Yasmin

Package leaflet: Information for the user

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

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. 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 treatment following a break of 4 weeks or more.
• Be vigilant and consult your doctor if you suspect symptoms of blood clots (see section 2 "Blood clots").

Leaflet contents:

1. What Yasmin is and what it is used for
2. Important information before taking Yasmin
   When not to use Yasmin
   Warnings and precautions
   BLOOD CLOTS
   Yasmin and cancer
   Psychiatric disorders
   Breakthrough 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 using machines
   Yasmin contains monohydrate lactose
3. How to take Yasmin
   When to start the first blister pack?
   Taking more Yasmin than you should
   Missing a Yasmin tablet
   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 use of 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 remarks
Before starting to take Yasmin, you should read the information about blood clots (thrombosis) in section 2. It is particularly important to be aware of the symptoms of blood clots (see section 2 "Blood clots").
Before starting Yasmin, your doctor will ask you several questions about your health and that of your close relatives. Your doctor will also measure your blood pressure and, if necessary, carry out other examinations.
This leaflet describes several situations in which you should stop taking Yasmin or when the effectiveness of Yasmin may be reduced. In such 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 Yasmin alters the monthly changes in body temperature and cervical mucus.
Yasmin, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or other sexually transmitted diseases.

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

Do not use Yasmin:

• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know you have blood clotting disorders—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you are undergoing surgery or will be immobile for a prolonged period (see section "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 diseases that may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage,
  • very high blood pressure,
  • very high levels of fats in the blood (cholesterol or triglycerides),
  • a condition called hyperhomocysteinemia;
• if you currently have (or have 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 dysfunction (kidney failure);
• if you have had or currently have liver tumours;
• if you have had breast or genital organ cancer or if such cancer is currently suspected;
• if you have unexplained vaginal bleeding;
• if you are allergic to ethinylestradiol or drospirenone, or any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, rash, or swelling.

Do not use Yasmin in patients with hepatitis C who are taking medicinal products containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section "Yasmin and other medicines").

Additional information for specific populations

Children and adolescents
Yasmin is not intended for use in girls who have not yet started menstruating.

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

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

Women with kidney function disorders
Do not take Yasmin if you have kidney failure or acute kidney failure. See also sections "When not to use Yasmin" and "Warnings and precautions".

Warnings and precautions
When should you contact your doctor?
Seek immediate medical advice if:

• you notice possible symptoms of a blood clot, which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the 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.
Discuss these with your doctor before starting Yasmin. In certain situations, special care is 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 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 disorder of red blood cells);
• if you have high blood fat levels (hypertriglyceridaemia) or 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 after delivery you can start taking Yasmin;
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see "Yasmin 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 appeared during pregnancy or during previous use of sex hormones [for example, hearing loss, porphyria (a blood disorder), herpes gestationis (a 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 changes (yellow-brown discolouration, so-called chloasma), in which case you should avoid excessive exposure to sunlight or ultraviolet radiation;
• if you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives that may cause breathing difficulties, seek immediate medical attention. Medicines containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.

BLOOD CLOTS
Using combined hormonal contraceptives such as Yasmin 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").

Recovery after 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
Seek immediate medical advice if you experience any of the following symptoms.
Are you experiencing any of these symptoms? What might be the likely cause?

BLOOD CLOTS IN VEINS
What could 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 the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in veins the highest?
The risk of blood clots in veins is greatest during the first year of taking 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 woman stops taking Yasmin, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of blood clots in veins?
The risk depends on a woman's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of blood clots in the legs or lungs associated with the use of Yasmin is low.

• In the course of one 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 the course of one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In the course of one year, about 9–12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Yasmin, will develop blood clots.
• The risk of blood clots depends on the individual's personal medical history (see "Factors increasing the risk of venous blood clots" below).

Factors increasing the risk of blood clots in veins
The risk of blood clots associated with the use of Yasmin is small, but certain factors may increase this risk. The risk is higher:

• if the patient has significant overweight (body mass index (BMI) above 30 kg/m²);
• if a close relative of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years). In this case, the patient may have inherited clotting disorders.
• if the patient needs to undergo surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue Yasmin several weeks before surgery or during immobilization. If the patient needs to stop taking Yasmin, 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 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, especially if the patient has another risk factor listed above.
Inform the doctor if any of these factors apply to the patient, even if uncertain. The doctor may decide to discontinue Yasmin.
Inform the doctor if any of the above conditions change during treatment with Yasmin, e.g. if a close relative is diagnosed with unexplained thrombosis or if the patient gains significant weight.

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

Factors increasing the risk of arterial blood clots
It should be emphasized that the risk of heart attack or stroke associated with the use of Yasmin is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Yasmin, it is recommended to stop smoking. If the patient is unable to quit smoking and is over 35 years old, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close relative has high levels of blood fats (cholesterol or triglycerides);
• if the patient suffers from migraines, especially 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 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 Yasmin, e.g. if the patient starts smoking, a close relative is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Yasmin and cancer
Breast cancer occurs slightly more frequently in women using combined oral contraceptives, but it is not known whether this is caused by the use of hormonal contraceptives. For example, more cancers may be detected in women using combined contraceptives because they are examined more frequently by doctors. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important to examine the breasts regularly and contact a doctor if any lumps are detected.
Rare cases of benign, and even more rarely malignant, liver tumors have been reported in women using combined oral contraceptives. These tumors may cause life-threatening intra-abdominal bleeding. If severe upper abdominal pain occurs, inform the doctor immediately.

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

Intermenstrual bleeding
During the first few months of taking Yasmin, unexpected bleeding (bleeding outside the pill-free week) may occur. If such bleeding persists for longer 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 according to the schedule, without vomiting or severe diarrhoea, and no other medicines have been taken, the likelihood of pregnancy is very low.
If expected withdrawal bleeding does not occur twice in a row, this may indicate pregnancy. Contact the doctor immediately. Do not start the next blister pack until pregnancy has been ruled out.

Yasmin and other medicines
Always inform your doctor about any medicines or herbal products you are currently taking. Also inform any other doctor, including a dentist, or pharmacist prescribing another medicine, that you are using Yasmin. They may advise whether additional contraceptive methods (e.g. condoms) are needed, and if so, for how long, or whether you need to change the use of another required medicine.
Some medicines may:

• affect the blood concentration of Yasmin,
• cause Yasmin to be less effective in preventing pregnancy,
• cause unexpected bleeding.

This applies to medicines used in the treatment of:

• 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 )

Yasmin may affect the action of other medicines, e.g.:

• 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 form of contraception before starting treatment with these medicines.
Yasmin may be restarted approximately 2 weeks after completion of treatment. See section "When not to use Yasmin".
Before taking any medicine, consult a doctor or pharmacist.

Yasmin with food and drink
Yasmin may be taken independently of meals. If necessary, it can be taken with a small amount of water.

Laboratory tests
If a blood test is required, inform the doctor or laboratory staff that you are taking Yasmin, as oral contraceptives may affect the results of certain tests.

Pregnancy
Yasmin must not be used during pregnancy. If the patient becomes pregnant while taking Yasmin, treatment should be stopped immediately and the doctor contacted.
If the patient wishes to become pregnant, she may stop taking Yasmin at any time (see also "Discontinuation of 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 the doctor.
Before taking any medicine, consult a doctor or pharmacist.

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

Yasmin contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult the doctor before taking Yasmin.

3. How to take Yasmin

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

When to start the first pack?

• If you have not used any hormonal contraceptive in the previous month
  Start taking Yasmin on the first day of your cycle (i.e., the first day of your menstrual period). If you start Yasmin on the first day of your period, you are protected against pregnancy immediately. You may also start between days 2 and 5 of your cycle, but in this case, you must use additional contraceptive precautions (e.g., condoms) for the first 7 days.

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

• After a miscarriage
  Follow your doctor’s advice.

• After childbirth
  You may start taking Yasmin between 21 and 28 days after delivery. If you start later than day 28, you must use a barrier method (e.g., condoms) for the first 7 days of taking Yasmin.

If you had sexual intercourse before (re)starting Yasmin after childbirth, you must first ensure you are not pregnant or wait until your next menstrual period.

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

Overdose of Yasmin

There have been no reports of serious harmful effects from taking too many Yasmin tablets.
If several tablets are taken at once, symptoms such as nausea, vomiting, or vaginal bleeding may occur. Such bleeding may even occur in girls who have not yet started menstruating but accidentally took the medicine.
If too many Yasmin tablets are taken or if a child swallows any, consult your doctor or pharmacist immediately.

Missed dose of Yasmin

• If less than 12 hours have passed since you missed a tablet, your 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 you miss, the higher the risk of pregnancy.

The risk of inadequate protection is greatest if you miss tablets at the beginning or end of the pack. Follow the rules below (also see the chart below):

• More than 1 tablet missed in the same pack
  Contact your doctor.
• One tablet missed in Week 1
  Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. 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, 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 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. 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 from the current pack and begin the 7-day tablet-free interval immediately ( 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 will be maintained.

• If you missed any tablet in the 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 – decision chart

Missed tablets from one pack? → Yes
↓
Had sexual intercourse in the week before missing the tablet?
→ Yes → Contact your doctor
→ No
↓
Only one tablet missed (taken more than 12 hours late)
↓
• Take the missed tablet
• Use barrier method (condoms) for next 7 days
• Complete the current pack
↓
Missed tablets in one pack?
→ Yes → Contact your doctor
→ No
↓
• Take the missed tablet
• Complete the current pack
↓
One of the following:
• Start the next pack immediately (without a tablet-free break)
• Or stop taking tablets, begin a tablet-free interval (no longer than 7 days, including the day the tablet was missed), then start the next pack

What to do if you vomit or have severe diarrhoea

If you vomit within 3 to 4 hours of taking a tablet or have severe diarrhoea, there is a risk that the active ingredients 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 more than 12 hours have passed, follow the advice given in the section "Missed dose of Yasmin".

Delaying withdrawal bleeding: what you should know

Even though not routinely recommended, withdrawal bleeding can be delayed by starting a new Yasmin pack immediately, skipping the tablet-free interval, and continuing 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 occur during the tablet-free week. To change this day, shorten ( but never extend – maximum 7 days! ) the tablet-free interval. For example, if your tablet-free week starts on Friday and you wish to change it to Tuesday (3 days earlier), start the new pack 3 days earlier than usual. If the tablet-free interval is very short (e.g., 3 days or less), withdrawal bleeding may not occur during that interval. Spotting or breakthrough bleeding may occur instead.

If you are unsure how to proceed, contact your doctor.

Stopping Yasmin

You may stop taking Yasmin at any time. If you do not wish to become pregnant, consult your doctor about other effective methods of birth control. If you wish to become pregnant, stop taking Yasmin and wait for 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 any medicine, this product may cause adverse reactions, although not everyone experiences them.
If any adverse reactions occur, especially severe and persistent ones, or changes in health status that the patient considers 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 the various risk factors associated with the use of combined hormonal contraceptives, see section 2, "Important information before using Yasmin".

Serious 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 "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, hair loss
• Vaginitis
• Fluid retention, changes in body weight

Rare adverse reactions (occur in 1 to 10 out of every 10,000 patients):

• Allergic (hypersensitivity) reactions, asthma
• Galactorrhoea (milk secretion from 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 veins or arteries, for example:
  • In the leg or foot (e.g. deep vein thrombosis)
  • In the lungs (e.g. pulmonary embolism)
  • Heart attack
  • Stroke
  • Mini-stroke or transient stroke-like symptoms, known as transient ischaemic attack (TIA)
  • Blood clots in the liver, stomach/intestines, kidneys or eyes

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 their occurrence).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products 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 reactions helps to provide more information on the safety of this medicine.

5. How to store Yasmin

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

What Yasmin contains

• The active substances in this medicine are drospirenone and ethinylestradiol. Each coated tablet contains 3 mg of drospirenone and 0.030 mg of ethinylestradiol.
• The other ingredients (excipients) are: Tablet core: monohydrate lactose, corn starch, pregelatinized corn starch, povidone K 25, magnesium stearate; coating: talc, macrogol 6000, hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172).

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

For more detailed information, please contact the marketing authorisation holder or the parallel importer:
Marketing authorisation holder in the Netherlands, country of export:
Bayer B.V., Siriusdreef 36, 2132 WT Hoofddorp, the Netherlands
Manufacturer:
Bayer AG, Müllerstrasse 178, 13353 Berlin, Germany
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing authorisation number in the Netherlands, country of export: RVG 23827
Parallel import authorisation number: 385/21
This medicinal product is authorised for sale in the Member States of the European Economic Area under the following names:

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

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