TEVALET 0.03 mg / 0.075 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tevalet 0.03 mg/0.075 mg coated tablets

Etinilestradiol/Gestodene

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 having a blood clot in the veins and arteries,

especially in the first year or when restarting a combined hormonal contraceptive

after a break of 4 weeks or more.

? Be alert and consult your doctor if you think you may have symptoms of a blood clot

(see section 2 “Blood clots”)

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others,

even if they have the same symptoms, as it may harm them.

• If you experience side effects, consult your doctor or pharmacist, even if they are

side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Tevalet and what is it used for

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

3. How to take Tevalet

4. Possible side effects

5. Storage of Tevalet

6. Contents of the pack and further information

1. What is Tevalet and what is it used for

Tevalet is a combined oral hormonal contraceptive. It inhibits ovulation and produces changes in cervical secretion. It is used to prevent pregnancy and to achieve ovulatory rest states.

This medication is presented in blisters (the packaging where the coated tablets are found) of 21 coated tablets.

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

General considerations

Before starting to use Tevalet, 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").

When not to use Tevalet:

You should not use Tevalet if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be more suitable.

Do not take Tevalet

If you are allergic to the active substances or to 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 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 if you spend a long time sitting or lying down (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 stroke-like symptoms).

If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:

Severe diabetes with blood vessel damage.

Very high blood pressure.

Very high levels of fat in the blood (cholesterol or triglycerides).

A condition called hyperhomocysteinemia.

If you have (or have ever had) a type of migraine called "migraine with aura".

If you have thrombogenic valvular heart disease (heart valve diseases that can cause blood clots).

If you have heart rhythm disorders that can cause blood clots (thrombogenic arrhythmias).

If you have or have had a severe liver disease, provided that liver function test values have not returned to normal.

If you have or have had liver tumors (benign or malignant).

If you have or suspect you have malignant diseases of the genital or breast organs.

If you have vaginal bleeding of unknown cause.

If you are pregnant or think you may be pregnant.

If you have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also section "Using other medicines").

When to be extra careful with Tevalet

If any of the risk situations mentioned below are present, your doctor should weigh the benefits of using this medicine against the possible risks and discuss them with you before you decide to start using it.

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

If the condition develops or worsens while you are using Tevalet, you should also tell 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 (an inherited disease of the red blood cells).

If you have high levels of fat in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).

If you need an operation or spend a long time sitting or lying down (see section 2 "Blood clots").

If you have just given birth, you are at a higher risk of blood clots. You should ask your doctor when you can start taking Tevalet after giving birth.

If you have inflammation of the veins just under the skin (superficial thrombophlebitis).

If you have varicose veins.

If you have heart disease (those that produce certain types of heart rhythm disorders).

If you have high blood pressure, especially if it gets worse or does not improve with anti-hypertensive medications.

If you have severe and recurrent migraines.

If you have diabetes.

If you have depression or a history of depression, as it may worsen or come back when using hormonal contraceptives.

If you have certain types of jaundice (yellowing of the whites of the eyes and skin) or liver function disorders.

If you have itching, especially if it occurred during a previous pregnancy.

If you have brown patches on the skin of your face, especially if you had them during a previous pregnancy. If so, avoid sunlight and ultraviolet radiation (e.g., sunbed).

• 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.

Also, contact your doctor if you think you may be pregnant.

BLOOD CLOTS

The use of a combined hormonal contraceptive like [fantasy name] increases your risk of having 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 (this is called "venous thrombosis", "venous thromboembolism", or VTE).

In the arteries (this is called "arterial thrombosis", "arterial thromboembolism", or ATE).

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

It is important to remember that the overall risk of a harmful blood clot due to Tevalet 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 use of a combined hormonal contraceptive.

If a blood clot forms in a vein in your leg or foot, it can cause deep vein thrombosis (DVT).

• If a blood clot moves from your leg and lodges in your lung, it can 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 having a blood clot in a vein higher?

The risk of having a blood clot in a vein is higher during the first year 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 medicine or a different one) after a break 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 Tevalet, your risk of having a blood clot returns to normal within a few weeks.

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

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will have a blood clot in a year.

Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 will have a blood clot in a year.

• Out of 10,000 women who use a combined hormonal contraceptive that contains gestodene, such as Tevalet, about 9-12 will have a blood clot in a year.

The risk of having a blood clot depends 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 having a blood clot with Tevalet 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 about 50).

In this case, you may have a hereditary blood clotting disorder.

• If you need to have surgery or spend a long time sitting or lying down due to an injury or illness, or if you have your leg in a cast. You may need to stop using Tevalet several weeks before surgery or while you have reduced mobility. If you need to stop using Tevalet, ask your doctor when you can start using it again.

As you get older (especially above about 35 years).

• If you have recently given birth.

The risk of having a blood clot increases with the number of risk factors you have.

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

It is important to inform your doctor if you suffer from any of the above conditions, even if you are not sure. Your doctor may decide that you should stop using Tevalet.

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

BLOOD CLOTS IN AN ARTERY

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

Like a blood clot in a vein, a 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 important to note that the risk of a heart attack or stroke due to Tevalet is very small, but it can increase:

• With age (above about 35 years).
• If you smoke. When using a combined hormonal contraceptive like Tevalet, 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 any of your close relatives have had a heart attack or stroke at a young age (less than about 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 (valvular heart disease, 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, the risk of having a blood clot may be increased further.

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

Tumors:

Cases of breast tumors have been observed with a slightly higher frequency in women using oral contraceptives, but it is not known if this is due to the treatment. For example, it could be that more tumors are detected in women using oral contraceptives because they visit their doctor more frequently. This increased frequency decreases gradually after stopping treatment. After ten years, the likelihood of having breast tumors will be the same as for women who have never used oral contraceptives.

Ovarian cancer occurs less frequently than breast cancer. The use of hormone therapy (HT) with estrogens alone or in combination with estrogen-progestogen has been associated with a slightly increased risk of ovarian cancer.

The risk of ovarian cancer varies with age. For example, in women between 50 and 54 years old who do not take HT, about 2 cases of ovarian cancer have been observed per 2,000 women over a 5-year period. In women taking HT for 5 years, about 3 cases have been observed per 2,000 patients (i.e., about 1 additional case).

In some studies, an increased risk of cervical cancer has been reported in users who have been taking combined oral contraceptives (COCs) for a long time, but there is still controversy about the extent to which this finding can be attributed to the effect of other factors, such as sexual behavior and sexually transmitted diseases.

In rare cases, benign and, more rarely, malignant liver tumors have been reported in users of COCs. This can cause internal bleeding, leading to severe abdominal pain. If this happens, you should contact your doctor immediately. A slight increase in the relative risk of cervical cancer and cervical intraepithelial neoplasia has been observed. Given the biological influence of COCs on the cervix, it is possible that the observed changes are related to this effect.

3. How to take Tevalet

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

Remember to take your medication, as forgetting to take coated pills can decrease the efficacy of the preparation.

The first pill is extracted from one of the boxes marked with the day of the week that corresponds (e.g., "LU" for Monday). The pills should be taken every day at approximately the same time, with a little liquid if necessary, and in the order indicated on the blister pack. A pill will be taken daily for 21 consecutive days. A new pack will be started after a 7-day interval without taking pills, during which a withdrawal bleeding usually occurs. The withdrawal bleeding, similar to a period, will appear two or three days after taking the last pill, and it is possible that it will not have finished before starting the next pack.

How to start taking Tevalet

??If you have not taken any hormonal contraceptive previously (in the previous month):

The pills will be started on the 1st day of the woman's natural cycle (i.e., the first day of menstrual bleeding). It can also be started on days 2 to 5 of the cycle, but in this case, it is recommended to use an additional barrier method during the first 7 days of pill taking.

??To replace another combined oral contraceptive (AOC):

You should start taking Tevalet the day after the end of the rest week (in case of taking 21-day contraceptives) or the day after finishing the intake of placebo pills (without active component) of your previous AHC (in case of 28-day contraceptives).

??To replace a method based exclusively on progestogens (minipill, injection, implant) or an intrauterine system that releases progestogens (IUS):

You can replace the minipill with Tevalet any day (if it is an implant or an IUS, the same day of its removal; if it is an injectable, the day that corresponds to the next injection), but in all cases, it is recommended to use an additional barrier method during the first 7 days of pill taking.

??After an abortion in the first trimester:

You can start taking Tevalet immediately. When you do so, you do not need to take additional contraceptive measures.

??After childbirth or an abortion in the second trimester:

It is recommended that you start taking Tevalet 21-28 days after childbirth or an abortion in the second trimester. If you do so later, you should use an additional barrier method during the first 7 days. However, if you have already had sexual intercourse, you should rule out that you have become pregnant before starting to take the AHC, or you should wait until you have your first menstrual period.

If you forgot to take Tevalet

Conduct to follow if you forget to take a pill

Contraceptive protection does not decrease if the intake of a pill is delayed by less than 12 hours.In this case, you should take the pill as soon as you remember and continue taking the following pills at the usual time (even if this means taking two pills on the same day). In this case, no additional contraceptive measures are necessary.

If you delay taking a pill by more than 12 hours, contraceptive protection may be reduced. The guidelines to follow in case of forgetfulness are governed by two basic rules:

1. You should never stop taking pills for more than 7 days.
2. You need to take pills continuously for 7 days to achieve adequate suppression of the hypothalamic-pituitary-ovarian axis.

Consequently, and following the above indications, in daily practice, the following can be advised:

??Week 1:

You should take the last forgotten pill as soon as you remember, even if this means taking two pills at the same time. From then on, you will continue taking the pills at the usual time. Additionally, during the following 7 days, you should use a barrier method, such as a condom. If you have had sexual intercourse in the 7 days prior to the forgotten pill, you should consider the possibility of having become pregnant. The more pills you have forgotten and the closer you are to the usual pill-free interval, the higher the risk of pregnancy.

??Week 2:

You should take the last forgotten pill as soon as you remember, even if this means taking two pills at the same time. From then on, you will continue taking the pills at the usual time. If you have taken the pills correctly in the 7 days prior to the forgotten pill, you will not need to take additional contraceptive measures. However, if you have forgotten to take more than 1 pill, it is advisable to take additional precautions for 7 days.

??Week 3:

The risk of reduced efficacy is imminent due to the proximity of the rest week. However, by adjusting the pill-taking schedule, it is still possible to prevent the decrease in contraceptive protection. Therefore, if you follow one of the following options, you will not need to take additional contraceptive measures, provided that you have taken all the pills correctly in the 7 days prior to the first forgetfulness. If this is not the case, you should follow the first of the two options indicated below and take additional contraceptive measures in the following 7 days.

1. You should take the last forgotten pill as soon as you remember, even if this means taking two pills at the same time. From then on, you will continue taking the pills at the usual time. You should start the next blister pack as soon as you finish the current one, without leaving a separation between them. It is unlikely that you will have a withdrawal bleeding (period) until you finish the second pack, but you may experience spotting or bleeding during the intake of the pills.

1. You can also stop taking the pills from the current blister pack. Then, you should complete an interval of up to 7 days without taking pills, including the days you forgot to take the pills, and then start again with the next blister pack.

If, in case of forgetting to take pills, you do not present withdrawal bleeding (period) in the first pill-free interval, you should consider the possibility of having become pregnant.

However, in case of doubt, consult your doctor.

Tips in case of gastrointestinal disorders

In case of severe gastrointestinal disorders, absorption may not be complete, and additional contraceptive measures should be taken.

If you suffer from vomiting in the 3-4 hours following the intake of a pill, you should follow the guidelines for forgetting to take a pill, as described in the section "Conduct to follow if you forget to take a pill". If you do not want to change your normal pill-taking schedule, you should take the necessary extra pill(s) from another pack.

How to delay a withdrawal bleeding

To delay a period, you should continue with the next pack without leaving the usual rest week. You can maintain this extension for as long as you want until you finish the second pack. During this period, you may experience bleeding or spotting. Then, you should leave the usual 7-day interval without pills and resume the regular intake of Tevalet.

To change the period to another day of the week than you are used to according to your current cycle, you can advise that you shorten the rest week by as many days as you want. The shorter the interval, the higher the risk that you will not have a withdrawal bleeding (period) and that you will experience bleeding or spotting during the intake of the next pack (as occurs when delaying a period).

If you take more Tevalet than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 915 620 420, indicating the medication and the amount ingested.

No serious adverse reactions have been reported due to overdose. The symptoms that may appear in this case are: nausea, vomiting, and, in adolescents, mild vaginal bleeding. There is no antidote, and treatment should be symptomatic.

If you interrupt treatment with Tevalet

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause 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 change in health that you think may be due to Tevalet, consult your doctor.

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").

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 you start using Tevalet"

The use of oral contraceptives has been associated with:

• Increased risk of intraepithelial neoplasia and cervical cancer.
• Increased risk of breast cancer diagnosis (see "Be especially careful with Tevalet").

The frequency of adverse effects is classified as:

Very common (At least 1 in 10 patients).

Common (At least 1 in 100 patients).

Uncommon (At least 1 in 1,000 patients).

Rare (At least 1 in 10,000 patients).

Very rare (Less than 1 in 10,000 patients).

Not known (Cannot be estimated from the available data)

Infections and Infestations

Common: Vaginitis (inflammation of the vagina), including candidiasis (fungal infection in the vagina).

Disorders of the Immune System

Rare: Allergic reactions such as urticaria (itching).

Very rare: Worsening of systemic lupus erythematosus.

Not known:Angioedema (swelling of the face, lips, mouth, and very rare cases of severe reactions accompanied by difficulty breathing, dizziness, and even loss of consciousness)

Metabolic and Nutrition Disorders

Uncommon: Changes in appetite (increase or decrease).

Rare: Glucose intolerance.

Very rare: Worsening of porphyria.

Psychiatric Disorders

Common: Mood changes, including depression; changes in libido (sexual desire).

Nervous System Disorders

Very common: Headaches, including migraines.

Common: Nervousness, vertigo.

Very rare: Worsening of chorea.

Eye Disorders

Rare: Intolerance to contact lenses.

Very rare: Optic neuritis, retinal vascular thrombosis (eye abnormalities and visual disorders).

Vascular Disorders

Uncommon: Increased blood pressure.

Rare: 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 stroke or temporary symptoms similar to those of a stroke, called 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).

Very rare: Worsening of varicose veins.

Gastrointestinal Disorders

Common: Nausea, vomiting, abdominal pain.

Uncommon: Colic, bloating.

Very rare: Pancreatitis, hepatic adenomas, hepatocellular carcinoma.

Hepatobiliary Disorders

Rare: Cholestatic jaundice.

Very rare: Cholecystopathy (gallbladder disorders), including gallstones.

Skin and Subcutaneous Tissue Disorders

Common:Acne.

Uncommon: Rash, photosensitivity reactions, chloasma (skin patches) that may persist, hirsutism (excessive hair growth), alopecia (hair loss).

Rare: Erythema nodosum (a type of skin inflammation with nodules on the legs).

Very rare: Erythema multiforme (a type of skin inflammation).

Renal and Urinary Disorders

Very rare: Hemolytic uremic syndrome.

Reproductive System and Breast Disorders

Very common: Bleeding, spotting.

Common: Breast pain, breast tension, breast enlargement, breast secretion, dysmenorrhea (painful menstruation), changes in menstrual flow, changes in vaginal secretion, and cervical ectropion (alteration of the cervical mucosa), amenorrhea (absence of menstruation).

General Disorders and Administration Site Conditions

Common: Fluid retention, edema (swelling), weight changes (gain or loss).

Investigations

Uncommon: Changes in blood lipid levels, including hypertriglyceridemia.

Rare: Decreased serum folate levels.

Reporting of Adverse EffectsIf you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear 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 medicine.

5. Storage of Tevalet

Keep this medicine out of sight and reach of children.

Below 30°C. Store in the original packaging.

Do not use Tevalet after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the pharmacy's SIGRE. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Tevalet

• The active ingredients are: ethinylestradiol, 0.03 mg, and gestodene, 0.075 mg.
• The other components are: lactose, cornstarch, povidone, calcium and sodium edetate, magnesium stearate, sucrose, povidone, polyglycol, calcium carbonate, talc, and glycerol montanate.

Appearance of the Product and Package Contents

Tevalet is presented in aluminum blisters of 21 tablets and 3x21 tablets.

The tablets are white, round, biconvex, and shiny.

Marketing Authorization Holder and Manufacturer

Holder:

Teva Pharma S.L.U.

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

Alcobendas 28108 Madrid (Spain)

Manufacturer:

Haupt Pharma Münster GmbH.

Schleebrüggenkamp 15

48159 Münster

Germany

Date of the Last Revision of this Prospectus: November 2022

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