Daylette

Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Daylette
3 mg + 0,02 mg, coated tablets
Drospirenone + Ethinylestradiol
Important information regarding 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 a doctor if the patient suspects 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 the patient.

• Keep this leaflet for future reference.
• If you have any doubts, 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, inform your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

1. What Daylette is and what it is used for
2. Important information 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 known as placebo tablets.
• Contraceptives containing two hormones are called combined hormonal contraceptives.

2. Important Information Before Using Daylette

General Notes
Before starting treatment with Daylette, you should read the information regarding 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 starting 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 case, may perform additional tests.
This leaflet describes several situations in which you should stop using Daylette or when its effectiveness 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 or temperature-based methods, as these may be unreliable because Daylette alters monthly changes in body temperature and cervical mucus.
Daylette, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted infections.

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;
• if you have known clotting disorders, such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you require surgery or will be immobile for a prolonged period (see section “Blood Clots”);
• if you have had a heart attack or stroke;
• if you have (or have had in the past) 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);
• if 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.
• if you currently have (or have had in the past) a type of migraine called “migraine with aura”;
• if you currently have (or have had in the past) liver disease and liver function remains abnormal;
• if you have kidney dysfunction (renal failure);
• if you currently have (or have had in the past) liver tumours;
• if you currently have (or have had in the past) or are suspected of having breast cancer or genital organ cancer;
• if you have any unexplained vaginal bleeding;
• if you are allergic to ethinylestradiol or drospirenone, or any of the other ingredients of this medicine (listed in section 6). Allergic reactions 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 taking 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 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 deep vein thrombosis in the leg, pulmonary embolism, heart attack, or stroke (see section below “Blood Clots”). For a description of symptoms of these serious adverse effects, see “How to Recognize Blood Clots”.

Inform your doctor if you have any of the following conditions.
Special caution may be required when using Daylette or any other combined oral contraceptive. Regular medical check-ups 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 with potential breathing difficulties, seek immediate medical attention. Medicines containing estrogens may induce or worsen symptoms of hereditary or acquired angioedema;
• if close relatives currently have or have 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 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 about when it is safe to start taking Daylette after childbirth;
• 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 occurred during pregnancy or previous use of sex hormones [e.g., hearing loss, porphyria (a blood disorder), herpes gestationis (blistering skin rash during pregnancy), Sydenham’s chorea (a nervous system disorder causing involuntary body movements)];
• if you have or have ever had chloasma (brownish pigmentation), also known as melasma, especially on the face. In such cases, avoid direct exposure to sunlight or ultraviolet radiation.

Discuss with your doctor before starting Daylette.

BLOOD CLOTS
Using combined hormonal contraceptives such as Daylette increases the risk of blood clots compared to not using hormonal contraception. 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 from a blood clot may not be 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 associated with using Daylette is low.

HOW TO RECOGNIZE BLOOD CLOTS
Seek immediate medical advice if you experience 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 in the foot, especially if accompanied by:
  Deep vein thrombosis

• pain or tenderness in the leg, felt only when standing or walking;

• increased warmth in the affected leg;

• skin discoloration of the leg, such as pallor, redness, or blueness.

• sudden onset of unexplained shortness of breath or rapid breathing;
  Pulmonary embolism

• sudden cough without an obvious cause, possibly with coughing up blood;

• sharp chest pain, which may worsen with 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 like respiratory tract infections (e.g., colds).

Symptoms most commonly affecting one eye:
Retinal vein thrombosis (blood clot in the eye)

• sudden loss of vision, or

• painless visual disturbances, which may progress to vision loss.

• chest pain, discomfort, pressure, heaviness;
  Heart attack

• squeezing or fullness in the chest, arm, or below the breastbone;

• feeling of fullness, indigestion, or choking;

• discomfort in the lower body radiating to the back, jaw, throat, arm, or stomach;

• sweating, nausea, vomiting, or dizziness;

• extreme weakness, restlessness, or breathlessness;

• rapid or irregular heartbeat.

• sudden weakness or numbness of the face, arms, or legs, especially on one side of the body;
  Stroke

• sudden confusion, speech or comprehension difficulties;

• sudden visual disturbances in one or both eyes;

• sudden walking difficulties, dizziness, loss of balance or coordination;

• sudden, severe, or prolonged headache without known cause;

• loss of consciousness or fainting with or without seizures.
  In some cases, stroke symptoms may be transient with nearly immediate and complete recovery, but you should seek immediate medical advice as you may be at risk of a subsequent stroke.

• swelling and slightly bluish skin discoloration of legs or arms;
  Blood clots blocking other blood vessels

• severe stomach pain (acute abdomen).

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

• Using combined hormonal contraceptives increases the risk of venous blood clots. Although these adverse effects are rare, they most commonly occur during the first year of use.
• If blood clots form in veins of the leg or foot, this may lead to 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 venous blood clots is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also increase when restarting combined hormonal contraceptives (same or different product) after a break of 4 weeks or more.
After the first year, the risk decreases but remains higher than in women not using combined hormonal contraceptives.
If you stop taking Daylette, the risk of blood clots returns to normal within a few weeks.

What determines the risk of blood clots?
The risk depends on your natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of blood clots in the legs or lungs associated with Daylette is low.

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

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

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

• if you are overweight [body mass index (BMI) above 30 kg/m²];
• if a close relative has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In this case, you may have inherited clotting disorders;
• if you require surgery, are immobile for a prolonged period due to injury or illness, or have a leg in plaster. You may need to stop taking Daylette several weeks before surgery or immobilisation. If you stop taking Daylette, ask your doctor when you can restart;
• with increasing age (especially over 35 years);
• if you have recently given birth (within the last few weeks).

The risk of blood clots increases with the number of risk factors present.
Long-haul flights (>4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor.
It is important to inform your doctor if any of these factors apply to you, even if you are uncertain. Your doctor may decide to discontinue Daylette.
Inform your doctor if any of these conditions change during treatment with Daylette, e.g., if a close relative develops unexplained thrombosis or if you gain significant weight.

BLOOD CLOTS IN ARTERIES
What may happen if blood clots form in arteries?
Similar to venous clots, arterial clots may 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 Daylette is very low, but may increase:

• with age (over approximately 35 years);
• if you smoke. When using a hormonal contraceptive such as Daylette, you are advised to stop smoking. If you cannot stop smoking and are over 35 years old, your doctor may recommend a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if a close relative had a heart attack or stroke at a young age (under 50 years). In this case, you may also be at increased risk;
• if you or a close relative have high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraines, especially migraine with aura;
• if you have heart disease (valve problems, heart rhythm disorder such as atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions or if any is particularly severe, the risk of blood clots may be further increased.
Inform your doctor if any of these conditions change during treatment with Daylette, e.g., if you start smoking, a close relative develops unexplained thrombosis, or if you gain significant weight.

Daylette and Cancer
A slightly increased incidence of breast cancer has been observed in women using combined oral contraceptives, but it is not known whether this is caused by the pills. For example, more tumours may be detected in women using combined oral contraceptives because they undergo more frequent medical examinations.
The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important to examine your breasts regularly and contact your doctor if you detect any lumps.
Benign liver tumours have been reported rarely, and malignant liver tumours very rarely, in women using oral contraceptives. If you experience unusual, severe abdominal pain, contact your doctor.

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

Intermenstrual 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 starts after several months, your doctor should investigate the cause.

What to do if no menstrual bleeding occurs during the placebo tablet period
If all active white tablets have been taken correctly, without vomiting or severe diarrhoea, and no other medicines have been taken, it is very unlikely that you are pregnant.
If expected menstrual bleeding does not occur for two consecutive cycles, pregnancy may be possible. Contact your doctor immediately. Do not start the next pack of Daylette until you confirm you are not pregnant.

Daylette with Other Medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Tell your doctor about any medicines or herbal products you are using. Also inform any other doctor, dentist, or pharmacist who may prescribe another medicine to be taken with Daylette.
They may advise whether you should use additional contraceptive methods (e.g., condoms), for how long, or whether doses of other medicines need adjustment.
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 may cause abnormal liver function test results (increased AlAT enzyme activity).
Before starting these medicines, your doctor will prescribe a different type of contraception.
Daylette may be restarted approximately 2 weeks after stopping the above treatment. See section “When Not to Use Daylette”.

Some medicines may affect the blood levels of Daylette and may cause reduced contraceptive effectiveness or 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),
  • pulmonary hypertension (bosentan),
  • symptomatic treatment of osteoarthritis (etoricoxib),
  • herbal product containing St John’s wort (Hypericum perforatum). If you wish to use herbal products containing St John’s wort while taking Daylette, consult your doctor first.

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

• cyclosporine (used to prevent organ transplant rejection),
• the antiepileptic lamotrigine (may lead to increased seizure frequency),
• tizanidine (used to treat muscle spasticity),
• theophylline (used to treat asthma).
  Before taking any medicine, consult your doctor or pharmacist.

Daylette with Food and Drink
Daylette may be taken with or without food, with a small amount of water if needed.

Laboratory Tests
If blood tests are required, inform your doctor or laboratory staff that you are taking oral contraceptives, as hormonal contraceptives may affect the results of certain tests.

Pregnancy and Breast-Feeding
If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using Daylette.

Pregnancy
Daylette must not be used during pregnancy. If you become pregnant while taking Daylette, stop immediately and contact your doctor. If you wish to become pregnant, you may stop taking Daylette at any time (see section: “Discontinuing Daylette”).

Before using any medicine, consult your doctor or pharmacist.

Breast-Feeding
Daylette is generally not recommended during breast-feeding. If you wish to take oral contraceptives while breast-feeding, contact your doctor.

Before using any medicine, consult your doctor or pharmacist.

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

Daylette contains lactose, orange-yellow (E110), and soya lecithin.
One coated white active tablet of Daylette (containing active substances) contains 48.53 mg of monohydrate lactose, and one coated green inactive tablet contains 37.26 mg of lactose.
If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before using this medicine.
White active tablets contain 0.070 mg of soya lecithin. If you are allergic to peanuts or soya, do not take this medicine.
Coated tablets without hormones (placebo tablets) contain orange-yellow (E110), a colouring agent that may cause allergic reactions.

3. How to use Daylette

This medicine should always be taken exactly as prescribed 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 tablets in Daylette are two different colours and are arranged in the correct order. The blister contains 28 tablets in total.

Take one tablet of Daylette every day, with a small amount of water if necessary. Tablets may be taken regardless of meals, but should be taken at about 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 taking tablets from a new blister (24 white tablets and 4 green placebo tablets). Therefore, there is no break between blister packs.

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

Preparing the blister

To help monitor correct tablet intake, the package contains 7 adhesive strips marked with the days of the week. Choose one strip starting with the day of the week on which the patient intends to begin taking the 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 blue line (in the frame). The name of each day of the week will correspond to a specific column of tablets.

The day of the week printed above each tablet will help verify whether the tablet has been taken that day. Follow the direction of the arrows 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 immediately, regardless of whether bleeding has stopped or not. This means that starting a new blister should always occur on the same day of the week, and withdrawal bleeding should begin on the same day each month. When used in this way, Daylette provides protection against pregnancy even during these 4 days when placebo tablets are taken.

When to start the first blister?

• If no hormonal contraceptives were used in the previous month
  Begin taking Daylette on the first day of the cycle (i.e. the first day of menstruation). If Daylette is started on the first day of menstruation, it provides immediate protection against pregnancy. Alternatively, treatment may begin between day 2 and day 5 of the cycle. In this case, however, 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 contraceptive 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 progestogen-releasing intrauterine system, IUS)
  Switching can occur on any day from progestogen-only pills (from an implant or progestogen-releasing intrauterine system, IUS, on the day of removal, or from injectable forms on the day of the next scheduled injection), but in all cases, additional contraceptive precautions (e.g. condoms) must be used for the first 7 days of tablet intake.

• After miscarriage
  Follow your doctor's advice.

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

• If breastfeeding and wishing to start Daylette after childbirth
  See section "Breast-feeding".

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

Taking more than the recommended dose of Daylette

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 develop. In young girls before the onset of the first menstruation, accidental intake of this medicine may also cause vaginal bleeding.

If too many Daylette tablets are taken or if a child swallows some of them, consult a doctor or pharmacist immediately.

Missed 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 one of the white active tablets (tablets 1–24 in the blister), follow these instructions:

• 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 following 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 greater the risk of pregnancy. The risk of incomplete protection is greatest if a white tablet is missed at the beginning or end of the blister. In such cases, follow the rules below (see also the chart below):

• More than one tablet missed from the blister
  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 following 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 following 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 the tablets at the usual time. Instead of taking the green placebo tablets from the pack, skip them (discard) and immediately start the next pack (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 intermenstrual 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, record the day on which the tablet was forgotten). 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 a patient forgets to take any tablet from the blister and no bleeding occurs during the placebo days, this may indicate pregnancy. Consult a doctor before starting the next blister.

Missed more than 1 white tablet from the same blister
Yes
Was there sexual intercourse in the previous week?
No

• Take the missed tablet
• Use a mechanical method (condoms) for the next 7 days
• Finish taking the tablets in the blister

Missed 1 white tablet (taken more than 24 hours late)
Days 1–7

• Take the missed tablet
• Finish taking the tablets in the blister

Days 8–14

• Take the missed tablet
• Finish taking the tablets in the blister

Days 15–24

• Take the missed tablet
• Finish taking the white tablets
• Discard the 4 green placebo tablets
• Immediately start taking tablets from the next blister

or

• Immediately stop taking the white tablets from the blister
• Start taking the 4 green placebo tablets immediately
• Then start taking tablets from the next blister

What to do in case of vomiting or severe diarrhoea

If vomiting occurs within 3–4 hours after taking the active white tablet or if severe diarrhoea develops, 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 instructions under "Missed dose of Daylette".

Delayed menstruation: what you should know

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 blister of Daylette 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 you should know

If the patient takes the 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 the green placebo tablets—(but never increase them—maximum 4 days!). For example, if the patient usually starts taking placebo tablets on Friday but would like 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 treatment with Daylette

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

If the patient wishes to become pregnant, she should 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 regarding 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 will experience them.
If any adverse effects occur, especially severe and persistent ones, or changes in health status that the patient considers to be related to the use of Daylette, medical advice should be sought.
Serious adverse effects
Contact a doctor immediately if the patient 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 disease) or arterial blood clots (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before taking Daylette".

The following adverse effects have been reported during the 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 periods or absence of periods.

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

• depression, nervousness,
• dizziness, tingling sensation, somnolence, migraine,
• varicose veins, increased blood pressure,
• abdominal pain, vomiting, dyspepsia, flatulence, gastritis, diarrhoea,
• acne, itching, rash,
• pain-related complaints, e.g. back pain, limb pain, muscle cramps,
• fungal vaginal infections, pelvic pain, breast enlargement, benign breast lumps, 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.

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

• fungal infection (mycosis),
• decreased number of red blood cells in the blood (anaemia), increased number of platelets (thrombocytopenia),
• allergic reaction,
• endocrine disorders (hormonal disturbances),
• 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. blepharitis, dry eye,
• abnormally rapid heartbeat,
• phlebitis, fainting,
• nosebleeds,
• abdominal distension, intestinal disorders, bloating sensation, abdominal hernia, fungal infection of the mouth, constipation, dry mouth,
• biliary or gallbladder pain, cholecystitis,
• yellow-brown skin patches, eruptions, hair loss, acneiform dermatitis, dry skin, nodular dermatitis, hirsutism, skin disorders, striae, dermatitis, photoallergic dermatitis, skin nodules,
• dyspareunia, vaginal inflammation (vulvovaginitis), post-coital bleeding, cessation of bleeding, breast cyst, increased number of breast gland cells (hyperplasia), malignant breast tumours, abnormal endometrial hyperplasia, atrophy or shrinkage of the endometrium, 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/intestines, kidneys or eye. The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clots).

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

• hypersensitivity,
• erythema multiforme (rash with red, target-shaped lesions or ulceration).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 to provide more information on the safety of the medicine.

5. How to store the medicine Daylette

Keep the 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 carton and blister pack. 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 pack 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, polyvinylpyrrolidone, polyethylene glycol copolymer, magnesium stearate.
Coating Opadry II White 85G18490 (polyvinyl alcohol, titanium dioxide (E 171), talc, polyethylene glycol 3350, soy lecithin).
Green coated tablets (placebo)
Core: microcrystalline cellulose, lactose, pregelatinized corn starch, magnesium stearate, colloidal anhydrous silica.
Coating Opadry II Green 85F21389 (polyvinyl alcohol, titanium dioxide (E 171), polyethylene glycol 3350, talc, indigo carmine, lake (E 132), quinoline yellow, lake (E 104), black iron oxide (E 172), orange yellow, 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 is embossed the code "G73", the other side is smooth.
Placebo coated tablet: green, round, biconvex coated tablet with a diameter of approximately 6 mm, without embossing.

Daylette 3 mg + 0.02 mg coated tablets are packed in PVC/PE/PVDC-Al blisters. The blisters are placed in a cardboard box containing the patient leaflet, a holder for blister storage, and adhesive strips labelled with days of the week.

Pack sizes:
1×(24+4) coated tablets
3×(24+4) coated tablets
6×(24+4) coated tablets

A cardboard sachet is included in the pack, into which the blister should be placed after removal from the protective foil.

For more detailed information about the medicine, contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing Authorisation number in Portugal, country of export: 5370168
Parallel Import Licence number: 521/15