DAYLETTE 3 mg/ 0.02 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Daylette 3mg/ 0.02 mg film-coated tablets EFG

drospirenone / ethinylestradiol

Important things 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 having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive after a break 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 the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the package leaflet:

1. What is Daylette and what is it used for
2. What you need to know before you start taking Daylette
3. How to take Daylette
4. Possible side effects
5. Storage of Daylette
6. Package contents and additional information

1. What is Daylette and what is it used for

• 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, namely drospirenone and ethinylestradiol.
• 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.

2. What you need to know before taking Daylette

General considerations

Before starting to use Daylette, you should read the information about blood clots in section 2. It is especially 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.

This prospectus describes several situations 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 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 infection (AIDS) or other sexually transmitted diseases.

Do not use Daylette

You should 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 blood vessel of the legs (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs,
• if you know 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 an operation or if you spend a long time without getting up (see section "Blood clots"),
• if you have ever had a heart attack or 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, temporary stroke symptoms),
• if you have any of the following diseases that may increase your risk of forming a clot in the arteries:

• severe diabetes with blood vessel 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 had) liver disease and your liver function is still not normal,
  • if your kidneys do not work well (renal insufficiency),
  • if you have (or have ever had) a tumor in the liver,
  • if you have (or have ever had) or if it is suspected that you have breast cancer or cancer of the genital 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 medicine (listed in section 6). This can be detected by the presence of itching, rash, or swelling.
• • Daylette contains soy lecithin. It should not be used in case of peanut or soy allergy.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Daylette.

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

In some situations, you should be particularly careful while using Daylette or any other combined hormonal contraceptive, and your doctor may need to perform regular checks on you. If any of the following conditions apply to you, you should inform your doctor before using Daylette. If the condition develops or worsens while you are using Daylette, you should also inform your doctor:

• if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Medicines that contain estrogens can cause or worsen the symptoms of hereditary and acquired angioedema.
• • if a close relative has or has had breast cancer,
  • if you suffer from liver or gallbladder disease,
  • if you have diabetes,
  • if you have depression or mood changes
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease),
• if you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system),
• if you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure),
• 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 an increased risk of pancreatitis (inflammation of the pancreas).

• if you need an operation or spend a long time without getting up (see section 2 "Blood clots"),
• if you have just given birth, you are at a higher risk of blood clots. You should ask your doctor when you can start taking Daylette after childbirth.
• if you have inflammation of the veins that are under the skin (superficial thrombophlebitis),
• if you have varicose veins,
• • if you have epilepsy (see "Other medicines and Daylette"),
  • if you have a disease that first appeared during pregnancy or previous use of sex hormones (e.g., loss of hearing, a blood disease called porphyria, blistering rash during pregnancy (herpes gestationalis), a nerve disease that causes sudden movements of the body (Sydenham's chorea)),
  • if you have or have ever had brownish-yellow patches on the skin (chloasma), called "pregnancy patches", 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 having 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 the veins (this is called "venous thrombosis", "venous thromboembolism" or VTE).
• in the arteries (this is called "arterial thrombosis", "arterial thromboembolism" or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious long-term effects or, very rarely, they can be fatal.

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if 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 the veins (venous thrombosis). However, these side 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 can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in a vein of another organ, such as the eye (retinal vein thrombosis)

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

The risk of having a blood clot in a vein is higher during the first year that you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medicine 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 having a blood clot returns to normal within a few weeks.

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

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 will have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains drospirenone, such as Daylette, between about 9 and 12 women will have a blood clot in a year.
• The risk of having 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 or BMI over 30 kg/m2).
• 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 the age of about 50).
• if you need an operation or spend a long time without getting up due to an injury or illness or if you have your leg in a cast. You may need to stop using Daylette several weeks before surgery or while you have reduced mobility. If you need to stop using Daylette, ask your doctor when you can start using it again.
• as you get older (especially above about 35 years).
• if you have recently given birth.

The risk of having a blood clot increases with the number of conditions you have.

Long-distance 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 important to inform your doctor if you suffer from any of the conditions above, even if you are not sure. Your doctor may decide that you should stop using Daylette.

If any of the conditions above change while you are using Daylette, for example, a close relative experiences a thrombosis without 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 stroke.

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

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

• with age (above about 35 years).
• if you smoke.When using a combined hormonal contraceptive like Daylette, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• 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). In this case, you may also be at higher risk of having 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 problem (valve disorder, heart rhythm disturbance called atrial fibrillation).
• if you have diabetes.

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

If any of the conditions above change while you are using Daylette, for example, you start smoking, a close relative experiences a thrombosis without 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 who take combined hormonal contraceptives, but it is not known if this is caused by the treatment. For example, it may be due to the fact that more tumors are detected in women who take combined contraceptives because they are examined more frequently by their doctor.

The occurrence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is important that you regularly check your breasts and should contact your doctor if you notice any lump.

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

Psychiatric disorders

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

Bleeding between periods

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

3. How to take Daylette

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

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

The two differently colored Daylette tablets are arranged in order. A blister pack contains 28 tablets.

Take one Daylette tablet per 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 a new blister pack immediately (24 white tablets and then 4 green tablets). Therefore, there is no break between two blister packs.

Due to the different composition of the tablets, it is necessary to start with the first tablet in position 1 of the blister pack marked with “Start” and then take the tablets every day. For the correct order, follow the direction of the arrows and the numbering of the blister pack.

Label preparation

To help you keep track, there are 7 adhesive labels in the form of a strip with the 7 days of the week marked. Choose the strip 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”.

Match the “?” symbol on the label with the same symbol on the blister pack and place the strip inside the area surrounded by a black line. Each day will align with a row of tablets.

Now, a day is shown above each tablet, and you can see if you have taken the tablet on a particular day. Follow the direction of the arrow on the card until you have taken all 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 on the second or third day after the last active white Daylette tablet. Once you have taken the last green tablet, you must start the next blister pack, whether the bleeding has stopped or not. This means you must start each blister pack on 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 also be protected against pregnancy during the 4 days when you are taking the placebo tablets.

When can you start with the first blister pack

• If you have not used a hormonal contraceptive in the previous month

Start taking Daylette on the first day of your cycle (i.e., 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 your cycle, but then you must use additional protective measures (e.g., a condom) for the first 7 days.

• Changing from a combined hormonal contraceptive, or a vaginal ring or combined contraceptive patch

You can start taking Daylette preferably the day after the last active tablet (the last tablet that contains active ingredients) of your previous CHC or, but no later than, the day after the tablet-free period 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.

• Changing from a progestogen-only method (progestogen-only pill – “mini-pill”, injection, implant, or intrauterine system that releases progestogen (IUS)).You can change any day from the progestogen-only pill (from an implant or IUS on the day of its removal, from an injectable when the next injection would be due), but in all these cases, you must use additional protective measures (e.g., a condom) for the first 7 days that you take the tablets.

• After an abortion

Follow your doctor's recommendations.

• After having a baby

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 (e.g., a condom) during the first 7 days of using Daylette.

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

• If you are breastfeeding and want to start taking Daylette again after having a baby

Read the section “Breastfeeding”.

If you are unsure when to start, consult your doctor.

If you take more Daylette than you should

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

If you take several tablets at once, you may feel sick, vomit, or have vaginal bleeding.

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

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

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

If you forget to take Daylette

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

Discard the forgotten placebo tablet.

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

• If you are less than 24 hourslate in taking a tablet, the protection against pregnancy is not reduced.

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

• If you are more than 24 hourslate in taking a tablet, the protection against pregnancy may be reduced. The more tablets you have missed, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is higher if you miss a white tablet at the beginning or end of the blister pack. In this case, you must follow the recommendations given in “If you forget to take Daylette”.

• You have missed more than one tablet in the blister pack

Contact your doctor.

• You have missed a tablet between days 1-7 (first row)

Take the missed tablet as soon as you remember, even if it means taking two tablets at the same time. Continue taking the tablets at the usual time and take additional precautionsfor the next 7 days, e.g., a condom. If you have had sex in the week before missing the tablet, you should know that there is a risk of pregnancy. In this case, contact your doctor.

• You have missed a tablet between days 8-14 (second row)

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

• You have missed a tablet between days 15-24 (third or fourth row)

You can choose between two options:

1. Take the missed tablet as soon as you remember, even if it means taking two tablets at the same time. Continue taking the tablets at the usual time. Instead of taking the green placebo tablets from this blister pack, discard them and start the next blister pack (the start day will be different).

It is likely that you will have your period at the end of the second blister pack, while taking the green placebo tablets, but you may have light bleeding or spotting during the second blister pack.

1. You can also stop 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 missed the tablet). If you want to start a new blister pack 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.

• If you have missed a tablet in the blister pack and do not have bleeding during the placebo days, this may mean that you are pregnant. You must contact your doctor before starting the next blister pack.

What to do in case of vomiting or severe diarrhea

If you vomit within 3-4 hours after taking an active white tablet or if you have had severe diarrhea, there is a risk that your body has not fully absorbed the active ingredients of the tablet.

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

Delaying your period: what you need to know

Although it is not recommended, you can delay your period by not taking the green placebo tablets from the 4th row and going directly to taking a new Daylette blister pack and finishing it. You may have light bleeding or spotting while taking the second blister pack. Finish the second blister pack by taking the 4 green placebo tablets from the 4th row. Then, start a new blister pack.

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

Changing the first day of your period: what you need to know

If you take the tablets according to the instructions, your period will start during the placebo days. If you need to change this day, reduce the number of placebo days – when you take the green placebo tablets – (but never increase them – 4 is the maximum!). For example, if you start taking the placebo tablets on a Friday and want to change it to a Tuesday (3 days earlier), you must start the new blister pack 3 days earlier than usual. You may not have any bleeding during this time. You may then have light bleeding or spotting.

If you are unsure how to act, consult your doctor.

If you stop taking Daylette

You can stop taking Daylette whenever 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 can more easily calculate the expected date of delivery.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. If you experience any adverse effect, especially if it is severe and persistent, or have any change in health that you think may be due to Daylette, consult your doctor.

Severe Adverse Effects

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

All women who take 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 section 2 "What you need to know before taking Daylette".

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

Common Adverse Effects (may affect up to 1 in 10 people):

• mood changes,

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

Uncommon Adverse Effects (may affect up to 1 in 100 people):

• depression, nervousness,
• dizziness, tingling sensation, drowsiness, migraine
• varicose veins, increased blood pressure,
• stomach pain, vomiting, indigestion, intestinal gas, stomach inflammation, diarrhea,
• acne, itching, rash,
• pain and discomfort, e.g., back pain, pain in the limbs, muscle cramps,
• vaginal fungal infection, pelvic pain, breast enlargement, benign breast lumps, uterine/vaginal bleeding (which usually subsides during continued treatment), genital discharge, hot flashes, vaginal inflammation (vaginitis), menstrual problems, painful menstruation, decreased duration of menstruation, heavy menstruation, vaginal dryness, abnormal vaginal smear, decreased interest in sexual relations,
• lack of energy, increased sweating, fluid retention, weight gain.

Rare Adverse Effects (may affect up to 1 in 1,000 people):

• candida (fungal infection),
• decrease in the number of red blood cells in the blood (anemia), increase in the number of platelets in the blood (thrombocytosis),
• allergic reaction,
• hormonal disorder (endocrine),
• increased appetite, loss of appetite, abnormally high potassium levels in the blood, abnormally low sodium levels in the blood,
• inability to experience an orgasm, insomnia,
• vertigo, tremor,
• eye disorders, e.g., eyelid inflammation, dry eyes,
• abnormally high heart rate,
• inflammation of a vein, fainting,
• nosebleed,
• abdominal enlargement, intestinal disorder, feeling of bloating, stomach hernia, oral fungal infection, constipation, dry mouth,
• bile duct or gallbladder pain, gallbladder inflammation,
• brownish-yellow spots on the skin, eczema, hair loss, acne-like skin inflammation, dry skin, skin inflammation with bumps, excessive hair growth, skin disorders, stretch marks, skin inflammation, light-sensitive skin inflammation, skin nodules,
• difficulty maintaining sexual relations or painful relations, vaginal inflammation (vulvovaginitis), post-coital bleeding, withdrawal bleeding, breast cyst, increased number of breast cells (hyperplasia), malignant breast tumors, abnormal growth of the cervical mucous membrane, decreased or deteriorated uterine lining, ovarian cysts, uterine enlargement,

• general malaise,
• weight loss,
• 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 or temporary stroke-like symptoms, called a transient ischemic attack (TIA)
  • blood clots in the liver, stomach/intestine, kidneys, or eye.

The risk 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).

Frequency Not Known (cannot be estimated from the available data):

• hypersensitivity,
• erythema multiforme (rash with target-like redness or blisters).

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Daylette

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

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

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

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's collection point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Daylette

• The active ingredients 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: