Patient Information Leaflet

Levetiracetam Sandoz 100 mg/ml Oral Solution

levetiracetam

Read this leaflet carefully before you or your child start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Levetiracetam is an antiepileptic medication (a medication for the treatment of epileptic seizures).

Levetiracetam is used:

• alone in adults and adolescents aged 16 years or older with recently diagnosed epilepsy to treat a form of epilepsy. Epilepsy is a disease where patients have seizures (crises). Levetiracetam is used for the form of epilepsy in which the seizures initially affect only one side of the brain, but may later extend to wider areas in both sides of the brain (partial onset seizures with or without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures.
• in combination with other antiepileptic medications to treat:
• partial onset seizures with or without generalization in adults, adolescents, children, and infants aged 1 month or older,
• myoclonic seizures (shock-like, short, muscle or group of muscles) in adults and adolescents aged 12 years or older with juvenile myoclonic epilepsy,
• primary generalized tonic-clonic seizures in adults and adolescents aged 12 years or older with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

Do not take Levetiracetam Sandoz

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

Warnings and precautions

Consult your doctor before starting to take levetiracetam:

• If you have kidney problems, follow your doctor's instructions, who will decide if you need to adjust your dose.
• If you notice any decrease in your child's growth or unexpected puberty development, contact your doctor.
• A small number of people taking antiepileptic medications, such as levetiracetam, have had thoughts of self-harm or suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.
• If you have a history or family history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease or are taking a treatment that makes you prone to arrhythmias or electrolyte imbalances.

Inform your doctor or pharmacist if any of the following adverse effects worsen or last more than a few days:

-Abnormal thoughts, feeling irritable, or reacting in an abnormally aggressive manner, or if you or your family and friends notice significant changes in mood or behavior.

-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 rare form of early-onset epilepsy (SCN8A mutation-associated epilepsy) 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 old.

Other medications and Levetiracetam Sandoz

Inform your doctor or pharmacist ifyou are taking, have taken recently, or may need to take any other medication.

Do not take macrogol (laxative medication) within one hour before and one 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 intend to become pregnant, consult your doctor before using this medication. Levetiracetam can 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 ruled out. Breastfeeding is not recommended during treatment.

Driving and operating machinery

Levetiracetam may affect your ability to drive or operate tools or machines, as it may cause drowsiness. This is more likely at the start of treatment or when increasing the dose. Do not drive or use machines until it is confirmed that your ability to perform these activities is not impaired.

Levetiracetam Sandoz contains parahydroxybenzoic acid methyl ester, maltitol, benzyl alcohol, and sodium.

This medication contains parahydroxybenzoic acid methyl ester (E 218), which may cause allergic reactions (possibly delayed).

This medication contains maltitol (E 965). If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains 1.6 micrograms of benzyl alcohol per ml. Benzyl alcohol may cause allergic reactions.

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

This medication should not be used for more than a week in children under 3 years old unless instructed by your doctor or pharmacist. Benzyl alcohol has been associated with a risk of severe adverse effects, including respiratory problems ("breathing difficulty") in children. Do not administer this medication to your newborn (up to 4 weeks old) unless recommended by your doctor.

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Take the oral solution as instructed by your doctor.

Monotherapy (from 16 years of age)

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

For patients 4 years of age or older, measure the appropriate dose using the 10 ml syringe included in the package.

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

When starting levetiracetam, your doctor will prescribe a lower dose for two weeks before administering the daily minimum dose.

Concomitant treatment

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

For patients 4 years of age or older, measure the appropriate dose using the 10 ml syringe included in the package.

Recommended dose: levetiracetam is taken twice a day, in two equal doses, with 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 appropriate pharmaceutical form of levetiracetam based on age, weight, and dose.

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

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

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

Dose in children from 6 months of age:

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

For infants from 1 month to less than 6 months of age, measure the appropriate dose using the 1 ml syringe included in the package.

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

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

Administration form:

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

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

Instructions for correct administration:

• Open the bottle: press the cap and unscrew in the opposite direction to the clock hands (figure 1),
• Separate the adapter from the syringe (figure 2). Insert the adapter into the neck of the bottle. Make sure it is securely attached.
• Take the syringe and insert it into the opening of the adapter. Place 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 corresponding to the dose in milliliters (ml) prescribed by your doctor (figure 4 c).
• Place the bottle upright. Remove the syringe from the adapter.
• Empty the contents of the syringe into a glass of water or a bottle by lowering the plunger to the end of the syringe (figure 5).
• Drink the contents of the glass or bottle entirely.
• Close the bottle with the plastic screw cap.
• Wash the syringe only with water (figure 6).

Treatment duration:

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

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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

The possible adverse effects of a levetiracetam overdose 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 compensate for the missed doses.

If you interrupt treatment with Levetiracetam Sandoz

The discontinuation of 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 the gradual withdrawal of levetiracetam.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Inform your doctor immediately, or go to the emergency service 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 edema),
• flu-like symptoms and a 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 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 the legs, arms, or feet, as it may be a sign of sudden kidney function decline,
• a skin rash that can form blisters and may appear as small dots (central dark spots surrounded by a lighter 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 deterioration (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported side effects are nasopharyngitis, drowsiness (drowsiness), 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,
• drowsiness (drowsiness), 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, lethargy (lack of energy and enthusiasm), tremor (involuntary shaking),
• vertigo (sensation of rotation),
• cough,
• abdominal pain, diarrhea, dyspepsia (heavy digestion, burning, and acidity), vomiting, nausea,
• skin rash,
• asthenia/fatigue (sensation of weakness).

Rare: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 thoughts and attempts, mental disorder, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation,
• amnesia (memory loss), memory deterioration (forgetfulness), abnormal coordination/ataxia (coordinated movements with disability), paresthesia (tingling), attention alterations (loss of concentration),
• diplopia (double vision), blurred vision,
• elevated or 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 [severe and important allergic reaction), Quincke's edema (swelling of the face, lips, tongue, and throat]),
• decrease in sodium concentration in the blood,
• suicide, personality disorders (behavior problems), abnormal thinking (slow thinking, difficulty concentrating),
• delirium,
• encephalopathy (see subsection “Inform your doctor immediately” for a detailed description of symptoms),
• epileptic seizures that may worsen or occur more frequently,
• involuntary and uncontrolled muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity),
• change in heart rhythm (electrocardiogram),
• pancreatitis,
• hepatic insufficiency, hepatitis,
• sudden decline in kidney function,
• skin rash, which may lead to blisters that may appear as small dots (central dark spots surrounded by a lighter 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 elevated creatine phosphokinase blood levels associated with it. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients,
• gait disturbance or difficulty walking,
• combination of fever, muscle rigidity, unstable blood pressure, and heart rate, confusion, low 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 and repeated thoughts or sensations or the urge to do something over and over (obsessive-compulsive disorder).

Reporting of side effects

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

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

Do not use this medication 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 after 7 months have passed since the first opening of the bottle.

Store in the original packaging to protect it from light.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

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 contents of the package

Levetiracetam Sandoz oral solution is a transparent liquid.

The 300 ml glass bottle of Levetiracetam Sandoz (for children aged 4 years and older, adolescents, and adults) is packaged in a cardboard box accompanied by a 10 ml oral syringe graduated every 0.25 ml and an adapter for the syringe.

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 accompanied by a 3 ml oral syringe graduated every 0.1 ml and an adapter for the syringe.

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 accompanied by an oral syringe graduated every 0.05 ml and an adapter for the syringe.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

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

Last review date of this leaflet:December 2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/