VIXPO

Package leaflet: Information for the patient

Vixpo, 3 mg + 0.02 mg, coated tablets
Drospirenone + Ethinylestradiol
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Important information about 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 a break of 4 weeks or more.
• Be vigilant and consult your doctor if you suspect symptoms of blood clots (see section 2. "Blood clots").

Contents of the leaflet
1. What Vixpo is and what it is used for
2. Important information before taking Vixpo
When not to use Vixpo
Warnings and precautions
Blood clots
Vixpo and cancer
Breakthrough bleeding
What to do if no bleeding occurs during the placebo tablet days
Vixpo and other medicines
Laboratory tests
Pregnancy and breastfeeding
Driving and operating machinery
Vixpo contains lactose

3. How to take Vixpo

Preparing the blister pack
When to start the first blister pack
Taking more Vixpo than recommended
Missing a dose of Vixpo
What to do in case of vomiting or severe diarrhoea
Delayed menstruation: what you should know
Changing the first day of menstruation: what you should know
Stopping Vixpo treatment
4. Possible side effects
5. How to store Vixpo
6. Contents of the pack and other information
1. What Vixpo is and what it is used for

• Vixpo is a contraceptive tablet used to prevent pregnancy.
• Each of the 24 pink tablets contains a small amount of two different female hormones, drospirenone and ethinylestradiol.
• The four white tablets contain no active substance and are called placebo tablets.
• Contraceptive tablets containing two hormones are known as combined hormonal contraceptives.

2. Important information before using Vixpo

General information
Before starting to take Vixpo, you should read the information about blood clots 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 using Vixpo, 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 may perform additional tests depending on your individual situation.
This leaflet describes several situations in which you should stop using the medicine or in which its effectiveness 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-based methods or temperature measurement. These methods may be unreliable because Vixpo affects monthly changes in body temperature and cervical mucus.
Like other hormonal contraceptives, Vixpo does not protect against HIV (AIDS) or other sexually transmitted infections.

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

• if you currently have (or have ever had) a blood clot in the veins of your legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know you have blood clotting disorders – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you require surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have previously had) 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 diseases 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 previously had) a type of migraine called "migraine with aura";
  • if you have (or have previously had) liver disease and liver function remains abnormal;
  • if you have kidney function disorders (kidney failure);
  • if you have (or have previously had) liver tumour;
  • if you have (or have previously had) or are suspected of having breast cancer or genital organ cancer;
  • if you have unexplained vaginal bleeding;
  • if you are allergic to ethinylestradiol or drospirenone, or any of the other ingredients of this medicine (listed in section 6). This may cause itching, rash, or swelling.

Do not use Vixpo if you have hepatitis C and are taking medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also "Vixpo and other medicines").

Additional information for special patient groups
Children and adolescents
Vixpo is not intended for use in patients who have not yet had their first menstrual period.

Women of advanced age
Vixpo is not intended for use after menopause.

Women with impaired liver function
Do not take Vixpo if you suffer from liver disease. See sections "When not to use Vixpo" and "Warnings and precautions".

Women with impaired kidney function
Do not take Vixpo if you suffer from kidney failure or acute kidney failure. See sections "When not to use Vixpo" and "Warnings and precautions".

Warnings and precautions
When should you contact your doctor?
You should 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"). For a description of symptoms of these serious adverse effects, see "How to recognize blood clots".

In certain situations, special caution is required when using Vixpo or any other combined oral contraceptive. Regular check-ups by your doctor may also be necessary.

You should inform your doctor if any of the following conditions develop or worsen while taking Vixpo.
Before starting Vixpo, discuss the following with your doctor or pharmacist:

• if a close relative has or has had breast cancer;
• if you have cancer;
• if you have liver disease (such as biliary obstruction, which may cause jaundice and itching) or gallbladder disease (such as gallstones);
• if you have kidney disease and are taking medicines that increase potassium levels in the blood. Your doctor may recommend monitoring of blood potassium levels;
• if you have diabetes;
• if you have depression. Some women using hormonal contraceptives, including Vixpo, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact your doctor as soon as possible for further medical advice;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (an autoimmune disorder);
• if you have hemolytic uremic syndrome (a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have high levels of fats in the blood (hypertriglyceridemia) or a 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 about how soon after delivery you can start taking Vixpo;
• if you have superficial thrombophlebitis (inflammation of veins under the skin with blood clots);
• if you have varicose veins;
• if you have epilepsy (see "Vixpo and 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 high blood pressure that does not respond to antihypertensive treatment;
• if you have or have ever had brownish facial patches, known as chloasma, especially on the face (melasma). In such cases, you should avoid direct exposure to sunlight or ultraviolet radiation while using Vixpo.
• if you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria potentially with breathing difficulties, seek immediate medical attention. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
Using combined hormonal contraceptives such as Vixpo 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").

Recovery from a blood clot is not always complete. 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 associated with using Vixpo is small.

HOW TO RECOGNIZE BLOOD CLOTS
Seek immediate medical attention if you experience any of the following symptoms.

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

• The use of combined hormonal contraceptives is associated with an increased risk of venous blood clots (venous thromboembolism), 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 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 blood 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 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 Vixpo, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of venous blood clots?
The risk depends on the individual'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 the use of Vixpo is small.

• 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 to 12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Vixpo, will develop blood clots.
• The risk of developing blood clots depends on the individual's medical history (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 Vixpo is small, but certain 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 an inherited clotting disorder;
• if the patient is due to undergo surgery, will be immobilized for a prolonged period due to injury or illness, or has a leg in a cast; it may be necessary to discontinue Vixpo several weeks before surgery or immobilization. If the patient must stop taking Vixpo, consult the doctor about when it is safe to restart the medication;
• with increasing age (especially over 35 years);
• if the patient has recently given 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 these factors apply to the patient, even if uncertain. The doctor may decide to discontinue Vixpo.
Inform the doctor if any of the above conditions change during treatment with Vixpo, for example, 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?
As with venous blood clots, arterial clots can lead to 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 Vixpo is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Vixpo, it is recommended to stop smoking. If the patient cannot stop smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
• if the patient has 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 blood fats (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valvular heart disease, arrhythmia known as atrial fibrillation);
• if the patient has diabetes.

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

Vixpo and cancer
A slightly higher incidence of breast cancer has been observed in women using combined oral contraceptives, but it is not known whether this is caused by taking the pills. It is possible, for example, that more tumors 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 breasts regularly and contact the doctor if any lump is detected.
Benign liver tumors have been reported rarely in women using oral contraceptives, and malignant liver tumors have been reported even more rarely. If the patient experiences symptoms such as unusual, severe abdominal pain, abdominal swelling (which may be due to liver enlargement), vomiting blood, blood in stool, or black tarry stools (which may indicate gastrointestinal bleeding), contact the doctor immediately.

Intermenstrual bleeding
During the first few months of taking Vixpo, unexpected bleeding (bleeding outside the placebo tablet period) may occur. If such bleeding persists for longer than a few months or begins after several months, the doctor should investigate the cause.

What to do if no bleeding occurs during the placebo tablet period
If all pink active tablets have been taken correctly, without vomiting, severe diarrhea, or use of other medications, it is very unlikely that the woman is pregnant.
If expected withdrawal bleeding does not occur for two consecutive cycles, this may indicate pregnancy. Contact the doctor immediately. The next pack of medication should only be started once pregnancy has been ruled out.

Vixpo and other medicines
Inform the doctor about all medicines currently or recently taken, including planned medications, as well as herbal medicines. Also inform any other doctor, dentist, or pharmacist prescribing other medicines about the use of Vixpo. They may advise whether additional contraceptive methods (e.g., condoms) are needed and, if so, for how long.
Do not use Vixpo if the patient has hepatitis C and is taking medications containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as they may cause abnormal liver function test results detected in blood tests (increased ALT activity).
The doctor will prescribe a different type of contraception before starting treatment with these medications.
Vixpo may be restarted approximately 2 weeks after completing treatment with these drugs (see "When not to use Vixpo").

Some medicines may affect the blood concentration of Vixpo and may make it less effective in preventing pregnancy or may cause unexpected bleeding. These include:

• medicines used to treat:
  • epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, felbamate, topiramate);
  • tuberculosis (e.g., rifampicin);
  • HIV infection and hepatitis C virus (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz) or other infectious diseases (griseofulvin or ketoconazole);
  • arthritis, osteoarthritis (etoricoxib);
  • pulmonary hypertension (bosentan);
• herbal medicines containing St. John's wort (Hypericum perforatum).

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

• medicines containing cyclosporine;
• the antiepileptic drug lamotrigine (this may lead to increased frequency of seizures);
• theophylline (a medicine used to treat breathing problems);
• tizanidine (a medicine used to treat pain and/or muscle spasms).

The doctor may monitor blood potassium levels if the patient is taking certain medicines used to treat heart conditions (such as diuretics).

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

Pregnancy and breastfeeding
Pregnancy
Vixpo must not be used during pregnancy. If the patient becomes pregnant while taking Vixpo, she should stop taking it immediately and contact her doctor.
If the patient wishes to become pregnant, she may stop taking Vixpo at any time (see section "Discontinuing Vixpo").

Breastfeeding
Vixpo is generally not recommended while breastfeeding. If the patient wishes to take oral contraceptives during breastfeeding, she should consult her doctor.

Driving and operating machinery
There is no information suggesting that Vixpo affects the ability to drive or operate machinery.

Vixpo contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Vixpo

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Each blister contains 24 pink active tablets and 4 white placebo tablets.
The tablets of Vixpo in two different colours are arranged in the correct order. Each blister contains
28 tablets.
Take one tablet daily, swallowing it with a small amount of water if necessary. The tablets may be taken
independently of meals, but at approximately the same time each day.
Be careful not to confuse the tablets: for the first 24 days take the pink tablet, then take the white
tablet for the last 4 days. Then immediately start taking tablets from a new blister (24 pink tablets and
4 white placebo tablets). Thus, there is no break between packs.
Due to differences in tablet composition, it is essential to start with the tablet in the upper left corner
of the blister and take them daily in sequence. To maintain the correct order, proceed in the direction
of the arrows on the blister.
Preparing the blister
To help track daily tablet intake, each pack of medicine includes 7 adhesive strips printed with days of
the week. Choose the strip where the first day of the week corresponds to the day you start the pack.
For example, if the first day of use is Wednesday, apply the strip starting with "WED".
Apply the label to the top of the blister, in the area marked "Place label here". This way, the first day
appears below the tablet marked "Start". Each tablet is marked above, allowing you to verify that the
correct tablets have been taken. Arrows indicate the order of tablet intake.
During the 4 days when the patient takes the white placebo tablets (placebo days), withdrawal
bleeding should occur (so-called withdrawal bleeding). This usually begins on the 2nd or 3rd day after
taking the last pink active tablet. After taking the last white placebo tablet, start the next blister
immediately, regardless of whether bleeding has stopped. This means that starting tablets from a new
blister should always occur on the same day of the week , and withdrawal bleeding should begin on
the same day each month.

Vixpo used in this way provides protection against pregnancy also during these 4 days when the
patient takes placebo tablets.
When to start the first blister?

• If no hormonal contraceptives were used in the previous month
  Begin taking Vixpo on the first day of the normal cycle (i.e. the first day of menstruation). If the medicine is started on the first day of menstruation, it provides immediate protection against pregnancy. The medicine may also be started between day 2 and day 5 of the cycle. However, in this case, the patient must use an additional contraceptive method (e.g. condoms) for the first 7 days of tablet intake.
• Switching from another combined hormonal contraceptive, combined contraceptive vaginal system, or transdermal contraceptive system
  Begin taking Vixpo the day after taking the last active tablet (containing active substances) of the previous contraceptive, but no later than the day following the tablet-free interval of the previous contraceptive (or after taking the last inactive tablet of the previously used contraceptive tablets). When switching from a combined contraceptive vaginal system or transdermal system, follow your doctor's advice.
• Switching from a progestogen-only method (progestogen-only pills, injections, implant, or progestogen-releasing intrauterine system (IUS))
  Switch may occur on any day from a progestogen-only pill (from an implant or IUS on the day of removal, or from an injectable form on the day of the next scheduled injection), but in all cases, additional contraceptive protection (e.g. condoms) must be used for the first 7 days of tablet intake.
• After miscarriage or termination of pregnancy
  Follow your doctor's advice.
• After childbirth
  Vixpo may be started on days 21–28 after delivery. If starting later than day 28, a mechanical contraceptive method (e.g. condoms) must be used for the first 7 days of taking the medicine.

If sexual intercourse occurred before (re)starting Vixpo, first confirm that pregnancy has not occurred or wait until the next menstrual period.

• If the patient is breastfeeding and wishes to (re)start Vixpo after childbirth
  See section "Breastfeeding".

If the patient is unsure when to start taking the medicine, she should consult her doctor.
Taking more than the recommended dose of Vixpo
There are no reports of serious harmful effects from taking too many tablets.
If several tablets are taken at once, nausea, vomiting, or vaginal bleeding may occur. Such bleeding may
even occur in girls who have not yet started menstruating but have accidentally taken this medicine.
If too many tablets of Vixpo are taken or if a child swallows some tablets, consult a doctor or
pharmacist immediately.
Missing a dose of Vixpo
The last 4 tablets in the fourth row of the blister are placebo tablets. If one of these tablets is missed,
this will not affect the medicine's effectiveness. Any missed placebo tablets should be discarded.
If the patient forgets to take a pink active tablet (tablets 1–24 in the blister), follow these steps:

• If the delay in taking the tablet is less than 24 hours , contraceptive effectiveness is maintained. Take the missed tablet as soon as remembered, then continue taking the next tablets at the usual time.
• If the delay in taking the tablet is more than 24 hours , contraceptive effectiveness may be reduced. The more tablets missed, the greater the risk of pregnancy. The risk of incomplete protection is greatest if the patient misses a pink tablet at the beginning or end of the blister. In such cases, follow the rules below (see also the chart below):
• More than one tablet has been missed from the blister
  Consult your doctor.
• One tablet was missed on days 1 to 7 (first row of tablets)
  Take the missed tablet as soon as remembered, even if this means taking two tablets at once. Continue taking the next tablets at the usual time and use additional protection , such as condoms, for the next 7 days. If sexual intercourse occurred in the week before the missed tablet, contact your doctor—pregnancy may have occurred.
• One tablet was missed on days 8 to 14 (second row of tablets)
  Take the missed tablet as soon as remembered, even if this means taking two tablets at once. Continue taking the next tablets at the usual time. Contraceptive protection is not reduced, so additional contraceptive methods are not necessary.
• One tablet was missed on days 15 to 24 (third or fourth row of tablets)
  Two options are available:
  1. Take the missed tablet as soon as remembered, even if this means taking two tablets at once. Continue taking the next tablets at the usual time. Instead of taking the white placebo tablets from this pack, discard them and start the next pack immediately (this will change the starting day).

Menstruation will most likely occur at the end of the second blister, during the intake of white placebo tablets, but spotting or menstrual-like bleeding may also occur during the intake of tablets from the second blister.

2. Alternatively, stop taking the pink active tablets and proceed directly to taking the white placebo tablets for no more than 4 days, including the days when tablets were missed (record the day on which the tablet was missed before taking the placebo tablets). If the patient wishes to start the next pack on the same day as usual, the placebo tablets may be taken for fewer than 4 days.

If either of these recommendations is followed, protection against pregnancy will be maintained.

• If the patient forgets to take any tablet from the blister and no bleeding occurs during the placebo days, this may indicate pregnancy. Consult a doctor before starting the next blister.

Missed tablet management chart

What to do in case of vomiting or severe diarrhoea
If vomiting occurs within 3–4 hours after taking a pink active tablet or if severe diarrhoea occurs, there is a risk that the active substances in the tablet have not been fully absorbed. This situation is similar to missing a tablet. In case of vomiting or diarrhoea, take another pink active tablet from a spare pack as soon as possible. If possible, take it within 24 hours of the usual tablet-taking time. If this is not possible or more than 24 hours have passed, follow the advice given in the section "Missing a dose of Vixpo".
Delayed menstruation: what you should know
Although not recommended, the patient may delay the onset of menstruation by skipping the white placebo tablets in the fourth row and immediately starting a new blister of Vixpo, continuing until the pack is finished. During intake of the second blister, light bleeding or menstrual-like bleeding may occur. Tablets from the second blister should be taken to the end, including the 4 white placebo tablets in the fourth row. Then start the next blister.
Consult your doctor before deciding to delay menstruation.
Changing the first day of menstruation: what you should know
If the patient takes the tablets as directed, bleeding will occur during the placebo tablet days. If the patient wishes to shift the day of bleeding onset, she should reduce the number of placebo days—when taking the white placebo tablets (but never increase them—maximum 4 days!). For example, if the patient usually starts taking placebo tablets on Friday and would like bleeding to start on Tuesday (3 days earlier), she must start the new blister 3 days earlier than usual. Bleeding may not occur at that time. Spotting or menstrual-like bleeding may occur instead.
If the patient is unsure how to proceed, she should consult her doctor.
Stopping use of Vixpo
The medicine may be discontinued at any time. If the patient does not wish to become pregnant, she should consult her doctor about other effective methods of contraception. If the patient wishes to become pregnant, she should stop taking Vixpo, use another contraceptive method, and wait until the first menstrual period before trying to conceive. This will make it easier to calculate the expected delivery date.
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 changes in health that the patient considers to be related to the use of Vixpo, medical advice should be sought from a doctor.

All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (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 Vixpo".

The following adverse reactions have been associated with the use of Vixpo:

• Common adverse reactions (occur in less than 1 in 10 people):
  • mood swings,
  • headache,
  • nausea,
  • breast pain, menstrual problems such as irregular periods or absence of periods.
• Uncommon adverse reactions (occur in less than 1 in 100 people):
  • depression, nervousness, drowsiness,
  • dizziness, tingling sensation,
  • migraine, varicose veins, high blood pressure,
  • abdominal pain, vomiting, indigestion, flatulence, gastritis, diarrhoea,
  • acne, itching, rash,
  • pain-related symptoms, e.g. back pain, limb pain, muscle cramps,
  • vaginal fungal infections, pelvic pain, breast enlargement, benign breast tumours, uterine/vaginal bleeding (which usually decreases with continued use of the medicine), vaginal discharge, hot flushes, vaginal inflammation, menstrual disorders, painful or scanty periods, very heavy periods, vaginal dryness, abnormal cervical smear test results, decreased interest in sex,
  • lack of energy, excessive sweating, fluid retention,
  • weight gain.
• Rare adverse reactions (occur in less than 1 in 1,000 people):
  • candidiasis (fungal infection),
  • anaemia, increased platelet count,
  • allergic reaction,
  • endocrine disorders,
  • increased appetite, loss of appetite, abnormally high blood potassium levels, abnormally low blood sodium levels,
  • inability to achieve orgasm, insomnia,
  • dizziness, tremor,
  • eye disorders, e.g. eyelid inflammation, dry eyes,
  • abnormally rapid heartbeat, dangerous 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 ischaemic attack (TIA),
    • blood clots in the liver, stomach/intestine, kidneys or eye.
  • phlebitis, nosebleeds, fainting,
  • abdominal distension, intestinal disorders, bloating, hiatus hernia, oral fungal infection, constipation, dry mouth,
  • biliary or gallbladder pain, cholecystitis,
  • yellow-brown skin patches, skin eruptions, hair loss, acneiform dermatitis, dry skin, nodular dermatitis, hirsutism, skin disorders, striae, dermatitis, photosensitive dermatitis, skin nodules,
  • painful or difficult sexual intercourse, vaginal inflammation (vulvovaginitis), post-coital bleeding, cessation of bleeding, breast cysts, increased number of breast gland cells (hyperplasia), malignant breast tumours, abnormal cervical endometrial hyperplasia, endometrial atrophy or shrinkage, ovarian cysts, uterine enlargement,
  • general malaise,
  • weight loss.

The likelihood of developing blood clots may be higher if the patient has other risk factors that increase this risk (see section 2 for further information on risk factors for blood clots and symptoms of blood clots).

The following adverse reactions have also been reported, but their frequency cannot be estimated from the available data: hypersensitivity, erythema multiforme (a rash with target-shaped redness or ulceration).

Immediate medical attention should be sought 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 accompanied by breathing difficulties (see also section "Warnings and precautions").

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. 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
Adverse reactions can also be reported to the marketing authorisation holder.

Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Vixpo medicine

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following EXP. The expiry date refers to the last day of the stated month. The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot indicates the batch number.
There are no special storage instructions for this medicine.
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 Vixpo contains
The active substances are: ethinylestradiol and drospirenone.

• Each pink coated active tablet contains 0.02 mg ethinylestradiol and 3 mg drospirenone.
• The white coated tablet does not contain any active substances. Other ingredients are:
• Active coated tablets (pink): Tablet core: monohydrate lactose, maize starch gelatinized, povidone K30 (E1201), sodium croscarmellose, polysorbate 80, magnesium stearate (E572). Tablet coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
• Inactive coated tablets (white): Tablet core: anhydrous lactose, povidone K30 (E1201), magnesium stearate. Tablet coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

What Vixpo looks like and contents of the pack
Each blister pack contains 24 pink, active coated tablets in the first, second, third and fourth row of the pack and 4 white coated placebo tablets in the fourth row.
Vixpo is available in boxes containing 1, 3, 6 and 13 blisters, each blister containing 28 (24+4) tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Laboratorios León Farma, S.A.
C/ La Vallina s/n
Pol. Ind. Navatejera, 24193 Villaquilambre, León
Spain
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Branch in Nowa Dęba,
ul. Metalowca 2, 39-460 Nowa Dęba