Yasmin

Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is 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 you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, 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 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. What you need to know 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 lactose monohydrate
3. How to take Yasmin
   When can you start the first blister pack?
   Taking more than the recommended dose of Yasmin
   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 treatment with 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 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 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 barrier methods. Do not use the calendar method or temperature monitoring method. 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 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 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 – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you require 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 ever had) a type of migraine called "migraine with aura";
• if you have (or have had in the past) 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 or currently have breast cancer or cancer of the genital organs, 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 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 whose menstrual cycles have not yet started.

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

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

Women with impaired kidney function
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
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").

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

Tell your doctor if you have any of the following conditions.
Before starting Yasmin, discuss these with your doctor. 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 breast cancer has occurred or occurs currently in your close family;
• 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 causing kidney failure);
• if you have sickle cell anaemia (a hereditary red blood cell disorder);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridaemia) or have a positive family history for 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 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 childbirth;
• 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 appeared during pregnancy or during previous use of sex hormones [for example, hearing loss, porphyria (a blood disorder), herpes gestationis (blistering skin rash during pregnancy), Sydenham's chorea (a nervous system disorder with sudden body movements)];
• if you have or have ever had skin pigmentation disorders (yellow-brown pigment changes, so-called chloasma), 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, 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 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").

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 caused by taking Yasmin is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Contact your doctor immediately if you notice 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 colour change in the leg, such as pallor, redness, or bluish discolouration;

• sudden unexplained shortness of breath or rapid breathing;

• sudden cough without an obvious cause, which may be associated with coughing up blood;

• sudden sharp chest pain, which may worsen with deep breathing;

• severe dizziness or vertigo;

• rapid or irregular heartbeat;

• severe stomach pain;

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

Symptoms most commonly affecting one eye: Retinal vein thrombosis (blood clot in the eye)

• sudden loss of vision or

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

• chest pain, discomfort, pressure, heaviness;

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

• feeling of fullness, indigestion, or choking;

• discomfort in the lower part of the 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;

• sudden weakness or numbness of the face, arms, or legs, Stroke especially on one side of the body;

• sudden confusion, speech disturbances, or difficulty understanding;

• sudden visual disturbances in one or both eyes;

• sudden difficulty walking, dizziness, loss of balance, or lack of coordination;

• sudden, severe, or prolonged headache without known cause;

• loss of consciousness or fainting with or without seizures.

In some cases, stroke symptoms may be transient with almost immediate and complete recovery; however, you should contact your doctor immediately, as you may be at risk of a further stroke.

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 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 venous blood clots highest?
The risk of venous blood clots is highest during the first year of first-time use of combined hormonal contraceptives. The risk may also be increased 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 does the risk of blood clots depend on?
The risk depends on the individual'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 to 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 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 significantly overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In such a case, the patient may have an inherited clotting disorder;
• if the patient requires surgery, will be 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, she should consult her doctor about when she can restart the medication;
• 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, particularly if the patient has another risk factor listed above.
The patient should inform her doctor if any of the listed factors apply, even if she is uncertain. The doctor may decide to discontinue the use of Yasmin.
The patient should inform her doctor 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.

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

Factors increasing the risk of arterial blood clots
It should be emphasized that the risk of heart attack or stroke associated with the use of Yasmin is very low, but it 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 a different 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 such a 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 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 are particularly severe, the risk of blood clots may be further increased.
The patient should inform her doctor if any of the above conditions change during treatment with Yasmin, for example, if she starts smoking, if a close family member is diagnosed with unexplained thrombosis, or if she gains significant weight.

Yasmin and cancer
Breast cancer occurs slightly more frequently in women who use combined oral contraceptives, but it is unknown whether this is caused by the use of hormonal contraceptives. For example, more cancers may be detected in women using combined oral 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 and, even more rarely, malignant liver tumors have been reported in women using combined oral contraceptives. These tumors have led to life-threatening intra-abdominal bleeding. If severe upper abdominal pain occurs, the patient should contact her doctor as soon as possible.

Psychiatric disorders
Some women using hormonal contraceptives, including Yasmin, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, the patient should contact her 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 starts after several months, the doctor should investigate the cause.

What to do if no 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 medications have been taken, the likelihood of pregnancy is very low.
If expected bleeding does not occur for two consecutive cycles, this may indicate pregnancy. The patient should contact her doctor immediately. She should not start the next pack until pregnancy has been ruled out.

Yasmin and other medicines
The patient should always inform her doctor about any medicines or herbal products she is currently taking. She should also inform any other doctor, including a dentist, or pharmacist prescribing another medicine that she is using Yasmin. They may advise whether additional contraceptive methods (e.g., condoms) are needed, 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 it to be 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 (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz),

• fungal infections (e.g., griseofulvin, ketoconazole),

• arthritis and osteoarthritis (etoricoxib),

• pulmonary hypertension (bosentan),

• herbal products containing St. John's wort ( Hypericum perforatum ).

Yasmin may 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 who are taking medicinal products containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as these 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 the 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, the patient should inform the doctor or laboratory staff that she is 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 taking it immediately and contact her doctor.
If the patient wishes to become pregnant, she may stop taking Yasmin at any time (see also section 3, "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 consult 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 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 necessary. Tablets may be taken with or without food, but they must be taken every day 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 "WED" 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 pack 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 blister pack should be started on the same day of the week, and withdrawal bleeding should occur during the same days of the week each month.

If you take Yasmin as directed, you are protected against pregnancy during the 7 days when you are not taking 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 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 contraceptive vaginal ring or transdermal patch
  You may start Yasmin the day after taking the last active tablet from your previous pack, but no later than the day after the tablet-free interval of your previous contraceptive ends (or the day 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 (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 a miscarriage
  Follow your doctor's advice.

• After childbirth
  You may start taking Yasmin between days 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 ensure that you are not pregnant, or wait until your next menstrual bleeding.

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

Overdose of Yasmin

There are 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 have accidentally taken the medicine.

If you or a child has taken too many Yasmin tablets or swallowed a number of them, consult your 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 next tablets at your usual time.

• If more than 12 hours have passed since you missed a tablet, contraceptive protection may be reduced. The more tablets missed, the higher the risk of pregnancy.

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

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

• 1 tablet missed in week 1
  Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Then 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.

• 1 tablet missed in week 2
  Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Then continue taking the remaining tablets at your usual time. Contraceptive protection is not reduced, and no additional precautions are needed.

• 1 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. Then 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 intermenstrual bleeding may occur during the second pack.

  2. Alternatively, you may 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 chart

Missed tablets:
Several tablets from one pack → Consult your doctor

Missed tablets:
Only 1 tablet

Week 1
Missed tablet (taken more than 12 hours late)
→
Had sexual intercourse in the week before missing the tablet?
Yes → Take the missed tablet + use barrier method (condoms) for next 7 days + finish the pack
No → Take the missed tablet + finish the pack

Week 2
Missed tablet (taken more than 12 hours late)
→
Take the missed tablet + finish the pack

Week 3
→
Option 1: Take the missed tablet + finish the pack + start next pack immediately (no break)
Option 2: Stop taking tablets + start tablet-free interval (no longer than 7 days, including the missed tablet) + start next pack

What to do if vomiting or severe diarrhoea occurs

If you vomit 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 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 given in the section "Missed dose of Yasmin".

Delaying withdrawal bleeding: what you should 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 intermenstrual bleeding may occur during the second pack. After the usual 7-day tablet-free interval, you must start taking tablets from the next blister pack.

You may ask your doctor for advice before deciding to delay withdrawal bleeding.

Changing the first day of withdrawal bleeding: what you should know

If you take the tablets as instructed, withdrawal bleeding will start during the tablet-free week. If you wish to change this day, you can do so by shortening (but never lengthening – maximum 7 days!) the tablet-free interval. For example, if the tablet-free week starts on Friday and you wish to change it to Tuesday (3 days earlier), you should 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 that interval. Spotting or intermenstrual bleeding may then occur.

If you are unsure how to proceed, 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 can cause adverse reactions, although not everyone will experience 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, please refer to section 2, "Important information before taking Yasmin".

Severe 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 lead to breathing difficulties (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 (milky discharge from the breasts),
• Hearing impairment,
• Nodular erythema (a skin condition characterized by red, painful nodules) or erythema multiforme (a rash presenting as redness or ulceration),
• Harmful blood clots in a vein or artery, 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 other risk factors (see section 2 for further information on risk factors for 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 to provide more information on the safety of this medicine.

5. How to store Yasmin

Keep this medicine out of sight and reach of children.
Do not store above 30°C. Store in the original packaging.
Do not use this medicine 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 pack and other information

What Yasmin contains

• The active substances in Yasmin are ethinylestradiol and drospirenone. Each coated tablet contains 0.030 mg of ethinylestradiol and 3 mg of drospirenone.
• The other ingredients (excipients) are: monohydrate lactose, maize starch, pregelatinised maize starch, povidone K 25, magnesium stearate, hypromellose, polyethylene glycol 6000, talc, 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 pack 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” in a regular hexagon.
• Yasmin is available in packs containing 1 or 3 blisters, each with 21 tablets. A cardboard sachet is included in the pack, in which the blister should be stored.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Ireland, the country of export:
Bayer Limited
1st Floor, The Grange Offices, The Grange, Brewery Road, Stillorgan, Co. Dublin, A94 H2K7,
Ireland
Manufacturer:
Bayer AG
13342 Berlin
Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Ireland, the country of export: PA1410/023/001
Parallel import authorisation number: 413/21
This medicinal product is authorised 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 the day-of-the-week symbols printed next to each tablet on the immediate packaging:
MON – Monday
TUE – Tuesday
WED – Wednesday
THU – Thursday
FRI – Friday
SAT – Saturday
SUN – Sunday