LEVETIRACETAM SANDOZ 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Levetiracetam Sandoz 250 mg film-coated tablets EFG

Levetiracetam Sandoz 500 mg film-coated tablets EFG

Levetiracetam Sandoz 1,000 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 for you only. Do 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. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

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

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

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

Levetiracetam Sandoz is used:

• on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy to treat a certain form of epilepsy. Epilepsy is a disease where patients have seizures (fits). Levetiracetam is used for the form of epilepsy in which the seizures initially affect only one side of the brain, but may then 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 fits, 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 Sandoz

Do not take Levetiracetam Sandoz

• 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

Consult your doctor before taking Levetiracetam Sandoz.

• If you have kidney problems, follow your doctor's instructions. He/she may decide if you need to adjust your dose,
• a small number of people taking antiepileptics such as levetiracetam have had thoughts of harming themselves or suicidal thoughts. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor,

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 behaving 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 after increasing the dose.

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 Sandoz, see a doctor as soon as possible.

Children and adolescents

Treatment with levetiracetam (monotherapy) is not indicated in children and adolescents under 16 years of age.

Other medicines and Levetiracetam Sandoz

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) during the hour before and the 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 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.

Driving and using machines

Levetiracetam 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.

Levetiracetam Sandoz contains sodium

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

3. How to take Levetiracetam Sandoz

Follow exactly the instructions given to you by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Take the number of tablets that your doctor has prescribed.

Levetiracetam Sandoz 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 Sandoz, your doctor will prescribe you 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.

Adults (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 Sandoz according to age, weight, and dose.

Levetiracetam Sandoz 100 mg/ml 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 Levetiracetam Sandoz tablets with a sufficient amount of liquid (e.g., a glass of water). You can take Levetiracetam Sandoz with or without food.

After oral administration of levetiracetam, a bitter taste may be noticed.

The tablets can be divided into equal doses.

Duration of treatment

• Levetiracetam Sandoz is used as a chronic treatment. You should continue with the treatment 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 Sandoz than you should

Possible side effects of an overdose of Levetiracetam Sandoz 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, phone: 91 562 04 20, indicating the medicine and the amount taken.

Your doctor will establish the best possible treatment for the overdose.

If you forget to take Levetiracetam Sandoz

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 taking Levetiracetam Sandoz

Stopping treatment with levetiracetam should be done gradually 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 levetiracetam.

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.

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 (anaphylaxis),
• 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, 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 looks like targets (central dark spots 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

• 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), tremors (involuntary shaking),
• vertigo (feeling of spinning),
• cough,
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea,
• rash,
• asthenia/fatigue (tiredness).

Uncommon:may affect up to 1 in 100 people

• decrease in the number of platelets in the blood, decrease in the number of white blood cells,
• weight loss, weight gain,
• suicidal attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, 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 values 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 (severe and important allergic reaction), Quincke's oedema (swelling of face, lips, tongue, and throat)),
• decrease in sodium levels in the blood,
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating),
• delirium,
• encephalopathy (see subsection "Tell your doctor immediately" for a more detailed description of symptoms),
• epileptic 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),
• pancreatitis,
• liver failure, hepatitis,
• skin rash that may form blisters and looks like targets (central dark spots 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, decreased 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.

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

• unwanted and repetitive 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 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. Storage of Levetiracetam Sandoz

Keep this medicine 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 CAD/EXP.

The expiry date is the last day of the month stated.

Store in the original package to protect from moisture.

For bottles, the shelf-life after first opening is 100 days.

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 Sandoz

• The active ingredient is levetiracetam.

Levetiracetam Sandoz 250 mg:

• Each film-coated tablet contains 250 mg of levetiracetam.
• The other ingredients are povidone K25, microcrystalline cellulose, sodium croscarmellose, crospovidone (Type A), anhydrous colloidal silica, talc, magnesium stearate,hypromellose, hydroxypropylcellulose, macrogol type 6000, titanium dioxide (E-171), talc, and aluminum lake indigo carmine (E-132).

Levetiracetam Sandoz 500 mg:

• Each film-coated tablet contains 500 mg of levetiracetam.
• The other ingredients are povidone K25, microcrystalline cellulose, sodium croscarmellose, crospovidone (Type A), anhydrous colloidal silica, talc, magnesium stearate, hypromellose, hydroxypropylcellulose, macrogol type 6000, titanium dioxide (E-171), talc, and yellow iron oxide (E-172).

Levetiracetam Sandoz 1,000 mg:

• Each film-coated tablet contains 1,000 mg of levetiracetam.
• The other ingredients are povidone K25, microcrystalline cellulose, sodium croscarmellose, crospovidone (Type A), anhydrous colloidal silica, talc, magnesium stearate, hypromellose, hydroxypropylcellulose, macrogol type 6000, titanium dioxide (E-171), and talc.

Product Appearance and Container Content

Levetiracetam Sandoz 250 mg are light blue, oval, biconvex, scored tablets with the imprint LVT/250 on one side.

Levetiracetam Sandoz 500 mg are yellow, biconvex, scored tablets with the imprint LVT/500 on one side.

Levetiracetam Sandoz 1,000 mg are white, oval, biconvex, scored tablets with the imprint LVT/1000 on one side.

The tablets are packaged in OPA/Alu/PVC-Alu blisters or HDPE bottles with a polypropylene screw cap and a silica gel capsule inserted in cardboard boxes.

Container sizes:

Levetiracetam Sandoz 250 mg:

Blister: 10, 20, 28, 30, 50, 50x1, 60, 100, 120, 200 film-coated tablets.

Bottle: 10, 20, 30, 50, 60, 100, 120, 200 film-coated tablets.

Levetiracetam Sandoz 500 mg and Levetiracetam Sandoz 1,000 mg:

Blister: 10, 28, 30, 50, 50 x 1, 60, 100, 120, and 200 film-coated tablets.

Bottle: 10, 20, 30, 50, 60, 100, 120, and 200 film-coated tablets.

Only some container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d

Verovškova 57,

1526 Ljubljana

Slovenia

or

LEK S.A.

ul. Domaniewska 50 C,

02-672 Warszawa

Poland

or

Lek Pharmaceuticals d.d

Trimlini 2 D,

9220 Lendava,

Slovenia

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179 Barleben

Germany

or

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A, RO-

540472 Targu-Mures

Romania

Date of Last Revision of this Leaflet:December 2023

Detailed 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/