Prospect: information for the user

Vonille 0.075 mg/0.03 mg EFG tablets

Gestodeno/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 suffering a blood clot in the veins and arteries, especially in the first year or when restarting use of a combined hormonal contraceptive after a pause 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 this prospect carefully before starting to take this medication, because it contains important information for you.

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

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

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

-If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

1. What is Vonille and for what it is used

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

3. How to take Vonille

4. Possible adverse effects

5. Storage of Vonille

6.Contents of the package and additional information

• Vonilleis a contraceptive pill used to prevent pregnancy.

• Each tablet contains a small amount of two different female hormones, called gestodeno and ethinylestradiol.

• Contraceptive pills like Vonille that contain two hormones are called "combined" contraceptives.

General Comments

Before starting to useVonille, 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 takeVonille, 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 perform some other tests. In this prospectus, several situations are described in which you should interrupt the use ofVonille, or in which the reliability ofVonillemay decrease. In these situations, you should not have sexual intercourse or should take additional non-hormonal contraceptive precautions, for example, use of a condom or other barrier method. Do not use the rhythm or basal body temperature method. These methods may not be reliable becauseVonillealters the monthly changes in body temperature and cervical mucus.

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

Do not take Vonille

You should not useVonilleif 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 leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE), or in other organs.
• If you know that 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 surgery or if you spend a lot of time without standing up (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 that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, symptoms of a stroke).
• if you have any of the following diseases that may increase your risk of forming a clot in the arteries:
• • Severe diabetes with vascular damage.
  • Very high blood pressure.
  • Very high levels of fat in the blood (cholesterol or triglycerides).
  • A condition called homocysteineemia.
• 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)liver disease and your liver function has not yet normalized;
• if you have or have had liver tumors;
• if you have (or have ever had), or if you suspect that you have breast cancer or cancer of the reproductive organs;
• if you have unexplained vaginal bleeding;
• if you are pregnant or suspect that you may be pregnant;
• if you are allergic to ethinylestradiol or gestodene, or to any of the other components of this medication (including in section 6).This may cause itching, rash, or inflammation.
• if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section “Use of Vonille with other medications”).

Warnings and Precautions

Consult your doctor,pharmacist, or nurse before starting to takeVonille.

Inform Your Doctor if You Suffer from Any of the Following Conditions.

If the condition develops or worsens while you are usingVonille, you should also inform your doctor.

• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
• If you have systemic lupus erythematosus (LES, a disease that affects your natural defense system).
• If you have hemolytic uremic syndrome (SUH: a blood clotting disorder that causes kidney failure).
• If you have sickle cell anemia (a hereditary disease of 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 pancreatitis (inflammation of the pancreas).
• If you need surgery or spend a lot of time without standing up (see section 2 “Blood Clots”).
• If you recently gave birth, you are at greater risk of developing blood clots. Ask your doctor when you can start takingVonilleagain after childbirth.
• If you have superficial thrombophlebitis (inflammation of the veins under the skin).
• If you have varicose veins.
• If a close relative has or has had breast cancer.
• If you have liver disease or bile duct disease.
• If you have diabetes.
• If you have depression.
• If you have epilepsy (see the section “Use of Vonille with other medications”).
• If you have a disease that appeared for the first time during pregnancy or during a previous use of sex hormones (for example, hearing loss, a blood disease called porphyria, skin rash with blisters during pregnancy (herpes gestationalis), a nervous disorder characterized by involuntary movements (Sydenham's chorea)).
• If you have or have had melasma (brown skin patches, especially on the face, known as “pregnancy mask”). In this case, you should avoid direct exposure to the sun or ultraviolet rays.
• If you experience symptoms of angioedema such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or breathing, contact a doctor immediately. Estrogen-containing products can cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive likeVonilleincreases your risk of developing 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 veins (called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• In arteries (called “arterial thrombosis”, “arterial thromboembolism” or ATE).

The recovery of blood clots is not always complete. In rare cases, there may be long-lasting or even fatal effects.

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attentionif 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 veins (venous thrombosis). However, these adverse 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 in the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism.
• In very rare cases, a blood clot can form in a vein in 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 of taking a combined hormonal contraceptive for the first time. The risk may be higher 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 is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop takingVonille, your risk of a blood clot returns to normal in 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) withVonilleis small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, 2 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone, or norgestimato, 5-7 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing gestodene likeVonille, 9-12 will develop 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 withVonilleis small, but some conditions increase the risk. Your risk is higher:

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

• If you need surgery or spend a lot of time without standing up due to an injury or illness or if you have a leg cast. You may need to interrupt the use ofVonillefor several weeks before the surgery or while you have limited mobility. If you need to interrupt the use ofVonille, ask your doctor when you can start using it again.
• With increasing age (especially over about 35 years).
• If you have given birth recently.

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

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

It is essential to inform your doctor if you have any of the above conditions, even if you are unsure. Your doctor may decide that you should interrupt the use ofVonille.

If any of the above conditions change while you are usingVonille, for example, a close relative experiences a blood clot without a known cause or you gain a lot of 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 blood clot in an artery can cause serious problems, for example, a heart attack or a stroke.

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

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

• With age (over about 35 years).

• If you smoke.When using a combined hormonal contraceptive likeVonille, you are advised to quit smoking. If you are unable to quit 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 (less than about 50 years). In this case, you may also be at higher risk of a heart attack or stroke.
• If you or a close relative has high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart condition (valve disorder, abnormal heart rhythm called atrial fibrillation).
• If you have diabetes.

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

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

Vonille and Cancer

Cancer of the breast has been observed slightly more frequently in women using combined hormonal contraceptives, but it is not known whether this is due to the treatment. For example, it may be that more tumors are detected in women taking combined hormonal contraceptives because they are examined by the doctor more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential to undergo regular breast examinations, and you should consult your doctor if you notice any lump.

In rare cases, benign tumors in the liver and, more rarely, malignant tumors have been reported in users of contraceptives. This can cause internal bleeding, which may cause severe abdominal pain.

Seek medical attention if you experience severe abdominal pain. You may need to stop takingVonille.

Cancer of the cervix has been reported more frequently in women using contraceptives for a long time. This finding may not be caused by the contraceptives, but may be related to sexual behavior or other factors.

Mental Disorders:

Some women who use combined hormonal contraceptives likeVonillehave 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 additional medical advice as soon as possible.

Spotting

During the first few months of takingVonille, you may experience unexpected bleeding (bleeding outside of the withdrawal 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 Withdrawal Week

If you have taken all the pills correctly, have not had severe vomiting or diarrhea, and have not taken other medications, it is highly unlikely that you are pregnant.

If your expected period does not arrive in two consecutive instances, you may be pregnant. Seek medical attention immediately. Do not start the next pack until you are certain that you are not pregnant.

Use of Vonille with Other Medications

Inform your doctor or pharmacist if you are taking,have recently takenor may need to take any other medication.

Always inform the doctor who prescribesVonillewhat medications or herbal supplements you are using.Also, inform any other doctor or dentist who prescribes another medication (or your pharmacist) that you are usingVonille. They may advise you to take additional contraceptive precautions (for example, condoms) and, if so, for how long.

•Some medications may reduce the effectiveness ofVonille, or may cause unexpected bleeding.

These include medications used to treat epilepsy (for example, phenytoin, topiramate, felbamate, lamotrigine, primidone, phenobarbital, carbamazepine, oxcarbazepine) and tuberculosis (for example, rifampicin), immunomodulators (ciclosporin), for HIV (ritonavir, nevirapina) or other infectious diseases (rifabutina, griseofulvina, ampicillin, tetracyclines), antibiotics (penicillin and tetracyclines), anti-inflammatory medications (phenylbutazone, dexamethasone), modafinil, theophylline, corticosteroids, and the herbal supplement St. John's Wort.

• If you want to use St. John's Wort while takingVonille, you should consult your doctor first.

•Vonillemay reduce the effectiveness of other medications, for example, medications containing ciclosporin (medication against infections), the antiepileptic medications lamotrigine or valproate (this may increase the frequency of seizures) or levothyroxine.

Do not useVonilleif you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir,glecaprevir/pibrentasvir, orsofosbuvir/velpatasvir/voxilaprevir, as these medicationsmay cause increases in liver enzyme levels (ALT).

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

You can start usingVonilleagain approximately 2 weeks after completing this treatment. See the section “Do not use Vonille”

Inform your doctor or pharmacist if you are taking,have recently takenor may need to take any other medication

Laboratory Tests

If you need a blood test, inform your doctor or the laboratory staff that you are taking this medication, as combined hormonal contraceptives can affect the results of some tests.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

If you are pregnant, do not takeVonille. If you become pregnant during treatment withVonille, stop treatment immediately and seek medical attention.

In general, it is not recommended to takeVonilleduring breastfeeding (while you are expressing milk). If you want to take the contraceptive while breastfeeding, you shouldconsult with your doctor.

Driving and Operating Machinery

There is no information to suggest that the use ofVonillehas any effect on your ability to drive or operate machinery.

Vonille contains lactose

If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

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 tablet ofVonilleevery day, with some water if necessary. You can take the tablets with or without food, but approximately at the same time every day.

The package (blister) contains 21 tablets. Next to each tablet is printed the day of the week when it should be taken. If, for example, you start on a Wednesday, take a tablet with "MIE" next to it. Follow the direction of the arrow on the package until you have taken the 21 tablets.

Do not take any tablets for 7 days afterwards. During these 7 days when no tablets are taken (called the rest week), menstruation should take place. Menstruation, which can also be called withdrawal bleeding.

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

If you use Vonille in this way, you are also protected against pregnancy during the 7 days when you take no tablets.

When can you start with the first package?

•If you have not taken any hormonal contraceptives in the past month.

Start taking Vonille on the first day of your cycle (i.e., the first day of your period). If you start taking 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 should use additional contraceptive methods (e.g., a condom) during the first 7 days.

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

You can 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 changing from a vaginal combined contraceptive ring or patch, follow your doctor's recommendations.

• Change from a progestin-only method (progestin-only pill, injection, implant, or intrauterine device releasing progestin (IUD)).

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

•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 one of the barrier methods (e.g., a condom) during the first 7 days of using Vonille.

If, after having a child, you have had sex again 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 section 2. "Pregnancy and breastfeeding".

If you take more Vonille than you should

No serious harm has been reported in cases of overdose of Vonille.

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

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

If you forgot to take Vonille

The risk of incomplete protection against pregnancy is maximum if you forget to take a tablet at the beginning or end of the package. Therefore, you should follow the following recommendations (see also the next diagram):

•If you forgot more than one tablet from this package

Consult your doctor.

• If you forgot a tablet in week 1

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the tablets at the usual time and useadditional precautions, for example, condoms, during the next 7 days. If you have had sex in the week before forgetting the tablet or have forgotten to start a new package after the rest period, there is a risk of pregnancy. In that case, consult your doctor.

• If you forgot a tablet in week 2

Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the tablets at the usual time. The protection against pregnancy does not decrease and you do not need to take additional precautions.

• If you forgot a tablet in week 3

You can choose between two options:

1. Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the tablets at the usual time. Instead of starting the rest period, start the next package.

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

2. You can also interrupt taking tablets and go directly to the rest period (noting the day you forgot to take the tablet). If you want to start a new package on the day you always start, your rest period should last less than 7 days.

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

• If you have forgotten to take some tablets and do not have a period during the first rest period, you may be pregnant. You should contact your doctor before starting the next package.

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 take additional contraceptive measures. If you experience vomiting in the 3-4 hours after taking the tablet or have severe diarrhea, the situation is similar to forgetting to take a tablet. After vomiting or diarrhea, you should take another tablet from a reserve package as soon as possible. If possible, take itwithin 12 hoursafter taking the usual tablet. If this is not possible or more than 12 hours have passed, you should follow the advice given in the section "If you forgot to take Vonille”.

Delay of your menstrual period: what you should know

Although not recommended, a delay in your menstrual period (withdrawal bleeding) is possible. You can start directly with a new package of Vonille instead of taking the rest period after the first package. You may experience spotting (drops or spots of blood) or bleeding disruption while using the second package. After the usual 7-day rest period,continue withthe next package.

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

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

If you take the tablets according to the instructions, your menstrual period will start duringthe week corresponding to the rest period. If you have to change the day, reduce the number of rest days (but never increase, 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 package 3 days earlier than usual. If you make the rest period very short (e.g., 3 days or less), you may not experience bleeding during these days. Then you may experience spotting (drops or spots of blood) or bleeding disruption.

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

If you interrupt treatment with Vonille

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

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

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

All women taking 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 starting to use Vonille”.

• Deleterious blood clots in a vein or artery, for example:
• • In a leg or foot (i.e., DVT).
  • In the lungs(i.e., PE).
  • Heart attack.
  • Stroke.
  • Mild or transient stroke-like symptoms, known as 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 angioedema symptoms: swelling of the face, tongue, and/or throat and/or difficulty swallowing or potentially life-threatening 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,
• Poor tolerance to contact lenses,
• Visual disturbances,
• Nausea,
• Acne,
• Migraine,
• Weight gain,
• Fluid retention,
• During the first few months of use, some women may experience bleeding or spotting between periods, but this usually stops once their body has adjusted to Vonille. If this continues, worsens, or starts again, contact your doctor,
• Amenorrhea,
• Hand pain,
• Loss of interest in sex,
• Depressive mood,
• Irritability.

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

• Hyperlipidemia,
• Vomiting,
• Hypertension.

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

• Liver disease,
• Dermatological and subcutaneous tissue disorders (lupus erythematosus),
• Middle ear disorders,
• Biliary calculi,
• Thrombosis (the formation of a clot in the blood vessels),
• Pigmentation disorders, which may occur even if you have been usingVonillefor several months. This may be reduced by avoiding excessive sunlight.
• Vaginal discharge changes.

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

• Movement disorders,
• Pancreatitis.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and box afterthe phrase “Do not use after:” or “EXP:”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 86°F (30°C). Store the packaging in the outer packaging to protect it from light.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Vonille

The active principles are gestodeno and etinilestradiol.

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

Appearance of the product and content of the packaging

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

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

Holder of the marketing authorization

Exeltis Healthcare S.L.

Avenida Miralcampo 7-Poligono Industrial Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

Responsible for manufacturing

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 tablets

Austria: Gestoden/ Ethinylestradiol Leon Farma 75 Mikrogramm/ 30 Mikrogramm Tablets

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

Last review date of this leaflet:November 2022

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