Yasmin

Package leaflet: Information for the user

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

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

Important information about combined hormonal contraceptives:

• When used correctly, they are one of the most reliable reversible methods of contraception.
• They slightly increase the risk of venous and arterial blood clots, 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 the patient suspects symptoms of blood clots (see section 2 "Blood clots").

Leaflet contents:

1. What Yasmin is and what it is used for
2. What you need to know before taking Yasmin
   When not to take Yasmin
   Warnings and precautions
   BLOOD CLOTS
   Yasmin and cancer
   Psychiatric disorders
   Intermenstrual bleeding
   What to do if no withdrawal bleeding occurs during the tablet-free week
   Yasmin and other medicines
   Yasmin with food and drink
   Laboratory tests
   Pregnancy
   Breast-feeding
   Driving and using machines
   Yasmin contains monohydrate lactose
3. How to take Yasmin
   When to start the first blister pack?
   Taking more Yasmin than you should
   If you forget to take Yasmin
   What to do if you vomit or have severe diarrhoea
   Delayed onset of withdrawal bleeding: what you need to know
   Changing the first day of withdrawal bleeding: what you need to know
   Stopping Yasmin before the end of the pack
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 you can start taking 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,
carry out 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 situations,
you should either avoid sexual intercourse or use additional non-hormonal
contraceptive methods, such as condoms or other barrier methods. Do not use
calendar-based methods or temperature monitoring. These methods may be unreliable because
Yasmin alters the monthly changes in body temperature and cervical mucus.
Yasmin, like other hormonal contraceptives, does not protect against
HIV infection (AIDS) or other sexually transmitted infections.

When not to use Yasmin
Do not use Yasmin if you have any of the conditions listed below. If you have any of the
conditions listed below, inform your doctor. Your doctor will discuss with you which other method of
birth control might be more suitable.
Do not use Yasmin:

• if you currently have (or have ever had) a blood clot in the deep veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know you have blood clotting disorders – 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 prolonged period (see section 2, "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 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 currently have (or have had in the past) a type of migraine called "migraine with aura";
• if you have had or currently have severe liver disease and liver function remains abnormal;
• if you have kidney function disorders (kidney failure);
• if you have had or currently have a liver tumour;
• if you have had breast cancer or genital organ cancer, or if such cancer is currently 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 use Yasmin in patients with hepatitis C who 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 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 have 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 the leg (deep vein thrombosis), in the lungs (pulmonary embolism), a heart attack or stroke (see section below "Blood clots").

For a description of the symptoms of these serious adverse events, see "How to recognize blood clots".
Tell your doctor if you have any of the following conditions.
Discuss these with your doctor before starting Yasmin. In certain situations, special care may be needed when using Yasmin or any other combined hormonal contraceptive, and regular check-ups by your doctor 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 red blood cell disorder),
• if you have high blood fat levels (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of pancreatitis,
• if you require surgery or will be immobile for a prolonged period (see section 2, "Blood clots"),
• if you are in the immediate postpartum period, as you are at increased risk of blood clots. Consult your doctor about when it is safe to start taking Yasmin after delivery,
• if you have superficial thrombophlebitis (inflammation of veins under the skin),
• if you have varicose veins,
• if you have epilepsy (see section 2, "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 occurred during pregnancy or previous use of sex hormones [e.g. hearing loss, porphyria (a blood disorder), herpes gestationis (a blistering skin rash during pregnancy), Sydenham's chorea (a nervous system disorder with sudden, involuntary movements)],
• if you have had or currently have 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 urticaria that may cause breathing difficulties, seek immediate medical attention. Medicines 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 medicines.
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").

Full 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.
Remember that the overall risk of harmful blood clots associated with the use of Yasmin is low.

HOW TO RECOGNIZE BLOOD CLOTS
Seek immediate medical advice if you experience any of the following symptoms.
Are you experiencing any of these symptoms? Likely cause:

• swelling of one leg or swelling along a vein in the leg or foot, especially if accompanied by:

  • pain or tenderness in the leg, felt especially when standing or walking;
  • increased warmth in the affected leg;
  • skin discoloration of the leg, e.g. pallor, redness,
  • or bluish discoloration;

• sudden unexplained shortness of breath or rapid breathing;

• sudden cough without 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.
common cold).

Symptoms most commonly affecting one eye:

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

Retinal vein thrombosis (blood clot in the eye)

• chest pain, discomfort, pressure, heaviness;
• squeezing or fullness in the chest, arm, or below the breastbone;
• feeling of fullness, indigestion, or choking;
• discomfort in the lower 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;

Heart attack

• sudden weakness or numbness of the face, arms, or legs,
• especially on one side of the body;
• sudden confusion, speech or comprehension difficulties;
• sudden visual disturbances in one or both eyes;
• sudden difficulty walking, dizziness, loss of balance or coordination;
• sudden, severe, or prolonged headache without known cause;
• loss of consciousness or fainting with or without seizures;

Stroke

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 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 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 factors influence 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.

• In one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In one year, about 9 to 12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Yasmin, will develop blood clots.
• The risk of blood clots 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, however some 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 relative of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g. below 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 use of Yasmin several weeks before surgery or periods of immobility. If the patient needs to stop taking Yasmin, she should consult her doctor about when she can resume taking the medicine.
• with increasing age (especially above 35 years);
• if the patient has given birth within the last 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 mentioned risk factor.
The doctor should be informed if any of the listed factors apply to the patient, even if she is uncertain. The doctor may decide to discontinue use of Yasmin.
The doctor should be informed if any of the above conditions change during treatment with Yasmin, for example, if a close relative is diagnosed with thrombosis of unknown cause 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 cause serious consequences, such as heart attack or stroke.

Factors increasing the risk of blood clots in arteries
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 (above approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Yasmin, it is recommended to stop smoking. 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 has overweight;
• if the patient has high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (below 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close relative has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valve disorder, heart rhythm disorder known as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions or if any of them is 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, if a close relative is diagnosed with thrombosis of unknown cause, or if the patient gains significant weight.

Yasmin and cancer
Breast cancer occurs slightly more frequently in women who use combined oral contraceptives, but it is not known whether this is caused by the use of hormonal contraceptives. For example, it may be that more cancers are 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 the doctor if any lumps are felt.
Rare cases of benign and even more rarely malignant liver tumors have been reported in women using combined oral contraceptives, which have led to life-threatening intra-abdominal bleeding. If severe upper abdominal pain occurs, the doctor should be contacted as soon as possible.

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, contact the doctor as soon as possible for further medical advice.

Intermenstrual bleeding
During the first few months of taking Yasmin, unexpected bleeding (bleeding outside the pill-free week) may occur. If such bleeding lasts 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 during the pill-free week
If all tablets have been taken according to the schedule, without vomiting or severe diarrhea, and no other medicines have been taken, it is very unlikely that pregnancy has occurred.
If expected withdrawal bleeding does not occur twice in succession, this may indicate pregnancy. The patient should contact the doctor 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.
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) should be used, and if so, for how long, or whether the use of another necessary medicine should be changed.
Some medicines may:

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

This applies to medicines used to treat:

• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine),
• tuberculosis (e.g. rifampicin),
• HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz),
• fungal infections (e.g. griseofulvin, ketoconazole),
• arthritis, degenerative joint disease (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 must not be used in patients with hepatitis C and who are 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 (increase in liver enzyme AlAT levels).
The doctor will recommend another type of contraception before starting treatment with the mentioned medicines.
Yasmin may be resumed approximately 2 weeks after completion of treatment. See section 2, "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 Yasmin is being taken, 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, she should stop taking it immediately and contact her doctor.
If the patient wishes to become pregnant, she may discontinue Yasmin at any time (see also section 3, "Discontinuing Yasmin").

Before taking any medicine, consult a doctor or pharmacist.

Breast-feeding
The use of Yasmin is not recommended during breast-feeding. If the patient wishes to take Yasmin while breast-feeding, she should contact 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 contact her doctor before taking Yasmin.

3. How to take Yasmin

Take one Yasmin tablet every day, with a small amount of water if necessary. Tablets may be taken with or without food, but should be taken daily at approximately the same time.
The blister pack contains 21 coated tablets. Next to each tablet is printed the symbol for the day of the week on which it should be taken. For example, if you start on Wednesday, take the tablet marked "WO" next to it (see "Translation of day-of-the-week symbols next to each tablet on the immediate packaging" at the end of this leaflet and on the sachet).
Move in the direction of the arrow on the blister until all 21 tablets have been taken.
Then, do not take any tablets for 7 days. During this 7-day break (also known as the "tablet-free week"), withdrawal bleeding usually begins. This so-called "withdrawal bleeding" 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 that each new pack should be started on the same day of the week, and withdrawal bleeding should occur on approximately the same days each month.
If you take Yasmin exactly as described above, you are protected against pregnancy even during the 7 days when you do not take tablets.

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 a combined hormonal vaginal ring or transdermal patch
  You may start Yasmin the day after taking the last active tablet from your previous contraceptive pack, but no later than the day after completing the tablet-free interval of your previous contraceptive (or after the last inactive tablet of your previous contraceptive). If switching from a combined contraceptive vaginal ring or transdermal 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 (from an implant or intrauterine system on the day of removal, or from an injectable method on the scheduled day of the next injection), but in all cases you must use additional contraceptive precautions (e.g. condoms) for the first 7 days of taking Yasmin tablets.

• After a 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 day 28, you must use a barrier method (e.g. condoms) for the first 7 days of taking Yasmin. If you have had sexual intercourse after childbirth and before (re)starting Yasmin, you must first ensure that you are not pregnant, or wait until your next menstrual period.

• If you are breastfeeding and wish to (re)start taking 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, symptoms such as nausea, vomiting, or vaginal bleeding may occur. Such bleeding may even occur in girls who have not yet started menstruating but have accidentally taken the medicine.
If you or a child has taken too many Yasmin tablets or swallowed a number of them, 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 the next tablets at your usual time.
• If more than 12 hours have passed since the missed tablet, contraceptive protection 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. Follow the rules below (see also the flowchart below):

• More than one 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 the same time. Continue taking the remaining tablets at your usual time and use additional contraceptive precautions, 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 the same time. 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 the same time. Continue taking the remaining tablets at your usual time. Do not take a break—start the next pack immediately. Withdrawal bleeding will most likely occur at the end of the second pack, but breakthrough bleeding or spotting 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, contraceptive protection will be maintained.

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

Missed tablet management flowchart

Missed several tablets from one pack
→ Consult your doctor

Only one tablet missed
→
Did sexual intercourse occur in the week before missing the tablet?

Week 1
Yes
→

• Take the missed tablet
• Use barrier method (condoms) for next 7 days and finish the pack

No
→

• Take the missed tablet and finish the pack
• Start the next pack immediately (without a break)

Week 2 or Week 3
Missed tablet (taken more than 12 hours late)
→

• Take the missed tablet and finish the pack
• Instead of the tablet-free week, start the next pack immediately
  OR
• Stop taking tablets from the current pack
• Start the tablet-free week (no longer than 7 days, including the day the tablet was missed)
• 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 may not have 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 in the section "Missed dose of Yasmin".

Delaying withdrawal bleeding: what you need to know

Although not routinely recommended, it is possible to delay withdrawal bleeding by going directly to a new Yasmin pack, skipping the tablet-free interval until the end of the second pack. Breakthrough bleeding or spotting may occur during the second pack. After the usual 7-day tablet-free interval, you must start taking tablets from the next pack.
You may ask your doctor for advice before deciding to delay withdrawal bleeding.

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

If you take your tablets as instructed, withdrawal bleeding will begin during the tablet-free week. If you wish to change this day, you can do so by shortening (but never extending—maximum 7 days!) the tablet-free interval. For example, if your tablet-free week starts on Friday and 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), you may not bleed during this interval. Breakthrough bleeding or spotting may then occur.
If you are unsure what to do, consult 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 using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone experiences them.
If any adverse reactions occur, especially severe and persistent ones, or changes in health status that the patient considers to be 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, see section 2, "Important information before taking Yasmin".

Serious adverse reactions
Seek immediate medical advice 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 2, "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, white 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, alopecia,
• 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 secretion from breasts),
• Hearing impairment,
• Nodular erythema (a skin condition characterised 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/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 increasing the likelihood of blood clots and symptoms of blood clots).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Store below 30°C. Keep in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the package. 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 pack and other information

What Yasmin contains

• The active substances in Yasmin are ethinylestradiol and drospirenone. Each coated tablet contains 0.03 mg ethinylestradiol and 3 mg drospirenone.
• The other ingredients (excipients) are: monohydrate lactose, maize starch, pregelatinized maize starch, povidone K 25, magnesium stearate (E 470b), coating: hypromellose (E 464), macrogol 6000, talc (E 553b), titanium dioxide (E 171), yellow iron oxide (E 172). See section 2 "Yasmin contains monohydrate lactose".

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 packs containing 1 or 3 blisters, each with 21 tablets. A cardboard pouch is included in the package, in which the blister should be placed.

For further detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing authorization holder in the Netherlands, country of export:
Bayer B.V., Siriusdreef 36, 2132 WT Hoofddorp, the Netherlands
Manufacturer:
Bayer AG, 13342 Berlin, Germany
Parallel importer:
InPharm Sp. z o.o., Strumykowa Street 28/11, 03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k., Chełmżyńska Street 249, 04-458 Warsaw, Poland
Marketing authorization number in the Netherlands, country of export: RVG 23827
Parallel import authorization number: 62/15
This medicinal product is authorized for marketing in the European Economic Area countries under the following trade names:

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

Translation of the weekday symbols next to each tablet on the immediate packaging:
MA - Monday
DI - Tuesday
WO - Wednesday
DO - Thursday
VR - Friday
ZA - Saturday
ZO - Sunday