Vibin mini

Leaflet accompanying the packaging: information for the user

Vibin mini, 3 mg + 0.02 mg, coated tablets

Drospirenone + Ethinylestradiol

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

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person.
• If you experience any undesirable effects, including any undesirable effects not mentioned in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Important information about combined hormonal contraceptives

• If 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 resuming use after a break of 4 weeks or more
• You should be vigilant and consult a doctor if you suspect that you have symptoms of a blood clot (see section 2 "Blood clots").

Table of contents of the leaflet

1. What is Vibin mini and what is it used for

2. Important information before using Vibin mini

3. How to use Vibin mini

4. Possible side effects

5. How to store Vibin mini

6. Contents of the packaging and other information

1. What is Vibin mini and what is it used for

• Vibin mini is a contraceptive pill and is used to prevent pregnancy.
• Each of the 21 pink tablets contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol.
• The 7 white tablets that do not contain active substances are also called placebo tablets.
• Contraceptive pills that contain two hormones are called "combined" pills.

2. Important information before using Vibin mini

General notes

Before starting to take Vibin mini, you should read the information about blood clots (thrombosis) in section 2. It is especially important to read about the symptoms of a blood clot (see section 2 "Blood clots").
Before you can start taking Vibin mini, your doctor will ask you a few questions about your health and the health of your close relatives. Your doctor will also measure your blood pressure and, depending on the individual case, may also perform some other examinations.
This leaflet describes several situations in which you should stop taking Vibin mini or in which the effectiveness of Vibin mini may be reduced. In such situations, you should either not have sexual intercourse or use additional non-hormonal contraceptive products, such as condoms or other mechanical methods. You should not use the calendar method or the temperature measurement method. These methods may be unreliable because Vibin mini modifies the monthly changes in body temperature and cervical mucus.

Vibin mini, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

When not to use Vibin mini

You should not use Vibin mini if you have any of the conditions listed below. If you have any of the conditions listed below, you should inform your doctor. Your doctor will discuss with you which other contraceptive method will be more suitable for you.

• if you currently have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if you know that you have blood clotting disorders - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you need to have surgery or will be immobilized for a long time due to injury or illness or have a leg in a cast. It may be necessary to stop taking Vibin mini for a few weeks before surgery or immobilization. If you need to stop taking Vibin mini, you should ask your doctor when you can resume taking the medicine;
• if you have had a heart attack or stroke;
• if you have had angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (temporary stroke symptoms);
• if you have any of the following diseases that 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 you have (or have had) a type of migraine called "migraine with aura";
• if you have (or have had) liver disease, and liver function is still abnormal;
• if you have kidney problems (kidney failure);
• if you have (or have had) liver cancer;
• if you have (or have had) or suspect you have breast cancer or cancer of the genital organs;
• 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 allergy may be the cause of itching, rash, or swelling. You should not use Vibin mini 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 "Vibin mini and other medicines").

Additional information for special patient groups Children and adolescents

Vibin mini is not intended for use in patients who have not yet had their first menstrual period.
Women of advanced age
Vibin mini is not intended for use after menopause.
Women with liver disease
You should not take Vibin mini if you have liver disease. See also sections "When not to use Vibin mini" and "Warnings and precautions".
Women with kidney disease
You should not take Vibin mini if you have kidney failure or acute kidney failure. See also sections "When not to use Vibin mini" and "Warnings and precautions".

Warnings and precautions

When should you contact your doctor?
You should contact your doctor immediately:

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

You should tell your doctor if you have any of the following conditions.

In certain situations, you should be particularly careful when using Vibin mini or any other combined hormonal contraceptive and may need to be regularly examined by your doctor. If these symptoms appear or worsen during the use of Vibin mini, you should also tell your doctor.

• if there is a history of breast cancer in your close family;
• if you have liver disease (or gallbladder disease);
• if you have diabetes;
• if you have depression. Some women using hormonal contraceptives, including Vibin mini, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, you should 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 (a disease that affects the body's natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a genetic disorder of red blood cells);
• if you have been told you have high levels of fats in the blood (hypertriglyceridemia) or have a family history of this condition. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if you have just given birth, in which case you are at increased risk of blood clots. You should ask your doctor when you can start taking Vibin mini after giving birth;
• if you have superficial thrombophlebitis (blood clots in the veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see section "Vibin mini and other medicines");
• if you have a disease that first appeared during pregnancy or while using sex hormones (e.g., hearing loss, a blood disease called porphyria, a skin rash with blisters during pregnancy (pregnancy pemphigoid), a nervous system disease characterized by involuntary movements of the body (Sydenham's chorea));
• if you have chloasma (skin discoloration, especially on the face and neck, so-called pregnancy spots). If so, you should avoid direct exposure to sunlight or ultraviolet radiation;
• if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives potentially with difficulty breathing, you should contact your doctor immediately. Estrogen-containing products may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Vibin mini, is associated with an increased risk of blood clots compared to not using the therapy.
Blood clots can form

• in the veins (hereinafter referred to as "venous thromboembolism" or "venous thromboembolic disease"),
• in the arteries (hereinafter referred to as "arterial thromboembolism" or "arterial thromboembolic disease").

Not all patients who have had a blood clot will fully recover. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

Remember that the overall risk of having a harmful blood clot due to Vibin mini is small.

HOW TO RECOGNIZE A BLOOD CLOT

You should contact your doctor immediately if you notice any of the following symptoms:
Are you experiencing any of these symptoms?
Why is the patient likely to suffer
from this condition?
Deep vein thrombosis

• swelling of the leg or swelling along a vein in the leg or foot, especially if accompanied by: pain or tenderness in the leg, which may only be felt while standing or walking, increased temperature in the affected leg, change in skin color of the leg, such as pallor, redness, or cyanosis.

Pulmonary embolism

• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe abdominal pain.

If you are unsure, you should contact your doctor, as some of these symptoms, such as coughing or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g., a cold).
Symptoms usually occur in one eye:

• sudden loss of vision;
• painless vision disturbances, which may progress to loss of vision. Retinal vein thrombosis (blood clot in the eye)

Heart attack

• chest pain, discomfort, pressure, or heaviness;
• a feeling of squeezing, fullness, or indigestion in the chest, arm, or below the breastbone;
• a feeling of fullness, indigestion, or choking;
• discomfort in the lower part of the body radiating to the back, jaw, throat, arm, and stomach;
• sweating, nausea, vomiting, or fainting;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat.

Stroke

• sudden weakness or numbness of the face, arms, or legs, especially on one side of the body;
• sudden confusion, speech disturbances, or difficulty understanding;
• sudden vision disturbances in one or both eyes;
• sudden difficulty walking, dizziness, loss of balance, or coordination;
• sudden, severe, or prolonged headache without a 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 having another stroke.
Blood clots blocking other

• swelling and slight bluish discoloration of the skin of the legs or arms;
• severe abdominal pain (acute abdomen). blood vessels

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). However, these side effects are rare. They most often occur in the first year of using combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot breaks loose from the leg and lodges in the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in a vein highest?

The risk of forming a blood clot in a vein is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of 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 you stop taking Vibin mini, 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 Vibin mini is small.

• During one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• During one year, about 5 to 7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• During one year, about 9 to 12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Vibin mini, 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).

Risk of blood clots in one year

Women who do not usecombined hormonal pills, patches, vaginal rings, and are not
pregnant
About 2 out of 10,000 women
Women using combined hormonal contraceptive pills containing levonorgestrel,
norethisterone, or norgestimate
About 5-7 out of 10,000 women
About 9-12 out of 10,000 women

Factors that increase the risk of blood clots in veins

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

• if you are significantly overweight (body mass index (BMI) over 30 kg/m);
• if someone in your 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, you may have a hereditary blood clotting disorder;
• if you need to have surgery or will be immobilized for a long time due to injury or illness or have a leg in a cast. It may be necessary to stop taking Vibin mini for a few weeks before surgery or immobilization. If you need to stop taking Vibin mini, you should ask your doctor when you can resume taking the medicine;
• with age (especially over 35 years old);
• if you have recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor.
It is essential to tell your doctor if any of these risk factors apply to you, even if you are not sure. Your doctor may decide to stop Vibin mini.
You should inform your doctor if any of the above conditions change during the use of Vibin mini, e.g., if someone in your close family is diagnosed with a blood clot without a known cause or if you gain weight significantly.

BLOOD CLOTS IN ARTERIES

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

Similarly to blood clots in veins, blood clots in arteries can have serious consequences, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

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

• with age (over about 35 years old);
• if you smoke. While using a hormonal contraceptive like Vibin mini, it is recommended to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may recommend a different type of contraception;

If you are not able to quit smoking and are over 35 years old, your doctor may recommend a different type of contraception.
Some medicines may:

• affect the level of Vibin mini in the blood
• make Vibin mini less effective in preventing pregnancy
• cause unexpected bleeding or spotting. This applies to:
• medicines used to treat epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine), tuberculosis (e.g., rifampicin), HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz), fungal infections (e.g., griseofulvin, ketoconazole), arthritis, degenerative joint disease (etoricoxib), high blood pressure in the blood vessels of the lungs (bosentan);
• herbal products containing St. John's Wort ( Hypericum perforatum).

Vibin mini may affect the action of other medicines, such as:

• medicines containing cyclosporin,
• antiepileptic medicines containing lamotrigine (may lead to an increased frequency of seizures),
• theophylline (a medicine used for breathing problems),
• tizanidine (a medicine used to treat muscle pain and/or muscle spasms).

You should not use Vibin mini 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, as they may cause abnormal liver function test results, detectable in blood tests (increased ALT activity).
Your doctor will prescribe a different type of contraception before starting treatment with these medicines.
Vibin mini can be used again after about 2 weeks after finishing treatment with these medicines (see "When not to use Vibin mini").
Before using any medicine, you should consult your doctor or pharmacist.

Vibin mini with food and drink

Vibin mini can be taken with or without food, and if necessary, it can be taken with a small amount of water.

Lab tests

If a blood test is necessary, you should tell your doctor or laboratory staff that you are using a contraceptive, as oral hormonal contraceptives may affect the results of some tests.

Pregnancy

Pregnant women should not take Vibin mini. If you become pregnant while taking Vibin mini, you should stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking Vibin mini at any time (see also "Stopping Vibin mini").
Before using any medicine, you should consult your doctor or pharmacist.

Breastfeeding

Vibin mini is not usually recommended for use during breastfeeding. If you want to use a contraceptive while breastfeeding, you should contact your doctor.
Before using any medicine, you should consult your doctor or pharmacist.

Driving and using machines

There is no information suggesting that the use of Vibin mini affects the ability to drive or use machines.

Vibin mini contains lactose and sodium

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to use Vibin mini

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
Each blister pack contains 21 pink tablets containing active substances and 7 white placebo tablets.
The tablets of Vibin mini in two different colors are arranged in the blister pack in a specific order. One blister pack contains 28 tablets.
You should take one Vibin mini tablet every day, if necessary with a small amount of water. You can take the tablets with or without food, but you should take them every day at about the same time.
Do not confuse the tablets:the pink tablets are taken for the first 21 days, and then the white tablets are taken for the last 7 days. A new blister pack should be started immediately (21 pink tablets, followed by 7 white tablets). There is no break between the two blister packs.
Due to the differences in the composition of the tablets, it is essential to start taking the tablets from the first tablet at the top left and continue taking the tablets every day. To maintain the correct order, you should move in the direction of the arrows on the blister pack.

Preparing the blister pack

To check that you have taken a tablet every day, each Vibin mini blister pack comes with 7 self-adhesive strips with the days of the week printed on them.
You should choose a strip that starts with the first day of your period. For example, if your period starts on a Wednesday, you should choose a strip that starts with "WED". You should stick the strip onto the top of the Vibin mini blister pack, where it says "Start". This way, the first day will be above the tablet marked "Start". Each tablet has been marked above, and you can check that you have taken the correct tablet. The arrows show the order in which the tablets should be taken.
During the 7 days when the white placebo tablets are taken (placebo days), you should experience bleeding (so-called withdrawal bleeding). This bleeding usually starts 2 or 3 days after taking the last pink tablet containing active substances. After taking the last white tablet, you should start a new blister pack, regardless of whether the bleeding has stopped. This means that you will start a new blister pack on the same day of the weekand that the bleeding should occur on the same days every month.
If you take Vibin mini in this way, you will also be protected against pregnancy during the 7 days when you take the placebo tablets.

When can you start the first blister pack?

• If you have not used a hormonal contraceptive in the previous month.You should start taking Vibin mini on the first day of your period (i.e., the first day of menstruation). If you start taking Vibin mini on the first day of your period, you are immediately protected against pregnancy. You can also start taking Vibin mini on days 2-5 of your cycle, but in this case, you should use additional contraceptive products (e.g., condoms) for the first 7 days.
• Switching from a combined hormonal contraceptive or a combined hormonal contraceptive vaginal ring or patch. You should start taking Vibin mini on the day after taking the last active tablet (the last tablet containing active substances) from the previous pack, but no later than the day after the end of the tablet-free period of the previous contraceptive. In the case of switching from a combined hormonal contraceptive vaginal ring or patch, you should follow your doctor's advice.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen). You can switch from a progestogen-only pill at any time (from an implant or intrauterine system on the day of its removal or from injections when the next injection would be due), but in all these cases, you should use additional contraceptive products (e.g., condoms) for the first 7 days of taking Vibin mini tablets.
• After a miscarriage or abortion.You should follow your doctor's advice.
• After childbirth.After giving birth, you can start taking Vibin mini from the 21st to the 28th day after delivery. If you start taking Vibin mini later than on the 28th day, you should use a mechanical contraceptive method (e.g., condoms) for the first 7 days of taking Vibin mini. If you have had sexual intercourse after giving birth, before starting Vibin mini, you should first make sure that you are not pregnant or wait for your next menstrual period.
• If you are breastfeeding and want to (again) start taking Vibin mini after giving birth.You should read the section "Breastfeeding".

If you are unsure when to start taking Vibin mini, you should consult your doctor.

What to do if you take more Vibin mini than you should

There are no reports of serious, harmful effects from taking too many Vibin mini tablets at once.
If you have taken several tablets at once, you may experience symptoms such as 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 you have taken too many Vibin mini tablets or if a child has swallowed them, you should consult your doctor or pharmacist.

What to do if you forget to take Vibin mini

The tablets in the fourthrow of the blister pack are placebo tablets. If you forget to take one of them, the contraceptive effectiveness of Vibin mini is maintained. You should discard the missed tablet.
If you miss a pink tablet containing active substances from the first, second, or thirdrow of the blister pack, you should follow these instructions:

• If it has been less than 12 hourssince you missed the tablet, your protection against pregnancy is not reduced. You should take the tablet as soon as possible and then take the next tablets at the usual time.
• If it has been more than 12 hourssince you missed the tablet, your protection against pregnancy may be reduced. The more tablets you miss, the higher the risk of becoming pregnant.

The risk of reduced protection against pregnancy is highest if you miss a pink tablet at the beginning or end of the blister pack. Therefore, you should follow these rules (see also the diagram below):

• Missing more than one tablet in a blister packYou should contact your doctor.
• Missing one tablet in week 1. You should take the missed tablet as soon as possible, even if it means taking two tablets at once. You should then take the next tablets at the usual time and use additional protection, such as condoms, for the next 7 days. If you have had sexual intercourse in the week before missing the tablet, you should contact your doctor - it is possible that you are pregnant.
• Missing one tablet in week 2. You should take the missed tablet as soon as possible, even if it means taking two tablets at once. You should then take the next tablets at the usual time. Your protection against pregnancy is not reduced, and you do not need to use additional protection.
• Missing one tablet in week 3. There are two options to choose from:
• 1. Take the missed tablet as soon as possible, even if it means taking two tablets at once. Take the next tablets at the usual time. Instead of taking the white placebo tablets from this blister pack, you should discard them and start taking the tablets from the next blister pack.

Bleeding will most likely occur at the end of the second blister pack, during the white placebo tablets, but you may also experience spotting or breakthrough bleeding during the second blister pack.

• 2. You can also stop taking the pink tablets containing active substances and go directly to the white placebo tablets for up to 7 days ( before starting the placebo tablets, you should note the day on which you missed the tablet). If you want to start the next blister pack on your usual start day, you can shorten the tablet-free period to less than 7 days.

If you follow one of these two instructions, your protection against pregnancy will be maintained.

• If you have missed a tablet from the blister pack and have not experienced bleeding during the placebo days, it may mean that you are pregnant. In this case, you should contact your doctor before starting the next blister pack.

Diagram of what to do if you miss a tablet

What to do if you experience vomiting or severe diarrhea

If you vomit within 3 to 4 hours after taking a pink tablet containing active substances or experience severe diarrhea, there is a risk that the active substances from the tablet have not been fully absorbed into your body. In this case, you may need to use additional contraceptive methods (e.g., condoms) to prevent pregnancy. The situation is similar to missing a tablet. After vomiting or diarrhea, you should take another pink tablet from a reserve pack as soon as possible. If possible, you should take it within 12 hoursof the normal time of taking the tablet. If this is not possible or more than 12 hours have passed, you should follow the instructions given in the section "If you forget to take Vibin mini".

Delaying your period: what you need to know

Even though it is not recommended, you can delay your period by skipping the white placebo tablets from the fourth row of the blister pack and starting a new blister pack of Vibin mini immediately. You may experience spotting or breakthrough bleeding during the second blister pack.

• You can also stop taking the pink tablets containing active substances and go directly to the white placebo tablets for up to 7 days ( before starting the placebo tablets, you should note the day on which you missed the tablet). If you want to start the next blister pack on your usual start day, you can shorten the tablet-free period to less than 7 days.

You should ask your doctor for advice before deciding to delay your period.
Before delaying your period, you should consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If side effects occur, especially severe and persistent or changes in health that the patient considers related to the use of Vibin mini, you should consult a doctor.
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). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, please refer to point 2 "Important information before taking Vibin mini".
You should immediately contact a doctor 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 with potential difficulty breathing (see also "Warnings and precautions").
The following side effects have been associated with the use of Vibin mini.
Common side effects(occurring in less than 1 in 10 people):

• mood swings
• headaches
• abdominal pain (stomach)
• acne
• breast pain, breast enlargement, breast tenderness, painful or irregular periods
• weight gain.

Uncommon side effects(occurring in less than 1 in 100 people):

• candidiasis (fungal infection)
• herpes simplex (cold sore)
• allergic reactions
• increased appetite
• depression, nervousness, sleep disorders
• tingling and numbness, dizziness of vestibular origin
• vision problems
• heart rhythm disorders or extremely rapid heart rate
• blood clots (thrombosis) in the lungs (pulmonary embolism), high blood pressure, low blood pressure, migraine, varicose veins
• sore throat
• nausea, vomiting, gastritis and/or enteritis, diarrhea, constipation
• sudden swelling of the skin and/or mucous membranes (e.g., tongue or throat) and/or difficulty swallowing or urticaria with difficulty breathing (angioedema)
• hair loss (alopecia), eczema, itching, rashes, dry skin, seborrheic dermatitis
• neck pain, limb pain, muscle cramps
• urinary tract infection
• breast tumor (benign and malignant), milk secretion in non-pregnant women (galactorrhea), ovarian cysts, sudden flushing of the face, amenorrhea, very heavy periods, discharge, vaginal infection or inflammation, vaginal dryness, pelvic pain (lower abdomen), abnormal Pap smear, decreased libido
• fluid retention, lack of energy, excessive thirst, increased sweating
• weight loss
• generalized pain.

Rare side effects(occurring in less than 1 in 1,000 people):

• asthma
• hearing problems
• erythema nodosum (characterized by painful, red nodules on the skin)
• erythema multiforme (characterized by a rash with red, painful borders)
• harmful blood clots in a vein or artery, for example: in the leg or foot (e.g., deep vein thrombosis) in the lungs (e.g., pulmonary embolism) heart attack stroke mini-stroke or transient stroke-like symptoms, known as transient ischemic attack (TIA) blood clots in the liver, stomach/intestine, kidneys, or eye.

The likelihood of blood clots may be higher if the patient has any other risk factors (see point 2 for further information on risk factors for blood clots and symptoms of blood clots).

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Monitoring of Adverse Reactions, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vibin mini

The medicine should be stored out of sight and reach of children.
Store at a temperature below 30°C.
Do not use this medicine after the expiry date stated on the blister and carton.
The expiry date refers to the last day of the specified month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Vibin mini contains

The Vibin mini blister pack contains 21 pink tablets containing active substances in rows 1, 2, and 3, and 7 white placebo tablets in row 4.

Active substance tablets:

The active substances of Vibin mini are ethinylestradiol 0.02 mg and drospirenone 3 mg.
Other ingredients of the medicine are:
Core: lactose monohydrate, cornstarch, povidone, croscarmellose sodium, polysorbate 80, magnesium stearate.
Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), brown iron oxide (E172).

Placebo tablets:

Core: anhydrous lactose, povidone, magnesium stearate.
Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

What Vibin mini looks like and what the pack contains

Active substance tablets are pink, round, film-coated tablets with a diameter of approximately 5.7 mm.
Placebo tablets are white, round, film-coated tablets with a diameter of approximately 5.7 mm.
Vibin mini is available in packs of 1, 2, or 3 blisters, each containing 28 tablets (21 active substance tablets and 7 placebo tablets).
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

Laboratorios Leon Farma, S.A.
C/ La Vallina, s/n,
Polígono Industrial Navatejera,
Villaquilambre
24193 (León), Spain
Polpharma S.A.
Production Plant in Nowa Dęba, ul. Metalowca 2, 39-460 Nowa Dęba
Date of last revision of the leaflet:February 2025