LEVETIRACETAM SANDOZ 100 mg/ml ORAL SOLUTION

2. What you need to know before taking Levetiracetam Sandoz

Do not take Levetiracetam Sandoz

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

Warnings and precautions

Talk to your doctor before taking levetiracetam:

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 your mood or behaviour.
• 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.

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 persist or worsen during treatment.

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

Children and adolescents

Monotherapy with levetiracetam 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) for 1 hour before and 1 hour after taking levetiracetam, as it may reduce its effect.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using 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 first. The risk of birth defects for the 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 these activities is not affected.

Levetiracetam Sandoz contains methyl parahydroxybenzoate, maltitol, benzyl alcohol, and sodium.

This medicine contains methyl parahydroxybenzoate (E 218), which may cause allergic reactions (possibly delayed).

This medicine contains maltitol (E 965). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains 1.6 micrograms of benzyl alcohol in each ml. Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant, breastfeeding, or have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

This medicine should not be used for more than one week in children under 3 years of age unless advised by your doctor or pharmacist. Benzyl alcohol has been linked to the risk of serious side effects, including respiratory problems ("gasping syndrome") in children. Do not give this medicine to your newborn (up to 4 weeks of age) unless recommended by your doctor.

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

3. How to take Levetiracetam Sandoz

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

Take the oral solution following the instructions given by your doctor.

Monotherapy (from 16 years of age)

Adults (≥18 years) and adolescents (from 16 years of age):

For patients from 4 years of age, measure the correct dose using the 10 ml syringe included in the box.

Recommended dose: levetiracetam is taken twice a day, in two equal doses, each individual dose between 5 ml (500 mg) and 15 ml (1500 mg).

When starting levetiracetam, your doctor will prescribe a lower dosefor two weeks before giving you the lowest daily dose.

Concomitant treatment

Dose in adults and adolescents (from 12 to 17 years of age):

For patients from 4 years of age, measure the correct dose using the 10 ml syringe included in the box.

Recommended dose: levetiracetam is taken twice a day, in two equal doses, each individual dose between 5 ml (500 mg) and 15 ml (1500 mg).

Dose in children from 6 months of age:

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

For children from 6 months to 4 years of age, measure the correct dose using the 3 ml syringe included in the box.

For children over 4 years of age, measure the correct dose using the 10 ml syringe included in the box.

Recommended dose: levetiracetam is taken twice a day, in two equal doses, each individual dose between 0.1 ml (10 mg) and 0.3 ml (30 mg) per kilogram of the child's body weight (see the following table for examples of doses).

Dose in children from 6 months of age:

Dosing in infants (from 1 month to less than 6 months):

For infants from 1 month to less than 6 months of age, measure the correct dose using the 1 mlsyringe included in the box.

Recommended dose: levetiracetam is taken twice a day, in two equal doses, each individual dose between 0.07 ml (7 mg) and 0.21 ml (21 mg) per kilogram of the infant's body weight (see the following table for examples of doses).

Dose in infants (from 1 month to less than 6 months of age):

Method of administration:

After measuring the correct dose with the suitable syringe, levetiracetam oral solution can be diluted in a glass of water or in a baby bottle.

You can take levetiracetam with or without food. After oral administration of levetiracetam, a bitter taste may be noticed.

Instructions for correct administration:

• Open the bottle: press the cap and unscrew it counterclockwise (figure 1),
• Separate the adapter from the syringe (figure 2). Insert the adapter into the neck of the bottle. Make sure it is well fixed.
• Take the syringe and insert it into the adapter opening. Put the bottle upside down (figure 3).
• Fill the syringe with a small amount of solution by lowering the plunger (figure 4 a), and then raise it to eliminate any possible bubbles (figure 4 b). Lower the plunger to the graduation mark that corresponds to the dose in milliliters (ml) prescribed by your doctor (figure 4 c).
• Put the bottle upright. Remove the syringe from the adapter.
• Empty the contents of the syringe into a glass of water or a baby bottle, lowering the plunger to the end of the syringe (figure 5).
• Drink the entire contents of the glass or baby bottle.
• Close the bottle with the plastic screw cap.
• Wash the syringe only with water (figure 6).

Duration of treatment:

• Levetiracetam is used as a chronic treatment. You should continue treatment with levetiracetam for the time indicated by your doctor.
• Do not stop your treatment without your doctor's recommendation, as your seizures may increase.

If you take more Levetiracetam Sandoz than you should

If you have taken more levetiracetam than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

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

Contact your doctor if you have taken more oral solution than you should. 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 the missed doses.

If you stop treatment with Levetiracetam Sandoz

Stopping treatment with Levetiracetam Sandoz should be done gradually to avoid an increase in seizures.

If your doctor decides to stop your treatment with levetiracetam, they will give you instructions for gradual withdrawal of levetiracetam.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Tell your doctor immediately, or go to the emergency department of your nearest hospital if you experience:

• weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic),
• swelling of the face, lips, tongue, or throat (Quincke's edema),
• flu-like symptoms and rash on the face followed by a prolonged rash with high temperature, elevated liver enzyme levels in blood tests, and an increase in a type of white blood cells (eosinophilia) and enlarged lymph nodes (Drug Hypersensitivity 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 it may be a sign of sudden decrease in renal function,
• a skin rash that can form blisters and may appear as small targets (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme),
• a generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome),
• a more severe form 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 (drowsiness), amnesia (memory loss), memory impairment (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported adverse effects are nasopharyngitis, drowsiness (feeling of sleep), headache, fatigue, and dizziness. Adverse effects such as drowsiness, weakness, and dizziness may be more frequent when treatment is initiated or the dose is increased. However, these adverse effects should decrease over time.

Very common:may affect more than 1 in 10 people

• nasopharyngitis,
• drowsiness (feeling of sleep), 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 rotation),
• cough,
• abdominal pain, diarrhea, dyspepsia (heavy digestion, heartburn, and acidity), vomiting, nausea,
• skin rash,
• asthenia/fatigue (feeling of weakness).

Uncommon:may affect up to 1 in 100 people

• decrease in platelet count in blood, decrease in white blood cell count,
• weight loss, weight gain,
• suicide attempt and suicidal thoughts, mental disorder, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation,
• amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (coordinated movements with disability), paresthesia (tingling), attention disorders (loss of concentration),
• diplopia (double vision), blurred vision,
• elevated/abnormal liver function test values,
• hair loss, eczema, pruritus,
• 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 [important and severe allergic reaction], Quincke's edema [swelling of face, lips, tongue, and throat]),
• decrease in sodium concentration in blood,
• suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating),
• delirium,
• encephalopathy (see subsection "Tell your doctor immediately" for a detailed description of symptoms),
• epileptic seizures that may worsen or occur more frequently,
• uncontrolled muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity),
• change in heart rate (electrocardiogram),
• pancreatitis,
• liver failure, hepatitis,
• sudden decrease in renal function,
• skin rash, which may lead to blisters that may appear as small targets (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis),
• rhabdomyolysis (muscle tissue breakdown) and increased creatine phosphokinase in blood. Prevalence is significantly higher in Japanese patients compared to non-Japanese patients,
• limping or difficulty walking,
• 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.

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

• unwanted and repetitive thoughts or feelings or the urge to do something over and over again (obsessive-compulsive disorder).

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Levetiracetam Sandoz

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the bottle and carton after CAD/EXP. The expiration date is the last day of the month indicated.

Do not use it more than 7 months after the first opening of the bottle.

Store in the original packaging to protect it from light.

Medicines should not be thrown down the drain or into the trash. Deposit the containers and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Levetiracetam Sandoz

• The active ingredient is levetiracetam. Each ml contains 100 mg of levetiracetam.
• The other components are: sodium citrate (for pH adjustment), citric acid (for pH adjustment), methyl parahydroxybenzoate (E-218), glycerol (E-422), potassium acesulfame (E-950), liquid maltitol (E-965), raspberry flavor (contains benzyl alcohol), purified water.

Appearance of the Product and Package Contents

Levetiracetam Sandoz oral solution is a clear liquid.

The 300 ml glass bottle of Levetiracetam Sandoz (for children from 4 years of age, adolescents, and adults) is packaged in a cardboard box with a 10 ml graduated oral syringe every 0.25 ml and a syringe adapter.

The 150 ml glass bottle of Levetiracetam Sandoz (for infants 6 months and older and children 2 to 4 years of age) is packaged in a cardboard box with a 3 ml graduated oral syringe every 0.1 ml and a syringe adapter.

The 150 ml glass bottle of Levetiracetam Sandoz (for infants 1 month to less than 6 months of age) is packaged in a cardboard box with a graduated oral syringe every 0.05 ml and a syringe adapter.

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

Remedica Ltd.

Limassol Industrial Estate,

P.O. Box 51706

CY-3508 Limassol

Cyprus

or

Galenica Pharmaceutical Industry S.A.

3rd Km Old National Road Chalkida Athens,

Chalcis, 341 00

Greece

or

Lek Pharmaceuticals d.d.

Trimlini 2D,

9220 Lendava

Slovenia

or

Lek Pharmaceuticals d.d.

Verovškova 57,

1526 Ljubljana

Slovenia

or

LEK S.A.

ul. Domaniewska 50 C

02-672 Warszawa

Poland

or

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

Str. Livezeni nr. 7A,

RO-540472 Targu-Mures

Romania

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Austria:Levetiracetam Sandoz 100 mg/ml - Lösung zum Einnehmen

Belgium:Levetiracetam Sandoz 100 mg/ml drank

Finland:Levetiracetam 1A farma 100 mg/ml oraaliliuos

France:LEVETIRACETAM SANDOZ 100 mg/ml, solution buvable

United Kingdom:Levetiracetam Sandoz 100 mg / 1 ml, Oral Solution

Netherlands:Levetiracetam Sandoz 100 mg/ml, drank

Sweden:Levetiracetam Sandoz

Date of the last revision of this prospectus:December 2023

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