Instructions for the user: package leaflet

Yasmin 0.03 mg / 3 mg film-coated tablets

ethinylestradiol/drospirenone
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others; it may be harmful to them.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives (CHCs):

They are one of the most reliable reversible methods of contraception, when used correctly.
They slightly increase the risk of developing blood clots in the veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
Be alert and contact your doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of this leaflet:

What Yasmin is and what it is used for
What you need to know before taking Yasmin
When not to use Yasmin
Warnings and precautions
Blood clots
Yasmin and cancer
Psychiatric disorders
Intermenstrual bleeding
What to do if menstruation does not occur during the tablet-free week
Other medicines and Yasmin
Yasmin with food and drink
Laboratory tests
Pregnancy
Breast-feeding
Driving and using machines
Yasmin contains lactose
How to take Yasmin
When to start the first pack
If you take more Yasmin than you should
If you forget to take Yasmin
What to do if you vomit or have severe diarrhoea
How to delay menstruation: what you need to know
How to change the day of onset of menstruation: what you need to know
If you stop taking Yasmin
Possible side effects
How to store Yasmin
Contents of the pack and other information

1. What Yasmin is and what it is used for

Yasmin is a contraceptive pill used to prevent pregnancy.
Each tablet contains a small amount of two different female hormones, drospirenone and ethinylestradiol.
Contraceptive pills containing two hormones are known as "combined" pills.

2. What you should know before taking Yasmin

General information
Before starting to use Yasmin, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).
Before you start taking Yasmin, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out other examinations.
This leaflet describes various situations in which you must stop taking Yasmin or in which the effectiveness of Yasmin may be reduced. In such situations, you should abstain from sexual intercourse or use additional non-hormonal contraceptive measures, such as condoms or another barrier method. Do not use the rhythm method or basal body temperature method. These methods may be unreliable because Yasmin alters the monthly fluctuations in body temperature and cervical mucus.
Yasmin, like all hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

When you must not use Yasmin
Do not use Yasmin if you have any of the conditions listed below. If you have any of the conditions listed below, consult your doctor. Your doctor will discuss with you other birth control methods that might be more suitable for your situation.

Do not use Yasmin

If you have (or have ever had) a blood clot in a blood vessel in your leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs
If you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies
If you are due to undergo surgery or will be confined to bed for a prolonged period (see section “Blood clots”)
If you have ever had a heart attack or stroke
If you have (or have ever had) angina pectoris (a condition causing severe chest pain and which may be an early sign of heart attack) or transient ischaemic attack (TIA – temporary stroke-like symptoms)
If you have any of the following conditions, which may increase the risk of clots forming in the arteries:
- Severe diabetes with blood vessel damage
- Very high blood pressure
- Very high levels of fats (cholesterol or triglycerides) in the blood
- A condition known as hyperhomocysteinaemia
If you have (or have ever had) a type of migraine called “migraine with aura”
If you have (or have ever had) liver disease and liver function is still abnormal
If your kidneys do not work properly (renal insufficiency)
If you have (or have ever had) a liver tumour
If you have (or have ever had) or are suspected of having breast or genital organ cancer
If you have unexplained vaginal bleeding
If you are allergic to ethinylestradiol or drospirenone or to any of the other ingredients of this medicine (listed in section 6). This condition may cause itching, skin rash or swelling.

Do not use Yasmin if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Yasmin”).

Additional information on specific populations
Children and adolescents
Yasmin is not indicated in women whose menstrual cycle has not yet begun.
Elderly patients
Yasmin is not indicated after menopause.
Women with impaired liver function
Do not take Yasmin if you suffer from liver disease. See also sections “Do not take Yasmin” and “Warnings and precautions”.
Patients with renal impairment
Do not take Yasmin if you suffer from renal insufficiency or acute renal failure. See also sections “Do not take Yasmin” and “Warnings and precautions”.

Warnings and precautions
When should you contact a doctor?
Seek urgent medical advice

If you notice signs suggestive of a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), in your lung (pulmonary embolism), a heart attack or a stroke (see the following section “Blood clots”). For a description of the symptoms of these serious side effects, see section “How to recognize a blood clot”.

Consult your doctor before taking Yasmin.
Inform your doctor if any of the following conditions apply to you.
In certain situations, you must be particularly careful when using Yasmin or any other combined oral contraceptive, and your doctor may need to examine you regularly. If any of these conditions develop or worsen while you are taking Yasmin, you must inform your doctor.

If a close relative has or has had breast cancer
If you have liver or gallbladder disease
If you have diabetes
If you suffer from depression
If you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)
If you have systemic lupus erythematosus (SLE, a disease affecting the body’s natural defence system)
If you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure)
If you have sickle cell anaemia (an inherited red blood cell disorder)
If you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas)
If you are due to undergo surgery or will be confined to bed for a prolonged period (see section 2 “Blood clots”)
If you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking Yasmin
If you have inflammation of veins near the skin surface (superficial thrombophlebitis)
If you have varicose veins
If you suffer from epilepsy (see “Other medicines and Yasmin”)
If you have a condition that first appeared during pregnancy or during previous use of sex steroids (e.g. hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (herpes gestationis), a nerve disorder causing sudden involuntary movements (Sydenham’s chorea))
If you have or have ever had chloasma (skin pigmentation, especially on the face or neck, also known as “melasma” or “pregnancy mask”). In this case, avoid direct exposure to sunlight or ultraviolet rays.
If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible breathing difficulties, contact your doctor immediately. Medicinal products containing oestrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Yasmin increases the risk of developing a blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can develop

In veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
In arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE). Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, these effects may be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with Yasmin is low.

HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical advice if you notice any of the following signs or symptoms.
Do you have one of these signs? What might you be suffering from?

Swelling in one leg or along a vein in the leg or foot, especially if accompanied by:

pain or tenderness in the leg which may only be felt when standing or walking • increased sensation of warmth in the affected leg • change in skin colour of the leg, such as paleness, reddish or bluish discolouration
sudden and unexplained shortness of breath or rapid breathing; • sudden cough without an obvious cause, possibly with blood; • sharp chest pain which may worsen when breathing deeply; • severe lightheadedness or dizziness; • rapid or irregular heartbeat; • severe stomach pain. If in doubt, inform your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for a milder condition such as a respiratory tract infection (e.g. a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: • sudden loss of vision or • painless blurring of vision which may progress to vision loss	Retinal vein thrombosis (blood clot in the eye)
chest pain, discomfort, pressure or heaviness • squeezing sensation or fullness in the chest, in one arm or under the sternum; • feeling of fullness, indigestion or suffocation; • discomfort in the upper body spreading to the back, jaw, throat, arms and stomach; • sweating, nausea, vomiting or dizziness; • extreme weakness, anxiety or shortness of breath; • rapid or irregular heartbeat	Heart attack
sudden numbness or weakness of the face, arm or leg, especially on one side of the body;	Stroke

Sudden confusion, difficulty speaking or understanding; •Sudden difficulty seeing with one or both eyes; •Sudden difficulty walking, dizziness, loss of balance or coordination; •Sudden severe or prolonged headache, with no known cause; •Loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you must still seek urgent medical attention as you may be at risk of another stroke.
Swelling and pale blue discoloration of a limb; •Severe stomach pain (acute abdomen)	Blood clots blocking other blood vessels

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

The use of combined hormonal contraceptives has been associated with an increased risk of blood clots forming in veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.
If a blood clot forms in a vein of the leg or foot, it can cause deep vein thrombosis (DVT).
If a blood clot travels from the leg and lodges in the lung, it can cause a pulmonary embolism.
Very rarely, a clot may form in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year when taking a combined hormonal contraceptive for the first time. The risk may also be higher when restarting a combined hormonal contraceptive (the same medication or a different one) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not using a combined hormonal contraceptive.
When you stop taking Yasmin, the risk of developing a blood clot returns to normal levels within a few weeks.

What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE (venous thromboembolism) and the type of combined hormonal contraceptive you are taking.

The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Yasmin is low.

Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.
Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as Yasmin, about 9–12 will develop a blood clot in one year.
The risk of developing a blood clot depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal contraceptive pill and who are not pregnant	About 2 women in 10,000
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5-7 women in 10,000
Women who use Yasmin	About 9-12 women in 10,000

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Yasmin is low, but certain conditions can increase this risk. Your risk is higher:

if you are very overweight (body mass index or BMI above 30 kg/m²);
if a close relative has had a blood clot in a leg, lung, or another organ at a young age (under approximately 50 years). In this case, you may have an inherited blood clotting disorder;
if you are scheduled for surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a plaster cast on your leg. You may need to stop taking Yasmin several weeks before surgery or during periods of reduced mobility. If you need to stop taking Yasmin, ask your doctor when you can start taking it again;
as you get older (especially over 35 years of age);
if you have given birth within the last few weeks. The risk of developing a blood clot increases when you have more than one of these conditions. Air travel (lasting >4 hours) may temporarily increase the risk of blood clots, especially if you have some of the other risk factors listed. It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to have you stop taking Yasmin. If any of the above conditions change while you are using Yasmin, for example, if a close relative develops thrombosis without a known cause or if you gain significant weight, contact your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?

Like blood clots in a vein, clots in an artery can cause serious problems, for example,
they can cause a heart attack or stroke.
Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of Yasmin is very low
but may increase:

with increasing age (over 35 years);
if you smoke. When using a combined hormonal contraceptive such as Yasmin, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years of age, your doctor may advise you to use a different type of contraceptive;
if you are overweight;
if you have high blood pressure;
if a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also be at increased risk of heart attack or stroke;
if you or a close relative have high levels of fat in the blood (cholesterol or triglycerides);
if you suffer from migraine, especially migraine with aura;
if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
if you have diabetes. If you have more than one of these conditions or if one of them is particularly severe, the risk of developing a blood clot may be even higher. If any of the above conditions change while you are using Yasmin, for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight, contact your doctor.

Yasmin and cancer
Breast cancer is observed slightly more frequently in women who use combined oral contraceptives, but it is not known whether this is due to the treatment. For example, it is possible that women who use the pill are diagnosed with more tumors because they undergo more frequent medical check-ups. The occurrence of breast cancer gradually decreases after stopping combined hormonal contraception. It is important that you regularly examine your breasts and contact your doctor if you feel any lumps.
Benign liver tumors have been observed rarely in women using oral contraceptives including Yasmin, and even more rarely, malignant liver tumors. Contact your doctor if you experience unusually severe abdominal pain.
Psychiatric disorders
Some women using hormonal contraceptives, including Yasmin, have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If mood changes or depressive symptoms occur, consult your 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 more than a few months or begins after several months, your doctor should investigate the cause.

What to do if menstruation does not occur during the pill-free week
If you have taken all tablets correctly, have not vomited or had severe diarrhea, and have not taken other
medicines, it is highly unlikely that you are pregnant.
If you miss two consecutive periods, you may be pregnant. Contact your doctor immediately. Do not start the next pack until you are certain you are not pregnant.
Other medicines and Yasmin
Always inform your doctor if you are taking any medicines or herbal products. Inform any other doctor or
dentist (or pharmacist) who prescribes you another medicine that you are taking Yasmin. They will advise you whether you need to use additional contraceptive measures (for example, a condom) and, if so, for how long, or whether the use of another medicine you may need should be modified.
Some medicines:

affect the levels of Yasmin in the blood;
may make it less effective in preventing pregnancy;
may cause unexpected bleeding. These include:
- medicines used to treat:
  o epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
  o tuberculosis (e.g., rifampicin)
  o HIV infection and Hepatitis C virus (ritonavir, nevirapine, efavirenz, known as protease inhibitors and non-nucleoside reverse transcriptase inhibitors)
  o fungal infections (griseofulvin, ketoconazole)
  o arthritis, osteoarthritis (etoricoxib)
  o high blood pressure in the pulmonary arteries (bosentan)
  o St. John’s wort, a herbal remedy

Yasmin may affect the action of other medicines, for example:

medicines containing cyclosporine;
the antiepileptic lamotrigine (this may lead to an increased frequency of epileptic seizures);
theophylline (used to treat respiratory problems);
tizanidine (used to treat muscle pain and/or muscle spasms). Do not use Yasmin if you have Hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these products may cause increases in liver function blood test results (increase in liver enzyme ALT). Your doctor will prescribe another type of contraceptive before starting treatment with these medicines. Yasmin may be restarted approximately 2 weeks after completion of this treatment. See section “Do not use Yasmin”.

Ask your doctor or pharmacist for advice before taking any medicine.
Yasmin with food and drink
Yasmin can be taken with or without food, if necessary with a little water.
Laboratory tests
If you need to have a blood test, inform your doctor or laboratory staff that you are taking the pill, as hormonal contraceptives may affect the results of certain tests.
Pregnancy

If you are pregnant, do not take Yasmin. If you become pregnant while taking Yasmin, stop immediately and contact your doctor. If you wish to become pregnant, you may stop taking Yasmin at any time (see also “If you stop taking Yasmin”).
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
The use of Yasmin is generally not recommended during breast-feeding. If you wish to take the pill while breast-feeding, you should consult your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There is no evidence to suggest that Yasmin affects the ability to drive or operate machinery.
Yasmin contains lactose
If you have an intolerance to certain sugars, contact your doctor before taking Yasmin.

3. How to take Yasmin

Take one Yasmin tablet every day, if necessary with a little water. You may take the tablets with or without food, but you must take them at approximately the same time each day.
The blister pack contains 21 film-coated tablets. Next to each tablet, the day of the week on which it should be taken is printed. For example, if you start on Wednesday, take the tablet next to the label WED. Follow the direction of the arrows on the blister pack until all 21 tablets have been taken.
Then do not take any tablets for 7 days. During these 7 days (the so-called "tablet-free interval"), your menstrual period should occur. This is called "withdrawal bleeding" and usually begins on the second or third day of the tablet-free interval.
Start a new blister pack on the eighth day after the last Yasmin tablet (i.e. after the 7-day break), regardless of whether your menstrual bleeding has stopped or not. This means you should start each new Yasmin blister pack on the same day of the week, and your periods will also begin each month on the same day.
If you take Yasmin as described above, you are protected against pregnancy even during the 7 days when you do not take tablets.

When can you start the first blister pack?

If you have not used a hormonal contraceptive in the previous month. Start taking Yasmin on the first day of your cycle (i.e. the first day of menstruation). If you start on the first day of your period, contraceptive protection is immediate. You may also start taking Yasmin between Day 2 and Day 5 of your cycle, but in this case you must use additional contraceptive measures (e.g. a condom) for the first 7 days.
Switching from a combined hormonal contraceptive, a combined contraceptive vaginal ring, or a contraceptive patch. Start taking Yasmin preferably on the day after the last active tablet (the last tablet containing active ingredients) of your previous pill, or at the latest on the day after the end of the tablet-free interval (or after the last inactive tablet of the previous pill). When switching from a combined contraceptive vaginal ring or a contraceptive patch, follow your doctor’s advice.
Switching from a progestogen-only method (progestogen-only pill, injection, implant, or progestogen-releasing intrauterine system (IUS)). You may switch on any day from the progestogen-only pill (from an implant or IUS on the day of its removal, from an injectable when your next injection is due), but in all these cases you must use additional contraceptive measures (e.g. a condom) for the first 7 days of tablet intake.
After an abortion Follow your doctor’s advice.
After childbirth You may start taking Yasmin between Day 21 and Day 28 after delivery. If you start later than Day 28, use a so-called barrier method (e.g. a condom) during the first 7 days of taking Yasmin. If you have had sexual intercourse after childbirth before starting (or restarting) Yasmin, make sure you are not pregnant or wait for your period.
If you are breastfeeding and wish to start (or restart) taking Yasmin Read the section “Breast-feeding”. Consult your doctor if you are unsure about when to start.

If you take more Yasmin than you should
There are no reports of serious harmful effects following an overdose of Yasmin tablets. If you take several tablets at once, you may experience nausea or vomiting or vaginal bleeding. Even girls who have not yet had their first period but have accidentally taken this medicine may experience such bleeding.
If you have taken too many Yasmin tablets, or if you discover that a child has taken any tablets, contact your doctor or pharmacist immediately.

If you forget to take Yasmin

If the delay in taking a tablet is less than 12 hours, contraceptive protection is not reduced. Take the tablet as soon as you remember, then continue taking the following tablets at your usual time.
If the delay in taking a tablet is more than 12 hours, contraceptive protection may be reduced. The greater the number of tablets forgotten, the higher the risk of becoming pregnant. The risk of incomplete contraceptive protection is greatest if you forget a tablet at the beginning or end of the pack. Therefore, follow the instructions below (see also the diagram below):
More than one tablet forgotten in this pack Consult your doctor.
One tablet forgotten in the first week Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time and use additional contraceptive measures (e.g. a condom) for the next 7 days. If you had sexual intercourse in the week before the missed tablet, you may be pregnant. In this case, consult your doctor.
One tablet forgotten in the second week

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. Contraceptive protection remains effective, so no additional precautions are necessary.

One tablet forgotten in the third week You have two options:
1. Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Skip the tablet-free interval and immediately start the next blister pack. You will most likely not have a period until the end of the second pack, or you may experience light bleeding or spotting during the second pack;
2. You may also stop taking tablets from the current pack and go directly to the 7-day break (including the day of the missed tablet in the count). If you wish to start the next blister pack on your usual day, observe an interval of less than 7 days.

If you follow either of these two recommendations, you will remain protected against pregnancy.

If you have forgotten any tablet in the pack and your period does not occur during the first tablet-free interval, you may be pregnant. Consult your doctor before starting a new pack.

What to do in case of vomiting or severe diarrhoea
If you vomit within 3–4 hours after taking a tablet or have severe diarrhoea, the active ingredients of the pill may not be fully absorbed by your body. This situation is similar to that which occurs when you forget to take a tablet. After vomiting or severe 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 instructions in the section “If you forget to take Yasmin”.

How to delay menstruation: what you need to know
Although not recommended, you can delay your period by continuing with a new blister pack of Yasmin instead of observing the 7-day break. During use of this second pack, you may experience light bleeding or spotting. Continue with the next blister pack after the usual 7-day break.
You may consult your doctor before deciding to delay your period.

How to change the day your period starts: what you need to know
If you take the tablets as directed, your period will start during the tablet-free week. To change the day your period starts, shorten the normal break between two packs (but never extend it – 7 days is the maximum!). For example, if your break normally starts on Friday and you wish to move it to Tuesday (3 days earlier), start the next blister pack 3 days earlier. If you make the break between cycles very short (e.g. 3 days or less), you may not have any bleeding during this interval. Afterwards, you may experience light bleeding or spotting.
Consult your doctor if you are unsure what to do.

If you stop taking Yasmin
You may stop taking Yasmin at any time. If you still wish to avoid pregnancy, consult your doctor for advice on other reliable methods of birth control. If you wish to become pregnant, stop taking Yasmin and wait for your period before trying to conceive. This will help you calculate the expected date of delivery more easily.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think could be due to Yasmin, tell your doctor.
All women taking combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you should know before taking Yasmin”.

Serious side effects
Contact a doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible difficulty breathing (see also section “Warnings and precautions”).

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

Common side effects (may affect between 1 and 10 women in 100)

menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness
headache, depressed mood
migraine
nausea
thick, whitish vaginal discharge, candidiasis

Uncommon side effects (may affect between 1 and 10 women in 1,000)

breast enlargement, changes in sexual desire
high blood pressure, low blood pressure
vomiting, diarrhoea
acne, skin rash, severe itching, hair loss (alopecia)
vaginal infection
fluid retention, changes in body weight

Rare side effects (may affect between 1 and 10 women in 10,000)

allergic reactions (hypersensitivity), asthma
breast discharge
hearing impairment
skin diseases such as nodular erythema (characterized by red, painful skin nodules) or erythema multiforme (characterized by target-shaped skin lesions or ulcers)
harmful blood clots in a vein or artery, for example: in a leg or foot (DVT), in a lung (PE), heart attack, stroke, mini-stroke, or temporary symptoms similar to stroke known as transient ischaemic attack (TIA), or blood clots in the liver, stomach/intestines, kidneys, or eye. The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help 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.
Do not store above 30°C. Keep in the original blister pack to protect it from moisture.
Expiry date
Do not use this medicine after the expiry date stated on the packaging after "Do not use after:" or "EXP.".
The expiry date refers to the last day of the stated month.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Yasmin contains

The active substances are drospirenone and ethinylestradiol. Each tablet contains 3 milligrams of drospirenone and 0.030 milligrams of ethinylestradiol.
The excipients are: monohydrate lactose, maize starch, pregelatinized maize starch, povidone K25, magnesium stearate, hypromellose, macrogol 6000, talc, titanium dioxide (E171), yellow iron oxide (E172). See section 2 “Yasmin contains lactose”.

Description of the appearance of Yasmin and package contents

Each Yasmin blister contains 21 light yellow film-coated tablets.
Yasmin tablets are film-coated; the tablet core is coated. The tablets are light yellow, round, with convex faces, and on one side are marked with the letters “DO” within a regular hexagon.
Yasmin is available in packages containing 1, 3, 6 and 13 blisters, each blister containing 21 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder
Bayer S.p.A. - Viale Certosa, 130 - 20156 - Milan, Italy.
Manufacturer
Bayer AG, 13342 Berlin, Germany.
Bayer Weimar GmbH und Co. KG, Doebereinerstrasse 20, 99427 Weimar, Germany.
This medicinal product is authorized 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, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden: Yasmin
France: Jasmine
Czech Republic, Hungary, Slovakia: Yadine
Estonia, Latvia, Lithuania, Slovenia: Yarina