Leaflet: information for the patient

Levetiracetam Almus500 mg film-coated tablets EFG

Read this leaflet carefully before you or your child start taking this medicine, because it contains important information for you.

−Keep this leaflet, as you may need to read it again.

−If you have any questions, consult your doctor or pharmacist.

−This medicine has been prescribed for you only, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

−If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What isLevetiracetam Almusand what it is used for

2.What you need to know before starting to takeLevetiracetam Almus

3.How to takeLevetiracetam Almus

4.Possible side effects

5.Storage ofLevetiracetam Almus

6.Contents of the pack and additional information

This medicationcontains500 mg of levetiracetam in a film-coated tablet.

Levetiracetam is an antiepileptic medication (a medication for the treatment of seizures in epilepsy).

It is used:

• alone in adults and adolescents aged 16 years or older with recently diagnosed epilepsy to treat a form of epilepsy. Epilepsy is a disease where patients have seizures (crises). Levetiracetam is used to treat the form of epilepsy in which seizures initially affect only one side of the brain, but may later spread to wider areas in both sides of the brain (partial onset seizures with or without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures.

• concurrently with other antiepileptic medications to treat:

- partial onset seizures with or without generalization in adults, adolescents, children, and infants aged 1 month or older

- myoclonic seizures (shock-like, brief, muscle or group of muscle seizures) in adults and adolescents aged 12 years or older with juvenile myoclonic epilepsy.

- primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents aged 12 years or older with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

Do not takeLevetiracetam Almus

Warnings and precautions

Consult your doctor before starting to takeLevetiracetam Almus:

• If you have kidney problems, follow your doctor's instructions, who will decide if you need to adjust your dose.
• If you notice any decrease in your child's growth or an unexpected onset of puberty, contact your doctor.
• A small number of people taking antiepileptic medications, such aslevetiracetam, have had thoughts of self-harm or suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.
• If you have a medical history or family history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or are taking a treatment that makes you prone to cardiac arrhythmias or electrolyte imbalances.

Inform your doctor or pharmacist if any of the following adverse effects worsen or last more than a few days:

• Abnormal thoughts, feeling irritable, or reacting more aggressively than normal, or if you or your family and friends notice significant changes in mood or behavior.
• Worsening of epilepsy:

In rare cases, 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 takingLevetiracetam tablets, see a doctor as soon as possible.

In a very rare form of early-onset epilepsy (SCN8A mutation-associated epilepsy) that causes multiple types of 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 old.

Use ofLevetiracetam Almuswith other medications

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

Do not take macrogol (laxative medication) within one hour before and one hour after taking levetiracetam, as it may reduce its effect.

Pregnancy and breastfeeding

If you are pregnant orbreastfeeding,believe you may be pregnant, or intend to become pregnant,consult your doctorbefore using this medication.

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

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

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

Nursing is not recommended during treatment.

Driving and operating machinery

Levetiracetam Almusmay impair your ability to drive or operate tools or machinery, as it may cause drowsiness. This is more likely at the start of treatment or when increasing the dose. Do not drive or operate machinery until it is confirmed that your ability to perform these activities is not affected.

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

Take the number of tablets prescribed by your doctor.

This medicationshould be taken twice a day, once in the morning and once at night, approximately at the same time each day.

Concomitant therapy and monotherapy (from 16 years of age)

• Adults (≥18 years) and adolescents (12 to 17 years) with a weight of 50 kg or more:

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

When starting to take levetiracetam tablets, your doctor will prescribe alower dosefor two weeks before administering the 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 at night, and the dose should be increased gradually to reach 1,000 mg per day after 2 weeks of treatment.

• Adolescents (12 to 17 years) with a weight equal to or less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form oflevetiracetam tabletsbased on weight and dose.

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

Your doctor will prescribe the most appropriate pharmaceutical form oflevetiracetambased on age, weight, and dose.

The oral solution is a more suitable formulation for infants and children under 6 yearsand for children and adolescents (6 to 17 years) with a weight less than 50 kg and when tablets do not allow for precise dosing.

Administration form

Swallow the tablets ofthis medicationwith 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, its bitter taste may be perceived.

Treatment duration

• Levetiracetamis used as a chronic treatment. Continue treatment withthis medicationfor the time indicated by your doctor.
• Do not stop treatment without your doctor's recommendation, as seizures may increase..

If you take moreLevetiracetam Almusthan you should

The possible adverse effects of a levetiracetam overdose are drowsiness, agitation, aggression, decreased alertness, respiratory inhibition, 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 Toxicological Information Service, phone 91 562 04 20 (indicating the medication and the amount ingested).

If you forgot to take Levetiracetam Almus:

Contact your doctor if you have missed one or more doses.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Levetiracetam Almus:

The discontinuation of treatment withthis medicationshould be done gradually under the guidance of your doctor to avoid an increase in seizures.If your doctor decides to stop your treatment with levetiracetam, they will give you instructionsfor the gradual withdrawal of that medication.

If you have any other doubts 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.

Inform your doctor immediately, or go to the emergency service of your nearest hospitalif you experience:

• weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic)
• swelling of the face, lips, tongue, or throat (Quincke's edema)
• flu-like symptoms and a rash on the face followed by a prolonged rash with high temperature, elevated liver enzyme levels in blood tests, and an increase in a type of white blood cell (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 the legs, arms, or feet, as it may be a sign of sudden kidney function decline
• a skin rash that can form blisters and may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
• a generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
• a more severe form that causes 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 decline (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

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

Muy frequent: may affect more than 1 in 10 people:

• nasopharyngitis;
• drowsiness (feeling sleepy), headache.

Frequent: mayaffect up to 1 in 10 people:

• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, nervousness, or irritability;
• seizures, balance disorder, dizziness (feeling unstable), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (feeling of rotation);
• cough;
• abdominal pain, diarrhea, dyspepsia (heavy digestion, burning, and acidity), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling weak).

Poco frequent: may affect up to 1 in 100 people:

• decreased platelet count, decreased white blood cell count;
• weight loss, weight gain;
• suicidal thoughts and attempts, mental changes, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory decline (forgetfulness), abnormal coordination/ataxia (coordinated movement altered), paresthesia (tingling), attention alterations (loss of concentration);
• diplopia (double vision), blurred vision;
• abnormal liver function test results;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

Raros:may affect up to 1 in 1000 people:

• infection;
• decreased count of all types of blood cells;
• severe hypersensitivity reactions (DRESS, anaphylactic reaction (severe allergic reaction), Quincke's edema (swelling of the face, lips, tongue, and throat));
• decreased sodium concentration in blood;
• suicide, personality disorders (behavior problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see subsection “Inform your doctor immediately” for a detailed description of symptoms);
• 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 insufficiency, hepatitis (inflammation of the liver);
• sudden decline in kidney function;
• skin rash, which may lead to blisters that may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), a generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis).
• rhabdomyolysis (muscle tissue breakdown) and elevated creatine phosphokinase blood levels associated. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.
• gait disturbance or difficulty walking.
• combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, and low level of consciousness (may be signs of a condition calledneuroleptic malignant syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Muy raros:may affect up to 1 in 10,000 people:

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

Comunicación de efectos adversos

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 Medicines for Human Use (Website:www.notificaRAM.es).

By reporting side effects, you can contribute to providing more information on the safety of the 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 after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Levetiracetam Almus

The active ingredient is levetiracetam.

Each tablet contains 500 mg of levetiracetam.

The other components are:

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

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 contents of the package

The 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 (5x 10), 60 (6x10), 100 (10x10), 120 (12x10) and 200 (20x 10) coated tablets and packs of 2x50 (100) and 4x50 (200) coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email:[email protected]

Responsible Manufacturer:

Laboratoires BTT

ZI de Krafft, 67150 Erstein,France

Holsten Pharma GmbH

Hahnstraße 31-35, 60528 Frankfurt am Main, Germany

Last review date of this leaflet: May 2024

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