Yasmin 3 mg/0.03 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Yasmin 3 mg/0.03 mg film-coated tablets

drospirenone/ethinylestradiol

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Important things you should know about combined hormonal contraceptives (CHCs):

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

Leaflet contents:

1. What Yasmin is and what it is used for 2

2. What you need to know before taking Yasmin 2

When you must not use Yasmin 2

Warnings and precautions 3

Blood clots 5

Yasmin and cancer 9

Psychiatric disorders……………………………………………………………………...9

Bleeding between periods 9

What to do if you do not have your period during the break week 9

Other medicines and Yasmin 9

Taking Yasmin with food and drink 10

Laboratory tests 10

Pregnancy 10

Breastfeeding 11

Driving and using machines 11

Yasmin contains lactose 11

3. How to take Yasmin 11

When you can start with the first blister pack 11

If you take more Yasmin than you should 12

If you forget to take Yasmin 13

What to do in case of vomiting or severe diarrhoea 14

Delayed period: what you should know 14

Change in the first day of your period: what you should know 15

If you stop treatment with Yasmin 15

4. Possible side effects 15

5. How to store Yasmin 16

6. Contents of the pack and other information…………………………………………….16

1. What Yasmin is and what it is used for

Yasmin is a contraceptive used to prevent pregnancy.

Each film-coated tablet contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.

Contraceptives that contain two hormones are known as combined contraceptives.

2. What you need to know before starting to take Yasmin

General considerations

Before you start using 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 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 some additional tests.

This patient leaflet describes several situations in which you should stop taking Yasmin, or in which the effect of Yasmin may be reduced. In such situations, you should either avoid sexual intercourse or use additional non-hormonal contraceptive precautions, for example, use of a condom or another barrier method. Do not use the rhythm method or the temperature method. These methods may not be reliable 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 any other sexually transmitted disease.

When not to use Yasmin

Do not use Yasmin if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you which other form of contraception would be most suitable.

Do not use Yasmin

• If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs.

• If you know you have a disorder affecting blood clotting, for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.

• If you are due to have surgery or if you are going to be immobile for a long time (see section “Blood clots”).

• If you have ever had a heart attack or a stroke.

• If you have (or have ever had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).

• If you have any of the following conditions that may increase your risk of developing a clot in the arteries:

• Severe diabetes with blood vessel damage.

• Very high blood pressure.

• Very high levels of fat in the blood (cholesterol or triglycerides).

• A condition called hyperhomocysteinaemia.

• If you have (or have ever had) a type of migraine called “migraine with aura”.

• If you have (or have ever had) a liver disease and your liver function has not returned to normal.

• If your kidneys do not work properly (renal failure).

• If you have (or have ever had) a tumour of the liver.

• If you have (or have ever had), or suspect you may have, breast cancer or cancer of the genital organs.

• If you have vaginal bleeding of unknown cause.

• If you are allergic to ethinylestradiol, drospirenone, or any of the other ingredients of this medicine (listed in section 6). This may cause itching, rash, or swelling.

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

Additional information on special populations

Children and adolescents

Yasmin is not indicated for use in women who have not yet had their first menstrual period.

Older women

Yasmin is not indicated for use after menopause.

Women with hepatic impairment

Do not take Yasmin if you have liver disease. See sections “Do not use Yasmin” and “Warnings and precautions”.

Women with renal impairment

Do not take Yasmin if you have impaired kidney function or acute renal failure. See sections “Do not use Yasmin” and “Warnings and precautions”.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Yasmin. When should you consult your doctor? Seek urgent medical assistance if you notice possible signs of a blood clot, which may mean you are experiencing a blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the lung (i.e. pulmonary embolism), a heart attack, or a stroke (see section “Blood clots” below). For a description of the symptoms of these serious adverse effects, see “How to recognize a blood clot”.

Inform your doctor if you have any of the following conditions

In certain situations, you should take special care when using Yasmin or any other combined contraceptive, and your doctor may need to examine you periodically. If any of these conditions develop or worsen while you are using Yasmin, you must also inform your doctor.

• If a close family member has or has ever had breast cancer.
• 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 disease).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• If you have sickle cell anemia (a hereditary red blood cell disorder).
• If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you require surgery or will be immobile for a prolonged period (see section 2 “Blood clots”).
• If you have recently given birth, you are at increased risk of developing blood clots. You should ask your doctor when you may start taking Yasmin after childbirth.
• If you have inflammation of the veins beneath the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you have epilepsy (see “Other medicines and Yasmin”, page 9).
• If you have systemic lupus erythematosus (SLE, a disease affecting your body's natural defense system).
• If you have a condition that first occurred during pregnancy or during previous use of sex hormones (for example, hearing loss, a blood disorder called porphyria, blistering rash during pregnancy (herpes gestationis), a nervous system disorder involving involuntary movements (Sydenham's chorea)).
• If you have or have ever had chloasma (skin discoloration, especially on the face or neck, also known as “melasma” or “pregnancy mask”). In such cases, 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, possibly accompanied by difficulty breathing, consult your doctor immediately. Medicinal products containing estrogens may induce or worsen symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Yasmin increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In veins (called “venous thrombosis”, “venous thromboembolism” or VTE).
• In arteries (called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, there may be serious long-term effects, and very rarely, they can be fatal.

It is important to remember that the overall risk of a harmful blood clot due to Yasmin is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if you notice any of the following signs or symptoms.

Are you experiencing any of these signs?	What could you be suffering from?
Swelling in one leg or along a vein in the leg or foot, especially when accompanied by: Pain or tenderness in the leg, which may only be noticeable when standing or walking. Increased warmth in the affected leg. Change in skin color of the leg, e.g., pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without a known cause or rapid breathing. Sudden cough without a clear cause, possibly producing blood. Sharp chest pain that may worsen when breathing deeply. Severe dizziness or lightheadedness. Fast or irregular heartbeat. Severe stomach pain. If you are unsure, consult a doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for a milder condition like a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: Sudden loss of vision. Or Painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye).
Chest pain, discomfort, pressure, or heaviness. Feeling of tightness or fullness in the chest, arm, or below the breastbone. Feeling of fullness, indigestion, or suffocation. Upper body discomfort spreading to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Severe weakness, anxiety, or shortness of breath. Fast or irregular heartbeat.	Heart attack.
Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body. Sudden confusion, difficulty speaking or understanding speech. Sudden vision problems in one or both eyes. Sudden difficulty walking, dizziness, loss of balance, or coordination. Sudden, severe, or prolonged headache without a 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 should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
Swelling and slight bluish 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 in veins (venous thrombosis). However, these adverse effects are rare. They occur most frequently during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form in a vein of another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein higher?

The risk of developing a blood clot in a vein is higher during the first year of first-time use of a combined hormonal contraceptive. The risk may also be increased if you restart taking a combined hormonal contraceptive (the same medication or a different one) after a break of 4 weeks or more.

After the first year, the risk decreases, but it remains somewhat higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Yasmin, your risk of developing a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?

The risk depends on your natural risk of venous thromboembolism (VTE) 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 small.

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

	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 out of 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone, or norgestimate	About 5–7 out of 10,000 women
Women who use Yasmin	About 9–12 out of 10,000 women

Factors that increase your risk of a blood clot in a vein

The risk of having a blood clot with Yasmin is small, but certain conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index or BMI above 30 kg/m²).
• If any of your close relatives has had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years). In this case, you might have an inherited blood clotting disorder.
• If you need surgery or if you spend a long time immobile due to injury, illness, or if your leg is in a cast. You may need to stop taking Yasmin several weeks before surgery or while you are less mobile. If you need to stop taking Yasmin, ask your doctor when you can start taking it again.
• As you get older (especially over about 35 years).
• If you have given birth within the last few weeks.

The risk of developing a blood clot increases the more of these conditions you have.

Air travel (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other listed risk factors.

It is important to inform your doctor if you have any of the above conditions, even if you are unsure. Your doctor may decide that you need to stop taking Yasmin.

If any of the above conditions change while you are using Yasmin—for example, a close relative experiences a thrombosis without a known cause or you gain a lot of weight—inform your doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can lead to a heart attack or stroke.

Factors that increase your risk of a blood clot in an artery

It is important to note that the risk of heart attack or stroke while using Yasmin is very small, but it may increase:

• With age (over about 35 years).
• If you smoke. When using a combined hormonal contraceptive such as Yasmin, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, 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 about 50 years). In this case, you may also have an increased risk of heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you suffer from migraines, especially migraines with aura.
• If you have a heart condition (valve disorder, heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

If you have more than one of these conditions or if any of them is particularly severe, the risk of developing a blood clot may be further increased.

If any of the above conditions change while you are using Yasmin—for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain a lot of weight—inform your doctor.

Yasmin and cancer

Slightly more cases of breast cancer have been observed in women using combined contraceptives, but it is not known whether this is due to the treatment. For example, more tumors may be detected in women taking combined contraceptives because they are examined by a doctor more frequently. The incidence of breast tumors gradually decreases after stopping combined hormonal contraceptives. It is important to have regular breast examinations, and you should see your doctor if you notice any lumps.

Rarely, benign liver tumors have been reported in users of hormonal contraceptives, and even more rarely, malignant tumors. See your doctor if you experience unusual severe abdominal pain.

Psychiatric disorders

Some women using hormonal contraceptives such as Yasmin have reported depression or depressive mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor for additional medical advice as soon as possible.

Bleeding between periods

During the first months of taking Yasmin, you may experience unexpected bleeding (bleeding outside the week of the break). If this bleeding persists beyond a few months, or begins after a few months, your doctor will investigate the cause.

What to do if you do not have your period during the break week

If you have taken all tablets correctly, have not vomited or had severe diarrhea, and have not taken other medications, it is very unlikely that you are pregnant.

If you miss two consecutive expected periods, you may be pregnant. See your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Other medicines and Yasmin

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines or herbal preparations. Also inform any other doctor or dentist who prescribes you another medicine (or your pharmacist) that you are taking Yasmin. They can advise you whether you need to take additional contraceptive precautions (e.g., condoms) and, if so, for how long, or whether you need to adjust the use of another medicine you require.

Some medicines:

• may affect the levels of Yasmin in the blood
• may make it less effective in preventing pregnancy
• may cause unexpected bleeding

This may occur with:

• 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)
  • high blood pressure in the blood vessels of the lungs (bosentan)
• herbal preparations containing St. John’s wort

Yasmin may influence the effect of other medicines, for example:

• medicines containing cyclosporine
• the antiepileptic lamotrigine (may lead to an increased frequency of seizures)
• theophylline (used to treat breathing problems)
• tizanidine (used to treat pain and/or muscle cramps)

Do not take Yasmin if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause increases in blood parameters measuring liver function (increase in liver enzyme ALT). Your doctor will prescribe another type of contraceptive before starting treatment with these medicines. Yasmin can be restarted approximately 2 weeks after completion of this treatment. See section “Do not use Yasmin.”

Consult your doctor or pharmacist before taking any medicine.

Taking Yasmin with food and drinks

Yasmin may be taken with or without food, and with a glass of water if needed.

Laboratory tests

If you require a blood test, inform your doctor or laboratory staff that you are taking a contraceptive, as hormonal contraceptives may influence the results of certain tests.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, you must not take Yasmin. If you become pregnant while taking Yasmin, stop treatment immediately and contact your doctor. If you wish to become pregnant, you may discontinue Yasmin at any time (see "If you stop taking Yasmin", page 15).

Consult your doctor or pharmacist before taking any medicine.

Breastfeeding

Yasmin is generally not recommended during breastfeeding. If you wish to take a contraceptive while breastfeeding, you should consult your doctor.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

There is no information suggesting that the use of Yasmin affects the ability to drive or operate machinery.

Yasmin contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Yasmin

Follow exactly the instructions for taking this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Take one Yasmin tablet every day, with some water if necessary. You may take the tablets with or without food, but always 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 a Wednesday, take a tablet marked "WED". Follow the direction of the arrow on the blister pack until you have taken all 21 tablets.

Afterwards, you must not take any tablets for 7 days. During these 7 days when no tablets are taken (called the "rest period"), menstruation should occur. The menstrual bleeding, also known as withdrawal bleeding, usually begins on the 2nd or 3rd day of the rest period.

On the 8th day after taking the last Yasmin tablet (i.e., after the 7-day rest period), you must start the next blister pack, even if bleeding has not yet stopped. This means you should begin each new blister pack on the same day of the week, and your period should occur on the same days each month.

If you use Yasmin in this way, you will also be protected against pregnancy during the 7 days when no tablets are taken.

When to start the first blister pack

• If you have not used any hormonal contraceptive in the previous month

Start taking Yasmin on the first day of your cycle (i.e., the first day of your period). If you start Yasmin on the first day of your period, you will be protected against pregnancy immediately. You may also start on days 2–5 of the cycle, but you must use additional contraceptive methods (e.g., a condom) during the first 7 days.

• Switching from a combined hormonal contraceptive, combined vaginal contraceptive ring, or patch

You may preferably start taking Yasmin the day after taking the last active tablet (the last tablet containing active ingredients) of your previous contraceptive, but no later than the day after the rest period of your previous contraceptive (or after taking the last inactive tablet of your previous contraceptive). When switching from a combined vaginal contraceptive ring or patch, follow your doctor's recommendations.

• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system IUS)

You may switch from the progestogen-only pill on any day (if you have an implant or IUS, on the same day of its removal; if you are using an injectable, at the time the next injection would have been due), but in all cases you must use additional contraceptive measures (e.g., a condom) during the first 7 days of tablet intake.

• After an abortion

Follow your doctor's recommendations.

• After giving birth

You may start taking Yasmin between 21 and 28 days after giving birth. If you start later than day 28, use one of the so-called barrier methods (e.g., a condom) during the first 7 days of using Yasmin.

If, after giving birth, you have already had sexual intercourse before starting Yasmin (again), you must be sure you are not pregnant or wait until your next menstrual period.

• If you are breastfeeding and wish to start (or restart) taking Yasmin after giving birth

Please read the section “Breastfeeding”, page 11.

Ask your doctor if you are unsure about when to start.

If you take more Yasmin than you should

There have been no reports of serious harm caused by overdose of Yasmin.

Symptoms that may occur if you take many tablets at once include feeling unwell, vomiting, or vaginal bleeding. This bleeding may even occur in girls who have not yet had their first menstrual period, if they have accidentally taken this medicine.

If you have taken too many Yasmin tablets, or if you discover that a child has taken them, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Yasmin

• If you are less than 12 hours late in taking a tablet, protection against pregnancy is not reduced. Take the tablet as soon as you remember, and continue taking the following tablets at your usual time.

• If you are more than 12 hours late in taking a tablet, protection against pregnancy may be reduced. The more tablets you miss, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is greatest if you miss a tablet at the beginning or end of the blister pack. Therefore, follow the recommendations below (see the diagram on page 14):

• Missing more than one tablet from the pack

Consult your doctor.

• Missing one tablet in week 1

Take the missed 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 and use additional precautions, for example, a condom, for the next 7 days. If you have had sexual intercourse in the week before missing the tablet, you may be pregnant. In this case, consult your doctor.

• Missing one tablet in week 2

Take the missed 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. Protection against pregnancy is not reduced, and you do not need to take additional precautions.

• Missing one tablet in week 3

You have two options:

1. Take the missed 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. Instead of starting the rest period, begin the next blister pack immediately.

You will likely have your period at the end of the second blister pack, although you may experience light bleeding or spotting similar to a period during the second pack.

2. You may also choose to stop taking tablets and go directly into the 7-day rest period (noting the day on which you missed the tablet). If you wish to start a new blister pack on the day you usually begin, your rest period will need to last less than 7 days.

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

• If you have missed taking any tablets and do not have bleeding during the first rest period, you may be pregnant. Contact your doctor before starting the next blister pack.

What to do in case of vomiting or severe diarrhoea

If you vomit within 3–4 hours after taking a tablet or suffer from severe diarrhoea, there is a risk that the active ingredients of the contraceptive may not be fully absorbed by your body. This situation is almost equivalent to missing a tablet. After vomiting or severe diarrhoea, take a tablet from a spare blister pack as soon as possible. If possible, take it within 12 hours of your usual time for taking the contraceptive. If this is not possible or more than 12 hours have passed, follow the advice in the section “If you forget to take Yasmin”, page 13.

Delaying your period: what you should know

Although not recommended, you may delay your period by starting a new Yasmin blister pack instead of taking the 7-day rest period and completing it. During the second pack, you may experience light bleeding or spotting. After the usual 7-day rest period, start the next blister pack.

You should seek advice from your doctor before deciding to delay your menstrual period.

Changing the first day of your period: what you should know

If you take the tablets as instructed, your period will begin during the rest period. If you wish to change that day, reduce the number of rest days (but never increase them – maximum 7!). For example, if your rest days usually begin on Fridays and you want to change to Tuesdays (3 days earlier), start a new blister pack 3 days earlier than usual. If you make the rest period very short (e.g., 3 days or fewer), bleeding may not occur during these days. In this case, you may experience light bleeding or spotting.

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

If you stop taking 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 contraception. If you wish to become pregnant, stop taking Yasmin and wait until your next period before trying to conceive. This will make it easier to calculate your estimated date of delivery.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. If you experience any adverse effect, especially if it is severe and persistent, or if you have any change in your health that you think may be due to Yasmin, consult your doctor.

All women who take combined hormonal contraceptives have a higher 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 need to know before starting Yasmin”.

Serious adverse 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 list of adverse effects has been associated with the use of Yasmin:

Frequent adverse effects (may affect up to 1 in 10 patients):

• menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness
• headache, depressed mood
• migraine
• nausea
• thick, whitish vaginal discharge and fungal vaginal infection

Uncommon adverse effects (may affect up to 1 in 100 patients):

• breast enlargement, changes in sex drive
• high blood pressure, low blood pressure
• vomiting, diarrhea
• acne, skin rash, intense itching, hair loss (alopecia)
• vaginal infection
• fluid retention and changes in body weight

Rare adverse effects (may affect up to 1 in 1000 patients):

• allergic reactions (hypersensitivity), asthma
• breast discharge
• hearing problems
• skin disorders such as erythema nodosum (characterized by painful, reddish skin nodules) or erythema multiforme (characterized by skin rash with target-shaped redness or ulcers)
• harmful blood clots in a vein or artery, for example:
  • in a leg or foot (i.e., DVT).
  • in a lung (i.e., PE).
  • heart attack.
  • stroke.
  • mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA).
  • 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 about conditions that increase the risk of blood clots and symptoms of a blood clot).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Yasmin

Keep this medicine out of the sight and reach of children.

Do not store above 30°C. Store in the original blister pack to protect it from moisture.

Do not use this medicine after the expiry date stated on the packaging after “EXP:”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Yasmin

• The active substances are drospirenone and ethinylestradiol.

Each active coated tablet contains 3 milligrams of drospirenone and 0.030 milligrams of ethinylestradiol.

• The other components (excipients) are:

Tablet core: lactose monohydrate, corn starch, pregelatinized corn starch, povidone K25, magnesium stearate (E-470b).

Tablet coating: hypromellose (E-464), macrogol 6000, talc (E-553b), titanium dioxide (E-171) and yellow iron oxide (E-172); see section 2 “Yasmin contains lactose”.

Nature of the product and pack contents

• Each Yasmin blister pack contains 21 pale yellow film-coated tablets.

• Yasmin tablets are film-coated, with a coated tablet core. The tablets are pale yellow, round, convex on both sides, and have the letters “DO” imprinted within a regular hexagon on one side.

• Yasmin is available in boxes containing 1, 3, 6, or 13 blisters, each blister containing 21 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 - 5

08970 Sant Joan Despí – Barcelona

Spain

Manufacturer

Bayer AG

13342 Berlin, Germany

Bayer Weimar GmbH und Co. KG

Döbereinerstraße 20

99427 Weimar, Germany

This medicinal product is authorized in the European Economic Area member states 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

Date of the most recent review of this leaflet: November 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)