Prospecto: information for the user

ETOSUXIMIDA FAES 250 mg hard capsules

Read this prospect carefully before starting to take this medicine, as 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 or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other peopleeven if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Content of theprospect

1. What Etosuximida Faes is and for what it is used.
2. What you need to know before starting to take Etosuximida Faes.
3. How to take Etosuximida Faes.
4. Possible adverse effects.
5. Storage of Etosuximida Faes.
6. Contents of the package and additional information.

Etosuximida Faes belongs to a group of medicines known as antiepileptics, which are used for the treatment of epilepsy.

Etosuximida Faes is primarily indicated for the treatment of patients with absence seizures (petit mal epilepsy). It may also be administered in combination with other antiepileptic medicines when other seizure manifestations of epileptic origin coexist with petit mal.

Do not take Etosuximida Faes

• If you are allergic (hypersensitive) to etosuximida or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Etosuximida Faes.

Your doctor needs to know, before you can start a treatment with etosuximida if you suffer from or have suffered in the past any of the following conditions:

• If you have symptoms such as persistent fever, sore throat, bruises, bleeding, or paleness. These symptoms may be due to the existence of a blood disorder. Inform your doctor immediately if you notice any of these symptoms.

• If you suffer from any disease that affects the kidneys and/or liver, as you will need special follow-up by your doctor throughout the treatment.

• A small number of people treated with some antiepileptics have had thoughts of harming themselves or committing suicide. If you ever experience these thoughts, contact your doctor as soon as possible.

• Severe skin reactions, including Stevens-Johnson syndrome (SSJ) and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported associated with treatment with Etosuximida Faes. Discontinue administration of Etosuximida Faes and seek medical attention immediately if any of the symptoms described in section 4 are noticed.

Your doctor may need to take blood and/or urine samples periodically for analysis.

Use of Etosuximida Faes with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Some medications may affect the way etosuximida works, or etosuximida may affect the efficacy of other medications taken at the same time.

These medications include:

• Antiepileptic medications such as carbamazepine, primidone, phenobarbital, and phenytoin, as they may reduce the efficacy of etosuximida. Valproic acid or sodium valproate may increase the toxicity of Etosuximida.
• Antibiotics such as isoniazid, as they may increase the toxicity of Etosuximida.

Additionally, the following medications may reduce the efficacy of Etosuximida:

• Antidepressants.
• Antimalarial medications (chloroquine, hydroxychloroquine, mefloquine).
• Antipsychotics, medications used for schizophrenia.
• Ginkgo biloba.

Other medications may increase the toxicity of Etosuximida, such as:

• Antihistamines, as Etosuximida increases their sedative effects.
• Ritonavir, used to treat HIV infection.

Etosuximida:

• may increase the sedative effects of alcohol
• may increase plasma concentrations of phenytoin,
• may decrease plasma concentrations of valproic acid/sodium valproate.

Your doctor may need to evaluate the amount of these medications in the blood to decide if any of them are affecting your treatment.

Taking Etosuximida Faes with food and alcohol

It is recommended to take this medication preferably after meals.

Alcohol

The use of etosuximida with alcohol may increase the side effects of the nervous system such as dizziness, drowsiness, and difficulty concentrating. Some people may also experience deterioration in thought and judgment. You should avoid or limit alcohol consumption during treatment with etosuximida.

Pregnancy and breastfeeding

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

Both epilepsy and treatment with Etosuximida carry a risk of congenital malformations. Therefore, if you are fertile and want to become pregnant, it is recommended that you consult your doctor to plan your pregnancy.

If you are pregnant, do not interrupt treatment with Etosuximida and inform your doctor immediately. Your doctor will weigh whether the expected benefit for the mother is greater than any possible risk to the fetus.

Breastfeeding

Etosuximida is excreted in breast milk. If you are breastfeeding, inform your doctor. Unless your doctor tells you otherwise, do not breastfeed your child during treatment with Etosuximida.

Driving and operating machinery

Etosuximida Faes may cause symptoms such as drowsiness, dizziness, or visual disturbances and may reduce your reaction time. These effects, as well as the underlying disease, may make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medication.

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

It is recommended to take Etosuximida Faes at the same time every day.

The recommended dose is:

Adults and children over 6 years old

The necessary dose of Etosuximida may vary from person to person. Most people start with a dose of 500 mg per day (1 capsule twice a day) and increase the dose to 1000-1500 mg per day (4-6 capsules divided into two doses). In some cases, it may be necessary to administer a daily dose as high as 2000 mg (8 capsules divided into two doses).

The capsules are administered orally. They should be swallowed whole with a glass of water, preferably after meals.Do not chew the capsules.

If you estimate that the action of Etosuximida Faes is too strong or too weak, inform your doctor or pharmacist.

Use in children under 6 years old

This medication presentation is not suitable for use in children under 6 years old, as it does not allow for safe and accurate dosing.

If you take more Etosuximida Faes than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediatelyor contact the emergency department of the nearest hospital and bring the medication with you. You can also callThe Toxicological Information Service Telephone 91.562.04.20, indicating the medication and the amount ingested.

In the event of an overdose, nausea, vomiting, depression of the central nervous system, including respiratory depression, and even coma may appear.

If you forget to take Etosuximida Faes

If you forget to take a dose, take it as soon as you remember, unless it is time to take the next dose. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Etosuximida Faes

Do not stop treatment with Etosuximida unless your doctor tells you to. If you stop treatment abruptly with Etosuximida, you may increase the frequency of seizures. If your doctor considers it necessary to stop treatment with this medication, he will decide on the most suitable alternative treatment for you.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Etouximida Faes and seek medical attention immediately if you notice any of the following symptoms:

• Red patches on the torso, patches are similar to white or circular macules, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, elevated body temperature, and enlarged lymph nodes (eosinophilia and systemic symptoms reaction to medication (DRESS)

Immediately contact your doctor if you experience any of these symptoms after taking this medicine. Although rare, these symptoms can be severe:

• If you develop a severe skin eruption that causes blisters and affects the mouth and tongue (or produces tongue inflammation) as these symptoms may indicate a severe allergic reaction. Your doctor will interrupt treatment in these cases.
• If you have bruises, fever, pale face, or severe sore throat. These may be the first symptoms of a blood abnormality, including a decrease in red, white blood cells, or platelets. Your doctor may need to perform regular blood tests to evaluate these effects.
• If you have skin rash and fever with gland inflammation, particularly in the first two months of treatment, which may be signs of a hypersensitivity reaction. If these signs are severe and you also have joint pain and inflammation, it may be related to a condition called systemic lupus erythematosus (LES).
• If the number of seizures you experience increases.

Other side effects that may occur are:

Blood and lymphatic system disorders:decrease in the number of white blood cells in the blood (leucopenia) or a type of white blood cell (neutrophils), decrease in the number of red blood cells, white blood cells, and platelets (pancytopenia).

Lymph node inflammation.

Blood changes (formation of hematomas or bleeding more easily, fever, sore throat, mouth ulcers, fatigue, repeated infections, or infections that do not heal). Your doctor may regularly extract blood samples to detect these effects.

Mental health disorders::sleep disorders, nightmares, speech problems, confusion, nervousness, aggression, feeling of persecution, or hyperactivity, inability to concentrate, increased sexual appetite, depression with suicidal thoughts.

Nervous system disorders::lethargy, headache, dizziness, irritability, numbness, fatigue, difficulty controlling movements, abnormal or uncoordinated movements, muscle contractions, hiccups.

Eye disorders::myopia.

Gastrointestinal disorders::loss of appetite and weight loss, nausea, vomiting, diarrhea, abdominal pain.

Skin and subcutaneous tissue disorders::skin rash including reactions similar to measles that are usually mild, urticaria. Hair loss has also been described.

Renal disorders::blood in the urine.

Reproductive system and breast disorders:vaginal bleeding.

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 directlyto the Spanish System for Pharmacovigilance of Medicines 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 out of sight and reach of children.

Store below 30°C.

Do not use Etosuximida Faes after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Etosuximida Faes 250 mg hard capsules

• The active ingredient is etosuximida. Each hard capsule contains 250 mg of etosuximida.
• The other components are:macrogol 6000 and hydrated colloidal silica. The gelatin capsule is composed of: gelatin, iron oxides (E172), erythrosine (E127), titanium dioxide (E171) and water.

Appearance of the product and content of the packaging

Etosuximida Faes is presented in packaging containing 30 hard capsules.

Each packaging contains three PVC/AL blisters with 10 gelatin capsules each, with a red cover and a grey body.

Holder of the marketing authorization

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

Last review date of this leaflet: January 2021

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