Epitiram

Package leaflet: Information for the patient

Epitiram 500 mg film-coated tablets, 1000 mg film-coated tablets

Levetiracetam
Generic Medicine
Please read all of this leaflet carefully before you start 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, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Epitiram is and what it is used for

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

• as monotherapy in adults and adolescents from the age of 16 years with newly diagnosed epilepsy, to treat a certain type of epilepsy. Epilepsy is a condition in which patients have repeated 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 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 and adolescents
  • myoclonic seizures (brief, shock-like spasms of a muscle or muscle group) in adults and adolescents from the age of 12 years with juvenile myoclonic epilepsy
  • primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents from the age of 12 years with idiopathic generalized epilepsy (the type of epilepsy believed to have a genetic cause).

2. What you need to know before taking Epitiram

Do not take Epitiram

• 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 Epitiram

• If you have kidney problems, follow your doctor's instructions. Your doctor may decide whether the dose needs to be adjusted.
• If you observe slowed growth or unexpected onset of puberty in a child (from 12 years of age), contact your doctor.
• A small number of people taking antiepileptic medicines such as Epitiram have experienced self-harming thoughts or suicidal ideation. 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:

• abnormal thoughts, feeling irritable or more aggressive than usual, or if you, 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 during treatment with Epitiram, consult a doctor as soon as possible.

Children and adolescents

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

Other medicines and Epitiram
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) for one hour before and one hour after taking levetiracetam, as it may cause a loss of effectiveness of levetiracetam.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may 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 congenital malformations in the unborn child cannot be completely ruled out. Breastfeeding is not recommended during treatment.

Driving and using machines
Epitiram 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. Do not drive or operate machinery until you have determined that your ability to perform these activities is not impaired.

Epitiram contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially 'sodium-free'.

3. How to take Epitiram

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
Take the number of tablets as instructed by your doctor.
Epitiram should be taken twice daily, once in the morning and once in the evening, approximately at
the same time each day.
Monotherapy

• Dose for adults and adolescents (from 16 years of age): Typical dose: between 1000 mg and 3000 mg per day. When starting Epitiram 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 1,000 mg, you should take 1 tablet in the morning and 1 tablet 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 per day. Example: if your daily dose is 1,000 mg, you should take 1 tablet in the morning and 1 tablet in the evening.

Method of administration:
Take Epitiram tablets with a sufficient amount of liquid (e.g. a glass of water). The score line is only intended to facilitate tablet splitting for easier swallowing and is not intended to divide the tablet into two equal doses. That is, if the tablet is divided to facilitate swallowing, both halves must be taken at the same time. After oral administration, a bitter taste of levetiracetam may be perceived.
Duration of treatment:

• Epitiram is used as a chronic treatment. Treatment with Epitiram 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 Epitiram than you should:
Possible adverse effects of an Epitiram overdose include drowsiness, agitation,
aggressiveness, decreased attention, respiratory depression, and coma.
Contact your doctor if you have taken more tablets than prescribed. The doctor will determine the most appropriate treatment for the overdose.
If you forget to take Epitiram:
Contact your doctor if you have forgotten to take one or more doses.
Do not take a double dose to make up for the missed tablet.
If you stop taking Epitiram:
Epitiram should be discontinued gradually to avoid an increase in seizures. If your doctor decides to discontinue treatment with Epitiram, they will provide you with specific instructions on how to taper off the medication gradually.
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 will experience them.
Contact your doctor immediately or go to the nearest emergency room if you experience:

• weakness, lightheadedness or dizziness, or have difficulty breathing, as these may be signs of a severe allergic (anaphylactic) reaction
• swelling of the face, lips, tongue, or throat (angioedema, also known as Quincke's edema)
• 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 worsening of kidney function
• a skin rash that may appear as blistering lesions 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 peeling of the skin, especially 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, 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 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, restlessness or irritability
• seizure, balance disorder, dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking)
• vertigo (spinning sensation)
• cough
• abdominal pain, diarrhea, 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 behavior, hallucinations, anger, confusion, panic attack, emotional 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 face, lips, tongue, and throat])
• decreased sodium concentration in the blood (hyponatremia)
• suicide, personality disorder (behavioral problems), thought disturbances (slowed thinking, inability to concentrate)
• delirium
• encephalopathy (see the section “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 worsening of kidney function
• skin rash that may appear as blistering lesions 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, 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. The incidence 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 may 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 Epitiram

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after Exp.: and on the
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 no longer required. This will help protect the environment.

6. Package contents and other information

What Epitiram contains
The active substance is called levetiracetam.
Each 500 mg tablet contains 500 mg of levetiracetam.
Each 1000 mg tablet contains 1000 mg of levetiracetam.
The excipients are:
Tablet core: povidone (K30), sodium croscarmellose, polyethylene glycol, colloidal anhydrous silica, magnesium stearate.
The 500 mg tablets are film-coated with Opadry II yellow 85F32004 containing: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), polyethylene glycol, talc, yellow iron oxide (E172).
The 1000 mg tablets are film-coated with Opadry II white 85F18422 containing: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), polyethylene glycol, talc.

Description of the appearance of Epitiram and pack sizes
Epitiram 500 mg film-coated tablets are packaged in PVC/Aclar-AL blisters containing 60 tablets.
Epitiram 1000 mg film-coated tablets are packaged in PVC/Aclar-AL blisters containing 30 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Neuraxpharm Italy S.p.A.
Via Piceno Aprutina, 47
63100 Ascoli Piceno (AP)
Italy

Manufacturer
PSI Supply nv
Axxes Business Park - Guldensporenpark 22 – Block C
9820 Merelbeke
Belgium
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 – Anagni (FR)
Italy