Teenia

LEAFLET INCLUDED IN THE PACKAGE: PATIENT INFORMATION

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Teenia(Arankelle)

3 mg + 0.02 mg, coated tablets

Drospirenonum + Ethinylestradiolum
Teenia and Arankelle are different trade names for the same drug.

Important information about combined hormonal contraceptives:

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• To a small extent, they increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
• One should be vigilant and consult a doctor if the patient suspects that symptoms of blood clots have occurred (see section 2 "Blood clots").

One should carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• One should keep this leaflet, so that it can be read again if necessary.
• In case of any doubts, one should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be passed on to others. The drug may harm another person.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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 using Teenia
• 3. How to use Teenia
• 4. Possible side effects
• 5. How to store Teenia
• 6. Package contents 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 containing two hormones are called combined contraceptive pills.

2. Important information before using Teenia

General notes

Before starting to take Teenia, one 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 use Teenia, the doctor will ask the patient a few questions about her health and about the health of her close relatives. The doctor will also measure her blood pressure and, depending on the individual case, may also perform some other tests.
This leaflet describes several situations in which one should stop using Teenia, or in which the effectiveness of Teenia may be reduced. In such situations, one should either not have sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. One should not use the observation method or the temperature measurement method. These methods may be unreliable, as 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 use Teenia

One should not use Teenia if the patient has any of the following conditions. If the patient has any of the following conditions, 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 drug (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 use this drug;
• 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 - such as 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) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (temporary stroke symptoms);
• 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) a type of migraine called "migraine with aura";
• if the patient has (or has had) liver disease, and liver function is still impaired;
• if the patient has kidney function disorders (kidney failure);
• if the patient has (or has had) liver cancer;
• if the patient has (or has had) or suspects breast cancer or genital cancer;
• if the patient has any unexplained vaginal bleeding.

One should not use Teenia in patients with hepatitis C and taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Teenia and other drugs").

Warnings and precautions

Before starting to use Teenia, one should discuss it with their doctor or pharmacist.
When should one contact their doctor?
One should contact their doctor immediately

• if the patient notices any possible symptoms of a blood clot, which may indicate that the patient has a blood clot in the leg (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), a heart attack, or a stroke (see below "Blood clots (thrombosis)"). To get a description of these serious side effects, see "How to recognize a blood clot".

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

In certain situations, one should be particularly careful when using Teenia or any other combined contraceptive pill, and it may also be necessary to have regular check-ups with their doctor. If any of the following conditions apply to the patient, they should tell their doctor before starting to use Teenia. If these symptoms appear or worsen while using Teenia, they should also tell their doctor.

• if the patient experiences symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives potentially with difficulty breathing, they should contact their doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary and acquired angioedema;
• if any of the patient's close relatives have had breast cancer;
• if the patient has liver or gallbladder disease;
• if the patient has diabetes;
• if the patient has depression or mood changes;
• if the patient has epilepsy (see "Teenia and other drugs");
• if the patient has a disease that first appeared during pregnancy or while using 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 the patient has or has had chloasma (skin discoloration, especially on the face or neck, so-called pregnancy spots). In this case, they should avoid direct exposure to sunlight or ultraviolet radiation;
• if the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if the patient has systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if the patient has hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if the patient has sickle cell anemia (a hereditary disease of red blood cells);
• if the patient has been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or has a family history of this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if the patient has recently given birth, they are at increased risk of blood clots. They should consult their doctor for information on how soon they can start taking Teenia after giving birth;
• if the patient has superficial thrombophlebitis (blood clots in the veins under the skin);
• if the patient has 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 called "venous thromboembolism" or "deep vein thrombosis");
• in arteries (also called "arterial thromboembolism").

Not everyone recovers fully from a blood clot. In rare cases, the effects of a blood clot can be long-term or, very rarely, fatal.

One should remember that the overall risk of harmful blood clots caused by Teenia is small.

HOW TO RECOGNIZE A BLOOD CLOT

One 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
these symptoms?

• 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;
• increased temperature in the affected leg;
• change in the color of the leg skin, e.g., pallor, redness, or cyanosis. Deep vein thrombosis

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, especially in the first year of using combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot breaks loose from the leg and lodges in 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 a vein 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 restarting combined hormonal contraceptives (the same or a different drug) 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 using 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 severely 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 a hereditary blood clotting disorder;
• if the patient needs to have surgery, is immobilized for a long time due to injury or illness, or has a leg in a cast. It may be necessary to stop using Teenia for a few weeks before surgery or immobilization. If the patient needs to stop using Teenia, they should ask their doctor when they can restart the drug;
• with 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.
Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell the doctor if any of these risk factors apply to the patient, even if they are not sure. The doctor may decide to stop the use of Teenia.
One should inform the doctor if any of the above conditions change while using Teenia, e.g., if someone in the patient's close family is diagnosed with a blood clot without a known cause or if the patient gains weight significantly.

BLOOD CLOTS IN ARTERIES

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

Similarly, as with 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 a 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 using a hormonal contraceptive, it is recommended to quit smoking. If the patient cannot quit smoking and is over 35 years old, the doctor may recommend using 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 increased 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, arrhythmia called atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher.
One should inform the doctor if any of the above conditions change while using Teenia, e.g., if the patient starts smoking, someone in their close family is diagnosed with a blood clot without a known cause, or if the patient gains weight significantly.

Teenia and cancer

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

Psychiatric disorders

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

Irregular bleeding

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

What to do if withdrawal bleeding does not occur during the withdrawal week

If all the tablets were taken correctly, there was no vomiting or severe diarrhea, and no other drugs were taken, it is very unlikely that the woman is pregnant.
If the expected withdrawal bleeding does not occur for two consecutive times, it may mean that the woman is pregnant. One should contact their doctor immediately. One should not start the next pack of Teenia until they are sure they are not pregnant.

Teenia and other drugs

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

• drugs used to treat
• epilepsy (e.g., barbiturates, carbamazepine, phenytoin, primidone, felbamate, oxcarbazepine, topiramate),
• tuberculosis (e.g., rifampicin),
• HIV infections and hepatitis C virus 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 use herbal products containing St. John's Wort while taking Teenia, they should consult their doctor first.

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

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

Before taking any drug, one should consult their doctor or pharmacist.

Teenia with food and drink

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

Lab tests

If a blood test is necessary, one should tell 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 drug.
Pregnancy
One 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 drug, one should consult their doctor or pharmacist.
Breastfeeding
Generally, Teenia should not be used while breastfeeding. If the patient wants to take Teenia while breastfeeding, they should contact their doctor.
Before taking any drug, one should consult their doctor or pharmacist.

Driving and using machines

There is no information suggesting that taking Teenia affects the ability to drive or use 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 drug.
Teenia also contains 0.070 mg of soy lecithin. If the patient is allergic to peanuts or soy, they should not take this drug.

3. How to use Teenia

This drug should always be taken as directed by the doctor or pharmacist. In case of doubt, one should consult their doctor or pharmacist.
One should take one Teenia tablet per day, if necessary with a small amount of water.
The tablets can be taken with or without food, but they should be taken every day at about the same time.
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. One should move in the direction of the arrow on the blister pack until all 21 tablets have been taken.
Then, one should not take any tablets for 7 days. During this 7-day break in taking the tablets (also called the withdrawal week), withdrawal bleeding should start. This is called "withdrawal bleeding" and usually starts on the 2nd or 3rd day of the withdrawal week.
On the 8th day after taking the last Teenia tablet (i.e., after the 7-day break in taking the tablets), one should start the next blister pack, regardless of whether the bleeding has stopped or not. This means that one should start each 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 uses Teenia in this way, they are also protected against pregnancy during the 7 days when they are not taking the tablets.

When can one start the first blister pack?

If no hormonal contraceptive was used in the previous month

One should start taking Teenia on the first day of their cycle (i.e., on 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. One can also start taking Teenia on days 2-5 of their cycle, but in that 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 transdermal patch)

It is best to start taking Teenia the next day after taking the last active tablet (containing active substances) of the previous contraceptive. However, one can start taking Teenia no later than the day after the end of the break in taking the previous contraceptive (or after the last tablet of the previous contraceptive that does not contain active substances). In the case of switching from a combined hormonal contraceptive vaginal ring or transdermal patch, one should follow the doctor's instructions.

Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen)

(IUS)

One can switch from a progestogen-only pill on any day, from an implant or intrauterine system on the day of its removal, or from an injection on the day the next injection is scheduled. However, in all cases, one should use additional contraceptive methods (e.g., condoms) for the first 7 days of taking Teenia.

After a miscarriage

One should follow the doctor's instructions.

After childbirth

One can start taking Teenia 21-28 days after giving birth. If one starts taking the tablets later than 28 days, 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 before starting to take Teenia again, they should first make sure they are not pregnant or wait for their next menstrual period.

If the patient is breastfeeding and wants to start taking Teenia again after childbirth

One should read the section on "Breastfeeding".
If the patient is unsure when to start taking Teenia, they should consult their doctor.

What to do if one takes more Teenia than they should

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

What to do if one misses a dose of Teenia

• if it has been less than 12 hourssince the missed tablet, contraceptive protection is not reduced. The tablet should be taken as soon as possible, and the next tablets should be taken at the usual time.
• if it has been more than 12 hourssince the missed tablet, contraceptive protection may be reduced. The more tablets that are missed, the higher the risk of becoming pregnant.

The risk of reduced contraceptive protection is highest if a tablet is missed at the beginning or end of the blister pack. In such a situation, one should follow the rules below (see also the diagram below).

Missed more than one tablet in this blister pack

One should contact their doctor.

Missed one tablet in the 1st week

One should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time, and one should use additional protection, 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, they should contact their doctor.

Missed one tablet in the 2nd week

One should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time. Contraceptive protection is not reduced, and one does not need to use additional protection.

Missed one tablet in the 3rd week

There are two options to choose from:

• 1. One should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time. One should skip the tablet-free period and start the next blister pack right away. Most likely, the menstrual period will occur at the end of the second blister pack, but it may also occur as a light or withdrawal-like bleeding during the use of tablets from the second blister pack.
• 2. One can also stop taking the tablets and go directly to the 7-day tablet-free period (one should note the day the tablet was missed). If the patient wants to start the new blister pack on their usual start day, the tablet-free period should be shorter than 7 days.
  If one follows one of these recommendations, contraceptive protection will be maintained.

Missed more than one tablet from
the same blister pack
One should contact their doctor
Yes
in the 1st
week
Did the patient have sexual intercourse in the week before missing the tablet?
No

• Take the missed tablet
• Use a mechanical method (condoms) for the next 7 days
• And finish the tablets from the blister pack in the 2nd week Missed 1 tablet (taken with a delay of more than 12 hours)
• Take the missed tablet and
• Finish the tablets from the blister pack
• Take the missed tablet
• Finish the tablets from the blister pack
• Do not take the 7-day break between packs
• Start taking the tablets from the next blister pack right away in the 3rd week or
• One should stop taking the tablets from the blister pack immediately
• Start the tablet-free week (no longer than 7 days, including the day the tablet was missed)
• Then start taking the tablets from the next blister pack

What to do if one vomits or has severe diarrhea

If vomiting occurs within 3-4 hours after taking a tablet or if severe diarrhea occurs, there is a risk that the active substances from the tablet may not have been fully absorbed into the body.
The situation is almost identical to missing a tablet. After vomiting or diarrhea, one should take another tablet from the reserve blister pack as soon as possible. If possible, one 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, one should follow the instructions given in the section "Missed dose of Teenia".

Delaying withdrawal bleeding: what to know

Although it is not recommended, the patient can delay the withdrawal bleeding by starting to take a new blister pack of Teenia, skipping the tablet-free period, until the end of the next pack. During the use of tablets from the second blister pack, light or withdrawal-like bleeding may occur. The next pack should be started after the usual 7-day tablet-free period.

Before making a decision to delay withdrawal bleeding, one should consult their doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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, she should consult her doctor. Severe side effects: The patient should immediately contact her 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 "Warnings and precautions"). All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For detailed information on the different risk factors associated with the use of combined hormonal contraceptives, the patient should refer to section 2 "Important information before taking Teenia".

Common side effects(may affect 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 affect up to 1 in 100 people)

• candidiasis (fungal infection);
• herpes simplex (viral infection);
• allergic reactions;
• increased appetite;
• depression, nervousness, sleep disorders;
• tingling and numbness, dizziness;
• vision disturbances;
• irregular heartbeat or abnormally fast 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 eruptions, 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, absence of menstruation, very heavy menstruation, discharge, vaginal dryness, pelvic pain, abnormal Pap smear (Pap classification or Pap test), decreased libido;
• fluid retention, lack of energy, excessive thirst, increased sweating;
• weight loss.

Rare side effects(may affect 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-like symptoms, known as a transient ischemic attack,
• blood clots in the liver, stomach, and/or intestine, kidneys, or eye.

The risk of developing blood clots may be higher if the patient has any other risk factors (see section 2 for more information on risk factors for blood clots 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 ulcers).

Reporting side effects

If any side effects occur, including any not listed in the leaflet, the patient should tell 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. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Teenia

The medicine 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 medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. The patient should ask her pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Teenia 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 methacrylic acid and acrylic acid, magnesium stearate. Coating:polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350, soybean lecithin.

What Teenia looks like and contents of the pack

The tablets are white or almost white, film-coated, round, biconvex, approximately 6 mm in diameter, with the imprint "G73" on one side, and the other side is smooth. Teenia, 3 mg + 0.02 mg, film-coated tablets are packaged in PVC/PE/PVDC-Aluminum blisters. The blisters are packaged in a carton box containing a patient leaflet and a cardboard pouch for storing the blisters. Pack size: 21 film-coated tablets. For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary

Manufacturer

Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary

Parallel importer:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź

Repackaged by:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź, Laboratorium Galenowe Olsztyn Sp. z o.o., ul. Spółdzielcza 25A, 11-001 Dywity, CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warszawa, Pharma Innovations Sp. z o. o., ul. Jagiellońska 76, 03-301 Warszawa, Marketing authorization number in Portugal, the country of export: 5370127, 5370135, 5370143, 5370150, Parallel import authorization number: 222/19, Translation of the day of the week symbols on the packaging:

Seg

• –Monday

Ter

• –Tuesday

Qua

• –Wednesday

Qui

• –Thursday

Sex

• –Friday

Sab

• –Saturday

Dom –Sunday

Date of revision of the leaflet: 28.05.2024

[Information about the trademark]