LEVETIRACETAM SUN 500 mg FILM-COATED TABLETS

2. What you need to know before you take Levetiracetam SUN

Do not takeLevetiracetam SUN

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

Warnings and precautions

Tell your doctor before you start taking Levetiracetam SUN

• if you have kidney problems, follow your doctor's instructions, as they will decide if you need a dose adjustment
• if you notice any decrease in your child's growth or an unexpected delay in puberty, contact your doctor
• a small number of people taking antiepileptics such as Levetiracetam SUN have had thoughts of harming themselves or suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor
• if you have a medical history or a family history of abnormal heart rhythms (visible on an electrocardiogram), or if you have a condition or are taking a treatment that may lead to abnormal heart rhythms 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 more aggressive than usual, or if you or your family and friends notice significant changes in mood or behaviour
• worsening of epilepsy

In rare cases, seizures may worsen or become more frequent, mainly during the first month after starting treatment or after increasing the dose.

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

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

Children and adolescents

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

Using Levetiracetam SUN with other medicines

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

If you are being treated with methotrexate and levetiracetam at the same time, the serum concentrations of these medicines should be carefully monitored.

Do not take macrogol (a medicine used as a laxative) for 1 hour before and 1 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 SUN 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.

The risk of birth defects for your baby cannot be completely excluded.

Breastfeeding is not recommended during treatment with Levetiracetam SUN.

Driving and using machines

Levetiracetam SUN 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 such activities is not affected.

3. How to take Levetiracetam SUN

Follow exactly the instructions given to you by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

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

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

Concomitant therapy and monotherapy (from 16 years of age)Adults(≥18 years) and adolescents(from 12 to 17 years) with a body weight of 50 kg or more:

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

When you first start taking Levetiracetam SUN, your doctor will prescribe a lower dosefor two weeks before giving you the lowest daily dose.

• For example:for a daily dose of 1000 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 1000 mg per day after 2 weeks of treatment.

Adolescents (from 12 to 17 years) with a body weight of 50 kg or less:Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam SUN according to your weight and dose.

Dose in infants (from 1 month to 23 months) and children (from 2 to 11 years) with a body weight below 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam SUN according to your age, weight, and dose.

Levetiracetam 100 mg/ml oral solution is a more appropriate formulation for infants and children under 6 years of age and adolescents (from 6 to 17 years) with a body weight below 50 kg, and when tablets do not allow for precise dosing.

Method of administration:

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

Duration of treatment:

• Levetiracetam SUN is used as a chronic treatment. You should continue to take Levetiracetam SUN for as long as your doctor has told you.

• Do not stop your treatment without your doctor's advice, as your seizures may increase.

If you take moreLevetiracetam SUNthan you should:

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

Possible side effects of an overdose of Levetiracetam SUN are drowsiness, agitation, aggression, decreased alertness, inhibition of breathing, 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.

If you forget to takeLevetiracetam SUN:

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

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

If you stop takingLevetiracetam SUN:

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

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

4. Possible side effects

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

Tell 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 (Quincke's oedema)
• 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 cell (eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• symptoms such as low urine output, tiredness, nausea, vomiting, confusion, and swelling of the legs, arms, or feet, as these may be signs of sudden kidney failure
• a skin rash that may form blisters and may look like targets (central dark spot surrounded by a paler area, with a dark ring on 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 that causes skin peeling over 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 (memory loss), 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

• loss of appetite (anorexia)
• depression, hostility or aggression, anxiety, insomnia, nervousness, or irritability
• seizures, balance disorder, dizziness (feeling unsteady)
• lethargy (lack of energy and enthusiasm); tremor (involuntary shaking);
• 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

• decreased number of platelets, decreased white blood cell count
• weight loss, weight gain
• suicidal attempt and suicidal thoughts, mental disorders, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation
• amnesia (memory loss), memory impairment (memory loss), abnormal coordination/ataxia (impaired coordination), paraesthesia (tingling);
• diplopia (double vision), blurred vision
• elevated liver enzymes in blood tests
• hair loss, eczema, itching
• muscle weakness, myalgia (muscle pain)
• injury

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

• infection
• decrease in all types of blood cells
• severe allergic reactions (DRESS, anaphylactic reaction, Quincke's oedema)
• decreased sodium levels in the blood
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating)
• seizures may worsen or become more frequent
• delirium
• encephalopathy (see section “Tell your doctor immediately” for a detailed description of symptoms)
• involuntary muscle spasms that affect 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 kidney failure
• skin rash that may form blisters and may look like targets (central dark spot surrounded by a paler area, with a dark ring on 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 that causes skin peeling over 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, decreased level of consciousness (may be signs of a condition 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, repeated thoughts or a 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Levetiracetam SUN

Keep out of the sight and reach of children.

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of Levetiracetam SUN

The active ingredient is levetiracetam. Each tablet contains 500 mg of levetiracetam.

The other components are: Corn starch, Povidone (K-30), Microcrystalline cellulose, Anhydrous colloidal silica, Crospovidone (Type B), Talc, Magnesium stearate, Opadry Yellow, (Hypromellose 6cP, Titanium dioxide (E171), Macrogol 400, Talc, Macrogol 4000, Yellow iron oxide (E172), Aluminum lake indigo carmine (E132)).

Product Appearance and Container Content

The film-coated tablets are yellow, oval, 18.5 x 9 mm, with "RB" and "19" engraved on each side of the score line on one face and smooth on the other face. The tablets can be divided into equal doses.

The containers contain 10, 20, 30, 50, 60, 100, 120, and 200 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

or

TERAPIA S.A.

124 Fabricii Street,

400 632 Cluj Napoca

Romania

Local Representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona, Spain

Tel.:+34 93 342 78 90

This medicinal product is authorized in the following Member States with the following names:

Date of last text revision: September 2023

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