LIOFORA DIARIO 3 mg / 0.02 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Liofora Diario 3 mg/0.02 mg Film-Coated Tablets

drospirenone/ethinylestradiol

Important things to 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 you start using a combined hormonal contraceptive again after a break of 4 weeks or more.
• Be aware and consult your doctor if you think you might have symptoms of a blood clot (see section 2 “Blood Clots”).

Contents of the Package Leaflet:

1. What is Liofora Diario and what is it used for .2
2. What you need to know before you start taking Liofora Diario 2

When not to use Liofora Diario 2

Warnings and precautions 4

Blood Clots 5

Liofora Diario and cancer 9

Psychiatric disorders……………………………………………….……………………...9

Intermenstrual bleeding 9

What to do if you do not have your period during the placebo days 9

Other medicines and Liofora Diario 9

Taking Liofora Diario with food and drink 10

Laboratory tests 10

Pregnancy 11

Breastfeeding 11

Driving and using machines 11

Liofora Diario contains lactose 11

1. How to take Liofora Diario 11

Preparing the pack 11

When you can start with the first pack 12

If you take more Liofora Diario than you should 13

If you forget to take Liofora Diario 13

What to do in case of vomiting or severe diarrhea 15

Delay of your menstrual period: what you should know 15

Change of your menstrual period's first day: what you should know 15

If you stop taking Liofora Diario 16

1. Possible side effects 16
2. Storing Liofora Diario 17
3. Contents of the pack and further information 18

1. What is Liofora Diario and what is it used for

• Liofora Diario is a contraceptive and is used to prevent pregnancy.

• Each of the 21 active film-coated tablets, pale pink in color, contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.

• The 7 film-coated tablets, white in color, do not contain active ingredients and are called placebo tablets.

• Contraceptives that contain two hormones are called combined contraceptives.

2. What you need to know before starting to take Liofora Daily

General considerations

Before starting to use Liofora Daily, 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 starting to take Liofora Daily, your doctor will ask you some questions about your personal and family medical history. The doctor will also measure your blood pressure and, depending on your personal situation, may carry out some other tests.

In this prospectus, several situations are described in which you should stop using Liofora Daily, or in which the effect of Liofora Daily may decrease. In such situations, you should not have sexual intercourse or should take additional non-hormonal contraceptive precautions, for example, use a condom or another barrier method. Do not use the rhythm or temperature method. These methods may not be reliable since Liofora Daily alters the monthly changes in body temperature and cervical mucus.

Liofora Daily, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

When you should not use Liofora Daily

You should not use Liofora Daily 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 Liofora Daily

• 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 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, temporary symptoms of a stroke).
• 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 ever had) a liver disease and your liver function has not yet normalized.
• 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 are suspected of having breast cancer or cancer of the sex organs.
• If you have vaginal bleeding, whose cause is unknown.

• If you are allergic to ethinylestradiol, drospirenone, or any of the other components of this medication (including those listed in section 6). This can cause itching, rash, or inflammation.

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

Additional information on special populations

Children and adolescents

Liofora Daily is not indicated for use in women who have not yet had their first menstrual period.

Older women

Liofora Daily is not indicated for use after menopause.

Women with liver insufficiency

Do not take Liofora Daily if you suffer from liver disease. See sections "Do not use Liofora Daily" and "Warnings and precautions".

Women with renal insufficiency

Do not take Liofora Daily if you are suffering from kidney malfunction or acute renal insufficiency. See sections "Do not use Liofora Daily" and "Warnings and precautions".

Warnings and precautions

Consult your doctor or pharmacist before starting to take Liofora Daily.

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

In some situations, you will need to be particularly careful while using Liofora Daily or any other combined contraceptive, and it may be necessary for your doctor to examine you periodically.

If the condition develops or worsens while you are using Liofora Daily, you should also inform your doctor.

• If a close relative has or has had breast cancer in the past.
• If you have any liver or gallbladder disease.
• If you have diabetes.
• If you have depression.
• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• If you have sickle cell anemia (an inherited 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 lot of time without getting up (see section 2 "Blood clots").
• If you have just given birth, you are at a higher risk of developing blood clots. You should ask your doctor when you can start taking Liofora Daily 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 medications and Liofora Daily", page 10).
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• If you have a disease that may have appeared for the first time during pregnancy or during previous use of sex hormones (e.g., hearing loss, a blood disease called porphyria, blistering skin rash during pregnancy (herpes gestationalis), a nervous system disease in which involuntary movements appear (Sydenham's chorea)).
• If you have or have ever had chloasma (a skin discoloration, especially on the face and neck, known as "pregnancy spots"). In this case, you should avoid direct exposure to the sun or ultraviolet rays.
• If you experience symptoms of angioedema such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or urticaria, with possible difficulty breathing, consult your doctor immediately. Medications that contain estrogens can induce or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Liofora Daily increases your risk of developing a blood clotcompared 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 essential to remember that the overall risk of a harmful blood clot due to Liofora Daily 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 clot can form in a vein of another organ, such as the eye (retinal vein thrombosis)

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

The risk of developing 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 also be higher if you start 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 Liofora Daily, your risk of developing a blood clot returns to normal within a few weeks.

What is the risk of developing 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 developing a blood clot in the leg or lung (DVT or PE) with Liofora Daily is small.

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will develop 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 develop a blood clot in a year.

• Out of 10,000 women who use a combined hormonal contraceptive that contains drospirenone, such as Liofora Daily, between 9 and 12 women will develop a blood clot in a year.

• The risk of developing 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 Liofora Daily 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). In this case, you may have a hereditary blood clotting disorder.
• If you need an operation or spend a lot of time without getting up due to an injury or illness, or if you have a leg in a cast. You may need to stop using Liofora Daily several weeks before the operation or while you have reduced mobility. If you need to stop using Liofora Daily, 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 developing a blood clot increases with the number of conditions you have.

Long-distance air travel (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 suffer from any of the above conditions, even if you are not sure. Your doctor may decide that you should stop using Liofora Daily.

If any of the above conditions change while you are using Liofora Daily, for example, a close relative experiences a thrombosis 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 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 Liofora Daily is very small, but it can increase:

• With age (above about 35 years).
• If you smoke.When using a combined hormonal contraceptive like Liofora Daily, 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 a high level 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 disorder called atrial fibrillation).
• If you have diabetes.

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

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

Liofora Daily and cancer

Breast cancer has been slightly more frequently observed in women using combined contraceptives, but it is not known if this is due to the treatment. For example, it may be that more tumors are detected in women taking combined contraceptives because they are examined by a doctor more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential to have your breasts examined regularly, and you should see your doctor if you notice any lump.

In rare cases, benign liver tumors, and even more rarely, malignant liver tumors, have been reported in users of hormonal contraceptives. See your doctor if you have severe unusual abdominal pain.

Psychiatric disorders

Taking Liofora Daily with food and drinks

Liofora Daily can be taken with or without food, and with some water if necessary.

Laboratory tests

If you need a blood test, tell your doctor or laboratory staff that you are taking a contraceptive, as hormonal contraceptives can influence the results of some tests.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, you should not take Liofora Daily. If you become pregnant during treatment with Liofora Daily, you must stop treatment immediately and contact your doctor. If you want to become pregnant, you can stop taking Liofora Daily at any time (see "If you stop treatment with Liofora Daily", page 16).

Consult your doctor or pharmacist before using any medication.

Breastfeeding

Generally, it is not recommended to take Liofora Daily during the breastfeeding period. If you want to take the contraceptive while breastfeeding, you should consult your doctor.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

There is no information that suggests the use of Liofora Daily has any effect on the ability to drive or use machinery.

Liofora Daily contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Liofora Daily

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

Each blister pack contains 21 active pink film-coated tablets and 7 white placebo film-coated tablets.

The two different types of colored tablets of Liofora Daily are arranged in order. A pack contains 28 tablets.

Take one Liofora Daily tablet every day, with some water if necessary. You can take the tablets with or without food, but approximately at the same time every day.

Do not get confused with the tablets: take one pink tablet every day for the first 21 days, followed by one white tablet for the last 7 days. Then, start a new pack (21 pink tablets and 7 white tablets). This way, there is no break between two packs.

Due to the different composition of the tablets, it is necessary to start with the first tablet located in the upper left area and then take one tablet every day. To maintain the order, follow the direction of the arrows on the pack.

Preparing the pack

To help you follow the order of intake, each Liofora Daily pack contains 7 self-adhesive strips with the 7 days of the week. Choose the strip of the week that starts with the day you take the first tablet. For example, if you take your first tablet on a Wednesday, use the strip that starts with "WED".

Stick the weekly strip on the top of the Liofora Daily blister pack, where it says "Place the strip here!", so that the first day is placed above the tablet marked with "Start".

This way, there is a day of the week indicated above each tablet, and you can see if you have taken a particular tablet. The arrows show the order in which you should take the tablets.

During the 7 days when you take the white placebo tablets (the placebo days), you usually start your period (also called withdrawal bleeding). Normally, the period starts on the second or third day after taking the last active pink tablet of Liofora Daily. Once you have taken the last white tablet, you should start the next pack, even if you have not finished your period. This means that you should start each pack on the same day of the weekthat you started the previous one, and that menstruation should take place during the same days every month.

If you take Liofora Daily as indicated, you are also protected against pregnancy during the 7 days when you are taking the placebo tablets.

When can you start with the first pack

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

Start taking Liofora Daily on the first day of your cycle (i.e., the first day of your period). If you start Liofora Daily on the first day of your period, you are immediately protected against pregnancy. You can also start on days 2-5 of your cycle, but you must use additional contraceptive methods (e.g., a condom) during the first 7 days.

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

You can start taking Liofora Daily preferably the day after taking the last active tablet (the last tablet that contains active ingredients) of your previous contraceptive, but no later than the day after the rest days of your previous contraceptive (or after taking the last inactive tablet of your previous contraceptive). When switching from a vaginal ring or patch, follow your doctor's recommendations.

• Switching from a progestin-only method (progestin-only pill, injection, implant, or intrauterine system)

You can switch from the progestin-only pill at any time (if it's an implant or intrauterine system, on the day of its removal; if it's an injectable, when the next injection is due), but in all cases, use additional contraceptive measures (e.g., a condom) during the first 7 days of tablet-taking.

• After an abortion

Follow your doctor's recommendations.

• After having a child

You can start taking Liofora Daily between 21 and 28 days after having a child. If you start later than day 28, use a barrier method (e.g., a condom) during the first 7 days of using Liofora Daily.

If, after having a child, you have had sexual intercourse before starting to take Liofora Daily again, you must be sure you are not pregnant or wait for your next menstrual period.

• If you are breastfeeding and want to start taking Liofora Daily again after having a child

Read the section "Breastfeeding", page 11.

Ask your doctor if you are not sure when to start.

If you take more Liofora Daily than you should

No cases have been reported where an overdose of Liofora Daily has caused serious harm.

The symptoms that may appear if you take many tablets at once may be feeling unwell or having vomiting or vaginal bleeding. This bleeding can occur even in girls who have not yet had their first menstrual period, if they have accidentally taken this medication.

If you have taken too many Liofora Daily tablets, or discover that a child has taken them, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service. Phone 915 620 420, indicating the medication and the amount taken.

If you forget to take Liofora Daily

The tablets in the fourthrow of the pack are the placebo tablets. If you forget to take one of these tablets, it will have no effect on the effect of Liofora Daily. Discard the forgotten placebo tablet.

If you forget to take an active pink tablet from the 1st, 2nd, or 3rdrow, do the following:

• If you are less than 12 hourslate in taking a tablet, the protection against pregnancy is not decreased. Take the tablet as soon as you remember and the following tablets at the usual time.

• If you are more than 12 hourslate in taking a tablet, the protection against pregnancy may be reduced. The more tablets you have forgotten, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is highest if you forget to take a pink tablet at the beginning or end of the pack. Therefore, you should follow these recommendations (see the diagram on page 16):

• Forgetfulness of more than one tablet in the pack

Consult your doctor.

• Forgetfulness of a tablet in week 1

Take the forgotten 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 use additional precautions, such as condoms, for the next 7 days. If you have had sexual intercourse in the week before forgetting the tablet, you may be pregnant. In this case, consult your doctor.

• Forgetfulness of a tablet in week 2

Take the forgotten 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 decreased, and you do not need to take additional precautions.

• Forgetfulness of a tablet in week 3

You can choose between two options:

1. Take the forgotten 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 white placebo tablets from this pack, discard them and start the next pack.

You will probably have your period at the end of the second pack, while taking the white placebo tablets, although you may experience light bleeding or spotting during the second pack.

1. You can also stop taking the active pink tablets and go directly to the 7 white 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 pack on the day you always start, take the placebo tablets for less than 7 days.

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

• If you have forgotten to take a tablet and do not have a menstrual period during the placebo days, you may be pregnant. Contact your doctor before starting the next pack.

What to do in case of vomiting or severe diarrhea

If you vomit within 3-4 hours after taking an active pink tablet, or have severe diarrhea, there is a risk that the active ingredients of the contraceptive will not be fully absorbed by the body. The situation is almost equivalent to forgetting a tablet. After vomiting or diarrhea, take another pink tablet from a reserve pack as soon as possible. If possible, take it within 12 hoursafter the usual time you take your contraceptive. If this is not possible or more than 12 hours have passed, follow the advice in the section "If you forget to take Liofora Daily", page 14.

Delayed menstrual period: what you should know

Although it is not recommended, you can delay your menstrual period if you do not take the white placebo tablets from the fourth row and start a new pack of Liofora Daily and finish it. You may experience light bleeding or spotting during the use of the second pack. Finish this second pack by taking the 7 white tablets from the 4th row. Then, start a new pack.

You should 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 start during the placebo week. If you want to change that day, reduce the number of placebo days – when you take the white placebo tablets – (but never increase them - 7 at most!). For example, if you normally start taking the placebo tablets on Fridays, and you want to change it to Tuesdays (3 days earlier), start a new pack 3 days earlier than usual. If you make the placebo interval very short (e.g., 3 days or less), you may not have bleeding during these days. Then, you may experience light bleeding or spotting.

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

If you stop treatment with Liofora Daily

You can stop taking Liofora Daily whenever you want. If you do not want to become pregnant, consult your doctor about other effective birth control methods. If you want to become pregnant, stop taking Liofora Daily and wait until your menstrual period before trying to become pregnant. This way, you will be able to calculate the estimated date of delivery more easily.

If you have any other doubts about the use of this medication, ask 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 if you have any change in health that you think may be due to Liofora Diario, consult your doctor.

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 Liofora Diario".

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 "Warnings and Precautions" section).

The following list of adverse effects has been related to the use of Liofora Diario.

Frequent Adverse Effects(may affect up to 1 in 10 patients):

1. changes in mood
2. headache
3. abdominal pain (stomach pain)
4. acne
5. pain in the breasts, increased breast size, breast tension, painful or irregular periods
6. weight gain

Infrequent Adverse Effects(may affect up to 1 in 100 patients):

1. Candida (a fungal infection)
2. cold sore (herpes simplex)
3. allergic reactions
4. increased appetite
5. depression, nervousness, sleep disorders
6. tingling sensation, dizziness
7. vision problems
8. irregular or unusually rapid heart rate
9. blood clots (thrombosis) in the lungs (pulmonary embolism), increased blood pressure, decreased blood pressure, migraine, varicose veins
10. sore throat
11. nausea, vomiting, inflammation of the stomach and/or intestine, diarrhea, constipation
12. hair loss (alopecia), eczema, itching, skin rashes, dry skin, seborrheic dermatitis
13. neck pain, limb pain, muscle cramps
14. bladder infection
15. breast lumps (benign or cancerous), milk production without being pregnant (galactorrhea), ovarian cysts, hot flashes, absence of menstruation, heavy menstruation, vaginal discharge, vaginal dryness, pain in the lower abdominal region (pelvic), abnormal cervical smears (Pap smear or Papanicolaou staining), decreased interest in sex
16. fluid retention, lack of energy, excessive thirst, increased sweating
17. weight loss

Rare Adverse Effects(may affect up to 1 in 1000 patients):

• asthma
• hearing problems
• erythema nodosum (characterized by painful nodules on the skin with a reddish color)
• erythema multiforme (skin rash with target-like lesions or ulcers)
• 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 or temporary stroke-like symptoms, known as a transient ischemic attack (TIA).
  • Blood clots in the liver, stomach/intestine, kidneys, or eye.

The likelihood 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).

Reporting 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 leaflet. 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 Liofora Diario

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiration date that appears on the packaging after "CAD:". 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 SIGRE Point in the pharmacy. 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 Liofora Diario

• The active ingredients are drospirenone and ethinylestradiol (as betadex clathrate).

Each active film-coated tablet is pink and contains 3 milligrams of drospirenone and 0.020 milligrams of ethinylestradiol (as betadex clathrate).

• The white film-coated tablets do not contain active ingredients.
• The other components are

Active film-coated tablets:

Tablet core: lactose monohydrate, cornstarch, magnesium stearate (E-470b),

Tablet coating: hypromellose (E-464), talc (E-553b), titanium dioxide (E-171), and red iron oxide (E-172).

Inactive film-coated tablets:

Tablet core: lactose monohydrate, microcrystalline cellulose, magnesium stearate (E-470b),

Tablet coating: hypromellose (E-464), talc (E-553b), and titanium dioxide (E-171).

See section 2 "Liofora Diario contains lactose".

Appearance and Package Contents

• Each Liofora Diario blister pack contains 21 active film-coated tablets in the 1st, 2nd, and 3rd rows of the blister pack and 7 inactive film-coated tablets in the 4th row.
• Both the pink and white Liofora Diario tablets are film-coated; the tablet core is coated.
• The active tablet is pink, round, with convex surfaces, and one side has the letters "DS" marked in a regular hexagon.
• The placebo tablet is white, round, with convex surfaces, and one side has the letters "DP" marked in a regular hexagon.
• Liofora Diario is available in boxes of 1, 3, 6, and 13 packages (blister packs), each containing 28 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 - 5

08970 Sant Joan Despí – Barcelona

Spain

Manufacturer

Bayer AG, 13342 Berlin, Germany

or

Bayer Weimar GmbH und Co. KG, Döbereinerstr. 20 99427 Weimar, Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

• Netherlands: Belanette 28

• Spain: Liofora Diario

Date of the last revision of this leaflet:May 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)