Daylette

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. The information on the immediate packaging is 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 you suspect symptoms of blood clot formation (see section 2 "Blood clots").

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

• Keep this leaflet, so that you can read it again if necessary.
• 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 them.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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 do not contain any 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 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 can 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 tests.
This leaflet describes several situations in which you should stop taking 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 methods or temperature-based methods. These methods may be unreliable because Daylette alters 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 take 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 contraceptive method may be more suitable.

Do not use Daylette:

• if you currently have (or have ever had) a blood clot in the blood vessels of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if you know you have blood clotting disorders—for example, 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 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);
• if you have any of the following diseases 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 ever had) a type of migraine called "migraine with aura";
• if you currently have (or have previously had) liver disease and liver function remains abnormal;
• if you have kidney function disorders (kidney failure);
• if you currently have (or have previously had) liver tumour;
• if you currently have (or have previously had) 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). 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 taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (also see section "Daylette with other medicines").

Warnings and precautions
Before starting to take Daylette, discuss it with your doctor or pharmacist.

When should you contact your doctor?
You should contact your doctor immediately:

• if you notice possible symptoms of blood clots, which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lungs (pulmonary embolism), a 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 blood clots".

Tell your doctor if you have any of the following conditions.
Special caution may be needed when taking Daylette or any other combined oral contraceptive. Regular medical check-ups may also be necessary. If you have any of the conditions listed below, inform your doctor before starting Daylette. If any of these symptoms appear or worsen during treatment with Daylette, you should 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 potentially with breathing difficulties, seek immediate medical attention. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema;

• if your 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 hemolytic uremic syndrome (a blood clotting disorder leading to kidney failure);

• if you have sickle cell anemia (an inherited disorder of red blood cells);

• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have a positive family history of this condition. Hypertriglyceridemia 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 with blood clots);

• 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, herpes gestationis (blistering skin rash during pregnancy), Sydenham's chorea (a nervous system disorder causing involuntary movements));

• if you have or have ever had brownish patches (chloasma), also known as melasma, especially on the face. In such cases, avoid direct exposure to sunlight or ultraviolet radiation.

Discuss this with your doctor before starting Daylette.

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 disorders").

Full recovery after a blood clot is not always possible. 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 taking Daylette is low.

HOW TO RECOGNIZE BLOOD CLOTS
Seek immediate medical attention 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, especially if accompanied by:
  • pain or tenderness in the leg, which may occur only 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;
• Sudden cough without an obvious cause, which may be associated with 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 shortness of breath, may be mistaken for milder conditions.

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 developing blood clots in veins (venous thrombosis). Although these adverse events 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 blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of taking combined hormonal contraceptives for the first time. 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 remains higher than in women who do not use combined hormonal contraceptives.
If a woman stops taking Daylette, the risk of blood clots returns to normal within a few weeks.

What does the risk of blood clots in veins depend on?
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 associated with the use of Daylette is small.

• In the course of one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and who are not pregnant will develop blood clots.
• In the course of 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 the course of 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's medical history (see "Factors that increase the risk of blood clots," below).

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

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

The risk of developing blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots, particularly if the patient has another risk factor listed above.
It is important to tell your doctor if any of the listed factors apply to you, even if you are uncertain. Your doctor may decide to discontinue the use of Daylette.
You should inform your doctor if any of the above conditions change during treatment with Daylette, for example, if a close family member is diagnosed with thrombosis of unknown cause or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in the arteries?
As with venous blood clots, arterial blood clots can cause serious consequences, such as heart attack or stroke.

Factors increasing the risk of arterial blood clots
It is important to note that the risk of heart attack or stroke associated with the use of Daylette is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Daylette, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years of age, her doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient 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 patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve disorder, heart rhythm disorder known as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of blood clots may be further increased.
You should inform your doctor if any of the above conditions change during treatment with Daylette, for example, if the patient starts smoking, a close family member is diagnosed with thrombosis of unknown cause, or if the patient gains significant weight.

Daylette and cancer
A slightly higher incidence of breast cancer has been observed in women using combined oral contraceptives, but it is not known whether this is caused by taking the pills. For example, more tumours 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 your doctor if you feel any lump.

Benign liver tumours have been reported, rarely, in women using oral contraceptives, and malignant liver tumours have been reported even more rarely. If the patient experiences an 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 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 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 have been taken correctly, there have been no episodes of vomiting or severe diarrhoea, and no other medicines have been taken, it is very unlikely that the woman is pregnant.
If expected menstrual bleeding does not occur in two consecutive cycles, this may indicate pregnancy. The patient should contact her doctor immediately. The next pack of Daylette should only be started once the patient has confirmed she is not pregnant.

Daylette and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines she plans to take.
Inform your doctor about any medicines or herbal products the patient is using. You should also inform any other doctor, dentist (or pharmacist) who may prescribe another medicine to be used together with Daylette.
These healthcare professionals may advise whether additional contraceptive methods (e.g. condoms) should be used, and if so, for how long, or whether the 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 (increased liver enzyme activity, AlAT).
Before starting these medicines, the doctor will prescribe another type of contraception.
Daylette may be restarted approximately 2 weeks after completing 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 remedy containing St John's wort ( Hypericum perforatum ). If the patient wishes to use herbal products containing St John's wort while taking Daylette, she should first consult her doctor.

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

• cyclosporine (a medicine used to prevent tissue rejection after organ transplant surgery),
• the antiepileptic drug lamotrigine (this may lead to an increased frequency of seizures),
• tizanidine (a medicine used to treat muscle spasticity),
• theophylline (a medicine 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, and should be swallowed with a small amount of water if necessary.
Laboratory tests
If a blood test is required, inform the 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 the patient is pregnant or breast-feeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before taking this medicine.
Pregnancy
Daylette must not be taken during pregnancy. If the patient becomes pregnant while taking Daylette, she should stop taking it immediately and contact her doctor.
If the patient wishes to become pregnant, she may stop taking Daylette at any time (see section: "Discontinuation of Daylette").
Before taking any medicine, consult your doctor or pharmacist.
Breast-feeding
Daylette is generally not recommended while breast-feeding. If the patient wishes to take oral contraceptives during breast-feeding, she should contact her doctor.
Before taking 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, lac (E 110) and soya lecithin.
One white coated active tablet of Daylette (containing the active substances) contains 48.53 mg of monohydrate lactose, and one green coated inactive tablet contains 37.26 mg of lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.
The white coated active tablets contain 0.07 mg of soya lecithin. If the patient is allergic to peanuts or soya, she should not take this medicine.
The green coated placebo tablets (non-hormonal) contain orange yellow, lac (E 110) – a dye which may cause allergic reactions.

3. How to take 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 every day, swallowing it with a small amount of water if necessary. The 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, then take the green tablet for the last 4 days. Then immediately start taking tablets from a new blister (24 white tablets and 4 green tablets). Therefore, there is no break between blisters.

Due to differences in tablet composition, it is essential to start taking the medicine from the tablet in position 1 on the blister marked as "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

To help monitor correct tablet intake, the package contains 7 adhesive strips labelled 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 apply the strip within the area bounded by the blue line (in the frame). The name of each day of the week will then correspond to a specific column of tablets.

The day of the week written above each tablet will help verify whether the tablet has been taken that day. Move 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 bleed). 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 taken in this way, Daylette provides protection against pregnancy also 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 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 the 2nd and 5th day 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 contraceptive patch)
  You may start 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 system (patch), follow your doctor's advice.

• Switching from a progestogen-only method (progestogen-only pills, injection, implant or intrauterine system releasing progestogen, IUS)
  You may switch on any day from progestogen-only pills (or from an implant or intrauterine system releasing progestogen, IUS, on the day of removal, or from an injectable form 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 tablet intake.

• After miscarriage
  Follow your doctor's advice.

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

• If the patient is breastfeeding and wishes to start taking Daylette (again) after childbirth
  Please read 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 appear. In young girls before the onset of the first menstruation, vaginal bleeding may also occur if the medicine is taken accidentally.
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 tablets is missed, this 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 of the blister), follow these instructions:

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

The risk of inadequate protection against pregnancy 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 chart below):

• More than one tablet has been missed from the blister
  Consult your doctor.
• One tablet was missed on days 1 to 7 (first row of tablets in the blister)
  Take the missed tablet as soon as you remember, 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 was missed on days 8 to 14 (second row of tablets in the blister)
  Take the missed tablet as soon as you remember, 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 was 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 you remember, 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 them) 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 green placebo tablets, but spotting or breakthrough bleeding may also occur during the second blister.
  2. You may also stop taking the white active tablets and go directly to taking the 4 green placebo tablets ( before taking the placebo tablets, record the day on which you forgot to take the tablet ). 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 has forgotten 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.

What to do in case of vomiting or severe diarrhoea

If vomiting occurs within 3–4 hours after taking the white tablet containing the active substance, or if severe diarrhoea occurs, there is a risk that the active substances from the tablet have not been completely absorbed by the body.
This situation is similar to missing tablets. 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 going directly to a new blister of Daylette until the pack is finished. During intake of the tablets from the second blister, slight bleeding or spotting may occur. Tablets from the second blister should be taken until 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 first day of menstruation: what you should know

If the patient takes the tablets as directed, menstrual bleeding will begin during the placebo days. If the patient wishes to change the day when bleeding occurs, she should reduce the number of placebo days—i.e. the days when green placebo tablets are taken—(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. However, 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, 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 about using 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 which the patient considers to be related to the use of Daylette, medical advice should be sought.
Serious adverse effects
Seek immediate medical advice if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and (or) throat and (or) difficulty in swallowing, or urticaria potentially accompanied by 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, refer to section 2: "Important information before using 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, dyspepsia, flatulence, gastritis, diarrhoea,
• acne, itching, rash,
• pain-related symptoms, e.g. back, limb pain, muscle cramps,
• vaginal fungal infection, pelvic pain, breast enlargement, benign breast tumours, uterine/vaginal bleeding (which usually decreases during 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 (mycosis),
• decreased number of red blood cells in the blood (anaemia), increased number of platelets (thrombocytopenia),
• allergic reaction,
• endocrine 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 eye,
• abnormally rapid heartbeat,
• phlebitis, fainting,
• nosebleed,
• abdominal distension, intestinal disorders, bloating sensation, abdominal hernia, oral fungal infection, constipation, dry mouth,
• biliary or gallbladder pain, gallbladder inflammation,
• yellowish-brown skin patches, skin eruptions, hair loss, acneiform dermatitis, dry skin, nodular dermatitis, excessive hair growth, skin disorders, stretch marks, dermatitis, photoallergic dermatitis, skin nodules,
• dyspareunia (painful intercourse), vaginal inflammation (vulvovaginitis), post-coital bleeding, bleeding cessation, breast cyst, increased number of breast gland cells (hyperplasia), malignant breast tumours, abnormal endocervical hyperplasia, endometrial atrophy or shrinkage, ovarian cysts, uterine enlargement,
• general malaise,
• weight loss,
• harmful blood clots in veins or arteries, 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 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 ulcerations).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: + 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 this medicine.

5. How to store the medicine Daylette

Keep the 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 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 ingredients are:
White coated tablets containing the active substances:
monohydrate lactose, corn starch, pregelatinized corn starch, graft copolymer of polyvinyl alcohol and
polyvinyl acetate, magnesium stearate.
Coating Opadry II 85G18490 White: polyvinyl alcohol, titanium dioxide (E 171), talc, polyethylene glycol
3350, soy lecithin.
Green coated tablets (placebo):
microcrystalline cellulose, lactose, pregelatinized corn starch, magnesium stearate, colloidal anhydrous
silica.
Coating Opadry II 85F21389 Green: polyvinyl alcohol, titanium dioxide (E 171), polyethylene glycol
3350, talc, indigo carmine lake (E 132), quinoline yellow lake (E 104), iron oxide black (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 there is an embossed marking "G73", the other side of
the tablet is smooth.
Placebo coated tablet: green, round, biconvex coated tablet with a diameter of approximately 6 mm,
without 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 pouch for storing the blister packs, and adhesive strips labelled with
days of the week.
Pack size:
1 x (24+4) coated tablets
For further detailed information, please contact the marketing authorization holder or the parallel
importer.
Marketing Authorization 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorization number in Portugal, country of export: 5370176
Parallel Import Authorization number: 267/20