LEVETIRACETAM ALMUS 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Levetiracetam Almus500 mg film-coated tablets EFG

Read the entire package leaflet carefully before you or your child starts taking this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Levetiracetam Almus and what is it used for
2. What you need to know before taking Levetiracetam Almus
3. How to take Levetiracetam Almus
4. Possible side effects
5. Storage of Levetiracetam Almus
6. Contents of the pack and further information

1. What is Levetiracetam Almus and what is it used for

This medicine contains 500 mg of levetiracetam in a film-coated tablet.

Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

It is used:

• as a single treatment in adults and adolescents from 16 years of age with newly diagnosed epilepsy to treat a form of epilepsy. Epilepsy is a disease where patients have seizures. Levetiracetam is used for the form of epilepsy where the seizures initially affect only one side of the brain but can later spread to wider areas on both sides of the brain (partial onset seizures with or without secondary generalisation). Your doctor has prescribed levetiracetam to reduce the number of seizures.

• in combination with other antiepileptic medicines to treat:

• partial onset seizures with or without secondary generalisation in adults, adolescents, children, and infants from 1 month of age
• myoclonic seizures (short, shock-like jerks of a muscle or a group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy
• primary generalised tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (a type of epilepsy that is thought to have a genetic cause)

2. What you need to know before taking Levetiracetam Almus

Do not takeLevetiracetam Almus

Warnings and precautions

Talk to your doctor before starting to take Levetiracetam Almus:

Tell your doctor or pharmacist if any of the following side effects get worse or last more than a few days:

• abnormal thoughts, feeling irritable or reacting more aggressively than usual, or if you or your family and friends notice significant changes in your mood or behaviour
• worsening of epilepsy:

Rarely, epileptic seizures may worsen or occur more frequently, mainly during the first month after starting treatment or increasing the dose. If you experience any of these new symptoms while taking Levetiracetam tablets, see a doctor as soon as possible.

In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations) that causes multiple types of epileptic seizures and loss of skills, you may notice that seizures persist or worsen during treatment

If you experience any of these new symptoms while taking Levetiracetam Almus, see a doctor as soon as possible

Children and adolescents

• Monotherapy with Levetiracetam Almus is not indicated in children and adolescents under 16 years of age

Use ofLevetiracetam Almuswith other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines

Do not take macrogol (a medicine used as a laxative) within one hour before and one hour after taking levetiracetam, as it may lose its effect

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine

Levetiracetam can only be used during pregnancy if, after careful evaluation, your doctor considers it necessary

Do not stop your treatment without first discussing it with your doctor

The risk of birth defects for your baby cannot be completely ruled out

Breastfeeding is not recommended during treatment with Levetiracetam Almus

Driving and using machines

Levetiracetam Almus may affect your ability to drive or use tools or machines, as it may cause drowsiness. This is more likely at the start of treatment or when the dose is increased. You should not drive or use machines until it is established that your ability to perform these activities is not affected

3. How to take Levetiracetam Almus

Follow exactly the instructions given to you by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again

Take the number of tablets that your doctor has prescribed for you

This medicine should be taken twice a day, once in the morning and once in the evening, approximately at the same time each day

Concomitant therapy and monotherapy (from 16 years of age)

• Adults (≥18 years) and adolescents (from 12 to 17 years) weighing 50 kg or more:

Recommended dose: between 1,000 mg and 3,000 mg per day

When starting levetiracetam tablets, your doctor will prescribe a lower dosefor two weeks before giving you the lowest daily dose

For example: for a daily dose of 1,000 mg, your reduced starting dose is 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening, and the dose should be gradually increased to 1,000 mg per day after 2 weeks of treatment

• Adolescents (from 12 to 17 years) weighing 50 kg or less:

Your doctor will prescribe the most suitable pharmaceutical form of levetiracetam tablets according to your weight and dose

• Dose in infants (from 1 month to 23 months) and children (from 2 to 11 years) weighing less than 50 kg:

Your doctor will prescribe the most suitable pharmaceutical form of levetiracetam according to age, weight, and dose

The oral solution is a more suitable formulation for infants and children under 6 years of age and for children and adolescents (from 6 to 17 years) weighing less than 50 kg and when tablets do not allow for precise dosing

Method of administration

Swallow the tablets of this medicine with a sufficient amount of liquid (e.g., a glass of water). You can take Levetiracetam tablets with or without food. After oral administration of levetiracetam, a bitter taste may be perceived

Duration of treatment

• Levetiracetam is used as a chronic treatment. You should continue treatment with this medicine for the time indicated by your doctor
• Do not stop your treatment without your doctor's advice, as your seizures may increase

If you take moreLevetiracetam Almusthan you should

Possible side effects of an overdose of levetiracetam are drowsiness, agitation, aggression, decreased alertness, respiratory depression, and coma

Contact your doctor if you have taken more tablets than you should. Your doctor will establish the best possible treatment for the overdose

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, telephone 91 562 04 20 (indicating the medicine and the amount ingested)

If you forget to take Levetiracetam Almus:

Contact your doctor if you have missed one or more doses

Do not take a double dose to make up for the missed doses

If you stop taking Levetiracetam Almus:

Stopping treatment with this medicine should be done gradually under the direction of your doctor to avoid an increase in seizures. If your doctor decides to stop your treatment with levetiracetam, he/she will give you instructions for gradual withdrawal of the medicine

If you have any further questions on 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

Inform your doctor immediately, or go to the casualty department of your nearest hospital if you experience:

• weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic reaction)
• swelling of the face, lips, tongue, or throat (angioedema)
• flu-like symptoms and rash on the face followed by a prolonged rash with high temperature, elevated liver enzymes in blood tests, and an increase in a type of white blood cells (eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• symptoms such as low urine output, fatigue, nausea, vomiting, confusion, and swelling of legs, arms, or feet, as this may be a sign of sudden decrease in kidney function
• a skin rash that may form blisters and may appear as small targets (dark spots in the centre surrounded by a paler area with a dark ring around the edge) (erythema multiforme)
• a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
• a more severe form causing skin peeling on more than 30% of the body surface (toxic epidermal necrolysis)
• signs of severe mental changes or if someone around you notices signs of confusion, drowsiness (drowsiness), amnesia (memory loss), memory impairment (forgetfulness), abnormal behaviour, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy

The most frequently reported side effects are nasopharyngitis, somnolence (feeling drowsy), headache, fatigue, and dizziness. Side effects such as drowsiness, weakness, and dizziness may be more frequent when starting treatment or increasing the dose. However, these side effects should decrease over time

Very common:may affect more than 1 in 10 people:

• nasopharyngitis
• somnolence (feeling drowsy), headache

Common:may affect up to 1 in 10 people:

• anorexia (loss of appetite)
• depression, hostility or aggression, anxiety, insomnia, nervousness, or irritability
• seizures, balance disorder, dizziness (feeling unsteady), lethargy (lack of energy and enthusiasm), tremor (involuntary tremor)
• vertigo (feeling of spinning)
• cough
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea
• skin rash
• asthenia/fatigue (feeling weak)

Uncommon:may affect up to 1 in 100 people:

• decrease in platelet count, decrease in white blood cell count
• weight loss, weight gain
• suicidal attempt and suicidal ideation, mental disorders, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional instability/mood swings, agitation
• amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (altered coordination of movements), paraesthesia (tingling), attention disturbances (loss of concentration)
• diplopia (double vision), blurred vision
• elevated/abnormal liver function tests
• hair loss, eczema, itching
• muscle weakness, myalgia (muscle pain)
• injury

Rare:may affect up to 1 in 1,000 people:

• infection
• decrease in the number of all types of blood cells
• severe hypersensitivity reactions (DRESS, anaphylactic reaction, angioedema)
• decrease in sodium levels in the blood
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating)
• delirium
• encephalopathy (see subsection "Inform your doctor immediately" for a detailed description of symptoms)
• epileptic seizures may worsen or occur more frequently
• involuntary muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity)
• change in heart rhythm (electrocardiogram)
• pancreatitis (inflammation of the pancreas)
• liver failure, hepatitis (inflammation of the liver)
• sudden decrease in kidney function
• skin rash, which may lead to blisters that may appear as small targets (dark spots in the centre surrounded by a paler area with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling on more than 30% of the body surface (toxic epidermal necrolysis)
• rhabdomyolysis (breakdown of muscle tissue) and increased creatine phosphokinase in the blood. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients
• limping or difficulty walking
• a combination of fever, muscle stiffness, unstable blood pressure, and heart rate, confusion, low level of consciousness (may be signs of a disorder called neuroleptic malignant syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients

Very rare:may affect up to 1 in 10,000 people:

• unwanted and repetitive thoughts or feelings or the urge to do something over and over again (obsessive-compulsive disorder)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines (Website: www.notificaRAM.es)

By reporting side effects, you can help provide more information on the safety of this medicine

5. Storage of Levetiracetam Almus

Keep this medicine out of the sight and reach of children

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated

This medicine does not require any special storage conditions

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment

6. Composition and additional information

Composition of Levetiracetam Almus

The active ingredient is levetiracetam.

Each tablet contains 500 mg of levetiracetam.

The other components are:

Tablet core: Corn starch, Povidone K30, anhydrous colloidal silica, magnesium stearate, talc.

Film coating: Opadry 85F32004: macrogol 3350, Yellow iron oxide (E172), polyvinyl alcohol, titanium dioxide (E171), talc.

Levetiracetam Almus is presented in blisters in cardboard boxes. Each blister contains 10 tablets.

Appearance of the product and packaging content

The film-coated tablets are yellow, oblong, scored, and marked with "500" on the same face.

The tablet can be divided into equal doses.

The packages contain 10 (1x10), 20 (2x10), 30 (3x10), 50 (5x10), 60 (6x10), 100 (10x10), 120 (12x10), and 200 (20x10) film-coated tablets and packs of 2x50 (100) and 4x50 (200) film-coated tablets.

Not all packaging sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Manufacturer:

Laboratoires BTT

ZI de Krafft, 67150 Erstein, France

Holsten Pharma GmbH

Hahnstraße 31-35, 60528 Frankfurt am Main, Germany

Date of the last revision of this prospectus: May 2024

"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/"