Yasminelle

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Yasminelle
0.02 mg + 3 mg, coated tablets
Ethinylestradiolum + Drospirenonum
Important information regarding 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 use following a break of 4 weeks or more.
• Be vigilant and consult a doctor if the user suspects symptoms of blood clot formation (see section 2 "BLOOD CLOTS").

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

• Keep this leaflet, as you may need to read it again.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If any side effects worsen or if any side effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Yasminelle is and what it is used for
2. Important information before taking Yasminelle When not to take Yasminelle Do not take Yasminelle: Warnings and precautions BLOOD CLOTS Yasminelle and cancer Psychiatric disorders Breakthrough bleeding What to do if withdrawal bleeding does not occur Yasminelle and other medicines Yasminelle with food and drink Laboratory tests Pregnancy Breast-feeding Driving and using machines
3. How to take Yasminelle When to start the first blister pack Taking more Yasminelle than recommended If you forget to take Yasminelle What to do if you vomit or have severe diarrhoea Delayed withdrawal bleeding: what you need to know Changing the first day of withdrawal bleeding: what you need to know Stopping use of Yasminelle
4. Possible side effects
5. How to store Yasminelle
6. Contents of the pack and other information

1. What Yasminelle is and what it is used for

• Yasminelle is a contraceptive tablet and is 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 Yasminelle

General remarks
Before starting 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 “BLOOD CLOTS”).
Before you can start taking Yasminelle, 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 using Yasminelle or in which the effectiveness 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 rhythm 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 infection with HIV (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 may 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 are undergoing surgery or will be immobile for a long time (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 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 previously had a type of migraine called “migraine with aura”;
• if you have had or currently have 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 genital 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 who have not yet started menstruating.
Older women
Yasminelle is not intended for use after menopause.
Women with liver function disorders
Do not take Yasminelle if you have liver disease. See also sections “When not to use Yasminelle” and “Warnings and precautions”.
Women with kidney function disorders
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
Seek immediate medical advice

• 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 effects, see section “How to recognize the occurrence of blood clots”.
You should tell your doctor if you have any of the following conditions.
Special caution is required when using Yasminelle or any other combined hormonal contraceptive, and regular check-ups by your doctor may be necessary. If any of these conditions develop or worsen during treatment with Yasminelle, you should also inform your doctor.

• if there is a history of, or current, 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 causing kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have hypertriglyceridaemia (elevated blood fat levels) 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 long time (see section “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 Yasminelle after childbirth;
• if you have superficial thrombophlebitis (inflammation of veins under the skin with blood clots);
• if you have varicose veins;
• if you have epilepsy (see section “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 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 involuntary movements));
• if you have or have ever had chloasma (skin pigmentation, especially on the face and neck, also known as melasma). 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 hives that may cause breathing difficulties, seek immediate medical attention. Medicinal products containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.

BLOOD CLOTS
Using combined hormonal contraceptives such as Yasminelle increases the 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 the veins (referred to as “venous thrombosis” or “venous thromboembolic disease”);
• in the 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 using Yasminelle is low.
HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you notice any of the following symptoms.
Is the patient experiencing any of these symptoms? Likely reason
for the patient’s
condition

• swelling of the leg or swelling along a vein in the leg or foot, Deep vein thrombosis

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

• The use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in veins (venous thrombosis). Although these adverse events are rare, they most commonly occur during the first year of using combined hormonal contraceptives.

• If blood clots form in the veins of the leg or foot, this may lead to 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 greatest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher when restarting a combined hormonal contraceptive (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 patient stops taking Yasminelle, the risk of blood clots returns to normal levels within a few weeks.

What factors influence the risk of blood clots?
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 Yasminelle is low.

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

The risk of developing blood clots depends on the individual’s medical history (see section “Factors that increase the risk of blood clots” below).

Factors increasing the risk of venous blood clots
The risk of developing blood clots associated with the use of Yasminelle is small, however
some 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. below 50 years of age). In this case, the patient may have an inherited tendency to form blood clots;
• if the patient requires surgery, is immobilized 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 during immobilization. If the patient must

discontinue taking Yasminelle, ask the doctor when it is safe to resume
taking the
medication;

• with increasing age (particularly over 35 years);
• if the patient has recently given birth (within the last few weeks).

The risk of developing blood clots increases with the number of risk factors present in the
patient.
Air travel (>4 hours) may temporarily increase the risk of venous blood clots,
especially if the patient has another risk factor present.
Inform the doctor if any of the listed risk factors apply to the patient, even if uncertain. The doctor may decide to discontinue the use of 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 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 Yasminelle is very small, 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 is unable to stop smoking and is over 35 years of age, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valvular heart disease, cardiac arrhythmia known as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them is particularly severe, the risk of arterial 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, if a close family member is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Yasminelle and cancer
In women using combined oral contraceptives, breast cancer has been observed slightly more frequently, but it is not known whether this is caused by taking the pill. For example, it may be that more cancers are detected in women using combined oral 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 the 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 unusual, severe abdominal pain occurs, contact the doctor immediately.

Psychiatric disorders
Some women using hormonal contraceptives, including Yasminelle, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact the doctor as soon as possible for further medical advice.

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

What to do if no withdrawal bleeding occurs
If all tablets have been taken according to the schedule, 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 currently taking.
Also inform any other doctor, including a dentist or pharmacist, who prescribes another medicine, that you are taking Yasminelle. They may advise whether additional contraceptive methods (e.g. condoms) are needed and, if so, for how long.
Some medicines may:

• affect the blood levels of Yasminelle;
• 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, 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).

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, 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.
Yasminelle may be restarted approximately 2 weeks after completing 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 taking it immediately and contact her doctor. If the patient wishes to become pregnant, she may discontinue Yasminelle at any time (see also section "Discontinuing Yasminelle").
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 consult her doctor before taking Yasminelle.

3. How to take Yasminelle

Take one Yasminelle tablet every day, with or without food, preferably at the same time each day, with a small amount of water.
The blister pack contains 21 coated tablets. Each tablet is marked with the day of the week it should be taken. For example, if you start on Wednesday, take the tablet marked "Wednesday" (see "Translation of days of the week marked on each tablet in the immediate packaging" at the end of this leaflet). 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), withdrawal bleeding usually begins on the 2nd or 3rd day.
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 pack should begin on the same day of the week, and withdrawal bleeding should occur during the same days of the 28-day cycle.
If Yasminelle is taken as directed, you are protected against pregnancy even during the 7 days when no tablets are taken.

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 menstruation). If you start Yasminelle 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 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 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 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, additional contraceptive precautions (e.g., condoms) must be used for the first 7 days of taking Yasminelle.
• After miscarriage: Follow your doctor’s advice.
• After childbirth: You may start taking Yasminelle between days 21 and 28 after delivery. If you start later than day 28, use a barrier method (e.g., condoms) for the first 7 days of taking Yasminelle. If sexual intercourse occurred before (re)starting Yasminelle after childbirth, you must first confirm 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 taking Yasminelle after childbirth: Please read the section "Breast-feeding".

Taking more Yasminelle than you should
There are 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 this medicine.
If too many Yasminelle tablets are taken or if a child has swallowed some, 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 chart below):

• More than one tablet missed in the same pack: Contact your doctor.
• One tablet missed in Week 1: Take the missed tablet as soon as possible, even if this means taking two tablets at once. Continue taking the remaining tablets at your usual time and use additional contraceptive protection, such as condoms, for the next 7 days. If you had sexual intercourse in the week before missing the tablet, be aware that pregnancy may have occurred. In this case, 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 once. Continue taking the remaining tablets at your usual time. Protection against pregnancy is not reduced, and no additional precautions are needed.
• One tablet missed in Week 3: You have two options:
  1. Take the missed tablet as soon as possible, even if this means taking two tablets at once. Continue taking the remaining tablets at your usual time. Do not take a tablet-free break; instead, start the next pack immediately.

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

2. You may also stop taking tablets from the current pack and start the 7-day tablet-free interval (note the day you missed the tablet). If you wish to start the new 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, protection against pregnancy will be maintained.

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

Missed several tablets from one pack: Consult your doctor.

What to do if you vomit or have 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 substances may not have been completely absorbed. This situation is similar to missing a tablet. After vomiting or diarrhoea, take another tablet from a spare pack as soon as possible. If possible, take it within 12 hours of your usual tablet-taking time. If this is not possible or if 12 hours have passed, follow the advice given in the section "Missed dose of Yasminelle".

Delaying withdrawal bleeding: what you should know
Although not recommended, withdrawal bleeding can be delayed by starting a new Yasminelle pack 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 should 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 begin during the tablet-free week. To change this day, shorten (but never extend – 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), start the new 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 occur instead.
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 how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

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 the 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 (hives), 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 00 people):

• mood changes
• 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 disturbances
• sensations of tingling and numbness, dizziness
• vision problems
• heart rhythm disturbances or abnormally rapid heartbeat
• blood clots (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 skin disorders (seborrhoeic dermatitis)
• neck pain, limb pain, muscle cramps
• urinary bladder infection
• breast lumps (benign and cancerous), milk secretion in non-pregnant women (galactorrhoea), ovarian cysts, sudden facial flushing, absence of menstruation, very heavy menstrual bleeding, vaginal discharge, vaginal dryness, lower abdominal pain (pelvic pain), abnormal cervical smear (Papanicolaou 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
• erythema nodosum (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 (mini-stroke) or transient stroke-like symptoms, known as transient ischaemic attack (TIA)
  • blood clots in the liver, stomach/intestine, kidneys or eye

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

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

5. How to store Yasminelle

Keep the medicine out of sight and reach of children.
No special storage instructions are required.
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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Yasminelle contains

• The active substances are: ethinylestradiol (Ethinylestradiolum) (in the form of ethinylestradiol beta-cyclodextrin clathrate) and drospirenone (Drospirenonum). Each tablet contains 0.02 milligrams of ethinylestradiol and 3 milligrams of drospirenone.
• Other components of the medicine are: monohydrate lactose, maize starch, magnesium stearate. Coating: hypromellose, talc, titanium dioxide (E 171), iron oxide red (E 172). See section 2 "Yasminelle contains monohydrate lactose".

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 bears the embossed letters "DS" within 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.
Responsible party 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Irish marketing authorisation number, country of export: PA1410/024/001
Parallel import authorisation number: 33/22
This medicinal product is authorised in the Member States of the European Economic Area 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 day-of-the-week markings adjacent to each tablet on the immediate packaging:
Monday - Monday
Tuesday - Tuesday
Wednesday - Wednesday
Thursday - Thursday
Friday - Friday
Saturday - Saturday
Sunday - Sunday