0.02mg / 3mg film-coated tablet 
ethinyl estradiol / drospirenone

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

Important information about combined hormonal contraceptives:

• They are one of the most reliable contraceptive methods available if used correctly

• The risk of a blood clot in the veins or arteries increases slightly, especially during the first year or when combined hormonal contraceptives start to be used again after a break of 4 weeks or longer

• Be aware and consult a doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

In this leaflet you will find information about: 
1. What Estrelen is and what it is used for 
2. What you need to know before you take Estrelen 
3. How to use Estrelen 
4. Possible side effects Contents of the pack
5. How to store Estrelen 
6. Contents of the packaging and other information 

1. What Estrelen is and what it is used for

Estrelen is a birth control pill and is used to prevent pregnancy.

• Each of the 24 pink tablets contains a small amount of two different female hormones, called drospirenone and Ethinylestradiol.

• The 4 white tablets do not contain any active substances and are also called placebo tablets.

• Birth control pills that contain two hormones are called combination pills.

Ethinyl estradiol and drospirenone contained in Estrelen may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before taking Estrelen

General information
Before using Estrelen, read the information on blood clots in section 2. You must read the symptoms of blood clots – see section 2, “Blood clots”.
Before you start taking Estrelen, your doctor will ask you some questions about your own and your loved ones’ medical history. Your doctor will also measure your blood pressure and, depending on your individual situation, possibly perform some other tests.
This brochure describes several different situations when you should stop taking Estrelen, or when the reliability of Estrelen may be reduced. In such situations, you should either refrain from intercourse or use extra non-hormonal contraceptives. for example condom or any other barrier method. Do not use the rhythm method (safe periods) or the temperature method. These methods may be unsafe because Estrelen affects the monthly changes in body temperature and cervical secretions.
Estrelen does not protect, like other hormonal contraceptives, against HIV – infection you ( AIDS ) and other sexually transmitted diseases.

Do not take Estrelen

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

• if you have (or have had) a blood clot in a blood vessel in your legs (deep vein thrombosis  DVT), in your lungs ( pulmonary embolism ), or any other organ

• if you know you have a disease that affects blood coagulation – e.g. protein C deficiency, protein S deficiency, antithrombin III deficiency, Factor V Leiden, or antiphospholipid antibodies

• if you need to have an operation or if you stay in bed for a longer period (see section “Blood clots”)

• if you have (or have had) a heart attack or stroke (stroke)

• if you have (or have had) angina (a condition that causes severe chest pain and maybe the first sign of a heart attack) or transient ischemic attack ( TIA – transient stroke symptoms)

• if you have any of the following diseases that may increase the risk of a blood clot in the arteries:

o severe diabetes with damaged blood vessels

o very high blood pressure

o a very high level of fat in the blood ( cholesterol or triglycerides )

o a condition called hyperhomocysteinemia

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

• if you have (or have ever had) liver disease and your liver function is still not normal

• if your kidneys are not working properly ( kidney failure )

• if you have (or ever had) a liver tumor

• if you have (or have ever had) or if you suspect you may have breast or genital cancer

• if you have vaginal bleeding without explanation

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

• if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also section “Other medicines and Estrelen”).

Warnings and cautions

When should you contact a doctor? Seek medical attention immediately– if you notice any possible signs of a blood clot which may mean that you have a blood clot in your leg (ie deep vein thrombosis ), a blood clot in your 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”.

In some situations, you should be extra careful when using Estrelen or another combination pill, and your doctor may need to examine you regularly.

Tell your doctor if any of the following conditions develop or get worse when you take Estrelen.

Talk to your doctor, pharmacist, or nurse before taking Estrelen.

• if a close relative has or has ever had breast cancer

• if you have cancer

• if you suffer from liver disease (such as obstruction of the bile duct, which can cause jaundice with symptoms such as itching ) or bile disease (such as gallstones )

• if you have kidney problems (other than those mentioned under “Do not take Estrelen”) and are taking medicines that increase potassium levels in your blood. Your doctor can check the potassium levels in your blood.

• if you suffer from diabetes

• if you suffer from depression. Some women who use hormonal contraceptives, including Estron, have reported depression or depression. Depression can be severe and can sometimes lead to suicidal thoughts. If you experience mood swings and symptoms of depression, you should contact a doctor as soon as possible for advice.

• if you have Crohn’s disease or ulcerative colitis ( chronic inflammatory bowel disease)

• if you have a systemic lupus erythematosus ( SLE – a disease that affects your natural immune system)

• if you have hemolytic uremic syndrome (HUS – a disorder of blood coagulation that leads to kidney failure )

• if you have sickle cell anemia (a hereditary disease of the red blood cells )

• if you have increased blood fats ( hypertriglyceridemia ) or a hereditary condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas)

• if you need to have an operation or stay in bed for a longer period (see section 2 “Blood clots”)

• if you have just given birth, you are at increased risk of getting blood clots. Ask your doctor how soon after giving birth you can start using Estrelen

• if you have an inflammation of the veins under the skin (superficial thrombophlebitis )

• if you have varicose veins.

• if you suffer from epilepsy (see “Other medicines and Estrelen”)

• if you suffer from a disease that first appeared during pregnancy or previous use of sex hormones (eg hearing loss, a blood disease called porphyria, skin rash with blistering during pregnancy ( herpes gestationis), a nerve disease that causes sudden body movements (Sydenham’s chorea)

• if you have high blood pressure during treatment that cannot be controlled with medication.

• if you have or have ever had golden-brown pigment spots (chloasma), so-called “pregnancy spots”, especially on the face. In this case, avoid direct exposure to sunlight or ultraviolet radiation while taking this medicine.

• if you suffer from hereditary angioedema, estrogen products may cause or worsen your symptoms. You should see a doctor immediately if you experience symptoms of angioedema, such as a swollen face, swollen tongue, and/or swollen throat and/or difficulty swallowing or rash in combination with difficulty breathing.

BLOOD CLOTS

Using combined hormonal contraceptives such as Estrelen increases the risk of blood clots compared to if you do not use these drugs. In rare cases, a blood clot can block the 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 lasting effects and, in very rare cases, be fatal.

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

HOW TO FEEL A BLOOD CLOTH AGAIN

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

Do you experience any of these signs? What can you possibly suffer 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 only felt when you stand or walk• increased heat in the affected leg• discoloration of the skin on the leg, e.g. pale, red or blue Deep vein thrombosis
• sudden unexplained shortness of breath or rapid breathing• sudden cough for no apparent reason that could cause you to cough up blood• severe chest pain that may increase with deep breathing• strong feeling of instability or dizziness• fast or irregular heartbeat• severe pain in the abdomen
If you are not sure, talk to a doctor because some of these symptoms, e.g. cough and shortness of breath, can be mistakenly interpreted as a mild condition such as a respiratory infection (such as a common cold).
Pulmonary embolism
Symptoms that usually occur in one eye: Immediate loss of vision or• blurred vision without pain that can lead to vision loss Retinal venous thrombosis (blood clot in the eye)
• chest pain, discomfort, pressure, heaviness• pressure or feeling of fullness in the chest, arm or below the sternum• feeling full, indigestion or feeling suffocated• discomfort in the upper body that radiates to the back, jaw, neck, arm and abdomen• sweating, nausea, vomiting or dizziness• extreme weakness, anxiety or shortness of breath• fast or irregular heartbeat Myocardial 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 difficulty walking, dizziness, loss of balance or coordination• sudden, severe or prolonged headache without a 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 having a new stroke.
Stroke
• swelling and slight blue discoloration of an arm or leg• severe pain in the abdomen ( acute abdomen) Blood clots that block other blood vessels

BLOOD CLOTS IN A FRIEND

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 the vein (venous thrombosis ). However, these side effects are rare. They usually 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 moves from the bone and stays in the lung, it can lead to a pulmonary embolism.

• In very rare cases, a blood clot may form in a vein in another organ such as the eye ( retinal venous thrombosis ).

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

The risk of developing a blood clot in a vein is greatest during the first year that you use combined hormonal contraceptives for the first time. The risk may also be higher if you start again with a combined hormonal contraceptive (the same product or another 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 Estrelen, 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 total risk of a blood clot in the leg or lungs with Estrelen is small.

– Of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 develop a blood clot in one year.

Of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel or norethisterone or norgestimate, about 5-7 develop a blood clot in one year.

Of 10,000 women who use a combined hormonal contraceptive containing drospirenone such as Estrelen, about 9 12 develop a blood clot in one year.

– The risk of blood clots varies depending on your medical history (see “Factors that may increase the risk of a blood clot” below).


Risk of developing a blood clot during a year
Women who do not use the combined contraceptive pill/patch/ring and who are not pregnant About 2 out of 10,000 women
Women using a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate About 5-7 out of 10,000 women
Women using Estrelen About 9-12 out of 10,000 women

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

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

• if you are very overweight (body mass index or BMI over 30 kg / m2)

• if someone in your family has had a blood clot in a bone, lung,g or another organ at a young age (eg under 50 years). In this case, you may have a hereditary blood-clotting disease

• if you need to have surgery, or stay in bed for a long period of time due to injury or illness, or if your leg is plastered. The use of Estrelen may need to be stopped for several weeks before an operation or while you are less mobile. If you have to stop taking Estrelen, ask your doctor when you can start taking it again

• with increasing age (especially if you are over 35 years old)

• if you gave birth a few weeks ago

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

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

You must tell your doctor if any of these conditions apply to you, even if you are unsure. Your doctor may decide that you need to stop taking Estrelen.

If any of the above conditions change when you use Estrelen, e.g. A close relative suffers from a blood clot with an unknown cause, or you gain a lot of weight, talk to your doctor.

BLOOD CLOTS IN AN ART

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

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 may increase the risk of a blood clot in an artery

It is important to know that the risk of a heart attack or stroke due to the use of Estrelen is very small but may increase:

• with increasing age (after about 35 years of age)

• if you smoke. When you use combined hormonal contraceptives Estrelen you should stop smoking. If you can not stop smoking and are over 35 years old, your doctor may advise you to use another 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 (younger than 50 years). In this case, you may also be at greater risk of a heart attack or 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 heart problems (valve 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 serious, the risk of developing a blood clot can be even greater.

If any of the above conditions change when you use Estrelen, e.g. If you start smoking, a close relative suffers from thrombosis of unknown cause, or you gain a lot of weight, talk to your doctor.

Estrelen and cancer

Breast cancer has been observed slightly more often in women using combination pills, but it is not known if this is caused by the treatment. For example, it may be that more tumors are detected in women who take combination pills because they are examined more often by their doctor. The incidence of breast tumors gradually decreases with the discontinuation of combined hormonal contraceptives. It is important to check your breasts regularly and you should contact your doctor if you notice a lump.

In rare cases, benign liver tumors, and in even more rare cases, malignant liver tumors, have been reported in users of the contraceptive pill. Contact your doctor if you experience unusually severe abdominal pain, swelling of the abdomen (which may be due to enlargement of the liver) or if you vomit blood, note blood in the stool or black tar-like stools as these may be signs of bleeding from the stomach.

Bleeding between periods

During the first few months of using Estrelen, you may experience unexpected bleeding (bleeding outside the days with placebo ). If you have such bleeding for more than a few months, or if it starts after a few months, your doctor will need to investigate the cause.

What to do in case of bleeding during the placebo days

If you have taken all the pink active tablets as you should, and have not vomited or had severe diarrhea, and have not taken any other medicines, it is highly unlikely that you are pregnant.

If the expected bleeding does not occur twice in a row, you may be pregnant. Contact your doctor immediately. Do not start the next map until you are sure you are not pregnant.

Other medicines and Estrelen

Always inform your doctor about which medicines or (traditional) herbal and herbal medicines you are already taking, have recently taken, or maybe taking. Also, tell any other doctor or dentist who prescribes other medicines to you (or pharmacist ) that you are taking Estrelen. They can tell you if you need to use extra contraceptives (eg condoms) and if so, for how long.

Do not use Estrelen if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir as it may cause elevated liver function tests in blood tests (elevation of the liver enzyme ALT ). Your doctor will prescribe another type of contraceptive before starting treatment with these medicines. Estrelen can be used again about 2 weeks after the end of treatment. See the section “Do not take Estrelen”.

• Some medicines may affect the blood levels of Estrelen and may make it less effective in preventing pregnancy or may cause unexpected bleeding. These include:

• medicines used to treat:

o Epilepsy (eg primidone, phenytoin , barbiturates , carbamazepine, oxcarbazepine, felbamate, topiramate)

or tuberculosis (eg rifampicin)

o HIV and Hepatitis C infections (medicines called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz) or other infections (medicines used to treat fungal infections such as griseofulvin or ketoconazole )

o arthritis or osteoarthritis (etoricoxib)

o high blood pressure in the blood vessels in the lungs ( bosentan )

o the herbal medicine St. John’s wort

Estrelen may affect the effectiveness of other medicines, for example:

o medicines containing ciclosporin

o antiepileptic lamotrigine (may lead to an increased frequency of seizures)

o Theophylline (for the treatment of respiratory problems)

o tizanidine (for the treatment of muscle pain and/or muscle cramps)

Your doctor may take blood samples to check your potassium levels if you are taking certain medicines to treat heart problems (eg diuretics).

Estrelen with food, drink, and alcohol

Laboratory tests

If you need to take a blood sample, tell your doctor or laboratory staff that you are taking this pill as hormonal contraceptives may affect the results of certain tests.

Pregnancy, breastfeeding, and fertility

Pregnancy

You should not take Estrelen if you are pregnant. If you become pregnant while taking Estrelen, stop taking it immediately and contact your doctor. If you want to get pregnant, you can stop taking Estrelen at any time (see also “If you stop taking Estrelen”).

Breast-feeding

The use of Estrelen is generally not recommended when breastfeeding. If you want to take the contraceptive pill while breastfeeding, contact your doctor.

Driving and using machines

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

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Estrel contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Estrelen.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.

3. How to use Estrelen

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Each blister contains 24 pink active tablets and 4 white placebo tablets.

The two different colored tablets of Estrelen are sorted in order. One blister card contains 28 tablets.

Take one tablet of Estrelen daily, if necessary with a small amount of water. You can take the tablets with a meal, or not, but you should take them at about the same time each day.

Do not mix the tablets: take one pink tablet for the first 24 days and then one white tablet for the last 4 days. You should then immediately start a new tablet chart (24 pink and then 4 white tablets). So you do not pause between two tablet maps.

Because the tablets have different compositions, you must start with the first tablet at the top left and then take one tablet every day. Follow the direction of the arrow for the correct sequence.

Prepare the map

To help the user keep track of the tablets, each Estrelen blister card comes with 7 labels, each with the 7 days of the week. Choose the weekly labels that start with the day you start taking the tablets. For example, if you started on a Wednesday, use the label that begins with “ONS”.

Attach the weekly label along the top edge of the map where it says “Place the label here” so that the first day above the tablet is marked as “1”. It is now indicated one day above each tablet and you can see if you have taken a particular tablet or not. The arrows show the order in which to take the tablets.

During the 4 days, you take white placebo tablets (the placebo days), the bleeding should begin (so-called dropout bleeding). This usually starts on the 2nd or 3rd day after the last pink active tablet Estrelen. When you have taken the last white tablet, you should start the next tablet chart, regardless of whether the bleeding has stopped or not. This means that you must start each tablet chart on the same day of the week and that the loss of bleeding must occur during the same days each month.

If you use Estrelen in this way, you are protected against pregnancy even during the 4 days you take placebo tablets.

When can you start with the first map?

• If you have not used a contraceptive with hormones in the previous month

Start taking Estrelen on the first day of your regular menstrual cycle. If you start taking Estrelen on the first day of your period, you will be immediately protected against pregnancy. You can also start days 2-5 of the cycle, but then you must use an extra contraceptive (eg condom) for the first 7 days.

• When changing from a combination contraceptive pill or a combined hormonal contraceptive in the form of a vaginal ring or transdermal patch

You should preferably start with Estrelen the day after you take the last active tablet (the last tablet containing active substances) of your previous pill, but no later than the day after the tablet-free days for your previous pill end (or after the last inactive tablet of your previous pill ). When changing from a vaginal ring or transdermal patch, follow the advice given to you by your doctor.

• V id change from one method only progestogen ( mini-pill, injection, implants (P-Rod) or progestogen spiral )

You can switch from mini-pills from an implant or IUD at any time, you should change it on the day it is removed, from a syringe at the time of the next planned injection, but in all these cases you must use extra protection (eg during the first 7 days of taking tablets.

• After a miscarriage abortion

Follow your doctor’s advice.

• After giving birth

You can start taking Estrelen between 21 and 28 days after giving birth. If you start after day 28, you must use extra protection (eg condoms) for the first 7 days of taking Estrelen.

If, after giving birth, you have had intercourse before starting to take Estrelen (again), you should first make sure that you are not pregnant or wait until your next period.

• If you are breast-feeding and want to start taking Estrelen (again) after giving birth

Read the section on “Breastfeeding”.

Ask your doctor what to do if you are unsure when to start.

If you use more Estrelen than you should 

There are no reports of serious adverse effects from the overdose of Estrelen tablets.

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

If you have taken too many Estrelen tablets or find that a child has ingested tablets, contact your doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to use Estrelen

The last 4 tablets on the 4th row of the map are placebo tablets. If you forget to take one of these tablets, it will have no effect on the reliability of Estrelen. Throw away the forgotten placebo tablet.

If you forget to take a pink, active tablet (tablets 1-24 on the map), do the following:

• Taking your tablet less than 24 hours late does not reduce the protection of the contraceptive. You should take the tablet as soon as you remember and continue taking the following tablets at the usual time.

• If you take your tablet more than 24 hours late, this means that the protection of the contraceptive may be reduced. The greater the number of tablets you forgot, the greater the risk of getting pregnant.

The risk of inadequate protection against pregnancy is greatest if you forget a pink tablet at the beginning or end of the tablet chart. You must therefore follow the rules below (see table):

• More than one missed tablet on this tablet map

Contact your doctor.

• One missed tablet between days 1-7 (first line)

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Continue to take the tablets at the time you usually use and use extra protection for the next 7 days, e.g. a condom. If you had intercourse during the week before you forgot to take the tablet, there is a risk that you are pregnant. In this case, contact your doctor.

• One missed tablet between days 8-14 (second line)

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. You should then continue to take your tablets at the usual time. The protection against pregnancy has not decreased and you do not need to use extra protection.

• One missed tablet between days 15-24 (third or fourth line)

You can choose between two options:

1. Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. You should then continue to take your tablets at the usual time. Instead of taking the white placebo tablets on the current tablet map, discard it and start the next tablet map (the starting day will be different).

You may have a period at the end of the second tablet – while taking the white placebo tablets – but you may experience a slight or menstrual-like bleeding while using the other tablet.

2. 2. You can also stop taking the pink active tablets and go straight and take up to 4 white placebo tablets (including the tablets for the days you missed (write down which day you forgot to take your tablet before you start taking the placebo tablets). want to start a new tablet map on the same day as usual, take placebo tablets for less than 4 days .

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

• If you forgot one of the tablets on a tablet chart and you do not experience any bleeding during the placebo days, it may mean that you are pregnant. You must then consult your doctor before starting the next tablet chart.

The following diagram describes what to do if you forget to take your tablet (s):

Schedule for forgotten tablet

What to do in case of vomiting or severe diarrhea

If you vomit within 3-4 hours after taking an active pink tablet, or if you have severe diarrhea, there is a risk that the active substance in the tablet will not be completely absorbed by the body. The situation is almost the same as when you forget to take a tablet. After vomiting or diarrhea, take a new pink tablet from a spare card as soon as possible. If possible, take it within 24 hours of the time you usually take your tablet. If this is not possible or if 24 hours have passed, follow the instructions in “If you forget to take Estrelen”.

Postpone your period: what you need to know

Although not recommended, you can delay your period by not taking the white placebo tablets on the 4th row but starting directly on a new tablet of Estrelen. You may experience a slight or menstrual-like bleeding when taking the other tablet map. End the second tablet map by taking the 4 white tablets on the 4th row. Then start the next tablet chart.

You should ask your doctor for advice before you decide to postpone your period.

Change the first day of your period: what you need to know

If you take the tablets according to the instructions, menstruation begins during the placebo days. If you want to change this day, reduce the number of placebo days – the days you take white placebo tablets – ( do not increase them – 4 is the maximum!). For example, if you normally start taking placebo tablets on a Friday and you want to change this to a Tuesday (three days earlier), start a new tablet chart three days earlier than normal. You may not experience any bleeding during this time. You may then experience a slight or menstrual-like bleeding.

Ask your doctor if you are unsure about what to do .

If you stop using Estrelen

You can stop taking Estrelen whenever you want. If you do not want to get pregnant, consult your doctor about other reliable contraceptives. If you want to get pregnant, stop taking Estrelen and wait for the next period before trying to conceive. It will then be easier to calculate the expected date of birth.

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

4. 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 serious and persistent, or have any change in your health that you think may be due to Estrelen, talk to your doctor.

There is an increased risk of blood clots in your veins (venous thromboembolism(VTE)) or blood clots in your arteries ( arterial thromboembolism (ATE)) for all women taking combined hormonal contraceptives. For more detailed information on the different risks of using combined hormonal contraceptives, see section 2 “What you need to know before taking Estrelen”.

If any of the following side effects occur, you may need urgent medical attention. Stop taking Estron and contact a doctor or go to the nearest hospital immediately.

Rare side effects (may affect up to 1 in 1,000 people):

• inflammation of the gallbladder

• hypersensitivity reactions (allergic reactions with symptoms such as swollen face, tongue and / or throat and / or difficulty swallowing or hives with difficulty breathing)

• harmful blood clots in a vein or artery, for example:

o in one leg or foot (ie deep vein thrombosis (DVT))

o heart attack

o stroke

o mini- stroke or temporary stroke- like symptoms, known as a transient ischemic attack ( TIA )

o blood clots in the liver, stomach / intestines, kidneys or eyes.

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

Other possible side effects are

Common side effects are (may affect up to 1 in 10 people :):

• Mood swings

• headache

• nausea

• chest pain, menstrual problems such as irregular menstruation, missed periods

Less common side effects are (may affect up to 1 in 100 people):

• depression, anxiety, drowsiness

• dizziness, tingling

• migraine , varicose veins, high blood pressure ( hypertension )

• abdominal pain, vomiting, indigestion, gas in the stomach, inflammation of the stomach, diarrhea

• acne , itching rash

• aches and pains such as back pain, pain in the extremities , muscle cramps

• vaginal fungal infection, pelvic pain, breast enlargement, benign lumps, uterine / vaginal bleeding (which often disappears with continued treatment), discharge from genitals, hot flashes, inflammation of the vagina ( vaginitis ), menstrual problems, painful menstruation, shortened periods, very difficult menstruation, dryness of the vagina , abnormal cell samples, decreased sex drive

• lack of energy, increased sweating, fluid retention (with signs such as swelling of the face and limbs),

• weight gain

• Rare side effects are (may affect up to 1 in 10, 00 people):

• candida (a fungal infection)

• anemia , increased platelet count

• allergic reaction

• hormonal ( endocrine ) disease

• increased appetite, decreased appetite, abnormally high concentration of potassium in the blood, abnormally low concentration of sodium in the blood

• inability to orgasm, insomnia

• dizziness, tremors

• eye diseases such as inflammation of the eyelid, dry eyes

• Abnormally fast heartbeat

• inflammation of a vein, nosebleeds, fainting

• enlarged abdomen, intestinal disease, feeling of bloating, stomach hernia, fungal infection in the mouth, constipation, dry mouth

• pain in the bile ducts or gallbladder

• eczema , hair loss, acne-like inflammation of the skin, dry skin, skin inflammation with boils, excessive hair growth, skin diseases, stretch marks on the skin, skin inflammation, photosensitive skin inflammation, skin lumps

• problems having intercourse or pain during intercourse, inflammation of the vagina(vulvovaginitis), bleeding after intercourse, bleeding, cysts, increased number of breast cells ( hyperplasia ), abnormal growths on the cervical mucosa , shrinkage or loss of the uterine lining (cystic cysts, ovarian cysts) ), enlarged uterus

• general malaise

• weight loss

Has been reported (occurs in unknown number of users):

o erythema multiforme (rash with annular redness or sores).

5. How to store Estrelen

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

Do not use this medicine after the date stated on the blister / carton after “EXP:”.

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

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. .

6. Contents of the packaging and other information

Content declaration

• The active substances are ethinylestradiol and drospirenone.

Each film-coated tablet contains 0.02 milligrams of ethinyl estradiol and 3 milligrams of drospirenone.

The white film-coated tablets do not contain any active substances.

• The other ingredients are:

• Pink active film-coated tablets:

• Tablet core: lactose monohydrate , pregelatinised starch (maize), povidone K-30 (E1201), croscarmellose sodium, polysorbate 80, magnesium stearate (E572).

• Film coating of the tablet: Polyvinyl alcohol partially hydrolysed, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172).

White inactive film-coated tablets:

• Tablet core: Anhydrous lactose , povidone K-30 (E1201), magnesium stearate (E572).

• Film coating of the tablet: Polyvinyl alcohol partially hydrolysed, titanium dioxide (E171), macrogol 3350, talc.

What the medicine looks like and contents of the pack

• Each tablet contains 24 map Estrelen pink, active -coated tablets on the 1st, 2nd, 3rd and 4th line and 4 white coated placebo tablets at the 4th line.

• Estrelen tablets, both pink and white, are coated; ie the tablet core is coated.

• Estrelen is available in packs of 1, 3, 6 and 13 cards, each with 28 (24 + 4) tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Evolan Pharma AB

Box 120

182 12 Danderyd

Manufacturer

Laboratories León Farma, SA

Poligono Industrial Navatejera;

La Vallina s / n;

24008-Villaquilambre, León

Spain

Muhammad Nadeem

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