Liofora 3 mg / 0.02 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Liofora 3 mg/0.02 mg film-coated tablets

drospirenone/ethinylestradiol

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you. Keep this leaflet as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them. If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Important information you should know about combined hormonal contraceptives (CHCs):

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

Package leaflet contents:

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

When you must not use Liofora 2

Warnings and precautions……………………………………………………………..….3

Blood clots 5

Liofora and cancer 9

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

Bleeding between periods 9

What to do if you do not have your period during the break week 10

Other medicines and Liofora 10

Taking Liofora with food and drinks 11

Laboratory tests 11

Pregnancy 11

Breast-feeding 11

Driving and using machines 11

Liofora contains lactose 11

3. How to take Liofora 11

When can you start the first pack? 12

If you take more Liofora than you should 13

If you forget to take Liofora 13

What to do in case of vomiting or severe diarrhoea 15

Delayed menstrual period: what you should know 15

Change in the onset of your menstrual period: what you should know 15

If you stop treatment with Liofora 16

4. Possible side effects 16
5. How to store Liofora 18
6. Contents of the pack and other information………………………….…………... …….18

1. What Liofora is and what it is used for

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

• Each film-coated tablet contains a small amount of two different female hormones called drospirenone and ethinylestradiol.

• Contraceptives containing two hormones are called combined contraceptives.

2. What you need to know before starting Liofora

General considerations

Before starting Liofora, 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 Liofora, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your personal situation, may carry out some additional tests.

This leaflet describes several situations in which you should stop using Liofora, or in which the effect of Liofora may be reduced. In such situations, you should not have sexual intercourse or should use additional non-hormonal contraceptive precautions, for example, use of a condom or another barrier method. Do not use the rhythm method or the temperature method. These methods may not be reliable because Liofora alters the monthly changes in body temperature and cervical mucus.

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

When not to use Liofora

Do not use Liofora 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 which other form of contraception would be most suitable.

Do not use Liofora

• If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs.

• If you know you have a disorder affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.

• If you require surgery or will be immobile for a long time (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 and may be the first sign of a heart attack) or transient ischaemic attack (TIA, temporary stroke-like symptoms).

• If you have any of the following conditions that may increase your risk of forming a blood 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) liver disease and your liver function has not returned to normal.

• If your kidneys do not function properly (renal insufficiency).

• If you have (or have ever had) a liver tumour.

• If you have (or have ever had), or if it is suspected that you have breast cancer or cancer of the genital organs.

• If you have vaginal bleeding of unknown cause.

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

Do not take Liofora 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 Liofora”).

Additional information on special populations

Children and adolescents

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

Older women

Liofora is not indicated for use after menopause.

Women with hepatic impairment

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

Women with renal impairment

Do not take Liofora if you have impaired kidney function or acute renal failure. See sections “Do not use Liofora” and “Warnings and precautions”.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Liofora.

When should you consult your doctor? Seek urgent medical assistance If you notice possible signs of a blood clot which may mean you are experiencing a blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the lung (i.e. pulmonary embolism), a heart attack, or a stroke (see section “Blood clots” below). For a description of the symptoms of these serious adverse effects, see “How to recognize a blood clot”.

Inform your doctor if you have any of the following conditions.

In certain situations, you should take special care when using Liofora or any other combined contraceptive, and your doctor may need to examine you periodically. If any of these conditions develop or worsen while you are using Liofora, you must also inform your doctor.

• If a close relative has or has previously had breast cancer.
• 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 red blood cell disorder).
• If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you require surgery or will be immobile for long periods (see section 2 “Blood clots”).
• If you have recently given birth, you are at increased risk of blood clots. You should ask your doctor when you can start taking Liofora after delivery.
• If you have inflammation of the veins beneath the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you have epilepsy (see “Other medicines and Liofora”, page 10).
• If you have systemic lupus erythematosus (SLE, a disease affecting your body’s natural defense system).
• If you have a condition that may have first appeared during pregnancy or a previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (herpes gestationis), a neurological disorder involving involuntary movements (Sydenham's chorea)).
• If you have or have ever had chloasma (skin discoloration, especially on the face and neck, also known as “pregnancy mask”). In such cases, avoid direct exposure to sunlight or ultraviolet radiation.
• If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or hives, possibly accompanied by breathing difficulties, consult your doctor immediately. Medicinal products containing estrogens may induce or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Liofora increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In the veins (known as “venous thrombosis”, “venous thromboembolism” or VTE).
• In the arteries (known as “arterial thrombosis”, “arterial thromboembolism” or ATE).

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

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if you notice any of the following signs or symptoms.

Are you experiencing any of these signs?	What might you be suffering from?
Swelling in one leg or along a vein in the leg or foot, especially when accompanied by: Pain or tenderness in the leg, which may only be noticeable when standing or walking. Increased warmth in the affected leg. Change in skin color of the leg, e.g., turning pale, red, or blue.	Deep vein thrombosis.
Sudden shortness of breath without known cause or rapid breathing. Sudden cough without clear cause, possibly bringing up blood. Sharp chest pain that may worsen when taking a deep breath. Severe dizziness or lightheadedness. Rapid or irregular heartbeat. Severe abdominal pain. If you are unsure, consult a doctor, as some of these symptoms such as cough or shortness of breath may be mistaken for a milder condition like a respiratory infection (e.g., a "common cold").	Pulmonary embolism.
Symptoms occurring more frequently in one eye: Sudden loss of vision. Or Painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye).
Chest pain, discomfort, pressure, or heaviness. Feeling of tightness or fullness in the chest, arm, or below the breastbone. Sensation of fullness, indigestion, or suffocation. Upper body discomfort radiating to the back, jaw, throat, arm, or stomach. Sweating, nausea, vomiting, or dizziness. Extreme weakness, anxiety, or shortness of breath. Rapid or irregular heartbeat.	Heart attack.
Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body. Sudden confusion, difficulty speaking or understanding speech. Sudden vision problems in one or both eyes. Sudden difficulty walking, dizziness, loss of balance, or coordination. Sudden, severe, or prolonged headache without known cause. Loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke.
Swelling and slight bluish discoloration of a limb. Severe abdominal pain (acute abdomen).	Blood clots blocking other blood vessels.

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 adverse effects are rare. They occur more frequently 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 travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may 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 of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same medication or a different one) after a break of 4 weeks or more.

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

When you stop taking Liofora, 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 venous thromboembolism (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 is small.

• Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in 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 in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as Liofora, between about 9 and 12 women will develop a blood clot in one year.
• Your personal risk of developing a blood clot depends on your individual medical history (see “Factors that increase your risk of a blood clot” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal contraceptive pill and who are not pregnant	About 2 out of 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone, or norgestimate	About 5–7 out of 10,000 women
Women who use Liofora	About 9–12 out of 10,000 women

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

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

• If you are overweight (body mass index or BMI above 30 kg/m²).
• If a close relative has had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years of age). In this case, you might have an inherited blood clotting disorder.
• If you need surgery or will be immobile for a long time due to injury or illness, or if your leg is in a cast. You may need to stop taking Liofora several weeks before surgery or while you are less mobile. If you need to stop taking Liofora, ask your doctor when you can start taking it again.
• As you get older (especially over about 35 years of age).
• If you have given birth within the last few weeks.

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

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 above.

It is important to inform your doctor if you have any of the above conditions, even if you are unsure. Your doctor may decide that you need to stop taking Liofora.

If any of the above conditions change while you are using Liofora—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 lead to a heart attack or stroke.

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

It is important to note that the risk of heart attack or stroke while using Liofora is very small, but it may increase:

• With age (over about 35 years).
• If you smoke. When using a combined hormonal contraceptive like Liofora, you are advised 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 about 50 years). In this case, you may also have an increased risk of heart attack or stroke.
• If you or a close relative has high levels of fat in the blood (cholesterol or triglycerides).
• If you suffer from migraines, especially migraines with aura.
• If you have a heart condition (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 is particularly severe, your risk of developing a blood clot may be further increased.

If any of the above conditions change while you are using Liofora—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 and cancer

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

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

Psychiatric disorders

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

Bleeding between periods

During the first few months of taking Liofora, you may experience unexpected bleeding (bleeding outside the rest week). If this bleeding persists beyond a few months or starts after a few months, your doctor will investigate the cause.

What to do if you do not have your period during the rest week

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

If you miss two consecutive expected periods, you may be pregnant. See your doctor immediately. Do not start the next pack until you are certain you are not pregnant.

Other medicines and Liofora

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines or herbal preparations. Also inform any other doctor or dentist who prescribes you another medicine (or your pharmacist) that you are taking Liofora. They can advise you whether you need to take additional contraceptive precautions (e.g., condoms) and, if so, for how long, or whether you need to adjust the use of another medicine you require.

Some medicines:

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

This may occur with:

• medicines used to treat:
  • epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
  • tuberculosis (e.g., rifampicin)
  • HIV and hepatitis C virus infections (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 containing St. John’s wort.

Liofora may affect the effect of other medicines, for example:

• medicines containing cyclosporine
• the antiepileptic lamotrigine (which may lead to an increased frequency of seizures)
• theophylline (used to treat respiratory problems)
• tizanidine (used to treat muscle pain and/or spasms)

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

Consult your doctor or pharmacist before using any medicine.

Taking Liofora with food and drink

Liofora may be taken with or without food, and should be taken with some water if necessary.

Laboratory tests

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

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, you must not take Liofora. If you become pregnant while taking Liofora, stop treatment immediately and contact your doctor. If you wish to become pregnant, you may discontinue taking Liofora at any time (see "If you stop taking Liofora", page 15).

Consult your doctor or pharmacist before using any medicine.

Breastfeeding

Liofora is generally not recommended during breastfeeding. If you wish to take a contraceptive while breastfeeding, you should consult your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

There is no information suggesting that taking Liofora has any effect on the ability to drive or operate machinery.

Liofora contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Liofora

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The pack (blister) contains 21 film-coated tablets. Next to each tablet is printed the day of the week on which it should be taken. For example, if you start on Wednesday, take a tablet marked "WED". Follow the direction of the arrow on the pack until you have taken all 21 tablets.

After this, do not take any tablets for 7 days. During these 7 days when no tablets are taken (called the "rest period"), you should experience menstruation. The bleeding, often referred to as withdrawal bleeding, usually starts on the 2nd or 3rd day of the rest period.

On the 8th day after taking the last Liofora tablet (i.e., after the 7-day rest period), start the next pack, even if your bleeding has not yet stopped. This means you should begin each new pack on the same day of the week, and your period should occur during the same days every month.

If you use Liofora in this way, you are also protected against pregnancy during the 7 days when you do not take any tablets.

When can you start the first pack?

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

Start taking Liofora on the first day of your cycle (i.e., the first day of your period). If you start Liofora on the first day of your period, you are protected against pregnancy immediately. You may 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, combined vaginal contraceptive ring, or contraceptive patch

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

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

You may switch from the progestogen-only pill on any day (if using an implant or IUS, on the same day of its removal; if using an injectable, at the time the next injection would be 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 advice.

• After giving birth

You may start taking Liofora 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 using Liofora.

If, after giving birth, you have already had sexual intercourse before starting to take Liofora (again), you must be sure you are not pregnant or wait until your next menstrual period.

• If you are breastfeeding and wish to start (or restart) taking Liofora after giving birth

Please read the section “Breastfeeding”, page 11.

Ask your doctor if you are unsure about when to start.

If you take more Liofora than you should

No serious harm has been reported from overdosing on Liofora.

Symptoms that may occur if you take many tablets at once include feeling unwell, vomiting, or vaginal bleeding. This bleeding may even occur in girls who have not yet had their first menstrual period, if they have accidentally taken this medicine.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist or call the Toxicology Information Service at telephone number 915 620 420, indicating the medicine and the amount taken.

If you forget to take Liofora

• If you are less than 12 hours late in taking a tablet, protection against pregnancy is not reduced. Take the missed tablet as soon as you remember and continue taking the following tablets at your usual time.
• If you are more than 12 hours late in taking a tablet, protection against pregnancy may be reduced. The more tablets you miss, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is greatest if you miss a tablet at the beginning or end of the pack. Therefore, follow the recommendations below (see the diagram on page 14):

• Missing more than one tablet from the pack

Consult your doctor.

• Missing one tablet in week 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 and use additional precautions, such as condoms, for the next 7 days. If you had sexual intercourse in the week before missing the tablet, you may be pregnant. In this case, consult your doctor.

• Missing one tablet in week 2

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. Protection against pregnancy is not reduced, and you do not need to take additional precautions.

• Missing one tablet in week 3

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 starting the rest period, begin the next pack immediately.

You will likely have your period at the end of the second pack, although you may experience light bleeding or spotting during the second pack.

2. Alternatively, you may stop taking tablets and go directly into the rest period (note the day on which you missed the tablet). If you wish to start a new pack on the day you usually start, your rest period will need to be less than 7 days.

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

• If you have missed taking any tablets and do not have a period during the first rest period, you may be pregnant. Contact your doctor before starting the next pack.

What to do in case of vomiting or severe diarrhoea

If you vomit within 3–4 hours after taking a tablet or suffer from severe diarrhoea, there is a risk that the active ingredients of the contraceptive are not fully absorbed by the body. This situation is almost equivalent to missing a tablet. After vomiting or diarrhoea, take a tablet from a spare pack as soon as possible. If possible, take it within 12 hours of your usual time for taking the 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”, page 13.

Delaying your menstrual period: what you should know

Although not recommended, you may delay your menstrual period by starting a new pack of Liofora instead of beginning the rest period and completing it. During the second pack, you may experience light bleeding or spotting. After the usual rest week, start the next pack.

You should seek advice from your doctor 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 menstrual period will begin during the week corresponding to the rest period. If you need to change the day, reduce the number of rest days (but never increase them – maximum 7 days!). For example, if your rest days usually start on Fridays and you want to change to Tuesdays (3 days earlier), start a new pack 3 days earlier than usual. If you make the rest period very short (e.g., 3 days or fewer), you may not have bleeding during these days. In this case, you may experience light bleeding or spotting later.

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

If you stop treatment with Liofora

You may stop taking Liofora whenever you wish. If you do not want to become pregnant, consult your doctor about other effective methods of birth control.

If you wish to become pregnant, stop taking Liofora and wait until your menstrual period before trying to conceive. This will make it easier to calculate your estimated date of delivery.

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

4. Possible adverse effects

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

If you experience any adverse effect, especially if it is severe and persistent, or if you have any change in your health that you think may be due to Liofora, consult your doctor.

All women who take combined hormonal contraceptives have an increased 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 associated with taking combined hormonal contraceptives, see section 2 “What you need to know before starting to take Liofora”.

Serious 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 hives with possible difficulty breathing (see also section “Warnings and precautions”).

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

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

• mood changes
• headache
• abdominal pain (stomach ache)
• acne
• breast pain, breast enlargement, breast tenderness, painful or irregular periods
• weight gain

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

• Candida (a fungal infection)
• cold sores (herpes simplex)
• allergic reactions
• increased appetite
• depression, nervousness, sleep disorders
• tingling sensation, dizziness
• vision problems
• irregular or unusually fast heart rate
• blood clots (thrombosis) in the lungs (pulmonary embolism), increased blood pressure, low blood pressure, migraine, varicose veins
• sore throat
• nausea, vomiting, inflammation of the stomach and/or intestine, diarrhea, constipation
• hair loss (alopecia), eczema, itching, skin rashes, dry skin, disorders of oily skin (seborrhoeic dermatitis)
• neck pain, limb pain, muscle cramps
• bladder infection
• breast lumps (benign or cancer), milk production without being pregnant (galactorrhoea), ovarian cysts, hot flushes, absence of menstruation, heavy periods, vaginal discharge, vaginal dryness, pain in the lower abdominal (pelvic) area, abnormal cervical smears (Papanicolaou or Papanicolaou staining), decreased interest in sex
• fluid retention, lack of energy, excessive thirst, increased sweating
• weight loss

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

• asthma
• hearing problems
• erythema nodosum (characterized by painful reddish nodules on the skin)
• erythema multiforme (skin rash with target-shaped redness 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.
  • Mini-stroke or temporary symptoms similar to stroke, 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 about conditions that increase the risk of blood clots and symptoms of a blood clot).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Liofora

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after "EXP:". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Package contents and other information

Composition of Liofora

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

Each coated tablet contains 3 milligrams of drospirenone and 0.020 milligrams of ethinylestradiol (as betadex clathrate).

• The other components (excipients) are lactose monohydrate, corn starch, magnesium stearate (E-470b), hypromellose (E-464), talc (E-553b), titanium dioxide (E-171), and red iron oxide (E-172); see section 2 “Liofora contains lactose”.

Appearance of the product and contents of the pack

• Each Liofora blister pack contains 21 pale pink film-coated tablets.
• Liofora contains film-coated tablets; the tablet core is coated.

The film-coated tablets are pale pink in colour, round, with convex surfaces, and one side is marked with the letters “DS” inside a regular hexagon.

• Liofora is available in boxes containing 1, 3, 6, and 13 packs (blister strips), each with 21 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area under the following names:

• Austria: Aliane

• Spain: Liofora

• Czech Republic, France, Netherlands: Belanette

• Hungary: Yasminelle

Date of the most recent review of this leaflet: May 2023

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