Yasminelle – Ethinylestradiol/drospirenone uses, dose and side effects

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Contents hide
1 What Yasminelle is and what it is used for
2 What you need to know before using Yasminelle
3 Warnings and precautions
4 Other medicines and Yasminelle
5 Yasminelle with food and drink
6 Pregnancy
7 Driving ability and use of machinery
8 Yasminelle contains lactose
9 How to use Yasminelle
10 If you have taken too much Yasminelle
11 If you forget to take Yasminelle
12 If you stop using Yasminelle
13 Possible side effects
14 How Yasminelle should be stored
15 Contents of the packaging and other information
16 What Yasminelle contains
17 What Yasminelle looks like and the contents of the package
18 Marketing Authorization Holder

0.02 mg/3 mg film-coated tablets
ethinylestradiol/drospirenone

What Yasminelle is and what it is used for

  • Yasminelle is a birth control pill and is used to prevent pregnancy.
  • Each film-coated tablet contains a small amount of two different female sex hormones; drospirenone and ethinylestradiol.
  • Birth control pills that contain two hormones are called combination birth control pills.

What you need to know before using Yasminelle

General notes
Before you start using Yasminelle, read the information about blood clots in section 2. You must read the symptoms of blood clots (see section 2, “Blood clots”).
Before you can start taking Yasminelle, your doctor/midwife will ask you some questions about your own and your close relatives’ medical history. The doctor/midwife will also measure your blood pressure and it is possible that, depending on your situation, the doctor/midwife will also take other samples.
This leaflet describes several situations when you must stop taking Yasminelle or when Yasminelle’s reliability may be reduced. In such situations, you should either refrain from having sex or use other, non-hormonal contraceptives, e.g. use a condom or another barrier method. Do not use the rhythm method or the temperature method. These methods can be unreliable, as Yasminelle affects the monthly changes in body temperature and cervical secretions.
yasminelle, like other hormonal contraceptives, does not protect against HIV infection ( AIDS ) or other sexually transmitted diseases.

Do not use Yasminelle

Do not use Yasminelle if you have any of the conditions listed below. If you have any of these conditions, you must tell the doctor. The doctor will discuss what other type of contraception might be more appropriate.

Do not use Yasminelle:

  • if you have (or have had) a blood clot in a blood vessel in the legs (deep vein thrombosis, DVT), in the lungs ( pulmonary embolism ), or in any other organ
  • if you know you have a disease that affects blood clotting – e.g. protein C deficiency, protein S deficiency, antithrombin III deficiency, Factor V Leiden or antiphospholipid antibodies
  • if you need to undergo an operation or if you will be bedridden for a long period (see the section “Blood clots”)
  • if you have ( or have had) a heart attack or a stroke
  • if you have (or have had) angina (a condition that causes severe chest pain and can be the first sign of a heart attack) or transient ischemic attack ( TIA – transient stroke symptoms)
  • if you have any of the following diseases that can increase the risk of a blood clot in the arteries:
    • severe diabetes with damaged blood vessels
    • very high blood pressure
    • a very high level of fat in the blood ( cholesterol or triglycerides )
    • a condition called hyperhomocysteinemia
  • if you have (or have had) a type of migraine called “migraine with aura”
  • if you have (or have had) liver disease and your liver function is not yet normal
  • if your kidneys are not working properly ( kidney failure )
  • if you have (or have had) a tumor in the liver
  • if you have (or have had) or if you are suspected of having breast or genital cancer
  • if you have unexplained vaginal bleeding
  • if you are allergic to ethinylestradiol or drospirenone, or any of the other ingredients of this medicine (listed in section 6). This can cause itching, rash, or swelling.
    Do not use Yasminelle if you have hepatitis C and are being treated with medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also section “Other medicines and Yasminelle”).

Additional information on special patient groups

Children and young people

Yasminelle is not intended for use by women who have not yet had their period.

Older women

Yasminelle is not intended for use after menopause.

Women with impaired liver function

Do not use Yasminelle if you have liver problems. See also the sections “Do not use Yasminelle” and “Warnings and precautions”.

Women with impaired renal function

Do not use Yasminelle if you have problems with your kidneys or acute kidney failure. See also the sections “Do not use Yasminelle” and “Warnings and precautions”.

Warnings and precautions

When should you contact a doctor?
Seek medical attention immediatelyif you notice possible signs of a blood clot which could mean you have a blood clot in the leg (ie deep vein thrombosis ), a blood clot in the lung (ie pulmonary embolism ), a heart attack or a stroke (see section ‘Blood clots’ below). For a description of the symptoms of these serious side effects, go to “How to recognize a blood clot”.

Tell your doctor if any of the following conditions apply to you.

In some situations, you need to be especially careful when using Yasminelle or other combined oral contraceptives, and it may be necessary for you to be checked regularly by your doctor/midwife. If the condition occurs or worsens while using Yasminelle, you should also contact a doctor.

  • if a close relative has or has had breast cancer
  • if you have any liver or biliary 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 hemolytic uraemic syndrome (HUS – a blood clotting disorder leading to kidney failure )
  • if you have sickle cell anemia (an inherited disorder of the red blood cells )
  • if you have increased blood fats ( hypertriglyceridemia ) or a genetic predisposition to this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas)
  • if you need to undergo an operation or will be bedridden for a longer period (see section 2 “Blood clots”)
  • if you have recently given birth, you are at increased risk of blood clots. Ask the doctor how soon after delivery you can start using Yasminelle
  • if you have an inflammation of the veins under the skin (superficial thrombophlebitis )
  • if you have varicose veins.
  • if you have epilepsy (see “Other medicines and Yasminelle”)
  • if you have systemic lupus erythematosus ( SLE – a disease that affects your natural immune system)
  • if you have a disease that first appeared during pregnancy or during previous use of sex hormones (e.g. hearing loss, a blood disorder called porphyria, skin rash with blisters during pregnancy (herpes of pregnancy), a nerve disorder that causes sudden twitching of the body (Sydenham’s chorea )
  • if you have or have had chloasma (a discoloration of the skin, especially on the face or neck, so-called “pregnancy spots”). In this case, avoid direct exposure to sunlight or ultraviolet light.
  • if you have hereditary angioedema, products containing estrogen may induce or worsen symptoms. You should see a doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives with difficulty breathing.

BLOOD CLOTS

If you use combined hormonal contraceptives such as Yasminelle 28, the risk of blood clots increases compared to if you do not use these preparations. In rare cases, 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).

It is not always possible to fully recover from blood clots. In rare cases, they can have serious lingering effects and, in very rare cases, be fatal.

It is important to remember that the overall risk of a dangerous blood clot due to Yasminelle 28 is small.

THIS IS HOW YOU RECOGNIZE A BLOOD CLOT

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

Are you experiencing any of these signs?What could you possibly be suffering from?
swelling of a leg or along a vein in the leg or foot, especially if you also get: pain or tenderness in the leg that is felt only when standing or walking increased heat in the affected leg discoloration of the skin on the leg, e.g. pale, red or blueDeep vein thrombosis
sudden unexplained shortness of breath or rapid breathing sudden coughing for no apparent reason which could lead to you coughing up blood severe chest pain that may increase with deep breath severe unsteadiness or dizziness fast or irregular heartbeat severe pain in the stomach if you are not sure, consult a doctor because some of these symptoms, e.g. cough and shortness of breath, can be mistaken for a milder condition such as a respiratory infection (e.g. a common cold).Pulmonary embolism
Symptoms that usually occur in one eye: immediate vision loss or blurred vision without pain that can lead to vision lossRetinal vein thrombosis (blood clot in the eye)
chest pain, discomfort, pressure, heavinesspressure or feeling fullness in the chest, arm, or below the sternum feeling of fullness, indigestion or feeling of suffocationdiscomfort in the upper body that radiates to the back, jaw, neck, arm, and stomach sweating, nausea, vomiting or dizziness extreme weakness, anxiety, or shortness of breakfast or irregular heartbeatsMyocardial infarction
sudden weakness or numbness in the face, arms, or legs, especially on one side of the body sudden confusion, difficulty speaking or understanding sudden vision problems in one or both eyes sudden trouble walking, dizziness, loss of balance or coordination sudden, severe or prolonged headache with no known cause unconsciousness or fainting with or without seizures sometimes the symptoms of a stroke can be short-lived with almost immediate or complete recovery, but you should still seek medical attention immediately because you are at risk of another stroke.Stroke
swelling and slight blue discoloration of an arm or leg severe pain in the stomach ( acute abdomen)Blood clots that block 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 increase in the risk of blood clots in the vein (venous thrombosis ). However, these side effects are rare. They most often occur during the first year of using a combined hormonal contraceptive.
  • If a blood clot forms in a vein in the leg or foot, it can lead to deep vein thrombosis (DVT).
  • If a blood clot dislodges from the leg and lodges in the lung, it can lead to a pulmonary embolism.
  • In very rare cases, a blood clot can form in a vein in another organ such as the eye ( retinal vein thrombosis ).

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

The risk of developing a blood clot in a vein is greatest during the first year that you first use combined hormonal contraceptives. The risk may also be higher if you start again with a combined hormonal contraceptive (the same product or a different product) after a break of 4 weeks or longer.

After the first year, the risk decreases, but it is always slightly higher than if you did not use a combined hormonal contraceptive.

When you stop using Yasminelle, the risk of a blood clot returns to normal within a few weeks.

How big is the risk of developing a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of a blood clot in the leg or lungs with Yasminelle is small.

  • Out of 10,000 women who are not using a combined hormonal contraceptive and are not pregnant, about 2 develop a blood clot within a year.
  • Out of 10,000 women using a combined hormonal contraceptive containing levonorgestrel or norethisterone or norgestimate, around 5-7 develop a blood clot within a year.
  • Out of 10,000 women using a combined hormonal contraceptive containing drospirenone such as Yasminelle, around 9-12 develop a blood clot within a year
  • The risk of blood clots varies depending on your medical history (see “Factors that can increase the risk of a blood clot” below).
Risk of developing a blood clot over a year
Women who do not use combined hormonal birth control pills and who are not pregnantAbout 2 in 10,000 women
Women using a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimateAbout 5-7 in 10,000 women
Women using YasminelleAbout 9–12 out of 10,000 women

Factors that can increase the risk of a blood clot in a vein

The risk of a blood clot with Yasminelle 28 is small, but certain conditions increase the risk. The risk is higher:

  • if you are overweight (body mass index or BMI over 30 kg/m 2 )
  • if someone in your family has had a blood clot in the bones, lungs, or another organ at a young age (e.g. under the age of about 50). In this case, you may have an inherited blood clotting disorder
  • if you need to undergo an operation, or are bedridden for an extended period due to injury or illness, or if your leg is cast. The use of Yasminelle may need to be stopped for several weeks before an operation or while you are less mobile. If you have to stop taking Yasminelle, ask your doctor when you can start taking it again
  • with increasing age (especially if you are over about 35)
  • if you have given birth a few weeks ago

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

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

You must tell the doctor if any of these conditions apply to you, even if you are not sure. The doctor may decide that you must stop taking Yasminelle.

If any of the above conditions change while using Yasminelle, e.g. a close relative suffers from a blood clot of unknown cause, or if you gain a lot of weight, talk to your doctor.

BLOOD CLOTS IN AN ARTERY

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

Just like a blood clot in a vein, a clot in an artery can lead to serious problems. It can e.g. cause a heart attack or stroke.

Factors that can increase the risk of a blood clot in an artery

You must know that the risk of a heart attack or stroke as a result of using Yasminelle is very small but may increase:

  • with increasing age (after about age 35)
  • if you smoke. When using combined hormonal contraceptives such as Yasminelle, you should stop smoking. If you cannot stop smoking and are over 35, your doctor may advise you to use another form of contraception
  • if you are overweight
  • if you have high blood pressure
  • if a close relative has had a heart attack or a stroke at a young age (younger than 50 years). In this case, you may also be at greater risk of a heart attack or a stroke
  • if you or a close relative have high blood fats ( cholesterol or triglycerides )
  • if you get migraines, especially migraines with an aura
  • if you have problems with your heart (valvular disease, a heart rhythm disorder called atrial fibrillation )
  • if you have diabetes.

If you have more than one of these conditions or if any of them are particularly severe, your risk of developing a blood clot may be even greater.

If any of the above conditions change while using Yasminelle, e.g. if you start smoking, a close relative has a thrombosis of unknown cause, or if you gain a lot of weight, talk to your doctor.

Yasminelle and cancer

Breast cancer has been observed slightly more often in women using combined oral contraceptives, but it is not known whether this is caused by the treatment. For example, it may be that more tumors are detected in women who use combined oral contraceptives because they are more often examined by doctors. The incidence of breast tumors gradually decreases after the end of treatment with combined hormonal contraceptives. It is important to regularly examine your breasts and you should contact your doctor if you feel a lump.

In rare cases, benign liver tumors, and in even fewer cases, malignant liver tumors, have been reported in oral contraceptive users. Contact your doctor if you experience unusually severe abdominal pain.

Mental disorders 

Some women using hormonal contraceptives, including Yasminelle, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If you experience mood changes and symptoms of depression, you should contact a doctor for advice as soon as possible.

Interstitial bleeding

During the first months when you use Yasminelle, you may have unexpected bleeding (bleeding outside the interweek). If this type of bleeding lasts longer than a few months, or if it occurs after a few months, your doctor/midwife needs to find out what is wrong.

What to do if you do not have any bleeding during the intervening week

If you took all the tablets correctly, did not vomit, and did not have severe diarrhea and if you did not take other medications, it is very unlikely that you became pregnant.

If the expected bleeding does not occur twice in a row, you may be pregnant. Contact your doctor/midwife immediately. Do not start the next tablet map until it is certain that you are not pregnant.

Other medicines and Yasminelle

Always tell your doctor/midwife which medicines or natural remedies you are already using. Also, tell other doctors or dentists who prescribe other medicines (or pharmacists) that you are using Yasminelle. They can tell you if you need to use additional contraceptive protection (eg condoms), and if so for how long, or if the use of another medicine you need needs to be changed.

Certain medicines

  • may affect the level of Yasminelle in the blood
  • may make it less effective at preventing pregnancy
  • may cause unexpected bleeding.

This applies, among other things

  • drugs used for the treatment of
    • epilepsy (eg primidone, phenytoin , barbiturates , carbamazepine, oxcarbazepine)
    • tuberculosis (eg rifampicin)
    • HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, and efavirenz)
    • fungal infections (eg, griseofulvin, ketoconazole )
    • arthritis, osteoarthritis (etoricoxib)
    • high blood pressure in the blood vessels of the lungs ( bosentan )
  • the natural remedy St. John’s wort

yasminelle can affect the effectiveness of other medicines, e.g.

  • medicines containing ciclosporin
  • the anti-epileptic medicine lamotrigine (this may lead to an increase in the number of seizures)
  • theophylline (to treat breathing problems)
  • tizanidine (for the treatment of muscle pain and/or muscle cramps)

Do not use Yasminelle if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir

as it can lead to increased liver values ​​(increase in the liver enzyme transaminase). The doctor will prescribe another contraceptive before starting treatment with this drug combination. yasminelle can be restarted approximately 2 weeks after treatment has ended. See the section “Do not use Yasminelle”.

Consult a doctor, midwife, or pharmacist before taking any medicine.

Yasminelle with food and drink

yasminelle can be taken with or without food, if necessary with a little water.

Laboratory tests
If you need to give a blood test, tell your doctor or the laboratory staff that you are using birth control pills, as hormonal contraceptives can affect the results of some tests.

Pregnancy

If you are pregnant, you should not use Yasminelle. If you become pregnant while taking Yasminelle, you must stop immediately and contact your doctor/midwife. If you want to get pregnant, you can stop taking Yasminelle at any time (see also “If you stop using Yasminelle”).

Consult a doctor, midwife, or pharmacist before taking any medicine.

Breastfeeding
In general, breastfeeding is not recommended while using Yasminelle. If you want to use the pill while breastfeeding, you should contact your doctor/midwife.

Consult a doctor, midwife, or pharmacist before taking any medicine.

Driving ability and use of machinery

There is no information to suggest that the use of Yasminelle affects the ability to drive or use machines.

Yasminelle contains lactose

If you have an intolerance to some sugars, talk to your doctor before taking Yasminelle.

How to use Yasminelle

Take one tablet of Yasminelle daily, with a small amount of water if necessary. You can take the tablets with or without food, but you should take the tablets at about the same time each day.

A tablet chart contains 21 film-coated tablets. Next to each tablet is written which day of the week the tablet should be taken. For example, if you start the tablet map on a Wednesday, you should take the tablet that says “WEDNESDAY”. Follow the direction of the arrow on the tablet chart until you have taken all 21 tablets.

After that, you should not take any tablets for 7 days. During these 7 tablet-free days (called the break or interweek) the bleeding should start. This is called “withdrawal bleeding” and it generally starts on the second or third day of the winter week.

On the eighth day after the last Yasminelle tablet (that is, after the intervening period of 7 days), you should start the next tablet chart, regardless of whether the bleeding has stopped or not. This means that you should start each tablet chart on the same day of the week and that the withdrawal bleeding should occur on the same days of each month.

If you use Yasminelle in this way, you are protected against pregnancy even during the 7 days when you do not take any tablets.

When can you start with the first tablet map?

  • If you have not used a hormonal contraceptive in the previous month
    Start Yasminelle on the first day of your menstrual cycle (ie the day your period starts). If you start Yasminelle on the first day of your period, you are immediately protected against pregnancy. You can also start on days 2-5 of the menstrual cycle, but then you must use additional protection methods (eg condoms) for the first 7 days.
  • Changing from a combined hormonal birth control pill, or combination preparation in the form of a vaginal ring or patch
    You can advantageously start Yasminelle the day after the last active tablet (the last tablet containing active substances) of your previous birth control pill, but no later than the day after the tablet-free period of your previous pill (or after the last inactive tablet of your previous pill ). When changing from a combination preparation in the form of a vaginal ring or patch, follow your doctor’s/midwife’s advice.
  • Changing from a progestagen-only method ( mini-pill, injection, implant, or a progestogen-releasing intrauterine system ( hormonal IUD ) ) You can change from mini-pills
    any day (from an implant or hormonal IUD on the day it is removed, from an injectable contraceptive at the time of the next injection ) but in all these cases you must use extra protection (e.g. a condom) during the first 7 days of tablet intake.
  • After a miscarriage
    Follow your doctor’s advice.
  • After delivery
    You can start with Yasminelle between 21 and 28 days after delivery. If you start later than day 28, use a so-called barrier method (eg a condom) for the first seven days of using Yasminelle.
    If you had sex before you start using Yasminelle (again) after giving birth, make sure you are not pregnant or wait until your next period.
  • If you are breastfeeding and wish to start Yasminelle (again) after giving birth
    Read the “Breastfeeding” section.

Ask your doctor/midwife what to do if you are not sure when to start.

If you have taken too much Yasminelle

There are no reports of serious adverse effects from taking too many Yasminelle tablets.

If you take several tablets at the same time, you may experience nausea, vomiting, or vaginal bleeding. Even girls who have not had their first period, but accidentally used this medicine, can experience this type of bleeding.

If you have taken too many Yasminelle tablets or discover that a child has swallowed tablets, you should contact a doctor or hospital for risk assessment and advice.

If you forget to take Yasminelle

  • If less than 12 hours have passed since you should have taken your tablet, the pregnancy prevention effect is not reduced. Take the tablet as soon as you remember and then take the next tablet at the usual time.
  • If more than 12 hours have passed since you should have taken your tablet, the contraceptive effect may be reduced. The more tablets you have forgotten, the greater the risk of pregnancy.

The risk of incomplete protection against pregnancy is greatest if you forget a tablet at the beginning or end of the tablet map. Therefore, you should follow the following rules (see also the diagram):

  • More than 1 tablet forgotten in the tablet chart
    Contact your doctor/midwife.
  • 1 tablet was forgotten during week 1
    Take the forgotten tablet as soon as you remember, even if it means you have to take two tablets at the same time. Then continue to take tablets at the usual time and use extra protection for the next seven days, e.g. condom. If you had sex the week before you forgot the pill, you could be pregnant. In that case, contact your doctor.
  • 1 tablet was forgotten during week 2
    Take the forgotten tablet as soon as you remember – even if it means you have to take two tablets at the same time. Continue taking tablets at the usual time. Protection against pregnancy is not reduced and you do not need to use extra protection.
  • 1 tablet was forgotten during week 3
    You can choose between two options:
    1. Take the forgotten tablet as soon as you remember, even if it means you have to take two tablets at the same time. Then continue to take the tablets at the usual time. Do not take a tablet break, but start the next tablet map.
      You are likely to have your period at the end of the second tablet chart – and you may have light or period-like bleeding while using the second tablet chart.
    2. You can also interrupt intake from the current tablet map and continue with the tablet-free period of 7 days ( note which day you forgot your tablet ). If you want to start on a new tablet map on the same day as you usually do, make the tablet-free period shorter than 7 days.

If you follow either of these two recommendations, you are still protected against pregnancy.

  • If you have forgotten a tablet in a tablet map and you do not have any bleeding during the first tablet-free period, it may mean that you are pregnant. Contact your doctor/midwife before starting the next tablet chart.
Forgotten tablet

If you vomit or have severe diarrhea
If you vomit within 3-4 hours after taking a tablet or if you have severe diarrhea, there is a risk that the active substances in the pill will not be completely absorbed by the body. This situation is almost the same as forgetting a tablet. After vomiting or diarrhea, take a new tablet from a spare tablet chart as soon as possible. If possible, take it within 12 hours of the time you normally take your pill. If this is not possible or if 12 hours have already passed, you should follow the advice under “If you forget to take Yasminelle”.

Staggering your period: what you need to know
Although not recommended, you can bring your period forward by starting straight away on a new Yasminelle chart without taking a tablet break and finishing that entire chart. You may have light or period-like bleeding while taking the second tablet chart. After the usual tablet break of 7 days, start on the next tablet map.

You can consult your doctor/midwife before deciding to postpone your period

Changing the first day of your period: what you need to know
If you take your pills as directed, your period will start during the pill-free week. If you have to change this day, you can reduce the number of tablet-free days ( but never extend – 7 is the maximum! ). For example, if you normally start your tablet-free days on a Friday, and you want it to start on a Tuesday (three days earlier), start on the new tablet map three days earlier than usual. If you take a very short tablet-free period (eg three days or less) you may not have any bleeding during this time. You may then have light or menstrual-like bleeding.

Contact your doctor/midwife if you are not sure what to do.

If you stop using Yasminelle

You can stop taking Yasminelle whenever you want. If you do not want to get pregnant, consult your doctor/midwife about other reliable methods of contraception. If you want to get pregnant, stop taking Yasminelle and wait for your period before trying to get pregnant. You will then be able to calculate the expected delivery date.

If you have further questions about this medicine, contact your doctor, midwife, or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you get any side effects, especially if they are severe or persistent, or if your health changes and you think it may be due to Yasminelle, talk to your doctor.

As with all women taking combined hormonal contraceptives, there is an increased risk of blood clots in your veins (venous thromboembolism, VTE) or blood clots in your arteries ( arterial thrombosis, ATE). More information about the different risks when using combined hormonal contraceptives can be found in section 2 “What you need to know before taking Yasminelle”.

Below is a list of side effects that have been associated with the use of Yasminelle.

Common side effects (between 1 and 10 in 100 users may be affected):

  • Mood swings
  • headache
  • stomach pain
  • acne
  • breast pain, breast enlargement, sore breasts, painful or irregular periods
  • weight gain

Uncommon side effects (between 1 and 10 in 1,000 users may be affected):

  • candida (fungal infection)
  • herpes simplex blisters
  • allergic reactions
  • increased appetite
  • depression, nervousness, sleep problems
  • tingling/pins and needles, dizziness ( vertigo )
  • visual disturbances
  • irregular heartbeat or unusually high heart rate
  • blood clot ( thrombosis ) in the lung ( pulmonary embolism ), increased blood pressure, decreased blood pressure, migraine, varicose veins
  • pharyngitis
  • nausea, vomiting, inflammation of the stomach and/or intestines, diarrhea, constipation
  • sudden swelling of the skin and/or mucous membranes (e.g. tongue or throat), and/or difficulty swallowing or hives along with difficulty breathing ( angioedema ), hair loss ( alopecia ), eczema, itching, rash, dry skin, increased skin peeling ( seborrhea )
  • neck pain, pain in arms/legs, muscle cramps
  • inflammation of the bladder
  • breast lumps (benign and cancerous), milk production without being pregnant ( galactorrhea ), ovarian tumor ( cyst ), hot flashes, absence of menstrual bleeding, very heavy menstrual bleeding, vaginal discharge, dry vagina, pelvic pain, abnormal smears (cell samples) from the cervix, decreased sex drive
  • fluid retention, lack of energy, severe thirst, increased sweating
  • weight loss

Rare side effects ( between 1 and 10 in 10,000 users may be affected):

  • asthma
  • impaired hearing
  • erythema nodosum (characterized by painful reddish nodules on the skin)
  • erythema multiforme (characterized by a rash with ring-shaped redness or sores).
  • dangerous blood clots in a vein or artery, such as:
    • in a leg or foot (ie DVT)
    • in the lungs
    • myocardial infarction
    • stroke
    • mini-stroke or transient stroke-like symptoms, called transient ischemic attack ( TIA )
    • blood clots in the liver, stomach/intestines, kidneys, or eyes.

The risk of developing a blood clot may be higher if you have other conditions that increase this risk (see section 2 for more information about the conditions that increase the risk of blood clots and the symptoms of a blood clot).

How Yasminelle should be stored

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

This medicine does not require any special storage instructions.

Use before the expiry date which is stated on the carton after “Exp. date.”

The expiration date is the last day of the specified month.

Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.

Contents of the packaging and other information

What Yasminelle contains

  • The active substances are ethinylestradiol (as betadexclatrate) and drospirenone.
    Each tablet contains 0.020 milligrams of ethinylestradiol (as betadexclathrate) and 3 milligrams of drospirenone.
  • Other ingredients are lactose monohydrate, corn starch, magnesium stearate (E470b), hypromellose (E464), talc (E553b), titanium dioxide (E171), and red iron oxide (E172).

What Yasminelle looks like and the contents of the package

  • Each Yasminelle blister contains 21 light pink film-coated tablets.
  • yasminelle is film-coated tablets; which means that the tablet is covered by an outer layer. The tablets are light pink, round, and have convex edges. One side is marked with the letters “DS” within an equilateral hexagon.
  • Yasminelle is available in packs of 1, 3, 6, and 13 tablet maps and each tablet map contains 21 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Bayer AB

Box 606

SE-169 26 Solna

Manufacturer

Bayer AG
133 42 Berlin

Germany

and

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

Germany

This medicine is registered in the member countries of the European Economic Area (EEA) under the following names:

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