Daylette 3 mg/0.02 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Daylette 3mg/0.02 mg film-coated tablets EFG

drospirenone / ethinylestradiol

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

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

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, as it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Daylette is and what it is used for
2. What you need to know before taking Daylette
3. How to take Daylette
4. Possible side effects
5. How to store Daylette
6. Contents of the pack and other information

1. What Daylette is and what it is used for

• Daylette is a hormonal contraceptive used to prevent pregnancy.
• Each of the 24 tablets contains a small amount of two different female hormones, specifically drospirenone and ethinylestradiol.
• The 4 green tablets do not contain active ingredients and are also called placebo tablets.

Hormonal contraceptives containing two hormones are known as "combined" contraceptives.

2. What you need to know before starting Daylette

General considerations

Before starting to take Daylette, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).

Before you can start taking Daylette, your doctor will ask you some questions about your personal medical history and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your individual circumstances, may carry out additional tests.

This leaflet describes several situations in which you should stop taking Daylette, or in which the effectiveness of Daylette may be reduced. In these situations, you should not have sexual intercourse or must use additional non-hormonal contraceptive precautions, e.g., use a condom or another barrier method.

Do not use rhythm or temperature methods. These methods may not be reliable because Daylette alters the monthly variations in body temperature and cervical mucus.

Daylette, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or other sexually transmitted diseases.

Do not use Daylette

You must not use Daylette if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you which other form of contraception would be more suitable.

Do not use Daylette

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

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

• if you need surgery or will be immobile for a long time (see section “Blood clots”),

• if you have ever had a heart attack or stroke,

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

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

• severe diabetes with blood vessel damage,

• very high blood pressure,

• very high levels of fat in the blood (cholesterol or triglycerides),

• a condition called hyperhomocysteinemia.

  • if you have (or have ever had) a type of migraine called “migraine with aura”,
  • if you have (or have ever had) liver disease and your liver function is still abnormal,
  • if your kidneys do not work properly (renal insufficiency),
  • if you have (or have ever had) a tumour in the liver,
  • if you have (or have ever had) or if it is suspected that you have breast cancer or cancer of the genital organs,
  • if you have vaginal bleeding of unknown cause,

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

  • Daylette contains soya lecithin. It must not be used if you are allergic to peanuts or soya.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Daylette.

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

Tell your doctor if you have any of the following conditions.

In certain situations, you must take special care when using Daylette or any other combined hormonal contraceptive, and your doctor may need to monitor you regularly. Inform your doctor before using Daylette if you have any of the following conditions. If any of these conditions develop or worsen while you are using Daylette, you must also inform your doctor:

• If you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible breathing difficulties, contact a doctor immediately. Medicinal products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

  • If a close relative has or has had breast cancer,
  • If you have liver or gallbladder disease,
  • If you have diabetes,
  • If you have depression or mood changes

• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease),

• If you have systemic lupus erythematosus (SLE, a disease affecting your body's natural defense system),

• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure),

• If you have sickle cell anemia (an inherited red blood cell disorder),

• If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).

• If you require surgery or will be immobile for a prolonged period (see section 2 “Blood clots”),

• If you have recently given birth, you are at increased risk of blood clots. Ask your doctor when you can start taking Daylette after childbirth.

• If you have inflammation of veins beneath the skin (superficial thrombophlebitis),

• If you have varicose veins,

• • If you have epilepsy (see “Other medicines and Daylette”),
  • If you have a condition that first occurred during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (herpes gestationis), a nerve disorder causing sudden involuntary movements (Sydenham's chorea)),
  • If you have or have ever had brownish pigmented patches (chloasma), known as “pregnancy mask,” especially on the face. If so, avoid direct exposure to sunlight or ultraviolet light.

Consult your doctor before taking Daylette.

BLOOD CLOTS

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

Blood clots can form:

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

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

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

HOW TO RECOGNIZE A BLOOD CLOT

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

Are you experiencing any of these signs?	What could you be suffering from?
swelling in one leg or foot, or along a vein in the leg or foot, especially when accompanied by: pain or tenderness in the leg, which may only be noticeable when standing or walking. increased warmth in the affected leg. skin color changes in the leg, e.g., turning pale, red, or blue.	Deep vein thrombosis
sudden shortness of breath without known cause or rapid breathing. sudden cough without clear cause, possibly bringing up blood. sharp chest pain that may worsen upon deep breathing. severe dizziness or lightheadedness. rapid or irregular heartbeat. severe abdominal pain. If you are unsure, consult a doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for a milder condition like a respiratory infection (e.g., a "common cold").	Pulmonary embolism
Symptoms occurring more frequently in one eye: sudden loss of vision, or painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye).
chest pain, discomfort, pressure, heaviness. feeling of tightness or fullness in the chest, arm, or under the breastbone. sensation of fullness, indigestion, or suffocation. upper body discomfort radiating to the back, jaw, throat, arm, or stomach. sweating, nausea, vomiting, or dizziness. extreme weakness, anxiety, or shortness of breath. rapid or irregular heartbeat.	Heart attack
sudden weakness or numbness of the face, arm, or leg, especially on one side of the body. sudden confusion, difficulty speaking or understanding speech. sudden vision problems in one or both eyes. sudden difficulty walking, dizziness, loss of balance or coordination. sudden, severe, or prolonged headache without known cause. loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
swelling and slight bluish discoloration of a limb. severe abdominal pain (acute abdomen).	Blood clots blocking other blood vessels.

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in veins (venous thrombosis). However, these adverse effects are rare. They occur more frequently during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form in a vein of another organ such as the eye (retinal vein thrombosis).

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

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

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

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

What is the risk of developing a blood clot?

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

The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Daylette is small.

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

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill/patch/ring and who are not pregnant	About 2 out of 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone, or norgestimate	About 5–7 out of 10,000 women
Women who use Daylette	About 9–12 out of 10,000 women

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

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

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

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

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

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

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

BLOOD CLOTS IN AN ARTERY

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

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

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

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

• with age (over about 35 years).
• if you smoke. When using a combined hormonal contraceptive like Daylette, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• if you are overweight.
• if you have high blood pressure.
• if a close relative has had a heart attack or stroke at a young age (under about 50 years). In this case, you may also have an increased risk of heart attack or stroke.
• if you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• if you suffer from migraines, especially migraines with aura.
• if you have a heart condition (valve disorders, heart rhythm disorder called atrial fibrillation).
• if you have diabetes.

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

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

Daylette and cancer

Breast cancer has been observed to be slightly more common in women taking combined hormonal contraceptives, but it is not known whether this is caused by the treatment. For example, it may be due to more frequent medical examinations in women taking combined contraceptives, leading to earlier detection of tumors.

The occurrence of breast tumors gradually decreases after stopping combined hormonal contraceptives. It is important that you regularly examine your breasts and contact your doctor if you notice any lumps.

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

Psychiatric disorders

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

Bleeding between periods

During the first few months of taking Daylette, you may experience unexpected bleeding (bleeding outside the placebo days). If this bleeding lasts longer than a few months, or if it starts after several months, your doctor should investigate the cause.

What to do if no bleeding occurs during the placebo days

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

If the expected bleeding does not occur twice in a row, you may be pregnant. Contact your doctor immediately. Start the next pack only if you are certain you are not pregnant.

Other medicines and Daylette

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Also inform any other doctor or dentist who prescribes you another medicine (or the pharmacist) that you are using Daylette.

They may advise you whether you need additional contraceptive precautions (e.g., condoms) and, if so, for how long, or whether you need to adjust the use of another medicine you require.

Do not use Daylette if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in blood markers of liver function (elevated liver enzyme ALT).

Your doctor will prescribe another type of contraceptive before starting treatment with these medications.

Daylette can be restarted approximately 2 weeks after completing this treatment. See section “Do not use Daylette.”

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

• medicines used to treat

  • epilepsy (e.g., barbiturates, carbamazepine, phenytoin, primidone, felbamate, oxcarbazepine, topiramate),
  • tuberculosis (e.g., rifampicin),

• HIV and hepatitis C virus infections (called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz),

  • high blood pressure in the blood vessels of the lungs (bosentan),
  • fungal infections (e.g., griseofulvin, ketoconazole),
  • symptomatic treatment of osteoarthritis (etoricoxib),
  • the herbal remedy St. John’s wort (Hypericum perforatum). If you wish to use products containing St. John’s wort while using Daylette, you must consult your doctor first.

Daylette may influence the effect of other medicines, e.g.:

• cyclosporine (a medicine used to prevent tissue rejection after organ transplant surgery),
• the antiepileptic lamotrigine (could lead to increased frequency of seizures),
• tizanidine (a medicine used to treat muscle spasticity),
• theophylline (a medicine used to treat asthma).

Consult your doctor or pharmacist before taking any medicine.

Daylette with food and drink

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

Laboratory tests

If you need to have a blood test, inform your doctor or laboratory staff that you are taking contraceptives, as hormonal contraceptives may affect the results of certain tests.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

If you are pregnant, you must not take Daylette. If you become pregnant while taking Daylette, stop taking it immediately and contact your doctor.

If you wish to become pregnant, you may stop taking Daylette at any time (see also “If you stop taking Daylette”).

Consult your doctor or pharmacist before taking any medicine.

Breastfeeding

In general, it is not recommended to use Daylette while breastfeeding. If you wish to take a contraceptive during breastfeeding, consult your doctor.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

There is no information suggesting that the use of Daylette affects driving or the use of machines.

Daylette contains lactose, sunset yellow colouring, and soy lecithin

The active white film-coated tablets of Daylette contain 48.53 mg of monohydrate lactose and the inactive green tablets contain 37.26 mg of lactose per film-coated tablet. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

The active white film-coated tablets contain 0.07 mg of soy lecithin. Do not use if you are allergic to peanuts or soy.

The film-coated tablets without hormonal content (placebo) contain the colouring sunset yellow FCF (E110), which may cause allergic reactions. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Daylette

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist.

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

The differently colored tablets of Daylette are arranged in order. One blister contains 28 tablets.

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

Do not confuse the tablets: take a white tablet for the first 24 days, followed by a green tablet for the last 4 days. Then immediately start a new blister (24 white tablets followed by 4 green tablets). Therefore, there is no break between two blisters.

Due to the different composition of the tablets, it is necessary to start with the first tablet in position 1 of the blister marked with “Start” and then take the tablets daily in sequence. For correct order, follow the direction of the arrows and the numbering on the blister.

Label preparation

To help you keep track, there are 7 adhesive labels in a strip showing the 7 days of the week. Choose the day-of-the-week strip that starts with the day you begin taking the tablets. For example, if you start on a Wednesday, use the adhesive label starting with “Wed”.

Align the “?” symbol on the label with the same symbol on the blister and place the strip within the area surrounded by a black line. Each day will now align with a row of tablets.

Now a day of the week appears over each tablet, allowing you to see whether you have taken the tablet on a particular day. Follow the direction of the arrow on the card until you have taken all 28 tablets.

During the 4 days when you are taking the green placebo tablets (the placebo days), you should experience bleeding (so-called withdrawal bleeding). This usually starts on the second or third day after the last active white tablet of Daylette. After taking the last green tablet, you must start the next blister, whether or not the bleeding has stopped. This means you should start each blister on the same day of the week, and the withdrawal bleeding should occur on the same days every month.

If you use Daylette in this way, you will be protected against pregnancy also during the 4 days when you are taking the placebo tablets.

When to start the first blister

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

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

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

You may preferably start taking Daylette the day after the last active tablet (the last tablet containing active ingredients) of your previous combined oral contraceptive (COC), or at the latest, the day after you finish the tablet-free interval of your previous contraceptive (or after the last inactive tablet of your previous contraceptive).

When switching from a vaginal ring or patch, follow your doctor's recommendations.

• Switching from a progestogen-only method (progestogen-only oral contraceptive – “mini-pill”, injection, implant, or intrauterine system releasing progestogen (IUS))

You may switch on any day from the progestogen-only pill (from an implant or IUS on the day of removal, from an injectable when the next injection would be due), but in all these cases you must use additional contraceptive precautions (e.g., a condom) for the first 7 days of taking the tablets.

• After an abortion

Follow your doctor's recommendations.

• After giving birth

You may start taking Daylette between 21 and 28 days after giving birth. If you start after day 28, you must use a barrier contraceptive method (e.g., a condom) for the first 7 days of using Daylette.

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

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

Read the section “Breastfeeding”.

If you are unsure when to start, consult your doctor.

If you take more Daylette than you should

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

If you take several tablets at once, you may feel unwell, vomit, or experience vaginal bleeding.

Even girls who have not yet started menstruating but have accidentally taken this medicine may experience this type of bleeding.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 915620420, indicating the medicine and the amount taken.

If you forget to take Daylette

The last 4 tablets in the 4th row of the blister are placebo tablets. If you forget to take one of these tablets, this has no effect on the effectiveness of Daylette.

Discard the forgotten placebo tablet.

If you forget a white active tablet (tablets 1–24 of your blister), you should do the following:

• If you are less than 24 hours late in taking a tablet, protection against pregnancy is not reduced.

Take the tablet as soon as you remember and then continue taking the following tablets at your usual time.

• If you are more than 24 hours late in taking a tablet, protection against pregnancy may decrease. The greater the number of tablets forgotten, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is greater if you forget a white tablet at the beginning or end of the blister. In this case, follow the rules below (see also the diagram):

• You have forgotten more than one tablet in the blister

Contact your doctor.

• You forgot a tablet between days 1–7 (first row)

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time and use additional precautions for the next 7 days, e.g., a condom. If you had sexual intercourse in the week before forgetting the tablet, you should be aware that there is a risk of pregnancy. In this case, contact your doctor.

• You forgot a tablet between days 8–14 (second row)

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Protection against pregnancy is not reduced, and additional precautions are not necessary.

• You forgot a tablet between days 15–24 (third or fourth row)

You have two options:

1. Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Instead of taking the green placebo tablets from this blister, discard them and start the next blister immediately (your starting day will be different).

You will most likely have your period at the end of the second blister while taking the green placebo tablets, but you may experience light bleeding or period-like bleeding during the second blister.

2. Alternatively, you may stop taking the active white tablets and go directly to the 4 green placebo tablets (before taking the placebo tablets, you must note the day on which you forgot the tablet). If you wish to start a new blister on the day you usually start, take the placebo tablets for fewer than 4 days.

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

• If you have forgotten any tablets in the blister and do not have bleeding during the placebo days, this may indicate that you are pregnant. You must contact your doctor before starting the next blister.

Yes

Day 1 - 7

Have you had sexual intercourse in the week before the missed pill?

No

Take the missed tablet Use a barrier method (condom) for the next 7 days Finish the blister pack

You have missed only 1 white tablet (and took it more than 24 hours late)

Day 8 - 14

Take the missed tablet as soon as you remember Continue taking the rest of the tablets in the blister pack at the usual time

Take the missed tablet and Finish taking the white tablets Discard the 4 green tablets Start the next blister pack
Day 15 - 24		or

Stop taking the white tablets immediately Go directly to the 4 green tablets Then start the next blister pack

What to do in case of vomiting or severe diarrhoea

If you vomit within 3–4 hours after taking a white active tablet or if you have had severe diarrhoea, there is a risk that your body has not fully absorbed the active substances from the tablet.

The situation is similar to missing a tablet. After vomiting or experiencing diarrhoea, you should take another white tablet from a reserve blister pack as soon as possible. If possible, take it within 24 hours of your usual contraceptive intake time. If this is not possible or more than 24 hours have passed, follow the instructions given under “If you forgot to take Daylette”.

Delaying your menstrual period: what you should know

Although not recommended, you may delay your period by skipping the green placebo tablets in the fourth row and starting directly with a new blister pack of Daylette, taking all its tablets. You may experience light bleeding or spotting similar to menstruation while taking the second blister pack. Complete the second pack by taking the 4 green placebo tablets in the 4th row. Then start a new blister pack.

You may wish to consult your doctor before deciding to delay your menstrual period.

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

If you take the tablets as directed, your period will begin during the placebo days. If you wish to change this day, reduce the number of placebo days – when you take the green placebo tablets – (but never increase them – 4 is the maximum!). For example, if you usually start the placebo tablets on a Friday and wish to change it to Tuesday (3 days earlier), you should start the new blister pack 3 days earlier than usual. It is possible that you will not have any bleeding during this time. You may later experience light bleeding or spotting similar to menstruation.

If you are unsure about what to do, consult your doctor.

If you stop treatment with Daylette

You may stop taking Daylette at any time. If you do not wish to become pregnant, consult your doctor about other reliable contraceptive methods.

If you wish to become pregnant, stop taking Daylette and wait for a menstrual period before trying to conceive. This will allow you to calculate the expected date of delivery more easily.

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

4. Possible adverse effects

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

Serious adverse effects

Contact a doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible difficulty breathing (see also section “Warnings and precautions”).

All women taking combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before starting to use Daylette”.

Below is a list of adverse effects that have been associated with the use of drospirenone/ethinylestradiol:

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

• mood changes,
• headache,
• nausea,
• breast pain, menstrual problems such as irregular periods, absence of periods.

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

• depression, nervousness,
• dizziness, tingling sensation, drowsiness, migraine,
• varicose veins, increased blood pressure,
• stomach pain, vomiting, indigestion, flatulence, stomach inflammation, diarrhoea,
• acne, itching, rash,
• pains and discomforts, e.g., back pain, limb pain, muscle cramps,
• vaginal fungal infection, pelvic pain, breast enlargement, benign breast lumps, uterine/vaginal bleeding (which usually resolves during continued treatment), genital discharge, hot flushes, vaginal inflammation (vaginitis), menstrual disorders, painful menstruation, shortened menstrual duration, heavy menstruation, vaginal dryness, abnormal vaginal smear, decreased interest in sexual intercourse,
• lack of energy, increased sweating, fluid retention, weight gain.

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

• candidiasis (fungal infection),

• decreased number of red blood cells in the blood (anaemia), increased number of platelets in the blood (thrombocytosis),

• allergic reaction,

• hormonal disorder (endocrine),

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

• inability to achieve orgasm, insomnia,

• dizziness, tremor,

• eye disorders, e.g., eyelid inflammation, dry eyes,

• abnormally rapid heart rate,

• vein inflammation, fainting,

• nosebleed,

• abdominal distension, intestinal disorder, bloated feeling, stomach hernia, oral fungal infection, constipation, dry mouth,

• bile duct or gallbladder pain, gallbladder inflammation,

• yellowish-brown skin patches, eczema, hair loss, acne-like skin inflammation, dry skin, skin inflammation with nodules, excessive hair growth, skin disorders, stretch marks, photosensitive skin inflammation, skin nodules,

• difficulty with or painful sexual intercourse, vaginal inflammation (vulvovaginitis), bleeding after intercourse, withdrawal bleeding, breast cyst, increased number of breast cells (hyperplasia), malignant breast tumours, abnormal growth of the cervical mucosa, decreased or impaired endometrial lining, ovarian cysts, uterine enlargement,

• general malaise,

• weight loss,

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

• • in a leg or foot (i.e. DVT)
  • in a lung (i.e. PE)
  • heart attack
  • stroke
  • transient ischaemic attack (TIA) or mild stroke-like symptoms
  • blood clots in the liver, stomach/intestine, kidneys or eye.

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

Frequency not known (cannot be estimated from available data):

• hypersensitivity,
• erythema multiforme (target-shaped rash or sores).

Reporting of adverse effects

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

5. Storage of Daylette

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

Do not store above 25°C. Store in the original packaging to protect from light.

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

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

6. Contents of the pack and other information

Composition of Daylette

• The active substances are 3 mg drospirenone and 0.02 mg ethinylestradiol in each white tablet.
• The other components are:

Active coated tablets (white):

Tablet core:

monohydrate lactose,

corn starch,

pregelatinized corn starch,

polyvinyl alcohol copolymer and macrogol,

magnesium stearate.

Coating:

polyvinyl alcohol,

titanium dioxide (E171),

talc,

macrogol 3350,

lecithin (soy).

Placebo coated tablets (green):

Tablet core:

microcrystalline cellulose,

lactose,

pregelatinized corn starch,

magnesium stearate,

anhydrous colloidal silica.

Coating:

polyvinyl alcohol,

titanium dioxide (E171),

macrogol 3350,

talc,

indigo carmine (E132),

quinoline yellow (E104),

black iron oxide (E172),

sunset yellow FCF (E110).

Nature of the product and pack contents

The active film-coated tablet is white or almost white, round, biconvex, with a diameter of approximately 6 mm. "G73" is engraved on one side, the other side is unmarked.

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

Daylette 3 mg/0.02 mg film-coated tablets EFG, is packaged in PVC/PE/PVDC/Al blisters. The blisters are contained in cardboard boxes with a leaflet, a blister holder, and adhesive labels with the days of the week on each one.

Pack sizes:

1×(24+4) coated tablets

3×(24+4) coated tablets

6×(24+4) coated tablets

13×(24+4) coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Gedeon Richter Plc.

1103 Budapest,

Gyömroi út 19-21.

Hungary

Further information about this medicinal product is available from the local representative of the Marketing Authorization Holder:

Gedeon Richter Ibérica S.A.

Sabino Arana, 28 4º 2º

08028 Barcelona

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain: Daylette

Hungary: Rezia

Portugal: Daylette

Date of the most recent revision of this leaflet: January 2023

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