Teenia

Package Leaflet: Information for the Patient

Teenia, 3 mg + 0.02 mg, Coated Tablets

Drospirenone + Ethinylestradiol

Important Information About Combined Hormonal Contraceptives:

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of blood clots in veins and arteries, especially during the first year of use or after resuming use after a break of 4 weeks or more.
• Caution should be exercised and a doctor consulted if the patient suspects that blood clot symptoms have occurred (see section 2 "Blood Clots").

The Patient Should Carefully Read the Leaflet Before Taking the Medication, as it Contains Important Information for the Patient.

• The patient should keep this leaflet to be able to read it again if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medication has been prescribed for a specific person. It should not be given to others. The medication may harm another person.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Teenia and what is it used for
• 2. Important information before taking Teenia
• 3. How to take Teenia
• 4. Possible side effects
• 5. How to store Teenia
• 6. Contents of the pack and other information

1. What is Teenia and what is it used for

• Teenia is a contraceptive pill and is used to prevent pregnancy.
• Each tablet contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.
• Contraceptives that contain two hormones are called combined contraceptive pills.

2. Important information before taking Teenia

General Notes

Before starting to take Teenia, the patient should read the information about blood clots (thrombosis) in section 2. It is especially important to read about the symptoms of blood clots - see section 2 "Blood Clots".
Before starting to take Teenia, the doctor will ask the patient a few questions about their health and the health of their close relatives. The doctor will also measure the patient's blood pressure and, depending on the individual case, may also perform some other examinations.
This leaflet describes several situations in which the patient should stop taking Teenia or in which the effectiveness of Teenia may be reduced. In such situations, the patient should either not have sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. The patient should not use the rhythm method or the temperature measurement method. These methods may be unreliable because Teenia modifies the monthly changes in body temperature and cervical mucus.

Teenia, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

When Not to Take Teenia

The patient should not take Teenia if they have any of the conditions listed below. If the patient has any of the conditions listed below, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.

• if the patient is allergic to ethinylestradiol or drospirenone or any of the other ingredients of this medication (listed in section 6). Symptoms of hypersensitivity may include: itching, rash, or swelling;
• Teenia contains soy lecithin. If the patient is allergic to peanuts or soy, they should not take this medication;
• if the patient currently has (or has ever had) a blood clot in the blood vessels of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if the patient knows they have blood clotting disorders - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2 "Blood Clots");
• if the patient has had a heart attack or stroke;
• if the patient has (or has had in the past) angina pectoris (a condition that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (a temporary stroke-like condition);
• if the patient has any of the following diseases, which may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fats in the blood (cholesterol or triglycerides),
• a disease called hyperhomocysteinemia;
• if the patient has (or has had in the past) a type of migraine called "migraine with aura";
• if the patient has (or has had in the past) liver disease, and liver function is still abnormal;
• if the patient has kidney problems (kidney failure);
• if the patient has (or has had in the past) liver cancer;
• if the patient has (or has had in the past) or suspects they have breast cancer or cancer of the genital organs;
• if the patient has any unexplained vaginal bleeding.

The patient should not take Teenia if they have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Teenia and other medicines").

Warnings and Precautions

Before starting to take Teenia, the patient should discuss it with their doctor or pharmacist.
When should the patient contact their doctor?
The patient should contact their doctor immediately

• if they notice any of the possible symptoms of a blood clot, which may indicate that they have a blood clot in the leg (deep vein thrombosis), lung (pulmonary embolism), heart attack, or stroke (see below "Blood Clots (Thrombosis)").

The patient should tell their doctor if they have any of the following conditions.

• if they experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives with difficulty breathing, they should contact their doctor immediately. Products containing estrogens may cause or worsen the symptoms of hereditary and acquired angioedema;
• if they have a family history of breast cancer;
• if they have liver or gallbladder disease;
• if they have diabetes;
• if they have depression or mood changes;
• if they have epilepsy (see "Teenia and other medicines");
• if they have a disease that first appeared during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disease called porphyria, a skin rash with blisters during pregnancy (pregnancy pemphigoid), a nervous system disease characterized by involuntary movements of the body (Sydenham's chorea));
• if they have (or have had in the past) chloasma (skin discoloration, especially on the face and neck, also known as melasma). In this case, they should avoid direct exposure to sunlight or ultraviolet radiation;
• if they have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if they have systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if they have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if they have sickle cell anemia (a genetic disorder of the red blood cells);
• if they have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have a family history of this condition. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if they need to have surgery or will be immobilized for a long time (see section 2 "Blood Clots");
• if they have just given birth, they are at a higher risk of blood clots. They should consult their doctor for information on when to start taking Teenia after giving birth;
• if they have superficial thrombophlebitis (blood clots in the veins under the skin);
• if they have varicose veins.

Blood Clots

The use of combined hormonal contraceptives, such as Teenia, is associated with an increased risk of blood clots compared to not using them. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur:

• in veins (also known as "venous thromboembolism" or "deep vein thrombosis");
• in arteries (also known as "arterial thromboembolism").

Not everyone who has a blood clot will recover completely. In rare cases, the effects of a blood clot can be long-lasting or, very rarely, fatal.

Remember that the overall risk of having a harmful blood clot due to Teenia is small.

How to Recognize a Blood Clot

The patient should contact their doctor immediately if they notice any of the following symptoms.
Is the patient experiencing any of these symptoms?
Why is the patient likely to be suffering from
a blood clot?

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking;

the patient may feel it when they are standing or walking;

• increased temperature in the affected leg;
• change in the color of the leg skin, such as pale, red, or purple.
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe stomach pain.

If the patient is unsure, they should contact their doctor,
because some of these symptoms, such as coughing or shortness of breath, can be mistaken for milder conditions, such as a respiratory infection (e.g., a cold).
Pulmonary embolism
Symptoms usually occur in one eye:

• sudden loss of vision or
• painless vision disturbances, which can lead to loss of vision. Retinal vein thrombosis (blood clot in the eye)
• chest pain, discomfort, pressure, or heaviness;
• a feeling of squeezing or fullness in the chest, arm, or below the breastbone;
• a feeling of fullness, indigestion, or choking;
• discomfort in the upper body that radiates to the back, jaw, throat, arm, and stomach;
• sweating, nausea, vomiting, or fainting;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat. Heart attack
• sudden weakness or numbness of the face, arms, or legs, especially on one side of the body;

Blood Clots in Veins

What Can Happen if a Blood Clot Forms in a Vein?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). Although these side effects are rare, they can occur most frequently during the first year of use of combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to deep vein thrombosis.
• If a blood clot breaks loose from the leg and travels to the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the Risk of Blood Clots in Veins the Highest?

The risk of forming a blood clot in a vein is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of combined hormonal contraceptives (the same or a different medication) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher compared to not using combined hormonal contraceptives.
If the patient stops taking Teenia, the risk of blood clots returns to normal within a few weeks.

What Factors Increase the Risk of Blood Clots in Veins?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of blood clots in the legs or lungs associated with Teenia is small.

• During a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• During a year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• During a year, about 9-12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Teenia, will develop blood clots.
• The risk of blood clots depends on the patient's individual medical history (see "Factors that Increase the Risk of Blood Clots" below).

Factors that Increase the Risk of Blood Clots in Veins

The risk of blood clots associated with Teenia is small, but some factors can increase this risk. The risk is higher:

• if the patient is overweight (body mass index (BMI) over 30 kg/m2);
• if someone in the patient's close family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years old). In this case, the patient may have inherited blood clotting disorders;
• if the patient needs to have surgery or will be immobilized for a long time due to injury or illness, or has a leg in a cast. It may be necessary to stop taking Teenia for a few weeks before surgery or immobilization. If the patient needs to stop taking Teenia, they should ask their doctor when they can resume taking it;
• with increasing age (especially over 35 years old);
• if the patient has recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Long-distance air travel (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to inform the doctor if any of these risk factors are present, even if the patient is unsure. The doctor may decide to stop the patient from taking Teenia.
If any of the above conditions change while taking Teenia, the patient should inform their doctor, e.g., if someone in their close family is diagnosed with a blood clot without a known cause or if the patient gains significant weight.

Blood Clots in Arteries

What Can Happen if a Blood Clot Forms in an Artery?

Similarly, to blood clots in veins, blood clots in arteries can cause serious consequences, such as a heart attack or stroke.

Factors that Increase the Risk of Blood Clots in Arteries

It is essential to note that the risk of heart attack or stroke associated with Teenia is very small, but it may increase:

• with age (over about 35 years old);
• if the patient smokes. While taking a hormonal contraceptive, it is recommended to quit smoking. If the patient is unable to quit smoking and is over 35 years old, their doctor may recommend a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the patient's close family has had a heart attack or stroke at a young age (under 50 years old). In this case, the patient may also be at a higher risk of having a heart attack or stroke;
• if the patient or someone in their close family has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, irregular heartbeat called atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of these conditions or if any of them are severe, the risk of blood clots may be even higher.
The patient should inform their doctor if any of these conditions change while taking Teenia, e.g., if they start smoking, someone in their close family is diagnosed with a blood clot without a known cause, or if they gain significant weight.

Teenia and Cancer

Women who use combined contraceptive pills may have a slightly higher risk of breast cancer, but it is not known if this is caused by the pill. For example, it may be that more tumors are detected in women who use combined contraceptive pills because they are examined by doctors more often.
The frequency of breast cancer decreases gradually after stopping combined hormonal contraceptives. It is essential to examine the breasts regularly and contact a doctor if any lump is found.
Women who use contraceptive pills have been reported to have, in rare cases, benign liver tumors, and in even rarer cases, malignant liver tumors. If the patient experiences severe abdominal pain, they should contact their doctor.

Mental Health

Some women who use hormonal contraceptives, including Teenia, have reported depression or mood changes. Depression can be severe and sometimes lead to suicidal thoughts. If symptoms of depression or mood changes occur, the patient should contact their doctor as soon as possible for further medical advice.

Irregular Bleeding

During the first few months of taking Teenia, unexpected bleeding (breakthrough bleeding) may occur. If such bleeding occurs more often than once every few months or starts after a few months, the patient's doctor should investigate the cause.

What to Do if No Withdrawal Bleeding Occurs During the Week Without Tablets

If the patient has taken all the tablets correctly, has not vomited, has not had severe diarrhea, and has not taken any other medications, it is very unlikely that they are pregnant.
If the expected withdrawal bleeding does not occur for two consecutive months, it may indicate pregnancy. The patient should contact their doctor immediately. They should not start the next pack of Teenia until they are sure they are not pregnant.

Teenia and Other Medicines

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
The patient should also inform other doctors or dentists who prescribe other medications that they are taking Teenia. The doctor will inform the patient if there is a need to use additional contraception (e.g., condoms) and if so, for how long, and if there is a need to change the dosage of other medications they are taking.
The patient should not take Teenia if they have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause abnormal liver function test results (increased liver enzyme activity).
Before starting these medications, the doctor will prescribe a different type of contraception.
The patient can start taking Teenia again after about 2 weeks after stopping the above-mentioned treatment. See section "When not to take Teenia".
Certain medications may affect the level of Teenia in the blood and may make it less effective in preventing pregnancy or may cause unexpected bleeding. These include:

• medications used to treat
• epilepsy (e.g., barbiturates, carbamazepine, phenytoin, primidone, felbamate, oxcarbazepine, topiramate),
• tuberculosis (e.g., rifampicin),
• HIV or hepatitis C infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),
• high blood pressure in the blood vessels of the lungs (bosentan),
• fungal infections (e.g., griseofulvin, ketoconazole),
• symptomatic treatment of osteoarthritis (etoricoxib),
• a herbal product containing St. John's Wort (Hypericum perforatum). If the patient wants to take herbal products containing St. John's Wort while taking Teenia, they should consult their doctor first.

Teenia may affect the action of other medications, such as:

• cyclosporine (a medication used to prevent rejection of transplanted organs),
• the antiepileptic medication lamotrigine (may increase the frequency of seizures),
• tizanidine (a medication used to treat muscle spasticity),
• theophylline (a medication used to treat asthma).

Before taking any medication, the patient should consult their doctor or pharmacist.

Teenia with Food and Drink

Teenia can be taken with or without food. If necessary, the patient can take the tablet with a small amount of water.

Lab Tests

If the patient needs to have a blood test, they should inform their doctor or laboratory staff that they are taking Teenia, as hormonal contraceptives may affect the results of some tests.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.
Pregnancy
The patient should not take Teenia if they are pregnant. If the patient becomes pregnant while taking Teenia, they should stop taking it immediately and contact their doctor.
If the patient wants to become pregnant, they can stop taking Teenia at any time (see section "Stopping Teenia").
Before taking any medication, the patient should consult their doctor or pharmacist.
Breastfeeding
Generally, Teenia should not be taken while breastfeeding. If the patient wants to take Teenia while breastfeeding, they should contact their doctor.
Before taking any medication, the patient should consult their doctor or pharmacist.

Driving and Using Machines

There is no information suggesting that taking Teenia affects the ability to drive or operate machines.

Teenia Contains Lactose and Soy Lecithin

Teenia contains 48.53 mg of lactose monohydrate. If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medication.
Teenia also contains 0.070 mg of soy lecithin. If the patient is allergic to peanuts or soy, they should not take this medication.

3. How to Take Teenia

The patient should always take this medication exactly as prescribed by their doctor or pharmacist. If they are unsure, they should consult their doctor or pharmacist.
The patient should take one Teenia tablet every day, with a small amount of water if necessary.
The tablets can be taken with or without food, but the patient should take them at the same time every day.
The blister pack contains 21 tablets. Next to each tablet, the day of the week is printed on which the tablet should be taken. If, for example, the patient starts taking the tablets on a Wednesday, the symbol "WED" is next to the tablet. The patient should move in the direction of the arrow on the blister pack until all 21 tablets have been taken.
Then, the patient should not take any tablets for 7 days. During this 7-day break (also called the "withdrawal bleed" period), the patient should experience bleeding. This is called "withdrawal bleeding" and usually starts on the 2nd or 3rd day of the break.
On the 8th day after taking the last Teenia tablet (i.e., after the 7-day break), the patient should start a new blister pack, regardless of whether the bleeding has stopped or not. This means that the patient should start each new blister pack on the same day of the week and that the withdrawal bleeding should occur every month on the same days.
If the patient takes Teenia in this way, they are also protected against pregnancy during the 7 days when they are not taking tablets.

When Can the Patient Start the First Blister Pack?

• If the patient has not used a hormonal contraceptive in the previous monthThe patient should start taking Teenia on the first day of their menstrual cycle (i.e., the first day of their period). If the patient starts taking Teenia on the first day of their period, they are immediately protected against pregnancy. The patient can also start taking Teenia on days 2-5 of their cycle, but in this case, they should use additional contraceptive methods (e.g., condoms) for the first 7 days.
• Switching from another combined hormonal contraceptive (combined oral contraceptive, combined hormonal contraceptive vaginal ring, or patch)The patient should start taking Teenia the next day after taking the last active tablet (containing active ingredients) of their previous contraceptive or no later than the day after the end of the break in taking their previous contraceptive (or after the last tablet of their previous contraceptive that does not contain active ingredients). When switching from a combined hormonal contraceptive vaginal ring or patch, the patient should follow their doctor's advice.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen)The patient can switch at any time from a progestogen-only pill (from an implant or intrauterine system releasing progestogen on the day it is removed, or from injections when the next injection is scheduled), but in all cases, the patient should use additional contraceptive methods (e.g., condoms) for the first 7 days of taking Teenia.
• After a miscarriageThe patient should follow their doctor's advice.
• After childbirthThe patient can start taking Teenia from 21 to 28 days after giving birth. If the patient starts taking Teenia more than 28 days after giving birth, they should use a mechanical method (e.g., condoms) for the first 7 days of taking Teenia. If the patient has had sexual intercourse after giving birth and before starting to take Teenia again, they should make sure they are not pregnant or wait for their next menstrual period.
• If the patient is breastfeeding and wants to start taking Teenia after childbirthThe patient should read the section "Breastfeeding".

If the patient is unsure when to start taking Teenia, they should consult their doctor.

What to Do if the Patient Takes More Than the Recommended Dose of Teenia

There are no reports of serious harmful effects from taking too many Teenia tablets at once.
If the patient takes several tablets at the same time, they may experience symptoms such as nausea or vomiting or may have vaginal bleeding. Also, in young girls before their first menstrual period, if they accidentally take this medication, they may experience vaginal bleeding.
If the patient takes too many Teenia tablets or if a child accidentally takes some, they should consult their doctor or pharmacist immediately.

What to Do if the Patient Misses a Dose of Teenia

• if it has been less than 12 hourssince the patient missed a tablet, their contraceptive protection is not reduced. The patient should take the tablet as soon as they remember and then take the next tablets at the usual time.
• if it has been more than 12 hourssince the patient missed a tablet, their contraceptive protection may be reduced. The more tablets the patient misses, the higher the risk of becoming pregnant.

The risk of reduced contraceptive protection is highest if the patient misses a tablet at the beginning or end of the blister pack. In this situation, the patient should follow the instructions below (see also the diagram below).

• The patient has missed more than one tablet in this blister packThe patient should contact their doctor.
• The patient has missed one tablet in the first weekThe patient should take the missed tablet as soon as they remember, even if it means taking two tablets at the same time. The patient should then take the next tablets at the usual time and use additional contraceptive methods, such as condoms, for the next 7 days. If the patient had sexual intercourse in the week before missing the tablet, they may be pregnant. In this case, the patient should contact their doctor.
• The patient has missed one tablet in the second weekThe patient should take the missed tablet as soon as they remember, even if it means taking two tablets at the same time. The patient should then take the next tablets at the usual time. The contraceptive protection is not reduced, and the patient does not need to use additional contraceptive methods.
• The patient has missed one tablet in the third weekThere are two options to choose from:
• 1. The patient should take the missed tablet as soon as they remember, even if it means taking two tablets at the same time. The patient should then take the next tablets at the usual time. The patient should skip the break without tablets and start the next blister pack right away. The patient will probably have their period at the end of the second pack, but they may also experience some bleeding or spotting during the second pack.
• 2. The patient can also stop taking the tablets and go directly to the 7-day break (the patient should make a note of the day they missed the tablet). If the patient wants to start the next pack on their usual start day, the break without tablets should be shorter than 7 days.

If the patient follows one of these instructions, their contraceptive protection will be maintained.

• If the patient has missed any of the tablets in the blister pack and does not have a withdrawal bleed during the first week without tablets, they may be pregnant. In this case, the patient should consult their doctor before starting the next pack.

What to Do if the Patient Experiences Vomiting or Severe Diarrhea

If the patient vomits within 3-4 hours after taking a tablet or experiences severe diarrhea, there is a risk that the active ingredients of the tablet may not have been fully absorbed into the bloodstream.
The situation is almost the same as if the patient had missed a tablet. After vomiting or diarrhea, the patient should take another tablet from the reserve blister pack as soon as possible. If possible, the patient should take it within 12 hoursafter the normal time of taking the tablet. If this is not possible or more than 12 hours have passed, the patient should follow the instructions given in the section "If you miss a dose of Teenia".

Delaying Withdrawal Bleeding: What the Patient Should Know

Although it is not recommended, the patient can delay their withdrawal bleeding by starting a new blister pack of Teenia, skipping the break without tablets, until the end of the next pack. During the tablets from the second pack, the patient may experience some bleeding or spotting. The patient will probably have their period at the end of the second pack.

Changing the First Day of Withdrawal Bleeding: What the Patient Should Know

If the patient takes the tablets as directed, their period will start during the week without tablets. If the patient wants to change this day, they should shorten ( but never lengthen - maximum 7 days!) the number of days without tablets. For example, if the break without tablets starts on a Friday, and the patient wants to change the day to Tuesday (3 days earlier), they should start the new blister pack 3 days earlier than usual. If the patient shortens the break without tablets (e.g., to 3 days or less), they may not have any withdrawal bleeding during the break. Instead, they may experience some bleeding or spotting during the second pack.

If the Patient is Unsure What to Do, They Should Contact Their Doctor.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. If any side effects occur, especially severe and persistent ones, or changes in health that the patient considers related to the use of Teenia medication, she should consult a doctor. Severe side effects: The patient should immediately contact a doctor if she experiences any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing, or hives potentially with difficulty breathing (see also the section "Warnings and precautions"). In all women using combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2 "Important information before using Teenia medication". Common side effects(may occur in up to 1 in 10 people)

• mood swings;
• headache;
• abdominal pain (stomach pain);
• acne;
• breast pain, breast enlargement, breast tenderness, painful or irregular periods;
• weight gain.

Uncommon side effects(may occur in up to 1 in 100 people)

• candidiasis (fungal infection);
• herpes simplex (viral infection);
• allergic reactions;
• increased appetite;
• depression, nervousness, sleep disturbances;
• tingling and numbness, dizziness;
• vision disturbances;
• irregular heartbeat or abnormally rapid heartbeat;
• pulmonary embolism, high blood pressure, low blood pressure, migraine, varicose veins;
• sore throat;
• nausea, vomiting, gastritis and/or enteritis, diarrhea, constipation;
• sudden swelling of the skin and/or mucous membranes (e.g., tongue or throat) and/or difficulty swallowing, or hives with difficulty breathing (angioedema), hair loss (alopecia), rash, itching, skin rashes, dry skin, seborrheic dermatitis;
• neck pain, limb pain, muscle cramps;
• urinary tract infection;
• breast lump (benign tumor and cancer), milk secretion in non-pregnant women (galactorrhea), ovarian cyst, hot flashes, amenorrhea, very heavy periods, discharge, vaginal dryness, lower abdominal pain (pelvic pain), abnormal Pap smear result (Pap classification or Pap test), decreased libido;
• fluid retention, lack of energy, excessive thirst, increased sweating;
• weight loss. Rare side effects(may occur in up to 1 in 1,000 people)
• hearing impairment;
• harmful blood clots in a vein or artery, for example:
• in the leg or foot (e.g., deep vein thrombosis),
• in the lungs (e.g., pulmonary embolism),
• heart attack,
• stroke, mini-stroke, or transient stroke symptoms, known as a transient ischemic attack,
• blood clots in the liver, stomach, and/or intestine, kidneys, or eye. The risk of blood clots may be higher if the patient has any other risk factors (see section 2 for more information on risk factors and symptoms of blood clots);
• asthma;
• erythema nodosum (characterized by painful red nodules on the skin);
• erythema multiforme (rash in the form of redness or ulceration).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform her doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medication.

5. How to store Teenia medication

The medication should be stored out of sight and reach of children. Do not store above 25°C. Store in the original packaging to protect from light. Do not use this medication after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month. Medications should not be disposed of via wastewater or household waste. The patient should ask her pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package contents and other information

What Teenia medication contains

• The active substances are drospirenone (3 mg) and ethinylestradiol (0.02 mg).
• The other ingredients are: Core: lactose monohydrate, corn starch, maize starch, copolymer of polyvinyl alcohol and polyethylene glycol, magnesium stearate. Coating: polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350, soybean lecithin.

What Teenia medication looks like and what the pack contains

The tablets are white or almost white, film-coated, round, biconvex, approximately 6 mm in diameter, with the inscription "G73" on one side, and the other side is smooth. Teenia medication, 3 mg + 0.02 mg, film-coated tablets, are packaged in PVC/PE/PVDC/Aluminum blisters. The blisters are packaged in a cardboard box containing a patient leaflet and a case for storing the blisters. Pack sizes: 1×21 film-coated tablets, 3×21 film-coated tablets, 6×21 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder:

GEDEON RICHTER POLSKA Sp. z o.o., ul. Ks. J. Poniatowskiego 5, 05-825 Grodzisk Mazowiecki, Poland

Manufacturer:

Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary. For more detailed information on the medication and its names in other European Economic Area member states, please contact: GEDEON RICHTER POLSKA Sp. z o.o., Medical Department, ul. Ks. J. Poniatowskiego 5, 05-825 Grodzisk Mazowiecki, Tel. +48 (22)755 96 48, lekalert@grodzisk.rgnet.org

Date of last revision of the leaflet: January 2023

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