0.02 mg / 3 mg film-coated tablets 
ethinyl estradiol and drospirenone

Important information about combined hormonal contraceptives:

  • They are one of the most reliable contraceptive methods available if used properly.
  • The risk of a blood clot in a vein or artery 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.
  • Pay attention and consult a doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

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 hurt them.
  • 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.

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

1. What Daylette is and what it is used for

  • Daylette is a birth control pill used to prevent pregnancy.
  • Each of the 24 white tablets contains a small amount of two different female hormones, Ethinyl estradiol, and drospirenone.
  • The 4 green tablets do not contain any active substances and are also called placebo tablets.
  • Birth control pills that contain two hormones are called combined birth control pills.

2. What you need to know before using Daylette

Generally

Before using Daylette, read the information on blood clots in section 2. You must read the symptoms of blood clots – see section 2, “Blood clots”).

Before you can start taking Daylette, your doctor will ask you some questions about your personal health history and that of your immediate relatives. Your doctor will also measure your blood pressure, and depending on your personal situation, may also take some other samples.

This information describes several situations where you should stop using Daylette, or when Daylette may be less reliable. In such situations, you should either not have intercourse or use an additional non-hormonal method of contraception, e.g. a condom or other barrier method. Do not use rhythm or temperature methods. These methods can be unreliable because Daylette changes the monthly changes that occur in body temperature and cervical secretions.

Daylette protection, like other hormonal contraceptives, is not against HIV – infection ( AIDS ) or other sexually transmitted diseases.

Do not use Daylette

Do not use Daylette 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.

Do not use Daylette

  • 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 clotting – 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 long period of time (see section “Blood clots”)
  • if you have had a heart attack or a 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 conditions that may increase the risk of a blood clot in your 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 ever 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 ever had) a tumor in your liver
  • if you have (or have ever had) or if you suspect you may have breast or genital cancer.
  • if you have unexplained vaginal bleeding
  • if you are allergic to Ethinyl estradiol, drospirenone, or any of the other ingredients of this medicine (listed in section 6). This can cause itching, rash, or swelling.
  • Daylette contains soy lecithin. Do not take this medicine if you are allergic to peanuts or soy.

Do not use Daylette if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also section “Other medicines and Daylette”).

Warnings and cautions

Talk to your doctor or pharmacist before taking Daylette.

When should you contact a doctor?
Seek medical attention immediately if you notice possible signs of a blood clot that may mean 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”.

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

In some situations, you need to be especially careful when using Daylette or any other combined pill, and your doctor may need to examine you regularly. If any of the following apply to you, tell your doctor before using Daylette. If the condition occurs or worsens when you use Daylette, you should also consult a doctor.

  • if a close relative has or has ever had breast cancer
  • if you have a disease of the liver or gallbladder
  • if you have diabetes
  • if you have depression or mood swings
  • if you have Crohn’s disease or ulcerative colitis ( chronic inflammatory bowel disease)
  • if you have a systemic lupus erythematosusSLE – 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
  • 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 Daylette
  • 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 Daylette)
  • if you have a disease that first appeared during pregnancy or with previous use of sex hormones (eg hearing loss, a blood disease called porphyria, skin rash with blisters during pregnancy ( herpes gestationis), a disease of the nerves that involves sudden movements of the body (Sydenhams Korea)
  • if you have or have had golden-brown pigment spots, “pregnancy spots” (chloasma), especially on the face. If so, avoid direct sunlight or ultraviolet light
  • If you have hereditary angioedema, estrogen-containing products may cause or worsen the symptoms. You should contact a doctor immediately if you experience symptoms of angioedema, e.g. swelling of the face, tongue, and/or pharynx and/or difficulty swallowing or hives along with difficulty breathing.

Talk to your doctor before taking Daylette.

BLOOD CLOTS

Using combined hormonal contraceptives such as Daylette 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 Daylette 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 soreness 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 breathingsevere instability or dizziness fast or irregular heartbeat severe pain in the abdomen 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 milder 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, heavinesspressure or feeling of fullness in the chest, arm, or below the sternum feeling full, indigestion or feeling of suffocationdiscomfort in the upper body that radiates to the back, jaw, neck, arm, and abdomensweating, nausea, vomiting or dizziness extreme weakness, anxiety or shortness of breakfast 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 coordinationsudden, severe or prolonged headache without 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 a 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 can 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 Daylette, 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 Daylette 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, approximately 5–7 develop a blood clot in one year.
  • Of 10,000 women who use a combined hormonal contraceptive that contains drospirenone such as Daylette, about 9-12 develop a blood clot in a 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 a combined hormonal contraceptive (birth control 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 Daylette 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 Daylette is small but some conditions increase the risk. The risk is higher:

  • if you are overweight (body mass index or BMI over 30 kg / m 2 )
  • if a close relative has had a blood clot in the bones, lungs, 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 Daylette may need to be discontinued for several weeks before surgery or while you are less mobile. If you have to stop taking Daylette, ask your doctor when you can start taking it again
  • with increasing age (especially if you are over about 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 (over 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 Daylette.

If any of the above conditions change when you use Daylette, 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 as a result of using Daylette is very small but may increase:

  • with increasing age (after about 35 years of age)
  • if you smoke. When you use combined hormonal contraceptives Daylette, 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 severe, the risk of developing a blood clot can be even greater.

If any of the above conditions change when you use Daylette, 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.

Daylette and cancer

Breast cancer has been observed somewhat more frequently in women using combined oral contraceptives, but it is not known if this is due to treatment. For example, it may be that more tumors are detected in women who use combined contraceptive pills because they are examined more often by doctors. The incidence of breast tumors gradually decreases after stopping the use of combined hormonal contraceptives. It is important that you check your breasts regularly and that you consult a doctor if you feel a lump.

In rare cases, benign liver tumors, and even more rare malignant tumors, have been reported in birth control pill users. Contact a doctor if you have unusually severe abdominal pain.

Mental disorders

Some women who use hormonal contraceptives, including Daylette, 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.

Bleeding between periods

During the first few months of taking Daylette, you may experience unforeseen bleeding (bleeding outside the placebo days). If the bleeding lasts for more than a few months, or if it starts after a few months, doctors must investigate what is wrong.

Do this if you do not experience any bleeding during the placebo days

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

If the expected bleeding does not occur twice in a row, you may be pregnant. Contact a doctor immediately. Only start with the next tablet chart if you are sure you are not pregnant.

Other drugs and Daylette

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

Also, tell other doctors or dentists who prescribe other medicines (or your pharmacist) that you are taking Daylette. They can advise you if you need to use additional protection (eg condoms) and if so for how long, or if they use of another medicine you need needs to be changed.

Do not use Daylette if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, as this may cause elevated liver function levels in the blood (increase in the liver enzyme ALT ).

Your doctor will prescribe a different type of contraceptive before you start treatment with these drugs.

You can start Daylette again about 2 weeks after stopping this treatment. See section “Do not use Daylette”.

Some medicines can affect the blood levels of Daylette and make it less effective in preventing pregnancy or causing unexpected bleeding. This includes drugs used to treat

  • epilepsy (eg barbiturates, carbamazepine, phenytoin, primidone, felbamate, oxcarbazepine, topiramate)
  • tuberculosis (eg rifampicin)
  • HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, eg ritonavir, nevirapine, efavirenz)
  • high blood pressure in the blood vessels of the lungs ( bosentan )
  • fungal infections (eg griseofulvin, ketoconazole )
  • treatment of the symptoms of osteoarthritis (etoricoxib)
  • the natural remedy St. John’s wort (Hypericum perforatum). If you want to use St. John’s wort while you are taking Midiana, consult your doctor first.

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

  • ciclosporin (medicines used to prevent transplant rejection )
  • the epilepsy drug lamotrigine (this may lead to an increased number of seizures).
  • tizanidine (a medicine used to treat muscle cramps)
  • theophylline (a medicine used to treat asthma )

Ask your doctor or pharmacist for advice before taking any medicine.

Daylette with food and drink

Daylette can be taken with or without food and if necessary with a small amount of water.

Laboratory samples

If you have to take blood samples, tell your doctor or laboratory staff that you are taking birth control pills as hormonal contraceptives may affect the results of certain tests.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You must not take Daylette if you are pregnant. If you become pregnant while taking Daylette, you must stop taking it immediately and consult a doctor.

If you want to get pregnant, you can stop taking Daylette at any time (see section “If you stop taking Daylette”).

Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding

Women should not take Daylette while breastfeeding. If you want to take birth control pills while breastfeeding, consult a doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

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

Daylette contains lactose, para-orange, and soy lecithin

The white active film-coated tablets contain 48.53 mg of lactose monohydrate and the green inactive tablets contain 37.26 mg of anhydrous lactose per film-coated tablet. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

The white active film-coated tablets contain 0.07 mg of soy lecithin. If you are allergic to peanuts or soy, do not use this medicine.

The hormone-free ( placebo ) film-coated tablets contain the dye para-orange (E110), which may cause allergic reactions.

3. How to take Daylette

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 active white tablets and 4 green placebo tablets.

Daylette’s two different colored tablets are placed in order. One tablet map contains 28 tablets.

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

Do not mix the tablets: take a white tablet for the first 24 days and then a green tablet for 4 days. You must then start with a new tablet card immediately (24 white and then 4 green tablets). There is no pause between the two tablet maps.

Because the composition of the tablets is different, you must start with the first tablet at number 1 on the tablet map where it says “Start” and then take one tablet every day. Keep track of this by following the direction of the arrows and the numbering on the tablet map.

Attach the adhesive strip:

To help you keep track of which tablet to take, seven adhesive strips marked with the seven days of the week are included. Choose the adhesive strip that starts with the day you start taking the tablets. For example, if you start on a Wednesday, use the sticker that begins with “Wed.”

Place the arrow “→” on the adhesive strip next to the same symbol on the blister map and place the strip in the area surrounded by a black line. For each day, there will now be a row of tablets.

Above each tablet is now a day of the week and you can see if you have taken a tablet on a particular day. Follow the direction of the arrow until you have taken all 28 tablets.

During the 4 days, you take the green placebo tablets (the placebo days), the bleeding should start (so-called dropout bleeding). This often starts on the second or third day after taking the last white active tablet of Daylette. After taking the last green tablet, start with the next tablet chart, whether or not the bleeding has stopped. This means that you should start each new tablet chart on the same day of the week, and that dropout bleeding should start on the same days each month.

If you take Daylette in this way, you will be protected against pregnancy even during the 4 days you take a placebo tablet.

When can you start with the first tablet map?

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

Start with the first day of the Daylette menstrual cycle (the day you get your period). If you start taking Daylette on the first day of your period, you will receive immediate protection against pregnancy. You can also start days 2–5 of the menstrual cycle, but then you must use additional protection (eg a condom) for the first 7 days.

• Change from a combined hormonal contraceptive (combined contraceptive pill, contraceptive ring, or contraceptive patch )

You can start with Daylette the day after you take the last active tablet (the last tablet containing the active substance) of your previously combined oral contraceptives, but no later than the day after stopping the tablet with your previous oral contraceptives (or after the last inactive tablet of your previous birth control pills ).

When changing from a combined vaginal ring or patch, follow the advice of your doctor.

• Switching from a method that contains only progestogens ( mini-pills, contraceptive syringe, implants, or from a hormone coil that releases progestogens )

You can change any day from mini-pills (from implants or IUDs the day it is removed, from the contraceptive syringe at the time of the next injection ) but in all these cases you must use extra protection (eg condoms) during the first 7 days you take the tablets.

• After a miscarriage

Follow your doctor’s instructions.

• After a birth

You can start taking Daylette between 21 and 28 days after giving birth. If you start later than day 28, you must use a so-called barrier method (eg condom) during the first 7 days you take Daylette.

If you have had intercourse after giving birth before starting to take Daylette (again), you must first check that you are not pregnant or wait until the next period.

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

Read the “Breastfeeding” section.

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

If you take more Daylette than you should

There are no reports of harmful effects from taking too many Daylette tablets.

If you take several tablets at the same time, you may experience nausea or vomiting, or bleeding from the vagina.

Even girls who have not yet menstruated can have such bleeding if they have taken this medicine by mistake.

If you have ingested too much medicine or if e.g. a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Daylette

The last 4 tablets on the 4th row of the tablet map are the placebo tablets. If you forget to take one of these tablets, it has no effect on contraception.

Discard the forgotten placebo tablets.

If you forget a white active tablet (tablets 1-24 on the tablet map), you must do the following:

  • If it has been less than 24 hours since you were to take a tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and then take the following tablets at the usual time.
  • If it has been more than 24 hours since you were taking a tablet, the protection against pregnancy may be reduced. The more tablets you have forgotten, the greater the risk of getting pregnant.

The risk of incomplete protection against pregnancy is greater if you forget to take a white tablet at the beginning or end of the tablet chart. You must therefore follow the rules below (see also the diagram):

• If you have forgotten more than one tablet on the tablet map

Contact a doctor.

• If you have forgotten a tablet between days 1 and 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 usual time and use extra protection for the next 7 days, e.g. condom. If you have had intercourse the week before you forgot the tablet, you must realize that there is a risk that you are pregnant. Contact a doctor in this case.

• If you have forgotten a tablet between days 8 and 14 (second 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 usual time. The protection against pregnancy is not reduced and you do not need to use extra protection.

• If you have forgotten a tablet between days 15 and 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. Continue to take the tablets at the usual time. Instead of taking the green placebo tablets on the tablet chart, discard them and start with the next tablet chart (the starting day will be different). 
    You will probably have a period at the end of the second tablet map, when you take the green placebo tablets, but you may experience a slight or menstrual-like bleeding period during the second tablet map.
  2. You can also stop taking the active white tablets and continue immediately with the 4 green placebo tablets ( before taking these placebo tablets, make a note of the day you forgot the tablet ). If you want to start a new tablet chart the same day you always start, take placebo tablets for less than 4 days.

If you follow either of these two recommendations, you will continue to be protected against pregnancy.

• If you have forgotten a tablet on a tablet chart and you do not get your period during the placebo days, it may mean that you are pregnant. You must consult a doctor before starting the next tablet chart.

Picture 1

Do this in case of vomiting or severe diarrhea

If you vomit within 3-4 hours after taking an active white tablet or if you develop severe diarrhea, there is a risk that the active substances in the tablet have not been fully absorbed by your body.

The situation is almost the same as if you forgot a tablet. After vomiting or diarrhea, take a white tablet from a spare card as soon as possible. If possible, the tablet should be taken within 24 hours after you would normally take the tablet. If this is not possible or if more than 24 hours have passed, follow the advice in If you forgot to take Daylette.

Postpone menstruation: this is what you need to know:

Although not recommended, it is possible to postpone a period by not taking the green placebo tablets from the 4th row and immediately start with the next Daylette tablet and end it. You may experience a slight or menstrual-like bleeding when using the other tablet map. End the second tablet map by taking the 4 green tablets from the 4th row. Then start with the next tablet chart.

Ask your doctor for advice before deciding if you want to delay your period.

Changing the first day of menstruation: this is what you need to know:

If you take the tablets as directed, your period will begin during the placebo days . If you want to change the day, reduce the number of placebo days when you take green placebo tablets ( but do not increase them – 4 is the maximum! ) Example: If you start taking the placebo tablets on a Friday, and you want to change it to a Tuesday (3 days earlier) you start with a new tablet map 3 days earlier than usual. You may not experience any bleeding during this period. You may then experience a slight or menstrual-like bleeding.

Contact a doctor if you do not know what to do.

If you stop taking Daylette

You can stop taking Daylette whenever you want. If you do not want to get pregnant, you can ask your doctor for advice on other reliable contraceptive methods.

If you want to get pregnant, stop taking Daylette and wait for the next period before trying to conceive. Then you can more easily 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 severe or persistent, or if your health changes and you think it may be due to Daylette, talk to your doctor.

An increased risk of blood clots in the veins (venous thromboembolism , VTE), or blood clots in the arteries are ( arterial thrombosis , ATE) are all women taking hormonal contraceptives combined. For more information on the different risks of using combined hormonal contraceptives, see section 2 “What you need to know before using Daylette”.

The following is a list of side effects that have been linked to the use of Daylette:

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

  • Mood swings
  • headache
  • nausea
  • chest pain, menstrual problems, e.g. irregular periods, no periods.

Uncommon side effects (may affect up to 1 in 100 people):

  • depression, nervousness
  • dizziness, tingling and numbness, drowsiness, migraine
  • varicose veins, high blood pressure
  • stomach pain, vomiting, indigestion, flatulence, inflammation of the stomach, diarrhea
  • acne , itching , rash
  • aches and pains, e.g. back pain, pain in arms and legs, muscle cramps
  • vaginal fungal infection, pelvic pain, breast enlargement, benign lumps of the uterus, bleeding from the uterus / vagina (which usually disappears with continued treatment), discharge from the vagina, hot flashes, inflammation of the vagina ( vaginitis ), menstrual problems, painful menstruation, fewer menstrual periods, very heavy menstruation, dry mucous membrane in the vagina, abnormal gynecological cell sample, decreased interest in sex
  • lack of energy, increased sweating, retention of fluid
  • weight gain.

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

  • fungal infection ( candida )
  • decreased number of red blood cells in the blood ( anemia ), increased number of platelets in the blood ( thrombocytemia )
  • 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, e.g. inflammation of the eyelid, dry eyes
  • abnormally fast heartbeats
  • inflammation in a friend, fainting
  • nosebleed
  • enlarged abdomen, intestinal problems, bloating, stomach hernia, fungal infection in the mouth, constipation, dry mouth
  • pain in the bile ducts or gallbladder, inflammation of the gallbladder
  • yellow-brown spots on the skin, eczema , hair loss, acne-like inflammation of the skin, dry skin, inflammation with lumps on the skin, severe hair growth, skin disease, stretch marks, skin inflammation, skin inflammation due to photosensitivity, lumps on the skin
  • difficult or painful to have intercourse, inflammation of the vagina (vulvovaginitis), bleeding after intercourse, loss of bleeding, breast cyst, increased number of breast cells ( hyperplasia ), malignant lumps in the breast, abnormal growth of the mucous membrane in the cervix, shrinkage or disappearance of the uterine cysts , enlargement of the uterus
  • general malaise
  • weight loss.
  • dangerous blood clots in a vein or artery , eg:
    • in one 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 on the conditions that increase the risk of blood clots and the symptoms of a blood clot).

The following side effects have also been reported and occur in an unknown number of users:

5. How to store Daylette

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

Do not store above 25 ° C. Store in the original package. Sensitive to light.

Do not use this medicine after the expiry date which is stated on the blister and carton. The expiration date is the last day of the specified month.

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 0.02 mg ethinyl estradiol and 3 mg drospirenone in each tablet.
  • The other ingredients are: White active film-coated tablets: Tablet core: lactose monohydrate corn starch pregelatinized corn starch macrogol poly (vinyl alcohol) graft polymer magnesium stearate. Film coating: poly (vinyl alcohol) titanium dioxide (E171) talc macrogol 3350 lecithin (soy). Green film-coated placebo tablets: Tablet core : microcrystalline cellulose anhydrous lactose pregelatinised maize starch magnesium stearate anhydrous colloidal silica. Film coating : poly (vinyl alcohol) 























    titanium dioxide (E171) 
    macrogol 3350 
    talc 
    indigo carmine (E132) quinoline yellow 
    (E104) 
    black iron oxide (E172) 
    para-orange FCF (E110).

What the medicine looks like and contents of the pack

The active film-coated tablet is a white or almost white, round biconvex film-coated tablet with a diameter of about 6 mm. Embossing on one side: “G73”, no embossing on the other side.

The film-coated placebo tablet is a green, round, biconvex film-coated tablet with a diameter of approximately 6 mm without embossing.

Daylette 0.02 mg / 3 mg film-coated tablets are packaged in PVC / PE / PVDC-Al blister packs. The blister packs are packed in cardboard boxes together with a package leaflet, a case for blister cards and stickers for the weekdays.

Pack sizes:

1 × (24 + 4) film-coated tablets

3 × (24 + 4) film-coated tablets

6 × (24 + 4) film-coated tablets

13 × (24 + 4) film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Gedeon Richter Plc.

Gyömrői out 19-21

1103 Budapest

Hungary

This medicinal product is authorized under the European Economic Area under the names:

Belgium: Daylette 0.02 mg / 3 mg compressed pellets

Hungary: Kylixa

Luxembourg: Daylette

Netherlands: Daylette

Muhammad Nadeem

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