VONILLE 0.075 mg/0.03 mg TABLETS

Introduction

Package Leaflet: Information for the User

Vonille 0.075 mg/0.03 mg tablets EFG

Gestodene/Ethinylestradiol

Important things you should 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 having a blood clot in the veins and arteries, especially in 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 package leaflet carefully before starting to take this medication, as it contains important information for you.

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

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

-This medication has been prescribed to you only, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Vonille and what is it used for
2. What you need to know before you start taking Vonille
3. How to take Vonille
4. Possible side effects
5. Storage of Vonille
6. Package contents and additional information

1. What is Vonille and what is it 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.
• Contraceptive pills 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 should read the information about blood clots in section 2. It is particularly important that you read 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. The doctor will also measure your blood pressure, and depending on your personal situation, may carry out some other tests. This leaflet describes several situations in which you should stop using Vonille, or in which the reliability of Vonille may be decreased. In such situations, you should not have sexual intercourse or should take additional non-hormonal contraceptive precautions, for example, use a condom or another barrier method. Do not use the rhythm or temperature method. These methods may not be reliable since Vonille alters the monthly changes in body temperature and cervical mucus.

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

Do not take Vonille

You should 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 what other form of contraception would be more suitable.

• If you have (or have ever had) a blood clot in a blood vessel of the legs (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs.
• If you know you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden or antiphospholipid antibodies.
• If you need an operation or if you spend a long time immobile due to injury or illness or if you have your leg immobilized. You may need to stop using Vonille several weeks before surgery or while you are less mobile. If you need to stop using Vonille, ask your doctor when you can start using it again.
• If you have ever had a heart attack or stroke.
• If you have (or have ever had) angina pectoris (a condition that causes 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 diseases that may increase your risk of forming a blood clot 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 liver tumors;
• If you have (or have ever had), or if you suspect you have breast cancer or cancer of the genitals;
• If you have vaginal bleeding of unknown cause;
• If you are pregnant or suspect you may 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 inflammation.
• If you have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Using Vonille with other medicines").

Warnings and precautions

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

Tell your doctor if you suffer from any of the following conditions.

If the condition develops or worsens while you are using Vonille, you should also tell your doctor.

• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• If you have hemolytic uremic syndrome (HUS: a blood clotting disorder that causes kidney failure).
• If you have sickle cell anemia (an inherited disease of the red blood cells);
• 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 developing pancreatitis (inflammation of the pancreas).
• If you need an operation or spend a long time immobile (see section 2 "Blood clots").
• If you have just given birth, you are at a higher risk of blood clots. You should ask your doctor when you can start taking Vonille after childbirth.
• If you have inflammation of the veins just under the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If any of your close relatives have had or have breast cancer.
• If you have any 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 a disease that first appeared during pregnancy or during previous use of sex hormones (e.g., loss of hearing, a blood disease called porphyria, blistering rash during pregnancy (herpes gestationis), a nervous disease in which involuntary movements appear (Sydenham's chorea)).
• If you have or have ever had chloasma (brownish patches on the skin, especially on the face, known as "pregnancy patches"). In this case, you should avoid direct exposure to the sun or ultraviolet rays.
• If you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat and/or difficulty swallowing or urticaria with difficulty breathing, contact a doctor immediately. Products containing estrogens may cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Vonille increases your risk of having a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In the veins (this is called "venous thrombosis", "venous thromboembolism" or VTE).
• In the arteries (this is called "arterial thrombosis", "arterial thromboembolism" or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious long-term effects or, very rarely, they can 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.

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 the veins (venous thrombosis). However, these side effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in a vein of another organ, such as the eye (retinal vein thrombosis).

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

The risk of a blood clot in a vein is higher during the first year you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medicine or a different one) after a break of 4 weeks or more.

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

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

What is the risk of a blood clot?

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

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

• Of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will have a blood clot in a year.
• Of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 will have a blood clot in a year.
• Of 10,000 women who use a combined hormonal contraceptive that contains gestodene, such as Vonille, about 9-12 will have a blood clot in a year.
• The risk of a blood clot will depend on your personal history (see "Factors that increase your risk of a blood clot" below).

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

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

• If you are overweight (body mass index or BMI over 30 kg/m2).
• If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before the age of about 50). In this case, you may have an inherited blood clotting disorder.

• If you need an operation or spend a long time immobile due to injury or illness or if you have your leg immobilized. You may need to stop using Vonille several weeks before surgery or while you are less mobile. If you need to stop using Vonille, ask your doctor when you can start using it again.
• As you get older (especially above about 35 years).
• If you have just given birth.

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

Long-haul flights (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.

It is important to tell your doctor if you suffer from any of the conditions above, even if you are not sure. Your doctor may decide that you should stop using Vonille.

If any of the conditions above change while you are using Vonille, for example, a close relative experiences a blood clot without a known cause or you gain much weight, tell 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 blood 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 due to Vonille is very small, but it can increase:

• With age (above 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 any of your close relatives have had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also be at higher risk of having a heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, heart rhythm disturbance called atrial fibrillation).
• If you have diabetes.

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

If any of the conditions above change while you are using Vonille, for example, you start smoking, a close relative experiences a blood clot without a known cause, or you gain much weight, tell your doctor.

Vonille and cancer

Breast cancer has been reported slightly more often in women who use combined contraceptives, but it is not known if this is due to the treatment. For example, it may be that more tumors are detected in women who take combined contraceptives because they are examined by a doctor more often. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is important to have your breasts checked regularly and you should see your doctor if you notice any lump.

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

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

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

Psychiatric disorders:

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

Bleeding between periods

During the first few months that you are taking Vonille, you may have unexpected bleeding (bleeding outside of the withdrawal bleed). If these bleeds persist for more than a few months, or start after a few months, your doctor should investigate the cause.

3. How to take Vonille

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Take one Vonille pill every day, with some water if necessary. You can take the pills with or without food, but always at approximately the same time every day.

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

After that, you should not take any pills for 7 days. During these 7 days when you do not take pills (called the rest week), you should have your period. The period, which can also be called withdrawal bleeding.

On the 8th day after taking the last pill (i.e., after the 7-day rest period), you should start with the next pack, even if you have not yet finished your period. This means you should start each pack on the same day of the week, and your period should take place 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 pills.

When can you start with the first pack?

• If you have not taken 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 can also start on days 2-5 of your cycle, but you must use additional contraceptive methods (e.g., a condom) during the first 7 days.

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

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

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

You can switch at any time, from an injectable on the day corresponding to the next injection, from a progestogen-only pill, an implant, or an IUD, on the day of its removal; but in all cases, use additional contraceptive measures (e.g., a condom) during the first 7 days of pill taking.

•After an abortion.

Follow your doctor's recommendations.

• After having a child.

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

If, after having a child, you have had sexual intercourse before starting to take Vonille again, you should be sure you are not pregnant or wait for your next menstrual period.

Ask your doctor if you are not sure when to start taking Vonille.

If you are breastfeeding and want to start taking Vonille again after having a child.

Vonille should not be used during breastfeeding. Read the section "2. Pregnancy and breastfeeding".

If you take more Vonille than you should

No cases have been reported in which an overdose of Vonille has caused serious harm.

The symptoms that may appear if you take many pills at the same time are nausea, dizziness, abdominal pain, drowsiness/fatigue, or vomiting. Adolescent girls may experience vaginal bleeding.

If you have taken too many Vonille pills or discover that a child has taken them, consult your doctor or pharmacist.

If you forget to take Vonille

• If you are less than 12 hourslate in taking a pill, your protection against pregnancy is not reduced. Take the pill as soon as you remember and the following pills at the usual time.
• If you are more than 12 hourslate in taking a pill, your protection against pregnancy may be reduced. The more pills you have missed, the greater the risk that your protection against pregnancy has been reduced.

The risk of incomplete protection against pregnancy is greatest if you miss a pill at the beginning or end of the pack. Therefore, you should follow these recommendations (see also the following diagram):

• If you missed more than one pill in this pack

Consult your doctor.

• If you missed a pill in week 1

Take the missed pill as soon as you remember, even if it means taking two pills at the same time. Continue taking the pills at the usual time and use additional precautions, such as condoms, for the next 7 days. If you have had sexual intercourse in the week before missing the pill or have missed starting a new pack after the rest week, you should consider the possibility of pregnancy. In this case, consult your doctor.

• If you missed a pill in week 2

Take the missed pill as soon as you remember, even if it means taking two pills at the same time. Continue taking the pills at the usual time. Your protection against pregnancy is not reduced, and you do not need to take additional precautions.

•If you missed a pill in week 3

You can choose between two options:

1. Take the missed pill as soon as you remember, even if it means taking two pills at the same time. Continue taking the pills at the usual time. Instead of starting the rest week, begin the next pack.

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

1. You can also stop taking pills and go directly to the rest week (noting the day you missed the pill). If you want to start a new pack on the day you usually do, your rest week should last less than 7 days.

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

• If you have missed taking a pill and do not have a period during the first rest week, you may be pregnant. You should contact your doctor before starting the next pack.

Advice in case of gastrointestinal disorders

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

Delay of your menstrual period: what you should know

Although it is not recommended, delaying your menstrual period (withdrawal bleeding) is possible. You can do this by starting directly with a new pack of Vonille instead of taking the rest week after the first pack. You may experience spotting (drops or spots of blood) or breakthrough bleeding while using the second pack. After the usual 7-day rest period, continue withthe next pack.

You should ask your doctor for advice before deciding to delay your menstrual period.

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

If you take the pills according to the instructions, your menstrual period will begin during the rest week. If you need to change the day, reduce the number of rest days (but never increase them, 7 at most!). For example, if your rest days start on a Friday and you want to change to a 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 less), you may not have bleeding during these days. Then you may experience spotting (drops or spots of blood) or breakthrough bleeding.

If you are not sure how to proceed, consult your doctor.

If you stop treatment with Vonille

You can stop taking Vonille whenever you want. If you do not want to become pregnant, consult your doctor about other effective birth control methods.

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

4. Possible side effects

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

All women who take combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section 2 "What you need to know before you start using Vonille".

• Harmful blood clots in a vein or artery, such as:
• • In a leg or foot (i.e., DVT).
  • In a lung (i.e., PE).
  • Heart attack.
  • Stroke.
  • Mild stroke or temporary symptoms similar to those of a stroke, called a transient ischemic attack (TIA).
  • Blood clots in the liver, stomach/intestine, kidneys, and eye.

The chances of having a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and 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 urticaria potentially with difficulty breathing (see also the section "Warnings and precautions").

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

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

• headache,
• nervousness,
• intolerance to contact lenses,
• visual disturbances,
• nausea,
• acne,
• migraine,
• weight gain,
• fluid retention,
• during the first few months of use, sometimes spotting or breakthrough bleeding may occur between periods, but this usually stops once your body has adjusted to Vonille. If this continues, worsens, or starts again, contact your doctor,
• absence of menstruation,
• breast pain,
• decreased libido,
• depressive mood,
• irritability.

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

• high levels of lipids in the blood,
• vomiting,
• hypertension.

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

• liver disease,
• skin and subcutaneous tissue disorders (lupus erythematosus),
• middle ear disorders,
• gallstones,
• thrombosis (formation of a blood clot in blood vessels),
• skin pigmentation disorders, which can occur even if you have been using Vonille for some months. This can be reduced by avoiding excessive sun exposure.
• changes in vaginal discharge.

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

• movement disorders,
• pancreatic disease.

Reporting side effects

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

5. Storage of Vonille

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

Do not use this medication after the expiration date shown on the pack and carton after the phrase "Do not use after:" or "EXP:". The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Place the packs and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packs and any unused medicines. This will help protect the environment.

6. Packaging Content and Additional Information

Vonille Composition

The active ingredients are gestodene and ethinylestradiol.

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

Product Appearance and Packaging Content

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

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

Marketing Authorization Holder

Exeltis Healthcare S.L.

Miralcampo Avenue 7-Miralcampo Industrial Estate

19200 Azuqueca de Henares, Guadalajara

Spain

Manufacturer

Laboratorios León Farma, S.A.

Navatejera Industrial Estate

La Vallina street, 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 tablets

Austria: Gestoden/ Ethinylestradiol Leon Farma 75 micrograms / 30 micrograms tablets

Spain: Vonille 0.075mg/0.03 mg tablets

Date of the Last Revision of this Prospectus:November 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es