Levetiracetam Zentiva: detailed information

Levetiracetam Zentiva 500 mg film-coated tablets
Levetiracetam Zentiva 1000 mg film-coated tablets
Equivalent medicine
Please read this leaflet carefully before taking this medicine, as 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, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Levetiracetam Zentiva is an antiepileptic medicine (a medicine used to treat epileptic seizures).
Levetiracetam Zentiva 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 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 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 from one month of age;
- 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;
- 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 (a type of epilepsy believed to have a genetic cause).

2. What you need to know before taking Levetiracetam Zentiva

Do not take Levetiracetam Zentiva:

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 Zentiva

If you have kidney problems, follow your doctor's instructions. Your doctor may decide whether the dose needs to be adjusted.
If you notice a slowing in your child's growth or unexpected onset of puberty, contact your doctor.
A small number of people taking antiepileptic medicines such as Levetiracetam Zentiva have experienced suicidal thoughts or self-harming thoughts. If you experience any symptoms of depression and/or have suicidal thoughts, contact your doctor.

Children and adolescents

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

Other medicines and Levetiracetam Zentiva
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.
Taking Levetiracetam Zentiva with food, drinks and alcohol
You may take levetiracetam with or without food. You may experience a bitter taste after administration. As a precautionary safety measure, do not take levetiracetam with alcohol.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, 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. Do not stop your treatment without discussing it with your doctor. The risk of birth defects for the unborn child cannot be completely ruled out.
Breastfeeding is not recommended during treatment.
Driving and using machines
Levetiracetam may impair your ability to drive or use tools or machinery, as levetiracetam may cause drowsiness. This is more likely at the beginning of treatment or after an increase in dose. Do not drive or operate machinery until you know how this medicine affects your ability to perform these activities.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

3. How to take Levetiracetam Zentiva

Take this medicine exactly as your doctor has instructed you. If you have any doubts,
consult your doctor or pharmacist.
Levetiracetam Zentiva must be taken twice daily, with half of the daily dose taken in the
morning and half in the evening, approximately at the same time each day.
Take the number of tablets as directed by your doctor.
Monotherapy
Dose for adults and adolescents (from 16 years of age):
Usual therapeutic dose: between 1,000 mg and 3,000 mg daily.
When you first start taking levetiracetam, your doctor will prescribe a lower starting dose for the first 2 weeks before increasing to the usual lowest therapeutic dose.
Example: if your daily dose is 1,000 mg, your initial reduced dose is 2 tablets of 250 mg in the
morning and 2 tablets of 250 mg in the evening.
Adjunctive therapy
Dose for adults and adolescents (from 12 to 17 years of age) weighing 50 kg or more:
Usual therapeutic dose: between 1,000 mg and 3,000 mg daily.
Example: if your daily dose is 1,000 mg, you may take 2 tablets of 250 mg in the morning and 2
tablets of 250 mg in the evening.
Dose for infants (from 1 to 23 months), children (from 2 to 11 years) and adolescents (from 12 to 17 years) weighing less than 50 kg:
Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam depending on age, weight, and required dose.
The oral solution is the most suitable formulation for infants and children under 6 years of age, for children and adolescents (from 6 to 17 years) weighing less than 50 kg, and when tablets do not allow accurate dosing.
Method of administration
Swallow Levetiracetam Zentiva tablets with sufficient liquid (e.g. a glass of water).
Duration of treatment:

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

The score line on the tablet is intended to facilitate breaking the tablet if you have difficulty swallowing it whole.
If you take more Levetiracetam Zentiva than you should
Possible adverse effects of an overdose of levetiracetam include drowsiness, agitation,
aggressiveness, decreased attention, respiratory depression, and coma.
Consult your doctor if you have taken more tablets than prescribed. Your doctor will determine the most appropriate treatment for the overdose.
If you forget to take Levetiracetam Zentiva
Consult 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 Zentiva
If treatment is to be discontinued, as with any other antiepileptic medicine, levetiracetam should be withdrawn gradually to avoid an increase in seizures. If your doctor decides to stop treatment with levetiracetam, they will give you instructions on how to gradually discontinue the medication.
If you have any questions 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.
Immediately contact your doctor or go to the nearest emergency room if you experience:

weakness, dizziness or lightheadedness, or have difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic)
swelling of the face, lips, tongue, and throat (Quincke's oedema)
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 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 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 behaviour, or other neurological signs including involuntary or uncontrolled movements. These could be symptoms of encephalopathy. The most frequently reported side effects are: nasopharyngitis, drowsiness, 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, headache.

Common (may affect from 1 to 10 in 100 people):

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

Uncommon (may affect from 1 to 10 in 1,000 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 behaviour, hallucinations, anger, confusion, panic attacks, emotional lability/mood changes, 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)
injury.

Rare (may affect from 1 to 10 in 10,000 people):

infection
decreased number of all types of blood cells
severe allergic reactions (DRESS, anaphylactic reaction [severe and serious allergic reaction], Quincke's oedema [swelling of face, lips, tongue, and throat])
suicide, personality disorder (behavioural problems), thought disturbances (slowed thinking, inability to concentrate)
delirium
encephalopathy (see sub-section “Immediately contact your doctor” for a detailed description of symptoms)
uncontrollable muscle spasms involving the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity)
pancreatitis
liver failure, hepatitis
sudden decrease in kidney function
skin rashes, which may blister and appear as small spots (dark central spots surrounded by a pale area with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling over more than 30% of the body surface area (toxic epidermal necrolysis)
decreased sodium concentration in the blood
rhabdomyolysis (breakdown of muscle tissue) and associated increase in blood creatine phosphokinase levels. 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levetiracetam Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister 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 Zentiva contains
The active substance is levetiracetam.
Levetiracetam Zentiva 500 mg: each film-coated tablet contains 500 mg of levetiracetam.
Levetiracetam Zentiva 1000 mg: each film-coated tablet contains 1,000 mg of levetiracetam.
The other components are:
Tablet core:
Povidone 30, croscarmellose sodium, anhydrous colloidal silica, sodium stearyl fumarate.
Tablet coating:
Hypromellose 2910/5, macrogol 6000, talc, titanium dioxide (E-171), simeticone emulsion (purified water 67.4%, simeticone 30.0%, methylcellulose 2.5%, sorbic acid 0.1%).
Levetiracetam Zentiva 500 mg also contains yellow iron oxide (E-172).

Description of the appearance of Levetiracetam Zentiva and package contents
Levetiracetam Zentiva 500 mg: yellow, film-coated, elongated tablet, approximately 16.1 mm in length and 7.6 mm in width, scored on both sides.
Levetiracetam Zentiva 1000 mg: white to off-white, film-coated, elongated tablet, approximately 19.1 mm in length and 10.1 mm in width, scored on both sides.
The score line is intended to facilitate breaking the tablet if you have difficulty swallowing it whole.
Levetiracetam Zentiva 500 mg and 1000 mg is packaged in PVC/Al blisters containing 20, 30, 60, 100, or 200 tablets.
This corresponds to 2, 3, 6, 10, or 20 blisters, each containing 10 tablets in a box.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva Italia S.r.l.
Viale L. Bodio, 37/B
20158 Milano, Italy

Manufacturer
Zentiva k.s.
U Kabelovny 130, Dolní Měcholupy - 10237 Prague 10
Czech Republic

This medicinal product is authorized in the European Economic Area member states under the
following names:
Estonia, Italy, Portugal, United Kingdom, Spain, Belgium, Luxembourg: Levetiracetam Zentiva.