Levetiracetam Stada

Leaflet attached to the packaging: patient information

Levetiracetam Stada 100 mg/mL oral solution

Levetiracetam

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Levetiracetam Stada and what is it used for
• 2. Important information before taking Levetiracetam Stada
• 3. How to take Levetiracetam Stada
• 4. Possible side effects
• 5. How to store Levetiracetam Stada
• 6. Contents of the packaging and other information

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

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

• as monotherapy (only Levetiracetam Stada) in the treatment of certain types of epilepsy in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Epilepsy is a condition where patients have recurring seizures. Levetiracetam is used to treat this type of epilepsy, where seizures initially occur in one part of the brain but may then spread to larger areas of both hemispheres of the brain (partial seizures with or without secondary generalization). The doctor has prescribed levetiracetam to reduce the number of seizures;
• as an adjunctive therapy (used in combination with other antiepileptic medicines):
• in the treatment of partial seizures or partial seizures with secondary generalization in adults, adolescents, children, and infants from 1 month of age,
• in the treatment of myoclonic seizures (short, shock-like muscle contractions) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy,
• in the treatment of primary generalized tonic-clonic seizures (large seizures, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalized epilepsy (a type of epilepsy that is likely to have a genetic basis).

2. Important information before taking Levetiracetam Stada

When not to take Levetiracetam Stada

• If the patient is allergic to levetiracetam, pyrrolidine derivatives, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Levetiracetam Stada, discuss it with your doctor.

• If the patient has kidney disease, this medicine should be used as recommended by the doctor.

The doctor may decide to adjust the dosage.

• Contact the doctor if the child taking levetiracetam experiences growth retardation or unexpected changes in puberty.
• In some patients treated with antiepileptic medicines, such as Levetiracetam Stada, suicidal thoughts or behaviors have occurred. In case of symptoms of depression and/or suicidal thoughts, contact the doctor.
• If there is a history of irregular heart rhythm (visible on an electrocardiogram) in the patient's family or previously in the patient, or if the patient has a disease and/or is taking medicines that cause a tendency to irregular heart rhythm or electrolyte imbalance.

Tell the doctor or pharmacist if any of the following side effects worsen or persist for more than a few days:

• Abnormal thoughts, irritability, or more aggressive reactions than usual, or significant mood or behavior changes noticed by the patient or their family and friends.
• Worsening of epilepsy. In rare cases, seizures may worsen or occur more frequently, especially in the first month after starting treatment or increasing the dose. If any of these new symptoms occur while taking Levetiracetam Stada, contact the doctor as soon as possible.

Children and adolescents

Levetiracetam Stada should not be used as monotherapy (only Levetiracetam Stada) in children and adolescents under 16 years of age.

Levetiracetam Stada and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not take macrogol (a medicine used for constipation) one hour before and one hour after taking levetiracetam, as it may reduce the effect of levetiracetam.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine. Levetiracetam can be used during pregnancy only if the doctor considers it necessary.
Do not stop treatment without discussing it with the doctor. The risk of birth defects in the fetus cannot be completely ruled out. During treatment, breastfeeding is not recommended.

Driving and using machines

Levetiracetam Stada may impair the ability to drive and operate tools or machines, as it may cause drowsiness. This is more likely at the beginning of treatment or after increasing the dose. It is not recommended to drive or operate machines until the effect of the medicine on the patient's ability to perform these activities is known.

Levetiracetam Stada contains methyl parahydroxybenzoate (E218), liquid maltitol (E965), sodium, and benzyl alcohol

Levetiracetam Stada oral solution contains methyl parahydroxybenzoate. The medicine may cause allergic reactions (possible late reactions).
Levetiracetam Stada oral solution contains liquid maltitol. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per 1 mL, i.e., the medicine is considered "sodium-free".
This medicine contains 0.0016 mg of benzyl alcohol per milliliter. Benzyl alcohol may cause allergic reactions.
Do not give to small children (under 3 years of age) for more than a week without consulting a doctor or pharmacist.
Pregnant or breastfeeding women should consult their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

3. How to take Levetiracetam Stada

This medicine should always be taken as recommended by the doctor or pharmacist. If in doubt, consult the doctor or pharmacist.
Levetiracetam Stada is taken twice a day, in the morning and evening, preferably at the same time of day.
The amount of oral solution taken must be in accordance with the doctor's recommendations.
Monotherapy (from 16 years of age)

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

For patients 4 years of age and older, the appropriate dose should be measured using the 10 mL syringe provided with the packaging.
Usual dose: Levetiracetam Stada should be taken twice a day, in two equal doses; the single dose is between 5 mL (500 mg) and 15 mL (1500 mg).
Treatment with Levetiracetam Stada starts with lower dosesfor the first two weeks, and then the dose is increased as recommended by the doctor to achieve the recommended value.
Adjunctive therapy

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

For patients 4 years of age and older, the appropriate dose should be measured using the 10 mL syringe provided with the packaging.
Usual dose: Levetiracetam Stada should be taken twice a day, in two equal doses; the single dose is between 5 mL (500 mg) and 15 mL (1500 mg).

Dosing in children 6 months of age and older:

The doctor will recommend the most suitable form of levetiracetam, depending on the age, weight, and dose.
For children from 6 months to 4 years of age, the appropriate dose should be measured using the 3 mL syringe provided with the packaging.
For children over 4 years of age, the appropriate dose should be measured using the 10 mL syringe provided with the packaging.
Usual dose: Levetiracetam Stada should be taken twice a day, in two equal doses; the single dose is between 0.1 mL (10 mg) and 0.3 mL (30 mg) per kilogram of the child's body weight. (Examples of doses are shown in the table below).

Dosing in children 6 months of age and older:

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

For infants from 1 month to less than 6 months of age, the appropriate dose should be measured using the 1 mL syringe provided with the packaging.
Usual dose: Levetiracetam Stada should be taken twice a day, in two equal doses; the single dose is between 0.07 mL (7 mg) and 0.21 mL (21 mg) per kilogram of the infant's body weight. (Examples of doses are shown in the table below).

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

Method of administration:

After measuring the correct dose using the appropriate syringe, Levetiracetam Stada oral solution can be added to a glass of water or to the liquid given to the child to drink from a bottle.
Levetiracetam Stada can be taken with or without food. After oral administration, levetiracetam may leave a bitter taste.
Method of administration:

• Open the bottle: press the cap and turn it counterclockwise (figure 1).
• Separate the adapter from the syringe (figure 2). Place the adapter on the bottle neck. Make sure it is well secured.
• Push the dosing syringe into the adapter opening. Turn the bottle upside down (figure 3).
• Fill the dosing syringe with a small amount of solution by pulling the plunger down (figure 4a), push the plunger to remove air bubbles (figure 4b), then pull the plunger down to the mark on the scale corresponding to the dose of solution in milliliters (mL) recommended by the doctor (figure 4c).
• Turn the bottle right side up. Remove the dosing syringe from the adapter.
• Pressing the plunger, empty the syringe by pouring the measured dose of solution into a glass of water or into the liquid in the bottle for the child (figure 5).
• Give the child the medicine mixed with water in the glass or bottle to drink.
• Close the bottle with the child-resistant cap.
• Wash the dosing syringe with water (figure 6).

Duration of treatment:

• Levetiracetam Stada is intended for long-term treatment. Treatment with Levetiracetam Stada should be continued for as long as recommended by the doctor.
• Do not stop treatment without consulting the doctor, as this may cause an increase in the frequency of seizures.

Taking a higher dose of Levetiracetam Stada than recommended

After overdosing on Levetiracetam Stada, somnolence, agitation, aggression, decreased consciousness, slowed breathing, and coma have been reported.
In case of taking a higher dose of Levetiracetam Stada than recommended, consult the doctor immediately, who will recommend the most appropriate treatment for the overdose.

Missing a dose of Levetiracetam Stada

Consult the doctor if one or more doses of Levetiracetam Stada have not been taken. Do not take a double dose to make up for the missed dose.

Stopping treatment with Levetiracetam Stada

If treatment with Levetiracetam Stada is to be stopped, the medicine should be discontinued gradually to avoid increasing the frequency of epileptic seizures. If the doctor decides to stop treatment with Levetiracetam Stada, they will also inform how to gradually discontinue the medicine.
In case of any further doubts about taking this medicine, consult the doctor or pharmacist.

4. Possible side effects

Like all medicines, Levetiracetam Stada can cause side effects, although not everybody gets them.

Immediately inform the doctor or contact the nearest hospital emergency department if the patient experiences:

• weakness, dizziness, or difficulty breathing, as these symptoms may indicate a severe allergic reaction (anaphylaxis);
• swelling of the face, lips, tongue, and throat (Quincke's edema);
• flu-like symptoms and rash on the face and then on the whole body, occurring with high fever, increased liver enzyme activity in blood tests, increased number of certain white blood cells (eosinophilia), and enlarged lymph nodes (drug rash with eosinophilia and systemic symptoms - DRESS syndrome);
• symptoms such as decreased urine output, fatigue, nausea, vomiting, confusion, and swelling of the feet, ankles, or legs, as this may be a sign of sudden worsening of kidney function;
• a skin rash that can cause blisters and looks like small targets (dark spot surrounded by a lighter area and a dark ring around) (multiform erythema);
• widespread rash with blisters and peeling skin, occurring mainly in the area of the mouth, eyes, nose, and genitals (Stevens-Johnson syndrome);
• a severe form of rash causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
• signs of serious mental changes or noticing in the patient signs of disorientation, somnolence, memory loss (amnesia), memory disorders (forgetfulness), behavioral disorders, or other neurological symptoms, including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most common side effects reported are: nasal congestion, somnolence, headache, fatigue, and dizziness. At the beginning of treatment or when increasing the dose, side effects such as somnolence, fatigue, or dizziness may occur more frequently. The severity of these symptoms usually decreases over time.

Very common (may affect more than 1 in 10 people):

• nasal congestion;
• somnolence, headaches.

Common (may affect up to 1 in 10 people):

• loss of appetite (anorexia);
• depression, hostility, or aggression, anxiety, insomnia, nervousness, or irritability;
• seizures, balance disorders, dizziness (feeling of swaying), lethargy (lack of energy and enthusiasm), tremors (involuntary trembling);
• dizziness (feeling of spinning);
• cough;
• abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea;
• rash;
• asthenia/fatigue (exhaustion).

Uncommon (may affect up to 1 in 100 people):

• decreased platelet count; decreased white blood cell count;
• weight loss, weight gain;
• suicidal thoughts and behaviors, mental disorders, abnormal behavior, hallucinations, anger, disorientation, panic attacks, emotional instability/mood changes, excitement;
• memory loss (amnesia), memory disorders (forgetfulness), ataxia (coordination disorders), paresthesia (tingling), attention disorders;
• double vision, blurred vision;
• abnormal liver test results;
• hair loss, rash, itching;
• muscle weakness, muscle pain;
• injuries.

Rare (may affect up to 1 in 1000 people):

• infections;
• decreased number of all types of blood cells;
• severe allergic reactions (drug rash with eosinophilia and systemic symptoms - DRESS syndrome), Quincke's edema (swelling of the face, lips, tongue, and throat);
• decreased sodium levels in the blood;
• suicide, personality disorders (behavioral disorders), thinking disorders (slow thinking, inability to concentrate);
• delirium;
• encephalopathy (detailed description of symptoms can be found in the subsection "Immediately inform the doctor");
• seizures may worsen or occur more frequently;
• involuntary muscle contractions of the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• changes in heart rhythm (electrocardiogram);
• pancreatitis;
• liver function disorders, hepatitis;
• sudden worsening of kidney function;
• a skin rash that can cause blisters and looks like small targets (dark spot surrounded by a lighter area and a dark ring around) (multiform erythema), widespread rash with blisters and peeling skin, occurring mainly in the area of the mouth, eyes, nose, and genitals (Stevens-Johnson syndrome), and a severe form of rash causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of striated muscle) and associated increased creatine phosphokinase activity in the blood. The occurrence is significantly more frequent in Japanese patients compared to other patients (non-Japanese).
• stuttering or difficulty walking;

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Levetiracetam Stada

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack, carton, and container after: EXP. The expiry date refers to the last day of the month stated.
This medicinal product does not require any special storage conditions.
After opening the bottle for the first time: Do not store above 25°C.
Do not use the medicine for more than 7 months after opening the bottle.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Levetiracetam Stada contains

• The active substance of the medicine is levetiracetam. Each milliliter of oral solution contains 100 mg of levetiracetam.
• The other ingredients (excipients) are: sodium citrate (to adjust pH), citric acid (to adjust pH), methyl parahydroxybenzoate (E218), glycerol (E422), acesulfame potassium (E950), liquid maltitol (E965), raspberry flavor (containing benzyl alcohol), purified water

What Levetiracetam Stada looks like and what the pack contains

Levetiracetam Stada 100 mg/mL oral solution is a clear liquid.
A glass bottle containing 300 mL of Levetiracetam Stada (for use in children from 4 years of age, adolescents, and adults), placed in a cardboard box with a 10 mL oral syringe (scaled every 0.25 mL) and a syringe connector.
A glass bottle containing 150 mL of Levetiracetam Stada (for use in infants and children from 6 months to less than 4 years of age), placed in a cardboard box with a 3 mL oral syringe (scaled every 0.1 mL) and a syringe connector.
A glass bottle containing 150 mL of Levetiracetam Stada (for use in infants from 1 month to less than 6 months of age), placed in a cardboard box with a 1 mL oral syringe (scaled every 0.05 mL) and a syringe connector.
Not all pack sizes may be marketed.

Marketing authorization holder

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer

Remedica Ltd
Aharnon Street, Limassol Industrial Estate,
Limassol 3056
Cyprus
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany:
Levetiracetam AL 100 mg/mL Lösung zum Einnehmen
Austria:
Levetiracetam STADA 100 mg/mL Lösung zum Einnehmen
Denmark:
Levetiracetam STADA
Spain:
Levetiracetam STADAGEN 100 mg/mL solución oral EFG
Finland:
Levetiracetam STADA 100 mg/mL oraaliliuos
France:
LEVETIRACETAM EG 100 mg/mL, solution buvable
Iceland:
Levetiracetam STADA 100 mg/mL mixtúra, lausn
Italy:
LEVETIRACETAM EUROGENERICI
Portugal:
Levetiracetam Ciclum Farma
Sweden:
Levetiracetam STADA 100 mg/mL oral lösning
Ireland:
Levetiracetam Clonmel 100 mg/mL oral solution
Malta:
Levetiracetam Clonmel 100 mg/mL oral solution
Poland:
Levetiracetam Stada
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Phone: +48 22 737 79 20

Date of the last revision of the leaflet: