Teenia

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
TEENIA (Arankelle)
3 mg + 0,02 mg, film-coated tablets
Drospirenone + Ethinylestradiol
TEENIA and Arankelle are different brand names of the same medicinal product.
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 blood clots in veins and arteries, especially during the first year of use or after restarting following a break 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 for future reference.
• If in doubt, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm someone else.
• If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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 film-coated tablet contains a small amount of two different female hormones: drospirenone and ethinylestradiol.
• Contraceptives 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 become familiar with the symptoms
of blood clots – see section 2. "Blood clots".
Before starting to use 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 perform additional tests.
This leaflet describes several situations in which you should stop using Teenia
or when the effectiveness of Teenia may be reduced. In such cases, 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 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 diseases.

When not to use Teenia
Do not use Teenia if you have any of the following conditions. If you have any of the
conditions listed below, inform your doctor. Your doctor will discuss with you which alternative method of contraception
would 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 soya lecithin. If you are allergic to peanuts or soya, you should not use this medicine;
• if you currently have (or have ever had) a blood clot in the blood vessels of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know you have disorders affecting blood clotting – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, presence of factor V Leiden or 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 which 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 problems (kidney failure);
• if you have (or have ever had) a liver tumour;
• if you have (or have ever had) or suspect you may have breast or genital organ cancer;
• if you have any unexplained vaginal bleeding.

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 (see also section "Teenia with other medicines").

Warnings and precautions
Before starting to use Teenia, discuss this with your doctor or pharmacist.
When should you contact your doctor?
You should contact your doctor immediately

• 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 stroke (see section below "Blood clots"). For a description of the 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.
In certain situations, special caution is required when using 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, inform your doctor before starting Teenia. If any of these symptoms develop or worsen during treatment with Teenia, inform your doctor immediately.

• if you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives possibly with difficulty breathing, contact your doctor immediately. Medicines 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 (herpes gestationis), a nervous system disorder with involuntary 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 defence system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridaemia) or have a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of 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 you can start taking Teenia after delivery;
• 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, increases the risk of
developing 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"). Full 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
using Teenia is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Contact your doctor immediately if you notice any of the following symptoms.
Are you experiencing any of these symptoms? What might be the likely
reason?

• swelling of the leg or swelling along a vein in the leg or foot, Deep vein thrombosis 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 paleness, redness or blueness.
• sudden unexplained shortness of breath or rapid breathing; Pulmonary embolism
• sudden cough without an obvious cause, which may be associated with coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or vertigo;
• rapid or irregular heartbeat;
• severe stomach pain.

If you are unsure, contact your doctor, as
some of these symptoms, such as cough or shallow breathing, may
be mistaken for milder conditions such as respiratory tract infection (e.g. cold).
Symptoms most commonly occur in one eye: Retinal vein thrombosis

• sudden loss of vision or (blood clot in the eye)
• painless visual disturbances, which may progress to vision loss.
• chest pain, discomfort, pressure, heaviness; Heart attack
• feeling of tightness or fullness in the chest, arm or below the breastbone;
• feeling of fullness, indigestion or choking;
• discomfort in the lower body radiating to the back, jaw, throat, arm or stomach;
• sweating, nausea, vomiting or dizziness;
• extreme weakness, anxiety or shallow breathing;
• rapid or irregular heartbeat.
• sudden weakness or numbness of the face, arms or legs, especially Stroke

on one side of the body;

• sudden confusion, speech or comprehension difficulties;
• sudden visual disturbances in one or both eyes;
• sudden difficulty walking, dizziness, loss of balance or coordination;
• sudden, severe or prolonged headache without known cause;
• loss of consciousness or fainting with or without seizures.

In some cases, stroke symptoms may be transient with
almost immediate and complete recovery,
however, you should contact your doctor immediately, as
you may be at risk of another stroke.

• swelling and slightly bluish discoloration of the skin of legs or arms; Blood clots blocking
• severe stomach pain (acute abdomen). other blood vessels

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

• Using combined hormonal contraceptives is associated with an increased risk of venous blood clots (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 veins in the leg or foot, this may lead to the development of 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 venous blood clots highest?
The risk of developing venous blood clots 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 another medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than when not using combined hormonal contraceptives.
If you stop using Teenia, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of blood clots?
The risk depends on the 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 small.

• In a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In a year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone or norgestimate will develop blood clots.
• In 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 your individual medical history (see "Factors increasing the risk of blood clots", below).

Risk of blood clots
within one year
Women who do not use combined hormonal tablets/patches/vaginal systems and are not pregnant: About 2 out of 10,000 women
Women using combined oral contraceptives containing levonorgestrel,
norethisterone or norgestimate: About 5-7 out of 10,000 women
Women using Teenia: About 9-12 out of 10,000 women

Factors increasing the risk of venous blood clots
The risk of blood clots associated with using Teenia is small, but some factors may increase this risk. The risk is higher:

• if you are overweight (body mass index (BMI) above 30 kg/m²);
• if a close relative has had blood clots in the legs, lungs or other organs at a young age (e.g. under 50 years). In this case, you may have inherited clotting disorders;
• if you require surgery, are immobile for a prolonged period due to injury or illness, or have a leg in a cast. You may need to stop using Teenia several weeks before surgery or immobilisation. If you need to stop using Teenia, ask your doctor when you can restart;
• with age (especially over 35 years);
• if you have recently given birth (within the last few weeks).

The risk of blood clots increases with the number of risk factors present.
Air travel (>4 hours) may temporarily increase the risk of blood clots,
especially if you have another risk factor.
It is important to inform your doctor if any of these factors apply to you, even if you are unsure. Your doctor may decide to discontinue Teenia.
Inform your doctor if any of the above conditions change during treatment with Teenia, e.g. if a close relative is diagnosed with thrombosis without known cause or if you gain 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 arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with using Teenia
is very small, but may increase:

• with age (over about 35 years);
• if you smoke. When using a hormonal contraceptive such as Teenia, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend using another type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under 50 years). In this case, you may also be at increased risk of heart attack or stroke;
• if you or a close relative have high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraines, especially migraines with aura;
• if you have heart disease (valve damage, heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of the above conditions or any of them is
particularly severe, the risk of blood clots may be further increased.
Inform your doctor if any of the above conditions change during treatment with Teenia, e.g. if you start smoking, a close relative is diagnosed with thrombosis without known cause, or if you gain significant weight.

Teenia and cancer
Breast cancer is observed slightly more frequently in women using combined oral contraceptives,
but it is not known whether this is caused by taking the pills. For example,
more tumours may be 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 your breasts regularly and
contact your doctor if you feel any lump.
Benign liver tumours have been reported, rarely, and malignant liver tumours, very rarely, in women using oral contraceptives. If
you experience unusually severe abdominal pain, contact your 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 your doctor as soon as possible
for further medical advice.

Intermenstrual bleeding
During the first few months of taking Teenia, unexpected bleeding (bleeding outside the pill-free week) may occur. If such bleeding occurs more than once every few months, or if it starts after several months, your 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, without vomiting or severe diarrhoea, and no other medicines have been taken, it is very unlikely that you are pregnant.
If withdrawal bleeding does not occur twice in succession, this may indicate pregnancy.
Contact your doctor immediately. Do not start the next pack of Teenia until you are certain you are not pregnant.

Teenia with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, and any medicines you plan to take.
You should also inform other doctors or your dentist who prescribe other medicines that you are using Teenia. Your doctor will inform you whether you need to use an additional contraceptive method (e.g. condoms) and, if so, for how long, and whether dosage adjustments of other medicines are needed.
Do not use Teenia in patients with hepatitis C who are taking medicines
containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or
sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause abnormal liver function test results (increased activity of liver enzymes ALT). Before starting these medicines, your doctor will prescribe another type of contraception. Teenia may be restarted approximately 2 weeks after stopping 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 infection and hepatitis C virus infection (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors (e.g. 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),
• herbal product containing St John's wort ( Hypericum perforatum ). If you wish to use herbal products containing St John's wort while taking Teenia, you should first consult your doctor.

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 medicine lamotrigine (may lead to increased frequency of seizures),
• tizanidine (a medicine used to treat muscle spasticity),
• theophylline (a medicine used to treat asthma).

Before taking any medicine, consult your doctor or pharmacist.

Teenia with food and drink
Teenia may be taken regardless of meals. If necessary, the tablet may be taken with a small amount of water.

Laboratory tests
If blood tests are required, inform your doctor or laboratory staff that you are taking Teenia, as hormonal contraceptives may affect the results of certain tests.

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

Pregnancy
Do not take Teenia if you are pregnant. If you become pregnant
while using Teenia, you must stop taking it immediately and contact your
doctor.
If you wish to become pregnant, you may stop using Teenia at any time (see section: "Discontinuing Teenia").
Before using any medicine, consult your doctor or pharmacist.

Breastfeeding
Teenia is generally not recommended while breastfeeding. If you wish to
take Teenia during breastfeeding, you should contact your doctor.
Before using any medicine, consult your doctor or pharmacist.

Driving and using machines
There is no information suggesting that Teenia affects the ability to
drive or operate machinery.

Teenia contains monohydrate lactose and soya lecithin
Teenia contains 48.53 mg of monohydrate lactose. If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before using this medicine.
Teenia also contains 0.07 mg of soya lecithin. If you are allergic to peanuts or soya, you should not use 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.
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 there is a symbol indicating 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 “Qua” (indicating Wednesday; see “Translation of symbols for days of the
week printed next to each tablet on the immediate packaging” at the end of this leaflet) 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 break from tablets (also called the
“tablet-free week”), withdrawal bleeding should begin. 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 each new blister
pack should be started on the same day of the week, and withdrawal bleeding should occur every
month during the same days.
If Teenia is taken as described above, protection against pregnancy is maintained during the 7
days when no tablets are 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 first tablet may be taken on days 2 to 5 of the cycle, but in this case, additional contraceptive methods (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 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 intrauterine system releasing progestogen, IUS) A switch can be made on any day from a progestogen-only pill (from an implant or intrauterine system releasing progestogen on the day of its removal, or from an injectable form on the day the next injection is due), but in all cases, additional contraceptive precautions (e.g. condoms) must be used for the first 7 days of taking Teenia tablets.

• After a miscarriage Follow your doctor’s advice.

• After childbirth Teenia may be started between 21 and 28 days after childbirth. If tablets are started 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 Teenia (again), she should first ensure she is not pregnant or wait until the next menstrual bleeding occurs.

• If a woman is breastfeeding and wishes to start (or restart) taking Teenia after childbirth Read the section “Breast-feeding”.

If a woman is unsure when to start taking the medicine, she should consult her doctor.
Taking more than the recommended dose 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 onset of the first menstruation, accidental intake of this medicine may
also cause vaginal bleeding.
If too many Teenia tablets are taken or if a child has swallowed some tablets, contact 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 inadequate protection against pregnancy is greatest if a tablet is missed at the
beginning or end of the blister pack. In such cases, follow the rules below (see also the chart below).

• More than one tablet missed in this blister 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 the same time. Continue taking the remaining tablets at the usual time and use additional contraceptive protection, such as 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 the same time. Continue taking the remaining tablets at the usual time. Protection against pregnancy is not reduced and no additional precautions are needed.
• One tablet missed in Week 3 Two options are available:
  1. Take the missed tablet as soon as remembered, even if this means taking two tablets at the same time. Continue taking the remaining tablets at the usual time. Skip the tablet-free interval and immediately start the next blister pack. Withdrawal bleeding will most likely occur at the end of the second blister pack, but light or menstruation-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 blister 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 will be maintained.

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

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”. Delayed withdrawal bleeding: what you should know
Although not recommended, a woman may delay withdrawal bleeding by starting a new Teenia blister pack immediately, skipping the tablet-free interval, and continuing until the end of the next pack. During the second pack, light or menstruation-like bleeding may occur. The next pack should then be started after the usual 7-day tablet-free interval.
Before deciding to delay withdrawal bleeding, consult your doctor.
Changing the first day of withdrawal bleeding: what you should know
If tablets are taken correctly, 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 usually starts on Friday and a woman wishes to change it to Tuesday (3 days earlier), she should start the new blister 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 menstruation-like bleeding may then occur instead.
If a woman is unsure what to do, she should contact her doctor.
Stopping use of 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 using 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 changes in health which the patient considers to be related to the use of Teenia, medical advice should be sought from a doctor.

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 possibly associated with difficulty breathing (see also section "Warnings and precautions").

All women using combined hormonal contraceptives have an increased risk of venous blood clots (venous thromboembolic disease) or arterial blood clots (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before using 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 simplex (viral infection caused by Herpes simplex virus);
• Allergic reactions;
• Increased appetite;
• Depression, nervousness, sleep disorders;
• Tingling and numbness, dizziness;
• Visual 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, 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, seborrheic skin disorders (seborrheic dermatitis);
• Neck pain, limb pain, muscle cramps;
• Urinary tract infection;
• Breast lump (benign lump and tumour), milk secretion in non-pregnant women (galactorrhea), ovarian cyst, hot flushes, absence of menstruation, very heavy menstrual bleeding, vaginal discharge, vaginal dryness, lower abdominal (pelvic) pain, abnormal cytological smear results (Papanicolaou classification or Pap smear), decreased sexual drive;
• 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 disturbance;
• Harmful blood clots in veins or arteries, 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 transient ischaemic attack,
• blood clots in the liver, stomach and/or intestine, kidneys or eye. The likelihood of blood clots may be higher if the patient has any other risk factors increasing this risk (see section 2 for further information on risk factors increasing the likelihood of 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 adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring 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 the medicine.

5. How to store Teenia

Keep this medicine 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 container. 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. Proper disposal helps protect the environment.

6. Contents of the pack and other information

What Teenia contains

• The active substances are drospirenone (3 mg) and ethinylestradiol (0.02 mg).
• The other ingredients are: monohydrate lactose, gelatinized maize starch, maize starch, grafted copolymer of polyethylene glycol and polyvinyl alcohol, magnesium stearate.
  Coating Opadry II White 85G18490: 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, with a diameter of approximately 6 mm, imprinted with the code "G73" on one side; the other side is smooth.
Teenia 3 mg + 0.02 mg film-coated tablets are packed in PVC/PE/PVDC-Aluminium blisters.
The blisters are placed in a cardboard box containing the patient leaflet and a sachet in which the blister should be stored.
Pack sizes:
1×21 film-coated tablets
3×21 film-coated tablets
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Marketing Authorisation Number in Portugal, country of export: 5370127
Parallel Import Licence Number: 122/16

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