Teenia

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language!
Teenia (Arankelle)
3 mg + 0,02 mg, coated tablets
Drospirenone + Ethinylestradiol
Teenia and Arankelle are different brand names of the same medicine.
Important information regarding combined hormonal contraceptives:

• When used correctly, they are one of the most reliable reversible methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting following an interval of 4 weeks or more.
• Be vigilant and consult a doctor if the patient suspects symptoms of blood clot formation (see section 2 "Blood clots").

Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Teenia is and what it is used for
2. What you need to know 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 Teenia is and what it is used for

• Teenia is a contraceptive tablet used to prevent pregnancy.
• Each tablet contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.
• Contraceptive preparations containing two hormones are known as combined oral contraceptives.

2. Important information before using Teenia

General notes
Before starting to take Teenia, you should read the information about blood clots (thrombosis) in section 2. It is particularly important to be aware of the symptoms of blood clots – see section 2 "Blood clots".
Before you can start taking Teenia, your doctor will ask you several questions about your health and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out some other tests.
This leaflet describes several situations in which you should stop taking Teenia or in which the effectiveness of Teenia may be reduced. In such situations, you should either avoid sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. Do not use fertility awareness-based methods or temperature monitoring methods. These methods may be unreliable because Teenia alters the monthly changes in body temperature and cervical mucus.
Teenia, like other hormonal contraceptives, does not protect against infection with HIV (AIDS) or other sexually transmitted infections.

When not to use Teenia
Do not take Teenia if you have any of the conditions listed below. If you have any of the conditions listed below, inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable.

• if you are allergic to ethinylestradiol or drospirenone or any of the other ingredients of this medicine (listed in section 6). Symptoms of hypersensitivity may include itching, rash, or swelling;
• Teenia contains soy lecithin. If you are allergic to peanuts or soy, you should not take this medicine;
• if you currently have (or have ever had) a blood clot in the blood vessels of your legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if you know you have disorders affecting blood clotting – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or presence of antiphospholipid antibodies;
• if you require surgery or will be immobile for a prolonged period (see section "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have had in the past) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following conditions that may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage,
  • very high blood pressure,
  • very high levels of fats in the blood (cholesterol or triglycerides),
  • a condition called hyperhomocysteinemia;
• if you currently have (or have ever had) a type of migraine called "migraine with aura";
• if you have (or have ever had) liver disease and liver function remains abnormal;
• if you have kidney disorders (kidney failure);
• if you have (or have ever had) liver tumour;
• if you have (or have ever had) or suspect you may have breast cancer or genital organ cancer;
• if you have any unexplained vaginal bleeding.

Do not take Teenia in patients with hepatitis C who are taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Teenia with other medicines").

Warnings and precautions
Before starting to take Teenia, discuss this with your doctor or pharmacist.

When to contact your doctor
Seek immediate medical advice if:

• you notice possible symptoms of blood clots, which may indicate that you have a blood clot in your leg (deep vein thrombosis), in your lungs (pulmonary embolism), a heart attack, or a stroke (see section below "Blood clots (thrombosis)"). For a description of symptoms of these serious adverse reactions, see "How to recognize the occurrence of blood clots".

Tell your doctor if you have any of the following conditions.
Special caution may be needed when taking Teenia or any other combined oral contraceptive, and regular check-ups by your doctor may be necessary. If any of the conditions listed below apply to you, tell your doctor before starting Teenia. If any of these conditions occur or worsen during treatment with Teenia, you should also inform your doctor.

• if you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives potentially with breathing difficulties, seek immediate medical attention. Medicinal products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema;
• if close relatives have or have ever had breast cancer;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you have depression or mood changes;
• if you have epilepsy (see "Teenia with other medicines");
• if you have a condition that first occurred during pregnancy or previous use of sex hormones (e.g. hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (pemphigoid gestationis), a nervous system disorder with involuntary body movements (Sydenham's chorea));
• if you have or have ever had chloasma (skin discoloration, especially on the face or neck, also known as melasma). In this case, avoid direct exposure to sunlight or ultraviolet radiation;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease affecting the body's natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder causing kidney failure);
• if you have sickle cell anemia (an inherited disorder of red blood cells);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have a positive family history of this condition. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• if you have recently given birth, as you are at increased risk of blood clots. Consult your doctor for advice on how soon after delivery you can start taking Teenia;
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins.

BLOOD CLOTS
Using combined hormonal contraceptives such as Teenia is associated with an increased risk of blood clots compared to not using such therapy. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

• in veins (referred to as "venous thrombosis" or "venous thromboembolic disease");
• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic events").

Complete recovery after a blood clot is not always possible. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots caused by taking Teenia is low.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you notice any of the following symptoms.

Do you experience any of these symptoms? What might be the likely cause?

• swelling of the leg or swelling along a vein in the leg or foot, especially if accompanied by:
• pain or tenderness in the leg, which may occur only when standing or walking;
• increased warmth in the affected leg;
• change in skin colour of the leg, such as pallor, redness, or blueness.

BLOOD CLOTS IN VEINS
What can happen if blood clots form in a vein?

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

When is the risk of developing blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of using combined hormonal contraceptives for the first time. The risk may also be increased when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than in women who do not use combined hormonal contraceptives.
If a woman stops taking Teenia, the risk of developing blood clots returns to normal within a few weeks.

What factors influence the risk of developing blood clots in veins?
The risk depends on the woman's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with using Teenia is low.

• In one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In one 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 developing blood clots depends on the individual medical history of the woman (see "Factors that increase the risk of blood clots," below).

Factors increasing the risk of blood clots in veins
The risk of blood clots associated with the use of Teenia is small, however
some factors may increase this risk. The risk is higher:

• if the patient has significant overweight (body mass index (BMI) above 30 kg/m²);
• if a close relative of the patient has been diagnosed with blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In this case, the patient may have inherited coagulation disorders;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue the use of Teenia several weeks before surgery or reduced mobility. If the patient must stop taking Teenia, ask the doctor when it is safe to resume taking the medicine;
• with increasing age (especially above 35 years);
• if the patient gave birth within the last few weeks.

The risk of developing 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,
particularly if the patient has another risk factor listed above.
It is important to inform the doctor if any of the listed factors apply to the patient,
even if uncertain. The doctor may decide to discontinue the use of Teenia.
Inform the doctor if any of the above conditions change during treatment with Teenia, e.g., if a close relative is diagnosed with unexplained thrombosis or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES
What can happen if blood clots form in arteries?
Similar to venous blood clots, arterial clots can cause serious
consequences, such as heart attack or stroke.

Factors increasing the risk of blood clots in arteries
It is important to emphasize that the risk of heart attack or stroke associated with the use of Teenia is
very small, but may increase:

• with age (above approximately 35 years);

• if the patient smokes cigarettes. While using a hormonal contraceptive such as Teenia, it is recommended to stop smoking. If the patient is unable to stop
  smoking and is over 35 years old, the doctor may recommend using another type of
  contraception;

• if the patient is overweight;

• if the patient has high blood pressure;

• if a close relative has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;

• if the patient or a close relative has high levels of fats in the blood (cholesterol or triglycerides);

• if the patient suffers from migraines, particularly migraines with aura;

• if the patient has heart disease (valve damage, heart rhythm disorder called atrial fibrillation);

• if the patient has diabetes.

If the patient has more than one of the above conditions or if any of them is
particularly severe, the risk of blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Teenia, e.g., if the patient starts smoking, if a close relative is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Teenia and cancer
Among women using combined oral contraceptives, breast cancer is observed slightly more frequently,
but it is not known whether this is caused by taking the pills. For example, it may be that
more cancers are detected in women using combined oral contraceptives
because they are examined more frequently by doctors.
The incidence of breast cancer gradually decreases after stopping
combined hormonal contraceptives. It is important to examine the breasts regularly and
contact the doctor if any lump is felt.
Rare cases of benign liver tumors and even rarer cases of malignant liver tumors have been reported in women using oral contraceptives. If the patient experiences unusually severe abdominal pain, contact the doctor.

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

Breakthrough bleeding
During the first few months of taking Teenia, unexpected bleeding (bleeding outside the pill-free week) may occur. If such bleeding occurs more often than once every few months, or if it starts after several months, the doctor should investigate the cause.

What to do if withdrawal bleeding does not occur during the pill-free week
If all tablets have been taken correctly, there have been no episodes of vomiting or severe diarrhoea, and no other medicines have been taken, it is very unlikely that the woman is pregnant.
If the expected withdrawal bleeding does not occur twice in succession, this may indicate pregnancy.
Contact the doctor immediately. Do not start the next pack of Teenia until pregnancy has been ruled out.

Teenia and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
The patient should also inform other doctors or dentists prescribing other medicines that she is taking Teenia. The doctor will inform the patient whether additional contraceptive methods (e.g., condoms) are needed, and if so, for how long, and whether dose adjustments of other medicines are required.
Do not use Teenia in patients with hepatitis C who are taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these products may cause abnormal liver function test results (increased blood levels of liver enzymes AlAT).
Before starting these medicines, the doctor will prescribe another type of contraception.
Teenia may be restarted approximately 2 weeks after completion of the above-mentioned treatment. See section "When not to use Teenia".
Some medicines may affect the blood levels of Teenia and may make it less effective in preventing pregnancy or may cause unexpected bleeding. These include:

• medicines 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 pulmonary blood vessels (bosentan),
• fungal infections (e.g. griseofulvin, ketoconazole),
• symptomatic treatment of osteoarthritis (etoricoxib),
• herbal product containing St. John's wort ( Hypericum perforatum ). If the patient wishes to use herbal products containing St. John's wort while taking Teenia, she should consult the doctor first.

Teenia may affect the action of other medicines, for example:

• cyclosporine (a medicine used to prevent rejection of transplanted tissue after organ transplantation),
• the antiepileptic drug lamotrigine (seizure frequency may increase),
• tizanidine (a medicine used to treat muscle spasticity),
• theophylline (a medicine used to treat asthma).

Before taking any medicine, consult a doctor or pharmacist.
Teenia with food and drink
Teenia can be taken independently of meals. If necessary, the tablet can be taken with a small amount of water.
Laboratory tests
If a blood test is required, inform the doctor or laboratory staff that Teenia is being taken, as hormonal contraceptives may affect the results of certain tests.
Pregnancy and breast-feeding
If the patient is pregnant or breast-feeding, suspects she may be pregnant, or plans to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Do not take Teenia if the patient is pregnant. If the patient becomes pregnant
while taking Teenia, she must stop taking it immediately and contact the doctor.
If the patient wishes to become pregnant, she may stop taking Teenia at any time (see section: "Discontinuing use of Teenia").
Before taking any medicine, consult a doctor or pharmacist.
Breast-feeding
Teenia is generally not recommended while breast-feeding. If the patient wishes to take Teenia during breast-feeding, she should contact her doctor.
Before taking any medicine, consult a doctor or pharmacist.
Driving and using machines
There is no information suggesting that taking Teenia affects the ability to drive
or operate machinery.
Teenia contains lactose and soy lecithin
Teenia contains 48.53 mg of monohydrate lactose. If the patient has previously been diagnosed with intolerance to certain sugars, she should contact the doctor before
using this medicine.
Teenia also contains 0.070 mg of soy lecithin. If the patient is allergic to peanuts or soy, she should not take this medicine.

3. How to use Teenia

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
Take one Teenia tablet daily, with or without a small amount of water.
The tablets may be taken with or without food, but should be taken every day at approximately
the same time.
The blister pack contains 21 tablets. Next to each tablet is printed the symbol for the day of the week
on which the tablet should be taken. For example, if a woman starts taking the tablets on a
Wednesday, the symbol “WED” appears next to the tablet. Move in the direction of the arrow on the
blister pack until all 21 tablets have been taken.
Then, do not take any tablets for 7 days. During this 7-day tablet-free interval (also called the
“week off”), withdrawal bleeding is expected to occur. This so-called “withdrawal bleeding” usually
starts on the 2nd or 3rd day of the tablet-free week.
On the 8th day after taking the last Teenia tablet (i.e. after the 7-day tablet-free interval), start a new
blister pack, regardless of whether bleeding has stopped or not. This means that each new blister
pack should be started on the same day of the week, and withdrawal bleeding should occur each
month on approximately the same days.
If a woman uses Teenia as directed, she is protected against pregnancy also during the 7 days when
tablets are not taken.

When to start the first blister pack?

• If no hormonal contraceptive has been used in the previous month
  Start taking Teenia on the first day of the cycle (i.e. the first day of menstruation). If a woman starts
  taking Teenia on the first day of her period, she is protected against pregnancy immediately.
  Alternatively, the tablet may be started on days 2 to 5 of the cycle, but in this case, an additional
  contraceptive method (e.g. condoms) must be used for the first 7 days.
• Switching from another combined hormonal contraceptive (combined oral contraceptive, combined contraceptive vaginal ring, or transdermal contraceptive patch)
  It is best to start taking Teenia the day after the last active tablet (containing active substances) of
  the previous contraceptive has been taken, but no later than the day after the tablet-free interval of
  the previous contraceptive ends (or after the last inactive tablet of the previous contraceptive).
  When switching from a combined contraceptive vaginal ring or transdermal patch, follow your
  doctor’s advice.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or progestogen-releasing intrauterine system (IUS))
  Switching may occur on any day from the progestogen-only pill (on the day of removal of an
  implant or IUS, or on the day the next injection is due), but in all cases, an additional barrier
  method (e.g. condoms) must be used for the first 7 days of taking Teenia tablets.
• After miscarriage
  Follow your doctor’s advice.
• After childbirth
  Teenia may be started between 21 and 28 days after childbirth. If tablet-taking begins later than
  day 28, a barrier method (e.g. condoms) must be used for the first 7 days of taking Teenia. If a
  woman has had sexual intercourse after childbirth and before starting (or restarting) Teenia, she
  should first ensure she is not pregnant or wait until the next menstrual bleeding occurs.
• If breastfeeding and wishing to start (or restart) Teenia after childbirth
  Please read the section “Breast-feeding”.

If a woman is unsure when to start taking the medicine, she should consult her doctor.

Overdose of Teenia

There are no reports of serious harmful effects from taking too many Teenia tablets.
If several tablets are taken at once, symptoms such as nausea or vomiting may occur, or vaginal
bleeding may appear. In young girls before the first menstrual period, accidental intake of this
medicine may also cause vaginal bleeding.
If an excessive number of Teenia tablets have been taken or if a child has swallowed some, consult
a doctor or pharmacist immediately.

Missed dose of Teenia

• If less than 12 hours have passed since the missed tablet, protection against pregnancy is not
  reduced. Take the missed tablet as soon as remembered, then continue taking the next tablets at
  the usual time.
• If more than 12 hours have passed since the missed tablet, protection against pregnancy may
  be reduced. The more tablets missed, the higher the risk of becoming pregnant.

The risk of reduced protection is greatest if a tablet is missed at the beginning or end of the
blister pack. In such a case, follow the instructions below (see also the chart below).

• More than one tablet missed in the same pack
  Contact your doctor.
• One tablet missed in Week 1
  Take the missed tablet as soon as remembered, even if this means taking two tablets at once.
  Continue taking the remaining tablets at the usual time and use additional protection (e.g.
  condoms) for the next 7 days. If sexual intercourse occurred in the week before the missed tablet,
  pregnancy may have occurred. In this case, contact your doctor.
• One tablet missed in Week 2
  Take the missed tablet as soon as remembered, even if this means taking two tablets at once.
  Continue taking the remaining tablets at the usual time. Protection against pregnancy is not
  reduced, and no additional protection is needed.
• One tablet missed in Week 3
  There are two options:
  1. Take the missed tablet as soon as remembered, even if this means taking two tablets at once.
     Continue taking the remaining tablets at the usual time. Skip the tablet-free interval and start the
     next blister pack immediately. Withdrawal bleeding will most likely occur towards the end of the
     second pack, but light or period-like bleeding may occur during the second pack.
  2. Alternatively, stop taking tablets and go directly into the 7-day tablet-free interval (you should
     note the day the tablet was missed). If a woman wishes to start the new pack on her usual
     starting day, the tablet-free interval should be shorter than 7 days.

If either of these options is followed, protection against pregnancy is maintained.

• If a woman has missed any tablets in the pack and no bleeding occurs during the first tablet-free
  week, she may be pregnant. In this case, consult a doctor before starting the next pack.

Missed tablets from the same pack → Consult your doctor

Yes
Was there sexual intercourse in the week
preceding the missed tablet?
No

• Take the missed tablet
• Use a barrier method (condoms) for the next 7 days
• And finish the tablets in the pack
  Missed 1 tablet in Week 1
• Take the missed tablet and (taken more than 12 hours late)
• Finish the tablets in the pack
• Take the missed tablet
• Finish taking the tablets in the pack
• Do not take a 7-day break between packs
• Start the next pack immediately
  Missed 1 tablet in Week 2
• Stop taking tablets from the current pack immediately
• Start the tablet-free week (no longer than 7 days, including the day the tablet was missed)
• Then start the next pack
  Missed 1 tablet in Week 3

What to do if vomiting or severe diarrhoea occurs
If vomiting occurs within 3 to 4 hours after taking a tablet, or if severe diarrhoea occurs, there is a
risk that the active substances in the tablet have not been completely absorbed. This situation is
similar to missing a tablet. After vomiting or diarrhoea, take another tablet from a spare blister pack
as soon as possible. If possible, take it within 12 hours of the usual tablet-taking time. If this is not
possible or more than 12 hours have passed, follow the advice given under “Missed dose of Teenia”.

Delaying withdrawal bleeding: what you should know
Although not recommended, a woman may delay withdrawal bleeding by starting a new pack of
Teenia immediately, skipping the tablet-free interval, and continuing until the end of the next pack.
During the second pack, light or period-like bleeding may occur. The following pack should then be
started after the usual 7-day tablet-free interval.
Before deciding to delay withdrawal bleeding, consult your doctor.

Changing the day of withdrawal bleeding: what you should know
If tablets are taken as directed, menstruation will begin during the tablet-free week. If a woman
wishes to change this day, she should shorten (but never extend—maximum 7 days!) the tablet-free
interval. For example, if the tablet-free interval normally starts on Friday and a woman wishes to
change it to Tuesday (3 days earlier), she should start the new pack 3 days earlier than usual. If the
tablet-free interval is very short (e.g. 3 days or less), no bleeding may occur during the break. Light
or period-like bleeding may then occur.

If a woman is unsure how to proceed, she should contact her doctor.

Stopping Teenia
Teenia may be stopped at any time. If a woman does not wish to become pregnant, she should
consult her doctor about other effective methods of birth control.
If a woman wishes to become pregnant, she should stop taking Teenia and wait for a menstrual
period before trying to conceive. This makes it easier to calculate the expected date of delivery.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any adverse reactions occur, especially severe and persistent ones, or any changes in health that the patient considers to be related to the use of Teenia, medical advice should be sought.

Serious adverse reactions
Seek immediate medical attention if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria potentially associated with breathing difficulties (see also section "Warnings and precautions").

All women using combined hormonal contraceptives have an increased risk of venous thromboembolism (blood clots in veins) or arterial thromboembolic events (blood clots in arteries). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, refer to section 2, "Important information before taking Teenia".

Common adverse reactions (may occur in up to 1 in 10 people)

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

Uncommon adverse reactions (may occur in up to 1 in 100 people)

• candidiasis (fungal infection);
• herpes (infection with Herpes simplex virus);
• allergic reactions;
• increased appetite;
• depression, nervousness, sleep disorders;
• tingling and numbness, dizziness;
• visual 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, diarrhoea, constipation;
• sudden swelling of the skin and/or mucous membranes (e.g. tongue or throat) and/or difficulty swallowing, or urticaria with breathing difficulties (angioedema), hair loss (alopecia), rash, itching, skin eruptions, dry skin, seborrhoeic skin disorders (seborrhoeic dermatitis);
• neck pain, limb pain, muscle cramps;
• cystitis;
• breast tumour (benign tumour and cancer), milk discharge in non-pregnant women (galactorrhea), ovarian cyst, hot flushes, absence of menstruation, very heavy menstruation, vaginal discharge, vaginal dryness, lower abdominal pain (pelvic pain), abnormal cytological smear results (Papanicolaou classification or Pap smear), decreased sexual desire;
• fluid retention, lack of energy, excessive thirst, increased sweating;
• weight loss.

Rare adverse reactions (may occur in up to 1 in 1,000 people)

• hearing disorder;
• 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 ischaemic attack (TIA);
• blood clots in the liver, stomach and/or intestines, kidneys or eye.

The likelihood of developing blood clots may be higher if the patient has any other risk factors that increase this risk (see section 2 for further 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 (a rash presenting as redness or ulceration).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Teenia

Keep this medicine out of sight and reach of children.
Do not store above 25℃. 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Teenia contains

• The active substances in this medicine are drospirenone (3 mg) and ethinylestradiol (0.02 mg).
• Other components are: Tablet core: monohydrate lactose, pregelatinized starch, corn starch, polyethylene glycol-grafted copolymer of polyvinyl alcohol, 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 engraved mark "G73" on one side, while the other side is smooth.
Teenia 3 mg + 0.02 mg, film-coated tablets, is packed in blisters made of PVC/PE/PVDC-Aluminium. The blisters are placed in a cardboard box containing the patient leaflet and a cardboard pouch for storing the blister packs.
Pack size: 21 film-coated tablets.
For more detailed information, please contact the marketing authorization holder or parallel importer.
Marketing Authorization Holder in Portugal, 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 in:
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, country of export:
Parallel Import Authorization Number: 222/19
Translation of the weekday symbols printed next to each tablet on the immediate packaging:
Seg – Monday
Ter – Tuesday
Qua – Wednesday
Qui – Thursday
Sex – Friday
Sab – Saturday
Dom – Sunday