Vines

Leaflet accompanying the packaging: information for the user

Vines, 60 micrograms + 15 micrograms, film-coated tablets

Gestodene + Ethinylestradiol

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• To a small extent, they 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 symptoms of blood clots have occurred (see section 2 "Blood clots").

The leaflet should be read carefully before taking the medicine, as it contains important information for the patient

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, a doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Vines and what is it used for

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

• 1. Inhibit the release of egg cells from 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 implantation of a fertilized egg.

2. Important information before taking Vines

General notes

Before starting to take Vines, the information about blood clots (thrombosis) in section 2 should be read.
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 about the health of her close relatives. The doctor will also measure blood pressure and, depending on the individual case, may perform some other examinations.
This leaflet describes several situations in which Vines should not be taken 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 take Vines

Vines should not be taken 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 medicine (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, deficiency of protein C, protein S, antithrombin III, presence of factor V Leiden or antiphospholipid antibodies;
• if the patient needs to undergo surgery or will be immobilized for a long time (see section "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 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 she has) cancer of the breast or other cancer, e.g. ovarian cancer, cervical cancer, or uterine cancer;
• if the patient has vaginal bleeding of unknown cause.

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

Warnings and precautions

Before starting to take Vines, the patient should discuss this with her doctor or pharmacist.
When should a doctor be contacted?
A doctor should be contacted immediately:

• -if the patient notices any of the symptoms of a blood clot, which may indicate that the patient has a blood clot in the leg (deep vein thrombosis), blood clot in the lungs (pulmonary embolism), heart attack, or stroke (see below "Blood clots (thrombosis)").

In order to obtain a description of the serious side effects mentioned, see "How to recognize a blood clot".

The doctor should be told if the patient has any of the following conditions.

In certain situations, caution should be exercised when taking Vines or any other combined hormonal contraceptive. Regular medical examination may also be necessary. If the patient has any of the following conditions, she should inform her doctor before starting to take Vines.
If these symptoms occur or worsen while taking Vines, the doctor should also be told.

• 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, the 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 body's 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 needs to undergo surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if the patient is immediately postpartum, she is at increased risk of blood clots. The doctor should be consulted to determine how soon Vines can be started after delivery;
• if the patient has superficial thrombophlebitis (inflammation of 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 medicines");
• if the patient has a disease that first appeared during pregnancy or while taking sex hormones (e.g. hearing loss, porphyria (a blood disease), herpes gestationis (a skin rash with blisters during pregnancy), Sydenham's chorea (a nervous system disease characterized by involuntary body movements));
• if the patient has chloasma (brownish patches on the skin, so-called pregnancy patches, especially on the face). In this case, the patient should 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 known as "venous thromboembolism" or "deep vein thrombosis");
• in arteries (also known as "arterial thromboembolism").

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 harmful blood clots associated with Vines is small.

HOW TO RECOGNIZE A BLOOD CLOT

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
these symptoms?

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking;
• increased temperature in the affected leg;
• change in skin color of the leg, such as pallor, redness, or discoloration. Deep vein thrombosis
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, which may be accompanied by coughing up blood;
• sharp chest pain, which may worsen with deep breathing;
• severe dizziness or fainting;
• rapid or irregular heartbeat;
• severe abdominal pain.

If the patient is unsure, she should contact a doctor,
because some of these symptoms, such as cough or
shortness of breath, may be mistaken for milder
Pulmonary embolism

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 occur most often in the first year of use of combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot moves from the leg and settles in the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

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

The risk of forming a blood clot in a vein is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher compared to not using combined hormonal contraceptives.
If the patient stops taking 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 depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of blood clots in the legs or lungs associated with Vines 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 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• -In a year, about 9-12 out of 10,000 women who use combined hormonal contraceptives containing gestodene, such as Vines, will develop blood clots.
• -The risk of blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots", below).

Factors that increase the risk of blood clots in veins

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

• if the patient is overweight (body mass index (BMI) over 30 kg/m);
• 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 undergo surgery or will be immobilized for a long time due to injury or illness or has a leg in a cast. It may be necessary to stop taking Vines for a few weeks before surgery or immobilization. If the patient needs to stop taking Vines, she should ask her doctor when she can resume taking it;
• 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.
Long-haul flights (>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 risk factors are present, even if the patient is not sure. The doctor may decide to stop Vines.
If any of the above conditions change while taking 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?

Similarly to 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 heart attack or stroke associated with Vines is very small, but it may increase:

• with age (over about 35 years old);
• -if the patient smokes. While taking 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 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 heart attack or stroke;
• if the patient or someone in her close family has 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 these conditions or if any of them are particularly severe, the risk of blood clots may be even higher. The doctor should be informed if any of these conditions change while taking Vines, e.g. the patient starts smoking, someone in her close family is diagnosed with a blood clot without a known cause, or the patient gains significant weight.

Pill and cancer

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

Psychiatric disorders

Some women taking 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, the patient should contact her doctor as soon as possible for further medical advice.

Irregular bleeding

During the first few months of taking Vines, unexpected bleeding (bleeding outside of the placebo days) may occur. If such bleeding persists for longer than a few months or starts after a few months, the 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 medicines were taken, it is very unlikely that the patient is pregnant.
If the next expected withdrawal bleeding does not occur, the patient may be pregnant. The patient should contact her doctor immediately. The patient should not start the next pack of Vines until she is sure she is not pregnant.

Children and adolescents

There is limited data on the use of Vines in adolescents under 18 years of age.

Vines and other medicines

The patient should tell her doctor or pharmacist about all medicines she is currently taking or has recently taken, as well as any medicines she plans to take.
The patient should also inform other doctors or dentists who prescribe other medicines (or pharmacists) that she is taking Vines. The doctor will inform the patient whether there is a need to use additional contraception (e.g. condoms) and if so, for how long.
Vines should not be taken 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 medicines, the doctor will prescribe a different contraceptive method.
Taking Vines can be resumed 2 weeks after the end of the above-mentioned treatment. See section "When not to take Vines".
Some medicines may affect the levels of Vines in the blood and reduce its effectiveness in preventing pregnancy or cause unexpected bleeding. These include medicines 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),
• the herbal remedy St. John's Wort (Hypericum perforatum). If the patient wants to take 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 medicines, such as:

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

Lab tests

If a blood test is necessary, the doctor or laboratory staff should be informed that the patient is taking Vines, as oral contraceptives may affect the results of some laboratory 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 taking this medicine.
Pregnant women should not take Vines. If the patient becomes pregnant or thinks she may be pregnant, she should stop taking Vines and contact her doctor immediately.
Vines should not be taken during breastfeeding. If the patient wants to take Vines during breastfeeding, she should discuss this with her doctor.

Driving and using machines

Vines can be taken while driving and operating machinery.

Vines contains lactose and orange yellow FCF (E 110)

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

3. How to take Vines

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should contact her doctor or pharmacist.
Each blister pack contains 24 yellow film-coated tablets containing the active substances and 4 green film-coated placebo tablets.
The tablets of Vines, marked with two different colors, are arranged in the correct order.
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 independently of meals, but each day at about the same time.
It is essential to avoid confusing the tablets: for the first 24 days, a yellow tablet should be taken, and for the last 4 days, a green tablet. Then, a new blister pack should be started immediately (24 yellow tablets and 4 green tablets). There is no break in taking the tablets between packs.
Due to the differences in the composition of the tablets, it is essential to start taking the tablets from the tablet located in the upper left corner of the blister pack and to take the tablets in the correct order, following the arrows on the packaging.

Preparing the blister pack

To help control the correct intake of tablets, the packaging contains 7 stickers in the form of strips marked with the days of the week. The patient should choose a strip that starts with the name of the day she intends to start taking the tablets. For example, if the patient wants to start taking Vines on Wednesday, she should apply the strip with "WED" written on it.
The patient should attach the symbol "" on the strip to the same symbol on the blister pack and apply the strip in the area limited by the black line (in the frame). The name of each day of the week will correspond to a specific column of tablets.
The name of the day of the week above each tablet will make it easier to check if the tablet was taken on a given day.
The patient should move in the direction of the arrow on the blister pack until all 28 tablets have been taken.
During the 4 days when the patient takes the green placebo tablets (placebo days), withdrawal bleeding should start. It usually starts on the 2nd or 3rd day after taking the last yellow Vines tablet containing the active substances. After taking the last green placebo tablet, the patient should start a new blister pack, regardless of whether the bleeding has stopped or not. This means that the patient should always start taking the tablets from a new pack on the same day of the week, and the withdrawal bleeding should start on the same day every month. Vines taken in this way will also protect against pregnancy during these 4 days when the patient takes the placebo tablets.

When to start taking the tablets from the first blister pack

If the patient did not use hormonal contraceptives 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 will provide 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 or the day after taking the last placebo tablet of 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 at any time, but the patient should also use a barrier method (e.g. condoms) for the first 7 days of tablet-taking.
Taking Vines after a miscarriage
The patient should follow her doctor's advice.
Taking Vines after childbirth
Vines can be started between 21 and 28 days after childbirth. If the patient starts taking the tablets later than 28 days after childbirth, she should use a barrier method (e.g. condoms) for the first 7 days of tablet-taking.
If the patient is breastfeeding and wants to start taking Vines again after childbirth
See section "Breastfeeding".
In case of any further doubts about taking Vines, the patient should contact her doctor or pharmacist.

Overdose of Vines

There are no reports of serious harmful effects from taking too many Vines tablets.
If several Vines tablets are taken at the same time, symptoms such as nausea and vomiting may occur. In young girls, vaginal bleeding may occur.
If too many Vines tablets are taken or if a child takes the tablets, the patient should contact her doctor or pharmacist immediately.

Missed dose of Vines

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 substance (tablets 1 to 24 on the blister pack), she should follow the instructions below:

• If the tablet is delayed by less than 12 hours, contraceptive protection is not reduced. The patient should take the tablet as soon as she remembers and take the next tablets 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 patient should follow the rules below:

More than one tablet has been missed from the blister pack
The patient should contact her doctor.
A tablet has been missed in days 1-7 (first row)
The patient should take the missed tablet as soon as she remembers, even if it means taking two tablets at the same time. Then, she should continue taking the tablets at the usual time of day and use a barrier method (e.g. condoms) for the next 7 days. If the patient had sexual intercourse during the week before missing the tablet, she should consider the possibility of pregnancy. In this case, she should contact her doctor.
A tablet has been missed in days 8-14 (second row)
The patient should take the missed tablet as soon as she remembers, even if it means taking two tablets at the same time. Then, she should continue taking the tablets at the usual time of day. Contraceptive protection is not reduced, so there is no need to use a barrier method.

• 1. The patient can take the missed tablet as soon as she remembers, even if it means taking two tablets at the same time. Then, she should continue taking the tablets at the usual time of day. Instead of taking the green placebo tablets from the blister pack, she should discard them (throw them away) and start a new pack (the start day will be different). Withdrawal bleeding will most likely occur after finishing the tablets from the second pack – during the green placebo tablets, but

it may occur as spotting or irregular bleeding during the tablets from the second pack.

• 2. The patient can also stop taking the yellow active tablets from the current pack and go directly to taking the 4 green placebo tablets (before taking the placebo tablets, the patient should make a note of the day she missed the tablet). If the patient wants to start the next pack on the same day as usual, she should take the placebo tablets 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 any tablet from the pack and does not have withdrawal bleeding during the placebo days, she may be pregnant. Before starting the next pack, the patient should contact her doctor.

More than 1yellow active tablet has been missed from the pack
The patient should consult her doctor
Yes
in days 1-7
Has sexual intercourse occurred in the week before missing the tablet?
No

• Take the missed tablet
• Use a barrier method (e.g. condoms) for the next 7 days
• Finish the tablets from the pack

Only 1yellow active tablet has been missed (taken with a delay of more than12 hours)
in days 8-
14

• Take the missed tablet
• Finish the tablets from the pack
• Take the missed tablet and
• Finish the yellow active tablets from the pack
• Discard the 4 green placebo tablets
• Start a new pack

in days 15-
24
or

• Stop taking the yellow active tablets from the pack immediately
• Start taking the 4 green placebo tablets (for no more than 4 days, including the day the tablet was missed)
• Then start a new pack

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If side effects occur, especially severe and persistent or changes in health status that the patient considers related to the use of Vines, a doctor should be consulted. A doctor should be contacted immediately 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 breathing difficulties (see also "Warnings and precautions"). All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, the "Important information before taking Vines" section should be consulted. Frequentside effects (may occur in up to 1 in 10 people):

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

Less frequentside 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 hair growth on the body.

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 due to 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 a transient ischemic attack,
• blood clots in the liver, stomach, intestine, kidneys, or eye. The likelihood of developing blood clots may be higher if the patient has any other risk factors (see section 2 for more information on risk factors for blood clots 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,
• coagulation disorders causing kidney failure (hemolytic-uremic syndrome).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist, or nurse should be informed. 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the use of the 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 pack. The expiry date refers to the last day of the given month. Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer needed. 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: Active film-coated tablets: lactose monohydrate, microcrystalline cellulose type 112, hypromellose, potassium polacrylate, magnesium stearate, titanium dioxide (E 171), triacetin, quinoline yellow, aluminum lake (E 104). Placebo film-coated tablets: microcrystalline cellulose type 12, anhydrous lactose, maize starch, magnesium stearate, colloidal silica anhydrous, polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, indigo carmine (E 132), quinoline yellow, aluminum lake (E 104), iron oxide black (E 172), orange yellow, aluminum lake (E 110).

What Vines looks like and what the pack contains

The active substance tablet is yellow, film-coated, round, biconvex, with a diameter of about 5.5 mm. On one side, it has the embossed inscription "G43", the other side is smooth. The placebo tablet is green, round, biconvex, film-coated, with a diameter of about 6 mm, without markings. Vines film-coated tablets, 60 micrograms + 15 micrograms, are packaged in blisters of transparent PVC/Aluminum foil. Each blister is packaged in a sachet made of laminated aluminum. Blisters in sachets are packaged in a cardboard box containing a patient leaflet, a case for storing blisters, and stickers in the form of strips marked with days of the week. Package sizes: 1×(24+4) film-coated tablets, 3×(24+4) film-coated tablets, 6×(24+4) film-coated tablets. Not all package sizes may be marketed.

Marketing authorization holder:

GEDEON RICHTER POLSKA Sp. z o.o., ul. Ks. J. Poniatowskiego 5, 05-825 Grodzisk Mazowiecki, Poland

Manufacturer:

Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary. For more detailed information about the medicine and its names in other European Economic Area member states, please contact: GEDEON RICHTER POLSKA Sp. z o.o., Medical Department, ul. Ks. J. Poniatowskiego 5, 05-825 Grodzisk Mazowiecki, Tel. +48 (22)755 96 48, lekalert@grodzisk.rgnet.org

Date of last revision of the leaflet: May 2023

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