Levetiracetam EG: detailed information

Patient Information Leaflet

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

Generic medicine
Please read all of this leaflet carefully before you or your child starts taking 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 others, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Levetiracetam is an antiepileptic medicine (a medicine used to treat epileptic seizures).
LEVETIRACETAM EG 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. Levetiracetam is used for the type of epilepsy in which the seizure starts in only one part 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.
as an add-on to other antiepileptic medicines to treat:
- partial seizures with or without secondary generalization in adults, adolescents, children and infants from one month of age;
- myoclonic seizures (brief, shock-like muscle jerks of a muscle or group of muscles) in adults and adolescents aged 12 years and older with Juvenile Myoclonic Epilepsy;
- primary generalized tonic-clonic seizures (grand mal 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

Do not take Levetiracetam EG

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

if you have kidney problems, follow your doctor's instructions. Your doctor may decide whether your dose needs to be adjusted;
if you notice slowed growth or unexpected onset of puberty in your child, contact your doctor;
a small number of people taking antiepileptic medicines such as LEVETIRACETAM EG have had suicidal thoughts or thoughts about harming themselves. 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 or your family and friends notice the onset of significant changes in mood or behaviour.
Worsening of epilepsy Seizures may rarely worsen or occur more frequently, mainly during the first month after starting treatment or increasing the dose. If you experience any of these new symptoms while taking LEVETIRACETAM EG, consult a doctor as soon as possible.

Children and adolescents
LEVETIRACETAM EG used alone (monotherapy) is not indicated in children and adolescents under 16 years of age.
Other medicines and Levetiracetam EG
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) within one hour before or one hour after taking
levetiracetam, as it may reduce the effectiveness of levetiracetam.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
LEVETIRACETAM EG may be used during pregnancy only if, after careful evaluation, your doctor considers it necessary.
Do not stop your treatment without discussing it with 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 may reduce your ability to drive or operate tools or machinery
because 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.
LEVETIRACETAM EG 750 mg film-coated tablets contain sunset yellow FCF (E110)
The colouring agent sunset yellow FCF (E110) may cause allergic reactions.

3. How to take Levetiracetam EG

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Take the number of tablets as instructed by your doctor.
LEVETIRACETAM EG must be taken twice daily, once in the morning and once in the evening, approximately at the same time each day.

Adjunctive therapy and monotherapy (from age 16 onwards)

Adults (≥ 18 years) and adolescents (12 to 17 years) weighing 50 kg or more: Recommended dose: between 1000 mg and 3000 mg daily. When you first start taking LEVETIRACETAM EG, your doctor will prescribe a lower dose for 2 weeks before increasing to the lowest recommended dose. Example: if your daily dose is to be 1000 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 1000 mg daily 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 EG 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.

An oral solution formulation is more appropriate for neonates and children under 6 years of age, and for children and adolescents (6 to 17 years) weighing less than 50 kg, or when tablets do not allow accurate dosing.

Method of administration:
Swallow LEVETIRACETAM EG tablets with a sufficient amount of liquid (e.g. a glass of water). You may take LEVETIRACETAM EG with or without food. After oral administration, you may experience a bitter taste of levetiracetam.

Duration of treatment:

LEVETIRACETAM EG is used as a chronic treatment. Treatment with LEVETIRACETAM EG should continue for as long as prescribed by your doctor.
Do not stop treatment without consulting your doctor: your seizures may increase.

If you take more Levetiracetam EG than you should
Possible adverse effects of an overdose of LEVETIRACETAM EG include drowsiness, agitation, aggression, decreased attention, respiratory depression, and coma.
Contact your doctor immediately if you have taken more tablets than prescribed. Your doctor will determine the most appropriate treatment for overdose.

If you forget to take Levetiracetam EG
Contact your doctor if you have forgotten to take one or more doses.
Do not take a double dose to make up for the missed dose.

If you stop taking Levetiracetam EG
If treatment is to be discontinued, LEVETIRACETAM EG must be gradually withdrawn to avoid an increase in seizures.
If your doctor decides to discontinue treatment with LEVETIRACETAM EG, they will provide you with instructions for gradual discontinuation.

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 everybody gets them.
Inform your doctor immediately or go to the nearest emergency room if you experience:

weakness, dizziness or lightheadedness, or if you have difficulty breathing, as these may be signs of a severe allergic (anaphylactic) reaction;
swelling of the face, lips, tongue, and throat (angioedema);
flu-like symptoms and facial rash 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 worsening of kidney function;
a skin rash which may present as blistering lesions resembling small targets (dark spots in the center surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome);
a more severe form of rash causing skin peeling affecting more than 30% of the body surface area (toxic epidermal necrolysis);
signs of serious mental disturbances, or if someone around you notices confusion, drowsiness, amnesia (memory loss), memory impairment (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, somnolence, headache, fatigue, and dizziness. At the beginning of treatment or when the dose is increased, side effects such as somnolence, 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;
somnolence (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 disorders, dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
vertigo (sensation of spinning);
cough;
abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea;
skin 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;
weight loss, weight gain;
suicide attempt and suicidal thoughts, mental disorder, abnormal behavior, hallucinations, anger, confusion, panic attacks, emotional instability/mood swings, agitation;
amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordination of movement), paresthesia (tingling), attention disorders (loss of concentration);
diplopia (double vision), blurred vision;
elevated/abnormal liver function test results;
hair loss, eczema, pruritus (itching);
muscle weakness, myalgia (muscle pain);
trauma (injuries).

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

infections;
reduction in the number of all types of blood cells;
severe allergic reactions (DRESS, anaphylactic reaction [severe and significant allergic reaction], angioedema [swelling of face, lips, tongue, and throat]);
reduced sodium concentration in the blood;
suicide, personality disorders (behavioral problems), abnormal thoughts (slowed thinking, inability to concentrate);
delirium;
encephalopathy (see the subsection “Inform 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);
changes in heart rhythm (electrocardiogram abnormalities);
pancreatitis;
liver failure, hepatitis;
sudden decrease in kidney function;
skin rash, which may blister and appear as small targets (dark spots in the center surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), widespread rash with blisters and skin peeling, especially 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 area (toxic epidermal necrolysis);
rhabdomyolysis (breakdown of muscle tissue) and associated increase in serum 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 effect, 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levetiracetam EG

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

6. Contents of the Pack and Other Information

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

The other components are:
Tablet core: microcrystalline cellulose, copovidone, anhydrous colloidal silica, magnesium stearate.
Tablet coating:
LEVETIRACETAM EG 250 mg film-coated tablets
Opadry II blue, composed of: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, indigo carmine
aluminium lake (E132).
LEVETIRACETAM EG 500 mg film-coated tablets
Opadry II yellow, composed of: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide
yellow (E172).
LEVETIRACETAM EG 750 mg film-coated tablets
Opadry II orange, composed of: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, sunset yellow
FCF aluminium lake (E110), iron oxide red (E172).
LEVETIRACETAM EG 1000 mg film-coated tablets
Opadry II white, composed of: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

Description of the appearance of Levetiracetam EG and contents of the pack
LEVETIRACETAM EG 250 mg film-coated tablets are blue, oblong, biconvex, film-coated tablets with a breakline
on one side and an approximate length of 12.8 mm. The tablet can be divided into equal doses.
LEVETIRACETAM EG 500 mg film-coated tablets are yellow, oblong, biconvex, film-coated tablets with a breakline
on one side and an approximate length of 16.4 mm. The tablet can be divided into equal doses.
LEVETIRACETAM EG 750 mg film-coated tablets are salmon-coloured, oblong, biconvex, film-coated tablets with
a breakline on one side and an approximate length of 18.6 mm. The score line is intended to facilitate breaking
the tablet for easier swallowing and is not intended to divide the tablet into equal doses.
LEVETIRACETAM EG 1000 mg film-coated tablets are white, oblong, biconvex, film-coated tablets with a breakline
on one side and an approximate length of 19.1 mm. The score line is intended to facilitate breaking the tablet
for easier swallowing and is not intended to divide the tablet into equal doses.

LEVETIRACETAM EG film-coated tablets are available in PVC/aluminum blisters.
The blisters of LEVETIRACETAM EG 250 mg film-coated tablets contain 30, 50, 60, 100 or 200 tablets.
The blisters of LEVETIRACETAM EG 500 mg film-coated tablets contain 5, 30, 50, 60, 100 or 200 tablets.
The blisters of LEVETIRACETAM EG 750 mg film-coated tablets contain 30, 50, 60, 100 or 200 tablets.
The blisters of LEVETIRACETAM EG 1000 mg film-coated tablets contain 5, 30, 50, 60, 100 or 200 tablets.
Not all pack sizes may be marketed.

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

Manufacturer
STADA Arzneimittel AG, Stadastr. 2-18, 61118 Bad Vilbel - Germany
Lamp San Prospero S.p.A., Via della Pace, 25/A 41030 San Prospero (Modena) - Italy

This medicinal product is authorized in the European Economic Area countries under the following names:
Germany: Levetiracetam AL 250/500/750/1000 mg Film Tablets
Italy: Levetiracetam EG 250/500/750/1000 mg film-coated tablets