TRIAGYNON COATED TABLETS

Introduction

Package Leaflet: Information for the User

Triagynon Coated Tablets

levonorgestrel / ethinylestradiol

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

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

Package Leaflet Contents

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

1. What is Triagynon and what is it used for

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

Triagynon is presented in blister packs (the container where the coated tablets are found) of 21 coated tablets.

2. What you need to know before taking Triagynon

General considerations

Before starting to use Triagynon, 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").

Do not use Triagynon

You should not use Triagynon 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.

• If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), or 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 immobile (see section "Blood clots").
• If you have ever had a heart attack or stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary stroke symptoms).

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

• Severe diabetes with blood vessel damage.
• Very high blood pressure.
• Very high levels of fat in the blood (cholesterol or triglycerides).
• A condition called hyperhomocysteinemia.

• If you have (or have ever had) a type of migraine called "migraine with aura".
• If you 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, unless liver function test values have normalized.
• If you have or have had liver tumors (benign or malignant).
• If you have or suspect the existence of malignant conditions of the genital organs or breasts.
• If you have vaginal bleeding of unknown cause.
• If you are pregnant or think you may be pregnant.
• If you are allergic to the active ingredients (levonorgestrel and ethinylestradiol) or to any of the other components of this medicine (listed in section 6).

Do not use Triagynon if you have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Other medicines and Triagynon").

Warnings and precautions

If some of the risk situations mentioned below are present, your doctor should assess the benefits of using Triagynon 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 Triagynon, you should also inform your doctor.

• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• If you have sickle cell anemia (an inherited disease of red blood cells).
• 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 an operation or spend a long time immobile (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 Triagynon after childbirth.
• If you have inflammation of the veins that are under the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you have heart disease (those that produce certain types of heart rhythm disorders).
• If you have high blood pressure, especially if it worsens or does not improve with anti-hypertensive medications.
• If you have severe and recurrent headaches (migraines).
• If you have diabetes.
• If you have depression or a history of depression, as it may worsen or recur 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 have had them during a previous pregnancy. If so, avoid sun exposure and ultraviolet radiation (e.g., sunlamp).
• If you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria with possible 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 Triagynon 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-term effects or, very rarely, they can be fatal.

It is important to remember that the overall risk of a harmful blood clot due to Triagynon 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 clot can form in a vein of another organ, such as the eye (retinal vein thrombosis).

When is the risk of 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 Triagynon, 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 your leg or lung (DVT or PE) with Triagynon 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, like Triagynon, about 5-7 will have a blood clot in a year.

• The risk of having a blood clot will depend on your personal history (see "Factors that increase your risk of a blood clot" below).

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

The risk of having a blood clot with Triagynon 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 their leg, lung, or other organ at a young age (i.e., before the age of about 50).
• If you need an operation or spend a long time immobile due to an injury or illness or if you have your leg in a cast. You may need to stop using Triagynon several weeks before surgery or while you are less mobile. If you need to stop using Triagynon, 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 conditions you have.

Long-haul 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 have any of the above conditions, even if you are not sure. Your doctor may decide that you should stop using Triagynon.

If any of the above conditions change while you are using Triagynon, for example, you start smoking, a close relative has 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 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 due to Triagynon is very small, but it can increase:

• With age (above about 35 years).
• If you smoke.When using a combined hormonal contraceptive like Triagynon, 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 even further.

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

• Tumors

There have been reports of breast cancer cases 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 chances of having breast cancer will be the same as for women who have never used oral contraceptives.

In some studies, an increased risk of cervical cancer has been reported in users who have been taking combined oral contraceptives for long periods, 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.

Rarely, benign and, even more rarely, malignant liver tumors have been reported in users of combined oral contraceptives. This can cause internal bleeding that leads 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 combined oral contraceptives on these lesions, it is recommended that, when prescribing a combined oral contraceptive, regular cervical smears be performed.

Malignant tumors can be life-threatening or have a fatal outcome.

• Psychiatric disorders

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

If a severe depression occurs, the medication should be stopped and an alternative contraceptive method used. Women with a history of depression should be monitored.

• Other conditions

In women with hypertriglyceridemia (increased triglycerides in the blood) or a family history of this condition, there may be an increased risk of pancreatitis (inflammation of the pancreas) during the use of combined oral contraceptives.

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

During the use of combined oral contraceptives, many users have been found to have small increases in blood pressure, although cases with clinical relevance are rare.

Clinical monitoring. If during the use of AOC, sustained arterial hypertension appears, you should consult your doctor.

In women who present endometrial hyperplasia (thickening of the inner wall of the uterus), the doctor must carefully assess the risk-benefit ratio before prescribing AOC and closely monitor the patient during the treatment period, performing periodic cervical cytologies.

The following conditions may appear or worsen with pregnancy and the use of AOC: jaundice (yellowish color of the white of the eye and skin) and/or pruritus (itching) related to cholestasis (stop or decrease in bile flow), formation of bile stones, porphyria (familial metabolic disorder), systemic lupus erythematosus (inflammatory dermatitis), hemolytic uremic syndrome (kidney disease with blood alterations), Sydenham's chorea (involuntary movements), herpes gestationis (skin and mucous lesions that appear in pregnancy), and hearing loss due to otosclerosis (a type of ear condition).

Acute or chronic disorders of liver function require the suspension of AOC use until liver function markers return to normal values. The reappearance of cholestatic jaundice, which first appeared during pregnancy or during previous use of sex hormones, requires the suspension of AOC.

AOCs can alter peripheral insulin resistance and glucose tolerance. There is no evidence that it is necessary to alter the therapeutic regimen in diabetics who use low-dose AOCs (with <0.05 mg of ethinylestradiol). However, diabetic women should be closely monitored while taking AOC.

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

Occasionally, chloasma (brown spots on the skin) may occur, especially in women with a history of chloasma gravidarum. If you have a tendency to chloasma, you should avoid sun exposure or ultraviolet rays while taking AOC.

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

Medical examination and consultation

Before starting or resuming treatment with Triagynon, it is necessary for your doctor to perform a complete medical history and physical examination, aimed at ruling out contraindications and observing precautions, and these must be repeated at least once a year during the use of combined oral contraceptives.

Reduced efficacy

The efficacy of AOCs may decrease if you forget to take a pill (see section "If you forgot to take Triagynon"), if you have gastrointestinal disorders such as vomiting or intense diarrhea (see section "Advice in case of gastrointestinal disorders"), or if you take other medication simultaneously (see section "Taking Triagynon with other medications").

Irregularities in cycle control

During the use of any AOC, spotting or vaginal bleeding between two periods may occur, especially during the first months of use. If these bleeding irregularities persist or occur after previously regular cycles, possible non-hormonal causes should be considered, and therefore, you should consult your doctor to take appropriate diagnostic measures to rule out malignant processes, infections, or pregnancy.

In some women, withdrawal bleeding (menstruation) may not occur during the week of rest. If you have taken the AOC following the instructions described in the section "How to take Triagynon", it is unlikely that you are pregnant. However, if you have not taken the AOC according to these instructions before the first absence, or if a second absence occurs, pregnancy should be ruled out before continuing to take the AOC.

Other medications and Triagynon

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Certain medications may interact, in these cases, it may be necessary to change the dose or interrupt treatment with one of the medications. It is especially important that you inform your doctor if you use any of the following medications.

The medications listed below may prevent combined hormonal contraceptives from working well, and if this happens, you could become pregnant:

• Treatment of hepatitis C virus and HIV (protease inhibitors and non-nucleoside reverse transcriptase inhibitors) and other infections (griseofulvin).
• Treatment of tuberculosis (rifampicin, rifabutin)
• Treatment of fungal infections (griseofulvin, azole antifungals, e.g., itraconazole, voriconazole, fluconazole)
• Treatment of bacterial infections (macrolide antibiotics, e.g., clarithromycin, erythromycin)
• Treatment of certain heart diseases and high blood pressure (calcium channel blockers, e.g., verapamil, diltiazem)
• Treatment of arthritis and osteoarthritis (etoricoxib)
• Certain antiepileptics (topiramate, barbiturics (phenobarbital), phenytoin, carbamazepine, primidone, oxcarbazepine, felbamate, ethosuximide).
• Antacids, including lansoprazole.
• Certain substances for mood elevation (modafinil)
• Grapefruit juice

Troleandomycin may increase the risk of intrahepatic cholestasis (bile accumulation in the liver) when administered concomitantly with AOCs.

You should not take herbal preparations containing St. John's Wort (Hypericum perforatum) simultaneously with Triagynon, as its efficacy may be reduced with a risk of unexpected pregnancy and intermenstrual bleeding. The decrease in the contraceptive effect lasts up to two weeks after stopping the St. John's Wort preparation.

It is advisable to use another reliable contraceptive method if you take any of the above-mentioned medications. The effect of some of these medications may last up to 28 days after treatment has been discontinued.

Triagynon may decrease the effect of oral anticoagulants, analgesics (such as paracetamol and salicylates), fibrates (medications to reduce triglyceride and/or cholesterol levels), lamotrigine, oral antidiabetics, and insulin, and increase the effect of other medications such as beta-blockers (metoprolol), theophylline (for asthma treatment), corticosteroids (such as prednisolone), cyclosporine (increasing the risk of liver toxicity), flunarizine (increasing the risk of milk secretion), midazolam, melatonin, and tizanidine.

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

Do not take Triagynon if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may produce increases in liver test results (increase in liver enzyme ALT).

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

Triagynon can be taken again approximately 2 weeks after the end of this treatment. Consult the section "Do not use Triagynon”.

You should consult the prescribing information for the medications you are taking concurrently to identify potential interactions.

Laboratory tests

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

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

Pregnancy and lactation

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

Triagynon is not indicated during pregnancy. If this circumstance occurs, you should immediately stop taking Triagynon and consult your doctor.

During the use of AOCs, small amounts of oral contraceptives may be eliminated through breast milk. These amounts may affect the child, so AOCs should not be used until the end of the lactation period.

Driving and using machines

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

Triagynon contains lactose and sucrose

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

3. How to take Triagynon

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

Remember to take your medication, as forgetting coated tablets can reduce the effectiveness of the preparation.

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

In the calendar package, on whose aluminum sheet the tablets are marked with numbering from 1 to 21, following a direction indicated by arrows, there are also 7 empty blisters, marked with the days of the week.

The first tablet is extracted from the box marked with the number "1", perforating at the same time, as a reminder, the empty blister marked with the corresponding day of the week, continuing the intake of tablets on successive days (in the order they are: first the light brown ones, then the white ones and finally the ochre-colored tablets), until the package is finished.

Tablets should be taken every day at approximately the same time, with a little liquid if necessary, and in the order indicated in the blister package. One tablet will be taken daily for 21 consecutive days. A new package will be started after a 7-day interval without taking tablets, during which a withdrawal bleed usually occurs. The withdrawal bleed, similar to menstruation, will appear two or three days after taking the last tablet, and it is possible that it will not have ended before starting the next package.

How to start taking Triagynon

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

Tablets 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 tablet intake.

• To replace a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch)

You should start taking Triagynon preferably the day after taking the last hormone-containing tablet of the previous COC, but no later than the day after the usual tablet-free interval or hormone-free tablet intake of your previous COC. This means that, at the latest, you should start treatment with Triagynon on the same day you would start a new package (blister) of your previous COC. In the case of using a vaginal ring or transdermal patch, you should start taking Triagynon preferably on the day of removal of the last ring or patch from a package for a cycle, or at the latest when the next application would be due.

• To replace a progestin-only method (progestogen-only pill, injection, implant), or an intrauterine system for progestogen release (IUS)

You can replace the progestogen-only pill with Triagynon on any day (if it's an implant or IUS, on the same day of its removal; if it's an injectable, on the day the next injection is due), but in all cases, you are advised to use an additional barrier method during the first 7 days of tablet intake.

• After an abortion in the first trimester

You can start taking Triagynon 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 Triagynon 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 must rule out the possibility of pregnancy before starting to take the COC, or you must wait until you have your first menstrual period.

If you forgot to take Triagynon

Contraceptive protection is not reduced if the intake of a tablet is delayed by less than 12 hours. In such a case, you should 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, you do not need to take any additional contraceptive measures.

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

1. Tablet intake should never be suspended for more than 7 days.
2. It is necessary to take tablets 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 tablet as soon as you remember, even if this means taking two tablets at the same time. From then on, you will continue taking the tablets 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 previous 7 days, you should consider the possibility of being pregnant. The more tablets you have forgotten and the closer you are to the usual tablet-free interval, the higher the risk of pregnancy.

• Week 2

You should take the last forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. From then on, you will continue taking the tablets at the usual time. If in the 7 days prior to the forgotten tablet you have taken the tablets correctly, you will not need to take additional contraceptive precautions. However, if you have forgotten to take more than 1 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. Nevertheless, by adjusting the tablet intake schedule, it is still possible to prevent the reduction of contraceptive protection. Therefore, if you follow one of the two options below, you will not need to take additional contraceptive precautions, provided that in the 7 days prior to the first forgetfulness you have taken all the tablets correctly. If this is not the case, you should follow the first of the two options indicated below and take additional contraceptive precautions in the following 7 days.

1. You should take the last forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. From then on, you will continue taking the tablets at the usual time. You should start the next blister package as soon as the current one is finished, without leaving a separation between them. It is unlikely that you will have a withdrawal bleed (menstruation) until you finish the second package, but you may experience spotting or intermenstrual bleeding during the intake of the following package.
2. You can also stop taking the tablets from the current blister package. Then, you should complete a tablet-free interval of up to 7 days, including the days you forgot to take the tablets, and then start again with the next blister package.

If, in case of forgetting to take tablets, you do not experience a withdrawal bleed (menstruation) in the first tablet-free interval, you should consider the possibility of being pregnant.

However, in case of doubt, consult your doctor.

Recommendations in case of gastrointestinal disorders

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

If you vomit within 3-4 hours after taking the tablet, you should follow the recommendations for managing forgotten tablets, as outlined in the "If you forgot to take Triagynon" section. If you do not want to change your normal tablet intake schedule, you should take the necessary extra tablet(s) from another package.

How to delay a withdrawal bleed

To delay a period, you should continue with the last 10 tablets from another Triagynon blister package without leaving the usual rest week. The extension of tablet intake can be maintained for a maximum of 10 days until the second package is finished. During this period, you may experience bleeding or spotting. Then, you should leave the usual 7-day tablet-free interval and resume regular Triagynon intake.

To change your period to another day of the week you are used to according to your current cycle, you can be advised to shorten the rest week by as many days as you wish. The shorter the interval, the higher the risk that a withdrawal bleed (menstruation) will not occur and that you will experience intermenstrual bleeding or spotting during the intake of the following package (as occurs when delaying a period).

Special populations

Pediatric population

Triagynon is only indicated after menarche (the first menstruation).

Geriatric population

It is not applicable. Triagynon is contraindicated after menopause.

Patients with hepatic impairment

Triagynon is contraindicated in women with severe hepatic disorders.

Patients with renal impairment

Triagynon has not been specifically studied in patients with renal impairment. There are no available data suggesting a change in treatment in this patient population.

If you take more Triagynon than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or nurse immediately, or call the Toxicological Information Service (Tel: 91 562 04 20), indicating the medication and the amount taken.

No serious adverse reactions have been reported due to overdose. The symptoms that may appear in this case are: nausea, vomiting, or vaginal bleeding. This bleeding can occur even in girls who have not yet had their first menstrual period, if they have accidentally taken this medication. There is no antidote, and treatment should be symptomatic.

If you stop taking Triagynon

You can stop taking Triagynon whenever you want. If you do not want to become pregnant, consult your doctor about other reliable contraceptive methods.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people experience them. If you experience any side effect, especially if it is severe and persistent, or if you have any change in health that you think may be due to Triagynon, consult your doctor.

Serious side effects

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 taking Triagynon".

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 "Warnings and precautions" section).

Adverse reactions are listed below, classified according to their frequency, based on the following criteria:

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

1. Infections and infestations

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

1. Disorders of the immune system

Rare: hypersensitivity (abnormal increase in skin sensitivity), allergic reactions such as very rare cases of severe reactions accompanied by difficulty breathing, dizziness, and even loss of consciousness.

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

1. Metabolic and nutritional disorders

Uncommon: changes in appetite (increase or decrease), fluid retention.

Rare: glucose intolerance.

Very rare: worsening of porphyria (a group of disorders of hemoglobin metabolism).

1. Psychiatric disorders

Common: mood changes, including depression.

Uncommon: decreased libido (sexual desire).

Rare: increased libido.

1. Nervous system disorders

Common: headaches, nervousness, dizziness.

Uncommon: migraine.

Very rare: worsening of chorea (a disorder that causes movement disturbances).

1. Eye disorders

Rare: intolerance to contact lenses.

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

1. Vascular disorders

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 possibilities 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 varices.

1. Gastrointestinal disorders

Common: nausea, abdominal pain.

Uncommon: vomiting, diarrhea, colic, bloating.

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

1. Hepatobiliary disorders

Rare: cholestatic jaundice (yellowing of the skin and eyes related to a blockage or reduction of bile flow).

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

1. Skin and subcutaneous tissue disorders

Common: acne.

Uncommon: skin rash, urticaria (itching), chloasma (skin discoloration) that may persist, hirsutism (excessive hair growth), alopecia (hair loss).

Rare: erythema nodosum (a type of skin inflammation with the appearance of nodules on the legs), erythema multiforme (a type of skin inflammation).

1. Renal and urinary disorders

Very rare: hemolytic uremic syndrome (a kidney disease with blood abnormalities).

1. Reproductive system and breast disorders

Very common: bleeding, spotting.

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

Uncommon: breast enlargement.

Rare: vaginal discharge, breast discharge.

1. General disorders and administration site conditions

Common: edema (swelling).

1. Investigations

Common: weight gain.

Uncommon: increased blood pressure, changes in blood lipid levels, including hypertriglyceridemia.

Rare: weight loss, decreased serum folate levels.

Description of selected adverse reactions

The following are very rare or delayed adverse reactions that are considered related to the group of combined oral contraceptives (see "Contraindications" and "Warnings and precautions" sections).

Tumors

• The frequency of breast cancer diagnosis among COC users is slightly increased. Since breast cancer is rare in women under 40, this increase is low in relation to the overall risk of breast cancer. The causality related to COC use is unknown.
• Hepatic tumors (benign and malignant)

Other disorders

• Women with hypertriglyceridemia (increased blood fats resulting in an increased risk of pancreatitis when using COCs)
• Hypertension
• Appearance or worsening of disorders whose association with COC use is not conclusive: jaundice and/or pruritus related to cholestasis; gallstone formation; a metabolic disorder called porphyria; systemic lupus erythematosus (a chronic autoimmune disease); hemolytic uremic syndrome (a disease with blood clotting); a neurological disorder called Sydenham's chorea; gestational herpes (a type of skin disorder that occurs during pregnancy); hearing loss related to otosclerosis
• Liver function disorders
• Changes in glucose tolerance or effect on peripheral insulin resistance
• Crohn's disease, ulcerative colitis
• Chloasma

Interactions

Interactions between oral contraceptives and other medications (e.g., St. John's Wort, medications for epilepsy, tuberculosis, HIV, and other infections) can lead to unexpected bleeding and/or contraceptive failure (see "Taking Triagynon with other medications" section).

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Triagynon

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

This medicine does not require special storage conditions.

Do not use Triagynon after the expiration date stated on the packaging.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the pharmacy's SIGRE point . Ask your pharmacist how to dispose of the packaging and any medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Triagynon

The active ingredients are: levonorgestrel and ethinylestradiol.

• 6 light brown coated tablets. Each tablet contains 0.05 mg of levonorgestrel and 0.03 mg of ethinylestradiol.

The other ingredients are: calcium carbonate, red iron oxide (E172), yellow iron oxide (E172), glycerol 85% (E422), lactose monohydrate, magnesium stearate, corn starch, glycolized montan wax, macrogol 6000, povidone 25, povidone 700000, sucrose, talc, and titanium dioxide (E171).

• 5 white coated tablets. Each tablet contains 0.075 mg of levonorgestrel and 0.04 mg of ethinylestradiol.

The other ingredients are: calcium carbonate, lactose monohydrate, magnesium stearate, corn starch, glycolized montan wax, macrogol 6000, povidone 25, povidone 700000, sucrose, and talc.

• 10 ochre-colored coated tablets. Each tablet contains 0.125 mg of levonorgestrel and 0.03 mg of ethinylestradiol.

The other ingredients are: calcium carbonate, yellow iron oxide (E172), glycerol 85% (E422), lactose monohydrate, magnesium stearate, corn starch, glycolized montan wax, macrogol 6000, povidone 25, povidone 700000, sucrose, talc, and titanium dioxide (E171).

Appearance of the Product and Package Contents

Triagynon is presented in a blister pack (the packaging containing the coated tablets) of 21 coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 - 5

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

Bayer AG

Müllerstrasse 178

13353 Berlin

Germany

or

Bayer Weimar GmbH und Co. KG, Weimar

Doebereinerstrasse 20

99427 Weimar

Germany

Date of Last Revision of this Leaflet:10/2022

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