Vonille 0.075 mg/0.03 mg tablets EFG

Spain
Brand name Vonille 0.075 mg/0.03 mg tablets EFG
Form tablets
Active substance / Dosage
GESTODENE · 0,075 mg
ETHINYLESTRADIOL · 0,030 mg
Prescription type Prescription Only Medicine
ATC code
G03A G03AA G03AA10
Registration number 80268
Manufacturer Exeltis Healthcare S.L.

Table of Contents

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vonille 0.075 mg/0.03 mg tablets EFG

Gestodene/Ethinylestradiol

Important things you need to know about combined hormonal contraceptives (CHCs):

  • They are one of the most reliable reversible contraceptive methods if used correctly.
  • They slightly increase the risk of developing a blood clot in veins and arteries, especially during the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
  • Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 "Blood clots").

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

  • Keep this leaflet, as you may need to read it again.

  • If you have any questions, consult your doctor, family planning nurse, or pharmacist.

  • This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.

  • If you experience adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Vonille is and what it is used for

  • Vonille is a contraceptive pill used to prevent pregnancy.
  • Each tablet contains a small amount of two different female hormones, called gestodene and ethinylestradiol.
  • Oral contraceptives like Vonille that contain two hormones are called "combined" contraceptives.

2. What you need to know before starting to take Vonille

General comments

Before starting to use Vonille, you must read the information about blood clots in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots”).

Before starting to take Vonille, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure, and depending on your personal situation, may carry out some additional tests. Several situations are described in this leaflet in which you should stop using Vonille, or in which the reliability of Vonille may decrease. In such situations, you should not have sexual intercourse or should use additional non-hormonal contraceptive precautions, for example, use of a condom or another barrier method. Do not use the rhythm method or the temperature method. These methods may not be reliable because Vonille alters the monthly changes in body temperature and cervical mucus.

Vonille, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or any other sexually transmitted disease.

Do not take Vonille

You must not use Vonille if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you which other form of contraception would be most suitable.

  • If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs.
  • If you know you have a disorder 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 long time (see section “Blood clots”).
  • If you have ever had a heart attack or a stroke.
  • If you have (or have ever had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).
  • If you have any of the following conditions that may increase your risk of developing blood clots in the arteries:
    • Severe diabetes with blood vessel damage.
    • Very high blood pressure.
    • Very high levels of fat in the blood (cholesterol or triglycerides).
    • A condition called hyperhomocysteinaemia.
  • If you have (or have ever had) a type of migraine called "migraine with aura";
  • If you have (or have ever had) inflammation of the pancreas (pancreatitis);
  • If you have (or have ever had) a liver disease and your liver function has not yet returned to normal;
  • If you have or have had liver tumours;
  • If you have (or have ever had), or if you suspect you have breast cancer or cancer of the reproductive organs;
  • If you have vaginal bleeding of unknown cause;
  • If you are pregnant or suspect you might be pregnant;
  • If you are allergic to ethinylestradiol or gestodene, or to any of the other ingredients of this medicine (listed in section 6). This may cause itching, rash, or swelling.
  • If you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Use of Vonille with other medicines”).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Vonille.

When should you consult your doctor?

Seek urgent medical attention

  • If you notice possible signs of a blood clot which may mean you are experiencing a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section "Blood clot (thrombosis)" below).

For a description of the symptoms of these serious side effects, see "How to recognize a blood clot".

Inform your doctor if you have any of the following conditions.

If any of these conditions develop or worsen while you are using Vonille, you must also inform your doctor.

  • If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
  • If you have systemic lupus erythematosus (SLE, a disease affecting your body's natural defense system).
  • If you have hemolytic uremic syndrome (HUS: a blood clotting disorder causing kidney failure).
  • If you have sickle cell anemia (a hereditary red blood cell disorder).
  • If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
  • If you require surgery or will be immobile for long periods (see section 2, “Blood clots”).
  • If you have recently given birth, you are at higher risk of developing blood clots. You should ask your doctor when you can start taking Vonille after childbirth.
  • If you have inflammation of the veins beneath the skin (superficial thrombophlebitis).
  • If you have varicose veins.
  • If a close relative has or has ever had breast cancer.
  • If you have liver or gallbladder disease.
  • If you have diabetes.
  • If you have depression.
  • If you have epilepsy (see section “Taking Vonille with other medicines”).
  • If you have had a condition that first appeared during pregnancy or during previous use of sex hormones (for example, hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (herpes gestationis), a nervous system disorder involving involuntary movements (Sydenham's chorea)).
  • If you have or have ever had chloasma (golden-brown pigmentation spots on the skin, especially on the face, known as “pregnancy mask”). In such cases, avoid direct exposure to sunlight or ultraviolet rays.
  • If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with breathing difficulty, contact a doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Vonille increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot can block blood vessels and cause serious complications.

Blood clots may form:

  • In the veins (called “venous thrombosis”, “venous thromboembolism” or VTE).
  • In the arteries (called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, there may be serious long-lasting effects, and very rarely, they may be fatal.

It is important to remember that the overall risk of a harmful blood clot due to Vonille is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if you notice any of the following signs or symptoms.

Are you experiencing any of these signs?

What could you possibly be suffering from?

  • Swelling in one leg or foot, or along a vein in the leg or foot, especially when accompanied by:
  • Pain or tenderness in the leg, which may only be noticeable when standing or walking.
  • Increased warmth in the affected leg.
  • Change in skin color of the leg, e.g., turning pale, red, or blue.

Deep vein thrombosis

  • Sudden shortness of breath without known cause or rapid breathing.
  • Sudden cough without clear cause, possibly bringing up blood.
  • Sharp chest pain that may worsen upon deep breathing.
  • Severe dizziness or lightheadedness.
  • Rapid or irregular heartbeat.
  • Severe stomach pain.

If you are unsure, consult a doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for a milder condition like a respiratory infection (e.g., a "common cold").

Pulmonary embolism

Symptoms occurring more frequently in one eye:

  • Sudden loss of vision. Or
  • Painless blurred vision, which may progress to vision loss.

Retinal vein thrombosis (blood clot in the eye).

  • Chest pain, discomfort, pressure, or heaviness.
  • Feeling of tightness or fullness in the chest, arm, or below the sternum.
  • Feeling of fullness, indigestion, or suffocation.
  • Upper body discomfort spreading to the back, jaw, throat, arm, or stomach.
  • Sweating, nausea, vomiting, or dizziness.
  • Severe weakness, anxiety, or shortness of breath.
  • Rapid or irregular heartbeat.

Heart attack

  • Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body.
  • Sudden confusion, difficulty speaking or understanding speech.
  • Sudden vision problems in one or both eyes.
  • Sudden difficulty walking, dizziness, loss of balance or coordination.
  • Sudden, severe, or prolonged headache without known cause.
  • Loss of consciousness or fainting, with or without seizures.

Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.

Stroke

  • Swelling and slight bluish discoloration of a limb.
  • Severe stomach pain (acute abdomen).

Blood clots blocking other blood vessels.

BLOOD CLOTS IN A VEIN

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

  • The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in veins (venous thrombosis). However, these adverse events are rare. They occur most frequently during the first year of using a combined hormonal contraceptive.
  • If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
  • If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
  • Very rarely, a clot may form in a vein of another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein higher?

The risk of developing a blood clot in a vein is higher during the first year of first-time use of a combined hormonal contraceptive. The risk may also be increased if you restart taking a combined hormonal contraceptive (the same medication or a different one) after a break of 4 weeks or more.

After the first year, the risk decreases, but it remains somewhat higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Vonille, your risk of developing a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?

The risk depends on your natural risk of venous thromboembolism (VTE) and the type of combined hormonal contraceptive you are taking.

The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Vonille is low.

  • Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot within one year.
  • Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5 to 7 will develop a blood clot within one year.
  • Among 10,000 women who use a combined hormonal contraceptive containing gestodene, such as Vonille, between 9 and 12 women will develop a blood clot within one year.
  • Your risk of developing a blood clot will depend on your personal medical history (see “Factors that increase your risk of a blood clot” below).

Risk of developing a blood clot in one year

Women who do not use a combined hormonal pill/patch/vaginal ring and who are not pregnant.

About 2 out of 10,000 women

Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate.

About 5-7 out of 10,000 women

Women who use Vonille

About 9-12 out of 10,000 women

Factors that increase your risk of a blood clot in a vein

The risk of having a blood clot with Vonille is small, but certain conditions increase the risk. Your risk is higher:

  • If you are overweight (body mass index or BMI above 30 kg/m²).

  • If any of your close relatives has had a blood clot in the leg, lung, or another organ at a young age (i.e., before approximately 50 years of age). In this case, you might have an inherited blood clotting disorder.

  • If you need surgery or if you are immobile for long periods due to injury, illness, or having a leg in a cast. You may need to stop taking Vonille several weeks before surgery or while you are less mobile. If you need to stop taking Vonille, ask your doctor when you can start taking it again.

  • With increasing age (especially over about 35 years).

  • If you have given birth within the last few weeks.

The risk of developing a blood clot increases the more of these conditions you have.

Air travel (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed above.

It is important to inform your doctor if you have any of the conditions listed above, even if you are unsure. Your doctor may decide that you need to stop taking Vonille.

If any of the conditions listed above change while you are using Vonille—for example, a close relative experiences a thrombosis without a known cause, or you gain significant weight—inform your doctor.

BLOOD CLOTS IN AN ARTERY

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

Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or stroke.

Factors that increase your risk of a blood clot in an artery

It is important to note that the risk of a heart attack or stroke from using Vonille is very small, but it may increase:

  • With age (over about 35 years).

  • If you smoke. When using a combined hormonal contraceptive like Vonille, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.

  • 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 about 50 years). In this case, you may also have an increased risk of heart attack or stroke.

  • If you or a close relative has high levels of fat in the blood (cholesterol or triglycerides).

  • If you suffer from migraines, especially migraines with aura.

  • If you have a heart condition (valve disorder, heart rhythm disorder called atrial fibrillation).

  • If you have diabetes.

If you have one or more of these conditions, or if any of them is particularly severe, your risk of developing a blood clot may be further increased.

If any of the conditions listed above change while you are using Vonille—for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain significant weight—inform your doctor.

Vonille and cancer

Slightly more cases of breast cancer have been observed in women using combined contraceptives, but it is not known whether this is due to the treatment. For example, more tumors may be detected in women taking combined contraceptives because they are examined by a doctor more frequently. The incidence of breast tumors gradually decreases after stopping combined hormonal contraceptives. It is important to have regular breast examinations, and you should see your doctor if you notice any lump.

Benign liver tumors have been reported rarely, and even more rarely malignant liver tumors, in users of hormonal contraceptives. This may cause internal bleeding leading to sudden severe abdominal pain.

See your doctor if you experience unusual, severe abdominal pain. You may need to stop taking Vonille.

Cases of cervical cancer occurring more frequently have been reported in women who use contraceptives for a long time. This finding may not be caused by contraceptives but could be related to sexual behavior or other factors.

Psychiatric disorders:

Some women using hormonal contraceptives such as Vonille have reported depression or a depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor for further medical advice as soon as possible.

Bleeding between periods

During the first few months of taking Vonille, you may experience unexpected bleeding (bleeding outside the pill-free week). If this bleeding persists beyond a few months, or starts after a few months, your doctor should investigate the cause.

What to do if you do not have your period during the pill-free week

If you have taken all tablets correctly, have not vomited or had severe diarrhea, and have not taken other medications, it is very unlikely that you are pregnant.

If you miss two consecutive expected periods, you may be pregnant. See your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Use of Vonille with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Always tell any doctor who is prescribing Vonille what medicines or herbal remedies you are using. Also inform any other doctor or dentist who prescribes you another medicine (or your pharmacist) that you are using Vonille. They may advise you whether you need to take additional contraceptive precautions (e.g., condoms) and, if so, for how long.

  • Some medicines may reduce the contraceptive effect of Vonille or may cause unexpected bleeding.

These include medicines used to treat epilepsy (e.g., hydantoin, topiramate, felbamate, lamotrigine, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine) and tuberculosis (e.g., rifampicin), immunomodulatory drugs (ciclosporine), HIV infections (ritonavir, nevirapine), or other infectious diseases (rifabutin, griseofulvin, ampicillin, tetracycline), antibiotics (penicillins and tetracyclines), anti-inflammatory drugs (phenylbutazone, dexamethasone), modafinil, theophylline, corticosteroids, and the herbal remedy St. John's wort.

  • If you wish to use herbal products containing St. John's wort while using Vonille, you should first consult your doctor.
  • Vonille may reduce the effectiveness of other medicines, for example, medicines containing ciclosporine (medicines for infections), the antiepileptic drugs lamotrigine or valproate (this could lead to an increase in seizure frequency), or levothyroxine.

Do not use Vonille if you have Hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause increases in liver function test results (elevated liver enzyme ALT).

Your doctor will prescribe another type of contraceptive before starting treatment with these medicines.

Vonille can be used again approximately 2 weeks after completion of this treatment. See the section “Do not use Vonille.”

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Laboratory tests

If you need a blood test, inform your doctor or laboratory staff that you are taking this medicine, as oral contraceptives may affect the results of some tests.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

If you are pregnant, do not take Vonille. If you become pregnant while being treated with Vonille, stop treatment immediately and contact your doctor.

In general, Vonille is not recommended during breastfeeding. If you wish to take a contraceptive while breastfeeding, you should consult your doctor.

Driving and using machines

There is no information suggesting that the use of Vonille affects the ability to drive or use machinery.

Vonille contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Vonille

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Take one Vonille tablet every day, with some water if necessary. You may take the tablets with or without food, but always at approximately the same time each day.

The pack (blister) contains 21 tablets. Next to each tablet, the day of the week on which it should be taken is printed. For example, if you start on a Wednesday, take a tablet with "WED" next to it. Follow the direction of the arrow on the pack until you have taken all 21 tablets.

Afterwards, you must not take any tablets for 7 days. During these 7 days without tablets (called the "rest period"), menstruation should occur. This bleeding, also known as withdrawal bleeding, is expected.

On the 8th day after taking the last tablet (i.e., after the 7-day rest period), you must start the next pack, even if your bleeding has not finished. This means you should start each new pack on the same day of the week, and your period should occur during the same days every month.

If you use Vonille in this way, you are also protected against pregnancy during the 7 days when you do not take any tablets.

When can you start the first pack?

•If you have not used any hormonal contraceptive in the previous month.

Start taking Vonille on the first day of your cycle (i.e., the first day of your period). If you start Vonille on the first day of your period, you are immediately protected against pregnancy. You may also start on days 2–5 of your cycle, but in this case, you must use additional contraceptive methods (e.g., a condom) during the first 7 days.

•Switching from a combined hormonal contraceptive, combined vaginal contraceptive ring, or patch.

You may start taking Vonille the day after the rest week of your previous contraceptive (or after taking the last inactive tablet of your previous contraceptive). When switching from a combined vaginal contraceptive ring or patch, follow your doctor's recommendations.

•Switching from a progestogen-only method (progestogen-only pill, injection, implant, or progestogen-releasing intrauterine device [IUD]).

You may switch on any day—from an injectable on the day the next injection would have been due, from a progestogen-only pill, implant, or IUD on the same day of removal—but in all cases, use additional contraceptive measures (e.g., a condom) during the first 7 days of tablet intake.

•After an abortion.

Follow your doctor's recommendations.

•After giving birth.

You may start taking Vonille between 21 and 28 days after giving birth. If you start later, use a barrier method (e.g., a condom) during the first 7 days of using Vonille.

If, after giving birth, you have already had sexual intercourse before starting Vonille (again), you must be sure you are not pregnant or wait until your next menstrual period.

Ask your doctor if you are unsure about when to start taking Vonille.

If you are breastfeeding and wish to start (or restart) taking Vonille after giving birth.

Vonille must not be used during breastfeeding. See section 2, "Pregnancy and breastfeeding."

If you take more Vonille than you should

No cases of serious harm due to overdose of Vonille have been reported.

Symptoms that may occur if you take many tablets at once include nausea, dizziness, abdominal pain, drowsiness/fatigue, or vomiting. Adolescent women may experience vaginal bleeding.

If you have taken too many Vonille tablets, or if you find that a child has taken them, consult your doctor or pharmacist.

If you forget to take Vonille

  • If you are less than 12 hours late in taking a tablet, protection against pregnancy is not reduced. Take the missed tablet as soon as you remember, and take the following tablets at the usual time.
  • If you are more than 12 hours late in taking a tablet, protection against pregnancy may be reduced. The more tablets you miss, the greater the risk that protection against pregnancy has decreased.

The risk of incomplete protection against pregnancy is highest if you miss a tablet at the beginning or end of the pack. Therefore, follow the recommendations below (see also the diagram below):

  • If you missed more than one tablet from this pack

Consult your doctor.

  • If you missed a tablet in week 1*

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at the usual time and use additional precautions, such as condoms, for the next 7 days. If you had sexual intercourse in the week before missing the tablet or failed to start a new pack after the rest period, consider that there may be a risk of pregnancy. In this case, consult your doctor.

  • If you missed a tablet in week 2*

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at the usual time. Protection against pregnancy is not reduced, and you do not need to take additional precautions.

•If you missed a tablet in week 3

You have two options:

  1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the tablets at the usual time. Instead of starting the rest period, begin the next pack immediately.

You will likely have your period at the end of the second pack, although you may experience light bleeding or breakthrough bleeding during the second pack.

  1. You may also stop taking tablets and go directly into the rest period (noting the day on which you missed the tablet). If you wish to start a new pack on the day you usually start, your rest period will need to be shorter than 7 days.

If you follow either of these two recommendations, you will remain protected against pregnancy.

  • If you have missed taking any tablets and do not have a period during the first rest period, you may be pregnant. You must contact your doctor before starting the next pack.
Medical flowchart in Spanish explaining procedures to follow if a tablet is forgotten during the first, second, or third week

Advice in case of gastrointestinal disturbances

In case of severe gastrointestinal disturbances (e.g., vomiting or diarrhea), absorption may not be complete, and you should use additional contraceptive measures. If you vomit within 3–4 hours after taking a tablet or have severe diarrhea, the situation is similar to missing a tablet. After vomiting or diarrhea, take another tablet from a spare pack as soon as possible. If possible, take it within 12 hours of when you normally took the tablet. If this is not possible or more than 12 hours have passed, follow the advice given in the section "If you forget to take Vonille."

Delaying your menstrual period: what you should know

Although not recommended, it is possible to delay your menstrual period (withdrawal bleeding). This can be done by starting a new pack of Vonille immediately, without taking the rest period after the first pack. You may experience spotting (small drops or blood stains) or breakthrough bleeding while using the second pack. After the usual 7-day rest period, continue with the next pack.

You should seek advice from your doctor before deciding to delay your menstrual period.

Changing the first day of your menstrual period: what you should know

If you take the tablets as instructed, your menstrual period will begin during the week corresponding to the rest period. If you need to change the day, reduce the number of rest days (but never increase them—maximum 7 days!). For example, if your rest days start on a Friday and you wish to change to Tuesday (3 days earlier), start a new pack 3 days earlier than usual. If you make the rest period very short (e.g., 3 days or fewer), bleeding may not occur during these days. In this case, you may experience spotting or breakthrough bleeding.

If you are unsure how to proceed, consult your doctor.

If you stop treatment with Vonille

You may stop taking Vonille at any time. If you do not wish to become pregnant, consult your doctor about other effective methods of birth control.

If you have any further questions about the use of this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vonille may cause side effects, although not everyone experiences them. If you experience any side effect, especially if it is severe and persistent, or if you have any change in health that you think may be due to Vonille, consult your doctor.

All women who take combined hormonal contraceptives have an increased risk of developing blood clots in veins (venous thromboembolism (VTE)) or blood clots in arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before starting to use Vonille”.

  • Harmful blood clots in a vein or artery, for example:
    • In a leg or foot (i.e., DVT).
    • In a lung (i.e., PE).
    • Heart attack.
    • Stroke.
    • Mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA).
    • Blood clots in the liver, stomach/intestines, kidneys, or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information about conditions that increase the risk of blood clots and the symptoms of a blood clot).

Contact a doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives potentially accompanied by difficulty breathing (see also the section “Warnings and precautions”).

The following list of side effects has been associated with the use of Vonille:

  • Common (may affect up to 1 in 10 women):

  • headache,

  • nervousness,

  • poor tolerance to contact lenses,

  • visual disturbances,

  • nausea,

  • acne,

  • migraine,

  • weight gain,

  • fluid retention,

  • during the first months of use, bleeding or spotting between periods may sometimes occur, but this usually stops once your body adjusts to Vonille. If this continues, worsens, or starts again, contact your doctor,

  • absence of menstruation,

  • pain in the hands,

  • loss of interest in sex,

  • depressed mood,

  • irritability.

  • Uncommon (may affect up to 1 in 100 women):

  • excess lipids in the blood,

  • vomiting,

  • hypertension.

  • Rare (may affect up to 1 in 1,000 women):

  • liver disease,

  • skin and subcutaneous tissue disorder (lupus erythematosus),

  • middle ear disorders,

  • gallstones,

  • thrombosis (formation of a blood clot in blood vessels),

  • pigmentation disorders, which may occur even after using Vonille for several months. This can be reduced by avoiding excessive sunlight exposure.

  • changes in vaginal discharge.

  • Very rare (may affect up to 1 in 10,000 women):

  • movement disorders,

  • pancreatic disease.

Reporting of side effects

If you experience any type of side effect, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vonille

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the container and outer packaging after the phrases “Do not use after:” or “EXP:”. The expiry date refers to the last day of the month indicated.

Do not store above 30°C. Keep the container in the outer packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the pharmacy's SIGRE collection point Black medical cross symbol surrounded by a circular arrow pointing clockwise on a white background. If you have any doubts, please ask your pharmacist how to dispose of unused containers and medicines. This helps protect the environment.

6. Contents of the pack and other information

Composition of Vonille

The active substances are gestodene and ethinylestradiol.

  • Each tablet contains 0.075 mg of gestodene and 0.03 mg of ethinylestradiol.
  • The other components are: monohydrate lactose, microcrystalline cellulose, povidone K-30, magnesium stearate and potassium polacrilin.

Appearance of the product and contents of the pack

Vonille tablets are round, white, approximately 5.7 mm in diameter, marked with a "C" on one side and "33" on the other.

Vonille is available in boxes of 1, 3 and 6 blisters, each containing 21 tablets.

Marketing Authorization Holder

Exeltis Healthcare S.L.

Avenida Miralcampo 7 - Poligono Industrial Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

Manufacturer

Laboratorios León Farma, S.A.

Pol. Ind. Navatejera

C/ La Vallina s/n, 24008 - Navatejera,

León, Spain.

This product is marketed in other countries under the following names:

Netherlands: Nhytida 0.075 mg / 0.030 mg tabletten

Austria: Gestoden/ Ethinylestradiol Leon Farma 75 Mikrigramm/ 30 Mikrogramm Tabletten

Spain: Vonille 0,075mg/0,03 mg tablets

Date of the most recent review of this leaflet: November 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es