Vixpo

Package Leaflet: Information for the Patient

Vixpo, 3 mg + 0.02 mg, Film-Coated Tablets

Drospirenone + Ethinylestradiol

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• The package leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in the package leaflet, they should tell their 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 blood clots in veins and arteries, especially in the first year of use or after restarting use after a break of 4 weeks or more.
• Vigilance should be exercised and a doctor consulted if the patient suspects that blood clot symptoms have occurred (see section 2, "Blood Clots").

Table of Contents of the Package Leaflet

1. What is Vixpo and What is it Used For

2. Important Information Before Taking Vixpo

When not to take Vixpo
Warnings and precautions
Blood clots
Vixpo and cancer
Irregular bleeding
What to do if bleeding does not occur during the placebo days
Vixpo and other medicines
Lab tests
Pregnancy and breastfeeding
Driving and using machines
Vixpo contains lactose

3. How to Take Vixpo

Preparing the blister pack
When to start the first blister pack
Taking more Vixpo than prescribed
Missing a dose of Vixpo
What to do in case of vomiting or severe diarrhea
Delaying menstruation: what to know
Changing the first day of menstruation: what to know
Stopping Vixpo

4. Possible Side Effects

5. How to Store Vixpo

6. Contents of the Pack and Other Information

1. What is Vixpo and What is it Used For

• Vixpo is a contraceptive pill 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 do not contain active ingredients and are called placebo tablets.
• Contraceptive pills containing two hormones are called combined hormonal contraceptives.

2. Important Information Before Taking Vixpo

General Notes

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

Like other hormonal contraceptives, Vixpo does not protect against HIV (AIDS) or other sexually transmitted diseases.

When Not to Take Vixpo

Vixpo should not be taken if the patient has any of the following conditions.
If the patient has any of the following conditions, she should inform her doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.

• if the patient currently has (or has ever had) a blood clot in the deep veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if the patient knows she has a blood clotting disorder - for example, deficiency of protein C, protein S, antithrombin III, factor V Leiden, or antiphospholipid antibodies;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2, "Blood Clots");
• if the patient has had a heart attack or stroke;
• if the patient has (or has ever had) angina pectoris (a condition that causes severe chest pain and may be a sign of a heart attack) or a transient ischemic attack (a temporary stroke-like condition);
• if the patient has any of the following diseases, which may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fats in the blood (cholesterol or triglycerides);
• a disease called hyperhomocysteinemia;
• if the patient has (or has ever had) a type of migraine called "migraine with aura";
• if the patient has (or has ever had) liver disease, and liver function is still not normal;
• if the patient has kidney disease (kidney failure);
• if the patient has (or has ever had) liver cancer;
• if the patient has (or has ever had) or is suspected to have breast cancer or cancer of the genital organs;
• if the patient has unexplained vaginal bleeding;
• if the patient is 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.

Vixpo should not be taken if the patient has hepatitis C and is taking medicines containing ombitasvir, 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 menstruation.
Women of Childbearing Age
Vixpo is not intended for use after menopause.
Women with Liver Disease
Vixpo should not be taken if the patient has liver disease. See sections "When not to take Vixpo" and "Warnings and precautions".
Women with Kidney Disease
Vixpo should not be taken if the patient has kidney failure or acute kidney failure. See sections "When not to take Vixpo" and "Warnings and precautions".

Warnings and Precautions

When to contact a doctor?
The patient should contact a doctor immediately

• if the patient notices any of the following symptoms, which could be signs of a blood clot: swelling of the leg or along a vein in the leg or foot, especially if it is accompanied by pain or tenderness in the leg, increased warmth in the affected leg, change in color of the leg, or tightness or swelling in a vein just below the surface of the skin (see section 2, "Blood Clots").

In certain situations, the patient should be cautious when taking Vixpo or any other combined hormonal contraceptive. Regular medical check-ups may also be necessary.

The Patient Should Tell Her Doctor if Any of the Following Conditions Occur or Worsen While Taking Vixpo

Before starting to take Vixpo, the patient should discuss the following with her doctor or pharmacist:

• if a close relative has had breast cancer or has ever had breast cancer;
• if the patient has cancer;
• if the patient has liver disease (such as cholestasis, which may cause yellowing of the skin and itching) or gallstones (such as gallstones);
• if the patient has kidney disease and is taking medicines that increase potassium levels in the blood. The doctor may recommend monitoring potassium levels in the blood.
• if the patient has diabetes;
• if the patient has depression. Some women taking hormonal contraceptives, including Vixpo, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, the patient should contact her doctor as soon as possible for further medical advice;
• if the patient has Crohn's disease or ulcerative colitis (a chronic inflammatory bowel disease);
• if the patient has systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if the patient has hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if the patient has sickle cell disease (a genetic disorder that affects red blood cells);
• if the patient has elevated 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 the patient needs to have surgery or will be immobilized for a long time (see section 2, "Blood Clots");
• if the patient has just given birth, she is at a higher risk of blood clots. The patient should contact her doctor for advice on when to start taking Vixpo after giving birth;
• if the patient has superficial thrombophlebitis (inflammation of a vein just below the surface of the skin);
• if the patient has varicose veins;
• if the patient has epilepsy (see "Vixpo and other medicines");
• if the patient has a condition that first appeared during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disease called porphyria, a skin rash that occurs during pregnancy, a neurological disorder that causes involuntary movements of the body);
• if the patient has high blood pressure that does not respond to treatment;
• if the patient has or has ever had chloasma (a skin condition that causes brown patches on the face), especially on the face. In this case, the patient should avoid direct exposureto sunlight or ultraviolet radiation while taking Vixpo.
• if the patient experiences symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives that may cause difficulty breathing, the patient should contact her doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

Blood Clots

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

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

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

It is Important to Remember that the Overall Risk of Having a Harmful Blood Clot Due to Vixpo is Small.

How to Recognize a Blood Clot

The patient should contact her doctor immediately if she notices any of the following symptoms.

Blood Clots in Veins

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

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

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

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

What Factors Increase the Risk of Blood Clots in Veins?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of blood clots in the legs or lungs associated with Vixpo 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 Vixpo, will develop blood clots.
• The risk of blood clots depends on the patient's individual medical history (see "Factors that Increase the Risk of Blood Clots" below).

Factors that Increase the Risk of Blood Clots in Veins

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

• if the patient is overweight (body mass index (BMI) over 30 kg/m^2);
• if someone in the patient's close family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years old); In this case, the patient may have a hereditary blood clotting disorder;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2, "Blood Clots");
• with age (especially over 35 years old);
• if the patient has just given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Air travel (more than 4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell the doctor if any of these risk factors are present, even if the patient is not sure. The doctor may decide to stop Vixpo.

Blood Clots in Arteries

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

Like blood clots in veins, blood clots in arteries can cause serious complications, such as a heart attack or stroke.

Factors that Increase the Risk of Blood Clots in Arteries

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

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

If the patient has more than one of these conditions or if any of them are severe, the risk of blood clots may be even higher.
The patient should inform her doctor if any of these conditions change while taking Vixpo, for example, if she starts smoking, if someone in her close family has a blood clot without a known cause, or if she gains weight significantly.

Vixpo and Cancer

Women taking combined oral contraceptives have a slightly higher risk of breast cancer than those not taking them, but it is not known whether this is caused by the medicine. It is possible that more breast cancers are detected in women taking combined oral contraceptives because they are examined by their doctors more often.
The incidence of breast cancer decreases gradually after stopping combined hormonal contraceptives. It is essential to examine the breasts regularly and contact a doctor if a lump is found.
Women taking oral contraceptives have also reported rare cases of benign liver tumors and, even more rarely, malignant liver tumors. If the patient experiences symptoms such as severe abdominal pain, liver enlargement (which may cause yellowing of the skin and eyes), vomiting blood, or black tarry stools (which may be signs of stomach bleeding), she should contact her doctor.

Irregular Bleeding

During the first few months of taking Vixpo, unexpected bleeding (bleeding outside of the placebo days) may occur. If such bleeding persists for more than a few months or starts after a few months, the doctor should investigate the cause.

What to Do if Bleeding Does Not Occur During the Placebo Days

If all the active tablets have been taken correctly, there has been no vomiting or severe diarrhea, and no other medicines have been taken, it is very unlikely that the patient is pregnant.
If the expected bleeding does not occur twice in a row, it may indicate pregnancy. The patient should contact her doctor immediately. The patient should only start the next pack of Vixpo when she is sure she is not pregnant.

Vixpo and Other Medicines

The patient should tell her doctor about all medicines she is currently taking or has recently taken, as well as any medicines she plans to take, including herbal remedies. The patient should also inform any other doctor or dentist prescribing other medicines (or pharmacist) that she is taking Vixpo. They may tell her whether she needs to use additional contraceptive methods (e.g., condoms) and for how long.
Vixpo should not be taken if the patient has hepatitis C and is taking medicines containing ombitasvir, paritaprevir, and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as they may cause abnormal liver function test results (increased ALT activity).
The doctor will prescribe a different type of contraception before starting treatment with these medicines.
Vixpo can be taken again about 2 weeks after stopping these medicines (see "When not to take Vixpo").
Certain medicines may affect the levels of Vixpo in the blood and make it less effective in preventing pregnancyor cause unexpected bleeding. These include:

• medicines used to treat:
• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, felbamate, topiramate);
• tuberculosis (e.g., rifampicin);
• HIV and hepatitis C infections (medicines called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz) or other infectious diseases (griseofulvin or ketoconazole);
• arthritis, degenerative joint disease (etoricoxib);
• high blood pressure in the blood vessels of the lungs (bosentan);
• herbal remedies containing St. John's Wort.

Vixpo may affect the action of other medicines, such as:

• medicines containing cyclosporin;
• the antiepileptic medicine lamotrigine (this may lead to an increased risk 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 potassium levels in the blood if the patient is taking certain medicines used to treat heart conditions (such as diuretics).

Lab Tests

If a blood test is necessary, the patient should tell her doctor or laboratory staff that she is taking oral contraceptives, as hormonal contraceptives may affect the results of some tests.

Pregnancy and Breastfeeding

Pregnancy
Women who are pregnant should not take Vixpo. If the patient becomes pregnant while taking Vixpo, she should stop taking it immediately and contact her doctor.
If the patient wants to become pregnant, she can stop taking Vixpo at any time (see "Stopping Vixpo").
Breastfeeding
It is generally not recommended to take Vixpo while breastfeeding. If the patient wants to take oral contraceptives while breastfeeding, she should contact her doctor.

Driving and Using Machines

There is no information to suggest that taking Vixpo affects the ability to drive or use machines.

Vixpo Contains Lactose and Sodium

If the patient has been diagnosed with an intolerance to some sugars, she should contact her doctor before taking Vixpo.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to Take Vixpo

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should contact her doctor or pharmacist.
Each blister pack contains 24 active pink tablets and 4 inactive white tablets.
The tablets are arranged in order. The blister pack contains 28 tablets.
The patient should take one tablet of Vixpo every day, with a little water if necessary. The tablets can be taken at any time of day, with or without food, but the patient should take them at the same time every day.
The patient should be careful not to mix up the tablets:for the first 24 days, she should take a pink active tablet, and then a white inactive tablet for the last 4 days. Then, she should start taking the tablets from a new blister pack (24 pink active tablets and 4 white inactive tablets) immediately. There is no break between the two packs.

Preparing the Blister Pack

To help the patient remember to take her tablets, a 7-day self-adhesive strip is included with each blister pack. The patient should choose a strip that starts with the first day of her period. For example, if the first day of her period is a Wednesday, she should use a strip that starts with "WED".
The strip should be stuck to the blister pack above the words "This sticker starts here". In this way, the first day is below the tablet marked "Start". Each tablet is marked above it, and the patient can check that she has taken the correct tablets. The arrows show the order in which the tablets should be taken.
During the 4 days when the patient takes the white placebo tablets (placebo days), she should experience bleeding (so-called withdrawal bleeding). This usually starts on the 2nd or 3rd day after taking the last pink active tablet. After taking the last white placebo tablet, the patient should start the next blister pack, regardless of whether the bleeding has stopped. This means that the patient should always start the new pack on the same day of the week, and the withdrawal bleeding should start on the same day every month.

• The patient is still protected against pregnancy during these 4 days when she is taking the placebo tablets.

When to Start the First Blister Pack

• If the patient has not used hormonal contraceptives in the previous monthThe patient should start taking Vixpo on the first day of her period (i.e., the first day of bleeding). If the patient starts taking Vixpo on the first day of her period, she will be protected against pregnancy immediately. The patient can also start taking Vixpo between the 2nd and 5th day of her period, but she will need to use an additional contraceptive method (e.g., condoms) for the first 7 days of tablet-taking.
• Changing from another combined hormonal contraceptive or a combined hormonal contraceptive vaginal ring or patchThe patient should start taking Vixpo the day after she takes the last active tablet from her previous contraceptive (but no later than the day after she takes the last inactive tablet). If the patient is changing from a combined hormonal contraceptive vaginal ring or patch, she should start taking Vixpo on the day she would normally start a new ring or patch.
• Changing from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine device (IUD))The patient can switch to Vixpo at any time, but she should use an additional contraceptive method (e.g., condoms) for the first 7 days of tablet-taking.
• After a miscarriage or abortionThe patient should follow her doctor's advice.
• After childbirthThe patient can start taking Vixpo between 21 and 28 days after giving birth. If the patient starts taking Vixpo more than 28 days after giving birth, she should use an additional contraceptive method (e.g., condoms) for the first 7 days of tablet-taking.

If the patient has had sex since giving birth and before starting Vixpo again, she should make sure she is not pregnant or wait until her next period.

• If the patient is breastfeeding and wants to start taking Vixpo again after giving birthSee "Breastfeeding".

If the patient is unsure when to start taking Vixpo, she should consult her doctor.

Taking More Vixpo Than Prescribed

There are no reports of serious harmful effects from taking too many Vixpo tablets at once.
If the patient takes several tablets at once, she may experience nausea, vomiting, or vaginal bleeding. This type of bleeding may occur even in girls who have not yet started their periods, but have taken the medicine by mistake.
If the patient takes too many Vixpo tablets or if a child accidentally swallows some, she should contact her doctor or pharmacist immediately.

Missing a Dose of Vixpo

The last 4 tablets in the fourth rowof the blister pack are placebo tablets. If the patient misses one of these tablets, it will not affect the effectiveness of the medicine. The patient should discard any placebo tablets she has missed.
If the patient misses one of the active pink tablets (tablets 1-24 in the blister pack), she should:

• if the delay in taking the tablet is less than 24 hours, the contraceptive effectiveness is maintained. The patient should take the tablet as soon as she remembers and then take the next tablets at the usual time.
• if the delay in taking the tablet is more than 24 hours, the contraceptive effectiveness may be reduced. The more tablets the patient misses, the higher the risk of pregnancy. The risk of reduced contraceptive protection is highest if the patient misses a pink tablet at the beginning or end of the pack. In this situation, the patient should follow the instructions below (see also the diagram below):
• Missed more than one tablet in the packThe patient should consult her doctor.
• Missed one tablet in days 1-7 (first row of tablets)The patient should take the missed tablet as soon as she remembers, even if it means taking two tablets at once. The patient should then take the next tablets at the usual time and use additional contraception, such as condoms, for the next 7 days. If the patient had sex in the week before missing the tablet, she should contact her doctor - she may be pregnant.
• Missed one tablet in days 8-14 (second row of tablets)The patient should take the missed tablet as soon as she remembers, even if it means taking two tablets at once. The patient should then take the next tablets at the usual time. The contraceptive protection is not reduced, so there is no need to use additional contraception.
• Missed one tablet in days 15-24 (third or fourth row of tablets)The patient has two options:
• 1. The patient should take the missed tablet as soon as she remembers, even if it means taking two tablets at once. The patient should then take the next tablets at the usual time. Instead of taking the white placebo tablets from this pack, the patient should discard them and start a new pack (this will change the start day).

The patient will most likely experience her period at the end of the second pack, during the placebo days, but she may experience spotting or breakthrough bleeding during the second pack.

• 2. The patient can also stop taking the active pink tablets and go directly to the placebo tablets for no more than 4 days (including the days she missed tablets) (make a note of the day she missed the tablet). If the patient wants to start the next pack on the same day as usual, she can take the placebo tablets for less than 4 days.

If the patient follows one of these options, her contraceptive protection will be maintained.

• if the patient misses any of the tablets in the pack and does not experience bleeding during the placebo days, she may be pregnant. The patient should contact her doctor before starting the next pack.

What to Do if the Patient Vomits or Has Severe Diarrhea

If the patient vomits within 3-4 hours of taking an active pink tablet or has severe diarrhea, there is a risk that the active ingredients in the tablet may not have been fully absorbed into the bloodstream.
The situation is almost the same as if the patient had missed a tablet. If the patient vomits or has severe diarrhea, she should take another active pink tablet from a spare pack as soon as possible. If possible, she should take it within 24 hours of the normal time for taking the tablet. If this is not possible or more than 24 hours have passed, the patient should follow the instructions for missing a tablet (see "Missing a dose of Vixpo").

4. Possible Side Effects

Like any medicine, this medicine may cause side effects, although not everybody gets them. If any side effects occur, especially severe and persistent ones, or changes in health that the patient considers related to the use of Vixpo, a doctor should be consulted.
In all women taking combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). To get detailed information about the various risk factors associated with the use of combined hormonal contraceptives, you should read section 2. "Important information before taking Vixpo".
The following side effects have been associated with the use of Vixpo:

• Common side effects(occurring in less than 1 in 10 people):
• mood swings,
• headache,
• nausea,
• breast pain, menstrual problems, such as irregular menstruation or absence of menstruation.
• Uncommon side effects(occurring in less than 1 in 100 people):
• depression, nervousness, drowsiness,
• dizziness, tingling sensation,
• migraine, varicose veins, high blood pressure,
• abdominal pain, vomiting, indigestion, gas, gastritis, diarrhea,
• acne, itching, rash,
• painful conditions, e.g. back pain, limb pain, muscle cramps,
• fungal infections of the vagina, pelvic pain, breast enlargement, benign breast tumors, uterine/vaginal bleeding (which usually decreases during continued use of the drug), vaginal discharge, hot flashes, vaginal inflammation, menstrual disorders, painful, scanty menstruation, very heavy menstruation, vaginal dryness, abnormal Pap smear, decreased libido,
• lack of energy, excessive sweating, fluid retention in the body,
• weight gain.
• Rare side effects(occurring in less than 1 in 1,000 people):
• candidiasis (fungal infection),
• anemia, increased platelet count,
• allergic reaction,
• hormonal disorders (endocrine),
• increased appetite, loss of appetite, abnormally high potassium levels in the blood, abnormally low sodium levels in the blood,
• inability to achieve orgasm, insomnia,
• dizziness, tremors,
• eye disorders, e.g. blepharitis, dry eyes,
• abnormally fast heartbeat, dangerous blood clots in a vein or artery, for example:
• in the leg or foot (e.g. deep vein thrombosis),
• in the lungs (e.g. pulmonary embolism),
• heart attack,
• stroke,
• mini-stroke or transient stroke symptoms, known as transient ischemic attack (TIA),
• blood clots in the liver, stomach/intestine, kidneys, or eye.
• phlebitis, nosebleeds, fainting,
• enlarged abdomen, intestinal disorders, feeling of bloating, esophageal hernia, oral thrush, constipation, dry mouth,
• biliary colic or cholecystitis,
• yellow-brown spots on the skin, rashes, hair loss, acne-like skin inflammation, dry skin, nodular skin inflammation, excessive hair growth, skin disorders, stretch marks, skin inflammation, photoallergic skin inflammation, skin tumors,
• difficult or painful sexual intercourse, vaginal inflammation (vulvovaginitis), post-coital bleeding, amenorrhea, breast cysts, increased number of breast gland cells (hyperplasia), malignant breast tumors, abnormal growth of the cervical mucosa, atrophy or shrinkage of the endometrium, ovarian cysts, uterine enlargement,
• general malaise,
• weight loss.

The likelihood of blood clots may be higher if a patient has any other risk factors (see section 2 for more information about risk factors for blood clots and symptoms of blood clots).
Additionally, the following side effects have been reported, the frequency of which cannot be determined from the available data: hypersensitivity, erythema multiforme (rash with redness in the shape of targets or ulcers).
A doctor should be consulted immediately if a patient experiences any of the following symptoms of angioedema: facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or urticaria potentially with breathing difficulties (see also "Warnings and precautions").

Reporting Side Effects

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

5. How to Store Vixpo

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the specified month. The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot indicates the batch number.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Package Contents and Other Information

What Vixpo Contains

The active substances of the medicine are: ethinylestradiol and drospirenone.

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

What Vixpo Looks Like and What the Package Contains

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Laboratorios León Farma, S.A.
C/ La Vallina s/n
Pol. Ind. Navatejera, 24193 Villaquilambre, León
Spain
Polpharma S.A.
Production Plant in Nowa Dęba,
Metalowca 2, 39-460 Nowa Dęba
Date of last update of the leaflet:October 2024