Levetiracetam Doc Generici: detailed information

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Package leaflet: information for the patient

LEVETIRACETAM DOC Generics 500 mg film-coated tablets, 750 mg film-coated tablets, 1,000 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before you or your child starts 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 others, even if their symptoms are the same as yours, as 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 DOC Generics is and what it is used for
What you need to know before taking LEVETIRACETAM DOC Generics
How to take LEVETIRACETAM DOC Generics
Possible side effects
How to store LEVETIRACETAM DOC Generics
Contents of the pack and other information

1. What LEVETIRACETAM DOC Generics is and what it is used for

Levetiracetam is an antiepileptic medicine (a medicine used to treat epileptic seizures). LEVETIRACETAM DOC Generics 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 recurrent 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 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 your seizures.
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 group of muscles) 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 DOC Generics

Do not take LEVETIRACETAM DOC Generics:

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

Warnings and precautions
Talk to your doctor before taking LEVETIRACETAM DOC Generics

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 a child, contact your doctor.
A small number of people taking antiepileptic medicines such as LEVETIRACETAM DOC Generics have experienced self-harming thoughts or suicidal ideation. If you experience any symptoms of depression and/or have suicidal thoughts, contact your doctor.
If you or a family member has a cardiac arrhythmia (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 for
more 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. In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations), which causes multiple seizure types and loss of existing abilities, you may notice that seizures persist or worsen during treatment.

If you develop any of these new symptoms while taking
LEVETIRACETAM DOC Generics, consult a doctor as soon as possible.

Children and adolescents
LEVETIRACETAM DOC Generics used alone (monotherapy) is not indicated in children and
adolescents under 16 years of age.

Other medicines and LEVETIRACETAM DOC Generics
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) within one hour before or one hour after taking levetiracetam, as it may cause loss of effectiveness of levetiracetam.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you might be pregnant, or are planning to have a baby, consult your doctor 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.
A risk of birth defects in 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.

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Driving and using machines
LEVETIRACETAM DOC Generics may reduce your ability to drive vehicles 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 use machinery until you are certain that your ability to perform these activities is not impaired.

LEVETIRACETAM DOC Generics 750 mg film-coated tablets contain
sunset yellow aluminium lake (E110), which may cause allergic reactions.

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3. How to take LEVETIRACETAM DOC Generics

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
LEVETIRACETAM DOC Generics is not available in all the pharmaceutical forms described. For dosages not achievable with LEVETIRACETAM DOC Generics, other medicinal products containing levetiracetam should be used.
Take the number of tablets as instructed by your doctor.
LEVETIRACETAM DOC Generics 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 1,000 mg and 3,000 mg per day. When starting LEVETIRACETAM DOC Generics for the first time, your doctor will prescribe a lower dose for 2 weeks before increasing to the lowest daily 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 oral solution 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:
LEVETIRACETAM DOC Generics is for oral use. Swallow the tablets with a sufficient amount of liquid (e.g. a glass of water). You may take LEVETIRACETAM DOC Generics with or without food. After oral administration, you may experience a bitter taste of levetiracetam.

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Duration of treatment:

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

If you take more LEVETIRACETAM DOC Generics than you should
Possible adverse effects of an overdose of LEVETIRACETAM DOC Generics include drowsiness, agitation, aggression, decreased attention, respiratory depression, and coma.
Contact your doctor if you have taken more tablets than you should. Your doctor will determine the best management for overdose.

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

If you stop taking LEVETIRACETAM DOC Generics
If treatment needs to be discontinued, LEVETIRACETAM DOC Generics should be gradually withdrawn to avoid an increase in seizures. If your doctor decides to stop treatment with LEVETIRACETAM DOC Generics, they will provide you with instructions on how to gradually discontinue the medicine.

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 everyone gets them.
Contact your doctor immediately 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 (anaphylactic) reaction
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, and increased levels of a type of white blood cells (eosinophilia), swollen lymph nodes, and involvement of other organs (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 kidney dysfunction
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)
widespread skin rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
a more severe form of skin 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, amnesia (memory loss), impaired memory (forgetfulness), abnormal behaviour, or other neurological signs including involuntary or uncontrolled movements

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(these could be symptoms of encephalopathy).

The most frequently reported side effects are: rhinopharyngitis, 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 up to 1 in 10 people):

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

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
suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucinations, anger, confusion, panic attack, affective lability/mood swings, agitation
amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired motor coordination), paresthesia (tingling), attention disturbance (loss of concentration)
diplopia (double vision), blurred vision
elevated/abnormal results in liver function tests
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 oedema [swelling of the face, lips, tongue, and throat])
decreased concentration of sodium in the blood
suicide, personality disorder (behavioural problems), thought disturbances (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)

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change in heart rhythm (electrocardiogram abnormalities)
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), widespread skin 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 (toxic epidermal necrolysis)
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 gait or difficulty walking
combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, 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 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 DOC Generics

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 DOC Generics contains
The active substance is levetiracetam.
Each film-coated tablet of LEVETIRACETAM DOC Generics 500 mg contains 500 mg of levetiracetam.
Each film-coated tablet of LEVETIRACETAM DOC Generics 750 mg
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contains 750 mg of levetiracetam.
Each film-coated tablet of LEVETIRACETAM DOC Generics 1 000 mg contains 1 000 mg of levetiracetam.

The other components are:
Tablet core: crospovidone (type B), povidone K30, anhydrous colloidal silica, magnesium stearate.
Coating:
LEVETIRACETAM DOC Generics 500 mg:
hypromellose, macrogol 400, titanium dioxide (E171), talc, yellow iron oxide (E172).
LEVETIRACETAM DOC Generics 750 mg:
hypromellose, macrogol 400, titanium dioxide (E171), talc, sunset yellow aluminium lake (E110), red iron oxide (E172).
LEVETIRACETAM DOC Generics 1 000 mg:
hypromellose, macrogol 400, titanium dioxide (E171), talc.

Description of the appearance of LEVETIRACETAM DOC Generics and package contents
LEVETIRACETAM DOC Generics 500 mg: yellow film-coated oval tablet, with a breakline on one side, measuring 16.5 x 7.7 mm. The tablet can be divided into equal parts.
LEVETIRACETAM DOC Generics 750 mg: orange film-coated oval tablet, with a breakline on one side, measuring 18.8 x 8.9 mm. The tablet can be divided into equal parts.
LEVETIRACETAM DOC Generics 1 000 mg: white film-coated oval tablet, with a breakline on one side, measuring 19.2 x 10.2 mm. The tablet can be divided into equal parts.

The film-coated tablets are packaged in aluminium/PVC-PE-PVDC blisters and placed in cardboard boxes containing:
LEVETIRACETAM DOC Generics 500 mg: 60 film-coated tablets.
LEVETIRACETAM DOC Generics 750 mg: 30 film-coated tablets.
LEVETIRACETAM DOC Generics 1 000 mg: 30 film-coated tablets.

It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milano, Italy.

Manufacturers:

Pharos MT Limited, Hf62x, Qasam Industrijali Hal Far, BBG 3000 Hal Far, Birzebbuga, Malta.
Rontis Hellas Medical And Pharmaceutical Products S.A., Larissa Industrial Area, 41 500, Larissa, Greece.
PharOS Pharmaceutical Oriented Services Ltd., Lesvou Street End, Thesi Loggos Industrial

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Zone, 144 52, Metamorfossi, Greece.

This medicinal product is authorised in the European Economic Area Member States under the following names:
Germany: Levetiracetam Doc Generici 500 mg, 750 mg, 1 000 mg Filmtabletten.
Italy: LEVETIRACETAM DOC Generics.