Levetiracetam Aurobindo: detailed information

Package leaflet: Information for the user

Levetiracetam Aurobindo 500 mg film-coated tablets, 1000 mg film-coated tablets

Generic medicine
Please read 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

as monotherapy in adults and adolescents from the age of 16 years with newly diagnosed epilepsy, to treat a specific type of epilepsy. Epilepsy is a condition in which patients have recurrent attacks (seizures). Levetiracetam is used for the type of epilepsy in which the initial seizure affects only one part of the brain but may subsequently spread to wider 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-onset seizures, with or without secondary generalization, in adults, adolescents, children and infants from 1 month of age;
myoclonic seizures (brief, shock-like spasms of a muscle or muscle group) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;
primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalized epilepsy (the type of epilepsy believed to have a genetic cause).

2. What you need to know before taking Levetiracetam Aurobindo

Do not take Levetiracetam Aurobindo

If you are allergic to levetiracetam, pyrrolidone derivatives, or any of the ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Levetiracetam Aurobindo:

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 development of puberty in the child, contact your doctor.
A small number of people taking antiepileptic medicines such as Levetiracetam Aurobindo have experienced self-harming thoughts or suicidal ideas. If you have any symptoms of depression and/or 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 heartbeat 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, mainly during the first month after starting treatment or increasing the dose. In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations), which causes multiple seizure types 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 Aurobindo,
consult a doctor as soon as possible.
Children and adolescents

Levetiracetam Aurobindo as monotherapy (used alone) is not indicated in children and adolescents under 16 years of age.

Other medicines and Levetiracetam Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines,
including those without a prescription.
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, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
Levetiracetam may be used during pregnancy only if, after careful evaluation, your doctor considers it
necessary. You should 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 Aurobindo 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 should not drive or
use machinery until you are sure that your ability to perform these activities is not impaired.

3. How to take Levetiracetam Aurobindo

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Take the number of tablets as instructed by your doctor.
Levetiracetam Aurobindo should be taken 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:
Recommended dose: between 1000 mg and 3000 mg per day.
When you first start taking Levetiracetam Aurobindo, your doctor will prescribe a lower dose for 2 weeks before increasing to your lowest daily 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 per day after 2 weeks.

Adolescents (12 to 17 years) weighing 50 kg or less:
Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Aurobindo 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 of levetiracetam 100 mg/mL is the most suitable 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 accurate dosing.

Method of administration:
Swallow the Levetiracetam Aurobindo tablets with a sufficient amount of liquid (e.g. a glass of water).
You may take Levetiracetam Aurobindo with or without food. After oral administration, a bitter taste of levetiracetam may be perceived.

Duration of treatment:

Levetiracetam Aurobindo is used as a chronic treatment. Treatment with Levetiracetam Aurobindo 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 Aurobindo than you should:
Possible adverse effects of an overdose of Levetiracetam Aurobindo 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 best management for the overdose.

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

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

If you have any questions about the use of 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.
Immediately contact your doctor or go to the nearest emergency room if you experience:

Weakness, feeling faint or dizzy, or if you have difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic reaction)
Swelling of the face, lips, tongue, or throat (angioedema / Quincke's edema)
Flu-like symptoms and a rash on the face followed by a widespread rash with high fever, increased liver enzyme levels observed in blood tests, increase in a type of white blood cells (eosinophilia), swollen lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms [DRESS])
Symptoms such as reduced urine volume, fatigue, nausea, vomiting, confusion, and swelling of legs, ankles, or feet, as these may indicate sudden reduction in kidney function
Skin rash which may present as blisters appearing like 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 rash causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis)
Signs of serious mental disturbances, or if someone around you notices confusion, drowsiness (lethargy), 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, 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;
convulsion, balance disorder, dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), and tremor (involuntary shaking);
vertigo (spinning sensation);
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 ideation, mental disorder, abnormal behavior, hallucinations, rage, confusion, panic attack, emotional instability / mood swings, agitation;
amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination / ataxia (impaired motor coordination), paresthesia (tingling), attention disturbance (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.

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 significant allergic reaction], angioedema [swelling of face, lips, tongue, and throat]);
decreased concentration of sodium in the blood (hyponatremia);
suicide, personality disorders (behavioral problems), thought disturbance (slowed thinking, inability to concentrate);
delirium;
encephalopathy (see the subsection "Immediately contact your doctor" 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);
change in heart rhythm (electrocardiogram abnormalities);
pancreatitis;
liver failure, hepatitis;
sudden reduction in kidney function;
skin rash which may present as blisters appearing like 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 over more than 30% of 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;
combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, and reduced level of consciousness (may be signs of a disorder 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

repetitive unwanted thoughts or urges to perform actions repeatedly (obsessive-compulsive disorder).

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 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 Aurobindo

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister pack, and label of the bottle after 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 Aurobindo contains
The active substance is called levetiracetam. Each film-coated tablet contains 500 mg or 1000 mg of
levetiracetam.
The other components are:
Tablet core: Maize starch, Anhydrous colloidal silica (E551), Povidone (K-30) (E1201), Talc (E553b), Magnesium stearate (E470b).
Film coating:
500 mg: Hypromellose 3cp & 6cp (E464), Titanium dioxide (E 171), Macrogol 4000, Iron oxide yellow (E 172).
1000 mg: Hypromellose 5cp (E464), Titanium dioxide (E 171), Macrogol 400.

Description of the appearance of Levetiracetam Aurobindo and contents of the pack
Film-coated tablet.
Levetiracetam Aurobindo 500 mg film-coated tablets
The film-coated tablets are yellow, oval-shaped, biconvex, engraved with a deep breakline separating “E” and “11” on one side and flat on the other side. The tablet can be divided into two equal parts.
Levetiracetam Aurobindo 1000 mg film-coated tablets
The film-coated tablets are white, modified oval-shaped, biconvex, engraved with a breakline separating “E” and “13” on one side and flat on the other side. The tablet can be divided into two equal parts.
Levetiracetam Aurobindo tablets are packaged in blisters or HDPE bottles.
Pack sizes:
Blister packs: 20, 30, 50, 60, 100, 200 and 500 film-coated tablets.
HDPE bottle: 30, 100, 200 and 500 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102
21047 - Saronno (VA)
Italy

Responsible manufacturer for batch release
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta
Generis Farmaceutica S.A.
Rua João de Deus, n. 19,
Venda Nova, 2700-487, Amadora
Portugal

This medicinal product is authorized in the European Economic Area countries under the following names:
France: Levetiracetam Arrow Lab 250 mg/500 mg/1000 mg, comprimé pelliculé sécable
Germany: Levetiracetam Aurobindo 250 mg/500 mg/750 mg/1000 mg Filmtabletten
Italy: Levetiracetam Aurobindo
Netherlands: Levetiracetam Aurobindo 250 mg/500 mg/750 mg/1000 mg, filmomhulde tabletten
Poland: Levetiracetam Aurovitas
Romania: Levetiracetam Aurobindo 250 mg/500 mg/1000 mg comprimat filmate