Yasminelle 3 mg / 0.02 mg film-coated tablets

Spain
Brand name Yasminelle 3 mg / 0.02 mg film-coated tablets
Form tablets, film-coated
Active substance / Dosage
DROSPIRENONE · 3,0 mg
ETHINYLESTRADIOL · 0,020 mg
Prescription type Prescription Only Medicine
ATC code
G03A G03AA G03AA12
Registration number 67982
Manufacturer Bayer Hispania S.L.
Yasminelle 3 mg / 0.02 mg film-coated tablets tablets, film-coated

Table of Contents

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Yasminelle 3mg/0.02 mg film-coated tablets

drospirenone/ethinylestradiol

Read the entire leaflet carefully before starting to take 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 alone, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Important information you need to 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 of use or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
  • Be alert and consult your doctor if you think you may be experiencing symptoms of a blood clot (see section 2, "Blood clots").

Package leaflet contents:

  1. What Yasminelle is and what it is used for 2
  2. What you need to know before taking Yasminelle 2

When you must not use Yasminelle 2

Warnings and precautions 3

Blood clots 5

Yasminelle and cancer 9

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

Bleeding between periods 9

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

Other medicines and Yasminelle 10

Taking Yasminelle with food and drink 10

Laboratory tests 10

Pregnancy 11

Breast-feeding 11

Driving and using machines 11

Yasminelle contains lactose 11

  1. How to take Yasminelle 11

When can you start the first pack? 12

If you take more Yasminelle than you should 12

If you forget to take Yasminelle 13

What to do in case of vomiting or severe diarrhoea 14

Delayed menstrual period: what you should know 14

Change in the first day of your menstrual period: what you should know 14

If you stop treatment with Yasminelle 15

  1. Possible side effects 15
  2. How to store Yasminelle 16
  3. Contents of the pack and other information ………………………………………17

1. What Yasminelle is and what it is used for

  • Yasminelle is a contraceptive and is 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 called combined contraceptives.

2. What you need to know before starting Yasminelle

General considerations

Before starting Yasminelle, 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 Yasminelle, 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 additional tests.

This leaflet describes several situations in which you should stop using Yasminelle, or in which the effectiveness of Yasminelle may be reduced. In such situations, you should 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 Yasminelle alters the monthly changes in body temperature and cervical mucus.

Yasminelle, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

When not to use Yasminelle

Do not use Yasminelle if you have any of the conditions listed below. Inform your doctor if you have any of these conditions. Your doctor will discuss with you what other form of contraception might be more suitable.

Do not use Yasminelle

  • 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 hyperhomocysteinemia.

  • 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 your liver function has not yet returned to normal.

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

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

  • If you have (or have ever had), or if it is suspected that you 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 take Yasminelle if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Yasminelle”).

Additional information on special populations

Children and adolescents

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

Older women

Yasminelle is not indicated for use after menopause.

Women with hepatic impairment

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

Women with renal impairment

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Yasminelle.

When should you consult your doctor?

Seek urgent medical attention

  • If you notice possible signs of a blood clot, which may indicate that 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 side 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 Yasminelle 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 Yasminelle, you must also inform your doctor.

  • If any close family member has or has previously had breast cancer.
  • If you have any 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 causing kidney failure).
  • If you have sickle cell anemia (an inherited 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 prolonged periods (see section 2 “Blood clots”).
  • If you have recently given birth, you are at increased risk of blood clots. You should ask your doctor when you can start taking Yasminelle after delivery.
  • 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 Yasminelle”, page 10).
  • If you have systemic lupus erythematosus (SLE, a disease affecting your body’s natural defense system).
  • If you have a condition that may have first appeared during pregnancy or a previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering rash during pregnancy (herpes gestationis), a neurological disorder involving involuntary movements (Sydenham’s chorea)).
  • If you have or have ever had chloasma (skin discoloration, especially on the face and neck, known as “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 with breathing difficulties, consult your doctor immediately. Medicines containing estrogens may induce or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Yasminelle 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 the veins (called “venous thrombosis”, “venous thromboembolism” or VTE).
  • In the 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 may be fatal.

It is important to remember that the overall risk of a harmful blood clot due to Yasminelle 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 might 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., turning 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 bringing up blood.
  • Sharp chest pain that may worsen when breathing deeply.
  • Severe dizziness or lightheadedness.
  • Rapid or irregular heartbeat.
  • Severe abdominal 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 complete 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 radiating to the back, jaw, throat, arm, or stomach.
  • Sweating, nausea, vomiting, or dizziness.
  • Extreme weakness, anxiety, or shortness of breath.
  • Rapid 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 abdominal 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 in 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 (PE).
  • 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 in which you take a combined hormonal contraceptive for the first time. The risk may also be higher 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 Yasminelle, 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 on 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 Yasminelle is small.

  • Among 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 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 Yasminelle, between 9 and 12 women will develop a blood clot in one year.
  • Your individual 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 in 10,000 women

Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate

About 5–7 in 10,000 women

Women who use Yasminelle

About 9–12 in 10,000 women

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

The risk of having a blood clot with Yasminelle 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 about 50 years). In this case, you may have an inherited blood clotting disorder.
  • If you need surgery or will be immobile for a long time due to injury, illness, or having a leg in a cast. You may need to stop taking Yasminelle several weeks before surgery or while you are less mobile. If you need to stop taking Yasminelle, 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 risk factors listed above.

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 Yasminelle.

If any of the above conditions change while you are using Yasminelle—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 may cause 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 with the use of Yasminelle is very small, but it may increase:

  • With age (over about 35 years).
  • If you smoke. When using a combined hormonal contraceptive such as Yasminelle, 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 a close relative has 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 disorders, 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 Yasminelle—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.

Yasminelle and cancer

Breast cancer has been observed slightly more often in women using combined contraceptives, but it is not known whether this is due to the treatment. For example, more tumours may be detected in women taking combined contraceptives because they are examined by a doctor more frequently. The incidence of breast tumours 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 lump.

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

Psychiatric disorders

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

Bleeding between periods

During the first few months of taking Yasminelle, you may experience unexpected bleeding (bleeding outside the week of tablet-free days). If this bleeding persists beyond a few months or starts after several months, your doctor will investigate the cause.

What to do if you do not have your period during the tablet-free week

If you have taken all the tablets correctly, have not vomited or had severe diarrhoea, and have not taken any other medicines, it is very unlikely that you are pregnant.

If you miss two consecutive 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 Yasminelle

Inform your doctor 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 Yasminelle. 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.

Some medicines:

  • may affect the levels of Yasminelle 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 (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

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

  • medicines containing cyclosporine
  • the antiepileptic lamotrigine (which 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 Yasminelle 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. Yasminelle can be restarted approximately 2 weeks after completion of this treatment. See section “Do not use Yasminelle”.

Consult your doctor or pharmacist before using any medicine.

Taking Yasminelle with food and drink

Yasminelle may be taken with or without food, and with some water if necessary.

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, breastfeeding and fertility

Pregnancy

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

Consult your doctor or pharmacist before using any medicine.

Breastfeeding

Yasminelle 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 using any medicine.

Driving and use of machines

There is no information suggesting that the use of Yasminelle has any effect on the ability to drive or operate machinery.

Yasminelle 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 Yasminelle

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

Take one Yasminelle 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 pack (blister) 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 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. Menstruation, which may also be referred to as withdrawal bleeding, usually begins on the 2nd or 3rd day of the rest period.

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

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

When can you start the first pack?

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

Start taking Yasminelle on the first day of your cycle (i.e., the first day of your period). If you start Yasminelle on the first day of your period, you are protected against pregnancy immediately. You may also start on days 2–5 of your cycle, but in this case 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 start taking Yasminelle preferably 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 it is an implant or IUS, on the same day of removal; if it is an injectable, at the time the next injection would be 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 Yasminelle 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 Yasminelle.

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

  • If you are breastfeeding and wish to start taking Yasminelle (again) after giving birth

Please read section “Breastfeeding”, page 11.

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

If you take more Yasminelle than you should

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

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 Yasminelle tablets, or if you find out that a child has taken them, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, contact your doctor or pharmacist or call the Toxicology Information Service. Telephone 915 620 420, indicating the medicine and the amount taken.

If you forget to take Yasminelle

  • If you are less than 12 hours late in taking a tablet, protection against pregnancy is not reduced. Take the missed 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 forget a tablet at the beginning or end of the 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, such as condoms, for the next 7 days. If you 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 pack immediately.

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

  1. You may also stop taking tablets and go directly into the rest period (note the day on which you missed the tablet). If you wish to start a new pack on the day you usually start, your rest period must 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 a period during the first rest period, you may be pregnant. Contact your doctor before starting the next pack.
Medical flowchart in Spanish explaining procedures for missed pill during week 1, 2, or 3

What to do in case of vomiting or severe diarrhea

If you vomit within 3–4 hours after taking a tablet or suffer from severe diarrhea, 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 diarrhea, take a tablet from a reserve 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 Yasminelle”, page 14.

Delaying your menstrual period: what you should know

Although not recommended, you may delay your menstrual period by starting a new pack of Yasminelle instead of taking the rest week and completing it. During the use of the second pack, you may experience light or breakthrough bleeding. After the usual rest week, start the next pack.

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

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

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

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

If you stop taking Yasminelle

You may stop taking Yasminelle at any time. If you do not wish to become pregnant, consult your doctor about other effective methods of contraception. If you wish to become pregnant, stop taking Yasminelle and wait until your menstrual period before trying to conceive. This will make it easier to calculate your estimated date of delivery.

If you have any other 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 could be due to Yasminelle, consult your doctor.

All women who take 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 need to know before starting to take Yasminelle”.

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 Yasminelle.

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

  • mood changes
  • headache
  • abdominal pain (stomach ache)
  • acne
  • breast pain, breast enlargement, breast tenderness, painful or irregular periods
  • weight gain

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

  • Candida (a fungal infection)
  • cold sores (herpes simplex)
  • allergic reactions
  • increased appetite
  • depression, nervousness, sleep disorders
  • tingling sensation, dizziness
  • vision problems
  • irregular or unusually fast heart rate
  • blood clots (thrombosis) in the lungs (pulmonary embolism), increased blood pressure, low blood pressure, migraine, varicose veins
  • sore throat
  • nausea, vomiting, inflammation of the stomach and/or intestines, diarrhoea, constipation
  • hair loss (alopecia), eczema, itching, skin rashes, dry skin, oily skin disorders (seborrhoeic dermatitis)
  • neck pain, limb pain, muscle cramps
  • bladder infection
  • breast lumps (benign and cancer), milk production without being pregnant (galactorrhoea), ovarian cysts, hot flushes, absence of periods, heavy periods, vaginal discharge, vaginal dryness, pain in the lower abdominal (pelvic) area, abnormal cervical smears (Papanicolaou test or Papanicolaou staining), decreased interest in sex
  • fluid retention, lack of energy, excessive thirst, increased sweating
  • weight loss

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

  • asthma
  • hearing problems
  • erythema nodosum (characterized by painful reddish skin nodules)
  • erythema multiforme (skin rash with target-like 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 on 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 can 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 Yasminelle

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after "EXP:". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point located at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Yasminelle

  • The active substances are drospirenone and ethinylestradiol (as betadex clathrate).

Each film-coated tablet contains 3 milligrams of drospirenone and 0.020 milligrams of ethinylestradiol (as betadex clathrate).

  • The other components (excipients) are lactose monohydrate, corn starch, magnesium stearate (E-470b), hypromellose (E-464), talc (E-553b), titanium dioxide (E-171), and red iron oxide (E-172); see section 2 “Yasminelle contains lactose”.

Appearance of the product and contents of the pack

  • Each Yasminelle blister contains 21 pale pink film-coated tablets.
  • Yasminelle contains film-coated tablets; the tablet core is coated. The tablets are pale pink in colour, round, with convex surfaces, and one side is marked with the letters “DS” within a regular hexagon.
  • Yasminelle is available in boxes containing 1, 3, 6, and 13 packs (blister packs), each with 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

or

Bayer Weimar GmbH und Co. KG, Döbereinerstr. 20, 99427 Weimar, Germany

This medicinal product is authorized in the European Economic Area member states under the following names:

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

  • France: Jasminelle

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

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