LEVETIRACETAM VIATRIS 500 mg FILM-COATED TABLETS

2. What you need to know before taking Levetiracetam Viatris

Do not take Levetiracetam Viatris

• If you are allergic to levetiracetam, to pyrrolidone derivatives or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before taking Levetiracetam Viatris:

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

A small number of people taking antiepileptics, such as levetiracetam, have had thoughts of harming themselves or suicide. If you have any symptoms of depression and/or thoughts of suicide, talk to your doctor.

• If you have a history of 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.

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 mood or behaviour.
• Worsening of epilepsy.

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

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

Children and adolescents

If you notice any decrease in your child's growth or an unexpected development of puberty, talk to your doctor.

Monotherapy with levetiracetam (single treatment) is not indicated in children and adolescents under 16 years of age.

Other medicines and Levetiracetam Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

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

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

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.

Pregnancy

Levetiracetam should 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 excluded.

Breastfeeding

Breastfeeding is not recommended during treatment, as levetiracetam passes into breast milk.

Driving and using machines

Levetiracetam may affect your ability to drive or use 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 use tools or machinery until you are sure that your ability to perform these activities is not affected.

3. How to take Levetiracetam Viatris

Follow the instructions for administration of this medicine exactly as prescribed 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.

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

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

The score line is only to facilitate breaking the tablet if you have difficulty swallowing it whole.

Concomitant therapy and monotherapy (from 16 years)

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

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

When you start taking levetiracetam, your doctor will prescribe a lower dose (500 mg per day)for two weeks before giving you the lowest general 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 in the evening.

Adolescents (12 to 17 years) weighing 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 to11 years), and adolescents (12 to17 years) weighing less than 50kg:

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

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

Duration of treatment

• Levetiracetam Viatris is used as chronic treatment. You should continue treatment with Levetiracetam Viatris 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 more Levetiracetam Viatris than you should

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

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 taken.

If you forget to take Levetiracetam Viatris

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

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

If you stop taking Levetiracetam Viatris

As with other antiepileptic medicines, stopping treatment with Levetiracetam Viatris should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with this medicine, he/she will give you instructions for gradual withdrawal.

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

Levetiracetam Viatris contains sodium

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

4. Possible side effects

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

The most frequently reported side effects are sore throat or nose (nasopharyngitis), drowsiness (somnolence), headache, fatigue, and dizziness. Some of the 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.

Tell your doctor immediately or go to the emergency department if you experience:

• Weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylaxis).
• Swelling of the face, lips, tongue, and throat (angioedema).
• Flu-like symptoms and facial rash, followed by a prolonged rash and high fever, high levels of 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]).
• Low urine output, tiredness, nausea, vomiting, confusion, and swelling of legs, ankles, or feet, as these may be signs of sudden kidney function decrease.
• A skin rash that may lead to blistering, with small dark centres surrounded by a paler area, and 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).
• A more severe rash 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 (tendency to sleep), amnesia (memory loss), altered memory (tendency to forget), abnormal behaviour, or other neurological signs, including uncontrolled involuntary movements. These may be symptoms of encephalopathy.
• Suicidal thoughts or attempts.
• Severe abdominal pain that spreads to the back, as this may be a sign of pancreatitis.

Tell your doctor immediately if you experience any of the following symptoms, as you may need medical attention:

Uncommon(may affect up to 1 in 100 people):

• Increased signs of infection, such as fever or mouth ulcers, which may be due to a decrease in white blood cells.

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 increased creatine phosphokinase in blood, associated. Prevalence is considerably higher in Japanese patients compared to non-Japanese patients.
• A combination of fever, muscle stiffness, unstable blood pressure and heart rate, confusion, low level of consciousness (may be signs of a disorder called malignant neuroleptic syndrome). 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).
• Drowsiness (somnolence), 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 of instability), 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 (weakness/tiredness).

Uncommon(may affect up to 1 in 100 people):

• Decreased platelet count, which may cause you to bruise or bleed more easily or for longer than usual.
• Weight loss, weight gain.
• Mental disorders, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation.
• Amnesia (memory loss), memory impairment (memory loss), coordination abnormality/ataxia (altered coordination of movements), paraesthesia (tingling), attention disorders (loss of concentration).

• Diplopia (double vision), blurred vision.

• Abnormal liver function test results.
• Hair loss, eczema, itching.
• Muscle weakness, myalgia (muscle pain).
• Injuries.

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

• Decreased number of blood cell types.
• Infection.
• Suicidal disorders or personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating).
• Delirium.
• Encephalopathy (see the “Tell your doctor immediately” subsection for a detailed description of symptoms).
• Seizures may worsen or occur more frequently.

• Uncontrolled muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity).
• Change in heart rhythm (electrocardiogram).
• Decreased sodium levels in the blood.
• Limping or difficulty walking.

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

• Unwanted repeated thoughts or urges 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. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam Viatris

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton, bottle, and blister after CAD or EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

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 Container Content

White, film-coated, oblong, biconvex tablet with a beveled edge, marked with an "M" to the left of the score and "615" to the right of the score on one face and blank on the other.

Levetiracetam Viatris tablets are supplied in blisters containing 20, 30, 50, 60, 90, 100, 120, or 200 film-coated tablets or unit-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 pack 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

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain Levetiracetam Viatris 500 mg film-coated tablets EFG

Netherlands Levetiracetam Mylan 500 mg film-coated tablets

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

Date of the last revision of this leaflet:March 2024.

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