day of the tablet-free week.

On the 8th day after taking the last Yasmin tablet (i.e., after the 7-day break), start the next blister pack, regardless of whether bleeding has stopped or not. This means each new pack should be started on the same day of the week, and withdrawal bleeding should occur on the same days each month.

If you take Yasmin exactly as described, you are protected against pregnancy during the 7 tablet-free days as well.

When to start the first pack

• If you have not used any hormonal contraceptive in the previous month
  Start taking Yasmin on the first day of your cycle (i.e., the first day of your menstrual period). If you start Yasmin on the first day of your period, you are protected against pregnancy immediately. You may also start between days 2 and 5 of your cycle, but in this case, you must use additional contraceptive precautions (e.g., condoms) for the first 7 days.

• Switching from a combined hormonal contraceptive or from a combined vaginal ring or transdermal patch
  Start Yasmin the day after taking the last active tablet from your previous contraceptive pack, but no later than the day after the tablet-free interval of your previous contraceptive ends (or after the last inactive tablet of your previous contraceptive).
  If switching from a combined vaginal ring or contraceptive patch, follow your doctor's advice.

• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen)
  You may switch at any time from progestogen-only pills (or on the day of removal of an implant or intrauterine system, or on the day of the next scheduled injection), but in all cases, you must use additional contraceptive precautions (e.g., condoms) for the first 7 days of taking Yasmin tablets.

• After miscarriage
  Follow your doctor's advice.

• After childbirth
  You may start taking Yasmin between 21 and 28 days after delivery. If you start later than 28 days after childbirth, you must use a barrier method (e.g., condoms) for the first 7 days of taking Yasmin.

If you had sexual intercourse after childbirth before (re)starting Yasmin, you must first ensure you are not pregnant, or wait until your next menstrual period.

• If you are breastfeeding and wish to start (or restart) Yasmin after childbirth
  Please read the section "Breast-feeding".

Overdose of Yasmin

There have been no reports of serious harmful effects from taking too many Yasmin tablets.
If several tablets are taken at once, nausea, vomiting, or vaginal bleeding may occur. Such bleeding may even occur in girls who have not yet started menstruating but accidentally took the medicine.
If an overdose of Yasmin is taken or if a child swallows any tablets, consult a doctor or pharmacist immediately.

Missed dose of Yasmin

• If less than 12 hours have passed since you missed a tablet, protection against pregnancy is not reduced. Take the missed tablet as soon as possible, then continue taking tablets at your usual time.
• If more than 12 hours have passed since you missed a tablet, protection against pregnancy may be reduced. The more tablets missed, the higher the risk of pregnancy.

The risk of inadequate protection is greatest if a tablet is missed at the beginning or end of the pack. Therefore, follow the rules below (see also the chart below):

• More than 1 tablet missed in the same pack
  Contact your doctor.

• One tablet missed in Week 1
  Take the missed tablet as soon as possible, even if this means taking two tablets at once. Continue taking the remaining tablets at your usual time and use additional contraceptive protection, such as condoms, for the next 7 days. If you had sexual intercourse in the week before missing the tablet, be aware that pregnancy may have occurred. In this case, consult your doctor.

• One tablet missed in Week 2
  Take the missed tablet as soon as possible, even if this means taking two tablets at once. Continue taking the remaining tablets at your usual time. Protection against pregnancy is not reduced, and no additional precautions are needed.

• One tablet missed in Week 3
  You have two options:

  1. Take the missed tablet as soon as possible, even if this means taking two tablets at once. Continue taking the remaining tablets at your usual time. Do not take a tablet-free break; instead, start the next blister pack immediately. Withdrawal bleeding will most likely occur at the end of the second pack, but spotting or breakthrough bleeding may occur during the second pack.
  2. Alternatively, stop taking tablets from the current pack and go directly to the 7-day tablet-free interval (note the day on which you missed the tablet). If you wish to start the next pack on your usual starting day, you may shorten the tablet-free interval to less than 7 days. If you follow either of these options, protection against pregnancy is maintained.

• If you missed any tablet from the pack and do not have withdrawal bleeding during the first tablet-free interval, this may indicate pregnancy. Contact your doctor before starting the next pack.

Missed tablets from one pack
Yes
Did you have sexual intercourse
in
during the week before missing
the tablet?
1.
No

• Take the missed tablet
• Use barrier method (condoms) for the next 7 days
• Finish the tablets in the current pack

Only one tablet • Take the missed tablet and
missed (taken more • Finish the tablets in the current pack
than 12 hours late) 2.

• Take the missed tablet and
• Finish the tablets in the current pack
• Instead of the tablet-free week, start the next pack immediately
• Immediately stop taking tablets from the current pack
• Start the tablet-free week (no longer than 7 days, including the missed tablet)
• Start the next pack

What to do if you experience vomiting or severe diarrhoea

If you vomit within 3 to 4 hours of taking a tablet or have severe diarrhoea, there is a risk that the active ingredients have not been completely absorbed. This situation is similar to missing a tablet. After vomiting or diarrhoea, take another tablet from a spare pack as soon as possible. If possible, take it within 12 hours of your usual tablet-taking time. If this is not possible or more than 12 hours have passed, follow the advice given in the section "Missed dose of Yasmin".

Delaying withdrawal bleeding: what you need to know

Although not recommended, it is possible to delay withdrawal bleeding by going directly to a new Yasmin blister pack, skipping the tablet-free interval until the end of the second pack. Spotting or breakthrough bleeding may occur during the second pack. After the usual 7-day tablet-free interval, start the next pack.

Consult your doctor for advice before deciding to delay withdrawal bleeding.

Changing the day of withdrawal bleeding: what you need to know

If you take the tablets as instructed, withdrawal bleeding will occur during the tablet-free week. If you wish to change this day, you can do so by shortening (but never extending — the tablet-free interval must not exceed 7 days) the tablet-free interval. For example, if the tablet-free interval usually starts on Friday, but you wish to change it to Tuesday (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 during this interval. Spotting or breakthrough bleeding may occur instead.

If you are unsure what to do, contact your doctor.

Stopping Yasmin

You may stop taking Yasmin at any time. If you do not wish to become pregnant, consult your doctor about other effective methods of birth control. If you wish to become pregnant, stop taking Yasmin and wait for a menstrual period before trying to conceive. This makes it easier to calculate the expected date of delivery.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any adverse reactions occur, especially severe and persistent ones, or any changes in health that the patient considers related to the use of Yasmin, medical advice should be sought.

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 using Yasmin".

Serious adverse reactions
Seek immediate medical attention if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing or urticaria, which may cause difficulty breathing (see also section "Warnings and precautions").

The following adverse reactions have been associated with the use of Yasmin:

Common adverse reactions (occur in 1 to 10 out of every 100 patients):

• Menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness,
• Headache, depressed mood,
• Migraine,
• Nausea,
• Thick, whitish vaginal discharge, candidiasis (fungal infection).

Uncommon adverse reactions (occur in 1 to 10 out of every 1,000 patients):

• Breast enlargement, changes in libido,
• High blood pressure, low blood pressure,
• Vomiting, diarrhoea,
• Acne, rash, itching, hair loss,
• Vaginitis,
• Fluid retention, changes in body weight.

Rare adverse reactions (occur in 1 to 10 out of every 10,000 patients):

• Hypersensitivity reactions (allergic reactions), asthma,
• Galactorrhoea (milk discharge from the breast),
• Hearing disorder,
• Nodular erythema (a skin condition characterized by red, painful nodules) or erythema multiforme (a rash presenting as redness or ulceration),
• Harmful blood clots in veins or arteries, for example:
  • in the leg or foot (e.g. deep vein thrombosis)
  • in the lungs (e.g. pulmonary embolism)
  • heart attack
  • stroke
  • mini-stroke or transient ischaemic attack (TIA)
  • blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2 for further information on factors increasing the risk of blood clots and symptoms of blood clots).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions 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 reactions helps provide more information on the safety of the medicine.

5. How to store Yasmin

Keep the medicine out of the sight and reach of children.
Do not store above 30°C. Store in the original packaging to protect from moisture.
Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of the stated 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 package and other information

What Yasmin contains

• The active substances in this medicinal product are drospirenone and ethinylestradiol. Each coated tablet contains 3 mg of drospirenone and 0.030 mg of ethinylestradiol.
• Other components (excipients): Tablet core: monohydrate lactose, corn starch, pregelatinized corn starch, povidone K 25, magnesium stearate; coating: hypromellose, macrogol 6000, talc, titanium dioxide (E 171), iron oxide yellow (E 172).

What Yasmin looks like and contents of the pack

• Each Yasmin blister contains 21 light yellow coated tablets.
• Yasmin tablets are film-coated tablets; the tablet core is covered with a coating. The tablets are light yellow, round, with convex surfaces, one side marked with the letters "DO" within a regular hexagon.
• Yasmin is available in packages containing 1 or 3 blisters, each with 21 tablets. A cardboard sleeve is included with the package, in which the blister should be placed.

For further detailed information, please contact the responsible party or parallel importer:
Responsible entity in Greece, country of export:
Bayer Hellas ABEE
Agisilaou 6-8, 151 23 Marousi, Attica, Greece
Manufacturer:
Bayer AG
Müllerstrasse 178, 13353 Berlin, Germany
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Authorization number in Greece, country of export: 4016/21-1-2016
Parallel import authorization number: 42/25
This medicinal product is authorized for marketing in the Member States of the European Economic Area under the following trade names:

• Austria, Belgium, Bulgaria, Croatia, Cyprus, Denmark, Finland, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden: Yasmin
• France: Jasmine
• Czech Republic, Hungary, Slovakia: Yadine
• Estonia, Latvia, Lithuania, Slovenia: Yarina

Translation of weekday symbols printed next to each tablet on the immediate packaging:
ΔΕΥ - Monday
ΤΡΙ - Tuesday
ΤΕΤ - Wednesday
ΠΕΜ - Thursday
ΠΑΡ - Friday
ΣΑΒ - Saturday
ΚΥΡ - Sunday