Package Leaflet: Information for the User

Liofora Daily 3 mg/0.02 mg Film-Coated Tablets

drospirenone/ethinylestradiol

Important information about combined hormonal contraceptives (CHCs):

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

1.What is Liofora Daily and for what it is used.2

2.What you need to know before starting to take Liofora Daily2

When not to use Liofora Daily2

Warnings and precautions4

Blood clots5

Liofora Daily and cancer9

Mental disorders……………………………………………….……………………...9

Spotting between periods9

What to do if you do not have your period during the placebo days9

Other medicines and Liofora Daily9

Taking Liofora Daily with food and drinks10

Laboratory tests10

Pregnancy11

Lactation11

Driving and operating machines11

Liofora Daily contains lactose11

3.How to take Liofora Daily11

Preparing the package11

When to start with the first package12

What to do if you take more Liofora Daily than you should13

What to do if you forget to take Liofora Daily13

What to do in case of severe vomiting or diarrhea15

Delayed menstrual period: what you should know15

Change in the first day of your menstrual period: what you should know15

What to do if you interrupt the treatment with Liofora Daily16

4.Possible side effects16

5.Storage ofLioforaDaily17

6.Contents of the package and additional information18

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

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

• The 7 film-coated white tablets that do not contain active ingredients are called placebo tablets.

• Contraceptives that contain two hormones are called combined contraceptives.

General Considerations

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

Before starting to take Liofora Diario, 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 perform some other tests.

In this prospectus, several situations are described in which you should interrupt the use of Liofora Diario, or in which the effect of Liofora Diario may decrease. In these 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 Diario alters the monthly changes in body temperature and cervical mucus.

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

When not to use Liofora Diario

You should not use Liofora Diario 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 Diario

• If you have (or have ever had) a blood clot in a vein of the legs (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs.
• If you know that you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need surgery or if you spend a lot of time without standing up (see section 2 “Blood Clots”).
• If you have ever had a heart attack or a stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, symptoms of a stroke).
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:

• Severe diabetes with vascular damage.
• Very high blood pressure.
• Very high levels of fat in the blood (cholesterol or triglycerides).
• A condition called hyperhomocysteinemia.

• If you have (or have ever had) a type of migraine called “migraine with aura”.
• If you have (or have ever had) a liver disease and your liver function has not normalized yet.
• If your kidneys do not function well (renal insufficiency).
• If you have (or have ever had) a liver tumor.
• If you have (or have ever had), or are suspected of having breast cancer or cancer of the reproductive organs.
• If you have vaginal bleeding, whose cause is unknown.

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

Do not take Liofora Diario 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 Diario”).

Additional information on special populations

Children and adolescents

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

Older women

Liofora Diario is not indicated for useafter menopause.

Women with liver insufficiency

Do not take Liofora Diario if you suffer from liver disease. See sections “Do not use Liofora Diario” and “Warnings and precautions”.

Women with renal insufficiency

Do not take Liofora Diario if you are suffering from kidney dysfunction or acute renal insufficiency. See sections “Do not use Liofora Diario” and “Warnings and precautions”.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeLiofora Diario.

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

In some situations, you should take special care while using Liofora Diario or any other combined hormonal contraceptive, and you may need to have regular check-ups with your doctor.

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

• If a close relative has or has had breast cancer.
• If you have any liver or gallbladder disease.
• If you have diabetes.
• If you have depression.
• If you have inflammatory bowel disease (Crohn's disease or ulcerative colitis).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• If you have sickle cell anemia (a genetic disorder of red blood cells).
• If you have high levels of fat in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you need surgery or spend a lot of time without standing up (see section 2 “Blood Clots”).
• If you recently gave birth, you are at higher risk of developing blood clots. Ask your doctor when you can start taking Liofora Diario after childbirth.
• If you have superficial thrombophlebitis (inflammation of the veins under the skin).
• If you have varicose veins.
• If you have epilepsy (see “Other medications and Liofora Diario”, 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 a previous use of sex hormones (for example, hearing loss, a blood disorder called porphyria, skin rash with blisters during pregnancy (herpes gestationalis), a nervous disorder characterized by involuntary movements (Sydenham's chorea)).
• If you have or have had melasma (a skin discoloration, especially on the face and neck, known as “pregnancy mask”). In that 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 containing estrogens can induce or worsen symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Liofora Diario increases your risk of developing ablood clotcompared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

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

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

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

HOW TO RECOGNIZE A BLOOD CLOT

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

BLOOD CLOTS IN A VEIN

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

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in veins (venous thromboembolism). However, these adverse effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism (PE).
• 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 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 be higher also if you restart taking a combined hormonal contraceptive (the same medication or a different medication) after a break of 4weeks 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 Diario, your risk of developing a blood clot returns to normal in 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 Diario is small.

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

• Of every 10,000women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone, or norgestimato, about 5-7will develop a blood clot in a year.

• Of every 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as Liofora Diario, about 9-12 women will develop a blood clot in a year.

• The risk of developing a blood clot will depend on your personal risk factors (see “Factors that increase your risk of a blood clot” below).

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

Your risk of developing a blood clot with Liofora Diario is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index (BMI) of 30kg/m2or higher).
• If one of your close relatives has had a blood clot in the leg, lung, or other organ at a young age (before about 50years). In this case, you may have a hereditary blood clotting disorder.
• If you need surgery or spend a lot of time without standing up due to an injury or illness or if you have a leg cast. You may need to interrupt the use of Liofora Diario for several weeks before surgery or while you have limited mobility. If you need to interrupt the use of Liofora Diario, ask your doctor when you can start using it again.
• With increasing age (especially above about 35years).
• If you have given birth recently.

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

Long flights (more than 4hours) may temporarily increase your 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 conditions above, even if you are unsure. Your doctor may decide that you should interrupt the use of Liofora Diario.

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

BLOOD CLOTS IN AN ARTERY

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

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

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

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

• With age (above about 35years).
• If you smoke.You are advised to quit smoking when using a combined hormonal contraceptive like Liofora Diario. If you are unable to quit smoking and are over 35years, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If one of your close relatives has had a heart attack or stroke at a young age (before about 50years). In this case, you may also be at higher risk of having a heart attack or stroke.
• If you or one of your close relatives has 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, 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, your risk of developing a blood clot may be increased even further.

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

Liofora Diario and cancer

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

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

Mental health disorders

Some women who use combined hormonal contraceptives like Liofora Diario have reported depression or a depressive mood. Depression can be severe and sometimes may induce suicidal thoughts. If you experience mood changes and depressive symptoms, consult your doctor for additional medical advice as soon as possible.

Spotting between periods

During the first few months of taking Liofora Diario, you may experience unexpected bleeding (bleeding outside the week when you take the white pills). If this bleeding persists beyond a few months or starts after a few months, your doctor will investigate what is wrong.

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

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

If your expected period does not arrive in two consecutive instances, you may be pregnant. Consult your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Other medications and Liofora Diario

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication or herbal preparations. You should also inform any other doctor or dentist who prescribes another medication (or your pharmacist) that you are taking Liofora Diario. They may advise you to take additional contraceptive precautions (for example, condoms) and, if so, for how long, or to modify the use of another medication that you need.

Some medications

• may affect the levels of Liofora Diario in the blood
• may make itless effective in preventing pregnancy
• may cause unexpected bleeding

This may occur with:

• medications used in the treatment of:
• • epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
  • tuberculosis (e.g. rifampicin)
  • infections with HIV and hepatitis C (the so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)
  • fungal infections (e.g. griseofulvin, ketoconazole)
  • arthritis, osteoarthritis (etoricoxib)
  • high blood pressure in the blood vessels of the lungs (bosentan)
• herbal preparations of St. John's Wort.

Liofora Diariomay affect the effectof other medications, for example:

• medications containing ciclosporin
• the antiepileptic lamotrigine (may lead to an increase in seizure frequency)
• theophylline (used to treat respiratory problems)
• tizanidine (used to treat muscle pain and/or cramps)

Do not take Liofora Diario if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver function parameters in the blood (elevated ALT levels). Your doctor will prescribe another type of contraceptive before starting this treatment. Liofora Diario can be taken again approximately 2 weeks after the end of this treatment. See the section “Do not use Liofora Diario”.

Consult your doctor or pharmacist before using any medication.

Taking Liofora Diario with food and drinks

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

Laboratory tests

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

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, do not take Liofora Diario. If you become pregnant during treatment with Liofora Diario, stop treatment immediately and consult your doctor. If you want to become pregnant, you can stop taking Liofora Diario at any time (see “If you interrupt treatment with Liofora Diario”, page 16).

Consult your doctor or pharmacist before using any medication.

Breastfeeding

Generally, it is not recommended to take Liofora Diario 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 operating machinery

There is no information to suggest that the use of Liofora Diario has any effect on your ability to drive or operate machinery.

Liofora Diario contains lactose

If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Each blister contains 21 active film-coated tablets of pale pink color and 7 white film-coated placebo 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 every day approximately at the same time.

Do not confuse the tablets: take one pale pink tablet every day for the first 21 days, followed by one white tablet for the last 7 days. Then you must start taking a new pack (21 pale pink tablets and 7 white tablets). In this way, there is no break between two packs.

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

Preparation of the pack

To help you follow the order of taking, each pack of Liofora Daily contains 7 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 adhesive strip of the week on the top of the Liofora Daily blister, where it is indicated “Stick the adhesive strip here!”, so that the first day is placed above the tablet marked with “Start”.

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

During the 7 days when you take white placebo tablets (the placebo days), you usually start your period (also called withdrawal bleeding). Normally, your period starts the second or third day after you have taken the last active tablet, of pale pink color, of Liofora Daily. Once you have taken the last white tablet, you must start a new pack, even if you have not finished your period. This means that you should start each packon the same day of the weekthat you started the previous one, and your period should occur 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 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 the 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 the cycle, but you must use additional contraceptive methods (e.g., a condom) during the first 7 days.

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

You can start taking Liofora Daily preferably on 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 combined contraceptive ring or patch, follow your doctor's recommendations.

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

You can switch from theprogestin-only pillany day (if it is an implant or an SLI, on the same day of its removal; if it is an injectable, on the day of the next injection), but in all cases use additional contraceptive methods (e.g., a condom) during the first 7 days of taking tablets.

• After an abortion

Follow your doctor's recommendations.

• After giving birth

You can start taking Liofora Daily between 21 and 28 days after giving birth. If you start later than day 28, use one of the so-called barrier methods (e.g., a condom) during the first 7 days of taking Liofora Daily.

If, after giving birth, you have already had sex 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 giving birth

Read the section “Breastfeeding”, page 11.

Ask your doctor if you are unsure when to start.

If you take more Liofora Daily than you should

No serious cases of overdose of Liofora Daily have been reported.

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

If you have taken too many Liofora Daily tablets, or if you 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 Toxicological Information Service. Phone 915 620 420, indicating the medication and the amount taken.

If you forgot to take Liofora Daily

The tablets of thefourthrow 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 pale pink tablet from the1st, 2nd, or 3rdrow, do the following:

• If you are lateless than 12 hoursin taking some tablets, the protection against pregnancy does not decrease. Take the tablet as soon as you remember and the subsequent tablets at the usual time.

• If you are latemore than 12 hoursin taking some tablets, the protection against pregnancy may decrease. The more tablets you have forgotten, the greater the risk of becoming pregnant.

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

• Forgetting more than one tablet from the pack

Consult your doctor.

• Forgetting a tablet in week 1

Take the forgotten tablet as soon as you remember, although this may mean taking two tablets at once. Continue taking the tablets at the usual time and useadditional precautions, such as condoms, during the next 7 days. If you have had sex in the week before forgetting the tablet, you may be pregnant. In that case, consult your doctor.

• Forgetting a tablet in week 2

Take the forgotten tablet as soon as you remember, although this may mean taking two tablets at once. Continue taking the tablets at the usual time. The protection against pregnancy does not decrease and you do not need to take additional precautions.

• Forgetting a tablet in week 3

You can choose between two options:

1. Take the forgotten tablet as soon as you remember, although this may mean taking two tablets at once. Continue taking the tablets at the usual time. Instead of taking the white placebo tablets of this pack, discard them and start a new pack.

You may experience bleeding during the use of the second pack, which may be similar to your period. Finish this second pack by taking the 7 white placebo tablets. Then start a new pack.

1. Alternatively, you can interrupt the taking of active pale pink tablets and pass 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 forless 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 period during the placebo days, you may be pregnant. Contact your doctor before starting a new pack.

What to do in case of vomiting or intense diarrhea

If you have vomiting in the 3-4 hours after taking an active pale pink tablet, or if you have intense 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 active pale pink tablet from a reserve pack as soon as possible. If possible, take itwithin 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 forgot to take Liofora Daily”, page 14.

Delay of your menstrual period: what you should know

Although not recommended, you can delay your menstrual period if you do not take the placebo tablets, start taking a new pack of Liofora Daily, and finish it. You may experience bleeding during the use of the second pack, which may be similar to your period. Finish this second pack by taking the 7 white placebo tablets. Then start a new pack.

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

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

If you take the tablets as indicated, your period will start during theweek of placebo. If you want to change that day, reduce the number of days with placebo –when you take the white placebo tablets-(but never increase - 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 interval of taking placebo tablets very short (e.g., 3 days or less), you may not experience bleeding during these days. Then you may experience bleeding similar to your period.

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

If you interrupt the treatment with Liofora Daily

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any side effect, especially if it is severe and persistent, or if you have any health changes that you think may be related to Liofora Diario, consult your doctor.

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

Severe side effects

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

The following list of side effects has been associated with the use of Liofora Diario.

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

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

Rare side effects(may affect up to 1 in 1000 patients):

• Asthma
• Auditory problems
• Eructation nodosa (characterized by painful red nodules on the skin)
• Eructation multiforme (skin rash with red spots or ulcers)
• Deleterious blood clots in a vein or artery, for example:
• • In a leg or foot (i.e., TVP).
  • In a lung (i.e., EP).
  • Myocardial infarction.
  • Stroke.
  • Transient ischemic attack (TIA) or temporary symptoms similar to a stroke.
  • 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 section2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

Reporting of side effects:

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

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

This medication does not require any special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after “CAD:”. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Liofora Diario

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

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

• The film-coated white tablets do not contain active principles.
• The other componentsare

Film-coated active tablets of pale pink color:

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

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

Film-coated inactive tablets of white color:

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

Film coating of the tablet:hypromellose (E-464), talc (E-553b) and titanium dioxide (E-171).

See section 2 “Liofora Diario contains lactose”.

Appearance of the product and contents of the package

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 - 5

08970 Sant Joan Despí – Barcelona

Spain

Responsible for manufacturing

Bayer AG, 13342 Berlin, Germany

or

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

This medicinal product is authorized in the member states of the European Economic Area with the following names:

• Netherlands:Belanette 28

• Spain:Liofora Diario

Date of the last review of this leaflet:May 2023

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