Daylette

Package leaflet: Information for the user

DAYLETTE

3 mg/0.02 mg film-coated tablets
drospirenone/ethinylestradiol
Equivalent medicine

Important things to know about combined hormonal contraceptives (CHCs):

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

Read this leaflet carefully before taking this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Daylette is and what it is used for
2. What you need to know before taking Daylette
3. How to take Daylette
4. Possible side effects
5. How to store Daylette
6. Contents of the pack and other information

1. What Daylette is and what it is used for

Daylette is a contraceptive pill used to prevent pregnancy.
Each of the 24 white active tablets contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.
The 4 green tablets do not contain any active substances and are also known as placebo tablets.
Contraceptive pills containing two hormones are called "combined" pills.

2. What you should know before taking Daylette

General warnings
Before starting Daylette, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).
Before you start taking Daylette, your doctor will ask you questions about your medical history and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your personal situation, may carry out other examinations.
This leaflet describes numerous situations in which you must stop taking Daylette, or conditions in which the reliability of Daylette may be reduced. In such situations, you should either avoid sexual intercourse or use other non-hormonal contraceptive methods, such as condoms or another type of barrier method.
Do not use fertility awareness-based methods or body temperature measurement. These methods may be unreliable because Daylette alters the monthly variations in body temperature and cervical mucus.
Daylette, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or any other sexually transmitted disease.

Do not take Daylette
Do not take Daylette if you have any of the conditions listed below. If you have any of the conditions listed below, consult your doctor. Your doctor will discuss with you other birth control methods that might be more suitable for your situation.
Do not use Daylette:

• if you have (or have ever had) a blood clot in a vein of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;

• if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or anti-phospholipid antibodies;

• if you are due to undergo surgery or will be confined to bed for a long period (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 causing severe chest pain that may be an early sign of heart attack) or transient ischaemic attack (TIA – temporary stroke-like symptoms);

• if you have any of the following diseases, which could increase the risk of clots forming in the arteries:

  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats (cholesterol or triglycerides) in the blood
  • a condition known as hyperhomocysteinaemia;

• 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 has not yet returned to normal;

• if your kidneys do not work properly (renal failure);

• if you have (or have ever had) a liver tumour;

• if you have (or have ever had) or if it is suspected that you may have breast or genital organ cancer;

• if you experience unexplained vaginal bleeding;

• if you are allergic to ethinylestradiol or drospirenone, or to any of the other ingredients of this medicine (listed in section 6). This may cause itching, rash, or swelling;

• DAYLETTE contains soya lecithin. If you are allergic to peanuts or soya, do not use this medicine.

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Daylette.

When should you contact a doctor?
Contact a doctor urgently:

• if you notice any possible signs of a blood clot, which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack, or a stroke (see the following section “Blood clot (thrombosis)”).

For a description of the symptoms of these serious side effects, see section “How to recognize a blood clot”.

Inform your doctor if any of the following conditions apply to you.
In certain situations, you need to be particularly careful when using Daylette or any other combined oral contraceptive, and your doctor may need to carry out regular check-ups. If any of the following conditions apply to you, you must inform your doctor before starting Daylette.
If any of these conditions develop or worsen while you are taking Daylette, you must inform your doctor.
If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible breathing difficulties, contact your doctor immediately. Medicinal products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema;

• if a close relative has or has ever had breast cancer;
• if you have liver or gallbladder disease;
• if you suffer from diabetes;
• if you suffer from 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 affecting the natural defence system);
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited red blood cell disorder);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are due to undergo surgery or will be confined to bed for a long period (see section 2 “Blood clots”);
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking Daylette;
• if you have inflammation of veins near the skin surface (superficial thrombophlebitis);
• if you have varicose veins;
• if you have epilepsy (see “Other medicines and Daylette”);
• if you have ever had a condition that first occurred during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, a blistering skin rash during pregnancy (herpes gestationis), a nervous system disorder causing sudden involuntary movements (Sydenham's chorea));
• if you have or have ever had brownish patches (chloasma), sometimes called “pregnancy mask”, particularly affecting the face. In this case, avoid direct exposure to sunlight or ultraviolet radiation.

Talk to your doctor before taking Daylette.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Daylette increases the risk of developing a blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can develop:

• in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, these effects can be fatal.

It is important to remember that the overall risk of a harmful blood clot associated with Daylette is low.

HOW TO RECOGNIZE A BLOOD CLOT

Contact a doctor immediately if you notice any of the following signs or symptoms.

Do you have any of these signs? You may have:

• swelling in one leg or along a vein in the leg or foot, especially if accompanied by:
  • pain or tenderness in the leg, felt only when standing or walking;
  • increased warmth in the affected leg;
  • change in skin colour of the leg, such as paleness, redness, or bluish discolouration.

Deep vein thrombosis

• sudden and unexplained shortness of breath or rapid breathing;
• sudden cough without an obvious cause, possibly with coughing up of blood;
• sharp chest pain that worsens when breathing deeply;
• severe dizziness or lightheadedness;
• rapid or irregular heartbeat;
• severe stomach pain.

Pulmonary embolism

If you are unsure, inform your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for a milder condition such as a respiratory tract infection (e.g., a “common cold”).

Symptoms occurring more frequently in one eye:

• sudden loss of vision or painless blurring of vision that may progress to loss of vision.

Retinal vein thrombosis (blood clot in the eye)

• pain, discomfort, pressure, or heaviness in the chest;
• sensation of tightness, pressure, or fullness in the chest, arm, or under the sternum;
• feeling of fullness, indigestion, or suffocation;
• discomfort in the upper body, radiating to the back, jaw, throat, arms, or stomach;
• sweating, nausea, vomiting, or dizziness;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat.

Heart attack

• sudden numbness or weakness of the face, arm, or leg, especially on one side of the body;
• sudden confusion, difficulty speaking or understanding;
• sudden difficulty seeing with one or both eyes;
• sudden difficulty walking, dizziness, loss of balance or coordination;
• sudden severe or prolonged headache without known cause.

Stroke

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 forming in veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher when restarting a combined hormonal contraceptive (the same or a different medicine) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not using a combined hormonal contraceptive.
When you stop taking Daylette, the risk of developing a blood clot returns to normal levels within a few weeks.

What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE (venous thromboembolism) and the type of combined hormonal contraceptive you are taking.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Daylette is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot over one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot over one year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as Daylette, about 9–12 will develop a blood clot over one year.
• Your risk of developing a blood clot depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Daylette is low, but certain conditions can increase this risk. Your risk is higher:

• if you are very overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in a leg, lung, or another organ at a young age (under approximately 50 years). In this case, you may have an inherited blood clotting disorder;
• if you are scheduled for surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in a cast. You may need to stop taking Daylette several weeks before surgery or during periods of reduced mobility. If you need to stop taking Daylette, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years);
• if you gave birth less than a few weeks ago.

The risk of developing a blood clot increases when you have more than one of these conditions.
Air travel (lasting >4 hours) may temporarily increase the risk of blood clot formation, especially if you have some of the other risk factors listed above.
It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to stop your use of Daylette.
If any of the above conditions change while you are using Daylette—for example, if a close relative develops thrombosis without a known cause or if you gain significant weight—contact your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems—for example, they may lead to a heart attack or stroke.

Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of Daylette is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Daylette, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke;
• if you or a close relative have high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions or if one of them is particularly severe, the risk of developing a blood clot may be even higher.
If any of the above conditions change while you are using Daylette—for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.

Daylette and tumors
Breast cancer has been detected slightly more frequently in women using combined oral contraceptives, but it is not known whether this is due to the treatment. For example, a higher number of tumors may be diagnosed in women taking the pill because they undergo medical examinations more frequently.
The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important that you regularly check your breasts and contact your doctor if you notice any lumps.
Rarely, benign liver tumors and even more rarely malignant liver tumors have been reported in women taking the pill. Contact your doctor if you experience unusually severe abdominal pain.

Psychiatric disorders
Some women using hormonal contraceptives, including Daylette, have reported depression or depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor as soon as possible for further medical advice.

Bleeding between menstrual periods
During the first few months of using Daylette, you may experience unexpected bleeding (bleeding not coinciding with the placebo tablet days). If this bleeding occurs for more than a few months, or if it starts after several months, your doctor should investigate the cause.

What to do if no bleeding occurs during the placebo tablet days
If you have taken all the white active tablets correctly, have not vomited or had severe diarrhea, and have not taken other medicines, it is very unlikely that you are pregnant.
If the expected withdrawal bleeding does not occur for two consecutive cycles, you may be pregnant. Contact your doctor immediately. Begin the next pack only if you are certain you are not pregnant.

Other medicines and Daylette
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Also inform any other doctor or dentist who prescribes you another medicine (or your pharmacist) that you are using Daylette.
They may advise you to use additional contraceptive precautions (e.g., condoms), and if so, for how long, or whether the use of another medicine you need should be modified.
Do not use Daylette if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines can cause increases in blood tests assessing liver function (increase in liver enzyme ALT).
Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
Daylette can be resumed approximately 2 weeks after completing this treatment. See the section “Do not use Daylette”.

Some medicines can affect the levels of Daylette in the blood and may reduce its effectiveness in preventing pregnancy, or cause unexpected bleeding. These include:

• medicines used to treat:
  o epilepsy (e.g., barbiturates, carbamazepine, phenytoin, primidone, felbamate, oxcarbazepine, topiramate)
  o tuberculosis (e.g., rifampicin)
  o HIV and hepatitis C virus infections (so-called protease inhibitors or non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)
  o high blood pressure in the blood vessels of the lungs (bosentan)
  o fungal infections (e.g., griseofulvin, ketoconazole)
  o symptomatic treatment of osteoarthritis (etoricoxib)
• the herbal remedy St. John’s wort (Hypericum perforatum). If you wish to use herbal products containing St. John’s wort while using Daylette, you must first consult your doctor.

Daylette may alter the effect of other medicines, for example:
o cyclosporine (a medicine used to prevent tissue rejection after organ transplantation)
o the antiepileptic lamotrigine (this may increase the frequency of seizures)
o tizanidine (a medicine used to treat muscle spasticity)
o theophylline (a medicine used to treat asthma).
Ask your doctor or pharmacist for advice before taking any medicine.

Daylette with food and drink
Daylette may 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 laboratory staff that you are taking the pill, as hormonal contraceptives may alter the results of certain tests.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
If you are pregnant, you must not take Daylette. If you become pregnant while taking Daylette, stop taking the medicine immediately and contact your doctor.
If you plan to become pregnant, you may stop taking Daylette at any time (see also “If you stop taking Daylette”).
Ask your doctor or pharmacist for advice before taking any medicine.

Breastfeeding
The use of Daylette is not recommended while breastfeeding. If you wish to take the pill while breastfeeding, you must contact your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
There is no information suggesting that taking Daylette affects the ability to drive or use machines.

Daylette contains lactose, sunset yellow and soy lecithin
The white film-coated active tablets in Daylette contain 48.53 mg of monohydrate lactose 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 certain sugars, contact your doctor before taking this medicine.
The white film-coated active tablets contain 0.07 mg of soy lecithin. If you are allergic to peanuts or soy, do not use this medicine. The film-coated tablets that do not contain hormones (placebo) contain the colouring agent “Sunset Yellow FCF” (E110), which may cause allergic reactions.

3. How to take Daylette

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Each blister contains 24 active white tablets and 4 green placebo tablets.
The Daylette tablets of two different colours are arranged in order. One blister contains 28 tablets.
Take one Daylette tablet every day, with or without a small amount of water. You may take the tablets with or without food, but they must be taken every day at approximately the same time.

Be careful not to confuse the tablets: take one white tablet daily for the first 24 days, followed by one green tablet for the last 4 days. Then, immediately start a new pack (24 white tablets and 4 green tablets). Therefore, there is no break between packs.

Because of the different composition of the tablets, you must start with the first tablet in position 1 of the strip, marked with “Start”, and then take one tablet each day.
Follow the direction of the arrows and the numbering on the pack for the correct order.

Preparing the pack

To help you keep track, there are 7 weekly adhesive strips labelled with the 7 days of the week.
Choose the adhesive strip corresponding to the day of the week that begins with the day you start taking the tablets. For example, if you start on Wednesday, use the adhesive strip starting with “Wed.”.

Align the symbol " " with the same symbol on the blister and place the strip on the area marked by the black line. Each day will then align with a row of tablets.
Each tablet is marked with a day, so you can see whether you have taken a tablet on a specific day. Follow the direction of the arrow on the blister until all 28 tablets have been taken.

During the 4 days of taking the green placebo tablets (the placebo days), your menstrual period usually begins (also known as withdrawal bleeding). Your period will normally start on the second or third day after taking the last active white tablet of Daylette. After taking the last green tablet, you must immediately start the next pack, even if bleeding has not stopped. This means you will start each new pack on the same day of the week, and your menstrual period will usually occur during the same days each month.

If you use Daylette in this way, you are protected from pregnancy even during the 4 days when you take the placebo tablets.

When can you start the first 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 menstrual period). If you start Daylette on the first day of your period, you are immediately protected against pregnancy. You may also start between days 2 and 5 of your cycle, but in this case you must use additional contraceptive methods (e.g. a condom) for the first 7 days.

If you are switching to Daylette from another combined hormonal contraceptive or combined oral contraceptive, vaginal ring, or contraceptive patch

Start Daylette preferably the day after taking the last active tablet (the last tablet containing active ingredients) of your previous pill, but no later than the day after the end of the break period of your previous pill (or after the last inactive tablet of your previous pill).

When switching from a vaginal ring or contraceptive patch containing a combined hormonal contraceptive, follow your doctor's advice.

If you are switching to Daylette from a progestogen-only contraceptive method (progestogen-only pill, injection, implant, or progesterone-releasing intrauterine device (IUD))

You may switch on any day from the progestogen-only pill (from an implant or IUD on the same day of removal, from an injectable contraceptive on the day the next injection would have been given), but in all these cases you must use additional contraceptive precautions (e.g. a condom) for the first 7 days of tablet-taking.

• After a spontaneous abortion Follow your doctor's advice.
• After childbirth You may start taking Daylette between 21 and 28 days after giving birth. If you start after 28 days, you must use a barrier method (e.g. a condom) during the first 7 days of using Daylette. If you have had sexual intercourse after childbirth before starting Daylette (again), you must first make sure you are not pregnant or wait for your next menstrual period.

If you are breastfeeding and wish to start taking Daylette again after childbirth
Read the section on “Breastfeeding”.

Ask your doctor for advice if you are unsure when to start.

If you take more Daylette than you should

No serious consequences have been reported from taking an excessive number of Daylette tablets.
If you take many tablets at once, you may experience nausea or vomiting, or vaginal bleeding.
Even young girls who have not yet started menstruating but have accidentally taken the medicine may experience such bleeding.
If you have taken too many Daylette tablets, or if you find that a child has taken some, consult your doctor or pharmacist.

If you forget to take Daylette

The last 4 tablets in the fourth row of the pack are placebo tablets. If you forget to take one of these tablets, this will not affect the reliability of Daylette.
Discard the forgotten placebo tablet.

If you miss an active white tablet (tablets 1–24 of the blister), do the following:

If the delay in taking the tablet is less than 24 hours, contraceptive protection is not reduced. Take the missed tablet as soon as you remember, and then continue taking the following tablets at your usual time.

If the delay in taking the tablet is more than 24 hours, contraceptive protection may be reduced. The more tablets you miss, the higher the risk of pregnancy.

The risk of incomplete contraceptive protection is greatest if you miss a white tablet at the beginning or end of the third week. Therefore, follow the rules below (see also the diagram):

More than one tablet missed in this pack
Consult your doctor.

One tablet missed between days 1–7 (first row)
Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time and use additional precautions for the next 7 days, for example a condom.
If you had sexual intercourse during the week before forgetting the tablet, be aware that there is a risk of pregnancy. In this case, consult your doctor.

One tablet missed between days 8–14 (second row)
Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Contraceptive protection against pregnancy is not reduced, and you do not need to take additional precautions.

One tablet missed between days 15–24 (third row)
You have two options:

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time. Instead of taking the green placebo tablets in this pack, discard them and immediately start the next pack (your starting day will be different). Your period will probably occur at the end of the second pack, while you are taking the green placebo tablets, but you may experience light bleeding or spotting during the second pack.
2. Alternatively, you may stop taking the active white tablets and go directly to the 4 green placebo tablets (before taking the placebo tablets, note the day on which you missed the tablet). If you wish to start a new pack on the day you usually start, take the placebo tablets for fewer than 4 days.

By following either of these two recommended options, you remain protected against pregnancy.

If you have missed any tablet in a pack and do not have a withdrawal bleed during the placebo days, this may mean you are pregnant. Consult your doctor before starting the next pack.

What to do if you vomit or have severe diarrhoea

If you vomit within 3–4 hours of taking an active white tablet, or if you have severe diarrhoea, there is a risk that the active ingredients in the tablet are not fully absorbed by your body.
This situation is almost the same as forgetting to take a tablet. After an episode of vomiting or diarrhoea, take another active white tablet from a spare blister as soon as possible. If possible, take this tablet within 24 hours of your usual tablet-taking time. If this is not possible or if more than 24 hours have passed, follow the instructions under “If you forget to take Daylette”.

Delayed menstrual period: what you should know

Although not recommended, it is possible to delay your menstrual period by not taking the green placebo tablets from the fourth row of the pack, but instead starting directly on a new pack of Daylette and taking all tablets in the new pack.
You may experience light bleeding or spotting during the second pack.

Finish this second pack by taking the 4 green tablets from the fourth row. Then start the next pack.

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 directed, your menstrual period will begin during the placebo days. If you need to change this day, reduce the number of days you take the green placebo tablets (but never extend it: 4 days is the maximum!). For example, if you usually start taking the placebo tablets on Friday but wish to start on Tuesday (3 days earlier), you should start a new blister 3 days earlier than usual. You may not have any bleeding during this time. Afterwards, you may experience light bleeding or spotting.

If in doubt, consult your doctor.

If you stop taking Daylette

You may stop taking Daylette at any time. If you do not wish to become pregnant, ask your doctor to recommend other reliable contraceptive methods. If you wish to become pregnant, stop taking Daylette and wait for a menstrual period before trying to conceive. This will make it easier to calculate the expected date of delivery.

If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. If you experience any side effect, especially if it is severe or persistent, or if you notice any change in your health that you think could be due to Daylette, inform your doctor.

Serious side effects

Contact your 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 hives with potential breathing difficulties (see also section “Warnings and precautions”).

An increased risk of developing blood clots in the veins (venous thromboembolism, VTE) or blood clots in the arteries (arterial thromboembolism, ATE) exists in all women taking combined hormonal contraceptives. For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before taking Daylette”.

The following is a list of side effects that have been associated with the use of Daylette:

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

• Mood changes
• Headache
• Nausea
• Chest pain, menstrual-related problems such as irregular or absent menstrual cycles.

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

• Depression, nervousness
• Dizziness, tingling, drowsiness, migraine
• Varicose veins, hypertension
• Stomach pain, vomiting, indigestion, intestinal gas, stomach inflammation, diarrhoea
• Acne, itching, rash
• General discomfort and pain, e.g. back pain, limb pain, muscle cramps
• Vaginal fungal infection, pelvic pain, breast tenderness, benign breast nodules, uterine/vaginal bleeding (which usually decreases with continued treatment), vaginal discharge, hot flushes, vaginal inflammation (vaginitis), menstrual irregularities, painful menstruation, reduced menstruation, excessive menstrual bleeding, vaginal dryness, abnormal vaginal smear, decreased interest in sex
• Weakness, increased sweating, fluid retention
• Weight gain.

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

• Candidiasis (fungal infection)
• Decrease in the number of white blood cells in the blood (leukopenia), 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 achieve orgasm, insomnia
• Dizziness, tremor
• Vision disorders, for example eyelid inflammation, dry eyes
• Rapid heartbeat
• Inflammation of a vein, fainting
• Nosebleeds
• Abdominal distension, intestinal disorders, bloating sensation, stomach hernia, fungal infection of the mouth, constipation, dry mouth
• Pain in the bile ducts or gallbladder, gallbladder inflammation
• Golden-brown skin spots, eczema, hair loss, acne-like skin inflammation, dry skin, nodular skin inflammation, excessive hair growth, skin disorders, stretch marks, skin inflammation, photosensitive skin inflammation, skin nodules
• Painful or difficult sexual intercourse, vaginal inflammation (vulvovaginitis), bleeding after intercourse, withdrawal bleeding, breast cysts, increased number of breast cells (hyperplasia), malignant breast nodules, abnormal growth of the cervical mucosa, endometrial atrophy or shrinkage, ovarian cysts, uterine enlargement
• General feeling of malaise
• Weight loss
• Harmful blood clots in a vein or an artery, for example:
  • in a leg or foot (DVT),
  • in a lung (PE),
  • heart attack,
  • stroke,
  • mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA),
  • blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood of developing 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).

Not known (frequency cannot be estimated from the available data):

• Hypersensitivity
• Erythema multiforme (skin rash with red or ulcerated disc-shaped lesions).

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 the medicine from light.
Do not use this medicine after the expiry date stated on the blister and the carton following Exp.
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Daylette contains
The active substances are 3 mg drospirenone and 0.02 mg ethinylestradiol in each white tablet.
The other components are:
Film-coated active white tablets:
Tablet core:
monohydrate lactose
corn starch
pregelatinized corn starch
poly(vinyl alcohol) graft copolymer
magnesium stearate.
Coating film:
poly(vinyl alcohol)
titanium dioxide (E171)
talc
macrogol 3350
lecithin (soy).
Green placebo tablets film-coated:
Tablet core:
microcrystalline cellulose
lactose
pregelatinized corn starch
magnesium stearate
anhydrous colloidal silica.
Coating film:
poly(vinyl alcohol)
titanium dioxide (E171)
macrogol 3350
talc
indigo carmine (E132)
quinoline yellow (E104)
black iron oxide (E172)
sunset yellow FCF (E110).

Description of the appearance of Daylette and the contents of the pack
The film-coated active tablet is a white or almost white, round, biconvex film-coated tablet with a diameter of approximately 6 mm. On one side there is the imprint “G73”, the other side has no imprint.
The film-coated placebo tablet is a green, round, biconvex film-coated tablet with a diameter of approximately 6 mm, without any imprint.
Daylette 3 mg/0.02 mg film-coated tablets are packed in PVC/PE/PVDC-Al blister packs. The blisters are placed in cardboard boxes containing a patient leaflet, a holder for the pack, and adhesive labels indicating the day of the week marked in a cell.
Pack sizes:
1x (24+4) film-coated tablets
3x (24+4) film-coated tablets
6x (24+4) film-coated tablets
13x (24+4) film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary

This medicinal product is authorized in the European Economic Area countries under the following names:
Hungary: Tentacia
Italy: Daylette

This patient leaflet was last updated on