Package Leaflet: Information for the User

Triagynon Coated Tablets

levonorgestrel / etinilestradiol

Important things you should know about combined hormonal contraceptives (CHCs):

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

1.What is Triagynon and what it is used for

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

3.How to take Triagynon

4.Possible side effects

5.Storage of Triagynon

6. Contents of the pack and additional information

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

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

General Considerations

Before starting to use Triagynon, read the information about blood clots in the section2. It is particularly important that you read the symptoms of a blood clot (see section2 “Blood Clots”).

Do not use Triagynon

Do 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 vein in your leg (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE) or in other organs.
• If you know that you have a disorder that affects blood clotting: for example, proteinC deficiency, proteinS deficiency, antithrombinIII deficiency, factorV Leiden or antiphospholipid antibodies.
• If you need surgery or if you spend a lot of time without standing up (see section“Blood Clots”).
• If you have ever had a heart attack or a stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary symptoms of a stroke).

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

• Severe diabetes with vascular damage.
• Very high blood pressure.
• High levels of fat in your 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 diseases that may cause blood clots).

• If you have arrhythmias that may cause blood clots (thrombogenic arrhythmias).

• If you have or have had severe liver disease, unless liver function test results have normalized.
• If you have or have had liver tumors (benign or malignant).
• If you have or suspect the presence of malignant diseases of the genital organs or breasts.
• If you have vaginal bleeding of unknown cause.
• If you are pregnant or suspect that you may be.
• If you are allergic to the active ingredients (levonorgestrel and ethinylestradiol) or to any of the other components of this medication (including in section 6).

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

Warnings and Precautions

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

Inform Your Doctor If You Suffer From Any of the Following Conditions.

If the condition develops or worsens while you are using Triagynon, 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 (LES, a disease that affects your natural defense system).
• If you have hemolytic-uremic syndrome (SUH, a blood clotting disorder that causes kidney insufficiency).
• If you have sickle cell anemia (a hereditary disease of red blood cells).
• If you have high levels of fat in your blood (hypertriglyceridemia) or known family history of this condition. Hypertriglyceridemia has been associated with a higher risk of pancreatitis (inflammation of the pancreas).
• If you need surgery or spend a lot of time without standing up (see section2 “Blood Clots”).
• If you recently gave birth, you are at higher risk of blood clots. Ask your doctor when you can start taking Triagynon after delivery.
• If you have superficial thrombophlebitis (inflammation of veins under the skin).
• If you have varicose veins.
• If you have heart diseases (those that cause 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 headaches (migraines) and they are frequent and intense.
• 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 (yellow discoloration 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 permanent brown spots on your face, especially if you had them during a previous pregnancy. If so, avoid sunlight and ultraviolet radiation (e.g., sunlamps).
• If you experience angioedema symptoms such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Estrogen-containing products can cause or worsen symptoms of hereditary and acquired angioedema.

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 suffering a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• In arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or TEA).

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

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek immediate medical attentionif you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN

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

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

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

The risk of a blood clot in a vein is higher during the first year you take a combined hormonal contraceptive for the first time. The risk may be higher if you restart taking a combined hormonal contraceptive (the same medication or a different one) after a 4-week or longer break.

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 a blood clot returns to normal in a few weeks.

What is the risk of a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of a blood clot in your leg or lung (DVT or PE) with Triagynon is small.

• Of every 10,000women who do not use a combined hormonal contraceptive and are not pregnant, 2 will develop a blood clot in a year.
• Of every 10,000women who use a combined hormonal contraceptive containing levonorgestrel like Triagynon, 5-7will develop a blood clot in a year.

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

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

Your risk of 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 greater than 30kg/m2).
• If one of your close relatives has had a blood clot in their leg, lung, or another organ at a young age (i.e., before about 50years). You may have an inherited blood clotting disorder.
• If you need surgery or spend a lot of time without standing up due to an injury or illness or if you have a leg cast. You may need to stop taking Triagynon for several weeks before surgery or while you have limited mobility. If you need to stop taking Triagynon, ask your doctor when you can start using it again.
• As you get older (especially over about 35years).
• If you have given birth recently.

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

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

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

If any of the above conditions change while you are using Triagynon, for example, a close relative experiences a blood clot 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 essential to note that the risk of a heart attack or stroke due to Triagynon is very small, but it may increase:

• With age (over about 35years).
• If you smoke.
• If you are overweight.
• If you have high blood pressure.
• If one of your close relatives has had a heart attack or stroke at a young age (less than about 50years). You may also be at higher risk of a heart attack or stroke.
• If you or one of your close relatives has high levels of fat in your blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

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

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

• Tumors

Cases of breast tumors have been observed with a slightly higher frequency in women using oral contraceptives, but it is unclear whether this is due to treatment. For example, tumors may be more likely to be 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 tumors will be the same as for women who never used oral contraceptives.

In some studies, an increased risk of cervical cancer has been reported in users who have been taking oral contraceptives for long periods, but controversy remains about the degree to which this finding can be attributed to other factors, such as sexual behavior and sexually transmitted diseases.

Rare cases of benign liver tumors and, even more rarely, malignant liver tumors have been observed in users of oral contraceptives. This can 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 oral contraceptives on these lesions, it is recommended that, when prescribing oral contraceptives, cervical cytology be performed periodically.

Malignant tumors can pose a threat to life or have a fatal outcome.

• Mental Health Disorders

Some women who use hormonal contraceptives like Triagynon have reported depression or a depressed mood. Depression can be severe and sometimes may lead to 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 case occurs, the medication should be discontinued, and an alternative contraceptive method should be used. Women with a history of depression should be closely monitored.

• Other Conditions

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

Women with hyperlipidemias (high levels of fat in the blood, such as triglycerides and/or cholesterol) should be monitored if they decide to take oral contraceptives.

During the use of oral contraceptives, many users experience small increases in blood pressure, although rare cases with clinical relevance are uncommon. If high blood pressure develops while using oral contraceptives, consult your doctor.

In women with endometrial hyperplasia (thickening of the inner uterine wall), the doctor must carefully assess the risk-benefit ratio before prescribing oral contraceptives and closely monitor the patient during treatment, performing cervical cytology periodically.

The following conditions may appear or worsen with pregnancy and with the use of oral contraceptives: jaundice (yellow discoloration of the whites of the eyes and skin) and/or pruritus (itching) related to cholestasis (bile flow obstruction), gallstone formation, porphyria (a hereditary metabolic disorder), systemic lupus erythematosus (inflammatory skin disease), hemolytic-uremic syndrome (kidney disease with blood abnormalities), Sydenham's chorea (involuntary movements), herpes gravidarum (skin and mucous membrane lesions that occur during pregnancy), and otosclerosis (a type of ear disorder).

Acute or chronic liver function disorders require the suspension of oral contraceptive use until liver function test results return to normal. The reappearance of cholestatic jaundice, which first appeared during pregnancy or during previous use of sex hormones, requires the suspension of oral contraceptives.

Oral contraceptives can alter peripheral resistance to insulin and glucose tolerance. There is no evidence that this requires a change in treatment in diabetic women taking low-dose oral contraceptives (with <0.05 mg of ethinylestradiol). However, diabetic women should be closely monitored while taking oral contraceptives.

Oral contraceptives have been associated with inflammatory bowel disease (Crohn's disease and ulcerative colitis).

Occasionally, melasma (brown skin patches) may occur, especially in women with a history of melasma during pregnancy. If you are prone to melasma, avoid exposure to the sun or ultraviolet radiation while taking oral contraceptives.

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

Medical Examination and Consultation

Before starting or restarting treatment with Triagynon, 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.

Reduced Efficacy

The efficacy of oral contraceptives may decrease if you forget to take a pill (see section “If you forgot to take Triagynon”), if you experience gastrointestinal disorders such as vomiting or severe diarrhea (see section “Advice in case of gastrointestinal disorders”), or if you take other medications simultaneously (see section “Taking Triagynon with other medications”).

Irregularities in Cycle Control

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

In some women, menstruation may not occur during the pill-free week. If you have taken the pill correctly as described in the section “How to take Triagynon,” it is unlikely that you are pregnant. However, if you did not take the pill correctly before the first missed period or if a second missed period occurs, you should rule out pregnancy before continuing to take the pill.

Other Medications and Triagynon

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

Certain medications may interact, in which case you may need to change the dosage or discontinue one of the medications. It is especially important to inform your doctor if you are using any of the following medications.

The medications listed below may prevent combined hormonal contraceptives from working properly, and if this occurs, you may become pregnant:

• Treatment of hepatitis C and HIV (inhibitors of protease 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)
• Some antiepileptics (topiramate, barbiturates (phenobarbital), phenytoin, carbamazepine, primidone, oxcarbazepine, felbamate, ethosuximide).
• Antacids, including lansoprazole.
• Some mood elevators (modafinil)
• Orange juice

Troleandomycin may increase the risk of intrahepatic cholestasis (bile accumulation in the liver) when administered concurrently with oral contraceptives.

You should not take herbal preparations containing St. John's Wort (Hypericum perforatum) simultaneously with Triagynon, as its efficacy may be reduced, resulting in an unplanned pregnancy and intermenstrual bleeding. The reduction in anticonceptive effect lasts for up to two weeks after stopping the herbal preparation.

It is recommended that you use another reliable contraceptive method if you take any of the above medications. The effect of some of these medications may last for up to 28 days after stopping treatment.

Triagynon may reduce the effect of 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 lactation), 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.

You should not take Triagynon if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increased liver enzyme levels (elevated ALT levels).

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

Triagynon can be restarted approximately 2 weeks after completing this treatment. See the section “Do not use Triagynon.”

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

Laboratory Tests

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

Inform your doctor if you are scheduled to undergo any laboratory tests, as you are using oral contraceptives.

Pregnancy and Breastfeeding

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

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

During the use of oral contraceptives, small amounts of the medication may be excreted in breast milk, which may affect the baby. Therefore, oral contraceptives are generally not recommended until breastfeeding has ended.

Driving and Operating Machinery

No adverse effects on driving or operating machinery have been observed.

Triagynon contains lactose and sucrose

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

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

Remember to take your medication, as forgetting coated tablets may 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 pack, on whose aluminum sheet the tablets have been marked with numbering from 1 to 21, following a direction indicated by arrows, there are, in addition, 7 empty alveoli, marked with the days of the week.

The first tablet is extracted from the marked box with the number “1”, perforating at the same time, as a reminder, the empty alveolus marked with the corresponding day of the week, continuing the taking of the tablets in the following days (in the order in which they are: first the light brown ones, then the white ones, and finally the ocre-colored tablets), until the pack is finished.

The tablets should be taken every day approximately at the same hour, with a little liquid if necessary and in the order indicated in the blister pack. One tablet will be taken daily for 21 consecutive days. A new pack will be started after a 7-day interval without taking tablets, during which a withdrawal bleeding usually occurs. The withdrawal bleeding, similar to menstruation, will 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 Triagynon

• If no hormonal contraceptive has been taken previously (in the past month)

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

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

It should be started taking Triagynon preferably the day after taking the last hormone-containing tablet of the COC that was taken previously, but, at the latest, on the day after the usual interval without taking tablets or without taking hormone-free tablets of the previous COC. This means that, at the latest, Triagynon treatment should be initiated on the same day that a new pack (blister) of the previous COC should be started. In the case of use of a vaginal ring or transdermal patch, it should be started taking Triagynon preferably on the day of removal of the last ring or patch of a pack, or at the latest when the next application should have been made.

• To replace a method based exclusively on progestogens (progestogen-only pill, injection, implant), or a progestogen-releasing intrauterine system (IUS)

You can replace the progestogen-only pill with Triagynon any day (if it is an implant or an IUS, on the day of its removal; if it is an injectable, on the day corresponding to the next injection), but in all cases, it is recommended to use an additional barrier method during the first 7 days of taking tablets.

• After a first-trimester abortion

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

• After childbirth or a second-trimester abortion

It is recommended that you start taking Triagynon 21-28 days after childbirth or a second-trimester abortion. If you do so later, you should use an additional barrier method for the first 7 days. However, if sexual relations have already taken place, you should rule out the possibility of pregnancy before starting to take the COC, or you should wait for your first menstrual period.

If you forgot to take Triagynon

The contraceptive protection does not decrease if the taking of a tablet is delayedless than 12 hours. In this case, you should take the tablet as soon as you remember it and continue taking the following tablets at the usual hour (although this may mean taking two tablets on the same day). In this case, you do not need to take any additional contraceptive measures.

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

1. Never suspend the taking of tablets for more than 7 days.
2. You must take the tablets uninterruptedly for 7 days to achieve an adequate suppression of the hypothalamic-pituitary-ovarian axis.

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

• Week 1

You should take the last forgotten tablet as soon as you remember it, although this may mean taking two tablets at the same time. From then on, you will continue taking the tablets at your usual hour. In addition, during the next 7 days, you should use a barrier method, such as a condom. If you have had sexual relations in the 7 days prior, you should consider the possibility of pregnancy. The more tablets you have forgotten and the closer you are to the usual interval without taking tablets, the greater the risk of pregnancy.

• Week 2

You should take the last forgotten tablet as soon as you remember it, although this may mean taking two tablets at the same time. From then on, you will continue taking the tablets at your usual hour. If you have taken the tablets correctly in the 7 days prior to the forgotten tablet, you will not need to take any additional contraceptive measures. However, if you have forgotten to take more than 1 tablet, it is recommended that you take additional precautions for 7 days.

• Week 3

The risk of reduction in effectiveness is imminent due to the proximity of the rest week. However, adjusting the tablet-taking program can still prevent the reduction in contraceptive protection. Therefore, if you follow one of the two options below, you will not need to take any additional contraceptive measures, provided that you have taken all the tablets correctly in the 7 days prior to the first forgetting. If not, you should follow the first of the two options indicated below and take additional contraceptive precautions for the next 7 days.

1. You should take the last forgotten tablet as soon as you remember it, although this may mean taking two tablets at the same time. From then on, you will continue taking the tablets at your usual hour. You should start the next blister pack as soon as the current one runs out, without leaving a gap 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 intermenstrual bleeding during the taking of the next pack.
2. You can also stop taking the tablets from the current blister pack. Then you should complete an interval of up to 7 days without taking tablets, including the days when you forgot to take the tablets, and then start again with the next blister pack.

If, in the case of forgetting to take tablets, you do not present withdrawal bleeding (period) in the first interval without tablets, you should consider the possibility of pregnancy.

However, in case of doubt, consult your doctor.

Recommendations in case of gastrointestinal disturbances

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

If you experience vomiting in the 3-4 hours following the taking of the tablet, you should follow the recommendations for managing forgotten tablets, as explained in the section “If you forgot to take Triagynon”. If you do not want to change your usual tablet-taking schedule, you should take the extra tablets needed from another pack.

How to delay withdrawal bleeding

To delay a period, you should continue with the last 10 tablets of another blister pack of Triagynon without leaving the usual rest week. The extension of the taking can be maintained for a maximum of 10 days until the second pack is finished. During that period, you may experience bleeding or spotting. Then you should leave the usual rest week of 7 days and resume regular taking of Triagynon.

To change the period to a different day of the week to which you are accustomed according to your current cycle, you can be advised to shorten the rest week by as many days as you want. The shorter the interval, the greater the risk of not having a withdrawal bleeding (period) and of experiencing intermenstrual bleeding or spotting during the taking of the next pack (as occurs when a period is delayed).

Special populations

Pediatric population

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

Geriatric population

No. Triagynon is contraindicated after menopause.

Patients with liver dysfunction

Triagynon is contraindicated in women with severe liver dysfunction.

Patients with renal dysfunction

Triagynon has not been specifically studied in patients with renal dysfunction. There are no available data that suggest a change in treatment in this population of patients.

If you take more Triagynon than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology 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.Vaginal bleeding may 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 interrupt treatment with Triagynon

You can interrupt treatment with 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.

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

Severe side effects

Women taking combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section2 “What you need to know before starting to take Triagynon”.

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 urticaria with possible difficulty breathing (also see section “Warnings and precautions”).

Adverse reactions are listed below, classified by their frequency according to the following criterion:

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 (vaginal inflammation), including candidiasis (vaginal fungal infection).

1. Immune system disorders

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

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

1. Metabolism and nutrition disorders

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

Rare: Glucose intolerance.

Very rare: Worsening of porphyria (metabolic disorders of hemoglobin).

1. Mental and behavioral 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 (movement disorder).

1. Eye disorders

Rare: Contact lens intolerance.

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

1. Vascular disorders

Rare: Harmful blood clots in a vein or artery, for example:

The risk of having a blood clot may be higher if you have any other condition that increases this risk (see section2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

Very rare: Worsening of varicose veins.

1. Gastrointestinal disorders

Common: Nausea, abdominal pain.

Uncommon: Vomiting, diarrhea, cramps, swelling.

Very rare: Pancreatitis (pancreas inflammation), hepatic adenomas (frequent non-cancerous liver tumors), hepatocellular carcinoma (liver cancer).

1. Hepatobiliary disorders

Rare: Cholestatic jaundice (yellowing of the white of the eye and skin related to bile flow obstruction or reduction).

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

1. Skin and subcutaneous tissue disorders

Common: Acne.

Uncommon: Skin rash, urticaria (itching), melasma (skin spots) 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 (renal disease with blood alterations).

1. Reproductive and breast disorders

Very common: Bleeding, spotting.

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

Uncommon: Breast enlargement.

Rare: Vaginal discharge, breast discharge.

1. General disorders and administration site conditions

Common: Edema (swelling).

1. Laboratory investigations

Common: Weight gain.

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

Rare: Weight loss, decreased serum folate levels.

Selected adverse reaction descriptions

The following list includes rare or delayed adverse reactions that are considered related to the group of combined oral contraceptives (see sections “Do not use Triagynon” and “Warnings and precautions”).

Tumors

• The frequency of breast cancer diagnosis among users of COCs is slightly increased. Since breast cancer is rare in women under 40, this increase is low compared to the overall risk of breast cancer. The causal relationship with the use of COCs is unknown.
• Benign and malignant liver tumors

Other alterations

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

Interactions

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

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:www.notificaRAM.es.By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special conditions for conservation.

Do not use Triagynon after the expiration date that appears on the packaging.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Triagynon

The active principles are: levonorgestrel and etinilestradiol.

• 6 brown-coated tablets. Each tablet contains 0.05 mg of levonorgestrel and 0.03 mg of etinilestradiol.

The other components are: calcium carbonate, red iron oxide (E172), yellow iron oxide (E172), 85% glycerol (E422), lactose monohydrate, magnesium stearate, cornstarch, glycolated beeswax, macrogol 6000, povidone 25, povidone 700000, saccharose, talc, and titanium dioxide (E171).

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

The other components are: calcium carbonate, lactose monohydrate, magnesium stearate, cornstarch, glycolated beeswax, macrogol 6000, povidone 25, povidone 700000, saccharose, and talc.

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

The other components are: calcium carbonate, yellow iron oxide (E172); 85% glycerol (E422), lactose monohydrate, magnesium stearate, cornstarch, glycolated beeswax, macrogol 6000, povidone 25, povidone 700000, saccharose, talc, and titanium dioxide (E171).

Appearance of the product and content of the container

Triagynon is presented in a blister pack (the container where the coated tablets are located) of 21 coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 - 5

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing

Bayer AG

Müllerstrasse 178

13353 Berlin

Germany

or

Bayer Weimar GmbH und Co. KG, Weimar

Doebereinerstrasse 20

99427 Weimar

Germany

Last review date of this leaflet:10/2022

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