Levetiracetam Doc Generici

Package leaflet: Information for the patient

LEVETIRACETAM DOC 500 mg film-coated tablets, 1000 mg film-coated tablets

Equivalent 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 other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What LEVETIRACETAM DOC is and what it is used for
2. What you need to know before taking LEVETIRACETAM DOC
3. How to take LEVETIRACETAM DOC
4. Possible side effects
5. How to store LEVETIRACETAM DOC
6. Contents of the pack and other information

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

Levetiracetam is an antiepileptic medicine (a medicine used to treat epileptic seizures).
LEVETIRACETAM DOC 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 in the type of epilepsy where the seizure initially 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). Levetiracetam has been prescribed by your doctor to reduce the number of 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 from 1 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 (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).

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2. What you need to know before taking LEVETIRACETAM DOC

Do not take LEVETIRACETAM DOC

• 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 DOC

• 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 a child, contact your doctor.
• A small number of people taking antiepileptic medicines such as LEVETIRACETAM DOC have experienced suicidal thoughts or self-harming thoughts. 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 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. If you experience any of these new symptoms while taking LEVETIRACETAM DOC, consult a doctor as soon as possible.

Children and adolescents
LEVETIRACETAM DOC as monotherapy is not indicated in children and adolescents under 16
years of age.
Other medicines and LEVETIRACETAM DOC
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 reduce the effectiveness of levetiracetam.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or 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. 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.
Breastfeeding is not recommended during treatment.
Driving and using machines
LEVETIRACETAM DOC 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 operate machinery until you are certain that your ability to perform these activities is not
impaired.
LEVETIRACETAM DOC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially ‘sodium-free’.

3. How to take LEVETIRACETAM DOC

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 DOC should 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: Typical dose: between 1000 mg and 3000 mg per day. When you first start taking LEVETIRACETAM DOC, your doctor will prescribe a lower dose for 2 weeks before increasing to the lowest typical dose. Example: if your daily dose should 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 less than or equal to 50 kg: Your doctor will prescribe the most appropriate pharmaceutical form of LEVETIRACETAM DOC based on weight and required dose.
• Dose for infants (1 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 DOC 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 LEVETIRACETAM DOC tablets with a sufficient amount of liquid (e.g., a glass of water). You may take LEVETIRACETAM DOC with or without food. After oral administration, you may experience a bitter taste of levetiracetam.
The score line on the tablet is intended to facilitate breaking the tablet if you have difficulty swallowing it whole. The score line is not designed for splitting the tablet. That is, if the tablet is divided to ease swallowing, both halves must be taken at the same time.

Duration of treatment:

• LEVETIRACETAM DOC 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 could increase the frequency of seizures.

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

If you forget to take LEVETIRACETAM DOC:
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 DOC:

• If treatment needs to be discontinued, LEVETIRACETAM DOC should be withdrawn gradually to avoid an increase in seizures. If your doctor decides to discontinue treatment with LEVETIRACETAM DOC, you will be given specific instructions on how to gradually stop taking it.

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 department 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 (angioedema)
• 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, increased levels of 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 kidney dysfunction
• a skin rash that may appear as blister-like lesions resembling small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
• a 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 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), memory impairment (forgetfulness), abnormal behaviour, or other neurological signs including involuntary or uncontrolled movements. These could be symptoms of encephalopathy.

The most commonly 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 frequent. 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 (sensation of unsteadiness), 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 thoughts, mental disorder, abnormal behaviour, hallucinations, anger, confusion, panic attack, affective lability/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 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 significant allergic reaction], angioedema [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 section “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)
• changes in heart rhythm (electrocardiogram)
• pancreatitis
• liver failure, hepatitis
• sudden decrease in kidney function
• skin rash that may appear as blister-like lesions resembling small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), a widespread skin 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 (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 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 DOC

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 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. Package contents and other information

What LEVETIRACETAM DOC contains
The active substance is called levetiracetam.
For 500 mg tablets: Each film-coated tablet of LEVETIRACETAM DOC 500 mg contains 500 mg of levetiracetam.
For 1000 mg tablets: Each film-coated tablet of LEVETIRACETAM DOC 1000 mg contains 1000 mg of levetiracetam.

The other components are:
Tablet core: povidone (K30), croscarmellose sodium, polyethylene glycol, colloidal anhydrous silica, magnesium stearate.

For 500 mg tablets: The 500 mg tablets are coated with Opadry II yellow 85F32004 containing: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), polyethylene glycol, talc, yellow iron oxide (E172).

For 1000 mg tablets: The 1000 mg tablets are coated with Opadry II white 85F18422 containing: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), polyethylene glycol, talc.

Description of the appearance of LEVETIRACETAM DOC and pack contents
For 500 mg tablets: LEVETIRACETAM DOC 500 mg film-coated tablets are yellow, oval-shaped, with a score line on one side and engraved "500" on the other side.
Available in PVC/Aclar-AL blisters containing 60 tablets.

For 1000 mg tablets: LEVETIRACETAM DOC 1000 mg film-coated tablets are white, oval-shaped, with a score line on one side and engraved "1000" on the other side.
Available in PVC/Aclar-AL blisters containing 30 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati, 40 – 20121 Milan – Italy.

Manufacturer:
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo 1 - 03012 Anagni (Frosinone) – Italy.

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