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Patient Information Leaflet

Levetiracetam Viatris 500 mg Film-Coated Tablets

Read this leaflet carefully before you 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, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others, 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 Levetiracetam Viatris is and what it is used for

2.What you need to know before you start taking Levetiracetam Viatris

3.How to take Levetiracetam Viatris

4.Possible side effects

5.Storage of Levetiracetam Viatris

6.Contents of the pack and additional informationl

Levetiracetam Viatris contains the active ingredient levetiracetam, which is an antiepileptic medication (a medication used for the treatment of seizures in epilepsy).

Levetiracetam Viatris is used:

• Alone, in adults and adolescents 16 years of age and older, with recently diagnosed epilepsy,to treat a form of epilepsy. Epilepsy is a disease where patients have seizures (crises). Levetiracetam Viatris is used for the form of epilepsy in which the seizures initially affect only one side of the brain, but may, afterwards, spread to wider areas on both sides of the brain (partial onset seizures with or without secondary generalization).Your doctor has prescribed Levetiracetam Viatris 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 1 month of age and older.

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

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

Do not take Levetiracetam Viatris

• If you are allergic to levetiracetam, to pyrrolidone derivativesor to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor before starting to take Levetiracetam Viatris:

• If you have kidney problems, follow your doctor's instructions, who will decide if you need to adjust your dose.

A small number of people taking antiepileptic medications, such as levetiracetam, have had thoughts of self-harm or suicide. If you have any symptoms of depression and/or suicidal thoughts, consult 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, orif 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 taking levetiracetam, see a doctor as soon as possible.

You may notice that seizures persist or worsen during treatment in a rare form of early-onset epilepsy (SCN8A mutation-associated epilepsy) that causes multiple types of seizures and loss of skills.

Children and adolescents

If you observe any decrease in your child's growth or an unexpected onset of puberty, consult your doctor.

Monotherapy with levetiracetam (exclusive treatment) is not indicated in children and adolescents under 16 years old.

Other medications and Levetiracetam Viatris

Inform your doctor or pharmacist if you are taking, have taken recentlyor may need to take any other medication, including those purchased without a prescription.

It is especially important to inform your doctor if you are taking:

• Methotrexate (medication used for psoriasis, inflammation, and some cancers).
• Macrogol (laxative medication).Do not take macrogol within one hour before and one hour after taking levetiracetam, as it may reduce its effect.
• Probenecid (medication used for gout).

Pregnancy and breastfeeding

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

Pregnancy

Levetiracetam can only be used during pregnancy if, after a 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.

Breastfeeding

It is not recommended to breastfeed during treatment, as levetiracetam passes into breast milk.

Driving and operating machinery

Levetiracetam may 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 the dose is increased. Do not drive or operate tools or 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.

Levetiracetam Viatris should be taken twice a day, once in the morning and once at night, approximately at the same time each day.

Swallow the Levetiracetam Viatris tablets with sufficient liquid (for example, a glass of water). You can take this medication with or without food.After oral administration of levetiracetam, its bitter taste may be perceived.

The groove is only for breaking the tablet if it is difficult to swallow it whole.

Concomitant therapy and monotherapy (from 16 years)

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

General dose: between 1000mg and 3000mg per day.

When starting to take levetiracetam, your doctor will prescribe alower dose (500 mg per day)for two weeks before administering the general lowest dose of 1000 mg.

For example:if your daily dose is 1000mg,your reduced starting dose is2 tablets of 250mg in the morning and 2 tablets of 250mg at night.

Adolescents (12 to 17 years) with a weight of 50 kg or less:

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

Dose in infants (1 to 23 months), children (2 to 11 years), and adolescents (12 to 17 years) with a weight of less than 50kg:

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

This may be available in oral solution, as it is a more suitable formulation for infants and children under 6 years old, and for children and adolescents (6 to 17 years old) weighing less than 50 kg, and when tablets do not allow for precise dosing.

Treatment duration

• Levetiracetam Viatris is used as chronic treatment. Continue treatment with Levetiracetam Viatris for the time indicated by your doctor.
• Do not interrupt your treatment without your doctor's recommendation, as this may increase your seizures.

If you take more Levetiracetam Viatris than you should

The possible adverse effects of a levetiracetam overdose are drowsiness, agitation, aggression, decreased alertness, respiratory inhibition, and coma.

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 Viatris

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 Viatris

Like with other antiepileptic medications, the discontinuation of treatment with Levetiracetam Viatris should be done gradually to avoid an increase in seizures.Your doctor will give you instructions for the gradual withdrawal.

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

Levetiracetam Viatris contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

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

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

Consult your doctor immediately or go to the nearest emergency service if you experience:

• Weakness, dizziness, or difficulty breathing, as it could be a sign of a severe allergic reaction (anaphylactic).
• Swelling of the face, lips, tongue, and throat (Quincke's edema).
• Symptoms such as the flu and facial rash, followed by a prolonged rash and high fever, elevated liver enzymes detected in blood tests, and an increase in a type of white blood cell (eosinophilia) and swollen 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, ankles, or feet, as it could be a sign of sudden kidney function decline.
• A skin rash that could lead to blisters and have a small dark spot in the center surrounded by a lighter area with a dark ring around the edge (erythema multiforme).
• A widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).(Stevens-Johnson syndrome)
• A more severe rash that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis).(toxic epidermal necrolysis)
• Signs of severe mental changes or if someone around you notices signs of confusion, drowsiness (tendency to sleep), amnesia (memory loss), memory alteration (tendency to forget), abnormal behavior, or other neurological signs, including involuntary and uncontrolled movements. They could be symptoms of encephalopathy.They could be symptoms of encephalopathy.
• Thoughts of suicide or attempted suicide.
• Severe abdominal pain that radiates to the back, as it could be a sign of pancreatitis.

Inform your doctor immediately if you experience any of the following symptoms, as they may require medical assistance:

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

• Signs of liver problems, such as abdominal pain, fever, pale stools, dark urine, yellowing of the skin and eyes.
• Rhabdomyolysis (muscle tissue breakdown) and elevated creatine phosphokinase in the blood associated. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.
• Combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, low level of consciousness (may be signs of a disorder called malignant neuroleptic syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Other side effects include:

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

• Nasopharyngitis (sore throat or nose).
• Somnolence (drowsiness), headache.

Common(may affect up to 1 in 10 people):

• Anorexia (loss of appetite).
• Depression, hostility or aggression, anxiety, insomnia, nervousness, or irritability.
• Convulsions, balance disorder, dizziness (sensation of instability), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking).
• Dizziness (sensation of rotation).
• Cough.
• Abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea.
• Skin rash.
• Asthenia/fatigue (weakness/tiredness).

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

• Reduction of platelet count, which causes bruising or bleeding more easily or for a longer time than normal.
• Weight loss, weight gain.
• Mental changes, abnormal behavior, hallucinations, irritability, confusion, panic attack, emotional instability/mood changes, agitation.
• Amnesia (memory loss), memory deterioration (lack of memory), abnormal coordination/ataxia (coordination of movements altered), paresthesia (tingling), attention alterations (loss of concentration).

• Diplopia (double vision), blurred vision.

• Abnormal results in liver function tests.
• Hair loss, eczema, itching.
• Muscle weakness, myalgia (muscle pain).
• Lesions.

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

• Repetitive unwanted thoughts or sensations or the urge to do something over and over (Obsessive-Compulsive Disorder).

Reporting of 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 Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting these side effects, you can contribute to providing more information on the safety of this 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 carton box, bottle, and blister pack after CAD or EXP. The expiration date is the last day of the month indicated.

This medication does notrequire special conditions for conservation.

Bottles: use within 3 months after the first opening. Once opened, keep the bottle perfectly closed.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Levetiracetam Viatris

• The active ingredient is levetiracetam. Each film-coated tablet contains 500 mg of levetiracetam.
• The other components are: Tablet core: povidone (E-1201), microcrystalline cellulose (E-460), sodium croscarmellose (E-466), magnesium stearate (E-572), sodium lauryl sulfate (E-487), anhydrous colloidal silica (E-551). Coating: titanium dioxide (E-171), polydextrose (E-1200), hypromellose (E-464), triacetin (E-1518), macrogol 8000, macrogol 400.

Appearance of the product and contents of the package

Film-coated tablet of white color, with an oblong, biconvex shape, beveled edge, marked with an “M” to the left of the groove and “615” to the right of the groove on one face and white on the other.

Levetiracetam Viatris tablets are supplied in blisters containing 20, 30, 50, 60, 90, 100, 120, or 200 film-coated tablets or single-dose blisters of 30 and 60 film-coated tablets. Levetiracetam Viatris tablets are packaged in bottles containing 60, 100, 120, 200, or 500 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

McDermott Laboratories Limited trading as Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road, Dublin 13

Ireland

or

Mylan Hungary Kft.

Mylan utca 1.

Komárom, 2900

Hungary

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of the European Economic Areawith the following names:

SpainLevetiracetam Viatris 500 mg film-coated tablets EFG

NetherlandsLevetiracetam Mylan 500 mg filmomhulde tabletten

United Kingdom (NI)Levetiracetam Mylan 500 mg Film-coated Tablets

Last review date of this leaflet:March 2024.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (https://www.aemps.gob.es/).