Vibin

Leaflet accompanying the packaging: information for the user

Vibin, 3 mg + 0.03 mg, film-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 them.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist.

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 and what is it used for

2. Important information before using Vibin

3. How to use Vibin

4. Possible side effects

5. How to store Vibin

6. Contents of the pack and other information

1. What is Vibin and what is it used for

• Vibin is a contraceptive pill and is used to prevent pregnancy.
• Each of the 21 yellow 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

General notes

Before starting to take Vibin, 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, 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 tests.
This leaflet describes several situations in which you should stop taking Vibin, or in which the effectiveness of Vibin 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 modifies the monthly changes in body temperature and cervical mucus.

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

When not to use Vibin

You should not use Vibin if you have any of the following conditions. If you have any of the following conditions, 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 you have blood clotting disorders - such as 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 (see section 2 "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have had in the past) 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, 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 you have (or have had in the past) a type of migraine called "migraine with aura";
• if you currently have (or have had in the past) pancreatitis;
• if you currently have (or have had in the past) liver disease, and liver function is still abnormal;
• if you have kidney problems (kidney failure);
• if you currently have (or have had in the past) liver cancer;
• if you currently have (or have had in the past) 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. Do not use Vibin if you have hepatitis C and are taking medicines containing ombitasvir, paritaprevir, and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also "Vibin and other medicines").

Additional information for special patient groups Children and adolescents

Vibin is not intended for use in patients who have not yet had their first menstrual period.
Women of advanced age
Vibin is not intended for use after menopause.
Women with liver disease
You should not take Vibin if you have liver disease. See also sections "When not to use Vibin" and "Warnings and precautions".
Women with kidney disease
You should not take Vibin if you have kidney failure or acute kidney failure. See also sections "When not to use Vibin" 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 a blood clot, which may indicate that you have a blood clot in your leg (deep vein thrombosis), a blood clot in your lungs (pulmonary embolism), a heart attack, or a stroke (see below "Blood clots"). To find 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 or any other combined hormonal contraceptive, and you may also need to be regularly examined by your doctor. If these symptoms occur or worsen while using Vibin, you should also tell your doctor:

• if there is a history of breast cancer in your close family;
• if you have liver or gallbladder disease;
• if you have kidney disease and are taking medicines that increase potassium levels in your blood;
• if you have diabetes;
• if you have depression. Some women using hormonal contraceptives, including Vibin, 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 disease of red blood cells);
• if you have been diagnosed with high levels of fats in your blood (hypertriglyceridemia) or have a family history of this disease. 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, as you are at increased risk of blood clots. You should consult your doctor to find out how soon you can start taking Vibin 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 and other medicines");
• if you have a disease that first occurred 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 body movements (Sydenham's chorea));
• if you currently have or have had 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 facial swelling, tongue and/or pharyngeal swelling, and/or difficulty swallowing, 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, is associated with an increased risk of blood clots, compared to not using the therapy.
Blood clots can occur

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

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

Remember that the overall risk of harmful blood clots caused by Vibin 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 these symptoms?
Deep vein thrombosis

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by: pain or tenderness in the leg, which may only be felt while standing or walking, increased temperature in the affected leg, changes in skin color, 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 stomach pain.

If you are unsure, you should contact your doctor,
because 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 vision loss. Retinal vein thrombosis (blood clot in the eye)
• chest pain, discomfort, pressure, heaviness;
• a feeling of squeezing or fullness in the chest, arm, or below the breastbone;
• a feeling of fullness, indigestion, or choking;
• a feeling of discomfort in the lower body radiating to the back, jaw, throat, arm, and stomach;
• sweating, nausea, vomiting, or dizziness;
• extreme weakness, anxiety, or shortness of breath;
• rapid or irregular heartbeat. Heart attack
• 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 headaches without a known cause; Stroke
• loss of consciousness or fainting with or without seizures.

In some cases, stroke symptoms may be temporary 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 stomach 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 moves from the leg and settles 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, 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 is small.

• During a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• During a 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 a year, about 9 to 12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Vibin, 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 a 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 is small, but some factors can increase this risk. The risk is higher:
Women taking Vibin

• if you are significantly overweight (body mass index (BMI) over 30 kg/m);
• if someone in your close family has had blood clots in their 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 for a few weeks before surgery or immobilization. If you need to stop taking Vibin, you should ask your doctor when you can resume taking it;
• 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.
Long-haul flights (>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.
You should inform your doctor if any of the above conditions change while taking Vibin, e.g., if someone in your close family is diagnosed with a blood clot without a known cause or if you gain significant weight.

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 heart attack or stroke associated with Vibin is very small, but it may increase:

• with age (over about 35 years);
• if you smoke. While using a hormonal contraceptive like Vibin, it is recommended to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may recommend using a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your close family has had a heart attack or stroke at a young age (under 50 years old). In this case, you may also be at increased risk of having a heart attack or stroke;
• if you or someone in your close family has high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraines, especially migraines with aura;
• if you have heart disease (valve damage, arrhythmia called atrial fibrillation);
• if you have diabetes.

If you have more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher.
You should inform your doctor if any of the above conditions change while taking Vibin, e.g., if you start smoking, if someone in your close family is diagnosed with a blood clot without a known cause, or if you gain significant weight.

Vibin and cancer

Women using combined hormonal contraceptives have a slightly higher incidence of breast cancer, but it is not known if this is caused by the medicine. For example, it may be that more tumors are detected in women using combined hormonal contraceptives because these women are examined by doctors more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives.
It is essential to examine your breasts regularly and contact your doctor if you feel any lump.
Women using combined hormonal contraceptives have also been reported to have, in rare cases, benign liver tumors, and in even rarer cases, malignant liver tumors. If you experience severe abdominal pain, you should contact your doctor.

Irregular bleeding

During the first few months of taking Vibin, you may experience unexpected bleeding (bleeding outside the period of taking the white placebo tablets). If such bleeding lasts longer than a few months or starts after a few months, your doctor should investigate the cause.

What to do if bleeding does not occur during the period of taking the placebo tablets

If you have taken all the active yellow tablets correctly, have not vomited, have not had severe diarrhea, and have not taken any other medicines, it is very unlikely that you are pregnant.
If the expected bleeding does not occur for two consecutive periods, it may mean that you are pregnant.
You should contact your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Vibin and other medicines

Always tell your doctor about all medicines or herbal products you are currently taking or have recently taken, as well as any medicines you plan to take. You should also tell any other doctor or dentist prescribing another medicine (or pharmacist) that you are taking Vibin. They may tell you that you need to use additional contraceptive methods (e.g., condoms) and for how long, and whether you need to change the dosage of other medicines you are taking.
Some medicines may:

• affect the level of Vibin in your blood
• make Vibin 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 infection and hepatitis C virus infection (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).
• If you are taking any of the above medicines with Vibin, you should use additional contraceptive methods (e.g., condoms) during treatment and for 28 days after stopping treatment.

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

• medicines containing cyclosporin,
• antiepileptic medicines containing lamotrigine (may increase the 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 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 this may cause abnormal liver function test results (increased ALT activity).
Your doctor will prescribe a different type of contraception before starting treatment with these medicines.
Vibin can be used again after about 2 weeks after stopping treatment with these medicines (see "When not to use Vibin").
Before taking any medicine, you should consult your doctor or pharmacist.

Vibin with food and drink

Vibin 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 taking a contraceptive, as oral hormonal contraceptives may affect the results of some tests.

Pregnancy

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

Breastfeeding

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

Driving and using machines

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

Vibin contains lactose

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to use Vibin

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 pack contains 21 yellow active tablets and 7 white placebo tablets.
The tablets in Vibin are colored differently and are arranged in the pack in a specific order.
One pack contains 28 tablets.
You should take one Vibin 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 yellow active tablets are taken for the first 21 days, and then the white placebo tablets are taken for the last 7 days. A new pack is started immediately (21 yellow active tablets, followed by 7 white placebo tablets). There is no break between the two packs.
Due to the different composition of the tablets, it is essential to start taking them from the first tablet at the top left and continue taking them every day in the direction of the arrows on the pack.

Preparing the pack

To check that you are taking a tablet every day, each Vibin 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 the strip that starts with "WED". You should stick the strip to the top of the Vibin pack, where it says "Start". This way, the first day will be above the tablet marked "Start". Each tablet is marked above, and you can check if 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), bleeding should occur (so-called withdrawal bleeding). This bleeding usually starts on the 2nd or 3rd day after taking the last yellow active tablet. After taking the last white tablet, you should start a new pack, regardless of whether the bleeding has stopped. This means that each new pack will be started on the same day of the week, and the bleeding should also occur on the same days every month.
If you take Vibin in this way, you are also protected against pregnancy during the 7 days when you take the placebo tablets.

When can you start the first pack?

• If you are not using a hormonal contraceptive in the previous month.You should start taking Vibin on the first day of your period (i.e., the first day of menstruation). If you start taking Vibin on the first day of your period, you are immediately protected against pregnancy. You can also start taking Vibin on days 2-5 of your cycle, but in this case, you should use additional contraceptive methods (e.g., condoms) for the first 7 days.
• Switching from a combined hormonal contraceptive or a combined hormonal contraceptive vaginal ring or patch.You can start taking Vibin preferably 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 previous contraceptive's tablet-free period (or after the last inactive tablet from the previous pack). When 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 at any time from a progestogen-only pill (from an implant or intrauterine system on the day of its removal or when the next injection would be due) but in all these cases, you should use additional contraceptive methods (e.g., condoms) for the first 7 days of taking Vibin.
• After a miscarriage or abortion.Follow your doctor's advice.
• After childbirth.You can start taking Vibin from 21 to 28 days after giving birth. If you start taking it later than 28 days, you should use a mechanical contraceptive method (e.g., condoms) for the first 7 days of taking Vibin. If you have had sexual intercourse after giving birth, before starting Vibin, you should first make sure you are not pregnant or wait for your next period.
• If you are breastfeeding and want to (again) start taking Vibin after childbirth.You should read the section "Breastfeeding".

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

What to do if you take more Vibin than you should

There are no reports of serious, harmful effects from taking too many Vibin tablets at once.
If several tablets are taken at the same time, symptoms such as nausea, vomiting, or vaginal bleeding may occur.
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 tablets or if a child has swallowed them, you should consult your doctor or pharmacist.

What to do if you miss a Vibin tablet

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

• If less than 12 hourshave passed since missing the tablet, contraceptive protection is not reduced. You should take the tablet as soon as possible and then take the next tablets at the usual time.
• If more than 12 hourshave passed since missing the tablet, contraceptive protection may be reduced. The more tablets you miss, the higher the risk of becoming pregnant.

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

• Missing more than one tablet in a packYou should contact your doctor.
• Missing one tablet in week 1You should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. 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 had sexual intercourse in the week before missing the tablet, it is possible that you may become pregnant. In this case, you should contact your doctor.
• Missing one tablet in week 2You should take the missed tablet as soon as possible, even if it means taking two tablets at the same time. You should then take the next tablets at the usual time. Contraceptive protection 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 the same time. Then take the next tablets at the usual time. Instead of taking the white placebo tablets from this pack, you should discard them and start taking tablets from the next pack.

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

• 2. You can also stop taking the yellow active tablets and go directly to the white placebo tablets for up to 7 days (including the days you missed tablets). (Before taking the placebo tablets, you should note the day you missed the tablet).

If you follow one of these two instructions, contraceptive protection will be maintained.

• If you miss any tablet from the pack and do not experience bleeding during the placebo period, you may be pregnant. In this case, you should contact your doctor before starting the next pack. How to proceed if you miss a tablet

What to do if you vomit or have severe diarrhea

If you vomit within 3-4 hours of taking a yellow active tablet or experience severe diarrhea, there is a risk that the active substances from the tablet have not been fully absorbed into your body. The situation is similar to missing a tablet. After vomiting or diarrhea, you should take another yellow active tablet from a reserve pack as soon as possible. If possible, you should take it within 12 hoursof the normal time you take your tablet. If this is not possible or more than 12 hours have passed, you should follow the instructions given in the section "What to do if you miss a Vibin tablet".

Delaying the start of bleeding: what you need to know

Even though it is not recommended, delaying the start of bleeding is possible by skipping the white placebo tablets from the fourth row and going directly to a new pack of Vibin until you finish it. You may experience spotting or breakthrough bleeding during the second pack. You should finish the second pack by taking the 7 white placebo tablets from the fourth row. Then start taking tablets from the next pack.
You can ask your doctor for advice before deciding to delay the start of bleeding.
from withdrawal bleeding.

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 ones, or changes in health status that the patient considers related to the use of Vibin, she should consult a doctor.
All women using combined hormonal contraceptives have an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2 "Important information before using Vibin".
You should immediately consult 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 hives potentially with difficulty breathing (see also the "Warnings and precautions" section).
The following side effects have been associated with the use of Vibin:
Common side effects(occurring in less than 1 in 10 people):

• headaches, depression,
• migraine,
• nausea,
• menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness,
• thick, white vaginal discharge and vaginal yeast infections.

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

• breast enlargement, changes in libido (interest in sex),
• high blood pressure, low blood pressure,
• vomiting, diarrhea,
• acne, skin rash, severe itching, hair loss (alopecia),
• vaginal infections,
• fluid retention and changes in body weight.

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

• allergic reactions (hypersensitivity), asthma,
• breast discharge,
• hearing problems,
• blockage of a blood vessel by a blood clot that has formed in another part of the body,
• erythema nodosum (characterized by painful, red lumps on the skin) or erythema multiforme (characterized by a rash with red, painful borders)
• harmful blood clots in a vein or artery, for example: o in the leg or foot (e.g., deep vein thrombosis) o in the lungs (e.g., pulmonary embolism) o heart attack o stroke o mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack (TIA) o 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 section 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 Monitoring of Adverse Reactions to Medicinal Products of the 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

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 after EXP. The expiry date refers to the last day of the month. The notation on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT indicates the batch number.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Vibin contains

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

Tablets containing active substances:

The active substances of Vibin are ethinylestradiol 0.03 mg and drospirenone 3 mg.
Other ingredients of the medicine are:
Core of the tablet: lactose monohydrate, corn starch, pregelatinized corn starch, crospovidone, povidone K 30, polysorbate 80, magnesium stearate.
Coating of the tablet: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172).

Placebo tablets:

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

What Vibin looks like and what the pack contains

The active substance tablets are yellow, round, film-coated tablets with a diameter of approximately 5.7 mm.
The placebo tablets are white, round, film-coated tablets with a diameter of approximately 5.7 mm.
Vibin is available in packs of 1 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
Metalowca 2, 39-460 Nowa Dęba
Date of last revision of the leaflet:February 2025