PATIENT INFORMATION LEAFLET

Daylette 3mg/ 0.02 mg Film-Coated Tablets

drospirenone / ethinylestradiol

Important Information You Should Know About Combined Hormonal Contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of suffering a blood clot in the veins and arteries, especially in the first year or when restarting use of a combined hormonal contraceptive after a pause of 4 weeks or more.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood Clots”).

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

• Daylette is a hormonal contraceptive and is used to prevent pregnancy.
• Each of the 24 tablets contains a small amount of two different female hormones, specifically drospirenone and ethinyl estradiol.
• The 4 green tablets do not contain active ingredients and are also called placebo tablets.

Hormonal contraceptives that contain two hormones are called "combined" contraceptives.

General Considerations

Before starting to use Daylette, you must read the information about blood clots in section 2. It is particularly important that you read the symptoms of a blood clot (see section 2 “Blood Clots”).

Before you can start taking Daylette, your doctor will ask you some questions about your personal medical history and that of your close relatives. Your doctor will also take your blood pressure and, depending on your personal situation, may perform some other tests.

In this prospectus, several situations are described in which you should stop taking Daylette, or in which the reliability of Daylette may be reduced. In these situations, you should not have sexual intercourse or you should take additional non-hormonal contraceptive precautions, e.g., use a condom or another barrier method.

Do not use rhythm or temperature methods. These methods may not be reliable because Daylette alters the monthly variations in body temperature and cervical mucus.

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

Do not use Daylette

Do not use Daylette if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be more suitable.

Do not use Daylette

• if you have (or have ever had) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs,
• if you know that you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies,
• if you need surgery or if you spend a lot of time without getting up (see section “Blood Clots”),
• if you have ever had a heart attack or a stroke,
• if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, symptoms of a stroke),
• if you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:

• severe diabetes with vascular damage,
• very high blood pressure,
• very high levels of fat in the blood (cholesterol or triglycerides),
• a condition called hyperhomocysteinemia.
• • if you have (or have ever had) a type of migraine called “migraine with aura”,
  • if you have (or have ever had) liver disease and your liver function is not yet normal,
  • if your kidneys do not function well (renal insufficiency),
  • if you have (or have ever had) a tumor in the liver,
  • if you have (or have ever had) or if you suspect that you have breast cancer or cancer of the reproductive organs,
  • if you have vaginal bleeding of unknown cause,

• if you are allergic to drospirenone or ethinylestradiol, or to any of the other components of this medication (including in section 6). This may be detected by the presence of itching, rash, or swelling.
• • Daylette contains soy lecithin. Do not use it in case of allergy to peanuts or soy.

Do not use Daylette if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section Other Medications and Daylette).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Daylette.

Inform your doctor if you suffer from any of the following conditions.

In some situations, you should have special care while using Daylette or any other combined hormonal contraceptive, and you may need to have regular check-ups. If you have any of the following conditions, inform your doctor before using Daylette. If the condition develops or worsens while you are using Daylette, 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 urticaria with possible difficulty breathing, contact a doctor immediately.Medicines containing estrogens can cause or worsen the symptoms of hereditary and acquired angioedema.
• • if a close relative has or has had breast cancer,
  • if you have liver disease or bile duct 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 (SLE, a disease that affects your natural defense system),
• if you have hemolytic uremic syndrome (HUS, a disorder of blood clotting that causes kidney insufficiency),
• if you have sickle cell anemia (a hereditary disease of red blood cells),
• if you have high levels of fat in the blood (hypertriglyceridemia) or known family history of this condition. Hypertriglyceridemia has been associated with a higher risk of pancreatitis (inflammation of the pancreas).

• if you need surgery or spend a lot of time without getting up (see section 2 “Blood Clots”),
• if you recently gave birth, you are at higher risk of blood clots. Ask your doctor when you can start taking Daylette after childbirth.
• if you have superficial vein inflammation under the skin (thrombophlebitis),
• if you have varicose veins,
• • if you have epilepsy (see “Other Medications and Daylette”),
  • if you have a disease that appeared for the first time during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, skin rash with vesicles during pregnancy (herpes gestationalis), a nervous disorder that causes sudden body movements (Sydenham's chorea)),
  • if you have or have ever had brownish-yellow skin patches (chloasma), especially on the face. If so, avoid direct exposure to sunlight or ultraviolet light.

Consult your doctor before taking Daylette.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Daylette increases your risk of suffering a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• in veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• in arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or TEA).

The recovery of blood clots is not always complete. In rare cases, there may be long-lasting or even fatal effects.

It is essential to remember that the overall risk of a harmful blood clot due to Daylette is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek immediate medical attentionif you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN

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

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in veins (venous thrombosis). However, these adverse effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism.
• In very rare cases, a blood clot can form in a vein in another organ, such as the eye (retinal vein thrombosis).

When is the risk of a blood clot in a vein higher?

The risk of a blood clot in a vein is higher during the first year in which you take a combined hormonal contraceptive for the first time. The risk may be higher if you restart taking a combined hormonal contraceptive (the same medication or a different one) after an interruption of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Daylette, your risk of a blood clot returns to normal in a few weeks.

What is the risk of a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of a blood clot in the leg or lung (DVT or PE) with Daylette is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, 2 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone, or norgestimato, 5-7 will develop a blood clot in a year.
• Of every 10,000 women who use Daylette, 9-12 will develop a blood clot in a year.
• The risk of a blood clot will depend on your personal history (see “Factors that increase your risk of a blood clot” below).

Factors that increase your risk of a blood clot in a vein

The risk of having a blood clot with Daylette is small, but some conditions increase the risk. Your risk is higher:

• if you are overweight (body mass index (BMI) of 30 kg/m2 or higher).
• if any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before about 50 years old). You may have an inherited disorder of blood clotting.
• if you need surgery or spend a lot of time without getting up due to an injury or disease or if you have your leg immobilized. You may need to stop using Daylette for several weeks before the surgery or while you have less mobility. If you need to stop using Daylette, ask your doctor when you can start using it again.
• with increasing age (especially above about 35 years).
• if you have given birth recently.

The risk of a blood clot increases the more conditions you have.

Long flights (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you have any of the conditions listed above, even if you are unsure. Your doctor may decide that you should stop using Daylette.

If any of the conditions listed above change while you are using Daylette, for example, a close relative experiences a blood clot without a known cause or you gain a lot of weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY

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

Like a blood clot in a vein, a blood clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

Factors that increase your risk of a blood clot in an artery

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

• with increasing age (above about 35 years).
• if you smoke.
• if you are overweight.
• if you have high blood pressure.
• if any of your close relatives have had a heart attack or stroke at a young age (less than about 50 years old). You may also be at higher risk of a heart attack or stroke.
• if you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• if you have migraines, especially migraines with aura.
• if you have a heart condition (valve disorder, arrhythmia called atrial fibrillation).
• if you have diabetes.

If you have one or more of these conditions or if any of them are particularly severe, your risk of a blood clot may be increased even further.

If any of the conditions listed above change while you are using Daylette, for example, you start smoking, a close relative experiences a blood clot without a known cause, or you gain a lot of weight, inform your doctor.

Daylette and Cancer

It has been observed that breast cancer is slightly more common in women taking combined hormonal contraceptives, but it is not known whether this is caused by the treatment. For example, it may be due to the fact that women taking combined contraceptives are examined more frequently by their doctor.

The appearance of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential that you regularly examine your breasts and contact your doctor if you notice any lump.

In rare cases, benign liver tumors and, in a smaller number of cases, malignant liver tumors have been reported in users of oral contraceptives. Contact your doctor if you have unusual abdominal pain.

Mental Health Disorders

Some women who use hormonal contraceptives, including Daylette, have reported depression or a depressed mood. Depression can be severe and, in some cases, may lead to suicidal thoughts. If you experience changes in your mood and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

Spotting between periods

During the first few months of taking Daylette, you may experience unexpected bleeding (bleeding outside of the placebo days). If this bleeding lasts more than a few months or starts after a few months, your doctor should investigate the cause.

What to do if no bleeding occurs during the placebo days

If you have taken all the active white pills correctly, have not had severe vomiting or diarrhea, and have not taken any other medication, it is very unlikely that you are pregnant.

If the expected bleeding does not occur twice consecutively, you may be pregnant. Contact your doctor immediately. Start the next pack only if you are sure you are not pregnant.

Other Medications and Daylette

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Also inform any other doctor or dentist who prescribes another medication (or pharmacist) that you use Daylette.

They may advise you to take additional contraceptive precautions (e.g., condoms) and, if so, for how long or if you need to modify the use of another medication that you need.

Do not use Daylette if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section Other Medications and Daylette).

Your doctor will prescribe another type of contraceptive before starting treatment with these medications.

Daylette can be restarted approximately 2 weeks after completing this treatment.See section “Do not use Daylette”.

Some medications may have an effect on the blood levels of Daylette and make it less effective for preventing pregnancy, or may cause unexpected bleeding. These include:

• medications used for the treatment of
• • epilepsy (e.g., barbiturates, carbamazepine, phenytoin, primidone, felbamate, oxcarbazepine, topiramate),
  • tuberculosis (e.g., rifampicin),

• infections with HIV and hepatitis C viruses (called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapina, efavirenz),
• • high blood pressure in the blood vessels of the lungs (bosentan),
  • fungal infections (e.g., griseofulvin, ketoconazole)
  • arthritic symptoms (e.g., etoricoxib)
  • St. John's Wort (Hypericum perforatum). If you want to use products containing St. John's Wort while using Daylette, you must consult your doctor first.

Daylette may affect the effect of other medications, e.g.

Consult your doctor or pharmacist before taking any medication.

Daylette with food and drinks

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

Laboratory tests

If you need to have a blood test, inform your doctor or the laboratory staff that you are taking hormonal contraceptives, as hormonal contraceptives can affect the results of some tests.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Pregnancy

If you are pregnant, do not take Daylette. If you become pregnant while taking Daylette, stop taking it immediately and contact your doctor.

If you want to become pregnant, you can stop taking Daylette at any time (see also “If you stop taking Daylette”).

Consult your doctor or pharmacist before taking any medication.

Breastfeeding

Generally, it is not recommended to use Daylette when a woman is breastfeeding. If you want to take the contraceptive during breastfeeding, consult your doctor.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

There is no information to suggest that the use of Daylette affects driving or operating machinery.

Daylette contains lactose, sunset yellow color, and soy lecithin

The white active film-coated tablets of Daylette contain 48.53 mg of lactose monohydrate and the green inactive tablets contain 37.26 mg of lactose per film-coated tablet. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medication.

The active film-coated tablets of Daylette contain 0.07 mg of soy lecithin. Do not use it in case of allergy to peanuts or soy.

The inactive film-coated tablets (placebo) contain sunset yellow FCF (E110) colorant, which may cause allergic reactions. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Each blister contains 24 active white tablets and 4 green placebo tablets.

The two tablets of different colors of Daylette are arranged in order. A blister contains 28 tablets.

Take one Daylette tablet a day, if necessary with a small amount of water. You can take the tablets with or without food, but you must take them every day at the same time.

Do not confuse the tablets:take a white tablet for the first 24 days, and then a green tablet for the last 4 days. Then, you must start immediately a new blister (24 white tablets and then 4 green tablets). Therefore, there is no break between two blisters.

Due to the different composition of the tablets, it is necessary to start with the first tablet in the blister marked with “Start” and then take the tablets every day. To follow the correct order, follow the direction of the arrows and the numbering of the blister.

Label preparation

To help you follow a control, there are 7 adhesive labels in the form of a strip with the 7 days of the week marked. Choose the adhesive label of the days of the week that starts with the day you start taking the tablets. For example, if you start on a Wednesday, use the label that starts with “Wed”.

Align the “?” symbol of the label with the same symbol of the blister and place the strip inside the area surrounded by a black line. Each day will be aligned with a row of tablets.

Now, a day is shown over each tablet, and you will be able to see if the tablet has been taken on a particular day. Follow the direction of the arrow of the card until you have taken the 28 tablets.

During the 4 days when you are taking the green placebo tablets (the placebo days), you should start bleeding (the so-called withdrawal bleeding). It usually starts the second or third day after the last active white tablet of Daylette. Once you have taken the last green tablet, you must start the next blister, whether the bleeding has stopped or not. This means that you must start each blisteron the same day of the week, and the withdrawal bleeding must occur on the same days every month.

If you use Daylette in this way, you will be protected against pregnancy also during the 4 days when you are taking the placebo tablets.

When can you start with the first blister

Start taking Daylette on the first day of the cycle (that is, the first day of your menstruation). If you start taking Daylette on the first day of your menstruation, you will be immediately protected against pregnancy. You can also start on days 2-5 of the cycle, but then you must use additional protection methods (for example, a condom) during the first 7 days.

You can start taking Daylette preferably on the day after the last active tablet (the last tablet that contains active principles) of your previous CHC or, but no later than the day after the period without tablets of your previous contraceptive (or after the last inactive tablet of your previous contraceptive).

When changing from a vaginal ring or patch, follow your doctor's recommendations.

Follow your doctor's recommendations.

You can start taking Daylette between 21 and 28 days after having a baby. If you start after day 28, you must use a barrier contraceptive method (for example, a condom) during the first 7 days of Daylette use.

If, after having a baby, you have had sex before starting to take Daylette (again), first make sure you are not pregnant or wait until your next menstrual period.

Read the “breastfeeding” section.

If you are not sure when to start, consult your doctor.

If you take more Daylette than you should

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

If you take several tablets at the same time, you may feel unwell, vomit, or experience vaginal bleeding.

Even girls who have not yet started menstruating but have accidentally taken this medication may experience this type of bleeding.

If you have taken too many Daylette tablets, or if you discover that a child has taken some tablets, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult immediately your doctor or pharmacist or call the Toxicological Information Service, phone 915620420 indicating the medication and the amount taken.

If you forgot to take Daylette

The last 4 tablets of the 4th row of the blister are placebo tablets. If you forget to take one of these tablets, it will have no effect on the efficacy of Daylette.

Throw away the forgotten placebo tablet.

If you forget an active white tablet (tablets 1-24 of your blister), you must do the following:

Take the tablet as soon as you remember and then take the next tablets at the usual time.

The risk of incomplete protection against pregnancy is greater if you forget to take a white tablet at the beginning or end of the blister. In this case, you must follow the following rules (see also the diagram):

Consult your doctor.

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at the usual time and takeadditional precautionsfor the next 7 days, for example, a condom. If you have had sex in the week before forgetting the tablet, you must know that there is a risk of pregnancy. In that case, consult your doctor.

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time.Continue taking the tablets at the usual time. The protection against pregnancy will not be reduced, and you do not need to take additional precautions.

You can choose between two options:

1. Take the forgotten tablet as soon as you remember, even if this means taking two tablets at the same time.Continue taking the tablets at the usual time. Instead of taking the green placebo tablets of this blister, throw them away and start a new blister (the start day will be different).

It is likely that you will have a light bleeding or a menstrual-like bleeding while taking the second blister.

1. You can also leave taking the active white tablets and go directly to the 4 green placebo tablets (before taking the placebo tablets, you must note the day you forgot to take the tablet). If you want to start a new blister on the day you always start, take the placebo tablets for less than 4 days.

If you follow one of these two recommendations, you will still be protected against pregnancy.

What to do in case of vomiting or severe diarrhea

If you vomit in the 3-4 hours after taking an active white tablet, or if you have had intense diarrhea, there is a risk that your body will not absorb the active principles of the tablet completely.

The situation is almost the same as forgetting a tablet. After vomiting or diarrhea, you must take another active white tablet from a reserve blister as soon as possible. If possible, take it within 24 hours after the usual time of taking the contraceptive. If this is not possible or more than 24 hours have passed, follow the recommendations given in “If you forgot to take Daylette”.

Retarding menstruation: what you should know

Although not recommended, you can delay your period by not taking the green placebo tablets of the fourth row and going directly to take a new Daylette blister and finish it. You may experiencea light bleeding or a menstrual-like bleeding while taking the second blister. Finish the second blister by taking the 4 green placebo tablets of the 4th row. Then, start a new blister.

You can ask your doctor for advice before deciding to delay your menstrual period.

Changing the first day of your menstrual period: what you should know

If you take the tablets as instructed, your period will startduring the placebo days. If you need to change this day, reduce the number ofdays of placebo–when you take the green placebo tablets– (but never increase–4 is the maximum!). For example, if you start taking the placebo tablets on a Friday, and you want to change it to a Tuesday (3 days earlier), you should start the new blister 3 days earlier than usual. You may not have any bleeding during this time. You may experience a light bleeding or a menstrual-like bleedingafterwards.

If you are not sure how to act, consult your doctor.

If you interrupt the treatment with Daylette

You can stop taking Daylette when you want. If you do not want to become pregnant, consult your doctor about other reliable contraceptive methods.

If you want to become pregnant, stop taking Daylette and wait until you have a menstrual period before trying to become pregnant. This way, you will be able to calculate your due date more easily.

If you have any other doubts about the use of this medication, consult your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.If you experience any side effect, especially if it is severe and persistent, or if you have any health changes that you think may be related to Daylette, consult your doctor.

Severe side effects

Contact a doctor immediately if you experience any of the following angioedema symptoms: facial swelling, tongue and/or throat swelling and/or difficulty swallowing or urticaria with possible difficulty breathing (also see the "Warnings and precautions" section).

All women taking combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section2 "What you need to know before starting to use Daylette".

Below is a list of side effects that have been associated with the use of drospirenone/ethinylestradiol:

Frequent side effects (may affect up to 1 in 10 people):

• mood changes,

• headache,
• nausea,
• breast pain, problems with your periods, such as irregular periods, absence of periods.

Less frequent side effects (may affect up to 1 in 100 people):

Rare side effects (may affect up to 1 in 1,000 people):

• general feeling of illness,
• weight loss,
• harmful blood clots in a vein or artery, for example:
• • in a leg or foot (i.e. DVT)
  • in a lung (i.e. PE)
  • heart attack
  • stroke
  • mild stroke or temporary symptoms similar to a stroke, known as a transient ischemic attack (TIA)
  • blood clots in the liver, stomach/intestine, kidneys, or eye.

The chances of having a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

Unknown frequency (cannot be estimated from available data):

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humanohttps://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 25°C. Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the blister pack and on the box. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the designated pharmacy drop-off point.In case of doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Daylette

• The active principles are 3 mg of drospirenone and 0.02 mg of ethinylestradiol in each white tablet.
• The other components are:

Active film-coated tablets (white):

Tablet core:

monohydrate lactose,

cornstarch,

pregelatinized cornstarch,

polyvinyl alcohol copolymer and macrogol,

magnesium stearate.

Coating:

polyvinyl alcohol,

titanium dioxide (E171),

talco,

macrogol 3350,

soy lecithin.

Placebo film-coated tablets (green):

Tablet core:

microcrystalline cellulose,

lactose,

pregelatinized cornstarch,

magnesium stearate,

anhydrous colloidal silica.

Coating:

polyvinyl alcohol,

titanium dioxide (E171),

macrogol 3350,

talco,

indigo carmine (E132),

quinoline yellow (E104),

iron oxide black (E172),

sunset yellow FCF (E110).

Appearance of the product and contents of the package

The active film-coated tablet is white or almost white, round, biconvex, with a diameter of approximately 6 mm. “G73” engraved on one face, the other face unengraved.

The placebo film-coated tablet is green, round, biconvex, with a diameter of approximately 6 mm, unengraved.

Daylette 3 mg/0.02 mg film-coated tablets, are packaged in PVC/PE/PVDC/Al blisters. The blisters are packaged in cardboard boxes with a leaflet, a blister cover and adhesive labels with the days of the week on each one.

Package sizes:

1×(24+4) film-coated tablets

3×(24+4) film-coated tablets

6×(24+4) film-coated tablets

13×(24+4) film-coated tablets.

Not all package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Gedeon Richter Plc.

1103 Budapest,

Gyömroi út 19-21.

Hungary

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Gedeon Richter Ibérica S.A.

Sabino Arana, 28 4th 2nd

08028 Barcelona

Spain

Thismedicinal product is authorized in themember states of the European Economic Areawith the following names:

Spain:Daylette

Hungary:Rezia

Portugal:Daylette

Revision date of this leaflet:January2023

Further detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.