Dailette

Leaflet accompanying the packaging: patient information

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.
• They slightly 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 blood clots 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 in case it needs to be read again.
• 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 side effects, including any side effects not listed in this leaflet, they should inform 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 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 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 the health of her close relatives. The doctor will also measure blood pressure and, depending on the individual case, may perform some other examinations.
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, such as condoms or other mechanical methods.
The observational method or temperature measurement method should not be used. These methods may be unreliable because Daylette modifies the monthly changes in body temperature and cervical mucus.

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

When not to use Daylette

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 - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2 "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 a transient ischemic attack (temporary 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 problems (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 they have breast cancer or cancer of the genital organs;
• 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 soy lecithin. If the patient is allergic to peanuts or soy, they should not use 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 should the patient contact their doctor?
The patient should see their doctor immediately

• if they notice any of the following symptoms, which could be signs of a blood clot: swelling of the leg or along a vein in the leg or foot, especially if it is accompanied by: pain or tenderness in the leg, which may only be felt when standing or walking; increased warmth of the affected leg; change in the color of the leg, such as paleness, redness, or discoloration.

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

In certain situations, the patient should exercise caution when using Daylette or any other combined oral contraceptive. Regular medical check-ups may also be necessary. If any of the following conditions are present, 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, which may be associated with difficulty breathing, they should see their doctor immediately. Products containing estrogens may cause or worsen the 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 (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 genetic disorder of red blood cells);
• if the patient has been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or has a family history of this condition. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if the patient has recently given birth, as they are at increased risk of blood clots. The patient should consult their doctor about 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 hormonal contraceptives (e.g., hearing loss, porphyria, a skin rash with blisters during pregnancy, Sydenham's chorea);

Before starting to use Daylette, the patient should discuss it with their doctor.

Blood Clots

The use of combined hormonal contraceptives, such as Daylette, is associated with an increased risk of blood clots, compared to not using them. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur:

• in the veins (also known as "venous thromboembolism" or "deep vein thrombosis");
• in the arteries (also known as "arterial thromboembolism").

Not everyone who has a blood clot will recover completely. In rare cases, the effects of a blood clot can be long-term or, very rarely, fatal.

Remember that the overall risk of having a harmful blood clot due to Daylette is small.

How to recognize a blood clot

The patient should see 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 be suffering from

• swelling of the leg or along a vein in the leg or foot, especially if it is accompanied by: pain or tenderness in the leg, which may only be felt when standing or walking; increased warmth of the affected leg; change in the color of the leg, such as paleness, redness, or discoloration;
• sudden severe difficulty breathing or rapid breathing;
• sudden cough 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 stomach pain.

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 thromboembolism). Although these side effects are rare, they can occur, especially in the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, it can lead to deep vein thrombosis.
• If a blood clot breaks loose from the leg and travels to the lungs, it can cause a 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 veins highest?

The risk of blood clots in veins is highest during the first year of using 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, but it is always higher than when not using combined hormonal contraceptives.
If the patient stops using Daylette, the risk of blood clots returns to normal within a few weeks.

What factors 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 severely overweight (body mass index (BMI) over 30 kg/m2);
• if someone in the patient's close family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years old). In this case, the patient may have a genetic blood clotting disorder;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• 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.
Long-haul flights (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to inform the doctor if any of these risk factors are present, even if the patient is not sure. The doctor may decide to stop the use of Daylette.
The patient should inform their doctor if any of these conditions change while using Daylette, e.g., if someone in their close family is diagnosed with a blood clot without a known cause or if the patient gains weight significantly.

Blood Clots in Arteries

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

Similar to blood clots in veins, blood clots in arteries can cause serious complications, 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 heart attack or stroke associated with Daylette is very small, but it may increase:

• with age (over approximately 35 years old);
• if the patient smokes.When using a hormonal contraceptive like Daylette, it is recommended to stop smoking. If the patient is unable to stop 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 someone in the patient's close family has 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 having a heart attack or stroke;
• if the patient or someone in their close family 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 damage, heart rhythm disturbance called atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of these conditions or if any of them are severe, the risk of blood clots may be even higher.
The patient should inform their doctor if any of these conditions change while using Daylette, e.g., if they start smoking, if someone in their close family is diagnosed with a blood clot without a known cause, or if they gain weight significantly.

Daylette and Cancer

Women using combined oral contraceptives have a slightly higher risk of breast cancer, but it is not known if this is caused by the pill. For example, it may be that more tumors are detected in women using combined oral contraceptives because they are examined by doctors more often.
The incidence of breast tumors decreases gradually after stopping the use of combined hormonal contraceptives. It is essential to examine the breasts regularly and consult a doctor if any lump is found.
Women using oral contraceptives have been reported to have, in rare cases, benign liver tumors, and even more rarely, malignant liver tumors. If the patient experiences severe abdominal pain, they should consult a doctor.

Psychiatric Disorders

Some women using hormonal contraceptives, including Daylette, have reported depression or mood changes. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, the patient should consult 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 placebo period) 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 placebo period

If all the active white tablets have been taken correctly, there has been no vomiting, or severe diarrhea, and no other medicines have been taken, it is very unlikely that the patient is pregnant.
If the expected menstrual bleeding does not occur for two consecutive periods, it may indicate pregnancy.
The patient should consult 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 inform 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 taken at the same time as Daylette.
These healthcare professionals may tell the patient whether they should use additional contraceptive methods (e.g., condoms) and for how long or whether they should change the dose of other medicines they are taking.
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 these medicines, the doctor will prescribe a different contraceptive method.
Daylette can be started again about 2 weeks after the end of the above-mentioned treatment. See section "When not to use Daylette".
Certain medicines may affect the level of Daylette in the blood and may cause reduced effectiveness in preventing pregnancyor 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),
• a herbal medicine 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 lamotrigine (this may lead to an increased risk 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 inform their doctor or laboratory staff that they are taking oral contraceptives, 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 baby, they should consult their doctor or pharmacist before using Daylette.
Pregnancy
Daylette should not be used during pregnancy. If the patient becomes pregnant while using Daylette, they should stop taking it immediately and consult their doctor.
If the patient wants to become pregnant, they can stop using Daylette at any time (see section "Stopping Daylette").
Before taking any medicine, the patient should consult their doctor or pharmacist.
Breastfeeding
Daylette is not recommended for use during breastfeeding. If the patient wants to take oral contraceptives while breastfeeding, they should consult their doctor.
Before taking 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 machinery.

Daylette Contains Lactose, Orange Yellow S, and Soy Lecithin

One active white film-coated tablet of Daylette contains 48.53 mg of lactose monohydrate, and one inactive green film-coated tablet contains 37.26 mg of lactose.
If the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking Daylette.
The active white tablets contain 0.070 mg of soy lecithin. If the patient is allergic to peanuts or soy, they should not use this medicine.
The inactive green tablets contain Orange Yellow S (E110) - a dye that may cause allergic reactions.

3. How to Use Daylette

This medicine should always be used as directed by the doctor. If the patient is unsure, they should consult their doctor or pharmacist.
Each blister pack contains 24 active white tablets and 4 inactive green tablets.
The tablets are arranged in order, with the days of the week marked on the blister pack.
The patient should take one Daylette tablet every day, with a small amount of water if necessary. The tablets can be taken at any time of day, with or without food, but the patient should try to 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 an active white tablet, and then an inactive green tablet for the last 4 days. After that, they should start a new blister pack (24 active white tablets and 4 inactive green tablets) immediately. There is no break between blister packs.

Preparing the Blister Pack

To help the patient keep track of their tablets, the packaging includes 7 stickers with the days of the week. The patient should choose a sticker that starts with the day they want to start taking the tablets. For example, if they want to start on a Wednesday, they should use the sticker that says "WED".
The patient should place the sticker on the blister pack, aligning the symbol " " on the sticker with the same symbol on the blister pack, and attach the sticker to the area outlined by the black line (in the frame). The day of the week on the sticker will correspond to the correct column of tablets.
The day of the week marked on each tablet will help the patient check if they have taken a tablet on a given day.
The patient should move through the tablets in the direction of the arrow on the blister pack until they have taken all 28 tablets.
During the 4 days when the patient takes the inactive green tablets (placebo days), they should experience bleeding (so-called withdrawal bleeding). This usually starts on the 2nd or 3rd day after taking the last active white tablet and may last until the end of the placebo period.

• The patient should start a new blister pack immediately, regardless of whether the bleeding has stopped or not. This means that the patient will always start a new blister pack on the same day of the week, and the withdrawal bleeding will occur on the same day every month.

Daylette provides contraceptive protection during these 4 days of placebo use.

When to Start the First Blister Pack

• If the patient has not used hormonal contraceptives in the previous monthThe patient should start taking Daylette on the first day of their period (the first day of menstruation). If the patient starts taking Daylette on the first day of their period, they will be protected against pregnancy immediately. The patient can also start taking Daylette between the 2nd and 5th day of their period, but they will need to use an additional contraceptive method (e.g., condoms) for the first 7 days of tablet-taking.
• Changing from a combined hormonal contraceptive (combined oral contraceptive, vaginal ring, or patch)The patient can start taking Daylette the day after taking the last active tablet of their previous combined hormonal contraceptive, but no later than the day after the usual tablet-free period or the day after taking the last inactive tablet of their previous contraceptive.
• Changing from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system)The patient can switch from a progestogen-only pill on any day, from an implant or intrauterine system on the day of its removal, or from an injection when the next injection is due. In all cases, the patient should use additional contraceptive methods (e.g., condoms) for the first 7 days of tablet-taking.
• After a miscarriageThe patient should follow their doctor's advice.
• After childbirthThe patient can start taking Daylette between 21 and 28 days after giving birth. If the patient starts taking Daylette more than 28 days after giving birth, they should use an additional contraceptive method (e.g., condoms) for the first 7 days of tablet-taking. If the patient has had sex since giving birth (again), they should make sure they are not pregnant before starting Daylette.
• If the patient is breastfeeding and wants to start using Daylette again after giving birthThe patient should read the section "Breastfeeding".

If the patient is unsure when to start the first blister pack, they should consult their doctor.

Overdose of Daylette

There have been no reports of serious harmful effects from taking too many Daylette tablets.
If the patient takes several tablets at once, they may experience nausea or vomiting or may have irregular bleeding. In young girls before their first 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, they should consult their doctor or pharmacist immediately.

4. Possible Side Effects

Like all medicines, Daylette can cause side effects, although not everybody gets them.
If side effects occur, especially serious and persistent ones or changes in health that the patient considers to be related to the use of Daylette, the patient should consult a doctor.
Serious side effects
The patient should immediately consult a doctor if she 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 different risk factors associated with the use of combined hormonal contraceptives, the patient should refer to section 2 "Important Information Before Taking Daylette".
The following side effects have been reported during the use of drospirenone and/or ethinylestradiol:

• mood changes,
• headache,
• nausea,
• breast pain, menstrual disorders, such as irregular menstruation or absence of menstruation.

Common side effects (may occur in up to 1 in 10 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, changes in menstrual bleeding, painful, scanty, or very heavy menstruation, vaginal dryness, abnormal Pap smear, decreased libido,
• lack of energy, increased sweating, fluid retention,
• weight gain.

Uncommon side effects (may occur in up to 1 in 100 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,
• nosebleeds,
• enlarged abdomen, gastrointestinal disorders, bloating, hernia, fungal infection of the mouth, constipation, dry mouth,
• bile duct or gallbladder pain, cholecystitis,
• brown-yellow 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, 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 patient should tell the doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information 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 carton and blister pack. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask the pharmacist how to dispose of medicines that are no longer needed. 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.
The other ingredients are:
White film-coated tablets containing active substances
Core: lactose monohydrate, corn starch, pregelatinized corn starch, copolymer of polyvinyl alcohol and polyvinyl acetate, magnesium stearate.
Coating: polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350, soybean lecithin.
Green film-coated tablets (placebo)
Core: microcrystalline cellulose (type 12), 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 Contents of the Pack

Active 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 is smooth.
Placebo film-coated tablet: green, round, biconvex film-coated tablet with a diameter of about 6 mm, without embossing.
Daylette 3 mg + 0.02 mg film-coated tablets are packaged in PVC/PE/PVDC/Aluminum blisters.
The blisters are packaged in a cardboard box, containing a patient information leaflet, a case for storing the blisters, and labels in the form of strips marked with the days of the week.
Pack sizes:
1×(24+4) film-coated tablets
3×(24+4) film-coated tablets
6×(24+4) film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Gedeon Richter Plc.
1103 Budapest
Gyömrői út 19-21
Hungary
To obtain more detailed information about the medicine and its names in other EU member states, the patient should contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 (22)755 96 48
lekalert@grodzisk.rgnet.org

Date of Last Revision of the Leaflet: January 2023

(marketing authorization holder's logo)