Verezana 0.03 mg/2 mg film-coated tablets EFG

Spain
Brand name Verezana 0.03 mg/2 mg film-coated tablets EFG
Form tablets, film-coated
Active substance / Dosage
ETHINYLESTRADIOL · 0,03 mg
DIENOGEST · 2 mg
Prescription type Prescription Only Medicine
ATC code
G03A G03AA G03AA16
Registration number 76948
Manufacturer Teva Pharma S.L.U.

Table of Contents

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Verezana 2 mg/0.03 mg film-coated tablets EFG

Dienogest/Ethinylestradiol

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

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could harm them.
  • If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. 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 developing blood clots in veins and arteries, especially during the first year of use 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”).

Leaflet contents

  1. What Verezana is and what it is used for
  2. What you need to know before taking Verezana
  3. How to take Verezana
  4. Possible side effects
  5. How to store Verezana
  6. Contents of the pack and other information

1. What Verezana is and what it is used for

Verezana is a combined hormonal medicine for women used to prevent pregnancy (a combined oral contraceptive, generally referred to as "the pill" in this leaflet).

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

In women in whom the predominant effect of male hormones (called "androgens") leads to the development of acne, Verezana improves these conditions.

Verezana is a medicine

  • used to prevent pregnancy (contraceptive "pill").
  • for the treatment of women with moderate acne who are willing to use an oral contraceptive after failure of appropriate topical treatments or oral antibiotics.

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

General considerations

Before starting to use Verezana, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”). Before you can start taking Verezana, your doctor will ask you some questions about your personal medical history and that of your close relatives. 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 must stop using {product name} or in which the effectiveness of Verezana may be reduced. In such situations, you should not have sexual intercourse or must use additional non-hormonal contraceptive precautions, for example 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 (AIDS) infection or any other sexually transmitted disease.

Acne will usually 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 must 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 which other form of birth control would be more appropriate.

  • If you are allergic to ethinylestradiol, dienogest, or any of the other components of this medicine (listed in section 6).
  • 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 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 forming a blood clot in the arteries:
    • Severe diabetes with blood vessel damage.
    • Very high blood pressure.
    • Very high levels of fat in the blood (cholesterol or triglycerides).
    • A condition called hyperhomocysteinemia.
  • If you have (or have ever had) a type of migraine called “migraine with aura”.
  • If you smoke (see section 2 “Blood clots”).
  • If you have (or have ever had) inflammation of the pancreas (pancreatitis) together with very high levels of fat in the blood (lipids) (hypertriglyceridemia), including severe disorders of lipid metabolism.
  • If you have (or have ever had) severe liver disorders (including Dubin-Johnson syndrome 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 current hormone-dependent cancer (e.g. of the breast or endometrium).
  • If you have (or have ever had) vaginal bleeding of unknown cause.
  • If you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also section “Use of Verezana with other medicines”).

Stop taking the pill immediately if any of the above conditions occur and consult your doctor. In the meantime, use non-hormonal contraceptive methods. For further information, see 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 help

  • 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 clot” below).

For a description of the symptoms of these serious adverse effects, see

“How to recognize a blood clot”.

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 your doctor may need to examine you regularly. If the condition develops or worsens while you are using Verezana, you must 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 affecting your natural defense system).
  • If you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing 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 need surgery or will be immobile for a long time (see section 2 “Blood clots”).
  • If you have recently given birth, you are at higher risk of blood clots. You should ask your doctor when you can start taking Verezana after childbirth.
  • If you have inflammation of veins beneath the skin (superficial thrombophlebitis).
  • If you have varicose veins.
  • If you have heart valve defects or heart rhythm disorders.
  • If you have a family history of breast cancer.
  • If you have liver disease or gallbladder disease or gallstones.
  • If you have jaundice or itching due to bile congestion.
  • If you have irregular brownish-yellow skin discoloration, especially on the face (chloasma), or if you experienced this during a previous pregnancy; in this case, avoid intense sunlight and ultraviolet radiation.
  • If you have certain disorders affecting hemoglobin formation (porphyria).
  • If you have depression.
  • If you have epilepsy.
  • If you have Sydenham’s chorea (St. Vitus’ dance).
  • If you had blistering rash during a previous pregnancy (herpes gestationis).
  • If you have hearing loss in the inner ear (hearing loss related to otosclerosis).
  • If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives potentially with breathing difficulties, contact a doctor immediately. Medicinal products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

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

Blood clots can form:

  • In the veins (called “venous thrombosis”, “venous thromboembolism” or VTE).
  • In the arteries (called “arterial thrombosis”, “arterial thromboembolism” or TEA).

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

It is important 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 help 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 foot, or along a vein in the leg or foot, especially when accompanied by:
    • Pain or tenderness in the leg, which may only be noticeable when standing or walking.
    • Increased warmth in the affected leg.
    • Change in skin color of the leg, e.g., becoming 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 pain that may worsen when taking a deep breath.
  • Severe chest pain or dizziness.
  • Faster or irregular heartbeat.
  • Severe stomach 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).

  • Pain, discomfort, pressure, or heaviness in the chest.
  • Feeling of tightness or fullness in the chest, arm, or below the breastbone.
  • Sensation of fullness, indigestion, or suffocation.
  • Upper body discomfort spreading to the back, jaw, throat, arm, or stomach.
  • Sweating, nausea, vomiting, or dizziness.
  • Severe weakness, anxiety, or shortness of breath.
  • Faster 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 stomach 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 is 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 highest during the first year of first-time use of a combined hormonal contraceptive. The risk may also be higher if you restart 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 remains somewhat 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 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 Verezana is low.

  • Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
  • Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5 to 7 will develop a blood clot in one year.
  • Among 10,000 women who use a combined hormonal contraceptive containing dienogest and ethinylestradiol, such as Verezana, between 8 and 11 will develop a blood clot in one year.

Your individual 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 pill/patch/ring 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 Verezina

About 8-11 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 Verezana is small, but certain conditions increase the risk. Your risk is higher:

  • If you are overweight (body mass index or BMI above 30 kg/m²).
  • If 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 will be immobile for a long time due to injury or illness, or if your leg is in a cast. You may need to stop using Verezana several weeks before surgery or while you are less mobile. If you need to stop using Verezana, ask your doctor when you can start taking it again.
  • With increasing age (especially over about 35 years).
  • 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) can temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed above.

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

If any of the above conditions change while you are using Verezana—for example, 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, 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 important to note that the risk of a heart attack or stroke while using Verezana is very small, but it may increase:

  • With age (over about 35 years).
  • If you smoke. When using a combined hormonal contraceptive like Verezana, 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 have an increased risk of 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 suffer from migraines, especially migraines with aura.
  • If you have a heart condition (valve disorders, heart rhythm disturbances such as 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 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

A slightly higher incidence of breast cancer has been observed in women using combined oral contraceptives, but it is not known whether this is caused by the treatment. For example, more tumors may be detected in women taking combined pills because their doctor examines them more frequently. The risk of breast tumors gradually decreases after stopping combined hormonal contraceptives. It is important to regularly examine your breasts and to contact your doctor if you feel any lumps.

Rare cases of benign liver tumors and, even more rarely, malignant liver tumors have been reported in users of oral contraceptives. 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 long-term use of the pill increases a woman's risk of developing cervical cancer. However, it is unclear to what extent sexual behavior (e.g., frequent partner changes) and other factors such as human papillomavirus (HPV) contribute to this risk.

When to consult your doctor

Regular check-ups

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

Additionally, 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 conditions affecting your family;
  • You feel a lump in your breast;
  • You are also taking other medications (see also the section “Other medicines 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 missed 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 using hormonal contraceptives such as Verezana have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor for further medical advice as soon as possible.

If you have unexpected bleeding (intermenstrual bleeding)

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

If you do not have your normal 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 being pregnant is extremely low. Continue taking Verezana as usual.

If you miss two consecutive periods, or if you have not been taking Verezana as directed before the missed period, pregnancy is possible. 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 medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Some medicines may cause intermenstrual bleeding and/or reduce the contraceptive effectiveness of Verezana.

Effect of other medicines on Verezana

Always inform your doctor about any medicines or herbal products you are already using. Also inform any other doctor or dentist who prescribes you a medicine (or your pharmacist) that you are taking Verezana. They can advise you whether you need to take additional contraceptive precautions (e.g., condoms) and, if so, for how long, or whether you should change the use of another medicine you need.

Some medicines

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

These include:

  • Medicines used to treat:
    • 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 to treat narcolepsy, a nervous system disorder)
  • The herbal remedy St. John’s wort

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

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

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

Effect of Verezana on other medicines

Verezana may affect the action of other medicines, for example:

  • the antiepileptic lamotrigine (this could lead to an increased frequency of seizures)
  • medicines containing cyclosporine
  • 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 medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this may cause increases in liver function test results (elevation of liver enzyme ALT).

Your doctor will prescribe another type of contraceptive before starting treatment with these medicines.

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

Also consider the package leaflets of other prescribed medicines.

Interactions with laboratory tests

Inform 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, adrenal cortex, kidney and thyroid function, as well as the levels of certain proteins in the blood, e.g., proteins affecting fat metabolism, carbohydrate metabolism, blood clotting, and fibrinolysis. However, these changes generally 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 medicine.

Pregnancy

Do not take Verezana during pregnancy. You must not be pregnant when you start taking Verezana. Stop taking Verezana immediately if you become pregnant while using it 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 human 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 reported.

Verezana contains lactose

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

Verezana contains sodium

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

3. How to take Verezana

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

For both indications—hormonal contraception and treatment of women with moderate acne—Verezana must be taken according to the following instructions. To maintain contraceptive efficacy, follow the instructions in the section “Missed tablet management”.

How and when should you take Verezana?

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

Take one tablet daily for 21 consecutive days at approximately the same time each day, following the row indicated on the blister pack.

The first tablet is taken from the individual blister marked with the day of the week you start (e.g., "Mon" for Monday).

Continue taking the tablets daily in the direction of the arrows until the entire blister pack is finished.

Then, do not take any tablets for 7 days. During this 7-day break, withdrawal bleeding (also known as "withdrawal bleed") usually occurs 2 to 3 days after taking the last tablet.

Resume taking tablets by starting the next blister pack on day 8, regardless of whether bleeding has stopped or not. This ensures that you always start a new pack on the same day of the week, and bleeding typically occurs around the same days each month.

If you take Verezana as directed, contraceptive protection continues throughout the 7-day break.

When should you start taking Verezana?

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

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

If taken correctly, Verezana provides contraceptive protection from the first day. If you start taking the pill between the second and fifth day of your cycle, an additional barrier contraceptive method (e.g., condom) should be used for the first 7 days of treatment.

If switching from another combined oral contraceptive pill, vaginal ring, or transdermal patch to Verezana:

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

If you have been taking a pill from a pack containing both active and inactive tablets, start taking Verezana the day after the last inactive tablet.

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

If you wish to use Verezana after a first-trimester spontaneous abortion (miscarriage):

Please speak with your doctor. In principle, you may start taking Verezana immediately.

If you wish to use Verezana after a second-trimester spontaneous abortion or after childbirth:

Your doctor will recommend that you start taking Verezana between days 21 and 28 after childbirth or a second-trimester miscarriage. If you start later than this, you should also use a barrier method (e.g., condom) for the first 7 days of taking Verezana.

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

If you are breastfeeding after childbirth and starting Verezana:

See the section “Breast-feeding”.

If you take more Verezana than you should

There are no reports of serious harmful effects after taking too many Verezana tablets. If you have taken several tablets at once, you may feel unwell, vomit, or experience vaginal bleeding. Even girls who have not yet started menstruating but have accidentally taken this medicine may experience such bleeding.

If you have taken more Verezana tablets than prescribed or discover that a child has taken some, consult your doctor or pharmacist.

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

If you forget to take Verezana

  • If less than 12 hours have passed since you missed only one tablet, the contraceptive effect of Verezana is still ensured. Resume taking the tablets as soon as possible and continue taking the following tablets at your usual time.
  • If more than 12 hours have passed, contraceptive protection is no longer fully guaranteed. The greater the number of tablets missed, the higher the risk of pregnancy.

The risk of pregnancy is higher if you miss a tablet at the beginning or end of the pack. Therefore, follow the rules below.

More than one tablet missed per pack

Consult your doctor.

The following procedures apply in case of missed tablets:

If you miss 1 tablet in week 1

Take it as soon as possible, even if this means taking two tablets at the same time. Then continue taking the tablets as usual. However, use an additional barrier contraceptive method (e.g., condom) for the next 7 days. If you had sexual intercourse during the week before missing the tablet, there is a risk of pregnancy. In this case, consult your doctor.

If you miss 1 tablet in week 2

Take it as soon as possible, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. If you have taken Verezana regularly during the 7 days prior to the missed tablet, contraceptive efficacy is maintained and no additional contraceptive measures are needed. If not, or if you missed more than one tablet, use an additional barrier contraceptive method (e.g., condom) for 7 days.

If you miss 1 tablet in week 3

Due to the proximity of the 7-day break, contraceptive protection is no longer fully guaranteed. However, contraceptive efficacy can be maintained by adjusting the dosing schedule. If one of the following procedures is followed, no additional contraceptive measures are necessary—but only if the pill was taken correctly during the 7 days prior to the first missed tablet. If not, follow the instructions under point 1 below. In addition, use an additional contraceptive method (e.g., condom) for the next 7 days.

You may choose between two options:

  1. Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. Skip the 7-day break and start the next blister pack immediately. Withdrawal bleeding is unlikely to occur until you finish the second pack. However, breakthrough bleeding or spotting may occur during the second pack.

or

  1. You may immediately stop taking tablets from the current pack and start the next pack after a break of no more than 7 days (note: the day you missed the tablet must be taken into account). If you wish to start the new pack on your usual day of the week, you may shorten the break period.

If you missed any tablets in the pack and do not have bleeding during the first tablet-free interval, you may be pregnant. Contact your doctor before starting the next pack.

What to do if you experience vomiting or diarrhoea?

If you vomit or have diarrhoea, the active ingredients in the tablet may not have been fully absorbed. Therefore, the contraceptive effect may be reduced, similar to missing a tablet. Additional contraceptive measures are required. If you vomit within 3–4 hours after taking a tablet or have severe diarrhoea, take another tablet as soon as possible. The replacement tablet should be taken within 12 hours of your usual tablet-taking time. If more than 12 hours have passed, follow the advice given in the section “If you forget to take Verezana”.

If you do not wish to change your tablet-taking schedule, you may take a tablet from another blister pack and use that pack later as a reserve.

What to do if you wish to delay withdrawal bleeding?

Although not recommended, you may delay withdrawal bleeding by starting the next Verezana blister pack immediately, without taking the 7-day break. Withdrawal bleeding can be delayed as long as desired, but no longer than until the end of the second blister pack. During this time, breakthrough bleeding or spotting may occur. After a regular 7-day break, you may resume taking the pill as usual.

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

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

If you take the tablets as directed, your period will occur approximately every 4 weeks on the same day. To change this day, simply shorten (but never extend) the tablet-free interval. For example, if your period usually starts on a Friday and you wish it to start on a Tuesday (3 days earlier), begin the new blister pack 3 days earlier than usual. If the tablet-free interval is very short (e.g., 3 days or less), you may not experience withdrawal bleeding during this time and may instead experience intermenstrual bleeding.

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

If you stop treatment with Verezana

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

If you wish to become pregnant, stop taking Verezana and wait for your menstrual bleeding before trying to conceive. This will make it easier to calculate your expected due date.

Additional information for special patient groups

Children and adolescents

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

Elderly patients

Verezana may only be used in women before menopause.

Patients with hepatic impairment

Verezana must not be used in women with severe liver disorders (see section 2 “Do not take Verezana”).

Patients with renal impairment

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

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

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 notice any change in your health that you think may be due to Verezana, 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 use Verezana”.

Serious adverse reactions

Serious 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 hives with possible difficulty breathing (see also section 2, “Warnings and precautions”).

The following adverse effects have been observed in clinical studies with ethinylestradiol 0.03 mg and dienogest 2 mg.

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

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

Uncommon adverse effects (may affect more than 1 in 100 people):

  • Genital inflammation (vaginitis/vulvovaginitis), fungal infections of the vagina (candidiasis, other vulvovaginal infections).
  • Increased appetite.
  • Depressive mood.
  • Dizziness.
  • Migraine.
  • High or low blood pressure; in rare cases, increase in 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 cutaneous exanthema).
  • Itching (in some cases generalized).
  • Irregular menstrual bleeding including heavy bleeding (menorrhagia), light bleeding (hypomenorrhea), irregular bleeding (oligomenorrhea), and absence of bleeding (amenorrhea).
  • Spotting (vaginal bleeding and metrorrhagia).
  • Painful menstruation (dysmenorrhea), pelvic pain.
  • Breast enlargement with swelling, edema.
  • Vaginal discharge.
  • Ovarian cysts.
  • Fatigue, with weakness, tiredness, and general malaise.
  • 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).
  • Urinary tract infection, bladder inflammation (cystitis).
  • Breast inflammation (mastitis).
  • Fungal infections (e.g., Candida), viral infections, cold sores (herpes labialis).
  • Influenza, bronchitis, upper respiratory tract infections, paranasal infection (sinusitis).
  • Asthma.
  • Increased respiratory rate (hyperventilation).
  • Benign proliferation in the uterus (fibroids).
  • Benign proliferation of fatty breast tissue (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 causing, for example, abnormal posture).
  • Dry or irritated eyes.
  • Vision disorders.
  • Sudden hearing loss, hearing impairment.
  • Tinnitus.
  • Vestibular disorders.
  • Rapid heartbeat.
  • 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 ischemic 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).

  • Inflammatory vein condition (thrombophlebitis).
  • Varicose veins (varicosis), venous disorders or pain.
  • Dizziness or fainting upon standing up after sitting or lying down (orthostatic hypotension).
  • Hot flushes.
  • Inflammation of the gastric mucosa (gastritis), intestinal inflammation (enteritis).
  • Gastric discomfort (dyspepsia).
  • Skin reactions/disorders such as allergic reactions, neurodermatitis/atopic dermatitis, eczema, psoriasis.
  • Excessive sweating.
  • Golden-brown pigmented patches (called melasma), especially on the face (melasma), pigmentation disorders/increased pigmentation.
  • Oily skin (seborrhea).
  • Dandruff.
  • Excessive hair growth (hirsutism).
  • Orange-peel skin (cellulitis).
  • Spider nevus (central red 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 proliferations (fibrocystic mastopathy), swelling of congenital accessory mammary glands outside the breast (accessory breasts).
  • Pain during intercourse.
  • Nipple discharge.
  • Menstrual disorders.
  • Peripheral edema (fluid accumulation in the body).
  • Flu-like illnesses, inflammations, fever.
  • Increased levels of triglycerides or cholesterol in the blood (hypertriglyceridemia, hypercholesterolemia).
  • Decrease or fluctuation in weight.

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

Mood changes, increased or decreased sexual desire (libido), intolerance to contact lenses, hives, skin and/or mucous membrane reactions with rash, nodules, blister formation or tissue death (erythema nodosum or erythema multiforme), secretion from mammary glands, 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 overall risk of developing breast cancer in relation to the general population is low. For more information, see the section “Verezana and cancer”.
  • Liver tumors (benign and malignant)
  • Cervical cancer

Other conditions

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

Interactions

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

Other serious 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 they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Verezana

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the outer packaging and on the blister after EXP. The expiry date is the last day of the month indicated.

Do not store above 30°C.

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

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Additional information

Composition of Verezana

The active substances 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) (from potato), magnesium stearate.

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

Appearance of Verezana and contents of the container

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

Verezana is available in packaging containing 21, 3 x 21 and 6 x 21 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma S.L.U.

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

Alcobendas 28108 Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig-Merckle-Straße 3, 89143 Blaubeuren

Germany

This medicinal product 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 most recent review of this leaflet: July 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/