Triagynon coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Triagynon coated tablets

levonorgestrel / ethinylestradiol

Important information 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 a blood clot in veins and arteries, especially during the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and consult your doctor if you think you may be experiencing symptoms of a blood clot (see section 2 “Blood clots”).

Package leaflet contents

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

1. What Triagynon is and what it is used for

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

Triagynon is supplied in a blister pack (the container holding the coated tablets) of 21 coated tablets.

2. What you need to know before starting Triagynon

General considerations

Before starting to use Triagynon, 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 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 which 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), 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 will be immobile for a long time (see section “Blood clots”).

• If you have ever had a heart attack or stroke.

• If you have (or have ever had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).

• If you have any of the following 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 valvulopathies (heart valve disorders that may lead to clot formation).

• If you have disorders of heart rhythm 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 are allergic to the active substances (levonorgestrel and ethinylestradiol) or to any of the other ingredients of this medicine (listed in section 6).

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

Warnings and precautions

If any 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 have any of the following conditions.

If any of these conditions develop or worsen 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 (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 require surgery or will be immobile for a prolonged period (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 Triagynon after childbirth.
• If you have inflammation of the veins beneath the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If you have heart diseases (those causing certain types of cardiac rhythm disorders).
• If you have high blood pressure, particularly if it worsens or does not improve with antihypertensive medications.
• If you have severe and recurrent migraines.
• If you have diabetes.
• If you have depression or a history of depression, as it may worsen or reappear while 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 permanent brown patches on the skin of your face, particularly if you had them during a previous pregnancy. In such a case, 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 Triagynon increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

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

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

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical assistance 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 adverse effects are rare. They occur more frequently during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein in 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.
• In very rare cases, 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 of first-time use of a combined hormonal contraceptive. 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 always somewhat higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Triagynon, 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 Triagynon 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 in one year.

• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, such as Triagynon, about 5 to 7 will develop a blood clot in 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).

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

The risk of having a blood clot with Triagynon 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 a close relative has had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years of age). In this case, you might have an inherited blood clotting disorder.
• If you need surgery or will be immobile for long periods due to injury, illness, or having a 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 over about 35 years of age).
• If you have given birth within the last few weeks.

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

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

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

If any of the above conditions change while you are using Triagynon—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?

Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can lead to 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 with the use of Triagynon is very small, but it may increase:

• With age (over 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 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 Triagynon—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 higher frequency of breast tumors has been observed in women using oral contraceptives, but it is unknown whether 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 gradually decreases after stopping treatment. After ten years, the likelihood of developing breast tumors will be the same as for women who have never used oral contraceptives.

Some studies have reported an increased risk of cervical cancer 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 reported rarely, and malignant liver tumors even more rarely, in users of COCs. These 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.

Malignant tumors can be life-threatening or fatal.

• Psychiatric disorders

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

If severe depression 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 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 hyperlipidemias (elevated blood fats such as triglycerides and/or cholesterol) should be monitored if they decide to take oral contraceptives.

Many users of COCs have shown small increases in blood pressure, although clinically significant cases are rare. If persistent 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 must carefully evaluate the risk-benefit ratio before prescribing COCs and monitor the patient closely during treatment, performing periodic cervical cytology.

The following conditions may appear or worsen during pregnancy and with the use of COCs: jaundice (yellowing of the whites of the eyes and skin) and/or pruritus (itching) related to cholestasis (reduced or stopped bile flow), gallstone formation, porphyria (inherited metabolic disorder), systemic lupus erythematosus (inflammatory skin disease), hemolytic uremic syndrome (a kidney disease with 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, which first appeared during pregnancy or previous use of sex hormones, requires discontinuation of the COC.

COCs may alter peripheral insulin resistance and glucose tolerance. There is no evidence that the treatment regimen needs to be changed in diabetic women using low-dose COCs (containing < 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 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 (AIDS) infection or other sexually transmitted diseases.

Medical examination and consultation

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

Reduced effectiveness

The effectiveness of COCs may decrease if you forget to take a tablet (see section “If you forget 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 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 section “How to take Triagynon,” 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.

Other medicines and Triagynon

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

Certain medicines may interact, and in such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines. It is especially important that you inform your doctor if you are taking any of the following medicines.

The medicines listed below 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 and non-nucleoside reverse transcriptase inhibitors) and other infections (griseofulvin).
• Treatment for tuberculosis (rifampicin, rifabutin).
• Treatment for fungal infections (griseofulvin, azole antifungals, e.g., itraconazole, voriconazole, fluconazole).
• Treatment for bacterial infections (macrolide antibiotics, 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 antiepileptic drugs (topiramate, barbiturates (phenobarbital), phenytoin, carbamazepine, primidone, oxcarbazepine, felbamate, ethosuximide).
• Antacids, including lansoprazole.
• Some mood-enhancing substances (modafinil).
• Grapefruit juice.

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

You must not take herbal preparations containing St. John's wort (Hypericum perforatum) simultaneously with Triagynon, as its effectiveness may be reduced, leading to unintended pregnancy and intermenstrual bleeding. The reduced contraceptive effect lasts up to two weeks after stopping St. John's wort.

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

Triagynon may reduce 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. It may also 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 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 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.

Triagynon can be restarted approximately 2 weeks after completion of this treatment. See the section "Do not use Triagynon."

Consult the prescribing information of any 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 undergoing any laboratory tests, inform your doctor that you are using oral contraceptives.

Pregnancy and breastfeeding

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

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

Small amounts of oral contraceptives may be excreted in breast milk during COC use. These amounts may affect the infant, so COCs generally should not be used until breastfeeding has ended.

Driving and using machines

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

Triagynon contains lactose and sucrose

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

3. How to take Triagynon

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

Remember to take your medicine, as missing 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 calendar pack contains, in addition to 21 tablets marked with numbers from 1 to 21 in the order indicated by arrows, seven empty compartments labeled with the days of the week.

The first tablet should be taken from the compartment marked with the number "1", while simultaneously perforating the empty compartment labeled with the corresponding day of the week as a reminder. Continue taking the tablets each day in the order indicated (first the light brown tablets, followed by the white tablets, and finally the ochre-colored tablets) until the pack is finished.

The tablets must be taken every day at approximately the same time, with a little 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 usually occurs. Withdrawal bleeding, similar to menstruation, typically appears two or three days after taking the last tablet, and may not have finished before starting the next pack.

How to start taking Triagynon

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

Start taking the tablets on day 1 of your natural cycle (i.e., the first day of menstrual bleeding). You may also start between days 2 and 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 a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch)

Start taking Triagynon preferably the day after taking the last active tablet of your previous COC, but no later than the day after completing the usual hormone-free interval or placebo tablets of your previous COC. This means that Triagynon treatment should begin no later than the day a new COC pack would normally start. If you have been using a vaginal ring or transdermal patch, start taking Triagynon preferably on the day of removal of the last ring or patch of a cycle pack, or at the latest when 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 Triagynon 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); however, in all cases, it is recommended to use an additional barrier method during the first 7 days of tablet intake.

• After a first-trimester abortion

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

• After childbirth or a second-trimester abortion

It is recommended to start taking Triagynon 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 should wait until your first menstrual period.

If you forget to take Triagynon

Contraceptive protection is not reduced if a tablet is taken less than 12 hours late. In this case, take the missed tablet as soon as you remember and continue taking the following tablets at your usual time (even if this means taking two tablets on the same day). 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 two basic rules should be observed:

1. You must not interrupt tablet intake 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.

Accordingly, and following the above guidelines, the following advice applies in daily practice:

• Week 1

Take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. Additionally, use a barrier method (e.g., a condom) for the next 7 days. If you had sexual intercourse in the previous 7 days, consider the possibility of pregnancy. The more tablets missed and the closer to the usual hormone-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. Then continue taking the tablets at your usual time. If you took all tablets correctly in the 7 days before the missed tablet, no additional contraceptive precautions are needed. However, if you missed more than one tablet, additional precautions are advisable for 7 days.

• Week 3

The risk of reduced effectiveness is imminent due to the proximity of the break week. However, by adjusting the tablet-taking schedule, contraceptive protection can still be maintained. Therefore, if you follow one of the two options below, no additional contraceptive precautions are necessary, provided that all tablets were taken 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 use additional contraceptive precautions for the next 7 days.

1. Take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then 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 spotting or intermenstrual bleeding may occur during tablet intake.
2. Alternatively, you may stop taking tablets from the current blister pack. Then complete a hormone-free interval of up to 7 days (including the days when tablets were missed), and then start the next blister pack.

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

In case of doubt, consult your doctor.

Recommendations in case of gastrointestinal disturbances

In case of severe gastrointestinal disturbances, absorption may be incomplete, and additional contraceptive measures should be taken.

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

How to delay withdrawal bleeding

To delay a period, continue taking the last 10 tablets from another Triagynon blister pack without taking the usual 7-day break. This extended intake may continue for up to 10 days until the second pack is finished. During this time, you may experience bleeding or spotting. Afterward, take the usual 7-day tablet-free interval and then resume regular Triagynon intake.

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

Special populations

• Pediatric population

Triagynon is only indicated after menarche (the onset of the first menstrual period).

• Elderly population

Not applicable. Triagynon is contraindicated after menopause.

• Patients with hepatic impairment

Triagynon is contraindicated in women with severe liver disease.

• Patients with renal impairment

Triagynon 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.

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 name of the medicine and the amount taken.

No serious adverse reactions due to overdose have been reported. Symptoms that may occur include nausea, vomiting, or vaginal bleeding. This bleeding may occur even 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 stop taking Triagynon

You may discontinue treatment with Triagynon at any time. If you do not wish to become pregnant, consult your doctor about other reliable contraceptive methods.

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

4. Possible adverse effects

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

Serious adverse effects

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

Adverse reactions are listed below, classified by frequency according to 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. Immune system disorders

Rare: hypersensitivity (abnormal increase in skin sensitivity), allergic-type 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 (chronic inflammatory autoimmune disorder).

1. Metabolism and nutrition disorders

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

Rare: glucose intolerance.

Very rare: worsening of porphyria (disorders of haemoglobin metabolism).

1. Psychiatric disorders

Common: mood changes, including depression.

Uncommon: decreased libido (sexual desire).

Rare: increased libido.

1. Nervous system disorders

Common: headache, nervousness, dizziness.

Uncommon: migraine.

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

1. Eye disorders

Rare: intolerance to contact lenses.

Very rare: optic neuritis, retinal vascular thrombosis (abnormalities in the eyes 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.
• 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.

1. Gastrointestinal disorders

Common: nausea, abdominal pain.

Uncommon: vomiting, diarrhoea, colic, bloating.

Very rare: pancreatitis (inflammation of the pancreas), hepatic adenomas (common non-cancerous liver tumours), hepatocellular carcinoma (malignant liver tumour).

1. Hepatobiliary disorders

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

Very rare: cholepathy (disorders of the gallbladder), including gallstones.

1. Skin and subcutaneous tissue disorders

Common: acne.

Uncommon: rash, urticaria (itching), chloasma (skin patches) which 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: haemolytic uraemic syndrome (kidney disease with blood abnormalities).

1. Reproductive system and breast disorders

Very common: bleeding, spotting.

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

Uncommon: breast enlargement.

Rare: vaginal discharge, breast discharge.

1. General disorders and administration site conditions

Common: oedema (swelling).

1. Investigations

Common: weight gain.

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

Rare: weight loss, decreased serum folate levels.

Description of selected adverse reactions

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

Tumours

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

Other alterations

• Women with hypertriglyceridaemia (increased blood fats resulting in increased risk of pancreatitis when COCs are used)
• Hypertension
• Onset or worsening of conditions 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 involving blood clots); a neurological disorder called Sydenham's chorea; herpes gestationis (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

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 Triagynon 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Triagynon

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

This medicine does not require any special storage conditions.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Triagynon

The active substances 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 components are: calcium carbonate, red iron oxide (E172), yellow iron oxide (E172), glycerol 85% (E422), monohydrate lactose, magnesium stearate, maize starch, glycol monostearate, 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 components are: calcium carbonate, monohydrate lactose, magnesium stearate, maize starch, glycol monostearate, macrogol 6000, povidone 25, povidone 700000, sucrose and talc.

• 10 beige coated tablets. Each tablet contains 0.125 mg of levonorgestrel and 0.03 mg of ethinylestradiol.

The other components are: calcium carbonate, yellow iron oxide (E172), glycerol 85% (E422), monohydrate lactose, magnesium stearate, maize starch, glycol monostearate, macrogol 6000, povidone 25, povidone 700000, sucrose, talc and titanium dioxide (E171).

Appearance of the product and contents of the pack

Triagynon is available in a blister pack (the container in which the coated tablets are located), containing 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 the latest revision of this leaflet: 10/2022

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