Vibin

Package leaflet: Information for the user

Vibin, 3 mg + 0,03 mg, coated tablets
Drospirenone + Ethinylestradiol
Please read all of this leaflet carefully before taking 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Important information about combined hormonal contraceptives:

• When used correctly, they are one of the most reliable reversible methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting 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”).

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

1. What Vibin is and what it is used for

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

2. What you need to know before taking Vibin

General remarks
Before starting to take Vibin, 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, your doctor will ask 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 certain 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 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 measurement method. These methods may be unreliable because Vibin modifies monthly changes in body temperature and cervical mucus.
Vibin, like other hormonal contraceptives, does not protect against infection with HIV (AIDS) or other sexually transmitted diseases.

When not to take Vibin
Do not take Vibin if you have any of the conditions listed below. If you have any of the conditions listed below, inform your doctor. Your doctor will discuss with you which other contraceptive method would 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 disorders affecting blood clotting – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you require surgery or will be immobile for a prolonged period (see section 2 “Blood clots”);
• if you have had a heart attack or stroke;
• if you have (or have 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, which may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage,
  • very high blood pressure,
  • very high levels of fats in the blood (cholesterol or triglycerides),
  • a condition called hyperhomocysteinemia.
• if you currently have (or have 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 remains abnormal;
• if you have kidney function disorders (kidney failure);
• if you currently have (or have had in the past) liver tumour;
• if you currently have (or have 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 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 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.
Elderly women
Vibin is not intended for use after menopause.
Women with liver function disorders
Do not take Vibin if you suffer from liver disease. See also sections “When not to take Vibin” and “Warnings and precautions”.
Women with kidney function disorders
Do not take Vibin if you suffer from kidney failure or acute kidney failure. See also sections “When not to take Vibin” 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 blood clots 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, special care is needed when taking Vibin or any other combined hormonal contraceptive, and regular check-ups by your doctor may be necessary. If any of these conditions develop or worsen during treatment with Vibin, you should also inform your doctor:

• if breast cancer is currently present or has occurred in the past 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 the 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 serious and sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact your doctor as soon as possible for further medical advice;
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (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 disorder of red blood cells);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a positive family history for this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2 “Blood clots”);
• if you have recently given birth, as you are at increased risk of blood clots. Consult your doctor for advice on how soon you can start taking Vibin 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 and other medicines”);
• if you have a condition that first occurred during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (pemphigoid gestationis), a nervous system disorder with involuntary movements (Sydenham’s chorea));
• if you currently have or have had in the past 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 angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing or urticaria potentially with breathing difficulties, seek immediate medical advice. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
Using combined hormonal contraceptives such as Vibin is associated with an increased risk of blood clots compared to not using such therapy. In rare cases, a blood clot may block a blood vessel and cause serious 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 disorders”).

Full recovery after a blood clot is not always possible. 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 is small.

HOW TO RECOGNIZE BLOOD CLOTS
Seek immediate medical advice if you experience any of the following symptoms:
Why?
Do you experience any of these symptoms?
Are you likely suffering from?

• Swelling of the leg or swelling along a vein in the leg or foot, Deep vein thrombosis especially if accompanied by:
  • pain or tenderness in the leg, which may occur only when standing or walking,
  • increased warmth in the affected leg,
  • skin discoloration of the leg, e.g., pallor, redness, or blueness.
• Sudden unexplained shortness of breath or rapid breathing; Pulmonary embolism
• Sudden cough without obvious cause, possibly accompanied by coughing up blood;
• Sudden chest pain, which may worsen with 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; Myocardial infarction
• Feeling of tightness 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 disorders;
• Sudden visual disturbances in one or both eyes;
• Sudden walking disorders, 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 immediate medical advice should be sought as you may be at risk of a further stroke.

• Swelling and slightly blue discoloration of the skin of 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 veins in 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 (same or different product) after a break of 4 weeks or more.
After the first year, the risk decreases, but it remains higher than in women not using combined hormonal contraceptives.
If you stop taking Vibin, the risk of blood clots returns to normal within a few weeks.

What does the risk of blood clots depend on?
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 is small.

• In one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In one year, about 5 to 7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In one year, about 9 to 12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Vibin, 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 About 2 out of 10,000 women
tablets, patches, vaginal systems and are not
pregnant
Women using combined hormonal contraceptive About 5-7 out of 10,000 women
tablets containing levonorgestrel,
norethisterone or norgestimate
Women using Vibin About 9-12 out of 10,000 women

Factors increasing the risk of venous blood clots
The risk of blood clots associated with taking Vibin is small, but some 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 immobilized for a prolonged period due to injury or illness, or have a leg in plaster. It may be necessary to stop taking Vibin several weeks before surgery or immobilization. If you need to stop taking Vibin, 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.
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 discontinue Vibin.
Inform your doctor if any of these conditions change during treatment with Vibin, 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 cause 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 is very small, but may increase:

• with age (over about 35 years);
• if you smoke. When using a hormonal contraceptive such as Vibin, you are advised to stop smoking. If you cannot stop smoking and are over 35 years old, your doctor may recommend another 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 these conditions change during treatment with Vibin, e.g., if you start smoking, a close relative is diagnosed with unexplained thrombosis, or if you gain significant weight.

Vibin and cancer
In women using combined hormonal contraceptives, breast cancer is observed slightly more often, but it is not known whether this is caused by the medicine. For example, it may be that more tumours are 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 lump.
Rarely, benign liver tumours and, even more rarely, malignant liver tumours have been reported in women using combined hormonal contraceptives. If you experience an unusual, severe abdominal pain, contact your doctor.

Breakthrough bleeding
During the first few months of taking Vibin, 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 if it starts after several months, your doctor should investigate the cause.

What to do if no bleeding occurs during the placebo tablet period
If all yellow active tablets have been taken correctly, without vomiting, severe diarrhoea, or use of other medicines, it is very unlikely that you are pregnant.
If 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 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. You should also inform any other doctor or dentist prescribing another medicine (or pharmacist) that you are taking Vibin. They will advise whether you need to use additional contraceptive methods (e.g., condoms), for how long, and whether dosage adjustments of other medicines are needed.
Some medicines may:

• affect the blood levels of Vibin,
• cause Vibin to be 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 (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz), fungal infections (e.g., griseofulvin, ketoconazole), arthritis, osteoarthritis (etoricoxib), high blood pressure in the pulmonary blood vessels (bosentan);
• herbal products containing St John’s wort ( Hypericum perforatum ).

If you are taking any of the above medicines together 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, 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 muscle spasms).

Do not take 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 detected in blood tests (increased ALT activity).
Your doctor will prescribe another type of contraception before starting treatment with these medicines.
Vibin may be restarted approximately 2 weeks after stopping treatment with these medicines (see “When not to take Vibin”).
Before taking any medicine, consult your doctor or pharmacist.

Vibin with food and drink
Vibin may be taken independently of meals. If necessary, 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 hormonal contraceptive, as oral hormonal contraceptives may affect the results of certain tests.

Pregnancy
Vibin must not be taken during pregnancy. If you become pregnant while taking Vibin, stop immediately and contact your doctor.
If you wish to become pregnant, you may stop taking Vibin at any time (see also “Stopping Vibin”).

Before taking any medicine, consult your doctor or pharmacist.

Breast-feeding
Vibin 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 affects the ability to drive or operate machinery.

Vibin contains lactose
If you have been previously diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Vibin

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 yellow tablets containing active substances and 7 white placebo tablets.
The Vibin tablets in two different colours are arranged in a specific order within the blister.
One blister contains 28 tablets.
Take one Vibin tablet daily, with a small amount of water if necessary.
The tablets may be taken with or without food, but they should be taken every day at about the
same time.
Do not confuse the tablets: take the yellow tablets for the first 21 days, followed by the white
placebo tablets for the last 7 days. A new blister should be started immediately (21 yellow tablets,
followed by 7 white tablets). There is therefore no break between two blisters.
Due to the differing composition of the tablets, it is essential to start from the first tablet in the
top left corner and continue taking the tablets each day in sequence. To maintain the correct order,
follow the direction of the arrows on the blister.
Preparing the blister
To help track daily tablet intake, each Vibin blister pack includes 7 self-adhesive strips printed with
days of the week. Choose the strip where the first day corresponds to the day you start the pack.
For example, if the first day of use is Wednesday, select the strip starting with “WED”. Apply the
label to the top of the Vibin blister pack, in the area marked “Start”. This way, the first day is
positioned above the tablet marked “Start”. Each tablet is labelled above, allowing you to verify that
the correct tablet has been taken. Arrows indicate the order of tablet intake.
During the 7 days when the white placebo tablets are taken (placebo week), withdrawal bleeding
should occur (so-called withdrawal bleeding). This bleeding usually begins on the 2nd or 3rd day
after the last active yellow tablet of Vibin is taken. 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 begin on the same day of the week, and withdrawal bleeding should occur on the same
days each month.
If the patient takes Vibin as directed, she is protected against pregnancy during the 7 days when
placebo tablets are taken.
When to start the first blister?

• If no hormonal contraceptive has been used in the previous month: Start taking Vibin on the first day of the normal cycle (i.e. the first day of menstruation). If the patient starts taking Vibin on the first day of her period, she is immediately protected against pregnancy. Alternatively, the tablets may be started on days 2–5 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 the day after the last active tablet (last tablet containing active substances) of the previous contraceptive pack, but no later than the day after the tablet-free interval of the previous contraceptive ends (or after the last inactive tablet of the previous contraceptive). When 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 may be started between days 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. If sexual intercourse has occurred after childbirth, the patient should first confirm she is not pregnant, or wait until the next menstrual bleeding before starting Vibin.
• If the patient is breastfeeding and wishes to (re)start taking Vibin 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 than you should
There are no reports of serious harmful effects from taking too many Vibin 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 too many Vibin tablets are taken or if a child swallows them, consult a doctor or pharmacist.
If you forget to take Vibin
The tablets in the fourth row of the blister are placebo tablets. If the patient forgets to take one of
these, the contraceptive efficacy of Vibin remains unchanged. Discard the missed tablet.
If a yellow 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 next 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 yellow 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 once. Continue taking the remaining 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, pregnancy may have occurred. In this case, contact your doctor.
• Missing one tablet in week 2: Take the missed tablet as soon as possible, even if this means taking two tablets at once. Continue taking the remaining tablets at the usual time. Protection against pregnancy is not reduced, and additional protection is not needed.
• Missing one tablet in week 3:

There are two options:

1. Take the missed tablet as soon as possible, even if this means taking two tablets at once. Continue taking the remaining tablets at the usual time. Instead of taking the white placebo tablets from this blister, discard them and 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 the intake of tablets from the second blister.

2. Alternatively, stop taking the active yellow tablets and proceed directly to taking the white placebo tablets for up to 7 days, including the days when tablets were missed ( before starting the placebo tablets, note the day on which the tablet was missed ). If the patient wishes to start a 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 forgets to take any tablet from the blister and no bleeding occurs during the placebo tablet period, this may indicate that she is pregnant. In this case, contact a doctor before starting the next blister. Flowchart for missed tablet management

What to do if vomiting or severe diarrhoea occurs
If vomiting occurs within 3 to 4 hours after taking a yellow tablet containing active substances, or if severe diarrhoea occurs, there is a risk that the active substances have not been fully absorbed. This situation has similar consequences to missing a tablet. After vomiting or diarrhoea, take another yellow 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 “If you forget to take Vibin”.
Delaying withdrawal bleeding: what you should know
Although not recommended, withdrawal bleeding can be delayed by skipping the white placebo tablets in the 4th row and immediately starting a new Vibin blister, continuing until it is finished. Spotting or breakthrough bleeding may occur during the intake of tablets from the second blister. Complete the second blister by taking the 7 white placebo tablets from the 4th row. Then start the next blister.
You may wish to 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 begin during the placebo tablet week. If a change in this day is desired, it can be achieved by shortening ( but never lengthening – 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), bleeding may not 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 treatment with Vibin
Vibin may be stopped 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, stop taking Vibin 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 everyone will experience them.
If any adverse effects occur, especially severe and persistent ones, or any changes in health status that the patient considers to be related to the use of Vibin, medical advice should be sought immediately.
All women using combined hormonal contraceptive products have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before taking Vibin".
Immediate medical attention must be sought if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria potentially accompanied by breathing difficulties (see also section "Warnings and precautions").

The following adverse effects have been associated with the use of Vibin:

Common adverse effects (occur in less than 1 in 10 people):

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

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

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

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

• allergic reactions (hypersensitivity), asthma,
• breast discharge,
• hearing problems,
• blockage of a blood vessel by a clot formed elsewhere in the body,
• erythema nodosum (painful red nodules on the skin) or erythema multiforme (rash with red, painful rings),
• 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 ischaemic attack (TIA)
  • blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood of developing blood clots may be higher if the patient has other risk factors (see section 2 for further information on factors increasing the risk 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 your 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 authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Vibin

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 after EXP. The expiry date refers to the last day of the stated month. The marking on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT indicates the batch number.
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 packaging 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 in this medicine are ethinylestradiol 0.03 mg and drospirenone 3 mg.
Other components of the medicine are:
Tablet core: monohydrate lactose, corn starch, pregelatinized corn starch, crospovidone,
povidone K 30, polysorbate 80, magnesium stearate.
Tablet coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171),
macrogol, talc, yellow 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 looks like and contents of the pack
The tablets containing active substances 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 cartons containing 1 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
POLPHARMA Pharmaceuticals S.A.
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
Metalowca 2, 39-460 Nowa Dęba