VEREZANA 0.03 mg / 2 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Verezana 2 mg/0.03 mg film-coated tablets EFG

Dienogest/Ethinylestradiol

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

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

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

Contents of the package leaflet

1. What is Verezana and what is it used for
2. What you need to know before you start taking Verezana
3. How to take Verezana
4. Possible side effects
5. Storing Verezana
6. Package contents and further information

1. What is Verezana and what is it used for

Verezana is a hormonal combination for women to prevent pregnancy (combined oral contraceptive, generally referred to as the “pill” in this package leaflet).

It contains a progestogen (dienogest) and an estrogen (ethinylestradiol).

In women where the major effect of male hormones (called “androgens”) leads to the appearance of acne, Verezana leads to an improvement of these conditions.

Verezana is a medicine

• to prevent pregnancy (“the pill” contraceptive).
• for the treatment of women with moderate acne who accept receiving a contraceptive pill after the failure of adequate local treatments or oral antibiotics.

2. What you need to know before starting to take Verezana

General considerations

Before starting to use Verezana, you should 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 you can start taking Verezana, your doctor will ask you some questions about your personal medical history and that of your close relatives. The doctor will also measure your blood pressure and, depending on your personal situation, may also perform some other tests.

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

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

Acne will normally improve within three to six months of treatment and may continue to improve even after six months. You should discuss with your doctor the need to continue treatment three to six months after its initiation and periodically thereafter.

Do not take Verezana

You should not use Verezana if you have any of the conditions listed below. If you have any of the conditions listed below, you must inform your doctor. Your doctor will discuss with you what other form of birth control would be more appropriate.

• If you are allergic to ethinylestradiol, dienogest, or any of the other components of this medication (included in section 6).
• If you have (or have ever had) a blood clot in a blood vessel of the legs (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE), or in other organs.
• If you know you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need an operation or spend a lot of time without getting up (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 that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary stroke symptoms).
• If you have any of the following diseases that may increase your risk of forming a clot in the arteries:
• • Severe diabetes with blood vessel damage.
  • Very high blood pressure.
  • Very high levels of fat in the blood (cholesterol or triglycerides).
  • A condition called hyperhomocysteinemia.
• If you have (or have ever had) a type of migraine called "migraine with aura."

• If you smoke (see section 2 "Blood clots").
• If you have (or have ever had) inflammation of the pancreas (pancreatitis) along with very high levels of fat in the blood (lipids) (hypertriglyceridemia), including severe lipid metabolism disorders.
• If you have (or have ever had) severe liver disorders (also Dubin-Johnson and Rotor syndrome) and liver function is still not normal.
• If you have (or have ever had) liver tumors (benign or malignant).
• If you have (or have ever had) suspected or actual cancer (e.g., breast or uterine lining) influenced by sex hormones.
• If you have (or have ever had) vaginal bleeding of unknown cause.
• If you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also the section "Using Verezana with other medications").

Stop taking the pill immediately if one of the above processes occurs and consult your doctor. In the meantime, use non-hormonal contraceptive methods. For more information, see the section "Warnings and precautions".

Warnings and precautions

Consult your doctor or pharmacist before starting to take Verezana.

When you need to take special care with Verezana

When should you consult your doctor?

Seek urgent medical attention

• If you notice possible signs of a blood clot that may mean you are suffering from 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 clot" below).

To obtain a description of the symptoms of these serious side effects, see

"How to recognize a blood clot".

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

In some situations, special care is needed when taking Verezana or any other combined pill, and your doctor may need to examine you regularly. If the condition develops or worsens while you are using Verezana, you should also inform your doctor.

• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• If you have sickle cell anemia (a hereditary disease of red blood cells).
• If you have high levels of fat in the blood (hypertriglyceridemia) or known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas).
• If you need an operation or spend a lot of time without getting up (see section 2 "Blood clots").
• If you have just given birth, you are at a higher risk of developing blood clots. You should ask your doctor when you can start taking Verezana after childbirth.
• If you have inflammation of the veins that are under the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you have heart valve defects, heart rhythm disorders;
• If you have breast cancer in close relatives;
• If you have liver or bile duct disease or gallstones;
• If you have jaundice or itching due to bile congestion;
• If you have an irregular brownish discoloration of the skin, especially on the face (chloasma), or if you have experienced it during a previous pregnancy; in this case, you should avoid intense sunlight and ultraviolet radiation;
• If you have certain problems with hemoglobin formation (porphyria);
• If you have depression;
• If you have epilepsy;
• If you have Sydenham's chorea (Saint Vitus' dance);
• If you have had a blistering rash during a previous pregnancy (gestational herpes);
• If you have inner ear hearing loss (otosclerosis-related hearing loss);
• If you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat and/or difficulty swallowing or urticaria potentially with difficulty breathing, contact a doctor immediately. Products containing estrogens may cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

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

Blood clots can form:

• In the veins (which is called "venous thrombosis", "venous thromboembolism", or VTE).
• In the arteries (which is called "arterial thrombosis", "arterial thromboembolism", or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious long-term effects or, very rarely, they can be fatal.

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

HOW TO RECOGNIZE A BLOOD CLOT

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

BLOOD CLOTS IN A VEIN

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

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in the veins (venous thrombosis). However, these side effects are rare. They occur more frequently in the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a clot can form in a vein of another organ, such as the eye (retinal vein thrombosis).

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

The risk of developing a blood clot in a vein is higher during the first year in which you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medication or a different one) after an interruption of 4 weeks or more.

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

When you stop taking Verezana, your risk of developing a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Verezana is small.

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel or norethisterone or norgestimate, about 5-7 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains dienogest and ethinylestradiol, like Verezana, between 8 and 11 will develop a blood clot in a year. The risk of developing a blood clot will depend on your personal history (see "Factors that increase your risk of a blood clot" below).

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

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

• If you are overweight (body mass index or BMI over 30 kg/m2).
• If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before the age of 50). In this case, you may have a hereditary blood clotting disorder.
• If you need an operation or spend a lot of time without getting up due to an injury or illness or if you have a leg in a cast. You may need to interrupt the use of Verezana several weeks before surgery or while you have reduced mobility. If you need to interrupt the use of Verezana, ask your doctor when you can start using it again.
• As you get older (especially above 35 years).
• If you have given birth in the past few weeks.

The risk of developing a blood clot increases with the number of conditions you have.

Long-haul flights (more than 4 hours) can temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you suffer from any of the above conditions, even if you are unsure. Your doctor may decide to interrupt the use of Verezana.

If any of the above conditions change while you are using Verezana, 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.

In 1-2% of these cases, the thrombosis is fatal.

BLOOD CLOTS IN AN ARTERY

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

Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or 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 Verezana is very small, but it can increase:

• With age (above 35 years).
• If you smoke.When using a combined hormonal contraceptive like Verezana, you are advised to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• If you are overweight.
• If you have high blood pressure.
• If any of your close relatives have had a heart attack or stroke at a young age (less than 50 years). In this case, you may also be at higher risk of having a heart attack or stroke.
• If you or any of your close relatives have 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, heart rhythm disorder).
• If you have diabetes.

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

If any of the above conditions change while you are using Verezana, 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.

Pill and cancer

It has been observed that breast cancer occurs slightly more frequently in women who use combined pills, but it is not known if this is caused by the treatment. For example, it may be that more tumors are detected in women who take combined pills because their doctor examines them more frequently. The risk of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential to regularly check your breasts and communicate with your doctor if you feel any lump.

In users of oral contraceptives, rare cases of benign and, in even fewer cases, malignant liver tumors have been reported. In isolated cases, these tumors could cause potentially life-threatening internal bleeding. Consult your doctor immediately if you have severe pain in the upper abdomen.

Some studies suggest that prolonged use of combined hormonal contraceptives may slightly increase the risk of cervical cancer. However, this may be due to factors other than the contraceptive itself, such as differences in sexual behavior or the number of sexual partners.

The pill increases a woman's risk of developing cervical cancer. However, it is not clear to what extent sexual behavior (e.g., frequent change of partner) and other factors such as the human papillomavirus (HPV) increase this risk.

When to consult your doctor

Regular check-ups

If you are taking the pill, your doctor will ask you to have regular check-ups. Normally, you should see your doctor at least once a year.

Also, consult your doctor immediately if

• you notice changes in your health, especially those mentioned in the section “Do not take Verezana”. Do not forget about diseases that affect your family;
• you feel a lump in your breast;
• you are also taking other medications (see also the section “Other medications and Verezana”);
• you are confined to bed for a prolonged period or are about to undergo surgery (consult your doctor at least four weeks in advance);
• you have any severe and unusual vaginal bleeding between periods;
• you forgot to take the tablets in the first week of taking the pill and had sexual intercourse in the previous 7 days;
• you have missed two consecutive periods despite taking the tablets regularly and suspect you are pregnant.

Psychiatric disorders

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

If you have unexpected bleeding (intermenstrual bleeding)

As with all pills, irregular bleeding (oligohemorrhage [spotting] or intratherapeutic hemorrhage) may occur, especially during the first few months. You may need to use sanitary protection, but continue taking your tablets as usual. The irregular vaginal bleeding will stop once your body has gotten used to taking the pill (generally after about 3 months). If you experience heavier vaginal bleeding similar to a normal monthly period or light vaginal bleeding that lasts for several days, you should consult your doctor.

If you do not have your regular monthly period

If you have been taking your tablets correctly, have not had vomiting or severe diarrhea, and have not been taking any other medication, the likelihood of you being pregnant will be extremely low. Continue taking Verezana as usual.

If you do not have two consecutive periods, or if you have not been taking Verezana as directed before the missed period, there is a possibility of pregnancy. Consult your doctor immediately. Do not take Verezana until your doctor has ruled out pregnancy.

Children and adolescents

Verezana should only be used after the first menstrual period (menarche).

Using Verezana with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medication.

Some medications may cause intermenstrual bleeding and/or alter the contraceptive effect of Verezana.

Effect of other medications on Verezana

Always inform your doctor which medications or herbal products you are already using. Also, inform any other doctor or dentist who prescribes you another medication (or the pharmacist) that you are taking Verezana. They may tell you if you need to take additional contraceptive precautions (e.g., condoms) and, if so, for how long, or if you should change the use of another medication that you need.

Some medications

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

These include:

• Medications used for the treatment of:
• • epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate)
  • high blood pressure in the blood vessels of the lungs (bosentan)
  • 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 (griseofulvin, ketoconazole)
  • arthritis, osteoarthritis (etoricoxib)
  • modafinil (an agent used for the treatment of narcolepsy, a nervous system disorder)
• The herbal remedy St. John's Wort

If you are being treated with any of the above-mentioned medications, you should also use a barrier method (e.g., a condom) temporarily or choose another contraceptive method. Use additional local contraceptives while taking other medications with Verezana and also for 28 days after stopping treatment with other medications.

If your treatment extends beyond the Verezana blister pack, start with the next blister pack without the tablet-free interval.

If prolonged treatment with any of the above-mentioned medications is required, you should choose another reliable non-hormonal contraceptive method.

Effect of Verezana on other medications

Verezana may affect the effect of other medications, for example:

• the antiepileptic lamotrigine (this could lead to an increased frequency of seizures)
• medications containing cyclosporin
• theophylline (used to treat respiratory problems)
• tizanidine (used to treat muscle pain or muscle cramps)

Do not use Verezana if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, as this may cause increases in liver test results (increase in liver enzyme ALT).Your doctor will prescribe another type of contraceptive before starting treatment with these medications.

Verezana can be used again approximately 2 weeks after the end of this treatment. See the section "Do not use Verezana”

Also, note the instructions for use of the other prescribed medications.

Interactions with laboratory tests

Tell your doctor or laboratory staff that you are taking the pill.

The use of Verezana may affect the results of certain laboratory tests, including liver function values, adrenal cortex, kidneys, and thyroid, as well as the amount of certain proteins in the blood, e.g., proteins that affect fat metabolism, carbohydrate metabolism, or blood coagulation and fibrinolysis. However, these changes usually remain within the normal range.

Verezana with food and drinks

Verezana can be taken with or without food, if necessary with a small amount of water.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not take Verezana during pregnancy. You should not be pregnant when you start taking Verezana. Stop taking Verezana immediately if you become pregnant during use and consult your doctor.

Breastfeeding

You should not take Verezana while breastfeeding, as milk production may be reduced and small amounts of the active ingredient may pass into breast milk. You should choose reliable non-hormonal contraceptive methods while breastfeeding.

Driving and using machines

No effects on the ability to drive or use machines have been described.

Verezana contains lactose

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

Verezana contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per coated tablet; this is, essentially “sodium-free”.

3. How to take Verezana

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

For both indications, hormonal contraception and treatment of women with moderate acne, Verezana should be taken according to the following instructions. To maintain contraceptive efficacy, follow the instructions in the section "Management of forgotten pills".

How and when should you take Verezana?

The pill should be swallowed whole, with a little liquid if necessary.

Take one pill for 21 consecutive days at approximately the same time of day as indicated by the row on the blister pack.

The first tablet is removed from the individual blister pack marked with the day of the week on which it is started (e.g., "Mon" for Monday).

The other tablets are taken daily in the direction of the arrows until the entire blister pack has been consumed.

Then, do not take any pills for 7 days. During this 7-day break, bleeding (withdrawal bleeding) usually occurs 2 to 3 days after taking the last pill.

Intake is resumed with the administration of pills from the next blister pack on day 8, regardless of whether bleeding is still present or not. On the one hand, this means that a new blister pack is always started on the same day of the week. On the other hand, bleeding always occurs around the same days of the month.

If you take Verezana as indicated, contraceptive protection also persists during the 7-day break periods.

When should you start taking Verezana?

If you have not taken any contraceptive pill in the last month:

Start taking Verezana on the first day of your cycle, e.g., the first day of menstruation.

If administered correctly, Verezana provides contraceptive protection from the first day. If you start taking the pill between the second and fifth day, you should use an additional barrier contraceptive method during the first 7 days of administration.

If you are switching from a different pill (with two hormonal substances), a vaginal ring, or a transdermal patch to Verezana:

If you have been taking a pill that is followed once a month by a break period after using the last active pill, start taking Verezana the day after the break period.

If you have been taking a "pill" from a package that contains active pills as well as inactive pills, start taking Verezana the day after taking the last inactive pill.

If you have been using a vaginal ring or patch, start taking Verezana the day after the ring or patch break period.

If you want to use Verezana after a spontaneous abortion in the first trimester (trimester) of pregnancy

Please, talk to your doctor. In principle, you can start taking Verezana immediately.

If you want to use Verezana after a spontaneous abortion in the second trimester (trimester) of pregnancy or after childbirth

If you want to start taking Verezana, your doctor will recommend that you start taking it between days 21 and 28 after childbirth or a spontaneous abortion in the second trimester. If you take it at a later date, you should also use a barrier method (e.g., condom) during the first 7 days of taking Verezana.

However, if you have already had sexual intercourse, you must ensure that you are not pregnant before starting to take Verezana; otherwise, you should wait for your next menstrual period.

If you want to breastfeed after the birth of a child and start taking Verezana

Read the section "Breastfeeding".

If you take more Verezana than you should

There are no reports of serious harmful effects after taking too many Verezana pills. If you have taken several pills at once, you may feel unwell, vomit, or bleed from the vagina. Even girls who have not yet started menstruating but have accidentally taken this medication may experience this type of bleeding.

If you have taken too many Verezana pills or discover that a child has taken some, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you have forgotten to take Verezana

• If less than 12 hours have passed since you forgot to take only one pill, the contraceptive effect of Verezana is still guaranteed. Resume taking the pills as soon as possible and continue taking the subsequent pills at the usual time.
• If more than 12 hours have passed, the contraceptive effect is no longer fully guaranteed. The greater the number of pills you have forgotten, the greater the risk of becoming pregnant.

The risk of becoming pregnant is greater if you forget a pill at the beginning or end of the blister pack. Therefore, you must follow the following rules.

More than one forgotten pill per blister pack

Consult your doctor.

Therefore, the procedure to follow in case of forgetting to take pills is as follows:

If you have forgotten to take 1 pill in week 1

Take it as soon as possible, even if it means taking two at the same time. Then, continue taking them in the usual way. However, during the next 7 days, you should use an additional barrier contraceptive method (e.g., condom). If you have had sexual intercourse the week before forgetting the pill, there is a risk of becoming pregnant. In this case, consult your doctor.

If you have forgotten to take 1 pill in week 2

Take it as soon as possible, even if it means taking two at the same time. Then, continue taking them at the usual time. If you have taken Verezana regularly for the 7 days prior to forgetting a pill, the contraceptive efficacy is guaranteed, and you do not need to take additional contraceptive measures. If not, or if you forgot to take more than 1 pill, it is recommended to use an additional barrier contraceptive method (e.g., condom) for 7 days.

If you have forgotten to take 1 pill in week 3

Given the proximity of the 7-day break period in administration, the contraceptive effect is no longer fully guaranteed. However, contraceptive efficacy is maintained by adjusting the administration schedule. If you follow one of the procedures below, then it is not necessary to take additional contraceptive measures, but only if the pill has been taken correctly for the 7 days prior to the first forgotten pill. If not, you should continue according to point 1 mentioned below. Additionally, you should use an additional contraceptive method (e.g., condom) during the next 7 days.

You can choose between two options:

1. Take it as soon as possible, even if it means taking two at the same time. Then, take the subsequent pills at the usual time. Skip the break period and start taking the pills from the next blister pack directly. It is very likely that no withdrawal bleeding will occur unless you have consumed the second blister pack. However, during the intake of pills from the second blister pack, bleeding or spotting may occur.

or

1. You can stop taking the pills from the current blister pack immediately and start taking the next blister pack directly after a break of no more than 7 days (you must take into account the day you forgot the pill!). If you want to start taking the pills from the new blister pack on the usual day of the week, you can shorten the break period.

If you have forgotten some of the pills from the blister pack and do not have bleeding during the first break period, you may be pregnant. Contact your doctor before starting the next blister pack.

What to do if you have vomiting or diarrhea?

If you experience vomiting or diarrhea, the active ingredients of the pill may not have been fully absorbed. Therefore, the effect may be reduced, similar to forgetting a pill. Additional contraceptive measures are necessary. If you vomit within 3-4 hours after taking a pill or have severe diarrhea, take another pill as soon as possible. The new pill should be taken within 12 hours after the time you normally take your pill. If more than 12 hours have passed, you should follow the advice given in "If you forgot to take Verezana".

If you do not want to change the administration schedule of the pills, you can take the corresponding pill from another blister pack and continue using this later as a reserve package.

What to do if you want to delay withdrawal bleeding?

Although it is not recommended, you can delay withdrawal bleeding by directly starting to take the pill from the next Verezana blister pack without the break period. Withdrawal bleeding can be delayed as much as you want, but no more than until the end of the second blister pack. During this period, bleeding or spotting may occur. After the regular 7-day break, you can continue taking the pill in the usual way.

You should consult your doctor before deciding to delay your menstrual period.

What to do if you want to change the day of the week when your menstrual period starts

If you take the pills according to the instructions, you will have your menstrual period every 4 weeks, approximately on the same day. If you want to change this day, simply shorten (never lengthen) the pill-free interval. If your menstrual period usually starts on a Friday and you want it to be on a Tuesday in the future (3 days earlier), take the first pill from the new blister pack three days earlier than usual. If you make the pill-free interval very short (e.g., 3 days or less), you may not have any withdrawal bleeding during these days. Then you may experience intermenstrual bleeding.

If you are not sure what to do, consult your doctor.

If you interrupt treatment with Verezana

You can stop taking Verezana at any time after consuming a blister pack. If you do not want to become pregnant, ask your doctor about other reliable contraceptive methods.

If you want to become pregnant, stop taking Verezana and wait for your menstrual bleeding before trying to become pregnant. You will be able to calculate the expected date of delivery more easily.

Additional information on special patient groups

Children and adolescents

Verezana can only be used after the first menstrual period (menarche).

Older patients

Verezana can only be used in women before menopause.

Patients with liver insufficiency

Verezana should not be used in women with severe hepatic disorders (see section 2 "Do not take Verezana").

Patients with renal insufficiency

The use of Verezana has not been studied in women with renal insufficiency. Available data do not suggest any change in treatment for this group of patients.

If you have any other doubts about the use of this medication, consult your doctor.

4. Possible Adverse Effects

Like all medications, this medication may produce adverse effects, although not all people suffer from them. If you experience any adverse effect, especially if it is severe and persistent, or have any health change that you think may be due to Verezana, consult your doctor.

All women who take combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section 2 "What you need to know before using Verezana".

Severe Adverse Reactions

Severe reactions associated with the use of the pill are described in section 2 "Warnings and Precautions", where you will find more detailed information.

Contact a doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat and/or difficulty swallowing or urticaria with possible difficulty breathing (see also section 2 "Warnings and Precautions").

In clinical studies, the following adverse effects have been observed with ethinylestradiol 0.03 mg and 2 mg of dienogest.

Frequent Adverse Effects (may affect more than 1 in 10 people):

• Headache.
• Chest pain, including discomfort and tenderness to palpation.

Uncommon Adverse Effects (may affect more than 1 in 100 people):

• Genital inflammation (vaginitis/vulvovaginitis), fungal infections in the vagina (candidiasis, other vulvovaginal infections).
• Increased appetite.
• Depressive mood.
• Dizziness.
• Migraine.
• High or low blood pressure; in rare cases, increased diastolic blood pressure (lower blood pressure value).
• Abdominal pain (including upper and lower abdominal pain, discomfort/bloating).
• Nausea, vomiting, or diarrhea.
• Acne.
• Hair loss (alopecia).
• Skin rash (including skin exanthema).
• Itching (in some cases all over the body).
• Irregular menstrual bleeding, including heavy bleeding (menorrhagia), light bleeding (hypomenorrhea), irregular bleeding (oligomenorrhea), and absence of bleeding (amenorrhea).
• Spotting (vaginal hemorrhage and metrorrhagia).
• Painful menstruation (dysmenorrhea), pelvic pain.
• Breast enlargement, with swelling, edema.
• Vaginal discharge.
• Ovarian cysts.
• Exhaustion, with weakness, fatigue, and general indisposition.
• Weight gain.

Rare Adverse Effects (may affect more than 1 in 1,000 people):

• Inflammation of the Fallopian tubes or ovaries.
• Inflammation of the cervix (cervicitis).
• Inflammation of the urinary tract, bladder inflammation (cystitis).
• Inflammation of the breast (mastitis).
• Fungal infections (e.g., candida), viral infections, herpes labialis.
• Flu, bronchitis, upper respiratory tract infections, paranasal infection (sinusitis).
• Asthma.
• Increased respiratory rate (hyperventilation).
• Benign uterine tumor (fibroid).
• Benign breast tissue tumor (breast lipoma).
• Anemia.
• Allergic reactions (hypersensitivity).
• Masculinization (virilism).
• Loss of appetite (anorexia).
• Depression, irritability, aggression.
• Insomnia, sleep disturbances.
• Circulatory disorders in the brain or heart, stroke.
• Dystonia (muscle disorder that produces, e.g., an abnormal posture).
• Dry or irritated eyes.
• Visual disturbances.
• Sudden hearing loss, hearing impairment.
• Tinnitus.
• Vestibular disorders.
• Accelerated heart rate.
• Harmful blood clots in a vein or artery, for example:
• • In a leg or foot (i.e., DVT).
  • In a lung (i.e., PE).
  • Heart attack.
  • Stroke.
  • Mild or temporary stroke-like symptoms, called a transient ischemic attack (TIA).
  • Blood clots in the liver, stomach/intestine, kidneys, or eye.

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

• Phlebitis.
• Varicose veins (varicosis), disorders or pain in the veins.
• Dizziness or fainting when standing up after sitting or lying down (orthostatic hypotension).
• Hot flashes.
• Gastric mucosa inflammation (gastritis), intestinal inflammation (enteritis).
• Gastric discomfort (dyspepsia).
• Skin reactions/disorders, such as allergic reactions, neurodermatitis/atopic dermatitis, eczema, psoriasis.
• Excessive sweating.
• Brownish-gold pigmentation spots (called pregnancy spots), especially on the face (melasma), coloration/discoloration.
• Oily skin (seborrhea).
• Dandruff.
• Excessive hair growth (hirsutism).
• Orange peel skin (cellulite).
• Spider nevus (red central spot with reddish extensions radiating outward, like a spider web).
• Lower back pain, chest pain.
• Bone and muscle discomfort, muscle pain (myalgia), pain in arms and legs.
• Cervical dysplasia (abnormal cell growth on the surface of the cervix).
• Pain or cysts in the Fallopian tubes and ovaries.
• Breast cysts, benign breast tumors (fibrocystic mastopathy), swelling of congenital accessory breast tissue outside the breast (accessory breasts).
• Pain during intercourse.
• Nipple discharge.
• Menstrual disorders.
• Peripheral edema (fluid accumulation in the body).
• Flu-like illnesses, inflammation, fever.
• Increased triglyceride or cholesterol levels in the blood (hypertriglyceridemia, hypercholesterolemia).
• Weight gain or loss

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

Mood changes, increased or decreased sexual desire (libido), contact lens intolerance, urticaria, skin and/or mucous membrane reactions with skin rash, nodules, blister formation, or tissue death (erythema nodosum or multiforme), breast secretion, fluid retention (edema).

Tumors

• The incidence of breast cancer diagnosis increases slightly with the use of Verezana. Since breast cancer rarely occurs in women under 40 years of age, the risk of developing breast cancer in relation to the general risk is low. For more information, see the section "Verezana and Cancer".
• Hepatic tumors (benign and malignant)
• Cervical cancer

Other Conditions

• Women with hypertriglyceridemia (increased blood fat that increases the risk of pancreatitis when using combined oral contraceptives)
• Hypertension
• Appearance or worsening of conditions for which the relationship with combined oral contraceptives is not definitive: jaundice and/or itching related to cholestasis (bile flow blockage), gallstone formation, a metabolic condition called porphyria, systemic lupus erythematosus (a chronic autoimmune disease), hemolytic uremic syndrome (a blood clotting disease), a neurological condition called Sydenham's chorea, gestational herpes (a type of skin condition that occurs during pregnancy), hearing loss related to otosclerosis
• Liver function disorders
• Changes in glucose tolerance or effect on peripheral insulin resistance
• Crohn's disease, ulcerative colitis
• Chloasma

Interactions

Unexpected bleeding and/or contraceptive failure may result from interactions between other medications and oral contraceptives (e.g., St. John's Wort, or medications for epilepsy, tuberculosis, HIV, and other infections). See section 2 "Effect of other medications on Verezana".

Other severe reactions to taking Verezana, as well as related symptoms, are described in section 2 "Warnings and Precautions".

Reporting Adverse Effects:

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

5. Storage of Verezana

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the outer packaging and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Keep the blister pack in the outer packaging to protect it from light.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional Information

Verezana Composition

The active ingredients are dienogest and ethinylestradiol. One film-coated tablet contains 2 mg of dienogest and 0.03 mg of ethinylestradiol.

The other components are:

Tablet core:lactose monohydrate, corn starch, povidone (30), sodium carboxymethyl starch (type A) (potato), magnesium stearate.

Tablet film coating:hypromellose (E464), hydroxypropylcellulose, talc, hydrogenated cottonseed oil, titanium dioxide (E 171)

Verezana Appearance and Packaging Content

Verezana is a film-coated tablet, round, biconvex, and white.

Verezana is marketed in packages containing 21, 3 x 21, and 6 x 21 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma S.L.U.

c/ Anabel Segura, 11 Edificio Albatros B, 1ª planta

Alcobendas 28108 Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig-Merckle-Straße 3, 89143 Blaubeuren

Germany

This medication is authorized in EEA member states under the following names:

Germany: LaViola

Czech Republic: VEREZANA 0.03 mg/2 mg

Spain: Verezana 2 mg/0.03 mg film-coated tablets EFG

Date of the last revision of this prospectus:July 2023

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