ETOSUXIMIDA FAES 250 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

ETOSUXIMIDE FAES 250 mg hard capsules

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of thepackage leaflet

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

1. What is Etosuximide Faes and what is it used for

Etosuximide Faes belongs to a group of medicines known as antiepileptics, which are used to treat epilepsy.

Etosuximide 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 medications when other convulsive manifestations of epileptic origin coexist with petit mal.

2. What you need to know before you take Etosuximide Faes

Do not take Etosuximide Faes

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Etosuximide Faes.

Your doctor needs to know, before you can start treatment with etosuximide, if you have or have had in the past any of the following conditions:

• a small number of people treated with some antiepileptics have had thoughts of self-harm or suicide. If at any time you have these thoughts, contact your doctor as soon as possible.

• serious skin reactions have been reported, including Stevens-Johnson syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS), associated with Etosuximide Faes treatment. Discontinue Etosuximide Faes and seek immediate medical attention if you notice any of the symptoms described in section 4.

Your doctor may need to take blood and/or urine samples periodically to analyze them.

Using Etosuximide Faes with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Some medicines may affect how etosuximide works, or etosuximide may affect the effectiveness of other medicines taken at the same time.

These medicines include:

• Antiepileptic medicines such as carbamazepine, primidone, phenobarbital, and phenytoin, as they may decrease the effectiveness of etosuximide. Valproic acid or sodium valproate may increase the toxicity of Etosuximide.
• Antibiotics such as isoniazid, as they may increase the toxicity of Etosuximide.

Additionally, the following medicines may decrease the effectiveness of Etosuximide:

• Antidepressants.
• Antimalarials, medicines used for malaria (chloroquine, hydroxychloroquine, mefloquine).
• Antipsychotics, medicines used for schizophrenia.
• Ginkgo biloba.

Other medicines may increase the toxicity of Etosuximide, such as:

• Antihistamines, as Etosuximide increases their sedative effects.
• Ritonavir, used for the treatment of AIDS virus infection.

Additionally, Etosuximide:

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

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

Taking with food and alcohol

It is recommended to take this medicine preferably after meals.

Alcohol

Taking etosuximide with alcohol may increase the side effects of the nervous system, such as dizziness, drowsiness, and difficulty concentrating. Some people may also experience impaired thinking and judgment. You should avoid or limit alcohol consumption during treatment with etosuximide.

Pregnancy and breastfeeding

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

Both epilepsy and treatment with Etosuximide carry a risk of congenital malformations. Therefore, if you are of childbearing age and wish to become pregnant, it is advisable to consult your doctor to plan your pregnancy.

If you are pregnant, do not stop treatment with Etosuximide 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

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

Driving and using machines

Etosuximide Faes may cause symptoms such as drowsiness, dizziness, or vision changes and decrease your reaction ability. These effects, as well as the disease itself, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medicine.

3. How to take Etosuximide Faes

Follow the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

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

The recommended dose is:

Adults and children over 6 years

The necessary dose of Etosuximide 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 up to 1000-1500 mg per day (4-6 capsules divided into two doses). In some cases, it may be necessary to administer a higher daily dose of up to 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 think the effect of Etosuximide Faes is too strong or too weak, tell your doctor or pharmacist.

Use in children under 6 years

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

If you take more Etosuximide Faes than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or contact the emergency service of the nearest hospital and take the medicine with you. You can also call the Toxicology Information Service Telephone 91.562.04.20, indicating the medicine and the amount taken.

In an overdose, nausea, vomiting, central nervous system depression, including respiratory depression, and even coma may occur.

If you forget to take Etosuximide 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 make up for the forgotten doses.

If you stop taking Etosuximide Faes

Do not stop treatment with Etosuximide unless your doctor tells you to. If you suddenly stop treatment with Etosuximide, the frequency of seizures may increase. If your doctor considers it necessary to stop treatment with this medicine, they will decide on the most suitable alternative treatment for you.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

Contact your doctor immediately if you experience any of these symptoms after taking this medicine. Although they are rare, these symptoms can be serious:

• If you develop a severe skin rash that produces blisters and affects the mouth and tongue (or tongue inflammation) as these symptoms may indicate that you are having a severe allergic reaction. Your doctor will discontinue treatment in these cases.
• If you have bruising, fever, pale face, or severe sore throat. These may be the first symptoms of a blood abnormality, including a decrease in red, white, or platelet cells. Your doctor may need to perform regular blood tests to evaluate these effects.
• If you have a 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 pain and joint inflammation, it may be related to a condition called systemic lupus erythematosus (SLE).
• If the number of epileptic seizures you suffer increases.

Other side effects that may occur are:

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

Lymph node inflammation.

Blood changes (easy bruising or bleeding, fever, sore throat, mouth ulcers, fatigue, repeated or persistent infections). Your doctor may need to take blood samples regularly to detect these effects.

Psychiatric 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: drowsiness, 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 mild reactions similar to measles, urticaria. Hair loss has also been reported.

Renal disorders: blood in the urine.

Reproductive system disorders: vaginal bleeding.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Etosuximide Faes

Keep out of the sight and reach of children.

Store below 30°C.

Do not use Etosuximide Faes after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

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

6. Package contents and further information

Composition of Etosuximide Faes 250 mg hard capsules

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

Appearance of the product and package contents

Etosuximide Faes is presented in packages containing 30 hard capsules.

Each package contains three PVC/AL blisters with 10 gelatin capsules each, with a red cap and gray body.

Marketing authorization holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

Date of the last revision of this leaflet: January 2021

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