Yasminelle

Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Yasminelle, 0.02 mg + 3 mg, film-coated tablets
Ethinylestradiolum + Drospirenonum
Important information about combined oral 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 a doctor if the user suspects symptoms of blood clots (see section 2 “BLOOD CLOTS”).

Read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm someone else, even if their symptoms are similar.
• If any side effects worsen or if any side effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Yasminelle is and what it is used for ........................................................................ 1
2. What you need to know before taking Yasminelle ............................................................. 1
   When not to take Yasminelle ......................................................................................... 1
   Do not take Yasminelle ................................................................................................. 1
   Warnings and precautions ............................................................................................. 1
   BLOOD CLOTS .............................................................................................................. 1
   Yasminelle and cancer ..................................................................................................... 1
   Breakthrough bleeding ................................................................................................... 1
   What to do if no withdrawal bleeding occurs ............................................................... 1
   Yasminelle and other medicines ..................................................................................... 2
   Laboratory tests .............................................................................................................. 2
   Pregnancy ......................................................................................................................... 2
   Breast-feeding .................................................................................................................. 2
   Driving and using machines ........................................................................................... 2
3. How to take Yasminelle ...................................................................................................... 2
   When to start the first blister pack ................................................................................. 2
   Taking more Yasminelle than recommended ................................................................ 2
   Missing a dose of Yasminelle ......................................................................................... 2
   What to do if you vomit or have severe diarrhoea ......................................................... 2
   Delayed onset of withdrawal bleeding: what you should know ................................... 2
   Change in the timing of withdrawal bleeding: what you should know ......................... 2
   Stopping Yasminelle treatment ...................................................................................... 2
4. Possible side effects ............................................................................................................. 2
5. How to store Yasminelle ..................................................................................................... 2
6. Contents of the pack and other information ....................................................................... 2

1. What Yasminelle is and what it is used for

• Yasminelle is a contraceptive tablet used to prevent pregnancy.
• Each film-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 Yasminelle

General remarks
Before starting to take Yasminelle, you should read the information about blood clots 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 Yasminelle, your doctor will ask 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 Yasminelle or when the reliability of Yasminelle may be reduced. In such cases, you should either avoid sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. Do not use the calendar method or temperature measurement method. These methods may be unreliable because Yasminelle alters the monthly changes in body temperature and cervical mucus.

Yasminelle, like other hormonal contraceptive products, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

When not to use Yasminelle
Do not use Yasminelle 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 contraception would be more suitable.

Do not use Yasminelle:

• 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;
• 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 “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 currently have or have had in the past 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 or suspect you may have breast cancer or cancer of the reproductive organs;
• if you have any unexplained vaginal bleeding.

Do not use Yasminelle 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 “Yasminelle and other medicines”).

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

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

Women with impaired liver function
Do not take Yasminelle if you have liver disease. See also sections “When not to use Yasminelle” and “Warnings and precautions”.

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

Warnings and precautions
When to contact your doctor
You should contact your doctor immediately

• if you notice any 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 effects, see “HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS”.

Tell your doctor if you have any of the following conditions.
Special caution may be needed when taking Yasminelle or any other combined hormonal contraceptive, and regular medical check-ups may be necessary. If any of these conditions develop or worsen during treatment with Yasminelle, inform your doctor.

• if there is a history of, or current occurrence of, breast cancer in your 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 leading to kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• 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 require surgery or will be immobile for a prolonged period (see section 2 “BLOOD CLOTS”);
• if you have recently given birth, as you are at increased risk of blood clots. Consult your doctor to find out how soon after delivery you can start taking Yasminelle;
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see “Yasminelle and 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 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, involuntary movements));
• if you have or have ever had chloasma (skin discoloration, especially on the face and neck, also known as “pregnancy mask”). If so, avoid direct 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 Yasminelle increases the risk of blood clots compared to not using such therapy. In rare cases, a blood clot may block a blood vessel and cause serious complications.

Blood clots may occur:

• in veins (referred to as “venous thrombosis” or “venous thromboembolic disease”);
• in arteries (referred to as “arterial thrombosis” or “arterial thromboembolic events”). 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 caused by taking Yasminelle is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Contact your doctor immediately if you notice any of the following symptoms.

Do you experience any of these symptoms?
What is the likely cause?

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

• pain or tenderness in the leg, which may only be felt when standing or walking,

• increased warmth in the affected leg,

• change in skin colour of the leg, such as pallor, redness, or blueness.

• sudden onset of unexplained shortness of breath or rapid breathing;
  Pulmonary embolism

• sudden onset of cough without an obvious cause, possibly accompanied by coughing up blood;

VENOUS BLOOD CLOTS
What can happen if blood clots develop in a vein

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

When the risk of venous blood clots is highest
The risk of venous blood clots is greatest 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 Yasminelle, the risk of blood clots returns to normal within a few weeks.

Factors influencing the risk of venous blood clots
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 Yasminelle is low.

• Among women who do not use combined hormonal contraceptives and are not pregnant, about 2 out of 10,000 will develop blood clots in a year.
• Among women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate, about 5–7 out of 10,000 will develop blood clots in a year.
• Among women who use combined hormonal contraceptives containing drospirenone, such as Yasminelle, about 9–12 out of 10,000 will develop blood clots in a year.

The risk of blood clots depends on a woman's individual medical history (see "Factors increasing the risk of venous blood clots" below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Yasminelle is low, but certain factors may increase this risk. The risk is higher:

• if the patient is very 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 this case, the patient may have an inherited tendency to form blood clots;
• if the patient needs to undergo surgery, will be immobile for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to stop taking Yasminelle several weeks before surgery or prolonged immobilisation. If the patient must stop taking Yasminelle, ask the doctor when it is safe to restart;
• 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 present.
Inform the doctor if any of the listed factors apply to the patient, even if uncertain. The doctor may decide to discontinue Yasminelle.
Inform the doctor if any of the above conditions change during treatment with Yasminelle, for example, if a close family member is diagnosed with unexplained thrombosis or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries
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 noted that the risk of heart attack or stroke associated with the use of Yasminelle is very low, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Yasminelle, it is recommended to stop smoking. If the patient cannot 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 this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valve disorder, heart rhythm disorder called atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Yasminelle, for example, if the patient starts smoking, a close family member is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Yasminelle and cancer
A slightly increased incidence of breast cancer has been observed in women using combined hormonal contraceptives, but it is not known whether this is caused by taking the pill. For example, more cancers may be detected in women using combined hormonal contraceptives because they are examined more frequently by their doctors. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important to examine breasts regularly and contact the doctor if any lumps are detected.
Benign liver tumours have been reported rarely, and malignant liver tumours very rarely, in women using oral contraceptives. If the patient experiences an unusual, severe abdominal pain, she should contact her doctor.

Psychiatric disorders
Some women using hormonal contraceptives, including Yasminelle, 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, contact the doctor as soon as possible for further medical advice.

Breakthrough bleeding
During the first few months of taking Yasminelle, unexpected bleeding (bleeding outside the pill-free week) may occur. If such bleeding persists for more than a few months, or 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 medicines have been taken, it is very unlikely that pregnancy has occurred.
If the expected withdrawal bleeding does not occur twice in succession, this may indicate pregnancy. Contact the doctor immediately. Do not start the next pack until pregnancy has been ruled out.

Yasminelle and other medicines
Always inform your doctor about any medicines or herbal products you are taking. Also inform any other doctor, including a dentist or pharmacist, who prescribes another medicine that you are using Yasminelle. They will advise whether additional contraceptive methods (e.g. condoms) are needed and for how long.
Some medicines may:

• affect the blood levels of Yasminelle;
• make it 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 ).

Yasminelle 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).

Yasminelle must not be used in patients with hepatitis C who are taking medicinal products containing ombitasvir with paritaprevir and ritonavir, dazabuvir, 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 a different type of contraception before starting these medicines.
Yasminelle may be restarted approximately 2 weeks after stopping the treatment. See section “When not to use Yasminelle”.

Before taking any medicine, consult your doctor or pharmacist.

Yasminelle with food and drink
Yasminelle 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 Yasminelle, as oral contraceptives may affect the results of certain tests.

Pregnancy
Yasminelle must not be used during pregnancy. If the patient becomes pregnant while taking Yasminelle, she should stop immediately and contact her doctor. If the patient wishes to become pregnant, she may discontinue Yasminelle at any time (see also “Stopping Yasminelle”, page 2).

Before taking any medicine, consult your doctor or pharmacist.

Breast-feeding
Yasminelle is generally not recommended during breast-feeding. If the patient wishes to take Yasminelle while breast-feeding, she should consult her doctor.

Before taking any medicine, consult your doctor or pharmacist.

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

Yasminelle contains monohydrate lactose
If the patient has an intolerance to certain sugars, she should contact her doctor before taking Yasminelle.

3. How to take Yasminelle

Take one Yasminelle tablet every day, with or without food, at about the same time each day, swallowing it with a small amount of water if needed.
The blister pack contains 21 coated tablets. Above each tablet is printed the day of the week on which it should be taken. For example, if you start on a Wednesday, take the tablet marked "Wednesday" above it (see: "Translation of the days of the week printed above each tablet" at the end of this leaflet and on the blister). 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 called the "tablet-free week"), a withdrawal bleed usually occurs. 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 Yasminelle tablet (i.e., after the 7-day break), start the next blister pack, regardless of whether bleeding has stopped or not. This means each new blister pack should always begin on the same day of the week, and withdrawal bleeding should occur on the same days of the week within each 28-day cycle.
If you take Yasminelle as directed, you are protected against pregnancy during the 7 tablet-free days as well.

When to start the first pack

• If you have not used any hormonal contraceptive in the previous month
  Start taking Yasminelle on the first day of your cycle (i.e., the first day of your menstrual period). If you start Yasminelle on the first day of your period, you are protected against pregnancy immediately. You may also start on days 2 to 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 vaginal contraceptive ring or transdermal patch
  You may start Yasminelle the day after taking the last active tablet from your previous 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 vaginal contraceptive ring or contraceptive patch, follow your doctor's advice.

• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen)
  You may switch on any day from the progestogen-only pill (on the day of removal of the 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 Yasminelle tablets.

• After miscarriage
  Follow your doctor's advice.

• After childbirth
  You may start taking Yasminelle between 21 and 28 days after childbirth. If you start later than 28 days after childbirth, you must use a barrier method (e.g., condoms) for the first 7 days of taking Yasminelle. If you have had sexual intercourse after childbirth before (re)starting Yasminelle, you must first ensure that you are not pregnant or wait until your next menstrual period.

If you are unsure when to start taking the medicine, consult your doctor.

• If you are breastfeeding and wish to (re)start Yasminelle after childbirth
  Please read the section "Breast-feeding", page 2.

Taking more than the recommended dose of Yasminelle
There have been no reports of serious harmful effects from taking too many Yasminelle 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 take too many Yasminelle tablets or a child swallows some of them, consult your doctor or pharmacist immediately.

Missed dose of Yasminelle

• 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 you missed a tablet, protection against pregnancy may be reduced. The more tablets missed, the higher the risk of pregnancy.

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

• More than one tablet missed in this 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. Then continue taking the remaining tablets at your usual time and use additional contraceptive precautions (e.g., 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. Then continue taking the remaining tablets at your usual time. Protection against pregnancy is not reduced, and additional precautions are not 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. Then continue taking the remaining tablets at your usual time. Do not take a tablet-free break; instead, start the next pack immediately.

Withdrawal bleeding will most likely occur at the end of the second pack, but spotting or breakthrough bleeding may occur during the second pack.

2. Alternatively, you may stop taking tablets and go directly to the 7-day tablet-free interval (note the day on which you missed the tablet). If you wish to start the next pack on your usual starting day, you may shorten the tablet-free interval to less than 7 days.

If you follow either of these options, protection against pregnancy is maintained.

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

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

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

Only 1 tablet
missed (taken • Take the missed tablet
more than 12 hours • Finish taking all tablets in the pack
late) in week 2

• Take the missed tablet
• Finish taking all tablets in the pack
• Start the next pack immediately, without a tablet-free break

in
or
week
3

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

What to do if you vomit or have severe diarrhoea
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 Yasminelle", page 2.

Delaying withdrawal bleeding: what you should know
Although not recommended, it is possible to delay withdrawal bleeding by starting a new pack of Yasminelle immediately, skipping the tablet-free interval until the end of the second pack. Spotting or breakthrough bleeding may occur during the second pack. After the usual 7-day tablet-free interval, you must start taking tablets from the next 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 the tablets as directed, withdrawal bleeding will occur during the tablet-free week. If you wish to change this day, you can do so by shortening (but never extending — maximum 7 days!) the tablet-free interval. For example, if your tablet-free interval 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), withdrawal bleeding may not occur during that interval. In this case, spotting or breakthrough bleeding may occur.
If you are unsure how to proceed, contact your doctor.

Stopping Yasminelle
You may stop taking Yasminelle 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 Yasminelle 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 effects

Like any medicine, Yasminelle may cause adverse effects, although not everyone experiences them. If any adverse effects occur, especially severe and persistent ones, or changes in health status which the patient considers to be related to the use of Yasminelle, medical advice should be sought from a doctor.

In all women using combined hormonal contraceptives, there is 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 Yasminelle".

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

The following adverse effects have been associated with the use of Yasminelle.

Common adverse effects (occur in 1 to 10 out of every 100 people):

• mood swings
• headache
• abdominal pain (stomach pain)
• acne
• breast pain, breast enlargement, breast tenderness, painful or irregular menstruation
• weight gain.

Uncommon adverse effects (occur in 1 to 10 out of every 1,000 people):

• candidiasis (fungal infection)
• herpes simplex
• allergic reactions
• increased appetite
• depression, nervousness, sleep disorders
• sensations of tingling and numbness, dizziness
• visual disturbances
• heart rhythm disorders or abnormally rapid heartbeat
• blood clot (thrombosis) in the lung (pulmonary embolism), high blood pressure, low blood pressure, migraine, varicose veins
• sore throat
• nausea, vomiting, gastritis and/or enteritis, diarrhoea, constipation
• hair loss (alopecia), eczema (rash), itching, skin rashes, dry skin, seborrhoeic dermatitis (sebaceous skin disorders)
• neck pain, limb pain, muscle cramps
• urinary tract infection
• breast lump (benign and malignant), milk discharge in non-pregnant women (galactorrhea), ovarian cysts, facial flushing, absence of menstruation, very heavy menstrual bleeding, vaginal discharge, vaginal dryness, lower abdominal pain (pelvic), abnormal cervical smear (Pap test), decreased sexual desire
• fluid retention, lack of energy, excessive thirst, increased sweating
• weight loss.

Rare adverse effects (occur in 1 to 10 out of every 10,000 people):

• asthma
• hearing impairment
• nodular erythema (a skin condition characterized by red, painful nodules)
• 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
  • transient ischaemic attack (TIA) or temporary stroke-like symptoms, known as transient ischaemic attack
  • blood clots in the liver, stomach/intestine, kidneys or eye

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

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Yasminelle

Keep this medicine out of sight and reach of children.
There are no special storage requirements for this medicinal product.
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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Yasminelle contains

• The active substances are: ethinylestradiol (Ethinylestradiolum) and drospirenone (Drospirenonum). Each tablet contains 0.02 milligrams of ethinylestradiol and 3 milligrams of drospirenone.
• Other components are: core: monohydrate lactose, maize starch, magnesium stearate (E 470b); coating: hypromellose (E 464), talc (E 553b), titanium dioxide (E 171) and colouring agent: iron oxide red (E 172).

What Yasminelle looks like and contents of the pack

• Each Yasminelle blister pack contains 21 light pink coated tablets.
• Yasminelle tablets are film-coated tablets; the tablet core is covered with a coating. The tablets are light pink, round with convex surfaces, and one side is marked with the letters "DS" in a regular hexagon.
• Yasminelle is available in packs containing 1 or 3 blisters, each blister containing 21 tablets.

For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Ireland, country of export:
Bayer Limited
1st Floor, The Grange Offices
The Grange, Brewery Road, Stillorgan
Co Dublin, A94 H2K7, Ireland
Manufacturer:
Bayer AG, Mullerstrasse 178, 13353 Berlin, Germany
Bayer Weimar GmbH und Co. KG, Döbereinerstr. 20, 99427 Weimar, Germany
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation number in Ireland, country of export: PA 1410/024/001
Parallel Import Licence Number: 136/21
This medicinal product is authorised for sale in the European Economic Area countries under the following trade names:

• Austria, Belgium, Cyprus, Czech Republic, Estonia, Finland, Greece, Spain, the Netherlands, Ireland, Lithuania, Luxembourg, Latvia, Malta, Germany, Norway, Poland, Portugal, Slovenia, Sweden, Italy: Yasminelle
• France: Jasminelle

Translation of the weekday names printed above each tablet:
Monday - Monday
Tuesday - Tuesday
Wednesday - Wednesday
Thursday - Thursday
Friday - Friday
Saturday - Saturday
Sunday - Sunday