Dailette

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Daylette

3 mg + 0.02 mg, film-coated tablets

Drospirenone + Ethinylestradiol

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• To a small extent, they increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
• Caution should be exercised and a doctor should be consulted if the patient suspects that symptoms of a blood clot have occurred (see section 2 "Blood clots").

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, a doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Daylette and what is it used for
• 2. Important information before using Daylette
• 3. How to use Daylette
• 4. Possible side effects
• 5. How to store Daylette
• 6. Contents of the packaging and other information

1. What is Daylette and what is it used for

• Daylette is a contraceptive pill and is 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 film-coated tablets do not contain active substances and are also called placebo tablets.
• Contraceptives containing two hormones are called combined 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 especially important to read about the symptoms of blood clots (see section 2 "Blood clots").
Before starting to use Daylette, the doctor will ask the patient a few questions about her health and about the health of her close relatives. The doctor will also measure blood pressure and, depending on the individual case, may also perform some other tests.
This leaflet describes several situations in which Daylette should not be used or in which the effectiveness of Daylette may be reduced. In such situations, either no sexual intercourse should be maintained or additional non-hormonal contraceptive methods should be used, e.g. condoms or other mechanical methods.
The observational method or temperature measurement method should not be used. These methods may be unreliable because Daylette modifies 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

Daylette should not be used if the patient has any of the following conditions. If the patient has any of the following conditions, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.
When not to use Daylette

• if the patient currently has (or has ever had) a blood clot in the blood vessels of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if the patient knows they have blood coagulation disorders - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient requires surgery or will be immobilized for a long time (see "Blood clots");
• if the patient has had a heart attack or stroke;
• if the patient has (or has had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or transient ischemic attack (transient stroke symptoms);
• if the patient has any of the following diseases, which may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fats in the blood (cholesterol or triglycerides),
• a disease called hyperhomocysteinemia.
• if the patient has (or has had in the past) a type of migraine called "migraine with aura";
• if the patient has (or has had in the past) liver disease, and liver function is still abnormal;
• if the patient has kidney function disorders (kidney failure);
• if the patient has (or has had in the past) liver cancer;
• if the patient has (or has had in the past) or suspects breast cancer or genital cancer;
• if the patient has any unexplained vaginal bleeding.
• if the patient is 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 the patient is allergic to peanuts or soya, they should not take this medicine.

Daylette should not be used in patients with hepatitis C and taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Daylette and other medicines").

Warnings and precautions

Before starting to use Daylette, the patient should discuss it with their doctor or pharmacist.
When to contact a doctor?
The patient should contact their doctor immediately

• if they notice any likely symptoms of a blood clot, which may indicate that they have a blood clot in their leg (deep vein thrombosis), blood clot in their lungs (pulmonary embolism), heart attack, or stroke (see below "Blood clots (thrombosis)").

In order to describe the symptoms of these serious side effects, see "How to recognize a blood clot".

The patient should tell their doctor if they have any of the following conditions.

In certain situations, the patient should be particularly careful when using Daylette or any other combined contraceptive pill. Regular medical check-ups may also be necessary. If any of the following conditions occur, the patient should inform their doctor before starting to use Daylette. If these symptoms occur or worsen during the use of Daylette, the patient should also tell their doctor.

• if the patient experiences symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives potentially with difficulty breathing, they should contact their doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary and acquired angioedema;
• if any of the patient's close relatives have had breast cancer;
• if the patient has liver or gallbladder disease;
• if the patient has diabetes;
• if the patient has depression or mood changes;
• if the patient has Crohn's disease or ulcerative colitis (a chronic inflammatory bowel disease);
• if the patient has systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if the patient has hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if the patient has sickle cell anemia (a hereditary disease of red blood cells);
• if the patient has elevated levels of fats in the blood (hypertriglyceridemia) or a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if the patient requires surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if the patient has recently given birth, they are at increased risk of blood clots. The patient should consult their doctor for information on how soon they can start taking Daylette after giving birth;
• if the patient has superficial thrombophlebitis (blood clots in the veins under the skin);
• if the patient has varicose veins;
• if the patient has epilepsy (see "Daylette and other medicines");
• if the patient has a disease that first appeared during pregnancy or while using sex hormones (e.g. hearing loss, a blood disease called porphyria, herpes gestationis (a skin rash that occurs during pregnancy), Sydenham's chorea (a nervous system disease characterized by involuntary movements of the body);

If the patient has any of the above conditions or if any of them are particularly severe, the risk of a blood clot may be even higher.
The patient should inform their doctor if any of the above conditions change during the use of Daylette, e.g. if they start smoking, if any of their close relatives are diagnosed with a blood clot without a known cause, or if they gain weight significantly.

Blood clots

The use of combined hormonal contraceptives, such as Daylette, is associated with an increased risk of blood clots, compared to when no therapy is used. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur:

• in veins (also called "venous thrombosis" or "venous thromboembolic disease");
• in arteries (also called "arterial thrombosis" or "arterial thromboembolic disease").

Not all patients who have a blood clot will recover completely. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

It should be remembered that the total risk of a blood clot caused by Daylette is small.

How to recognize a blood clot

The patient should contact their doctor immediately if they notice any of the following symptoms.
Is the patient experiencing any of these symptoms?
Why is the patient likely to suffer

• swelling of the leg or swelling along a vein in the leg or foot, deep vein thrombosis, especially if it is accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking;
• increased temperature in the affected leg;
• change in skin color of the leg, e.g. pallor, redness, or cyanosis
• sudden onset of unexplained shortness of breath or rapid breathing;
• sudden onset of coughing without an obvious cause, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe abdominal pain.

If the patient is unsure, they should contact their doctor, because some of these symptoms, such as coughing or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g. a cold).

Blood clots in veins

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

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

When is the risk of blood clots in a vein highest?

The risk of forming a blood clot in a vein is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher compared to when combined hormonal contraceptives are not used.
If the patient stops using Daylette, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots?

The risk depends on the natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The total risk of blood clots in the legs or lungs associated with Daylette is small.

• During a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• During a year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• During a 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 blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots", below).

Risk of blood clots in a year

Women who do not usecombined hormonal pills/plasters/systems and are not pregnant
About 2 out of 10,000 women
Women using combined hormonal contraceptive pills
containing levonorgestrel, norethisterone, or norgestimate
About 5-7 out of 10,000 women
Women using Daylette
About 9-12 out of 10,000 women

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with Daylette is small, but some factors can increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) over 30 kg/m2);
• if any of the patient's close relatives have had blood clots in their legs, lungs, or other organs at a young age (e.g. under 50 years old). In this case, the patient may have hereditary blood coagulation disorders;
• if the patient must undergo surgery or will be immobilized for a long time due to injury or illness or has a leg in a cast. It may be necessary to stop using Daylette for a few weeks before surgery or immobilization. If the patient must stop using Daylette, they should ask their doctor when they can resume using the medicine;
• with age (especially over 35 years old);
• if the patient has recently given birth.

The risk of 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, especially if the patient has another risk factor.
It is essential to tell the doctor if any of the above factors are present, even if the patient is unsure. The doctor may decide to stop using Daylette.
The patient should inform their doctor if any of the above conditions change during the use of Daylette, e.g. if they start smoking, if any of their close relatives are diagnosed with a blood clot without a known cause, or if they gain weight significantly.

Blood clots in arteries

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

Similarly to blood clots in veins, blood clots in arteries can cause serious consequences, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is essential to note that the risk of a heart attack or stroke associated with Daylette is very small, but it may increase:

• with age (over about 35 years old);
• if the patient smokes. While using a hormonal contraceptive like Daylette, it is recommended to quit smoking. If the patient cannot quit smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if any of the patient's close relatives have had a heart attack or stroke at a young age (under 50 years old). In this case, the patient may also be at increased risk of a heart attack or stroke;
• if the patient or any of their close relatives have had 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 damage, arrhythmia called 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 a blood clot may be even higher.
The patient should inform their doctor if any of the above conditions change during the use of Daylette, e.g. if they start smoking, if any of their close relatives are diagnosed with a blood clot without a known cause, or if they gain weight significantly.

Daylette and cancer

In women using combined contraceptive pills, breast cancer is slightly more common, but it is not known if this is caused by the pills. For example, it may be that more tumors are detected in women using combined contraceptive pills because they are examined by doctors more often.
The frequency of breast cancer decreases gradually after stopping the use of combined hormonal contraceptives. It is essential to examine the breasts regularly and contact a doctor if any lump is felt.
In rare cases, women using contraceptive pills have been reported to have benign liver tumors, and in even rarer cases, malignant liver tumors. If the patient experiences unusual, severe abdominal pain, they should contact their 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 and symptoms of depression occur, the patient should contact their doctor as soon as possible for further medical advice.

Irregular bleeding

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

What to do if menstrual bleeding does not occur during the days of taking placebo tablets

If all the white tablets containing active substances were taken correctly, there was no vomiting or severe diarrhea, and no other medicines were taken, it is very unlikely that the patient is pregnant.
If the expected menstrual bleeding does not occur for two consecutive times, it may indicate pregnancy.
The patient should contact their doctor immediately. They should only start the next pack of Daylette when they are sure they are not pregnant.

Daylette and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should tell their doctor about any herbal products they are using. They should also inform any other doctor or dentist (or pharmacist) who may prescribe another medicine to be used at the same time as Daylette.
These individuals may say whether additional contraceptive methods should be used (e.g. condoms) and for how long or whether the doses of other medicines being taken should be changed.
Daylette should not be used in patients with hepatitis C and 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).
Before starting to take these medicines, the doctor will prescribe a different type of contraception.
Daylette can be started again after about 2 weeks from the end of the above-mentioned treatment. See the section "When not to use Daylette".
Some medicines may affect the level of Daylette in the blood and may reduce its 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 (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)
• fungal infections (e.g. griseofulvin, ketoconazole),
• high blood pressure in the blood vessels of the lungs (bosentan),
• symptomatic treatment of osteoarthritis (etoricoxib),
• herbal products containing St. John's wort (Hypericum perforatum). If the patient wants to use herbal products containing St. John's wort while taking Daylette, they should consult their doctor first.

Daylette may affect the action of other medicines, such as:

• cyclosporin (a medicine used to prevent organ rejection after transplants),
• the antiepileptic medicine 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, the patient should consult their doctor or pharmacist.

Daylette with food and drink

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

Lab tests

If a blood test is necessary, the patient should tell their doctor or laboratory staff that they are taking contraceptive pills, as hormonal contraceptives may affect the results of some tests.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using Daylette.
Pregnancy
Women who are pregnant should not take Daylette. If the patient becomes pregnant while using Daylette, they should stop taking it immediately and contact their doctor.
If the patient wants to become pregnant, they can stop using Daylette at any time (see the section "Stopping Daylette").
Before using any medicine, the patient should consult their doctor or pharmacist.
Breastfeeding
Daylette is not usually recommended for women who are breastfeeding. If the patient wants to take contraceptive pills while breastfeeding, they should contact their doctor.
Before using any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

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

Daylette contains lactose, orange yellow S, and soya lecithin

One white, active film-coated tablet of Daylette (containing active substances) contains 48.53 mg of lactose monohydrate, and one green, inactive film-coated tablet contains 37.26 mg of lactose. If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before using Daylette.
The white, active tablets contain 0.07 mg of soya lecithin. If the patient is allergic to peanuts or soya, they should not take this medicine.
The green, inactive tablets (placebo) contain orange yellow S, and lac (E 110) - a dye that may cause allergic reactions.

3. How to use Daylette

This medicine should always be used as directed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.
Each blister pack contains 24 white tablets containing active substances and 4 green placebo tablets.
The tablets of Daylette, marked with two different colors, are arranged in the correct order.
The blister pack contains 28 tablets.
The patient should take one Daylette tablet every day, with a small amount of water if necessary. The tablets can be taken with or without food, but the patient should take them at the same time every day.
The patient should be careful not to mix up the tablets: for the first 24 days, they should take a white tablet, and then a green tablet for the last 4 days. Then, they should start taking the tablets from a new blister pack (24 white tablets and 4 green tablets) immediately. There is no break between the two blister packs.
Because of the differences in the composition of the tablets, it is necessary to start taking the medicine from the tablet in position 1 on the blister pack marked as "Start". The tablets should be taken every day. To maintain the correct order, the patient should move in the direction of the arrows and numbering on the blister pack.

Preparing the blister pack

To help control the correct taking of the tablets, the packaging contains 7 stickers in the form of strips marked with the symbols of the days of the week. The patient should choose one strip that starts with the symbol of the day they intend to start taking the tablets. For example, if they want to start using Daylette on a Wednesday, they should apply the strip with the inscription "Wed".
The patient should attach the symbol "" on the strip to the same symbol on the blister pack and stick the strip in the area limited by the black line (in the frame). The symbol of each day of the week will correspond to a specific column of tablets.
The symbol of the day of the week above each tablet will make it easier to check if the tablet has been taken on a given day.
The patient should move in the direction of the arrow on the blister pack until all 28 tablets have been taken.
During the 4 days when the patient takes the green placebo tablets (placebo days), menstrual bleeding (so-called "withdrawal bleeding") should start. It usually starts on the 2nd or 3rd day after taking the last white tablet of Daylette containing active substances. After taking the last green placebo tablet, the patient should start the next blister pack, regardless of whether the bleeding has stopped or not. This means that the use of tablets from a new blister pack should always start on the same day of the week, and the withdrawal bleeding should start on the same day every month.
Daylette used in this way also protects against pregnancy during these 4 days when the patient takes the placebo tablets.

When can the first blister pack be started?

If no hormonal contraceptives were used in the previous month

Daylette should be started on the first day of the cycle (i.e. on the first day of menstruation). If Daylette is started on the first day of menstruation, it provides immediate protection against pregnancy. Daylette can 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 taking the tablets.

Changing from a combined hormonal contraceptive (combined oral contraceptive, vaginal ring, or patch)

Daylette can be started the day after taking the last active tablet of the previous combined oral contraceptive, but no later than the day after the usual break in taking the previous combined oral contraceptive (or after taking the last inactive tablet of the previously used tablets).
In the case of changing from a vaginal ring or transdermal patch, the patient should follow the doctor's instructions.

Changing from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen, IUS)

The patient can switch at any time from a progestogen-only pill (from an implant or intrauterine system releasing progestogen, IUS on the day of its removal or from injections on the day of the planned next injection), but in all cases, they should use additional contraceptive methods (e.g. condoms) for the first 7 days of taking the tablets.

After a miscarriage

The patient should follow the doctor's instructions.

After childbirth

Daylette can be started between the 21st and 28th day after childbirth. If Daylette is started later than 28 days, the patient should use a mechanical method (e.g. condoms) for the first 7 days of taking Daylette.
If the patient has had sexual intercourse after giving birth (again), they should first make sure they are not pregnant or wait for their next menstrual period.

If the patient is breastfeeding and wants to start using Daylette (again) after giving birth

The patient should read the section "Breastfeeding".

In case of doubt about when to start the first blister pack, the patient should contact their doctor.

Using more Daylette than prescribed

There are no reports of serious harmful effects from taking too many Daylette tablets at once.
If several tablets are taken at the same time, the patient may experience nausea or vomiting or may have vaginal bleeding. Also, in young girls before their first menstrual period, if they accidentally take this medicine, they may experience vaginal bleeding.
If the patient has taken too many Daylette tablets or if a child has swallowed some of them, they should consult their doctor or pharmacist immediately.

Missing a dose of Daylette

The last 4 tablets in the fourth row of the blister pack are placebo tablets. If one of these tablets is missed, it will not affect the effectiveness of Daylette. The patient should discard the missed placebo tablet.
If the patient forgets to take one of the white, active tablets (tablets 1-24 from the blister pack), they should:

• if it has been less than 24 hourssince the tablet was missed, the contraceptive protection is not reduced. The patient should take the tablet as soon as they remember and then take the next tablets at the usual time.
• if it has been more than 24 hourssince the tablet was missed, the contraceptive protection may be reduced. The more tablets the patient misses, the higher the risk of pregnancy.

The risk of reduced contraceptive protection is highest if the patient misses a white, active tablet at the beginning or end of the blister pack. In such a situation, the patient should follow the rules below (see also the diagram below):

• More than one tablet has been missed from the blister packThe patient should consult their doctor.
• One tablet has been missed in days 1-7 (first row of tablets in the blister pack)The patient should take the missed tablet as soon as they remember, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time, and the patient should use additional protection, such as condoms, for the next 7 days. If the patient had sexual intercourse in the week before missing the tablet, they should be aware that there is a risk of pregnancy. In this case, they should contact their doctor.
• One tablet has been missed in days 8-14 (second row of tablets in the blister pack)The patient should take the missed tablet as soon as they remember, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time. The contraceptive protection is not reduced, so there is no need to use additional contraceptive methods.
• One tablet has been missed in days 15-24 (third or fourth row of tablets in the blister pack)The patient has two options:
• 1. The patient should take the missed tablet as soon as they remember, even if it means taking two tablets at the same time. Then, they should continue taking the tablets at the usual time. Instead of taking the green placebo tablets from the pack, they should skip them (discard them) and start the next pack (the start day will change). It is likely that menstrual bleeding will occur at the end of the second pack, during the green placebo tablets, but it may also occur as spotting or irregular bleeding during the second pack.
• 2. The patient can also stop taking the white, active tablets and go directly to taking the 4 green placebo tablets ( before taking the placebo tablets, the patient should note the day they missed the tablet). If the patient wants to start the next pack on the same day as before, they can take the placebo tablets for less than 4 days.

If the patient follows one of these rules, the contraceptive protection will be maintained.

• If the patient misses any of the tablets from the blister pack and does not experience menstrual bleeding during the placebo days, it may mean that they are pregnant. The patient should contact their doctor before starting the next blister pack.

Missed tablet procedure

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If side effects occur, especially severe and persistent ones or changes in health that the patient considers related to the use of Daylette, a doctor should be consulted.
Severe side effects
A doctor should be contacted 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 hives potentially with difficulty breathing (see also the section "Warnings and precautions").
In all women taking combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, see section 2 "Important information before taking Daylette".
The following side effects have been reported during the use of drospirenone and/or ethinylestradiol:
Common side effects (may occur in up to 1 in 10 people):

• mood swings,
• headache,
• nausea,
• breast pain, menstrual irregularities, such as irregular or absent menstruation.

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

• depression, nervousness,
• dizziness, tingling sensation, drowsiness, migraine,
• varicose veins, high blood pressure,
• abdominal pain, vomiting, indigestion, gas, gastritis, diarrhea,
• acne, itching, rash,
• painful conditions, e.g. back pain, limb pain, muscle cramps,
• vaginal fungal infections, pelvic pain, breast enlargement, benign breast tumors, uterine/vaginal bleeding (which usually decreases during continued use of the medicine), vaginal discharge, hot flashes, vaginal inflammation, menstrual disorders, painful, scanty, or very heavy menstruation, vaginal dryness, abnormal Pap smear, decreased libido,
• lack of energy, increased sweating, fluid retention,
• weight gain.

Rare side effects (may occur in up to 1 in 1000 people):

• fungal infection (fungal infection),
• decrease in red blood cell count (anemia), increase in platelet count (thrombocytopenia),
• allergic reaction,
• hormonal disorders (endocrine),
• increased appetite, loss of appetite, abnormal high potassium levels in the blood, abnormal low sodium levels in the blood,
• inability to achieve orgasm, insomnia,
• dizziness, tremors,
• eye disorders, e.g. conjunctivitis, dry eye,
• abnormal rapid heartbeat,
• phlebitis, fainting,
• nasal bleeding,
• enlarged abdomen, gastrointestinal disorders, feeling of bloating, hernia, oral fungal infection, constipation, dry mouth,
• bile duct or gallbladder pain, cholecystitis,
• yellow-brown spots on the skin, rashes, hair loss, acne-like skin inflammation, dry skin, nodular skin inflammation, excessive hair growth, skin disorders, stretch marks, skin inflammation, photoallergic skin inflammation, skin nodules,
• difficult or painful sexual intercourse, vaginal inflammation (vulvovaginitis), post-coital bleeding, amenorrhea, breast cysts, breast hyperplasia, malignant breast tumors, abnormal cervical smear, cervical erosion or atrophy, 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 stroke-like symptoms, known as a transient ischemic attack,
• 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 more information on risk factors for blood clots and symptoms of blood clots).
Frequency not known (frequency cannot be estimated from the available data):

• hypersensitivity,
• erythema multiforme (rash with redness in the shape of a target or ulcers).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 .
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Daylette

The medicine should be stored 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 month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Package contents 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 film-coated tablets containing active substances:
Core: lactose monohydrate, corn starch, pregelatinized corn starch, copolymer of methacrylic acid and acrylic acid, magnesium stearate.
Coating:polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350, soy lecithin.
Green film-coated tablets (placebo):
Core: microcrystalline cellulose, lactose, pregelatinized corn starch, magnesium stearate, silicon dioxide,
Coating:polyvinyl alcohol, titanium dioxide (E 171), macrogol 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 what the pack contains

Active substance film-coated tablet: white or almost white, round, biconvex film-coated tablet with a diameter of about 6 mm. One side has the embossing "G73", the other side of the tablet is smooth.
Placebo film-coated tablet: green, round, biconvex film-coated tablet with a diameter of about 6 mm, without embossing.
Daylette film-coated tablets are packaged in PVC/PE/PVDC-Al blisters.
Blisters are packaged in a cardboard box containing a patient leaflet, a case for storing blisters, and stickers in the form of strips marked with days of the week.

Pack sizes:

28 tablets (1 x 28 film-coated tablets)
84 tablets (3 x 28 film-coated tablets)
168 tablets (6 x 28 film-coated tablets)

Marketing authorization holder in Portugal, the 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., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Authorization number in Portugal, the country of export:5370176
5370168
Parallel import authorization number:70/20

Date of leaflet approval: 24.01.2025

[Information about the trademark]