Patient Information Leaflet

Unipitiram 1500 mg film-coated tablets

Levetiracetam
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 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Unipitiram is and what it is used for

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

as monotherapy in adults and adolescents aged 16 years and older with newly diagnosed epilepsy, to treat a specific type of epilepsy. Epilepsy is a condition in which patients experience 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-onset seizures, with or without generalization, in adults, adolescents, and children aged 6 years 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 (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 Unipitiram

Do not take Unipitiram:

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 Unipitiram

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

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 than usual, or if you or your family or friends notice the onset of 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 Keppra, consult a doctor as soon as possible.

Children and adolescents
Unipitiram as monotherapy (used alone) is not indicated in children and adolescents under 16 years of age or weighing less than
50 kg.
Other medicines and Unipitiram
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 a loss of effectiveness of levetiracetam.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Levetiracetam may be used during pregnancy only if, after careful evaluation, your doctor considers it necessary.
You must 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
Unipitiram may reduce your ability to drive or use 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 have determined that your ability to perform these activities is not impaired.

3. How to take Unipitiram

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.
Unipitiram should be taken twice daily, once in the morning and once in the evening, approximately at the
same time each day.
Unipitiram is not suitable for initiating therapy, for dose adjustments, or for gradual discontinuation.
Unipitiram is not available in all the pharmaceutical forms described below. For these
doses and pharmaceutical forms, particularly for initial dosing and dose adjustments,
other medicinal products containing levetiracetam should be used.
Monotherapy

Dose for adults and adolescents (from 16 years of age): Typical dose: between 1000 mg and 3000 mg daily. When starting Unipitiram for the first time, your doctor will prescribe a lower dose for 2 weeks before increasing to the lowest typical dose. Example: if your daily dose is 1000 mg, your initial reduced dose would be 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: Typical dose: between 1000 mg and 3000 mg daily. Example: if your daily dose is 1000 mg, you may take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.
Dose for children (from 6 to 11 years) and adolescents (from 12 to 17 years) weighing less than 50 kg: Unipitiram tablets are not indicated for the treatment of children and adolescents weighing less than 50 kg.

Method of administration
Swallow the Unipitiram tablets with sufficient liquid (e.g. a glass of water). You may
take Unipitiram with or without food.
The tablet may be divided into two equal doses.
Duration of treatment

Unipitiram is used as a chronic treatment. Treatment with Unipitiram 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 Unipitiram than you should
Possible adverse effects of an overdose of Unipitiram include drowsiness, agitation, aggression,
reduced attention, respiratory depression, and coma.
Contact your doctor if you have taken more Unipitiram than prescribed. Your doctor will determine the most appropriate treatment for the overdose.
If you forget to take Unipitiram
Contact your doctor if you have forgotten to take one or more doses.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Unipitiram
If treatment with Unipitiram is to be discontinued, it must be gradually withdrawn to avoid an
increase in seizures. If your doctor decides to stop treatment with Unipitiram, they will provide you
with instructions on how to gradually discontinue Unipitiram.
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.
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 a 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])
symptoms such as reduced urine volume, fatigue, nausea, vomiting, confusion, and swelling of the legs,
ankles, or feet, as these may be signs of sudden decrease in kidney function
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 )
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 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 (loss of memory), impaired memory (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: rhinopharyngitis, drowsiness, headache, fatigue, and
dizziness. At the beginning of treatment or when the dose is increased, side effects such as drowsiness,
tiredness, 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 (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
vertigo (sensation of spinning);
cough;
abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
skin 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), impaired memory (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], Quincke’s oedema [swelling of the face, lips, tongue, and throat]);
decreased sodium concentration in the blood;
suicide, personality disorder (behavioural problems), thought disturbances (slow 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);
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 ), 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 affecting more than 30% of the body surface ( 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 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 http://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 Unipitiram

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp" and on the blister after "Expiry".
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. Package contents and other information

What Unipitiram contains
The active substance is called levetiracetam.
One tablet contains 1500 mg of levetiracetam.
The other components are:
Tablet core: crospovidone Type A, crospovidone Type B, povidone, colloidal anhydrous silica,
magnesium stearate.
Coating: hypromellose, titanium dioxide (E171), talc, macrogol, iron oxide yellow (E172), indigo carmine
aluminium lake (E132).
Description of the appearance of Unipitiram and pack contents
The 1500 mg film-coated tablets of Unipitiram are green, oval-shaped, engraved on one side.
The tablets are packaged in aluminum-PVC/PE/PVDC blisters.
Unipitiram tablets are supplied in blisters contained in cardboard boxes with 30 film-coated tablets.
Marketing Authorization Holder
Neuraxpharm Italy SpA
Via Piceno Aprutina 47
63100 Ascoli Piceno
Italy
Manufacturer
Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. Box 3012 Larisa Industrial Area, Larisa, 41004, Greece
PharOS MT Ltd.
HF 62X, Hal Far Industrial Estate, Birzebbugia, BBG 3000, Malta
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