Label: Information for the User

Verezana 2 mg/0.03 mg Film-Coated Tablets EFG

Dienogest/Ethinylestradiol

Read the entire label carefully before starting to take the medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Important things 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 suffering a blood clot in the veins and arteries, especially in the first year or when restarting use of a combined hormonal contraceptive after a pause of 4 weeks or more.
• Be aware and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood Clots”).

Verezana is a combination hormonal for women to prevent pregnancy (combined oral contraceptive, generally described as "the pill" in this prospectus).

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

In women in whom the major effect of male hormones (called "androgens") causes the appearance of acne, Verezana produces an improvement of these ailments.

Verezana is a medication

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

General Considerations

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

• If you smoke (see section 2 “Blood Clots”).
• If you have (or have ever had) pancreatitis (inflammation of the pancreas) along with very high levels of fat in the blood (hypertriglyceridemia), including severe lipid metabolism disorders.
• If you have (or have ever had) severe liver disorders (also Dubin-Johnson and Rotor syndromes) and liver function is not yet 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 endometrial cancer) influenced by sex hormones.
• If you have (or have ever had) unexplained vaginal bleeding.
• 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 “Use of Verezana with other medications”).

Stop taking the pill immediately if one of the processes mentioned above occurs and consult your doctor. Meanwhile, 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 be extra careful with Verezana

Inform 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 it may be necessary for your doctor 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 disorder of red blood cells).
• If you have high levels of fat in the blood (hypertriglyceridemia) or known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you need surgery or spend a lot of time without getting up (see section 2 “Blood Clots”).
• If you recently gave birth, you are at greater risk of blood clots. Ask your doctor when you can start taking Verezana after delivery.
• If you have superficial thrombophlebitis (inflammation of the veins under the skin).
• If you have varicose veins.
• If you have heart valve defects, heart rhythm disorders;
• If you have a family history of breast cancer;
• If you have liver or gallbladder disease or gallstones;
• If you have jaundice or itching due to bile congestion;
• If you have an irregular discoloration of the skin, brown-yellow in color, especially on the face (melasma), 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;
• If you have a rash with blisters during a previous pregnancy (herpes gestationalis);
• If you have inner ear hearing loss (otosclerosis-related hearing loss);
• If you experience symptoms of angioedema such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria potentially with difficulty breathing, contact a doctor immediately. Products containing estrogens can cause or worsen symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Verezana increases your risk of suffering 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 veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• In arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or ATE).

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

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 assistanceif you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN

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

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

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

The risk of a blood clot in a vein is higher during the first year in which a combined hormonal contraceptive is taken for the first time. The risk may be higher if you start taking a combined hormonal contraceptive again (the same medication or a different medication) 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 a blood clot returns to normal in a few weeks.

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

• Of every 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, 2 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel or noretisterone or norgestimato, 5-7 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing dienogest and etinilestradiol, such as Verezana, between 8 and 11 will develop a blood clot in a year.The risk of 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 a blood clot is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index (BMI) of 30 kg/m2or higher).
• 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 about 50 years old). In this case, you may have an inherited blood clotting disorder.
• If you need surgery or spend a lot of time without getting up due to an injury or illness or if you have a leg cast. You may need to stop using Verezana for several weeks before surgery or while you have limited mobility. If you need to stop using Verezana, ask your doctor when you can start using it again.
• As you get older (especially over about 35 years old).
• If you have given birth recently.

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

Long flights (over 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you have any of the conditions mentioned above, even if you are unsure. Your doctor may decide that you need to stop using Verezana.

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

In about 1%-2%of these cases, 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 blood clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

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

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

• With age (over about 35 years old).
• If you smoke.Verezana advises you 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 about 50 years old). In this case, you may also be at greater risk of a heart attack or stroke.
• If you 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 called atrial fibrillation).
• If you have diabetes.

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

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

Pill and Cancer

Cancer of the breast has been observed slightly more frequently in women using combined pills, but it is not known whether this is caused by the treatment. For example, it may be that more tumors are detected in women taking 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 inform your doctor if you feel any lump.

In users of combined pills, rare cases of benign liver tumors and, in fewer cases, malignant liver tumors have been described. In isolated cases, these tumors may cause potentially fatal internal bleeding. Consult your doctor immediately if you have severe pain in the upper abdomen

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

When to consult your doctor

Regular check-ups

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

Additionally, consult your doctor immediately if

Mental health 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.

Unexpected bleeding (intermenstrual bleeding)

Like all pills, irregular bleeding (oligohemorrhage [spotting] or intermenstrual hemorrhage) may occur, especially during the first few months. You may need to use sanitary protection, but continue taking your pills as usual. Irregular vaginal bleeding will stop once your body has adjusted to taking the pill (usually after about 3 months). If you experience heavy vaginal bleeding similar to a normal menstrual period or light vaginal bleeding that lasts for several days, you should consult your doctor.

Not having a normal menstrual period

If you have been taking your pills correctly, have not had severe vomiting or diarrhea, and are not taking any other medication, the likelihood of 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 instructed 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).

Use of Verezana with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to 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 what medications or herbal products you are already using. Also, inform any other doctor or dentist who prescribes another medication (or 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 need to change another medication that you need.

Some medications

These include:

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

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

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

Effect of Verezana on other medications

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

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

Also, note the prospectuses of other prescribed medications.

Interactions with laboratory tests

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

Verezana may affect the results of certain laboratory tests, including liver function, adrenal cortex, kidney function, and thyroid function, as well as the levels of certain proteins in the blood, e.g., proteins affecting fat metabolism, carbohydrate metabolism, or blood clotting 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, or if you think you might 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 decrease and small amounts of the active ingredient may pass into breast milk. You should choose non-hormonal contraceptive methods while breastfeeding.

Driving and operating machinery

No effects on the ability to drive or operate machinery have been described.

Verezana contains lactose

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

Verezana contains sodium

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

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 "Management of missed pills" section.

How and when should Verezana be taken?

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 in the blister pack.

The first pill is removed from the individual blister marked with the day of the week when it starts to be taken (e.g., "Lun" for Monday).

The remaining pills are taken daily in the direction of the arrows until the entire blister is consumed.

Do not take any pills for 7 days after that. During this 7-day break, a bleeding (hemorrhage by deprivation) usually occurs 2 to 3 days after taking the last pill.

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

If you take Verezana as indicated, the contraceptive protection persists even during the 7-day breaks.

When should Verezana be started?

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

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

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

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

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

If you have been taking a "pill" from a package that contains active pills in addition to inactive ones, start taking Verezana the day after taking the last inactive pill.

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

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 delivery

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

However, if you have already had sex, 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 "Lactation."

If you take more Verezana than you should

There are no reports of serious adverse 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.

Consult your doctor or pharmacist if you have taken too many Verezana pills or if a child has taken some.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological 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 risk of becoming pregnant is greater if you forget a pill at the beginning or end of the blister.

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

More than one pill forgotten per blister

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, although this means taking two at the same time. Then, continue taking them at the usual time. However, during the 7 days following the pill forgetfulness, an additional barrier contraceptive method (e.g., condom) should be used. If you had sex 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, although this means taking two at the same time. Then, continue taking them at the usual time. If you have taken Verezana regularly for 7 days before 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 in administration, the contraceptive effect is no longer fully guaranteed. However, contraceptive efficacy is maintained through an adjustment of the administration schedule. If one of the following procedures is followed, then no additional contraceptive measures are necessary, but only if the pill has been taken correctly for 7 days before the first forgetfulness. If not, you should continue according to the point 1 mentioned below. In addition, an additional contraceptive method (e.g., condom) should be used for 7 days.

You can choose between two options:

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

or

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

If you have forgotten one of the pills from the blister and do not have bleeding during the first break without pills, it is possible that you are pregnant. Contact your doctor before starting the next blister.

What to do if you have vomiting or diarrhea?

If you experience vomiting or diarrhea, the active principles 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 intense diarrhea, take another pill as soon as possible. The new pill should be taken within 12 hours after the usual time. 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 and continue using this one later as a reserve package.

What to do if you want to delay the bleeding by deprivation?

Although not recommended, you can delay the bleeding by deprivation directly by starting to take the pill from the next Verezana blister without the break. The bleeding by deprivation can be delayed as long as you want, but no longer than until the end of the second blister. During this period, bleeding or spotting may occur. After the regular 7-day break, you can continue taking the pill as usual.

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 approximately every 4 weeks on the same day. If you want to change this day, simply shorten (never lengthen) the interval without pills. If your menstrual period usually starts on a Friday and you want it to start on a Tuesday in the future (3 days earlier), take the first pill from the new blister 3 days earlier than usual. If you make the interval without pills too short (e.g., 3 days or less), it is possible that you will not have any bleeding by deprivation during these days. Then you may experience intermenstrual bleeding.

If you are unsure of what to do, consult your doctor.

If you interrupt the treatment with Verezana

You can stop taking Verezana at any time after consuming a blister. 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 period before trying to become pregnant. You will be able to calculate your expected delivery date 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 liver disorders (see section 2 "Do not take Verezana").

Patients with renal insufficiency

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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. If you experience any side effect, especially if it is severe and persistent, or if you have any health changes that you think may be related to Verezana, consult your doctor.

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

Immediately contact a doctor 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 were observed with etinilestradiol 0.03 mg and 2 mg of dienogest.

Frequent adverse effects (can affect more than 1 in 10 people):

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

Less frequent adverse effects (can 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, an increase in diastolic blood pressure (lower value of blood pressure).
• Abdominal pain (including upper and lower abdominal pain, discomfort/gas).
• Nausea, vomiting, or diarrhea.
• Acne.
• Hair loss (alopecia).
• Skin rash (including cutaneous exanthema).
• Itching (in some cases throughout the body).
• Irregular menstrual bleeding including heavy bleeding (menorrhagia), light bleeding (hypomenorrhea), irregular bleeding (oligomenorrhea), and absence of bleeding (amenorrhea).
• Spotting (vaginal bleeding and metrorrhagia).
• Menstrual pain (dysmenorrhea), pelvic pain.
• Enlargement of the breasts, with swelling, edema.
• Vaginal discharge.
• Ovarian cysts.
• Fatigue, with weakness, tiredness, and general malaise.
• Weight gain.

Rare adverse effects (can affect more than 1 in 1,000 people):

• Inflammation of the Fallopian tubes or ovaries.
• Inflammation of the cervix.
• Inflammation of the urinary tract, inflammation of the bladder (cystitis).
• Inflammation of the breast (mastitis).
• Fungal infections (e.g., candida), viral infections, herpes labial.
• Influenza, bronchitis, upper respiratory tract infections, sinusitis.
• Asthma.
• Increased respiratory rate (hyperventilation).
• Benign proliferation in the uterus (myoma).
• Benign proliferation of breast tissue (breast lipoma).
• Anemia.
• Allergic reactions (hypersensitivity).
• Virilization (virilism).
• Loss of appetite (anorexia).
• Depression, irritability, aggression.
• Insomnia, sleep disturbances.
• Circulatory disorders in the brain or heart, stroke.
• Dystonia (muscle alteration that produces, e.g., an abnormal posture).
• Dry or irritated eyes.
• Vision disorders.
• Sudden hearing loss, alteration of hearing.
• Tinnitus.
• Vestibular disorders.
• Increased heart rate.
• Detrimental 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 symptoms similar to a stroke, known as a transient ischemic attack (TIA).
• Blood clots in the liver, stomach/intestine, kidneys, or eye.

The chances 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 (inflammation of the veins).
• Varicose veins (varicosis), vein disorders or pain.
• Dizziness or fainting when standing up after sitting or lying down (orthostatic hypotension).
• Hot flashes.
• Inflammation of the gastric mucosa (gastritis), intestinal inflammation (enteritis).
• Discomfort in the stomach (dyspepsia).
• Reactions/skin disorders, such as allergic reactions, neurodermatitis/atopic dermatitis, eczema, psoriasis.
• Intense sweating.
• Brownish-yellow patches (called melasma), skin disorders, or increased pigmentation.
• Oily skin (seborrhea).
• Dandruff.
• Excessive hair growth (hirsutism).
• Orange skin (cellulitis).
• Spider-like nevi (red central spot with radiating reddish extensions, like a spider's web).
• Lower back pain, chest pain.
• Muscle and bone pain, muscle pain (myalgia), pain in arms and legs.
• Cervical dysplasia (abnormal growth of cells on the surface of the cervix).
• Pain or cysts in the Fallopian tubes and ovaries.
• Cysts in the breasts, benign proliferations in the breasts (fibrocystic breast disease), additional congenital breast glands outside the breast (accessory breasts).
• Pain during intercourse.
• Nipple discharge.
• Menstrual disorders.
• Peripheral edema (accumulation of fluid in the body).
• Influenza-like illnesses, inflammation, fever.
• Increased triglycerides or cholesterol levels in the blood (hypertriglyceridemia, hypercholesterolemia).
• Weight loss or fluctuation

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

Mood changes, increased or decreased libido, incompatibility of contact lenses, urticaria, skin and/or mucous membrane reactions with skin rash, nodules, blistering, or tissue death (erythema nodosum or multiforme), nipple discharge, fluid retention (edema).

Tumors

Other conditions

Interactions

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

Other severe reactions from taking Verezana, as well as related symptoms, are described in section 2 “Warnings and precautions”.

Reporting of adverse effects:

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

Keep this medication out of the 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 at a temperature above 86°F (30°C).

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

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

Composition of Verezana

The active principles are dienogest and etinilestradiol. A coated tablet contains 2 mg of dienogest and 0.03 mg of etinilestradiol.

The other components are:

Tablet core:lactose monohydrate, cornstarch, povidone (30), carboxymethylcellulose sodium (type A) (from potato), magnesium stearate.

Coating of the tablet:hypromellose (E464), hydroxypropylcellulose, talc, cottonseed oil, hydrogenated, titanium dioxide (E 171)

Appearance of Verezana and packaging content

Verezana is a coated tablet, round, biconvex, and white in color.

Verezana is marketed in packaging that contains 21, 3 x 21, and 6 x 21 coated tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma S.L.U.

c/ Anabel Segura, 11 Edificio Albatros B, 1st floor

Alcobendas 28108 Madrid (Spain)

Responsible manufacturer

Merckle GmbH

Ludwig-Merckle-Straße 3, 89143 Blaubeuren

Germany

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

Germany:LaViola

Czech Republic:VEREZANA 0.03 mg/2 mg

Spain:Verezana 2 mg/0.03 mg coated tablets EFG

Last review date of this leaflet:July2023

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