Levetiracetam stada

Patient Information Leaflet

Levetiracetam Stada 100 mg/mL oral solution
Levetiracetam
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

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

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

Levetiracetam is an antiepileptic medicine (a medicine used to treat epileptic seizures).
Levetiracetam Stada is used:

• as monotherapy (using only Levetiracetam Stada) in the treatment of certain forms of epilepsy in adults and adolescents aged 16 years and older with newly diagnosed epilepsy. Epilepsy is a condition in which patients have recurrent seizures. Levetiracetam is used to treat a type of epilepsy in which seizures start in one part of the brain and may then spread to larger areas of both brain hemispheres (partial seizures with or without secondary generalisation). Your doctor has prescribed levetiracetam to reduce the number of seizures;
• as add-on therapy used together with other antiepileptic medicines:
• in the treatment of partial or secondarily generalised partial seizures in adults, adolescents, children and newborns from 1 month of age,
• in the treatment of myoclonic seizures (brief, shock-like jerks of a muscle or group of muscles) in adults and adolescents aged 12 years and older with juvenile myoclonic epilepsy,
• in the treatment of primary generalised tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents aged 12 years and older with idiopathic generalised epilepsy (a type of epilepsy that is likely to have a genetic basis).

2. Important information before using Levetiracetam Stada

When not to use Levetiracetam Stada

• If the patient is allergic to levetiracetam, pyrrolidone derivatives, or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Before starting treatment with Levetiracetam Stada, please discuss this with your doctor.
• If the patient has kidney disease, this medicine should be used according to the doctor's instructions.

The doctor may decide to adjust the dosage.

• Contact the doctor if a child taking levetiracetam experiences slowed growth or unexpected changes in development.
• In some patients treated with antiepileptic medicines such as Levetiracetam Stada, thoughts about self-harm or suicidal thoughts have occurred. If symptoms of depression and/or suicidal thoughts occur, contact your doctor.
• If the patient has a family history or personal history of irregular heart rhythm (detected on electrocardiogram), or if the patient has a disease and/or is taking medicines that may predispose to irregular heart rhythm or electrolyte imbalance. Inform your doctor or pharmacist if any of the following adverse reactions worsen or persist for more than a few days:
• Unusual thoughts, irritability, more aggressive behaviour than usual, or significant changes in mood or behaviour noticed by the patient or their family and friends.
• Worsening of epilepsy In rare cases, seizures may increase in frequency or severity, especially during the first month of treatment or after an increase in dose. If any of these new symptoms occur while taking Levetiracetam Stada, contact your doctor as soon as possible.

Children and adolescents
Levetiracetam Stada is not indicated for monotherapy (using Levetiracetam Stada alone) in children and adolescents under 16 years of age.

Levetiracetam Stada and other medicines
Tell your 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 or one hour after taking levetiracetam, as this may reduce the effect of levetiracetam.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine. Levetiracetam may be used during pregnancy only if, after careful evaluation, the treating doctor considers it necessary. Do not stop treatment without discussing it with the treating doctor. The risk of congenital malformations in the unborn child cannot be completely ruled out. Results from two studies do not suggest an increased risk of autism or intellectual disability in children born to mothers treated with levetiracetam during pregnancy. However, available data on the effects of levetiracetam on neurodevelopment in children are limited. Breastfeeding is not recommended during treatment.

Driving and operating machinery
Levetiracetam Stada may impair the ability to drive and operate tools or machinery, as use of Levetiracetam Stada may cause drowsiness. This is more likely at the beginning of treatment or after an increase in dose. Driving and operating machinery are not recommended 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. This may cause allergic reactions (including delayed-type reactions).
Levetiracetam Stada oral solution contains liquid maltitol. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per 1 mL; therefore, this medicine is considered "sodium-free".

This medicine contains 0.0016 mg of benzyl alcohol in each millilitre. Benzyl alcohol may cause allergic reactions.
Do not administer to young children (under 3 years of age) for longer than one week without medical or pharmacist advice.
Pregnant or breastfeeding women should consult a doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult a doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).

3. How to use Levetiracetam Stada

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
Levetiracetam Stada should be taken twice daily, in the morning and evening, preferably at the same
time each day.
The amount of oral solution taken must be in accordance with your doctor's instructions.

Monotherapy (in patients aged 16 years and older)
Adults (aged ≥ 18 years) and adolescents (aged 16 years and older):
For patients aged 4 years and older, the appropriate dose should be measured using the 10 mL syringe supplied with the package.
Typical dose: Levetiracetam Stada should be taken twice daily in two equal doses; the single dose ranges between 5 mL (500 mg) and 15 mL (1500 mg).
Treatment with Levetiracetam Stada is initiated at lower doses for the first two weeks, then the dose is increased according to your doctor's instructions until the recommended dose is reached.

Adjunctive therapy
Dosage in adults and adolescents (aged 12 to 17 years):
For patients aged 4 years and older, the appropriate dose should be measured using the 10 mL syringe supplied with the package.
Typical dose: Levetiracetam Stada should be taken twice daily in two equal doses; the single dose ranges between 5 mL (500 mg) and 15 mL (1500 mg).

Dosage in children aged 6 months and older:
Your doctor will recommend the most appropriate formulation of levetiracetam, depending on the child's age, body weight, and required dose.

• For children aged 6 months to under 4 years, the appropriate dose should be measured using the 3 mL syringe supplied with the package.
• For children aged 4 years and older, the appropriate dose should be measured using the 10 mL syringe supplied with the package.
  Typical dose: Levetiracetam Stada should be taken twice daily in two equal doses; the single dose ranges between 0.1 mL (10 mg) and 0.3 mL (30 mg) per kg of the child's body weight. (Examples of dosing are shown in the table below).

Dosage in children aged 6 months and older:

Dosage for infants (from 1 month to below 6 months of age):
For children from 1 month to below 6 months of age, the appropriate dose should be measured using the 1 mL syringe provided in the package.
The usual dosage: Levetiracetam Stada should be taken twice daily, in two equal doses; the single dose ranges from 0.07 mL (7 mg) to 0.21 mL (21 mg) per kg of the infant's body weight. (Examples of dosages are shown in the table below).
Dosage for infants (from 1 month to below 6 months of age):

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

• Open the bottle: press down on the cap and turn it counterclockwise (Figure 1).
• Separate the adapter from the syringe. Place the adapter onto the neck of the bottle. Ensure it is securely attached.
• Insert the dosing syringe into the opening of the adapter. Turn the bottle upside down (Figure 3).
• Fill the dosing syringe with a small amount of solution by pulling the plunger down (Figure 4 a), then push the plunger to expel any air bubbles (Figure 4 b). Next, pull the plunger down to the mark corresponding to the dose of solution in millilitres (mL) prescribed by the doctor (Figure 4 c).
• Turn the bottle upright. Remove the dosing syringe from the adapter.
• Pressing on the plunger, empty the syringe by pouring the measured dose of solution into a glass of water or into the liquid in the child’s bottle (Figure 5).
• Give the child the medication 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 directed by the doctor.
• Do not discontinue treatment without consulting your doctor, as this may lead to an increased frequency of seizures. Accidental overdose of Levetiracetam Stada
  Following overdose of Levetiracetam Stada, somnolence, agitation, aggression,
  decreased level of consciousness, respiratory depression, and coma have been reported.
  If an overdose of Levetiracetam Stada has been taken, seek immediate medical advice. A doctor will determine the most appropriate treatment for overdose.
  Missed dose of Levetiracetam Stada
  Contact your doctor if one or more doses of the medication have been missed. Do not take a double dose to make up for a missed dose.
  Discontinuation of Levetiracetam Stada
  If treatment with Levetiracetam Stada is to be discontinued, the medicine should be withdrawn gradually to avoid increased frequency of epileptic seizures. If your doctor decides to discontinue treatment with Levetiracetam Stada, they will also advise you on how to taper the dose gradually.
  If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
You should immediately inform a 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 or throat (angioedema, Quincke's oedema);
• flu-like symptoms and rash on the face, followed by a rash spreading over the entire body, accompanied by high fever, increased liver enzyme activity observed 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 reduced urine output, fatigue, nausea, vomiting, confusion, and swelling of the feet, ankles or legs, as these may indicate sudden worsening of kidney function;
• skin rash, which may lead to blistering and appear as small target-like lesions (a dark center surrounded by a lighter area and a dark ring around it) (erythema multiforme);
• extensive rash with blisters and peeling skin, mainly affecting the area around the mouth, eyes, nose and genitals (Stevens-Johnson syndrome);
• a more severe form of rash causing skin detachment from over 30% of the body surface (toxic epidermal necrolysis);
• signs of serious mental disturbances, or if you notice symptoms of disorientation, drowsiness, memory loss (amnesia), memory impairment (forgetfulness), behavioural disturbances, or other neurological symptoms including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most commonly reported adverse reactions are: inflammation of the mucous membranes of the nose and throat, somnolence, headache, fatigue and dizziness. At the beginning of treatment or when the dose is increased, adverse reactions such as somnolence, fatigue or dizziness may occur more frequently. The intensity of these symptoms usually decreases over time.

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

• inflammation of the mucous membranes of the nose and throat;
• somnolence, headache.

Common (may affect less than 1 in 10 people):

• loss of appetite;
• depression, feeling of hostility or aggression, anxiety, insomnia, nervousness or irritability;
• seizures, balance disorders, dizziness (feeling of swaying), lethargy (lack of energy and motivation), tremor (involuntary shaking);
• vertigo (spinning sensation);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• rash;
• asthenia/fatigue.

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

• decreased platelet count; decreased white blood cell count;
• weight decrease, weight increase;
• suicidal thoughts and suicide attempts, mental disorders, abnormal behaviour, hallucinations, feeling of anger, disorientation, panic attacks, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory disorders (forgetfulness), ataxia (impaired coordination of movement), paresthesia (tingling), difficulty concentrating;
• double vision, blurred vision;
• elevated/abnormal liver function test results;
• hair loss, acne, 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), angioedema (swelling of the face, lips, tongue and throat);
• decreased sodium concentration in the blood;
• suicide, personality disorders (behavioural disturbances), thought disorders (slow thinking, inability to concentrate);
• delirium;
• encephalopathy (a detailed description of symptoms is provided in the section "You should immediately inform a doctor");
• seizures may worsen or occur more frequently;
• involuntary muscle contractions of the head, trunk and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• change in heart rhythm (electrocardiographic examination);
• pancreatitis;
• liver function disorders, hepatitis;
• sudden worsening of kidney function;
• skin rash, which may lead to blistering and appear as small target-like lesions (a dark center surrounded by a lighter area and a dark ring around it) (erythema multiforme), extensive rash with blisters and peeling skin, mainly affecting the area around the mouth, eyes, nose and genitals (Stevens-Johnson syndrome), and a severe form of rash causing skin detachment from over 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of striated muscles) and associated increase in creatine kinase activity in the blood. Occurrence is significantly more frequent in Japanese patients compared to other (non-Japanese) patients.
• limping or difficulty walking.

Reporting of adverse reactions

If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, you should inform a doctor or pharmacist.

Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Levetiracetam Stada

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

6. Contents of the pack and other information

What Levetiracetam Stada contains

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

What Levetiracetam Stada looks like and contents of the pack
Levetiracetam Stada 100 mg/mL oral solution is a clear liquid.
A glass bottle containing 300 mL of Levetiracetam Stada oral solution (for use in children from 4 years of age, adolescents and adults), presented in a cardboard box with a 10 mL oral syringe (graduated in 0.25 mL increments) and a syringe connector.
A glass bottle containing 150 mL of Levetiracetam Stada oral solution (for use in infants and children from 6 months up to below 4 years of age), presented in a cardboard box with a 3 mL oral syringe (graduated in 0.1 mL increments) and a syringe connector.
A glass bottle containing 150 mL of Levetiracetam Stada oral solution (for use in infants from 1 month up to below 6 months of age), presented in a cardboard box with a 1 mL oral syringe (graduated in 0.05 mL increments) and a syringe connector.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20