Daylette

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Daylette
3 mg + 0,02 mg, coated tablets
Drospirenonum + Ethinylestradiolum
Important information about combined hormonal contraceptives

• When used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting following a break of 4 weeks or more.
• Be vigilant and consult your doctor if you suspect symptoms of blood clot formation (see section 2 "Blood clots").

Please read this leaflet carefully before taking the medicine, as it contains
important information for you

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. 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 contraceptive tablet used to prevent pregnancy.
• Each of the 24 white tablets contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.
• The four green coated tablets contain no active substance and are also called placebo tablets.
• Contraceptives containing two hormones are known as combined hormonal contraceptives.

2. Important information before using Daylette

General notes
Before starting to take Daylette, you should read the information about blood clots (thrombosis) in section 2. It is particularly important to be aware of the symptoms of blood clots (see section 2, "Blood clots").
Before you start taking Daylette, your doctor will ask you several questions about your health and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out other examinations.
This leaflet describes several situations in which you should stop using Daylette or in which the effectiveness of Daylette may be reduced. In such cases, you should either avoid sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods.
Do not use fertility awareness-based methods or temperature monitoring methods. These methods may be unreliable because Daylette modifies the monthly changes in body temperature and cervical mucus.
Daylette, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

When not to use Daylette
Do not use Daylette if you have any of the conditions listed below. If any of these conditions apply to you, inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable.

Do not use Daylette if:

• you currently have (or have ever had) a blood clot in the blood vessels of your legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• you know you have blood clotting disorders, such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• you are undergoing surgery or will be immobile for a prolonged period (see section "Blood clots");
• you have had a heart attack or stroke;
• you have (or have previously had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• you have any of the following conditions that may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage,
  • very high blood pressure,
  • very high levels of fats in the blood (cholesterol or triglycerides),
  • a condition called hyperhomocysteinemia;
• you currently have (or have previously had) a type of migraine called "migraine with aura";
• you currently have (or have previously had) liver disease and liver function remains abnormal;
• you have kidney dysfunction (kidney failure);
• you currently have (or have previously had) liver tumour;
• you currently have (or have previously had) or are suspected of having breast or genital organ cancer;
• you have any unexplained vaginal bleeding;
• you are allergic to ethinylestradiol or drospirenone or any of the other ingredients of this medicine (listed in section 6). Symptoms of hypersensitivity may include itching, rash, or swelling;
• Daylette contains soya lecithin. If you are allergic to peanuts or soya, you should not take this medicine.

Do not use Daylette in patients with hepatitis C who are being treated with medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Daylette with other medicines").

Warnings and precautions
Before starting to use Daylette, discuss this with your doctor or pharmacist.

When to contact your doctor
Seek immediate medical advice if:

• you notice possible symptoms of blood clots, which may indicate that you have a blood clot in your leg (deep vein thrombosis), lungs (pulmonary embolism), heart attack, or stroke (see section below "Blood clots (thrombosis)").

For a description of the symptoms of these serious adverse effects, see "How to recognize the occurrence of blood clots".

Tell your doctor if you have any of the following conditions.
In certain situations, special caution is required when using Daylette or any other combined oral contraceptive. Regular check-ups by your doctor may also be necessary. Inform your doctor before starting Daylette if you have any of the following conditions. If any of these symptoms develop or worsen during treatment with Daylette, inform your doctor immediately.

• If you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria possibly with breathing difficulties, seek immediate medical attention. Medicinal products containing estrogens may induce or worsen symptoms of hereditary or acquired angioedema;
• if close relatives currently have or have previously 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 (a disease affecting the body's natural defence system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have hypertriglyceridaemia (elevated blood fat levels) or a positive family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2, "Blood clots");
• if you have recently given birth, as you are at increased risk of blood clots. Consult your doctor to find out how soon after delivery you can start taking Daylette;
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see "Daylette with other medicines");
• if you have a condition that first appeared during pregnancy or previous use of sex hormones (e.g. hearing loss, a blood disorder called porphyria, pemphigoid gestationis (a blistering skin rash during pregnancy), Sydenham's chorea (a nervous system disorder causing involuntary movements));
• if you have had or currently have brownish pigmentation spots (chloasma), especially on the face. In such cases, avoid direct exposure to sunlight or ultraviolet radiation.

Before starting Daylette, discuss this with your doctor.

BLOOD CLOTS
Using combined hormonal contraceptives such as Daylette is associated with an increased risk of blood clots compared to not using such therapy. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

• in veins (referred to as "venous thrombosis" or "venous thromboembolic disease");
• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic events").

Recovery after a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots caused by using Daylette is low.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you notice any of the following symptoms.

Do you experience any of these symptoms? What might be the likely cause?

• swelling of the leg or swelling along a vein in the leg or foot – deep vein thrombosis, especially if accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking;
• increased warmth in the affected leg;
• change in skin colour of the leg, such as pallor, redness, or blueness;
• sudden unexplained shortness of breath or rapid breathing – pulmonary embolism;
• sudden cough without an obvious cause, possibly accompanied by coughing up blood;
• sharp chest pain, which may worsen on deep breathing;
• severe dizziness or vertigo;
• rapid or irregular heartbeat;
• severe stomach pain.

If you are unsure, consult your doctor, as some of these symptoms, such as cough or breathlessness, may be mistaken for milder conditions such as respiratory tract infections (e.g. cold).

BLOOD CLOTS IN VEINS
What can happen if blood clots form in veins?

• The use of combined hormonal contraceptives is associated with an increased risk of venous blood clots (venous thrombosis). Although these adverse effects are rare, they most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of venous blood clots highest?
The risk of developing venous blood clots is greatest during the first year of first-time use of combined hormonal contraceptives. The risk may also be higher when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it always remains higher than when not using combined hormonal contraceptives.
If a woman stops taking Daylette, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of blood clots?
The risk depends on the individual's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs while using Daylette is small.

• In one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In one year, about 9–12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Daylette, will develop blood clots.
• The risk of developing blood clots depends on the individual medical history of the woman (see "Factors that increase the risk of blood clots" below).

Risk of blood clots
within one year
Women who do not use combined hormonal tablets, patches, or vaginal systems and are not pregnant: About 2 per 10,000 women
Women using combined oral contraceptives containing levonorgestrel, norethisterone, or norgestimate: About 5–7 per 10,000 women
Women using Daylette: About 9–12 per 10,000 women

Factors increasing the risk of venous blood clots
The risk of blood clots associated with using Daylette is small, but certain factors may increase this risk. The risk is higher:

• if the woman is overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In this case, the woman may have an inherited clotting disorder;
• if the woman needs to undergo surgery, will be immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to stop taking Daylette several weeks before surgery or periods of limited mobility. If the woman must stop taking Daylette, she should consult her doctor about when she can restart the medication;
• with increasing age (especially over 35 years);
• if the woman has given birth within the last few weeks.

The risk of developing blood clots increases with the number of risk factors present in the woman.
Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if the woman has another listed risk factor.
It is important to inform the doctor if any of the listed factors apply to the woman, even if she is uncertain. The doctor may decide to discontinue the use of Daylette.
The woman should inform her doctor if any of the above conditions change during treatment with Daylette, e.g., if a close family member is diagnosed with thrombosis of unknown cause or if she gains significant weight.

BLOOD CLOTS IN ARTERIES
What can happen if blood clots form in arteries?
Similar to venous blood clots, arterial clots can cause serious consequences, such as heart attack or stroke.

Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with using Daylette is very low, but it may increase:

• with age (above approximately 35 years);
• if the woman smokes. When using a hormonal contraceptive such as Daylette, it is recommended to stop smoking. If the woman is unable to quit smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
• if the woman is overweight;
• if the woman has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years). In this case, the woman may also be at increased risk of heart attack or stroke;
• if the woman or a close family member has high levels of fats in the blood (cholesterol or triglycerides);
• if the woman has migraines, especially migraines with aura;
• if the woman has heart disease (valve damage, heart rhythm disorder called atrial fibrillation);
• if the woman has diabetes.

If the woman has more than one of the above conditions, or if any of them is particularly severe, the risk of blood clots may be further increased.
The woman should inform her doctor if any of the above conditions change during treatment with Daylette, e.g., if she starts smoking, a close family member is diagnosed with thrombosis of unknown cause, or if she gains significant weight.

Daylette and cancer
Slightly more cases of breast cancer have been observed in women using combined oral contraceptives, but it is not known whether this is caused by taking the pills. For example, more cancers may be detected in women using combined oral contraceptives because they are examined more frequently by doctors.
The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important to examine the breasts regularly and contact a doctor if any lump is felt.
Benign liver tumors have been reported rarely, and malignant liver tumors very rarely, in women using oral contraceptives. If the woman experiences unusual, severe abdominal pain, she should contact her doctor.

Psychiatric disorders
Some women using hormonal contraceptives, including Daylette, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact a doctor as soon as possible for further medical advice.

Breakthrough bleeding
During the first few months of taking Daylette, unexpected bleeding (bleeding outside the placebo tablet period) may occur. If such bleeding persists for longer than a few months, or if it starts after several months, the doctor should investigate the cause.

What to do if no menstrual bleeding occurs during the placebo tablet days
If all the white, active tablets were taken correctly, there were no episodes of vomiting or severe diarrhea, and no other medications were taken, it is very unlikely that the woman is pregnant.
If the expected menstrual bleeding does not occur for two consecutive cycles, pregnancy may be possible. The woman should contact her doctor immediately. The next pack of Daylette should only be started once pregnancy has been ruled out.

Daylette and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the woman plans to take.
Inform the doctor about any medicines or herbal products being used. Also inform any other doctor or dentist (or pharmacist) who may prescribe another medicine to be used alongside Daylette.
These healthcare providers may advise whether additional contraceptive methods (e.g., condoms) should be used, and if so, for how long, or whether doses of other medicines need to be adjusted.
Do not use Daylette in patients with hepatitis C who are taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these products may cause abnormal liver function test results in blood (increased activity of liver enzymes ALT).
Before starting these medications, the doctor will prescribe another type of contraception.
Daylette may be restarted approximately 2 weeks after completion of the above-mentioned treatment. See section "When not to use Daylette."

Some medicines may affect the blood levels of Daylette and may cause reduced effectiveness in preventing pregnancy or may cause unexpected bleeding. These include:

• Medicines used to treat:
• epilepsy (e.g., barbiturates, carbamazepine, phenytoin, primidone, oxcarbazepine, felbamate, topiramate),
• tuberculosis (e.g., rifampicin),
• HIV and hepatitis C virus infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz),
• fungal infections (e.g., griseofulvin, ketoconazole),
• high blood pressure in the pulmonary blood vessels (bosentan),
• symptomatic treatment of osteoarthritis (etoricoxib),
• herbal medicines containing St. John's wort ( Hypericum perforatum ). If the woman wishes to use herbal products containing St. John's wort while taking Daylette, she should consult her doctor first.

Daylette may affect the action of other medicines, for example:

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

Before taking any medicine, consult a doctor or pharmacist.

Daylette with food and drink
Daylette can be taken with or without food, swallowed with a small amount of water if needed.

Laboratory tests
If a blood test is required, inform the doctor or laboratory staff that the woman is taking oral contraceptives, as hormonal contraceptives may affect the results of certain tests.

Pregnancy and breastfeeding
If the woman is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using Daylette.

Pregnancy
Daylette must not be used during pregnancy. If the woman becomes pregnant while taking Daylette, she should stop immediately and contact her doctor.
If the woman wishes to become pregnant, she may stop taking Daylette at any time (see section: "Discontinuing Daylette").

Before using any medicine, consult a doctor or pharmacist.

Breastfeeding
Daylette is generally not recommended during breastfeeding. If the woman wishes to take oral contraceptives while breastfeeding, she should consult her doctor.

Before using any medicine, consult a doctor or pharmacist.

Driving and operating machinery
There is no information suggesting that Daylette affects the ability to drive or operate machinery.

Daylette contains lactose, orange yellow, lake (E 110), and soy lecithin
One white, active coated tablet of Daylette (containing active substances) contains 48.53 mg of monohydrate lactose, and one green, inactive coated tablet contains 37.26 mg of lactose. If the woman has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before using the medicine.
The white, active tablets contain 0.07 mg of soy lecithin. If the woman is allergic to peanuts or soy, she should not use this medicine.
The green coated placebo tablets (non-hormonal) contain orange yellow, lake (E 110)—a dye that may cause allergic reactions.

3. How to use Daylette

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Each blister contains 24 white tablets containing the active substance and 4 green placebo tablets.
The Daylette tablets, marked with two different colours, are arranged in the correct order.
The blister contains 28 tablets in total.

Take one Daylette tablet daily, with a small amount of water if necessary. Tablets may be taken regardless of meals, but should be taken at approximately the same time each day.

Be careful not to confuse the tablets: for the first 24 days, take the white tablet, followed by the green placebo tablet for the last 4 days. Then immediately start a new blister pack (24 white tablets and 4 green tablets). Therefore, there is no break between packs.

Due to differences in tablet composition, treatment must begin with the tablet in position 1 on the blister marked “Start”. Tablets must be taken daily. To maintain the correct order, follow the direction of the arrows and numbering on the blister.

Preparing the blister pack

To help monitor correct tablet intake, the package contains 7 adhesive strips marked with symbols for the days of the week. Choose one strip that starts with the symbol corresponding to the day the patient intends to begin taking tablets. For example, if starting treatment on Wednesday, use the strip marked “Wed.”.

Align the symbol “  ” on the strip with the same symbol on the blister and affix the strip within the area bounded by the black line (in the frame). Each day-of-the-week symbol will then correspond to a specific column of tablets.

The day-of-the-week symbol above each tablet will help verify whether the tablet has been taken on a given day. Proceed in the direction of the arrow on the blister until all 28 tablets have been taken.

During the 4 days when the patient takes the green placebo tablets (placebo days), withdrawal bleeding should occur (so-called “withdrawal bleeding”). This usually begins on the 2nd or 3rd day after taking the last active white tablet of Daylette. After taking the last green placebo tablet, start the next blister pack immediately, regardless of whether bleeding has stopped or not. This means that starting a new blister pack should always occur on the same day of the week, and withdrawal bleeding should begin on the same day each month.

Daylette, when used in this way, provides protection against pregnancy even during these 4 days when the patient is taking placebo tablets.

When to start the first blister?

• If no hormonal contraceptives have been used in the previous month
  Begin taking Daylette on the first day of the menstrual cycle (i.e., the first day of menstruation). If Daylette is started on the first day of menstruation, it provides immediate protection against pregnancy. Daylette may also be started between day 2 and day 5 of the cycle. However, in this case, the patient must use an additional contraceptive method (e.g., condoms) for the first 7 days of tablet intake.

• Switching from a combined hormonal contraceptive (combined oral contraceptive, vaginal ring, or patch)
  Begin taking Daylette the day after taking the last active tablet of the previous combined oral contraceptive, but no later than the day following the tablet-free interval of the previous combined oral contraceptive (or after the last inactive tablet of the previously used contraceptive tablets).
  When switching from a vaginal ring or transdermal patch, follow your doctor’s instructions.

• Switching from a progestogen-only method (progestogen-only pills, injection, implant, or intrauterine system releasing progestogen, IUS)
  Switching can occur on any day from a progestogen-only pill (from an implant or intrauterine system releasing progestogen, IUS, on the day of removal, or from injectable forms on the day of the next scheduled injection), but in all cases, additional barrier methods (e.g., condoms) must be used for the first 7 days of taking Daylette tablets.

• After miscarriage
  Follow your doctor’s advice.

• After childbirth
  Daylette may be started between day 21 and day 28 after childbirth. If Daylette is started later than day 28, a barrier method (e.g., condoms) must be used for the first 7 days of taking Daylette. If sexual intercourse occurred after childbirth and before starting Daylette (again), first ensure that pregnancy has not occurred or wait until the next menstrual period.

• If the patient is breastfeeding and wishes to start (or restart) taking Daylette after childbirth
  Refer to the section “Breast-feeding”.

If in doubt about when to start the first blister, consult your doctor.

Taking more Daylette than prescribed

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

If several tablets are taken at once, nausea or vomiting may occur, or vaginal bleeding may appear. In young girls before the onset of the first menstruation, accidental ingestion of this medicine may also cause vaginal bleeding.

If too many Daylette tablets are taken or if a child swallows some tablets, seek medical advice immediately from a doctor or pharmacist.

Missing a dose of Daylette

The last 4 tablets in the fourth row of the blister are placebo tablets. If one of these placebo tablets is missed, it will not affect the effectiveness of Daylette. Discard the missed placebo tablet.

If the patient forgets to take a white active tablet (tablets 1–24 from the blister), the following steps should be taken:

• If less than 24 hours have passed since the missed tablet, contraceptive protection is not reduced. Take the missed tablet as soon as remembered, then continue taking the next tablets at the usual time.
• If more than 24 hours have passed since the missed tablet, contraceptive protection may be reduced. The more tablets missed, the higher the risk of pregnancy.

The risk of incomplete contraceptive protection is greatest if the patient forgets a white tablet at the beginning or end of the blister. In such cases, follow the rules below (see also the chart below):

• More than one tablet from the blister has been missed
  Consult your doctor.

• One tablet missed on days 1 to 7 (first row of tablets in the blister)
  Take the missed tablet as soon as remembered, even if this means taking two tablets at once. Continue taking the next tablets at the usual time and use additional protection, such as condoms, for the next 7 days. If sexual intercourse occurred in the week before the missed tablet, be aware that there is a risk of pregnancy. In this case, consult your doctor.

• One tablet missed on days 8 to 14 (second row of tablets in the blister)
  Take the missed tablet as soon as remembered, even if this means taking two tablets at once. Continue taking the next tablets at the usual time. Contraceptive protection is not reduced, so additional contraceptive methods are not necessary.

• One tablet missed on days 15 to 24 (third or fourth row of tablets in the blister)
  Two options are available:

  1. Take the missed tablet as soon as remembered, even if this means taking two tablets at once. Then continue taking tablets at the usual time. Instead of taking the green placebo tablets from the pack, skip them (discard) and start the next pack immediately (the starting day will change). Menstruation will most likely occur at the end of the second blister, during the intake of the green placebo tablets, but spotting or breakthrough bleeding may also occur during the second blister.
  2. Alternatively, stop taking the active white tablets and go directly to taking the 4 green placebo tablets (before taking the placebo tablets, write down the day on which the tablet was missed). If the patient wishes to start the next pack on the same day as before, the placebo tablets may be taken for fewer than 4 days.

If either of these recommendations is followed, protection against pregnancy will be maintained.

• If the patient forgets to take any tablet from the blister and no bleeding occurs during the placebo days, this may indicate pregnancy. Consult your doctor before starting the next blister.

Missed tablet management chart
Missed more than 1 white tablet from the same blister
Consult your doctor

What to do in case of vomiting or severe diarrhoea

If vomiting occurs within 3–4 hours after taking an active white tablet, or if severe diarrhoea occurs, there is a risk that the active substances from the tablet have not been fully absorbed. This situation is similar to missing a tablet. In case of vomiting or diarrhoea, take another white tablet from a spare pack as soon as possible. If possible, take it within 24 hours of the usual tablet-taking time. If this is not possible or more than 24 hours have passed, follow the advice given in the section “Missing a dose of Daylette”.

Delayed menstruation: what to know
Yes
Was there sexual intercourse in the
Day 1–7
previous week?
No

• Take the missed tablet
• Use a barrier method (condoms) for the next 7 days
• Finish taking tablets from the blister
• Take the missed tablet and Missed 1 white tablet (taken with delay of more than 24 hours) - Take the missed tablet
• Finish taking white tablets
• Discard 4 green placebo tablets
• Immediately start taking tablets from the next blister
  or
• Immediately stop taking white tablets from the blister Day 15–24 - Start taking 4 green placebo tablets immediately
• Then start taking tablets from the next blister

Even though not recommended, the patient may delay the onset of menstruation by skipping the green placebo tablets in the fourth row and moving directly to a new Daylette blister until its contents are exhausted. During intake of the second blister, slight bleeding or spotting may occur. Tablets from the second blister should be taken to the end, including the 4 green placebo tablets in the fourth row. Then start the next blister.

Before deciding to delay bleeding, consult your doctor.

Changing the day of menstruation: what to know
If the patient takes tablets as directed, menstrual bleeding will occur during the placebo days. If the patient wishes to shift the day of bleeding, she should reduce the number of placebo days (while taking green placebo tablets) — but never increase them (maximum 4 days). For example, if the patient usually starts placebo tablets on Friday but wishes bleeding to start on Tuesday (3 days earlier), she must start the new blister 3 days earlier than usual. Bleeding may not occur at that time, but slight bleeding or spotting may occur later.

If the patient is unsure how to proceed, she should consult her doctor.

Stopping Daylette

Daylette may be discontinued at any time. If the patient does not wish to become pregnant, consult your doctor about other effective methods of birth control.

If the patient wishes to become pregnant, stop taking Daylette, use another contraceptive method, and wait for the first menstrual period. This will make it easier to calculate the expected date of delivery.

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
If any adverse effects occur, especially severe and persistent ones, or changes in health that the user considers to be related to the use of Daylette, medical advice should be sought.

Serious adverse effects
Seek immediate medical attention if the user experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria potentially associated with breathing difficulties (see also section "Warnings and precautions").

All women using combined hormonal contraceptives have an increased risk of venous blood clots (venous thromboembolic disorders) or arterial blood clots (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, see section 2, "Important information before taking Daylette".

The following adverse effects have been reported during use of drospirenone and/or ethinylestradiol:

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

• mood swings,
• headache,
• nausea,
• breast pain, menstrual problems such as irregular or absent periods.

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

• depression, nervousness,
• dizziness, tingling sensation, drowsiness, migraine,
• varicose veins, increased blood pressure,
• abdominal pain, vomiting, indigestion, flatulence, gastritis, diarrhoea,
• acne, itching, rash,
• pain-related complaints, e.g. back, limb or muscle pain,
• vaginal fungal infections, pelvic pain, breast enlargement, benign breast tumours, uterine/vaginal bleeding (which usually decreases with continued use of the medicine), vaginal discharge, hot flushes, vaginal inflammation, menstrual disorders, painful, scanty or very heavy periods, vaginal dryness, abnormal cervical smear test results, decreased interest in sex,
• lack of energy, excessive sweating, fluid retention.
• weight gain.

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

• fungal infection (fungal disease),
• decreased number of red blood cells in the blood (anaemia), increased number of platelets (thrombocytopenia),
• allergic reaction,
• endocrine (hormonal) disorders,
• increased appetite, loss of appetite, abnormally high potassium levels in the blood, abnormally low sodium levels in the blood,
• inability to achieve orgasm, insomnia,
• dizziness, tremor,
• eye disorders, e.g. eyelid inflammation, dry eyes,
• abnormally fast heartbeat,
• phlebitis, fainting,
• nosebleeds,
• abdominal distension, intestinal disorders, bloating, abdominal hernia, oral fungal infection, constipation, dry mouth,
• biliary or gallbladder pain, gallbladder inflammation,
• yellow-brown skin patches, pimples, hair loss, acneiform dermatitis, dry skin, nodular skin inflammation, excessive hair growth, skin disorders, stretch marks, skin inflammation, photoallergic dermatitis, skin nodules,
• painful or difficult sexual intercourse, vaginal inflammation (vulvovaginitis), bleeding after intercourse, cessation of bleeding, breast cysts, increased number of breast gland cells (hyperplasia), malignant breast tumours, abnormal cervical endometrial hyperplasia, endometrial atrophy or shrinkage, ovarian cysts, uterine enlargement,
• general malaise,
• weight loss,
• harmful blood clots in a vein or artery, for example:
• in the leg or foot (e.g. deep vein thrombosis),
• in the lungs (e.g. pulmonary embolism),
• heart attack,
• stroke,
• mini-stroke or transient ischaemic attack (TIA),
• blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood of developing blood clots may be higher if the user has other risk factors (see section 2 for further information on factors increasing the risk of blood clots and symptoms of blood clots).

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

• hypersensitivity,
• erythema multiforme (rash with disc-shaped redness or ulceration).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309; website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Daylette

Keep this medicine out of 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 packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Daylette contains
The active substances are drospirenone (3 mg) and ethinylestradiol (0.02 mg) in each white tablet.
Other components are:
White coated tablets containing the active substances:
Core: monohydrate lactose, corn starch, pregelatinized corn starch, graft copolymer of polyethylene glycol and polyvinyl alcohol, magnesium stearate.
Coating: polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350, soy lecithin.
Green coated tablets (placebo):
Core: microcrystalline cellulose, lactose, pregelatinized corn starch, magnesium stearate, anhydrous colloidal silica.
Coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, indigo carmine, aluminium lake (E 132), quinoline yellow, aluminium lake (E 104), black iron oxide (E 172), orange yellow, aluminium lake (E 110).

What Daylette looks like and contents of the pack
Coated tablet containing the active substance: white or almost white, round, biconvex coated tablet with a diameter of approximately 6 mm. On one side, there is an embossed mark "G73"; the other side is smooth.
Placebo coated tablet: green, round, biconvex coated tablet with a diameter of approximately 6 mm, without any embossing.
Daylette coated tablets are packed in PVC/PE/PVDC-Al blisters.
The blisters are packed in a cardboard box containing the patient leaflet, a holder for storing the blisters, and adhesive labels in the form of strips marked with symbols indicating the days of the week.

Pack sizes:
28 tablets (1 x 28 coated tablets)
84 tablets (3 x 28 coated tablets)
168 tablets (6 x 28 coated tablets)

For more detailed information, please contact the responsible party or the parallel importer.

Responsible party in Portugal, country of export:
Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary

Manufacturer:
Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary

Parallel importer:
InPharm Sp. z o.o., Strumykowa 28/11, 03-138 Warsaw, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k., Chełmżyńska 249, 04-458 Warsaw, Poland

Marketing authorization number in Portugal, country of export: 5370176
Parallel import authorization number: 70/20