LEVETIRACETAM SANDOZ 250 mg FILM-COATED TABLETS

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

Do not take Levetiracetam Sandoz

• 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

Consult your doctor before taking Levetiracetam Sandoz.

• If you have kidney problems, follow your doctor’s instructions. He/she may decide if you need a dose adjustment,
• 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 suicidal thoughts, contact your doctor,

Tell your doctor or pharmacist if any of the following side effects gets worse or lasts more than a few days:

• Abnormal thoughts, feeling irritable or more aggressive than usual or if you or your family and friends notice any significant changes in your mood or behaviour.
• Worsening of epilepsy

In rare cases, the seizures may become worse or more frequent, mainly during the first month after the start of treatment or the increase of the dose.

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

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

Children and adolescents

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

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 laxative medicine) for one hour before and one hour after taking levetiracetam as it may reduce the effect of levetiracetam.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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 the potential benefit to the mother justifies the potential risk to the foetus.

Do not stop your treatment without consulting your doctor.

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

Breast-feeding is not recommended during treatment with Levetiracetam Sandoz.

Driving and using machines

Levetiracetam may impair your ability to drive or operate tools or machinery, as it may cause somnolence. 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 sodium (23 mg) per film-coated tablet, i.e., 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 as prescribed by your doctor.

Levetiracetam Sandoz 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) weighing 50 kg or more:

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

When you first start taking Levetiracetam Sandoz, your doctor will prescribe you a lower doseduring 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 less than or equal to 50 kg:

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

Levetiracetam Sandoz 100 mg/ml oral solution is a more appropriate formulation for infants and children under 6 years and for children and adolescents (from 6 to 17 years) weighing less than 50 kg and when tablets do not allow an accurate dosage.

Method of administration

Swallow Levetiracetam Sandoz tablets with a sufficient amount of liquid (e.g., a glass of water). You may take Levetiracetam Sandoz with or without food.

After oral administration, the bitter taste of levetiracetam may be experienced.

The tablets can be divided into equal doses.

Duration of treatment

• Levetiracetam Sandoz is used as a chronic treatment. You should continue the treatment for as long as your doctor has instructed.
• Do not stop your treatment without consulting your doctor, as this may increase your seizures.

If you take more Levetiracetam Sandoz than you should

Possible side effects of an overdose of Levetiracetam Sandoz are somnolence, agitation, aggression, decreased alertness, respiratory depression and coma.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone: 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 a forgotten dose.

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 the 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 fever, elevated liver enzymes in blood tests and an increased number of a type of white blood cells (eosinophilia) and swollen lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)),
• symptoms such as decreased urine output, tiredness, nausea, vomiting, confusion and swelling of the feet, ankles, or hands, as these may be signs of sudden kidney failure,
• a skin rash which may form blisters and looks like the centre of a target (erythema multiforme), a widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis),
• signs of serious mental changes or if someone around you notices signs of confusion, somnolence (drowsiness), amnesia (loss of memory), 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 somnolence, fatigue and dizziness may be more frequent at the start of treatment or when the dose is increased. However, these 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,
• rash,
• asthenia/fatigue (tiredness).

Uncommon:may affect up to 1 in 100 people

• decrease in the number of blood platelets, 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 swings, agitation,
• amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordination of movements), paraesthesia (tingling), attention disturbances (loss of concentration),
• diplopia (double vision), blurred vision,
• elevated/abnormal 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),
• decrease in blood sodium levels,
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty concentrating),
• delirium,
• encephalopathy (see section “Tell your doctor immediately” for a more detailed description of the symptoms),
• seizures may become worse or more frequent,
• uncontrolled muscle spasms affecting the head, torso and limbs,
• difficulty controlling movements, hyperkinesia (hyperactivity),
• change in heart rhythm (electrocardiogram),
• pancreatitis,
• liver failure, hepatitis,
• a skin rash that may form blisters and looks like the centre of a target (erythema multiforme), a widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing 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 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 and repeated thoughts or a feeling of doing 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 Medicines 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 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 EXP.

The expiry date refers to the last day of the month.

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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Packaging 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 Packaging 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.

Package 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 package 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 the 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/