Levetiracetam Eg Stada: detailed information

Package leaflet: Information for the patient

LEVETIRACETAM EG STADA 250 mg film-coated tablets, 500 mg film-coated tablets, 750 mg film-coated tablets, 1000 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before you or your child takes this medicine because
it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What LEVETIRACETAM EG STADA is and what it is used for
What you need to know before taking LEVETIRACETAM EG STADA
How to take LEVETIRACETAM EG STADA
Possible side effects
How to store LEVETIRACETAM EG STADA
Contents of the pack and other information

1. What LEVETIRACETAM EG STADA is and what it is used for

Levetiracetam is an antiepileptic medicine (a medicine used to treat epileptic seizures).
LEVETIRACETAM EG STADA is used:

as monotherapy in adults and adolescents aged 16 years and older with newly diagnosed epilepsy, to treat a certain type of epilepsy. Epilepsy is a condition in which patients have repeated seizures (convulsions). Levetiracetam is used for that form of epilepsy in which seizures initially involve only one side of the brain, but may subsequently spread to broader areas on both sides of the brain (partial-onset seizures with or without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures (epileptic attacks) you experience;
as add-on therapy to other antiepileptic medicines to treat:
- partial-onset seizures, with or without secondary generalization, in adults, adolescents, children, and infants aged 1 month and older;
- myoclonic seizures (brief, shock-like jerks of a muscle or muscle group) in adults and adolescents aged 12 years and older with juvenile myoclonic epilepsy;
- primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents aged 12 years and older with idiopathic generalized epilepsy (the type of epilepsy believed to have a genetic cause).

2. What you need to know before taking LEVETIRACETAM EG STADA

Do not take LEVETIRACETAM EG STADA:

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 EG STADA.

If you have kidney problems, follow your doctor's instructions. Your doctor may decide whether the dose needs to be adjusted.
If you notice slowed growth or unexpected onset of puberty in the child, contact your doctor.
A small number of patients treated with antiepileptic medicines such as LEVETIRACETAM EG STADA have reported suicidal thoughts or self-harming behaviour. If you experience any symptoms of depression and/or have suicidal thoughts, contact your doctor.
If you or a family member has a heart rhythm disorder (visible on electrocardiogram), or if you have a disease and/or are taking medicines that may cause irregular heartbeats or electrolyte imbalances.

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

Unusual thoughts, feeling irritable, or more aggressive reactions than usual, or if you, your family, or friends notice significant changes in mood or behaviour.
Worsening of epilepsy. Seizures may rarely worsen or occur more frequently, especially during the first month after starting treatment or increasing the dose. If you experience any of these new symptoms during treatment with LEVETIRACETAM EG STADA, consult a doctor as soon as possible.

Children and adolescents
LEVETIRACETAM EG STADA as monotherapy is not indicated in children and adolescents under 16 years of age.
Other medicines and LEVETIRACETAM EG STADA
Inform 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) one hour before or one hour after taking
levetiracetam, as it may cause a loss of effectiveness of levetiracetam.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, please
consult your doctor before taking this medicine. Levetiracetam may be used during pregnancy only if, after
careful evaluation by your doctor, it is considered clinically necessary.
You must not stop your treatment without consulting your doctor. A risk of birth defects for the unborn child
cannot be completely ruled out. 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 impact of levetiracetam on children's neurological development are limited.
Breastfeeding is not recommended during treatment.
Driving and using machines
LEVETIRACETAM EG STADA may reduce your ability to drive or use tools or machinery, as it may cause drowsiness. This is more likely at the beginning of treatment or after a dose increase. You must not drive or operate machinery until you are certain that your ability to perform these activities is not affected.
750 mg
LEVETIRACETAM EG STADA contains the colouring agent Sunset Yellow aluminium lake (E110), which
may cause allergic reactions.

3. How to take LEVETIRACETAM EG STADA

Take this medicine exactly as your doctor or pharmacist has told you. If you are
unsure, consult your doctor or pharmacist.
LEVETIRACETAM EG STADA is not available in all the pharmaceutical forms described. For dosages
that cannot be achieved with LEVETIRACETAM EG STADA, other medicinal products containing
levetiracetam should be used.
Take the number of tablets as instructed by your doctor.
Take LEVETIRACETAM EG STADA twice daily, once in the morning and once in the evening,
approximately at the same time each day.
Adjunctive and monotherapy (from age 16 onwards)

Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more: Typical dose: between 1,000 mg and 3,000 mg per day. When you first start taking LEVETIRACETAM EG STADA, your doctor will prescribe a lower starting dose for 2 weeks before increasing to the typical lowest dose. Example: if your daily dose is to be 1,000 mg, your initial reduced dose is 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening, and the dose will be gradually increased to reach 1,000 mg per day after 2 weeks.
Adolescents (12 to 17 years) weighing less than or equal to 50 kg: Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam based on weight and required dose.
Dose for infants (1 month to 23 months) and children (2 to 11 years) weighing less than 50 kg: Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam based on age, weight, and required dose.

Levetiracetam 100 mg/ml oral solution is the most appropriate formulation for infants and children
under 6 years of age, for children and adolescents (6 to 17 years) weighing less than 50 kg, and
when tablets do not allow for accurate dosing.
Method of administration
LEVETIRACETAM EG STADA is for oral use.
Swallow the tablets with a sufficient amount of liquid (e.g. a glass of water).
LEVETIRACETAM EG STADA may be taken independently of food. After oral administration,
you may experience a bitter taste of levetiracetam.
Duration of treatment

LEVETIRACETAM EG STADA is used as a chronic treatment. Treatment with LEVETIRACETAM EG STADA should continue for as long as prescribed by your doctor.
Do not stop treatment without consulting your doctor, as this could increase the frequency of seizures.

If you take more LEVETIRACETAM EG STADA than you should
Possible adverse effects of an overdose of LEVETIRACETAM EG STADA include drowsiness,
agitation, aggression, reduced attention, respiratory depression, and coma.
Contact your doctor if you have taken more LEVETIRACETAM EG STADA than you should. Your doctor
will determine the most appropriate treatment for the overdose.
If you forget to take LEVETIRACETAM EG STADA
Contact your doctor if you have forgotten to take one or more doses.
Do not take a double dose to make up for a forgotten dose.
If you stop taking LEVETIRACETAM EG STADA
If treatment with LEVETIRACETAM EG STADA needs to be discontinued, it should be
gradually withdrawn to avoid an increase in seizures. If your doctor decides to stop treatment
with LEVETIRACETAM EG STADA, they will provide you with instructions on how to gradually discontinue
LEVETIRACETAM EG STADA.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Contact your doctor immediately or go to the nearest emergency room if you experience:

weakness, feeling dizzy or lightheaded, or have difficulty breathing, as these may be signs of a severe allergic (anaphylactic) reaction;
swelling of the face, lips, tongue, and throat (Quincke's edema);
flu-like symptoms and rash on the face followed by widespread rash with high fever, increased liver enzyme levels observed in blood tests, increase in a type of white blood cells (eosinophilia), and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms [DRESS, Drug Reaction with Eosinophilia and Systemic Symptoms]);
symptoms such as reduced urine volume, fatigue, nausea, vomiting, confusion, and swelling of legs, ankles, or feet, as these may indicate sudden decrease in kidney function;
a skin rash that may appear as blisters resembling small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
a widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome);
a more severe form of skin rash causing skin peeling affecting more than 30% of the body surface (toxic epidermal necrolysis);
signs of serious mental disturbances, or if someone around you notices confusion, drowsiness, amnesia (memory loss), impaired memory (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrolled movements. These could be symptoms of encephalopathy.

The most frequently reported side effects are nasopharyngitis, drowsiness (somnolence), headache, fatigue, and dizziness. At the beginning of treatment or when the dose is increased, side effects such as drowsiness, fatigue, and dizziness may be more common. However, these effects should decrease over time.
Very common (may affect more than 1 in 10 people):

nasopharyngitis;
drowsiness (somnolence), headache.

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

anorexia (loss of appetite);
depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
seizure, balance disorder, dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
vertigo (spinning sensation);
cough;
abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea;
rash;
asthenia/fatigue (tiredness).

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

decreased number of platelets in the blood, decreased number of white blood cells in the blood;
weight loss, weight gain;
suicidal attempt and suicidal ideation, mental disorder, abnormal behavior, hallucinations, anger, confusion, panic attack, affective lability/mood swings, agitation;
amnesia (memory loss), impaired memory (forgetfulness), abnormal coordination/ataxia (impaired motor coordination), paresthesia (tingling), attention disturbance (loss of concentration);
diplopia (double vision), blurred vision;
elevated or abnormal liver function test results;
hair loss, eczema, pruritus (itching);
muscle weakness, myalgia (muscle pain);
trauma.

Rare (may affect up to 1 in 1,000 people):

infection;
decreased number of all types of blood cells;
severe allergic reactions (DRESS, anaphylactic reaction [severe and serious allergic reaction], Quincke's edema [swelling of the face, lips, tongue, and throat]);
decreased concentration of sodium in the blood;
suicide, personality disorder (behavioral problems), thought disorders (slowed thinking, inability to concentrate);
delirium;
encephalopathy (see the subsection "Contact your doctor immediately" for a detailed description of symptoms);
seizures may worsen or occur more frequently;
uncontrollable muscle spasms involving the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
alteration in heart rhythm (electrocardiogram);
pancreatitis;
liver failure, hepatitis;
sudden decrease in kidney function;
skin rash that may appear as blisters resembling small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling affecting more than 30% of the body surface (toxic epidermal necrolysis);
rhabdomyolysis (breakdown of muscle tissue) and associated increase in blood creatine phosphokinase. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
limping or difficulty walking.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store LEVETIRACETAM EG STADA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging or on the blister after the wording “EXP.”
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What LEVETIRACETAM EG STADA contains
The active substance is levetiracetam.
Each film-coated tablet of LEVETIRACETAM EG STADA 250 mg contains 250 mg of levetiracetam.
Each film-coated tablet of LEVETIRACETAM EG STADA 500 mg contains 500 mg of levetiracetam.
Each film-coated tablet of LEVETIRACETAM EG STADA 750 mg contains 750 mg of levetiracetam.
Each film-coated tablet of LEVETIRACETAM EG STADA 1000 mg contains 1000 mg of levetiracetam.

The other components are:
Tablet core:
Crospovidone (Type B), Povidone K30, anhydrous colloidal silica, magnesium stearate.

Tablet coating:
250 mg:
Hypromellose, macrogol 400, titanium dioxide (E171), talc; indigo carmine, aluminium lake (E132).
500 mg:
Hypromellose, macrogol 400, titanium dioxide (E171), talc, yellow iron oxide (E172).
750 mg:
Hypromellose, macrogol 400, titanium dioxide (E171), talc, Sunset Yellow, aluminium lake (E110), red iron oxide (E172).
1000 mg:
Hypromellose, macrogol 400, titanium dioxide (E171), talc.

Description of the appearance of LEVETIRACETAM EG STADA and contents of the pack
250 mg: Film-coated oval tablets, blue in colour, with a score line on one side and measuring 12.9 x 6.1 mm. The tablet can be divided into equal doses.
500 mg: Film-coated oval tablets, yellow in colour, with a score line on one side and measuring 16.5 x 7.7 mm. The tablet can be divided into equal doses.
750 mg: Film-coated oval tablets, orange in colour, with a score line on one side and measuring 18.8 x 8.9 mm. The tablet can be divided into equal doses.
1000 mg: Film-coated oval tablets, white in colour, with a score line on one side and measuring 19.2 x 10.2 mm. The tablet can be divided into equal doses.

The film-coated tablets are packaged in Al/PVC-PE-PVDC blisters placed in cardboard boxes containing:
LEVETIRACETAM EG STADA 250 mg is available in cardboard packs containing 50, 100 and 200 film-coated tablets.
LEVETIRACETAM EG STADA 500 mg is available in cardboard packs containing 50, 60, 100 and 200 film-coated tablets.
LEVETIRACETAM EG STADA 750 mg is available in cardboard packs containing 50, 100 and 200 film-coated tablets.
LEVETIRACETAM EG STADA 1000 mg is available in cardboard packs containing 30, 50, 100 and 200 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., Via Pavia 6, 20136 Milano, Italy

Manufacturers
Rontis Hellas Medical and Pharmaceutical Products S.A., P.O. Box 3012 Larisa Industrial Area Larisa 41004 - Greece
PharOS MT Ltd, HF 62X, Hal-Far Industrial Estate Birzebbugia BBG3000 - Malta
STADA Arzneimittel AG, Stadastrasse 2 – 18, 61118 Bad Vilbel - Germany