Yasmin

Patient Information Leaflet

Yasmin, 0.03 mg + 3 mg, coated tablets
(ethinylestradiolum + drospirenonum)
Please read all of this leaflet carefully before you start taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell 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 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").

Leaflet Contents:

1. What Yasmin is and what it is used for ........................................................................................... 2
2. Before you take Yasmin .................................................................................................................. 2
   When not to take Yasmin .............................................................................................................. 2
   Warnings and precautions ........................................................................................................... 3
   BLOOD CLOTS ............................................................................................................................. 5
   Yasmin and cancer ....................................................................................................................... 9
   Psychological disorders .............................................................................................................. 9
   Breakthrough bleeding .................................................................................................................. 9
   What to do if no withdrawal bleeding occurs .............................................................................. 9
   Yasmin and other medicines ....................................................................................................... 9
   Yasmin with food and drink ....................................................................................................... 10
   Laboratory tests .......................................................................................................................... 10
   Pregnancy .................................................................................................................................... 10
   Breast-feeding ............................................................................................................................ 10
   Driving and using machines ....................................................................................................... 10
   Yasmin contains lactose .............................................................................................................. 11
3. How to take Yasmin ....................................................................................................................... 11
   When can you start the first blister pack? ................................................................................... 11
   Taking more Yasmin than you should ........................................................................................ 12
   If you forget to take Yasmin ........................................................................................................ 12
   What to do if you vomit or have severe diarrhoea ...................................................................... 15
   Delayed withdrawal bleeding: what you need to know ............................................................. 15
   Changing the first day of withdrawal bleeding: what you need to know ................................... 15
   Stopping Yasmin ........................................................................................................................ 15
4. Possible side effects ....................................................................................................................... 15
5. How to store Yasmin ..................................................................................................................... 17
6. Contents of the pack and other information .................................................................................. 17

1. What Yasmin is and what it is used for

• Yasmin is a contraceptive pill used to prevent pregnancy.
• Each coated tablet contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol.
• Contraceptive pills 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 may carry out other examinations if necessary.
This leaflet describes several situations in which you should stop taking Yasmin or in which 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 mechanical methods. Do not use the rhythm method or temperature-based methods. These methods may be unreliable because Yasmin alters the monthly changes in body temperature and cervical mucus.
Yasmin, like other hormonal contraceptive products, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

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

• if you currently have (or have ever had) a blood clot in the veins of your legs (deep vein thrombosis), in your 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 previously had) 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 diseases 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 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 dysfunction (kidney failure);
• if you currently have or have previously had liver tumours;
• if you have previously 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). Reactions 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.
Elderly women
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 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 symptoms of these serious adverse events, see "How to recognize the occurrence of blood clots".

You should tell your doctor if you have any of the following conditions.
Before starting Yasmin, discuss these with your doctor. In certain situations, special caution may be 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, you should also 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 (an inherited red blood cell disorder),
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a positive 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 then at increased risk of blood clots. Consult your doctor for advice on how soon you can 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 page 9 "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 with sudden body movements)],
• if you have developed or have previously developed skin pigmentation changes (yellow-brown discolouration, 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, contact your doctor immediately. 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 hormonal contraception.
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 THE OCCURRENCE OF BLOOD CLOTS
Contact your doctor immediately if you experience any of the following symptoms.

Do you experience any of these symptoms? What is the 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, which may occur only when standing or walking,
• increased warmth in the affected leg,
• skin colour change in the leg, e.g. pallor, redness, or blueness,
• sudden unexplained shortness of breath or rapid breathing;
• sudden coughing without an obvious cause, which may be associated with coughing up blood;
• sharp chest pain, which may worsen on deep breathing;
• severe dizziness or lightheadedness;
• rapid or irregular heartbeat;
• severe stomach pain;
  If you are unsure, contact your doctor, as some of these symptoms, such as cough or breathlessness, may be mistaken for milder conditions such as respiratory tract infections (e.g. cold).

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

• Use of combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thromboembolism). 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 venous blood clots is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when restarting combined hormonal contraceptives (either 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 patient stops taking Yasmin, the risk of blood clots returns to normal levels within a few weeks.

What factors influence the risk of blood clots in veins?
The risk depends on the individual's baseline 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's personal medical history (see "Factors that increase 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 is 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 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 prolonged 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 recently 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 risk factor listed above. Inform the doctor if any of the listed 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 cause 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, 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 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 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, especially migraines with aura;
• if the patient has heart disease (valve problems, heart rhythm disorders 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 is 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.

Yasmin and cancer
In women using combined oral contraceptives, breast cancer occurs slightly more frequently, but it is not known whether this is caused by the use of hormonal contraceptives. For example, it may be that more breast 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 a doctor if any lumps are felt.
Rare cases of benign and even rarer cases of malignant liver tumours have been reported in women using combined oral contraceptives, which have led to life-threatening intra-abdominal bleeding. If severe upper abdominal pain occurs, contact a doctor immediately.

Psychiatric disorders
Some women using hormonal contraceptives, including Yasmin, have reported depression or depressed mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact a doctor immediately 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
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 the expected withdrawal bleeding does not occur twice in succession, this may indicate pregnancy. Contact a doctor immediately. Do not start the next pack 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 you should use additional contraceptive methods (e.g. condoms), and if so, for how long, or whether you should adjust the use of another necessary medicine.
Some medicines may:

• affect the blood concentration of Yasmin,
• make Yasmin less effective 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, 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 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 (increased levels of the liver enzyme AlAT).
The doctor will recommend another type of contraception before starting treatment with these medicines. Yasmin may be restarted 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, she should stop immediately and contact her doctor.
If the patient wishes to become pregnant, she may stop taking Yasmin at any time (see also page 15 "Stopping 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 contact her doctor.

Before taking any medicine, consult a doctor or pharmacist.

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

Yasmin contains 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 or without a small amount of water. 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, the day of the week on which it should be taken is printed. For example, if you start on Wednesday, take the tablet marked "Wed." Proceed in the direction of the arrow on the blister until all 21 tablets have been taken.
After this, 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 a new blister pack, regardless of whether bleeding has stopped or not. This means that each new blister 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 as described above, you are protected against pregnancy during the 7 days when you do not take tablets.

When to start the first blister 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 immediately protected against pregnancy. You may also start on days 2–5 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 contraceptive vaginal ring or transdermal patch
  Start taking Yasmin the day after taking the last active tablet of your previous contraceptive, 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 contraceptive vaginal ring or 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 form on the day the next injection is due), 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 day 21 and 28 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 had sexual intercourse after childbirth before (re)starting Yasmin, you must first confirm that you are not pregnant or wait until your next menstrual bleeding.

• If you are breastfeeding and wish to start (or restart) taking Yasmin after childbirth
  Please read the section "Breast-feeding", page 10.

Taking more than the recommended dose 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 too many Yasmin tablets are taken or if a child swallows several tablets, consult a doctor or pharmacist immediately.

Missed dose of Yasmin

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

The risk of inadequate contraceptive protection is greatest if tablets are missed at the beginning or end of the blister pack. Therefore, follow the rules below (see also the chart on page 14):

• More than 1 tablet missed in this blister 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 there is a risk of pregnancy. In this case, contact 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. Contraceptive protection 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 blister pack, but spotting or breakthrough bleeding may occur during the second pack.
2. You may also stop taking tablets from the current blister 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 new blister pack on your usual starting day, the tablet-free interval may be shortened to less than 7 days. If you follow either of these recommendations, contraceptive protection will be maintained.

If you missed any tablet from the blister pack and no bleeding occurred during the first tablet-free interval, this may indicate pregnancy. Contact your doctor before starting the next blister pack.

Missed tablets
Consult your doctor
from one blister pack
yes
Did sexual intercourse occur in
the week before missing
the tablet?
no

• Take the missed tablet
• Use a barrier method (e.g., condoms) for the next 7 days
• and finish the tablets in the blister pack

Only one tablet
missed (taken • Take the missed tablet and
more than 12 hours late) in week 2 • finish the tablets in the blister pack

• Take the missed tablet and
• finish the tablets in the blister pack
• Instead of the tablet-free week, start the next blister pack immediately

or
in week 3

• Immediately stop taking tablets from the current blister pack
• Start the tablet-free week (no longer than 7 days, including the missed tablet)
• Start the next blister pack

What to do if you experience vomiting or severe diarrhoea
If vomiting occurs within 3 to 4 hours after taking a tablet or if you 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 blister pack as soon as possible. If possible, take it within 12 hours of your usual tablet-taking time. If this is not possible or if more than 12 hours have passed, follow the advice in the section "Missed dose of Yasmin", page 12.

Delayed withdrawal bleeding: what you should know
Even though this is 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 blister pack. Spotting or breakthrough bleeding may occur during the second blister pack. After the usual 7-day tablet-free interval, start taking tablets from the next blister pack.
You may consult your doctor for advice before deciding to delay withdrawal bleeding.

Changing the first day of withdrawal bleeding: what you should know
If you take tablets as instructed, withdrawal bleeding will begin during the tablet-free week. If you wish to change this day, do so by shortening (but never extending – maximum 7 days!) the tablet-free interval. For example, if your tablet-free interval starts on Friday and you wish to change to Tuesday (3 days earlier), start the new blister pack 3 days earlier than usual. If the tablet-free interval is very short (e.g., 3 days or less), bleeding may not occur during this interval. Spotting or breakthrough bleeding may then occur.
If you are unsure how to proceed, 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 your next 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 side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any side effects, especially severe or persistent ones, or any changes in health that you think may be related to taking Yasmin, consult your doctor.
All women taking combined hormonal contraceptives have an increased risk of blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with combined hormonal contraceptives, see section 2, "Important information before taking Yasmin".

Serious side effects
Contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat and/or difficulty swallowing, or hives, possibly causing breathing difficulties (see also section "Warnings and precautions").

The following side effects have been associated with the use of Yasmin:

Common side effects (occur in 1 to 10 out of 100 women):

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

Uncommon side effects (occur in 1 to 10 out of 1,000 women):

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

Rare side effects (occur in 1 to 10 out of 10,000 women):

• Allergic reactions (hypersensitivity), asthma
• Breast discharge
• Hearing disturbance
• Nodular erythema (skin condition with red, painful nodules) or erythema multiforme (rash with 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
  • transient ischaemic attack (TIA), also known as mini-stroke
  • blood clots in the liver, stomach/intestine, kidneys, or eye

The risk of developing blood clots may be higher if you have other risk factors (see section 2 for more information on risk factors for blood clots and symptoms of blood clots).

Reporting side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Yasmin
Keep the medicine out of sight and reach of children.
Do not store above 30°C. Keep in the original blister to protect from moisture.
Do not use this medicine after the expiry date stated on the packaging, after "Expiry date:". The expiry date refers to the last day of the stated month.
Do not dispose of medicines via the sewage system or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment.

6. Contents of the pack and other information

What Yasmin contains

• The active substances are drospirenone and ethinylestradiol. Each coated tablet contains 3 mg drospirenone and 0.030 mg ethinylestradiol.
• Other ingredients (excipients): monohydrate lactose, corn starch, pregelatinized corn starch, povidone K25, magnesium stearate, hypromellose, macrogol 6000, talc, titanium dioxide (E 171), yellow iron oxide (E 172). See section 2, "Yasmin contains lactose".

What Yasmin looks like and contents of the pack

• Each Yasmin blister pack contains 21 light yellow coated tablets.
• Yasmin tablets are coated; the tablet core is covered with a film coating. Tablets are light yellow, round, with convex surfaces; one side is marked with the letters "DO" in a regular hexagon.
• Yasmin is available in packs containing 1, 3, 6, or 13 blisters, each with 21 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Bayer AG
Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Germany

Manufacturer
Bayer AG
Müllerstrasse 178
13353 Berlin
Germany
Bayer Weimar GmbH und Co. KG
Doebereinerstrasse 20
99427 Weimar
Germany

For more detailed information, contact your doctor or the representative of the marketing authorization holder:
Bayer Sp. z o.o.
Al. Jerozolimskie 158
02-326 Warsaw, Poland
Tel. (0-22) 572 35 00

This medicinal product is authorized for sale in the European Economic Area countries under the following 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