Label: information for the user

Edelsine 0.250 mg/0.035 mg tablets

Norgestimato/Ethinylestradiol

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

(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 label carefully before starting to take this medication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this label. See section 4.

Edelsine is a low-dose combination of oral contraceptives that serves to prevent pregnancy.

Each tablet contains two types of female hormones, norgestimato and ethinylestradiol.

Edelsine prevents the egg from being released from the ovary, so you cannot become pregnant. Additionally, Edelsine makes the fluid (mucus) in your cervix thicker, making it difficult for sperm to enter the uterus. The contraceptive effect begins from the first tablet.

General Considerations

Before starting to use this medication, 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”).

When Not to Use Edelsine

Do not use this medication 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 vein in your leg (deep vein thrombosis, DVT), in your 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, temporary symptoms of a stroke).
• If you have any of the following diseases that may increase your risk of forming a blood clot in your arteries:

• Severe diabetes with vascular damage.
• Very high blood pressure.
• Very high levels of fat in your blood (cholesterol or triglycerides).
• A condition called hyperhomocysteinemia.

• If you have (or have ever had) a type of migraine called “migraine with aura”.
• If you are allergic to norgestimato, ethinylestradiol or to any of the other components of this medication (including in section 6).
• If you have severe liver disease, while liver function values have not returned to normal.
• If you have any type of liver tumor (malignant or benign).
• If you know or suspect that you have breast cancer or cancer of the reproductive organs.
• If you have abnormal growth of the endometrial mucosa (endometrial hyperplasia).
• If you have unexplained vaginal bleeding.
• If you have jaundice associated with pregnancy or previous use of hormonal contraceptives.
• If you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other Medications and Edelsine”).

Do not use this medication if you:

• Are pregnant or think you might be pregnant.
• Are in menopause.

When to Have Special Care with Edelsine

Warnings and Precautions

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

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

If the condition develops or worsens while using this medication, you must also inform your doctor.

• Consult your doctor immediately if you experience symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, difficulty swallowing or potential difficulty breathing. Medications containing estrogens can cause or worsen symptoms of hereditary and acquired angioedema.
• 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 (HUS, a disorder of blood clotting that causes kidney insufficiency).
• If you have sickle cell anemia (a hereditary disease of red blood cells).
• If you have very high levels of fat in your 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 blood clots. Ask your doctor when you can start taking Edelsine after delivery.
• If you have superficial thrombophlebitis (inflammation of veins under the skin).
• If you have varicose veins.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Edelsine increases your risk of suffering 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 (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• In arteries (which is 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 Important to Remember that the Global Risk of a Harmful Blood Clot Due to This Medication is Small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek Urgent Medical Assistanceif 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 thromboembolism). 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 in your leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from your leg and lodges in your lung, it may cause a pulmonary embolism (PE).
• 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 Greater?

The risk of a blood clot in a vein is greater during the first year in which you start taking a combined hormonal contraceptive for the first time. The risk may be greater 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 taking this medication, 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 global risk of a blood clot in your leg or lung (DVT or PE) with this medication is small.

• Of every 10,000 women who are not taking any combined hormonal contraceptive and are not pregnant, about 2 may develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone or norgestimato like Edelsine, between 5 and 7 women may develop a blood clot in a year.
• The risk of having a blood clot will vary depending on your personal medical history (see “Factors That Increase Your Risk of a Blood Clot” below).

Factors That Increase Your Risk of a Blood Clot in a Vein

Your risk of a blood clot with this medication is small, but some conditions increase the risk. Your risk is greater:

• If you are overweight (body mass index (BMI) of 30 kg/m2or higher).
• If any of your close relatives have had a blood clot in their leg, lung, or other organ at a young age (i.e., before about 50 years old). In this case, you may have a hereditary disorder of blood clotting.
• If you need surgery or spend a lot of time without standing up due to an injury or illness, or if you have your leg immobilized. You may need to stop taking this medication for several weeks before the operation or while you have less mobility. If you need to stop taking this medication, ask your doctor when you can start taking it again.
• As you get older (especially over about 35 years old).
• If you have given birth recently.

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

Long flights (over 4 hours) may temporarily increase your 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 conditions above, even if you are unsure. Your doctor may decide that you need to stop taking this medication.

If any of the conditions above change while you are using this medication, 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, it can cause 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 to using this medication is very small, but it may increase:

• With age (over about 35 years old).
• If You Smoke. When using a combined hormonal contraceptive like Edelsine, 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 contraception.
• 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 old). In this case, you may also be at greater risk of a heart attack or stroke.
• If you or any of your close relatives have high levels of fat in your blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, arrhythmia 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 conditions above change while you are using this medication, 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.

Additionally, consult your doctor, pharmacist, or nurse before starting to take this medication, and inform them if you are in any of these situations, so that your doctor can decide if you can use oral contraceptives and establish the frequency of medical check-ups during treatment with this medication. Inform your doctor if you suffer from any of the following conditions or if they develop or worsen while using this medication:

• If you have epilepsy.
• If you have liver or gallbladder problems.
• If you have or have had melasma (yellow-brown skin patches, skin patches during pregnancy, especially on the face). If this occurs, you should avoid exposure to the sun and UV radiation.

Inform your doctor if any of these conditions appear or worsen during treatment with this medication.

Oral Contraceptives and Cancer

The risk of breast cancer, in general, increases with age. This risk is increased with oral contraceptives. In comparison with developing cancer at some point in life, the increase in risk associated with the use of oral contraceptives is small. The increase in risk of breast cancer decreases gradually over the 10 years following the suspension of oral contraceptive use. The diagnosis of breast cancer in women using oral contraceptives has not advanced as much as in women who are not using them.

Rarely, benign and even malignant liver tumors have been found in women using oral contraceptives. These tumors can be life-threatening due to internal bleeding. Consult your doctor if you experience sudden pain or severe abdominal pain.

More cases of cervical cancer have been found when oral contraceptives have been used for a long time. This is not necessarily related to the use of oral contraceptives and may be due to sexual behavior or other factors.

Mental Health Disorders

Some women who use hormonal contraceptives like Edelsine 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 additional medical advice as soon as possible.

Spotting Between Periods

During the first few months of taking this medication, unexpected bleeding (bleeding outside of the menstrual period) may occur. If this bleeding persists for more than a few months or starts after a few months, your doctor should investigate what is wrong.

Missing Periods

If you have taken all the pills correctly, have not vomited, and have not had severe diarrhea, and you are not taking other medications, it is highly unlikely that you are pregnant. However, if this persists for two consecutive months, you should have a gynecological examination or a pregnancy test before continuing treatment with this medication. Consult your doctor if you forgot to take some pills and your period has not arrived.

The blood levels of nutrients and folates may be lower in women taking oral contraceptives. This may be important in women who become pregnant shortly after stopping oral contraceptive treatment.

The following conditions may occur or worsen both during pregnancy and while using oral contraceptives, but a link has not been confirmed:

• Jaundice and itching associated with bile obstruction (cholestasis)
• Bile stones
• Porphyria (increased secretion of blood pigments)
• Lupus erythematosus (a disease of the connective tissue)
• Sickle cell anemia (a blood disorder that damages the kidneys)
• Corea de Sydenham
• Herpes gestational (a rare skin disease that occurs during pregnancy)
• Otosclerosis (a type of hearing loss)
• Severe depression or a history of this condition.

Women using oral contraceptives should undergo regular medical check-ups. The frequency of these check-ups is based on the potential risk of oral contraceptives affecting a condition or disease.

Edelsine, like other oral contraceptives, does not protect against HIV (AIDS) or other sexually transmitted diseases.

Other Medications and Edelsine

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. They can advise you if you need to take additional contraceptive precautions.

Do not use Edelsine if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications can cause increases in liver function values in the blood (elevated ALT levels).

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

You can restart using this medication 2 weeks after completing this treatment (see section “When Not to Use Edelsine”).

Some medications and herbal treatments can affect the blood levels of this medication, potentially reducing the effectiveness of pregnancy prevention or causing unexpected bleeding. These include medications for the treatment of:

• Epilepsy (such as: hydantoins, barbiturates, carbamazepine, felbamate, oxcarbazepine, phenytoin, primidone, and topiramate)
• Tuberculosis and other infections (such as: griseofulvin and rifampicin)
• HIV/AIDS and hepatitis C (the so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as: ritonavir, nevirapine, efavirenz, atazanavir, indinavir, and etravirine)
• Pulmonary hypertension (bosentan)
• St. John's Wort (a medicinal herb used for depression)

This medication can affect the effectiveness of other medications, such as:

• Ciclosporin (an immunosuppressive medication to prevent transplant rejection)
• Lamotrigine used for epilepsy (this may increase the risk of seizures)

Pregnancy, Breastfeeding, and Fertility

Consult your doctor or pharmacist before taking any medication.

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

Pregnancy

Do not take this medication during pregnancy. If you become pregnant, stop treatment and contact your doctor. Inform your doctor if you have taken this medication during pregnancy.

Breastfeeding

It is possible that using this medication during breastfeeding may affect the baby. Therefore, do not take this medication during breastfeeding unless your doctor advises you to. Breastfeeding mothers should monitor the volume of milk as this medication may reduce milk production.

Fertility

This medication is used to prevent pregnancy.

Driving and Operating Machines

No known effects.

Edelsine Contains Lactose

If your doctor has told you that you have a lactose intolerance, consult 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.

The contraceptive effect begins with the first pill.

Each calendarized blister contains 21 pills.

First treatment cycle

Take the first pill on the first day of your menstruation. Continue taking 1 pill a day (you must take the pills in consecutive order to check that you have taken a pill each day). It is recommended to take the pills always at the same time, for example, before going to bed.

After taking the 21 pills from a package, a 7-day break will begin during which menstruation will appear. If menstruation does not appear, you should start a new 21-day treatment, after a 7-day break.

Second cycle and subsequent

Start the next treatment cycle/calendarized blister on the same day of the week that you started the previous cycle. If menstruation does not appear after the second cycle, consult your doctor.

Delayed menstruation

Once all the pills from a package have been taken, start a new one for the days you want to delay menstruation. Then, take a 7-day break, and continue with a new package of 21 pills, with a new start day.

Intermenstrual bleeding

The treatment should be continued even if intermenstrual bleeding or spotting appears. This type of bleeding disappears after the first three treatment cycles. If bleeding persists, you should consult your doctor or healthcare professional.

What to do in case of vomiting or intense diarrhea

If you vomit within 3 hours of taking the pill or if you have intense diarrhea for more than 24 hours, the contraceptive effect may not be sufficient, so you should use an additional non-hormonal contraceptive method (e.g. condom) for 7 days after recovery. If diarrhea or vomiting persists, contact your doctor or healthcare professional.

If you take more Edelsine than you should

If you have taken more Edelsine than you should or if, for example, a child accidentally ingests this treatment, consult your doctor to evaluate the risks and provide instructions on how to act.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20.

If you forgot to take Edelsine:

• If more than12 hourshave passed since the time you should have taken the pill, the contraceptive protection may be reduced. Take the pill as soon as you remember and continue taking the remaining pills at the usual time.
• If more than12 hourshave passed since the time you should have taken the pill, the contraceptive protection may be reduced. The risk of pregnancy increases particularly if you forget to take a pill at the beginning or end of the treatment cycle. In this case, you should do the following:

If you forgot to take more than 1 pill from the cycle

Consult your doctor.

If you forgot to take 1 pill in week 1

Take the forgotten pill as soon as you remember, even if it means taking two pills at once. Then, continue taking the pills at the usual time and remember to use an additional contraceptive method (other than hormonal contraceptives, e.g. condom) for the next 7 days. If you had sexual intercourse in the 7 days prior, you may be pregnant, so you should contact your doctor immediately.

If you forgot 1 pill in week 2

Take the forgotten pill as soon as you remember, even if it means taking two pills at once. Then, continue taking the remaining pills at the usual time. If you have taken the pills correctly for the 7 days prior to the forgotten pill, the contraceptive effect of the pills is not reduced and you do not need to use an additional contraceptive method.

If you forgot 1 pill in week 3

You will have to choose one of the following options:

1. Take the forgotten pill as soon as you remember, even if it means taking two pills at once. Then, take the remaining pills at the usual time. You should start the next package as soon as you finish the current one, i.e. there should be no break between packages. It is unlikely that you will have withdrawal bleeding until you finish the second package, but you may have spotting or bleeding during the taking of the pills from this second package.
2. Discontinue taking pills from the current package and start a new package after a 7-day break (including the day you forgot the pill).

If you forgot to take a pill and subsequently do not have withdrawal bleeding in the next 7-day break, you may be pregnant. Consult your doctor before starting a new package.

If you interrupt treatment with Edelsine

You can stop taking this medication at any time. If you do not want to get pregnant, ask your doctor for advice on other reliable methods of birth control. If you want to get pregnant, stop taking this medication.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication 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 changes that you think may be related to this medication, consult your doctor.

Severe side effects

Contact your doctor immediately if you experience any of the following angioedema symptoms: facial, tongue, and/or throat swelling and/or difficulty swallowing or potentially difficulty breathing (see also the "Warnings and precautions" section).

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 take Edelsine".

The following side effects have been reported with Edelsine:

Very common side effects (may affect more than 1 in 10 people)

• Headache.
• Nausea, vomiting, and diarrhea.
• Vaginal bleeding between periods.
• Painful periods.
• Abnormal bleeding due to deprivation (with early menstrual flow)

Common side effects (may affect up to 1 in 10 people)

• Urinary tract infection.
• Vaginal infection.
• Allergic reaction.
• Swelling due to excess water (water retention)
• Mood problems such as depression.
• Mood changes.
• Difficulty sleeping.
• Nervousness.
• Migraines.
• Drowsiness.
• Stomach pain.
• Abdominal distension.
• Constipation.
• Gas.
• Acne.
• Skin rash.
• Muscle cramps.
• Pain in the limbs.
• Back pain.
• Loss of one or more periods.
• Vaginal discharge.
• Breast pain.
• Chest pain.
• Swelling.
• Sensation of fatigue or weakness.
• Weight gain.

Rare side effects (may affect up to 1 in 100 people)

• Abnormal cervical smear.
• Weight gain or loss.
• Increased or decreased appetite.
• Anxiety.
• Changes in sex interest.
• Fainting.
• Numbness or tingling in the skin.
• Visual problems.
• Dry eyes.
• Palpitations.
• High blood pressure or increased blood pressure.
• Hot flashes.
• Difficulty breathing.
• Hair loss.
• Excessive body hair.
• Itching with or without urticaria.
• Redness of the skin.
• Decoloration of the skin.
• Muscle pain.
• Breast secretion.
• Breast enlargement.
• Ovarian cysts.
• Vaginal and skin dryness.
• Weight loss.
• Breast cancer.
• Benign liver tumor.
• Benign chest nodule.
• Abnormal changes in breast tissue.
• Abnormal fats in the blood (such as cholesterol).
• Convulsions or seizures.
• Difficulty wearing contact lenses.
• Swelling of the face, tongue, and throat that causes difficulty swallowing or breathing and may be accompanied by skin rash.
• Red and painful lumps in the arms and legs.
• Nocturnal sweating.
• Decreased milk production.

Rare side effects (may affect up to 1 in 1,000 people)

• Detrimental 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.
  • Transient ischemic attack (TIA) or temporary symptoms similar to a stroke.
  • Blood clots in the liver, stomach/intestine, kidneys, or 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).

• Fluid-filled lump in the chest.
• Problems with appetite.
• Sensation of dizziness as if everything is spinning.
• Increased heart rate.
• Pancreatitis (inflammation of the pancreas).
• Hepatitis (inflammation of the liver).
• Excessive sweating.
• Increased sensitivity to light.

Side effects of unknown frequency (frequency cannot be estimated from available data)

• Blood clots in a vein – this may cause blockage of the blood vessels in the liver, leading to liver enlargement, pain, and swelling around the abdomen (Budd-Chiari syndrome).
• Worsening of symptoms of hereditary and acquired angioedema (inflammation of the face, tongue, and/or throat, difficulty swallowing, or urticaria potentially with difficulty breathing).

The following side effects have been associated with the use of hormonal contraceptives in general: benign and malignant liver tumors, bile duct obstruction, jaundice caused by bile duct obstruction, gallstones, uterine fibroid enlargement, increased cervical erosion, reversible infertility (ability to become pregnant) after stopping the use of hormonal contraceptives, premenstrual syndrome, dandruff, hirsutism (excessive hair growth), gestational herpes (rare skin disease that appears during pregnancy), melasma (pigmentation spots that may become permanent), hematomas (skin bleeding), changes in the cornea, involuntary movement disorder, increased sensitivity to sugars.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance 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 medication.

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 after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25º C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Edelsine

• The active principles are norgestimato and etinilestradiol. Each tablet contains 0.250 mg of norgestimato and 0.035 mg of etinilestradiol.
• The other components (excipients) are: anhydrous lactose, magnesium stearate, pregelatinized cornstarch, crospovidone, and aluminum lake containing indigo carmine (E132).

Appearance of the product and contents of the packaging

Edelsine are blue-colored, round tablets, with “C 250” engraved on both faces.

Each blister pack contains 21 tablets.

The packaging may contain: 1 x 21 or 3 x 21 tablets.

Holder of the marketing authorization

Laboratorios Effik S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Responsible for manufacturing

Delpharm Lille SAS

Parc d'Activités Roubaix-Est

22 Rue de Toufflers

CS 50070

59452 LYS-LEZ-LANNOY Cedex

France

Laboratoire EFFIK

Bâtiment “Le Newton”

9-11 Rue Jeanne Braconnier

92366 Meudon La Forêt Cedex

France

Last review date of this leaflet: September 2022

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