Package leaflet: Information for the user

Vibin mini, 3 mg + 0,02 mg, coated tablets
Drospirenone + Ethinylestradiol
Please read all of this leaflet carefully before starting to take this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them.
If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. 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 during the first year of use or after restarting use following a break of 4 weeks or more.
Be alert and consult your doctor if you suspect symptoms of blood clots (see section 2 “Blood clots”).

Contents of the leaflet
1. What Vibin mini is and what it is used for
2. What you need to know before taking Vibin mini
3. How to take Vibin mini
4. Possible side effects
5. How to store Vibin mini
6. Contents of the pack and other information

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

Vibin mini is a contraceptive tablet 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, which do not contain active substances, are also called placebo tablets.
Contraceptive tablets containing two hormones are known as “combined” pills.

2. What you need to know before taking Vibin mini

General warnings
Before starting to take Vibin mini, you should read the information about blood clots (thrombosis) in section 2. It is especially important to be aware of the symptoms of blood clots (see section 2 “Blood clots”).
Before you can start taking Vibin mini, your doctor will ask you several questions about your health and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your individual case, may perform other tests.
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 cases, you should either avoid sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. Do not use the calendar method or temperature monitoring method. These methods may be unreliable because Vibin mini alters the monthly changes in body temperature and cervical mucus.
Vibin mini, like other hormonal contraceptives, does not protect against infection with HIV (AIDS) or other sexually transmitted diseases.

When not to take Vibin mini
Do not take Vibin mini if you have any of the conditions listed below. If you have any of the following conditions, inform your doctor. Your doctor will discuss with you which other contraceptive method may be more suitable.

if you currently have (or have ever had) a blood clot in the veins of your legs (deep vein thrombosis), in your lungs (pulmonary embolism), or in other organs;
if you know you have a blood clotting disorder – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
if you are undergoing surgery or will be immobile 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 condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
if you have any of the following conditions that may increase the risk of an arterial blood clot:
- severe diabetes with blood vessel damage,
- very high blood pressure,
- very high levels of fats in the blood (cholesterol or triglycerides),
- a condition called hyperhomocysteinemia.
if you currently have (or have ever had in the past) a type of migraine called “migraine with aura”;
if you currently have (or have ever had in the past) liver disease and liver function remains abnormal;
if you have kidney problems (kidney failure);
if you currently have (or have ever had in the past) liver tumour;
if you currently have (or have ever had in the past) or suspect breast cancer or genital organ cancer;
if you have any 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 cause itching, rash or swelling. Do not take 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.
Elderly women
Vibin mini is not intended for use after menopause.
Women with liver function disorders
Do not take Vibin mini if you suffer from liver disease. See also sections “When not to take Vibin mini” and “Warnings and precautions”.
Women with kidney function disorders
Do not take Vibin mini if you suffer from kidney failure or acute kidney failure. See also sections “When not to take Vibin mini” and “Warnings and precautions”.

Warnings and precautions
When should you contact your doctor?
Seek immediate medical advice if:

you notice possible symptoms of blood clots, which may indicate that you have a blood clot in your leg (deep vein thrombosis), in your lungs (pulmonary embolism), a heart attack or stroke (see section below “Blood clots”). For a description of symptoms of these serious side effects, see “How to recognize blood clots”.

Tell your doctor if you have any of the following conditions.
In certain situations, extra caution is needed when taking Vibin mini or any other combined hormonal contraceptive, and regular check-ups by your doctor may be necessary. If any of these symptoms develop or worsen during treatment with Vibin mini, inform your doctor.

if there is currently or has ever been 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 you experience mood changes or symptoms of depression, 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 affecting the body’s natural defence system);
if you have haemolytic uraemic syndrome (a blood clotting disorder causing kidney failure);
if you have sickle cell anaemia (an inherited disease of red blood cells);
if you have been diagnosed with high levels of fats in the blood (hypertriglyceridaemia) or have a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
if you require surgery or will be immobile for a long time (see section 2 “Blood clots”);
if you have recently given birth, as you are at increased risk of blood clots. Consult your doctor for advice on how soon you can start taking Vibin mini after childbirth;
if you have superficial thrombophlebitis (inflammation of veins under the skin);
if you have varicose veins;
if you have epilepsy (see section “Vibin mini and other medicines”);
if you have a condition that first appeared during pregnancy or previous use of sex hormones (e.g. hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (pemphigoid gestationis), a nervous system disorder with involuntary movements (Sydenham’s chorea));
if you currently have or have ever had chloasma (skin pigmentation, especially on the face and neck, also known as melasma). If so, avoid direct exposure to sunlight or ultraviolet radiation;
if you experience symptoms of hereditary or acquired angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives potentially with breathing difficulties, seek immediate medical attention. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
Using combined hormonal contraceptives such as Vibin mini is associated with an increased risk of blood clots compared to not using hormonal contraception. In rare cases, a blood clot may block a blood vessel and cause serious problems.
Blood clots may occur:

in veins (referred to as “venous thrombosis” or “venous thromboembolic disease”),
in arteries (referred to as “arterial thrombosis” or “arterial thromboembolic events”).

Recovery after a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots caused by taking Vibin mini is small.

HOW TO RECOGNIZE BLOOD CLOTS
Seek immediate medical advice if you experience any of the following symptoms:
Are you experiencing any of these symptoms? Why might you be suffering?

swelling of the leg or swelling along a vein in the leg or foot, Deep vein thrombosis especially if accompanied by: o pain or tenderness in the leg, which may occur only when standing or walking, o increased warmth in the affected leg, o skin discoloration of the leg, e.g. pallor, redness, or blueness.
sudden unexplained shortness of breath or rapid breathing; Pulmonary embolism
sudden cough without an obvious cause, which may be associated with coughing up blood;
sudden chest pain, which may worsen on deep breathing;
severe dizziness or vertigo;
rapid or irregular heartbeat;
severe stomach pain.

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

sudden loss of vision;
painless visual disturbances, which may progress to vision loss.
chest pain, discomfort, pressure, heaviness; Heart attack
squeezing or fullness in the chest, arm, or below the breastbone;
feeling of fullness, indigestion, or choking;
discomfort in the lower body radiating to the back, jaw, throat, arm, or stomach;
sweating, nausea, vomiting, or dizziness;
extreme weakness, anxiety, or shortness of breath;
rapid or irregular heartbeat.
sudden weakness or numbness of the face, arms, or legs, Stroke especially on one side of the body;
sudden confusion, speech or understanding difficulties;
sudden visual disturbances in one or both eyes;
sudden difficulty walking, dizziness, loss of balance or coordination;
sudden, severe or prolonged headache without known cause;
loss of consciousness or fainting with or without seizures.

In some cases, stroke symptoms may be transient
with almost immediate and complete recovery,
but you should seek immediate medical advice, as
you may be at risk of a further stroke.

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

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

Using combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thrombosis). However, these side effects are rare. They most commonly occur during the first year of using combined hormonal contraceptives.
If blood clots form in the veins of the leg or foot, this may lead to deep vein thrombosis.
If a blood clot travels from the leg and lodges in the lungs, this may cause pulmonary embolism.
In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of venous blood clots highest?
The risk of venous blood clots is highest during the first year of first-time use of combined hormonal contraceptives. The risk may also be higher when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, but it remains higher than when not using combined hormonal contraceptives.
If you stop taking Vibin mini, the risk of blood clots returns to normal within a few weeks.

What determines the risk of blood clots?
The risk depends on your natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of blood clots in the legs or lungs associated with taking Vibin mini 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 to 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 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 your individual medical history (see “Factors increasing the risk of blood clots” below).

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

Factors increasing the risk of venous blood clots
The risk of blood clots associated with taking Vibin mini is small, but certain factors may increase this risk. The risk is higher:

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

The risk of blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor.
It is important to tell your doctor if any of these factors apply to you, even if you are unsure. Your doctor may decide to stop using Vibin mini.
Inform your doctor if any of the above conditions change during treatment with Vibin mini, e.g. if a close relative is diagnosed with unexplained thrombosis or if you gain significant weight.

BLOOD CLOTS IN ARTERIES
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots may lead to serious consequences, such as heart attack or stroke.

Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with taking Vibin mini is very low, but may increase:

with age (over about 35 years);
if you smoke. When using a hormonal contraceptive such as Vibin mini, you are advised to stop smoking. If you
cannot stop 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 a close relative has had a heart attack or stroke at a young age (under 50 years). In this case, you may also be at increased risk of heart attack or stroke;
if you or a close relative have high levels of fats in the blood (cholesterol or triglycerides);
if you have migraines, especially migraines with aura;
if you have heart disease (valve disorder, heart rhythm disorder called atrial fibrillation);
if you have diabetes.

If you have more than one of the above conditions or if any of them are particularly severe, the risk of blood clots may be further increased.
Inform your doctor if any of the above conditions change during treatment with Vibin mini, e.g. if you start smoking, a close relative is diagnosed with unexplained thrombosis, or if you gain significant weight.

Vibin mini and cancer
Slightly more cases of breast cancer have been observed in women using combined hormonal contraceptives, but it is not known whether this is caused by the medicine. For example, more tumours may be detected in women using combined hormonal contraceptives because these women are examined more frequently by doctors. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives.
It is important to examine your breasts regularly and contact your doctor if you feel any lumps.
In rare cases, benign liver tumours and, even more rarely, malignant liver tumours have been reported in women using combined hormonal contraceptives. If you experience unusual, severe abdominal pain, contact your doctor.

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

What to do if no bleeding occurs during the placebo tablet period
If all the active pink tablets have been taken correctly, without vomiting or severe diarrhoea, and no other medicines have been taken, it is very unlikely that you are pregnant.
If the expected bleeding does not occur for two consecutive cycles, this may indicate pregnancy. Contact your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Vibin mini and other medicines
Always tell your doctor about all medicines or herbal products you are currently taking or have recently taken, and any medicines you plan to take. Also inform any other doctor or dentist prescribing another medicine (or pharmacist) that you are taking Vibin mini. They may advise you to use additional contraceptive methods (e.g. condoms), and if so, for how long, and whether dosage adjustment of other medicines is needed.
Some medicines may:

affect the blood levels of Vibin mini,
make Vibin mini less effective in preventing pregnancy,
cause unexpected bleeding or spotting. These include:
medicines used to treat epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine),
tuberculosis (e.g. rifampicin),
HIV and hepatitis C virus infections (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, for example:

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

Do not take 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 detected in blood tests (increased ALT activity).
Your doctor will prescribe another type of contraception before starting treatment with these medicines.
Vibin mini can be restarted approximately 2 weeks after stopping treatment with these medicines (see “When not to take Vibin mini”).

Before taking any medicine, consult your doctor or pharmacist.

Vibin mini with food and drink
Vibin mini can be taken regardless of meals. If needed, it can be taken with a small amount of water.

Laboratory tests
If blood tests are required, inform your doctor or laboratory staff that you are using a contraceptive product, as oral hormonal contraceptives may affect the results of certain tests.

Pregnancy
Do not take Vibin mini if you are pregnant. If you become pregnant while taking Vibin mini, stop taking it immediately and contact your doctor. If you wish to become pregnant, you may stop taking Vibin mini at any time (see also “Stopping Vibin mini”).

Before taking any medicine, consult your doctor or pharmacist.

Breast-feeding
Vibin mini is generally not recommended while breast-feeding. If you wish to use a contraceptive during breast-feeding, contact your doctor.

Before taking any medicine, consult your doctor or pharmacist.

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

Vibin mini contains lactose and sodium
If you have been previously diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered “sodium-free”.

3. How to take Vibin mini

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
Each blister contains 21 pink tablets containing active substances and 7 white placebo tablets.
The Vibin mini tablets in two different colours are arranged in a specific order on the blister. One blister contains 28 tablets.
Take one Vibin mini tablet every day, with or without a small amount of water. The tablets may be taken with or without food, but should be taken daily at approximately the same time.
Do not confuse the tablets: the pink tablets are taken for the first 21 days, followed by the white placebo tablets for the last 7 days. A new blister should be started immediately (21 pink tablets, followed by 7 white tablets). Therefore, there is no break between two blisters.
Due to differences in tablet composition, it is essential to start from the first tablet at the top left corner and continue taking the tablets each day in sequence. To maintain the correct order, move in the direction of the arrows printed on the blister.
Preparing the blister
To help track daily tablet intake, each Vibin mini blister is supplied with 7 self-adhesive strips printed with days of the week.
Select the strip where the first day of the week corresponds to the day you start the pack. For example, if the first day of use falls on a Wednesday, choose the strip where the first day is marked “WED”. Apply the label to the top of the Vibin mini blister, in the area marked “Start”. This way, the first day appears above the tablet marked “Start”. Each tablet is thus clearly identified, allowing you to verify that the correct tablet has been taken. The arrows indicate the order in which tablets should be taken.
During the 7 days when the white placebo tablets are taken (placebo week), a withdrawal bleed should occur (so-called withdrawal bleeding). This bleeding usually starts on the 2nd or 3rd day after taking the last active pink tablet of Vibin mini. After taking the last white tablet, start the next blister immediately, regardless of whether bleeding is still ongoing. This means that each new blister will always be started on the same day of the week, and the withdrawal bleed should occur on the same days each month.
If the patient takes Vibin mini as directed, protection against pregnancy is maintained even during the 7 days when taking the placebo tablets.
When to start the first blister?

If no hormonal contraceptive has been used in the previous month: Start taking Vibin mini on the first day of the normal menstrual cycle (i.e. the first day of menstruation). If the patient starts taking Vibin mini on the first day of her period, she is protected against pregnancy immediately. It is also possible to start between days 2 and 5 of the cycle, but in this case, additional contraceptive methods (e.g. condoms) must be used for the first 7 days.
Switching from a combined hormonal contraceptive or a combined contraceptive vaginal ring or transdermal patch: Start taking Vibin mini preferably the next day after taking the last active tablet (last tablet containing active substances) of the previous pack, but no later than the day after the tablet-free interval of the previous contraceptive product ends (or after the last inactive tablet of the previous product). If switching from a combined contraceptive vaginal ring or transdermal patch, follow your doctor’s advice.
Switching from a progestogen-only method (progestogen-only mini-pill, injection, implant, or intrauterine system releasing progestogen): Switching can occur on any day from the progestogen-only mini-pill (from an implant or intrauterine system, switch on the day of removal; from an injectable form, switch on the day of the next scheduled injection), but in all these cases, additional contraceptive methods (e.g. condoms) must be used for the first 7 days of tablet intake.
After miscarriage or termination of pregnancy: Follow your doctor’s advice.
After childbirth: After delivery, Vibin mini can be started between day 21 and 28. If the patient starts taking the medicine later than day 28, a mechanical contraceptive method (e.g. condoms) should be used for the first seven days of taking Vibin mini. If sexual intercourse has occurred after childbirth, the patient should ensure she is not pregnant before starting Vibin mini, or wait until the next menstrual bleed.
If the patient is breastfeeding and wishes to (re)start taking Vibin mini after childbirth: Read section “Breast-feeding”.

If the patient is unsure when to start taking the medicine, she should consult her doctor.
Taking more Vibin mini than prescribed
There are no reports of serious harmful effects from taking too many Vibin mini tablets.
If several tablets are taken at once, symptoms such as nausea, vomiting, or vaginal bleeding may occur. Such bleeding may even occur in girls who have not yet started menstruating but have accidentally taken this medicine.
If an overdose of Vibin mini tablets is taken or if a child swallows any tablets, consult a doctor or pharmacist immediately.
Missed dose of Vibin mini
The tablets in the fourth row of the blister are placebo tablets. If the patient misses one of these, the contraceptive efficacy of Vibin mini remains unchanged. Discard the missed tablet.
If a pink tablet containing active substances from the 1st, 2nd or 3rd row of the blister is missed, follow the instructions below:

If less than 12 hours have passed since the missed tablet, protection against pregnancy is not reduced. Take the missed tablet as soon as possible, then continue taking the following tablets at the usual time.
If more than 12 hours have passed since the missed tablet, protection against pregnancy may be reduced. The more tablets missed, the greater the risk of becoming pregnant.

The risk of inadequate protection is greatest if a pink tablet is missed at the beginning or end of the blister. Therefore, follow the rules below (see also the chart below):

Missing more than one tablet in a blister: Contact your doctor.
Missing one tablet in week 1: Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the following tablets at the usual time and use additional protection, such as condoms, for the next 7 days. If sexual intercourse occurred in the week before the missed tablet, consult your doctor – pregnancy may be possible.
Missing one tablet in week 2: Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the following tablets at the usual time. Contraceptive protection is not reduced, and no additional protection is needed.
Missing one tablet in week 3: Two options are available:
1. Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the following tablets at the usual time. Instead of taking the white placebo tablets from this blister, discard them and immediately start taking tablets from the next blister.

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

Alternatively, stop taking the active pink tablets and immediately start taking the white placebo tablets for up to 7 days ( before starting the placebo tablets, note the day on which the tablet was missed ). If the patient wishes to start the new blister on her usual starting day, the tablet-free interval can be shortened to less than 7 days.

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

If the patient has missed any tablet from the blister and no withdrawal bleeding occurs during the placebo tablet period, this may indicate that she is pregnant. In this case, consult a doctor before starting the next blister.

Missed tablet management chart
What to do if vomiting or severe diarrhoea occurs
If vomiting occurs within 3 to 4 hours after taking a pink tablet containing active substances, or if severe diarrhoea occurs, there is a risk that the active substances have not been fully absorbed. In such a case, additional contraceptive methods (e.g. condoms) may be needed to prevent pregnancy. The situation is similar in effect to missing a tablet. After vomiting or diarrhoea, take another pink tablet from a spare pack as soon as possible. If possible, take it within 12 hours of the usual tablet-taking time. If this is not possible or more than 12 hours have passed, follow the advice given in the section “Missed dose of Vibin mini”.
Delaying withdrawal bleeding: what you should know
Although not recommended, it is possible to delay withdrawal bleeding by skipping the white placebo tablets in the 4th row and immediately starting a new Vibin mini blister, continuing until it is finished. Spotting or breakthrough bleeding may occur during intake of the second blister. Complete the second blister by taking 7 white placebo tablets from the 4th row. Then start the next blister.
You may consult your doctor for advice before deciding to delay withdrawal bleeding.
Changing the first day of bleeding: what you should know
If the patient takes the tablets as instructed, bleeding will start during the placebo tablet week. If a change in this day is desired, it can be achieved by shortening ( but never extending – maximum 7 days !) the placebo tablet period – when the white placebo tablets are taken. For example, if the placebo tablet period starts on Friday and the patient wishes to change it to Tuesday (3 days earlier), start the new blister 3 days earlier than usual. If the placebo tablet period is very short (e.g. 3 days or less), no bleeding may occur during these days. As a result, spotting or breakthrough bleeding may occur.
If the patient is unsure how to proceed, she should contact her doctor.
Stopping use of Vibin mini
Vibin mini can be discontinued at any time. If the patient does not wish to become pregnant, she should consult her doctor about other effective methods of birth control. If she wishes to become pregnant, she should stop taking Vibin mini and wait for a menstrual period before trying to conceive. This will make it easier to calculate the expected date of delivery.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
If any adverse effects occur, especially severe and persistent ones, or changes in health status that the patient considers to be related to the use of Vibin mini, medical advice should be sought from a physician.
All women using combined hormonal contraceptives have an increased risk of venous blood clots (venous thromboembolic disease) or arterial blood clots (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before taking Vibin mini".
Immediate medical attention should be sought if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria possibly associated with breathing difficulties (see also section "Warnings and precautions").
The following adverse effects have been associated with the use of Vibin mini.
Common adverse effects (occur in less than 1 in 10 people):

mood swings
headache
abdominal pain (stomach pain)
acne
breast pain, breast enlargement, breast tenderness, painful or irregular menstruation
weight gain.

Uncommon adverse effects (occur in less than 1 in 100 people):

candidiasis (fungal infection)
cold sores (herpes simplex)
allergic reactions
increased appetite
depression, nervousness, sleep disorders
sensations of tingling and numbness, vertigo
vision problems
heart rhythm disturbances or abnormally fast heartbeat
blood clot (thrombosis) in the lungs (pulmonary embolism), high blood pressure, low blood pressure, migraine, varicose veins
sore throat
nausea, vomiting, gastritis and/or enteritis, diarrhoea, constipation
sudden swelling of the skin and/or mucous membranes (e.g. tongue or throat) and/or difficulty swallowing or urticaria with breathing difficulties (angioedema)
hair loss (alopecia), eczema, itching, rashes, dry skin, seborrhoeic skin disorders (seborrhoeic dermatitis)
neck pain, limb pain, muscle cramps
urinary tract infection
breast lump (benign and cancer), milk secretion in non-pregnant women (galactorrhoea), ovarian cysts, sudden facial flushing, absence of menstruation, very heavy menstrual bleeding, vaginal discharge, vaginal infection or inflammation, vaginal dryness, lower abdominal pain (pelvic pain), abnormal cervical smear (Papanicolaou test or Pap smear), decreased libido
fluid retention, lack of energy, excessive thirst, increased sweating
weight loss
generalized pain.

Rare adverse effects (occur in less than 1 in 1,000 people):

asthma
hearing problems
nodular erythema (manifesting as painful red nodules on the skin)
erythema multiforme (manifesting as a rash with red, painful rings)
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 ischaemic attack symptoms, known as transient ischaemic attack (TIA)
o blood clots in the liver, stomach/intestines, kidneys or eye.

The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2 for further information on risk factors increasing the likelihood of blood clots and symptoms of blood clots).
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Vibin mini

Keep this medicine out of sight and reach of children.
Store 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 stated month.
The label on the packaging shows the expiry date after the abbreviation EXP, and the batch number after the abbreviation Lot/LOT.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What 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.
Tablets containing active substances:
The active substances in this medicine are ethinylestradiol 0.02 mg and drospirenone 3 mg.
Other components of the medicine are:
Tablet core: monohydrate lactose, pregelatinized corn starch, povidone, sodium croscarmellose, polysorbate 80, magnesium stearate.
Tablet 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:
Tablet core: anhydrous lactose, povidone, magnesium stearate.
Tablet coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.
What Vibin mini looks like and contents of the pack
The tablets containing active substances are pink, 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 mini is available in boxes containing 1, 2, or 3 blisters, each blister containing 28 tablets (21 tablets containing active substances and 7 placebo tablets).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
Laboratorios Leon Farma, S.A.
C/ La Vallina, s/n,
Polígono Industrial Navatejera,
Villaquilambre
24193 (León), Spain
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Site in Nowa Dęba, ul. Metalowca 2, 39-460 Nowa Dęba