Vines

Leaflet accompanying the packaging: user information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Vines (Varianta)

60 micrograms + 15 micrograms, film-coated tablets

Gestodene + Ethinylestradiol
Vines and Varianta are different trade names for the same drug.

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.
• Caution should be exercised and a doctor should be consulted if the patient suspects that blood clot symptoms have occurred (see section 2 "Blood clots").

It is necessary to carefully read the contents of the leaflet before using the drug, as it contains important information for the patient

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, a doctor or pharmacist should be consulted.
• The drug has been prescribed for a specific person. It should not be given to others. The drug may harm another person.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Vines and what is it used for
• 2. Important information before using Vines
• 3. How to take Vines
• 4. Possible side effects
• 5. How to store Vines
• 6. Contents of the packaging and other information

1. What is Vines and what is it used for

Vines is a combined oral contraceptive, commonly known as a "pill".
The combined oral contraceptive protects against pregnancy in three ways. The hormones contained in the drug:

• 1. Inhibit the release of egg cells by the ovaries every month (ovulation).
• 2. Thicken the discharge (in the cervix area) making it difficult for sperm to reach the egg cell.
• 3. Change the mucous membrane of the uterus to prevent the implantation of a fertilized egg.

2. Important information before using Vines

General notes

Before starting to use Vines, it is necessary to read the information about blood clots (thrombosis) in section 2. It is especially important to read about the symptoms of blood clots (see section 2 "Blood clots").
Before Vines can be started, the doctor will ask the patient a few questions about her health and the health of her close relatives. The doctor will also measure blood pressure and, depending on the individual case, may perform some other tests.
This leaflet describes several situations in which Vines should be stopped or in which the effectiveness of Vines may be reduced. In such situations, either no sexual intercourse should be maintained or additional non-hormonal contraceptive methods should be used, e.g. condoms or other mechanical methods.
The observational method or temperature measurement method should not be used. These methods may be unreliable because Vines modifies the monthly changes in cervical mucus.
Vines, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

When not to use Vines

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

• if the patient is allergic to gestodene or ethinylestradiol or any of the other ingredients of this drug (listed in section 6);
• if the patient currently has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if the patient knows she has a blood clotting disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if the patient requires surgery or will be immobilized for a long time (see "Blood clots");
• if the patient has had a heart attack or stroke;
• if the patient has (or has 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 (transient stroke symptoms);
• if the patient has any of the following diseases, which may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage;
• very high blood pressure;
• very high levels of fats in the blood (cholesterol or triglycerides);
• hyperhomocysteinemia;
• if the patient has (or has had in the past) a type of migraine called "migraine with aura";
• if the patient has (or has had in the past) eye diseases (e.g. retinopathy);
• if the patient has (or has had in the past) liver tumors;
• if the patient currently has (or has had in the past) liver disease, and liver function is still abnormal;
• if the patient currently has (or has had in the past) pancreatitis;
• if the patient has kidney function disorders (kidney failure);
• if the patient has (or suspects) breast cancer or other tumors, e.g. ovarian cancer, cervical cancer, or uterine cancer;
• if the patient has vaginal bleeding of unknown cause.

Vines should not be used in patients with hepatitis C and taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also "Vines and other drugs").

Warnings and precautions

Before starting to use Vines, it is necessary to discuss it with a doctor or pharmacist.
When to contact a doctor?
A doctor should be contacted immediately:

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

The patient should tell the doctor if she has any of the following conditions.

In certain situations, it is necessary to exercise particular caution when using Vines or any other combined hormonal contraceptive. Regular medical check-ups may also be necessary. If the patient has any of the following conditions, she should inform her doctor before starting to use Vines.
If these symptoms occur or worsen during the use of Vines, the doctor should also be informed.

• if the patient experiences symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, potentially with breathing difficulties, a doctor should be contacted immediately. Products containing estrogens may cause or worsen symptoms of hereditary and acquired angioedema;
• if the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if the patient has systemic lupus erythematosus (a disease that affects the natural defense system);
• if the patient has hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if the patient has sickle cell anemia (a hereditary disease of red blood cells);
• if the patient has been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or has a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if the patient requires surgery or will be immobilized for a long time (see "Blood clots");
• if the patient has recently given birth, she is at increased risk of blood clots. A doctor should be consulted to find out how soon Vines can be started after giving birth;
• if the patient has superficial thrombophlebitis (blood clots in the veins under the skin);
• if the patient has varicose veins;
• if there is a history of breast cancer in the patient's close family;
• if the patient has liver or gallbladder disease;
• if the patient has diabetes;
• if the patient has depression or mood changes;
• if the patient has epilepsy (see "Vines and other drugs");
• if the patient has a disease that first appeared during pregnancy or while using sex hormones (e.g. hearing loss, porphyria (a blood disease), herpes gestationis (a skin rash during pregnancy), Sydenham's chorea (a nervous system disease characterized by involuntary body movements));
• if the patient has or has ever had chloasma (brown pigmentation spots, so-called pregnancy spots, especially on the face). In this case, it is necessary to avoid direct exposure to sunlight or ultraviolet radiation.

BLOOD CLOTS

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

• in veins (also called "venous thromboembolism" or "venous thrombotic event");
• in arteries (also called "arterial thromboembolism" or "arterial thrombotic event"). Not all patients who have had a blood clot will recover fully. In rare cases, the effects of a blood clot can be permanent or very rarely fatal.

It should be remembered that the overall risk of having a harmful blood clot due to Vines is small.

HOW TO RECOGNIZE BLOOD CLOTS

A doctor should be contacted immediately if any of the following symptoms are noticed.
Is the patient experiencing any of these symptoms?
Why is the patient likely to be 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 only be felt when standing or walking;
• increased temperature in the affected leg;
• change in skin color of the leg, e.g. pale, red, or blue discoloration.
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;

Pulmonary embolism

• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe abdominal pain.

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

• sudden loss of vision, or
• painless vision disturbances, which may lead to loss of vision.

Retinal vein thrombosis (blood clot in the eye)

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

Myocardial infarction (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;

BLOOD CLOTS IN VEINS

What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). Although these side effects are rare, they usually 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 drug) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher compared to not using combined hormonal contraceptives.
If the patient stops using Vines, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots in veins?

The risk of blood clots due to Vines is small, but some factors can increase this risk. The risk is higher:

• if the patient is severely overweight (body mass index (BMI) over 30 kg/m2);
• if someone in the patient's close family has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years old). In this case, the patient may have a hereditary blood clotting disorder;
• if the patient needs to have surgery or will be immobilized for a long time (see "Blood clots");
• with age (especially over 35 years old);
• if the patient has recently given birth. The risk of blood clots increases with the number of risk factors present in the patient.

Air travel (over 4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell the doctor if any of these factors apply to the patient, even if the patient is unsure. The doctor may decide to stop Vines.
If any of the above conditions change during the use of Vines, e.g. someone in the patient's close family is diagnosed with a blood clot without a known cause or the patient gains significant weight, the doctor should be informed.

BLOOD CLOTS IN ARTERIES

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

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

Factors that increase the risk of blood clots in arteries

It is essential to note that the risk of a heart attack or stroke due to Vines is very small, but it may increase:

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

If the patient has more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher.
The doctor should be informed if any of the above conditions change during the use of Vines, e.g. the patient starts smoking, someone in the patient's close family is diagnosed with a blood clot without a known cause, or the patient gains significant weight.

Tablet and tumor

In women using combined oral contraceptives, breast cancer is slightly more common, but it is not known if this is caused by their use. For example, more tumors may be detected in women using combined oral contraceptives because they are examined by doctors more often. The frequency of breast tumors decreases gradually after stopping the use of combined hormonal contraceptives. It is essential to examine the breasts regularly and contact a doctor if any lump is felt.
In rare cases, benign liver tumors have been reported in women using oral contraceptives, and in even rarer cases, malignant liver tumors. If the patient feels unusual, severe abdominal pain, she should contact a doctor.

Psychiatric disorders

Some women using hormonal contraceptives, including Vines, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, a doctor should be contacted as soon as possible for further medical advice.

Irregular bleeding

During the first few months of using Vines, unexpected bleeding (bleeding outside the period of taking placebo tablets) may occur. If such bleeding persists for more than a few months or starts after a few months, a doctor should be consulted.

What to do if withdrawal bleeding does not occur during the placebo days

If all the tablets were taken correctly, there was no vomiting or severe diarrhea, and no other drugs were taken, it is very unlikely that the woman is pregnant.
If withdrawal bleeding does not occur twice in a row, it may indicate pregnancy. A doctor should be contacted immediately. The next pack of Vines should not be started until it is certain that the patient is not pregnant.

Children and adolescents

There are limited data on the use of Vines in adolescents under 18 years old.

Vines and other drugs

The patient should tell her doctor or pharmacist about all the drugs she is currently taking or has recently taken, as well as any drugs she plans to take.
The patient should also inform other doctors or dentists who prescribe other drugs (or pharmacists) about the use of Vines. The doctor will inform the patient whether there is a need to use additional contraception (e.g. a condom) and if so, for how long.
Vines should not be used in patients with hepatitis C and taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these products may cause abnormal liver function test results (increased liver enzyme activity).
Before starting to take these drugs, the doctor will prescribe a different contraceptive method.
Vines can be started again about 2 weeks after the end of the above-mentioned treatment. See "When not to use Vines".
Some drugs may affect the blood levels of Vines and reduce its effectiveness in preventing pregnancy or may cause unexpected bleeding. These include drugs used to treat:

• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate),
• tuberculosis (e.g. rifampicin),
• HIV and hepatitis C virus infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),
• high blood pressure in the blood vessels of the lungs (bosentan),
• sleep disorders (modafinil),
• symptomatic treatment of osteoarthritis (etoricoxib),
• certain infections (e.g. griseofulvin),
• a herbal remedy commonly known as St. John's Wort (Hypericum perforatum). If the patient wants to use herbal products containing St. John's Wort, she should consult her doctor, as Vines may not be suitable for her.

Vines may affect the effectiveness of other drugs, such as:

• cyclosporin (a drug used to prevent the rejection of transplanted tissue after organ transplants),
• the antiepileptic drug lamotrigine (which may lead to an increased frequency of seizures),
• tizanidine (a drug used to treat muscle spasticity),
• theophylline (a drug used to treat asthma).

Laboratory tests

If a blood test is necessary, the doctor or laboratory staff should be informed that Vines is being taken, as oral contraceptives may affect the results of some tests.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this drug.
Pregnant women should not take Vines. If the patient becomes pregnant or thinks she may be pregnant, she should stop taking Vines immediately and contact her doctor.
Vines should not be used during breastfeeding. If the patient wants to take Vines during breastfeeding, she should discuss it with her doctor.

Driving and using machines

Vines can be used while driving and operating machinery.

Vines contains lactose, lactose monohydrate, and orange yellow S (E 110)

Vines contains lactose and lactose monohydrate. If the patient has been diagnosed with intolerance to some sugars, she should contact her doctor before taking Vines.
The inactive green tablets contain orange yellow S (E 110), which may cause allergic reactions.

3. How to take Vines

This drug should always be used as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
Each blister pack contains 24 yellow film-coated tablets and 4 green film-coated placebo tablets.
The tablets are arranged in the correct order and are marked with two different colors.
The blister pack contains 28 tablets.
One Vines tablet should be taken every day, if necessary, with a small amount of water. The tablets can be taken with or without food, but it is recommended to take them at the same time every day.
It is essential to take the tablets in the correct order, following the direction of the arrows on the blister pack. After taking the last green placebo tablet, a new blister pack should be started immediately. There should be no gap between the packs.

Vines used in this way also protects against pregnancy during the 4 days when the placebo tablets are taken.

When to start taking the tablets from the first pack

If hormonal contraceptives were not used in the previous month
Vines should be started on the first day of the menstrual cycle (i.e. on the first day of menstrual bleeding). If Vines is started on the first day of menstrual bleeding, it provides immediate protection against pregnancy.
Switching from another combined hormonal contraceptive or vaginal ring or transdermal patch to Vines
Vines should be started on the day after taking the last active tablet of the previous combined oral contraceptive or on the day after the usual break, during which no tablets are taken, or during which placebo tablets are taken from the previous contraceptive. In this case, the patient is protected against pregnancy.
Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen) to Vines
Vines can be started on any day (in the case of an implant or intrauterine system, on the day of its removal, and in the case of an injection, on the day the next injection is due). In all these cases, an additional contraceptive method (e.g. a condom) should be used for the first 7 days of taking the tablets.

What to do if a tablet is missed

The last 4 tablets in the fourth row of the blister pack are placebo tablets. If one of these tablets is missed, it will not affect the effectiveness of Vines.
The missed placebo tablet should be discarded.
If the patient forgets to take a yellow tablet containing the active substances (tablets 1-24 on the blister pack), she should follow these instructions:

• If the tablet is delayed by less than 12 hours, contraceptive protection is not reduced. The tablet should be taken as soon as possible, and the next tablets should be taken at the usual time.
• If the tablet is delayed by more than 12 hours, contraceptive protection may be reduced. The more tablets that are missed, the higher the risk of pregnancy.

The risk of reduced contraceptive protection is highest if a yellow tablet is missed at the beginning or end of the pack. Therefore, the following rules should be followed:

More than one tablet has been missed from the pack
A doctor should be contacted.
A tablet has been missed on days 1-7 (first row)
The missed tablet should be taken as soon as possible, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time, and an additional contraceptive method (e.g. a condom) should be used for the next 7 days. If sexual intercourse took place in the week before the tablet was missed, pregnancy should be considered. In this case, a doctor should be contacted.
A tablet has been missed on days 8-14 (second row)
The missed tablet should be taken as soon as possible, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time. Contraceptive protection is not reduced, so there is no need to use an additional contraceptive method.
A tablet has been missed on days 15-24 (third or fourth row)
There are two options:

• 1. The missed tablet should be taken as soon as possible, even if it means taking two tablets at the same time. The next tablets should be taken at the usual time. Instead of taking the green placebo tablets from the pack, they should be discarded (thrown away), and a new pack should be started. Withdrawal bleeding will most likely occur after finishing the tablets from the second pack - during the green placebo tablets. However, spotting or irregular bleeding may occur during the tablets from the second pack.
• 2. The patient can also stop taking the yellow tablets containing the active substances from the current pack and go directly to taking the 4 green placebo tablets (before taking the placebo tablets, the day the tablet was missed should be recorded). If the patient wants to start the next pack on the same day as usual, the placebo tablets should be taken for less than 4 days. If the patient follows one of the above instructions, she will still be protected against pregnancy. If the patient misses a tablet from the pack and does not have withdrawal bleeding during the placebo days, she may be pregnant. Before starting the next pack, a doctor should be contacted.

What to do if vomiting or severe diarrhea occurs

If vomiting occurs within 3-4 hours of taking a yellow tablet containing the active substances, or if severe diarrhea occurs, there is a risk that the active substances in the tablet may not be fully absorbed into the body.
The situation is almost identical to missing a tablet. If vomiting or diarrhea occurs, the patient should take another yellow tablet from a spare pack as soon as possible.
If possible, it should be taken within 12 hours of the usual time of taking the tablets.
If this is not possible and more than 12 hours have passed, the patient should follow the instructions in the "Missed tablet" section.

Delaying withdrawal bleeding: what to know

The patient can delay withdrawal bleeding by skipping the green placebo tablets from the fourth row and starting a new pack of Vines immediately. During the tablets from the second pack, there may be some bleeding or spotting. The tablets from the second pack should be taken until the end, including the 4 green placebo tablets from the fourth row. Then, a new pack should be started.
Before deciding to delay withdrawal bleeding, the patient can consult her doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If side effects occur, especially severe and persistent ones or changes in health that the patient considers related to the use of Vines, consult a doctor. You should immediately contact a doctor if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing or hives potentially with difficulty breathing (see also "Warnings and precautions"). In all women using combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, refer to section 2 "Important information before using Vines". Frequentside effects (may occur in up to 1 in 10 people):

• vaginitis, including vaginal fungal infections (candidiasis),
• mood changes, including depression, sexual disorders (libido disorders),
• dizziness,
• nausea,
• vomiting,
• abdominal pain,
• restlessness,
• headache
• acne,
• breast tenderness,
• breast sensitivity,
• breast discharge,
• painful menstruation,
• changes in menstrual bleeding intensity,
• weight changes,
• edema.

Infrequentside effects (may occur in up to 1 in 100 people):

• changes in appetite,
• changes in blood lipid levels,
• migraine,
• high blood pressure,
• abdominal pain caused by muscle cramps,
• bloating,
• skin rash,
• yellow-brown spots on the face (chloasma),
• hair loss,
• increased body hair. Rareside effects (may occur in up to 1 in 1000 people):
• severe allergic reaction with rare cases of hives, pain due to skin and mucous membrane swelling (angioedema) and respiratory and circulatory symptoms,
• increased blood glucose levels (glucose intolerance),
• eye irritation from contact lenses,
• jaundice,
• nodular fever (erythema nodosum),
• harmful blood clots in a vein or artery, for example:
• in the leg or foot (e.g. deep vein thrombosis),
• in the lungs (e.g. pulmonary embolism),
• heart attack, stroke,
• mini-stroke or transient stroke symptoms, known as transient ischemic attack,
• 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-increasing factors (see section 2 for more information on risk-increasing factors and symptoms of blood clots).

Very rareside effects (may occur in up to 1 in 10,000 people):

• liver disease,
• systemic connective tissue diseases (systemic lupus erythematosus),
• metabolic disorders known as porphyria,
• movement disorders,
• eye disorders,
• pancreatitis,
• gallstones and gallbladder disease,
• skin disorder,
• blood clotting disorders causing kidney failure (hemolytic-uremic syndrome).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. 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, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vines

The medicine should be stored out of sight and reach of children. Do not store above 30°C. Store in the original packaging to protect from light and moisture. Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the specified month. Medicines should 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. Package contents and other information

What Vines contains

The active substances of Vines are gestodene (60 micrograms) and ethinylestradiol (15 micrograms) in each yellow tablet.

Other ingredients are:

Yellow, active film-coated tablets: lactose monohydrate, microcrystalline cellulose, polyacrylate potassium, magnesium stearate. Coating:lactose monohydrate, hypromellose, titanium dioxide (E 171), triacetin, quinoline yellow (E 104).

Green, inactive film-coated tablets (placebo): microcrystalline cellulose, lactose, corn starch, magnesium stearate, colloidal silica anhydrous. Coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, indigo carmine (E 132), quinoline yellow (E 104), iron oxide black (E 172), orange yellow S (E 110).

What Vines looks like and what the pack contains

The active tablet is yellow, film-coated, round, biconvex, approximately 5.5 mm in diameter. On one side, it has the embossed "G43", the other side is smooth. The placebo tablet is green, round, biconvex, film-coated, approximately 6 mm in diameter, without markings. The film-coated tablets are packaged in PVC/Aluminum blisters. Each blister is packaged in a laminated aluminum sachet. The blisters in sachets are packaged in a cardboard box containing a patient leaflet, a cardboard sachet for storing blisters, and stickers in the form of strips marked with days of the week. Pack sizes: 1×(24+4) film-coated tablets, 3×(24+4) film-coated tablets, 6×(24+4) film-coated tablets. For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Austria, the country of export:

Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary

Manufacturer:

Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Austrian export license number: 1-30481

Parallel import license number: 144/20

Date of leaflet approval: 27.05.2025

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