Liofora Diario 3 mg / 0.02 mg film-coated tablets: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Liofora Daily 3 mg/0.02 mg film-coated tablets

drospirenone/ethinylestradiol

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Keep this leaflet as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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 blood clots 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:

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

When you must not use Liofora Diario 2

Warnings and precautions 4

Blood clots 5

Liofora Diario and cancer 9

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

Bleeding between periods 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

Breast-feeding 11

Driving and using machines 11

Liofora Diario contains lactose 11

How to take Liofora Diario 11

Pack preparation 11

When you can start 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 diarrhoea 15

Delayed menstrual period: what you should know 15

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

If you stop treatment with Liofora Diario 16

Possible side effects 16
How to store Liofora Diario 17
Contents of the pack and other information 18

1. What Liofora Diario is and what it is 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 referred to as placebo tablets.
Contraceptives containing two hormones are known as combined contraceptives.

2. What you need to know before starting Liofora Diario

General considerations

Before starting to use Liofora Diario, you should 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 starting Liofora Diario, 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 individual situation, may carry out some additional tests.

This leaflet describes several situations in which you should stop using Liofora Diario, or in which the effect of Liofora Diario 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 Diario alters the monthly changes in body temperature and cervical mucus.

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

When you must not use Liofora Diario

Do 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 which other form of contraception would be most suitable.

Do not use Liofora Diario

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 need surgery or will be immobile for a long time (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 causing severe chest pain and may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).
If you have any of the following conditions that may increase your risk of developing 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 yet returned to normal.
If your kidneys are not working properly (renal failure).
If you have (or have ever had) a liver tumour.
If you have (or have ever had), or if it is suspected that you 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 Diario if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines 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.

Elderly women

Liofora Diario is not indicated for use after menopause.

Women with hepatic impairment

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

Women with renal impairment

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

Warnings and precautions

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

When should you consult your doctor?

Seek urgent medical attention

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 Diario 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 Diario, you must also inform your doctor.

If a close family member 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. Ask your doctor when you may start taking Liofora Diario after childbirth.
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 Diario,” 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 occurred during pregnancy or a previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering rash during pregnancy (herpes gestationis), a nervous 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 difficulty breathing, 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 Diario 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 veins (known as “venous thrombosis,” “venous thromboembolism,” or VTE).
In 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 Diario 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 noticed when standing or walking. Increased warmth in the affected leg. Change in skin color of the leg, e.g., pale, red, or blue.	Deep vein thrombosis.
Sudden shortness of breath without a known cause or rapid breathing. Sudden cough without a 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, heaviness. Feeling of tightness or fullness in the chest, arm, or below the breastbone. Feeling 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 a 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 veins (venous thrombosis). However, these adverse effects are rare. They occur most 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 first-time use of a combined hormonal contraceptive. 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 remains 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 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 Diario 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 within 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 within one year.
Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as Liofora Diario, between about 9 and 12 women will develop a blood clot within one year.
Your risk of developing a blood clot will depend on your personal 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 Diario	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 Diario is small, but some conditions increase the risk. Your risk is higher:

If you are overweight (body mass index or BMI above 30 kg/m²).
If any of your close relatives have 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 may have an inherited blood-clotting disorder.
If you need surgery or if you are immobile for long periods due to injury, illness, or having a leg in plaster. You may need to stop taking Liofora Diario several weeks before surgery or while you are less mobile. If you need to stop taking Liofora Diario, 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.

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 Diario.

If any of the above conditions change while you are using Liofora Diario—for example, if a close relative experiences thrombosis without a known cause or if 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 a heart attack or stroke from using Liofora Diario is very small, but it may increase:

With age (over about 35 years).
If you smoke. When using a combined hormonal contraceptive such as Liofora Diario, 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 a close relative has had a heart attack or stroke at a young age (under about 50 years). In this case, you may also be at higher risk of heart attack or stroke.
If you or a close relative have 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, the risk of developing a blood clot may be further increased.

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

Liofora Diario and cancer

Slightly more cases of breast cancer have been observed 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 tumors have been reported in users of contraceptives. See your doctor if you have unusual severe abdominal pain.

Psychiatric disorders

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

Bleeding between periods

During the first few months of taking Liofora Diario, you may experience unexpected bleeding (bleeding outside the week when you are taking the white tablets). 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 placebo days

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

If you do not have your expected period for two consecutive cycles, you may be pregnant. See your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Other medicines and Liofora Diario

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines or herbal preparations. Also inform any other doctor or dentist who prescribes you a medicine (or your pharmacist) that you are taking Liofora Diario. They can advise you whether you need 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 Diario 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 infections (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 Diario may affect the effect of other medicines, for example:

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

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

Consult your doctor or pharmacist before using any medicine.

Taking Liofora Daily with food and drink

Liofora Daily may be taken with or without food, and 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 Daily. If you become pregnant while taking Liofora Daily, stop treatment immediately and contact your doctor. If you wish to become pregnant, you may discontinue taking Liofora Daily at any time (see "If you stop taking Liofora Daily", page 16).

Consult your doctor or pharmacist before using any medicine.

Breastfeeding

In general, it is not recommended to take Liofora Daily during breastfeeding. If you wish to take the contraceptive while breastfeeding, you should consult your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

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

Liofora Daily contains lactose

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

3. How to take Liofora Diario

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

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

The two different colored tablets of Liofora Diario are arranged in order. One pack contains 28 tablets.

Take one tablet of Liofora Diario 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.

Do not take the wrong tablet: take one light 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). In this way, there is no break between packs.

Due to the different composition of the tablets, it is necessary to start with the first tablet located at the top left corner and then take one tablet each day. To maintain the correct order, follow the direction of the arrows on the pack.

Preparing the pack

To help you follow the correct order of tablet intake, each Liofora Diario pack contains 7 self-adhesive strips with the 7 days of the week. Choose the weekly strip starting with the day on which you take your first tablet. For example, if you take your first tablet on a Wednesday, use the strip starting with “WED”.

Stick the weekly adhesive strip to the top of the Liofora Diario blister, where it says “Place adhesive strip here!”, so that the first day is positioned above the tablet marked “Start”.

In this way, each tablet has a day of the week indicated above it, allowing you to see whether 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), your period (also called withdrawal bleeding) usually begins. Typically, the period starts on the second or third day after taking the last active light pink tablet of Liofora Diario. After taking the last white tablet, you must start the next pack, even if your period has not yet finished. This means you should start each pack on the same day of the week as you started the previous one, and your menstruation should occur during the same days each month.

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

When to start the first pack

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

Start taking Liofora Diario on the first day of your cycle (i.e., the first day of your period). If you start Liofora Diario 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 ring, or patch

You may start taking Liofora Diario preferably 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 days of your previous contraceptive (or after taking the last inactive tablet of your previous contraceptive). When switching from a combined vaginal 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 a progestogen-only pill on any day (if using an implant or IUS, on the same day of removal; if using an injectable, at the time of the next scheduled injection), but in all cases use additional contraceptive measures (e.g., a condom) during the first 7 days of taking tablets.

After an abortion

Follow your doctor’s recommendations.

After giving birth

You may start taking Liofora Diario 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 Diario.

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

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

Read the “Breast-feeding” section, page 11.

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

If you take more Liofora Diario than you should

No serious harm has been reported from overdose of Liofora Diario.

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 Diario tablets, or 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. Telephone 915 620 420, indicating the medicine and amount taken.

If you forget to take Liofora Diario

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

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

If you are less than 12 hours late in taking a tablet, protection against pregnancy is not reduced. Take the 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 forget, the higher the risk of becoming pregnant.

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

Missing more than one tablet in 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 tablets at your usual time and use additional precautions, e.g., 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 tablets at your usual time. Protection against pregnancy is not reduced, and you do not need additional precautions.

Missing one tablet in week 3

You have two options:

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking tablets at your usual time. Instead of taking the white placebo tablets from this pack, discard them and start the next pack immediately.

You will likely 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.

You may also stop taking the active light pink tablets and go directly to the 7 white placebo tablets (before taking the placebo tablets, you must note the day on which you missed the tablet). If you wish to start a new pack on the day you usually start, take the placebo tablets for fewer than 7 days.

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

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

Medical flowchart in Spanish explaining procedures to follow in case of missed pink tablets in three different weeks

What to do in case of vomiting or severe diarrhea

If you vomit within 3–4 hours after taking an active light pink tablet, or have severe diarrhea, 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 diarrhea, take another light pink 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 Diario”, page 14.

Delaying your menstrual period: what you should know

Although not recommended, you may delay your menstrual period by not taking the white placebo tablets in the fourth row and instead starting a new pack of Liofora Diario and completing it. During the second pack, you may experience light bleeding or spotting. Finish this second pack by taking the 7 white tablets in the 4th row. Then 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 period will start during the placebo week. If you wish to change that day, reduce the number of placebo days – when you take the white placebo tablets – (but never increase them – maximum 7 days!). For example, if you normally start taking placebo tablets on Fridays and want to change 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. In this case, you may experience light bleeding or spotting.

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

If you stop taking Liofora Diario

You may stop taking Liofora Diario at any time. If you do not wish to become pregnant, consult your doctor about other effective methods of birth control. If you wish to become pregnant, stop taking Liofora Diario and wait for 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 Diario, 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 Diario”.

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 breathing difficulties (see also section “Warnings and precautions”).

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

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

changes in mood
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 heartbeat
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, diarrhoea, constipation
hair loss (alopecia), eczema, itching, skin rashes, dry skin, seborrheic skin disorders (seborrheic dermatitis)
neck pain, limb pain, muscle cramps
bladder infection
breast lumps (benign or cancerous), milk production without being pregnant (galactorrhoea), ovarian cysts, hot flushes, absence of periods, heavy periods, vaginal discharge, vaginal dryness, pelvic pain, abnormal cervical smears (Papanicolaou test 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 skin nodules)
erythema multiforme (skin rash with target-like 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 stroke-like symptoms, known as transient ischaemic attack (TIA).
- Blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information about conditions that increase the risk of blood clots and symptoms of a blood clot).

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect 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 Diario

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 is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Liofora Diario

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

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

The white film-coated tablets do not contain any active substances.
Other components are:

Light pink film-coated active tablets:

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

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

White film-coated inactive tablets:

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

Film coating: 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 pack

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

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:

Netherlands: Belanette 28
Spain: Liofora Diario

Date of the most recent revision 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)