Tevalet 0.03 mg/0.075 mg film-coated tablets: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Tevalet 0.03 mg/0.075 mg coated tablets

Ethinyloestradiol/Gestodene

Read all of this 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 further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, talk to your doctor or pharmacist, even if they are 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”).

Contents of the leaflet

What Tevalet is and what it is used for
What you need to know before taking Tevalet
How to take Tevalet
Possible side effects
How to store Tevalet
Contents of the pack and other information

1. What Tevalet is and what it is used for

Tevalet is a combined oral hormonal contraceptive. It inhibits ovulation and produces changes in cervical secretions (produced by the cervix). It is used to prevent pregnancy and to achieve ovarian rest (reduction or interruption of ovarian activity).

This medicine is supplied in blisters (the packaging containing the coated tablets) of 21 coated tablets.

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

General considerations

Before starting to use Tevalet, 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”).

Do not take Tevalet

You must 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 which other form of contraception would be more suitable.

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 affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
If you require surgery or if you are going to 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 diseases that may increase your risk of developing a clot in the arteries:
Severe diabetes with blood vessel damage.
Very high blood pressure.
Very high levels of fat in the blood (cholesterol or triglycerides).
A condition called hyperhomocysteinemia.
If you have (or have ever had) a type of migraine called "migraine with aura".
If you have thrombogenic valvulopathies (heart valve disorders that may lead to clots).
If you have heart rhythm disorders with risk of clot formation (thrombogenic arrhythmias).
If you have or have had severe liver disease, as long as liver function test results have not returned to normal.
If you have or have had liver tumours (benign or malignant).
If you have or are suspected of having malignant conditions of the genital organs or breasts.
If you have vaginal bleeding of unknown cause.
If you are pregnant or suspect you might be pregnant.
If you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also section "Use of other medicines")

Warnings and precautions

When should you consult your doctor?

Seek urgent medical attention

If you notice possible signs of a blood clot which may indicate that 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 (thrombosis)” below).

For a description of the symptoms of these serious side effects, see “How to recognize a blood clot”.

Consult your doctor or pharmacist before starting to take Tevalet.

If any of the risk situations described below apply to you, your doctor should evaluate 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 have any of the following conditions.

If any of these conditions develop or worsen while you are taking Tevalet, 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 body's natural defense system).
If you have hemolytic uremic 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 are undergoing surgery or will be immobile for prolonged periods (see section 2, “Blood clots”).
If you have recently given birth, you are at increased risk of developing blood clots. You should ask your doctor when you can start taking Tevalet after delivery.
If you have inflammation of the veins beneath the skin (superficial thrombophlebitis).
If you have varicose veins.
If you have heart diseases (those caused by certain types of cardiac arrhythmias).
If you have high blood pressure, particularly if it worsens or does not improve with antihypertensive medications.
If you suffer from severe and recurrent migraines.
If you have diabetes.
If you have depression or a history of depression, as it may worsen or reappear when using hormonal contraceptives.
If you have certain types of jaundice (yellowing of mucous membranes, eyes, and/or skin) or liver function disorders.
If you have itching, especially if it occurred during a previous pregnancy.
If you have permanent brown patches on the skin of your face, particularly if they occurred during a previous pregnancy. In such cases, avoid sunlight and ultraviolet radiation (e.g., sunbeds).
If you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat and/or difficulty swallowing, or hives with possible breathing difficulties, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary and acquired angioedema.

Also contact your doctor if you think you might be pregnant.

BLOOD CLOTS

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

Blood clots may form:

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

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

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

HOW TO RECOGNIZE A BLOOD CLOT

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


Are you experiencing any of these signs?	What might you be suffering from?
Swelling in one leg or 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. turning pale, red, or blue	Deep vein thrombosis
Sudden shortness of breath without known cause or rapid breathing Sudden cough without clear cause, possibly producing blood Sharp chest pain that may worsen when breathing deeply Severe dizziness or lightheadedness Rapid 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 such as 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 an eye)
Pain, discomfort, pressure, or heaviness in the chest Feeling of tightness or congestion in the chest, arm, or beneath the sternum Sensation of fullness, indigestion, or suffocation Upper body discomfort radiating to the back, jaw, throat, arm, or stomach Sweating, nausea, vomiting, or dizziness Extreme weakness, anxiety, or shortness of breath Rapid or irregular heartbeat	Heart attack
Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body. Sudden confusion, difficulty speaking or understanding speech Sudden vision problems in one or both eyes Sudden difficulty walking, dizziness, loss of balance or coordination Sudden, severe, or prolonged headache without 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 has been associated with an increased risk of blood clots in veins (venous thrombosis). However, these adverse effects are rare. They occur most frequently during the first year of using a combined hormonal contraceptive.
If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
Very rarely, a clot may form in a vein of another organ such as the eye (retinal vein thrombosis).

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

The risk of developing a blood clot in a vein is higher during the first year in which you take a combined hormonal contraceptive for the first time.

The risk may also be higher if you restart taking a combined hormonal contraceptive (the same medication or a different one) after a break of 4 weeks or more.

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

When you stop taking Tevalet, 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 Tevalet is small.

Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot within one year.
Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot within one year.
Among 10,000 women who use a combined hormonal contraceptive containing gestodene, such as Tevalet, between 9 and 12 women will develop a blood clot within one year.
Your risk of developing a blood clot will depend on your personal medical history (see “Factors that increase your risk of a blood clot” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal 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 Tevalet	About 9 – 12 out of 10,000 women

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

The risk of having a blood clot with Tevalet 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). In this case, you may have an inherited blood clotting disorder.
If you require surgery or if you remain immobile for long periods due to injury or illness, or if your leg is in a cast. You may need to stop using Tevalet several weeks before surgery or while you are less mobile. If you need to stop using Tevalet, ask your doctor when you can start using it again.
With increasing age (especially over about 35 years).
If you gave birth less than a few weeks ago.

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

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

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 Tevalet.

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

BLOOD CLOTS IN AN ARTERY

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

As with a blood clot in a vein, a clot in an artery can cause serious problems. For example, it may 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 heart attack or stroke from using Tevalet is very small, but it may increase:

With age (over 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 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 a close relative has 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 disorders 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 Tevalet, for example, you start smoking, a close relative experiences thrombosis without a known cause, or you gain significant weight, inform your doctor.

??Tumors:

A slightly increased frequency of breast tumors has been observed in women using contraceptive pills, but it is unknown whether this is due to the treatment. For example, more tumors may be detected in women using contraceptive pills because they visit their doctor more frequently. This increased frequency gradually decreases after stopping treatment. After ten years, the likelihood of having breast tumors will be the same as in women who have never used contraceptive pills.

In some studies, an increased risk of cervical cancer has been reported in women who have used combined oral contraceptives (COCs) for long periods, but controversy remains regarding how much this finding may be attributed to other factors such as sexual behavior and sexually transmitted infections.

Benign liver tumors have been rarely reported, and malignant ones even more rarely, in users of COCs. This may cause internal bleeding leading to severe abdominal pain. If this occurs, 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 these lesions, it is recommended that cervical cytology be performed periodically when prescribing a COC.

Ovarian cancer occurs less frequently than breast cancer. The use of hormone replacement therapy (HRT) with estrogens alone or with a combination of estrogens and progestogens has been associated with a slightly higher risk of ovarian cancer.

The risk of ovarian cancer varies with age. For example, in women aged 50 to 54 years not using HRT, about 2 cases of ovarian cancer have been observed per 2,000 women over a 5-year period. In women treated with HRT for 5 years, about 3 cases per 2,000 women have been observed (i.e., about 1 additional case).

Malignant tumors can be life-threatening or fatal.

Psychiatric disorders

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

If a severe depressive disorder develops, the medication should be discontinued and an alternative contraceptive method used. Women with a history of depression should be closely monitored.

??Other conditions:

In women with hypertriglyceridemia (elevated triglycerides in the blood), or with a family history of the same, there may be an increased risk of pancreatitis (inflammation of the pancreas) during the use of COCs.

Women who have been treated for hyperlipidemia (elevated blood fats such as triglycerides and/or cholesterol) should be monitored if they decide to take oral contraceptives.

During the use of COCs, many users have shown small increases in blood pressure, although cases with clinical relevance are rare. If sustained high blood pressure develops during COC use, consult your doctor.

In women with endometrial hyperplasia (thickening of the inner lining of the uterus), the doctor should carefully evaluate the risk-benefit ratio before prescribing COCs and closely monitor the patient during treatment, performing periodic cervical cytology.

The following conditions may appear or worsen during pregnancy and with the use of COCs: jaundice (yellowing of mucous membranes, eyes, and/or skin) and/or pruritus (itching) related to cholestasis (cessation or reduction of bile flow), gallstone formation, porphyria (a disorder of hemoglobin metabolism), systemic lupus erythematosus (inflammatory skin disease), hemolytic uremic syndrome (a disease causing blood abnormalities), Sydenham's chorea (involuntary movements), herpes gestationis (skin and mucous membrane lesions appearing during pregnancy), and hearing loss due to otosclerosis (a type of ear disorder).

Acute or chronic disorders of liver function require discontinuation of COC use until liver function markers return to normal. Recurrence of cholestatic jaundice (yellowing of mucous membranes, eyes, and/or skin related to cessation or reduction of bile flow), which first appeared during pregnancy or previous use of sex hormones, requires discontinuation of the COC.

COCs may alter peripheral insulin resistance and glucose intolerance. There is no evidence that the treatment regimen needs to be changed in diabetic women using low-dose COCs (with < 0.05 mg ethinylestradiol). However, diabetic women should be carefully monitored while taking COCs.

The use of COCs has been associated with Crohn's disease and ulcerative colitis (inflammatory bowel diseases).

Occasionally, chloasma (brown patches on the skin) may occur, especially in women with a history of chloasma gravidarum (occurring during pregnancy). If you are prone to chloasma, you should avoid exposure to sunlight or ultraviolet rays while taking COCs.

Women should be advised that oral contraceptives do not protect against HIV infection (AIDS) or other sexually transmitted diseases.

Examination and medical consultation

Before starting or resuming treatment with Tevalet, your doctor must perform a complete medical history and physical examination to rule out contraindications and observe precautions, and these should be repeated at least once a year during the use of combined oral contraceptives.

Reduction of efficacy

The efficacy of COCs may decrease if you forget to take a tablet (see section “If you forgot to take Tevalet”), if you experience gastrointestinal disorders such as vomiting or severe diarrhea (see section “Recommendations in case of gastrointestinal disorders”), or if you take other medications simultaneously (see section “Taking Tevalet with other medicines”).

Irregularities in cycle control

During the use of any COC, spotting or vaginal bleeding between periods may occur, especially during the first months of use. If these bleeding irregularities persist or occur after previously regular cycles, non-hormonal causes should be considered, and you should see your doctor for appropriate diagnostic measures to rule out malignancies, infections, or pregnancy.

In some women, withdrawal bleeding (period) may not occur during the rest week. If you have taken the COC as directed in the “How to take Tevalet” section, it is unlikely that you are pregnant. However, if you have not taken the COC as directed before the first missed period, or if a second period is missed, pregnancy should be ruled out before continuing COC use.

If you have any doubts about any of the above points, consult your doctor before taking Tevalet.

Other medicines and Tevalet

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicine.

Certain medicines may interact. In these cases, it may be necessary to change the dose or discontinue treatment with one of the medicines. It is especially important that you inform your doctor if you are using any of the following medicines:

The following medicines may prevent combined hormonal contraceptives from working properly, and if this occurs, you could become pregnant:

Treatment for hepatitis C virus and HIV (protease inhibitors, e.g., ritonavir and nelfinavir, and non-nucleoside reverse transcriptase inhibitors, e.g., nevirapine) and other infections (griseofulvin).
Treatment for tuberculosis (rifampicin, rifabutin)
Treatment for fungal infections (griseofulvin, azole antifungals, e.g., clarithromycin, erythromycin)
Treatment for certain heart conditions and high blood pressure (calcium channel blockers, e.g., verapamil, diltiazem)
Treatment for arthritis and osteoarthritis (etoricoxib)
Some antiepileptics (topiramate, barbiturates (phenobarbital), phenytoin, carbamazepine, primidone, oxcarbazepine, felbamate, ethosuximide).
Antacids including lansoprazole.
Some substances to elevate mood (modafinil).
Grapefruit juice

You must not take herbal preparations containing St. John's wort (Hypericum perforatum) simultaneously with Tevalet, as its efficacy may be reduced, increasing the risk of unintended pregnancy and intermenstrual bleeding. The reduction in contraceptive effect lasts up to two weeks after stopping St. John's wort preparations.

It is advisable to use another reliable contraceptive method if you are taking any of the above-mentioned medicines. The effect of some of these medicines may last up to 28 days after stopping treatment.

Tevalet may reduce the effect of oral anticoagulants, analgesics (such as paracetamol and salicylates), fibrates (medicines to reduce triglyceride and/or cholesterol levels), lamotrigine (anticonvulsant), oral antidiabetics and insulin, and increase the effect of other drugs such as β-blockers (metoprolol), theophylline (for asthma treatment), corticosteroids (such as prednisolone), cyclosporine (increasing the risk of liver toxicity), flunarizine (increasing the risk of lactation), midazolam, melatonin, and tizanidine.

You should never take another medicine on your own initiative without your doctor's recommendation, as some combinations should be avoided.

Do not take Tevalet if you have Hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this may cause increases in liver function test results (elevated liver enzyme ALT).

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

Tevalet can be used again approximately 2 weeks after completion of this treatment. See the section “Do not use Tevalet.”

You should consult the prescribing information of the medicines you are taking concurrently to identify possible interactions.

Laboratory tests

The use of oral contraceptives may affect the results of certain laboratory tests.

If you are advised to undergo any laboratory test, inform your doctor that you are using oral contraceptives.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using any medicine.

Tevalet is not indicated during pregnancy. If you become pregnant, you must stop taking Tevalet immediately and consult your doctor.

During the use of COCs, small amounts of oral contraceptives may be excreted in breast milk, but there is no evidence that this adversely affects the child's health. However, COCs generally should not be used until breastfeeding has ended.

If you wish to use Tevalet after childbirth or after a second-trimester abortion: see section “How to take Tevalet.”

Driving and use of machines

No effects on the ability to drive or use machinery have been observed.

Tevalet contains lactose, sucrose, and sodium

This medicine contains lactose and sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

3. How to take Tevalet

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Remember to take your medicine, as forgetting coated tablets may reduce the effectiveness of the preparation.

Combined oral contraceptives, when taken correctly, have a failure rate of approximately 1% per year. The failure rate may increase if tablets are missed or taken incorrectly.

The first tablet should be taken from one of the boxes marked with the corresponding day of the week (e.g., "MO" for Monday). Tablets must be taken every day at approximately the same time, with some liquid if necessary, and in the order indicated on the blister pack. One tablet should be taken daily for 21 consecutive days. A new pack should be started after a 7-day interval without tablets, during which withdrawal bleeding (menstruation) usually occurs. Withdrawal bleeding, similar to menstruation, will typically appear two or three days after taking the last tablet, and it may not have finished before starting the next pack.

How to start taking Tevalet

??If no hormonal contraceptive has been used previously (in the previous month):

Tablets should be started on day 1 of the woman's natural cycle (i.e., the first day of menstrual bleeding). Alternatively, they may be started on days 2 to 5 of the cycle; however, in this case, it is recommended to use an additional barrier method during the first 7 days of tablet intake.

??To replace another combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch):

You should preferably start taking Tevalet the day after taking the last active (hormone-containing) tablet of your previous COC, or at the latest, the day after the usual tablet-free interval or intake of non-hormonal tablets of your previous COC ends. This means that treatment with Tevalet must be started no later than the day on which a new pack (blister) of the previous COC would have been started. If you have been using a vaginal ring or transdermal patch, you should preferably start taking Tevalet on the day of removal of the last ring or patch of a cycle pack, or at the latest on the day the next application would have been due.

??To replace a progestogen-only method (progestogen-only pill, injection, implant) or a progestogen-releasing intrauterine system (IUS):

You may switch from a progestogen-only pill to Tevalet on any day (if using an implant or IUS, on the same day of removal; if using an injectable, on the day the next injection would be due), but in all cases, it is recommended to use an additional barrier method, such as a condom, during the first 7 days of tablet intake.

??After a first-trimester abortion:

You may start taking Tevalet immediately. In this case, no additional contraceptive measures are necessary.

??After childbirth or a second-trimester abortion:

It is recommended to start taking Tevalet 21–28 days after childbirth or a second-trimester abortion. If you start later, you should use an additional barrier method for the first 7 days. However, if sexual intercourse has already occurred, pregnancy must be ruled out before starting the COC, or you must wait until your first menstrual period.

If you take more Tevalet than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 915 620 420, indicating the medicine and the amount ingested. It is recommended to bring the packaging and leaflet to the healthcare professional.

No serious adverse reactions due to overdose have been reported. Symptoms that may occur in such cases are: nausea, vomiting, and, in adolescents, vaginal bleeding. This bleeding may even occur in girls who have not yet had their first menstrual period, if they have accidentally taken this medicine. There is no antidote, and treatment should be symptomatic.

If you forget to take Tevalet

Contraceptive protection is not reduced if a tablet is taken less than 12 hours late. In this case, take the tablet as soon as you remember and continue taking the following tablets at the usual time (even if this means taking two tablets on the same day). In this case, no additional contraceptive measures are necessary.

If you are more than 12 hours late in taking a tablet, contraceptive protection may be reduced. The following guidelines are based on two basic rules:

You must never stop taking tablets for more than 7 days.
It is necessary to take tablets continuously for 7 days to achieve adequate suppression of the hypothalamic-pituitary-ovarian axis.

Accordingly, and following the above guidance, the following practical advice applies:

??Week 1:

Take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. After that, continue taking the tablets at your usual time. Additionally, use a barrier method, such as a condom, for the next 7 days. If you have had sexual intercourse in the previous 7 days, consider the possibility of pregnancy. The more tablets you have missed and the closer you are to the usual tablet-free interval, the higher the risk of pregnancy.

??Week 2:

Take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. After that, continue taking the tablets at your usual time. If you have taken all tablets correctly in the 7 days before the missed tablet, no additional contraceptive precautions are needed. However, if you have missed more than one tablet, 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 tablet-taking schedule, contraceptive protection can still be maintained. Therefore, if you follow one of the following options, you will not need additional contraceptive precautions, provided that you took all tablets correctly in the 7 days before the first missed tablet. If this is not the case, follow the first of the two options below and adopt additional contraceptive precautions for the next 7 days.

Take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. After that, continue taking the tablets at your usual time. Start the next blister pack immediately after finishing the current one, without any break between packs. Withdrawal bleeding (menstruation) is unlikely to occur until after finishing the second pack, but you may experience spotting or breakthrough bleeding during tablet intake.
You may also stop taking tablets from the current blister pack. Then complete a tablet-free interval of up to 7 days, including the days when you missed tablets, and then restart with the next blister pack.

If, after missing tablets, you do not experience withdrawal bleeding (menstruation) during the first tablet-free interval, consider the possibility of pregnancy.

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

Recommendations 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 vomit within 3–4 hours after taking a tablet, follow the advice for missed tablets as described in the section “If you forget to take Tevalet.” If you do not wish to change your normal tablet-taking schedule, take the necessary extra tablet(s) from another pack.

How to delay withdrawal bleeding (menstruation)

To delay a period, continue with the next pack of Tevalet without taking the usual 7-day break. You may extend this for as long as desired until the second pack is finished. During this time, you may experience bleeding or spotting. Then take the usual 7-day tablet-free break and resume regular intake of Tevalet.

To shift the period to another day of the week than your current cycle, you may shorten the break by as many days as desired. The shorter the interval, the higher the risk of no withdrawal bleeding (menstruation) occurring and of experiencing intermenstrual bleeding or spotting during the next pack intake (as occurs when delaying a period).

Special populations

Paediatric population

Tevalet is only indicated after menarche (onset of first menstruation).

Elderly population

Not applicable. Tevalet is contraindicated after menopause.

Patients with hepatic impairment

Tevalet is contraindicated in women with severe hepatic impairment.

Patients with renal impairment

Tevalet has not been specifically studied in patients with renal impairment. There are no available data suggesting a need to modify treatment in this patient population.

4. Possible adverse effects

Like all medicines, this medicine can produce adverse effects, although not everyone experiences them. If you experience any adverse effect, especially if it is severe and persistent, or if you have any change in your health that you think may be due to Tevalet, consult your doctor.

All women who take combined hormonal contraceptives have an increased risk of developing blood clots in veins (venous thromboembolism (VTE)) or blood clots in arteries (arterial thromboembolism (ATE)). For more detailed information about the different risks of taking combined hormonal contraceptives, see section 2 “What you need to know before starting to use Tevalet”.

Serious adverse effects

Contact your 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 the section “Warnings and precautions”).

The use of oral contraceptives has been associated with:

Increased risk of cervical intraepithelial neoplasia and cervical cancer.
Increased risk of diagnosis of breast cancer (see “Take special care with Tevalet”).

Adverse effects are listed in decreasing order of severity within each frequency interval.

Very common: May affect more than 1 in 10 people

Common: May affect up to 1 in 10 people

Uncommon: May affect up to 1 in 100 people

Rare: May affect up to 1 in 1,000 people

Very rare: May affect up to 1 in 10,000 people

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).

Immune system disorders

Rare: Allergic-type reactions such as very rare cases of urticaria (itching) and severe reactions accompanied by difficulty breathing, dizziness and even loss of consciousness.

Very rare: Worsening of systemic lupus erythematosus (chronic inflammatory autoimmune disorder).

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

Metabolism and nutrition disorders

Uncommon: Changes in appetite (increase or decrease).

Rare: Glucose intolerance.

Very rare: Worsening of porphyria (a disorder of hemoglobin metabolism).

Psychiatric disorders

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

Nervous system disorders

Very common: Headaches, including migraines.

Common: Nervousness, dizziness.

Very rare: Worsening of chorea (a disease causing movement disorder).

Eye disorders

Rare: Intolerance to contact lenses.

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

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.

???Mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA).

???Blood clots in the liver, stomach/intestine, kidneys or eye.

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

Very rare: Worsening of varicose veins.

Gastrointestinal disorders

Common: Nausea, vomiting, abdominal pain.

Uncommon: Colic, bloating.

Very rare: Pancreatitis (inflammation of the pancreas), hepatic adenomas (common non-cancerous liver tumors), hepatocellular carcinoma (malignant liver tumor).

Hepatobiliary disorders

Rare: Cholestatic jaundice (yellowish coloration of mucous membranes, eyes and/or skin related to interruption or reduction of bile flow).

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

Skin and subcutaneous tissue disorders

Common: Acne.

Uncommon: Skin rash, photosensitivity reactions (abnormal increase in skin sensitivity), chloasma (skin patches) which may persist, hirsutism (excessive hair growth), alopecia (hair loss).

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

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

Renal and urinary disorders

Very rare: Haemolytic uraemic syndrome (a disease causing blood abnormalities).

Reproductive system and breast disorders

Very common: Bleeding, spotting.

Common: Breast pain, breast tenderness, breast enlargement, breast discharge, dysmenorrhoea (painful menstruation), changes in menstrual flow, changes in vaginal discharge and cervical ectropion (alteration of the cervical mucosa), amenorrhoea (absence of menstruation).

General disorders and administration site conditions

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

Investigations

Uncommon: Changes in blood lipid levels (fats), including hypertriglyceridaemia.

Rare: Decrease in serum folate levels (folic acid derivatives).

Description of selected adverse reactions

Listed below are very uncommon or delayed-onset adverse reactions considered related to the group of combined oral contraceptives (see sections “Do not use Tevalet” and “Warnings and precautions”).

Tumours

The frequency of breast cancer diagnosis among users of COCs is very slightly increased. Since breast cancer is rare in women under 40 years of age, this increase is low in relation to the overall risk of breast cancer. Causality related to the use of COCs is unknown.
Liver tumours (benign and malignant)

Other disorders

Women with hypertriglyceridaemia (increased blood fats resulting in increased risk of pancreatitis when COCs are used)
Hypertension
Onset or worsening of disorders whose association with COC use is not conclusive: jaundice and/or pruritus related to cholestasis (blocked bile flow); gallstone formation; a metabolic disorder called porphyria; systemic lupus erythematosus (a chronic autoimmune disease); haemolytic uraemic syndrome (a disease with development of blood clots); a neurological disorder called Sydenham's chorea; gestational herpes (a type of skin disorder occurring during pregnancy); hearing loss related to otosclerosis
Alterations in liver function
Changes in glucose tolerance or effect on peripheral insulin resistance
Crohn’s disease, ulcerative colitis
Chloasma (skin patches)

Interactions

Interactions between oral contraceptives and other medicines (e.g. St. John’s wort, medicines for epilepsy, tuberculosis, HIV and other infections) may lead to unexpected bleeding and/or contraceptive failure (see section “Taking Tevalet with other medicines”).

Reporting of adverse effects If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tevalet

Keep this medicine out of the sight and reach of children.

Store below 30°C. Keep in the original packaging.

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

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Tevalet

The active substances are: ethinylestradiol, 0.03 mg and gestodene, 0.075 mg.
The other components are: lactose, corn starch, povidone, calcium sodium edetate, magnesium stearate, sucrose, povidone, polyglycol, calcium carbonate, talc and glycolized montan wax.

Appearance of the medicinal product and contents of the pack

Tevalet is available in aluminum blisters containing 21 tablets and 3x21 tablets.

The tablets are white, round, biconvex and glossy.

Marketing Authorization Holder and Manufacturer

Holder:

Teva Pharma S.L.U.

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

Alcobendas 28108 Madrid (Spain)

Manufacturer:

Haupt Pharma Münster GmbH.

Schleebrüggenkamp 15

48159 Münster

Germany

Date of the most recent revision of this leaflet: October 2025

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