LEPSITAM 250 mg Tablets

Contents of the leaflet

1. B. PATIENT INFORMATION LEAFLET
2. Patient Information Leaflet: Information for the Patient
3. Lepsitam, 250 mg, coated tablets
4. Lepsitam, 500 mg, coated tablets
5. Lepsitam, 750 mg, coated tablets
6. Lepsitam, 1000 mg, coated tablets
   1. You should read the contents of this leaflet before taking the medicine.
   2. Table of Contents of the Leaflet
   3. What is Lepsitam and what is it used for
7. Important information before taking Lepsitam
   1. When not to take Lepsitam
   2. Warnings and precautions
   3. Children and adolescents
   4. Lepsitam and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Lepsitam 250mg, 750mg coated tablets contain orange yellow S (E110)
   8. Lepsitam 1000mg coated tablets contain lactose
8. How to take Lepsitam
   1. Method of administration:
   2. Duration of treatment:
   3. Taking a higher dose of Lepsitam than recommended
   4. Missing a dose of Lepsitam
   5. Stopping treatment with Lepsitam:
9. Possible side effects
   1. You should immediately inform your doctor or contact the nearest hospital emergency department if you experience:
   2. Uncommon: may occur no more frequently than in 1 in 100 patients
   3. Rare: may occur no more frequently than in 1 in 1,000 patients
   4. Reporting side effects
10. How to store Lepsitam
11. Contents of the pack and other information
    1. What Lepsitam contains
    2. What Lepsitam looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer
    5. Date of last revision of the leaflet: 06/2020

B. PATIENT INFORMATION LEAFLET

Patient Information Leaflet: Information for the Patient

Lepsitam, 250 mg, coated tablets

Lepsitam, 500 mg, coated tablets

Lepsitam, 750 mg, coated tablets

Lepsitam, 1000 mg, coated tablets

Levetiracetam

You should read the contents of this leaflet before taking the medicine.

• -You should keep this leaflet, so you can read it again if you need to.
• -If you have any further questions, you should ask your doctor or pharmacist.
• -This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• -If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1.

What is Lepsitam and what is it used for

Lepsitam is an antiepileptic medicine (used to treat seizures in epilepsy).
Lepsitam is used:

• as the only medicine in patients from 16 years of age with newly diagnosed epilepsy for the treatment of a specific form of epilepsy. Epilepsy is a condition where patients have repeated seizures. Lepsitam is used to treat a form of epilepsy where seizures initially occur in one part of the brain but can then spread to larger areas of both halves of the brain (partial seizures with or without secondary generalization). Your doctor has prescribed Lepsitam to reduce the number of seizures.
• in patients who are already taking another antiepileptic medicine for the treatment of:
• partial seizures with or without secondary generalization in infants from 1 month of age, children and adolescents
• myoclonic seizures in adolescents from 12 years of age with juvenile myoclonic epilepsy
• primary generalized tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalized epilepsy

2. Important information before taking Lepsitam

When not to take Lepsitam

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

Warnings and precautions

Before starting treatment with Lepsitam, you should tell your doctor:

• If kidney disease has been diagnosed, Lepsitam should be taken as directed by your doctor. Your doctor may decide to adjust the dose.
• If any slowing of growth or unexpected premature puberty has been observed in the child, you should contact your doctor.
• In some patients treated with antiepileptic medicines such as Lepsitam, thoughts of self-harm or suicide have occurred. If symptoms of depression and/or suicidal thoughts occur, you should contact your doctor.

You should inform your doctor or pharmacist if any of the following side effects worsen or persist for more than a few days:

• Unusual thoughts, irritability, or more aggressive than usual reactions or significant mood or behavioral changes noticed by the patient or their family and friends.

Children and adolescents

Lepsitam should not be used as monotherapy (as the only medicine) in children and adolescents under 16 years of age.

Lepsitam and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should not take macrogol (a medicine used for constipation) 1 hour before and 1 hour after taking levetiracetam, as it may prevent levetiracetam from working.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor before taking this medicine.
Lepsitam may be used during pregnancy only if your doctor considers it necessary.
You should not stop treatment with this medicine without discussing it with your doctor.
The risk of birth defects cannot be completely excluded.
Breastfeeding is not recommended during treatment.

Driving and using machines

Lepsitam may affect your ability to drive or operate tools or machines, as it may cause drowsiness. This is more likely at the beginning of treatment or after increasing the dose. You should not drive or operate machinery until it has been determined how the medicine affects you.

Lepsitam 250mg, 750mg coated tablets contain orange yellow S (E110)

The dye orange yellow (E 110) may cause an allergic reaction.

Lepsitam 1000mg coated tablets contain lactose

If you have previously been diagnosed with intolerance to some sugars (e.g. lactose), you should contact your doctor before taking the medicine.

3. How to take Lepsitam

Lepsitam should always be taken as directed by your doctor. If you have any doubts, you should consult your doctor.
Lepsitam must be taken twice a day, in the morning and evening, at approximately the same time every day.
You should take the number of coated tablets as directed by your doctor.
Monotherapy

• Dose in adults and adolescents (from 16 years of age)The usual dose is: from 1000 mg to 3000 mg per day.

If you are taking the medicine for the first time, your doctor will initially prescribe a lower dosefor 2 weeks, and then the minimum usual dose.
For example, if the daily dose is 1000 mg, the initial lower dose is
1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening.
Adjunctive therapy

• Dose in adults and adolescents (from 12 to 17 years of age) with a body weight of 50 kg or more

The usual dose is: from 1000 mg to 3000 mg per day.
For example, if the daily dose is 1000 mg, you can take 2 tablets of 250 mg in the morning and
2 tablets of 250 mg in the evening.

• Dose in infants and children (from 1 to 23 months), children (from 2 to 11 years) and adolescents (from 12 to 17 years) with a body weight of less than 50 kg

Your doctor will prescribe the most suitable form of Lepsitam, depending on age, body weight, and dose.
Levetiracetam 100 mg/ml oral solution is a more suitable form for infants and children under 6 years of age, for children and adolescents (from 6 to 17 years of age) with a body weight below 50 kg, and when it is not possible to administer the correct dose in tablets, and for patients who are unable to swallow tablets.

Method of administration:

Lepsitam coated tablets should be swallowed, washed down with a sufficient amount of liquid (e.g. a glass of water). Lepsitam can be taken with or without food.
After oral administration of levetiracetam, a bitter taste may be felt.

Duration of treatment:

• Lepsitam is used for long-term treatment. You should continue treatment with Lepsitam for as long as your doctor recommends.
• Do not stop treatment without consulting your doctor, as this may cause an increase in the frequency of seizures.

Taking a higher dose of Lepsitam than recommended

Possible side effects after overdose of Lepsitam include drowsiness, agitation, aggression, decreased alertness, respiratory depression, and coma.
If you have taken a higher dose of coated tablets than recommended, you should immediately contact your doctor or pharmacist. Your doctor will recommend the best possible treatment for overdose.

Missing a dose of Lepsitam

You should contact your doctor if you have missed one or more doses of the medicine.
You should not take a double dose to make up for the missed coated tablet.

Stopping treatment with Lepsitam:

If treatment with Lepsitam is to be stopped, the medicine should be gradually discontinued in order to avoid an increase in the frequency of epileptic seizures.
If your doctor decides to stop treatment with Lepsitam, they will also inform you how to gradually discontinue the medicine.
If you have any further doubts about taking the medicine, you should contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lepsitam can cause side effects, although not everybody gets them.

You should immediately inform your doctor or contact the nearest hospital emergency department if you experience:

• Weakness, dizziness, or difficulty breathing, as these symptoms may indicate a severe allergic reaction (anaphylaxis)
• Swelling of the face, lips, tongue, and throat (Quincke's edema)
• Flu-like symptoms and rash on the face and then on the whole body, with high fever, increased liver enzyme activity in blood tests, increased number of certain white blood cells (eosinophilia), and lymph node enlargement (drug rash with eosinophilia and systemic symptoms - DRESS syndrome)
• Symptoms such as decreased urine output, fatigue, nausea, vomiting, confusion, and swelling of the feet, ankles, or legs, as this may be a sign of sudden worsening of kidney function
• A skin rash that can cause blisters and looks like small targets (a dark spot surrounded by a lighter area and a dark ring around it) (erythema multiforme)
• A widespread rash with blisters and peeling skin, mainly on the mouth, eyes, nose, 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 changes or if you notice in the patient: confusion, drowsiness, amnesia (memory loss), memory disorders (forgetfulness), behavioral disorders, or other neurological symptoms, including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most commonly reported side effects are: inflammation of the nasal passages and throat, drowsiness, headache, fatigue, and dizziness. At the beginning of treatment or after increasing the dose, symptoms such as drowsiness, fatigue, or dizziness may occur. These effects should decrease over time.
Very common:may occur more frequently than in 1 in 10 patients

• inflammation of the nasal passages and throat;
• drowsiness; headache.

Common:may occur no more frequently than in 1 in 10 patients

• loss of appetite (anorexia);
• depression, feeling hostile or aggressive, anxiety, insomnia, nervousness, or irritability;
• seizures, balance disorders, dizziness (feeling of spinning), lethargy (lack of energy and enthusiasm), tremors (involuntary trembling);
• dizziness (feeling of swaying);
• cough;
• abdominal pain, nausea, dyspepsia (indigestion), diarrhea, vomiting;
• rash;
• asthenia/fatigue (exhaustion).

Uncommon: may occur no more frequently than in 1 in 100 patients

• decreased platelet count, decreased white blood cell count;
• weight loss; weight gain;
• abnormal behavior, feeling angry, disorientation, hallucinations, mental disorders, suicidal thoughts and attempts, panic attacks, emotional instability/mood swings, agitation;
• paresthesia (tingling), amnesia (memory loss), memory disorders (forgetfulness), ataxia (disorder of movement coordination), attention disorders;
• double vision, blurred vision;
• increased/liver enzyme abnormalities in liver function tests;
• hair loss urticaria, itching;
• injuries.

Rare: may occur no more frequently than in 1 in 1,000 patients

• infection;
• decreased number of all types of blood cells;
• severe allergic reactions (DRESS syndrome, anaphylactic reaction [severe and serious allergic reaction], Quincke's edema [swelling of the face, lips, tongue, and throat])
• decreased sodium levels in the blood;
• suicide, personality disorders (behavioral disorders), thinking disorders (slow thinking, inability to concentrate);
• delirium;
• encephalopathy (a detailed description of symptoms is given in the subsection "You should immediately inform your doctor");
• involuntary muscle contractions of the head, torso, and limbs, difficulty controlling movements, hyperkinesia (overactivity);
• pancreatitis;
• liver function disorders, hepatitis;
• sudden worsening of kidney function;
• a skin rash that can cause blisters and looks like small targets (a dark spot surrounded by a lighter area and a dark ring around it) (erythema multiforme), a widespread rash with blisters and peeling skin, mainly on the mouth, eyes, nose, and genitals (Stevens-Johnson syndrome), and a more severe form of rash causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of striated muscle) and associated increased creatine phosphokinase activity in the blood. The incidence is significantly higher in Japanese patients compared to other patients (non-Japanese).
• paralysis or difficulty walking.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lepsitam

The medicine should be stored in a place inaccessible to children.
Do not use this medicine after the expiry date stated on the carton and blister after "Expiry Date" and (or) "EXP". The expiry date refers to the last day of the given month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Lepsitam contains

The active substance is levetiracetam.
Each Lepsitam 250 mg coated tablet contains 250 mg of levetiracetam.
Each Lepsitam 500 mg coated tablet contains 500 mg of levetiracetam.
Each Lepsitam 750 mg coated tablet contains 750 mg of levetiracetam.
Each Lepsitam 1000 mg coated tablet contains 1000 mg of levetiracetam.
In addition, the medicine contains:
Core: calcium phosphate dihydrate, microcrystalline cellulose, crospovidone (type A),
hydroxypropylcellulose
Lepsitam, 250 mg, coated tablets
Coating: hypromellose, titanium dioxide (E171), talc, propylene glycol (E1520), indigo carmine (E132), orange yellow S (E110), quinoline yellow (E104)
Lepsitam, 500 mg, coated tablets
Coating: hypromellose, titanium dioxide (E171), hydroxypropylcellulose, propylene glycol (E1520), sorbitan monooleate, potassium sorbate, vanillin, quinoline yellow (E104)
Lepsitam, 750 mg, coated tablets
Coating: hypromellose, macrogol 4000, titanium dioxide (E 171), macrogol 4000, iron oxide red (E172), indigo carmine (E132), orange yellow S (E110)
Lepsitam, 1000 mg, coated tablets
Coating: titanium dioxide (E 171). lactose monohydrate, hypromellose, macrogol 4000,

What Lepsitam looks like and contents of the pack

Lepsitam 250 mg coated tablets are blue, elongated, biconvex coated tablets.
Lepsitam 500 mg coated tablets are yellow, elongated, biconvex coated tablets.
Lepsitam 750 mg coated tablets are pink, elongated, biconvex coated tablets.
Lepsitam 1000 mg coated tablets are white, elongated, biconvex coated tablets
The coated tablets are packaged in white, non-transparent blisters with PVC/PE/PVDC/Aluminum foil in a cardboard box.
Lepsitam 250 mg coated tablets
Cardboard boxes contain 20, 30, 50, 60, 100, or 200 coated tablets.
Lepsitam 500 mg coated tablets
Cardboard boxes contain 10, 20, 30, 50, 60, 100, 120, and 200 coated tablets.
Lepsitam 750 mg coated tablets
Cardboard boxes contain 20, 30, 50, 60, 80, 100, 120, and 200 coated tablets.
Lepsitam 1000 mg coated tablets
Cardboard boxes contain 10, 20, 30, 50, 60, 100, and 200 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Pharmathen International S.A.
4, Dervenakion str.,
15351 Pallini, Attiki
Greece

Manufacturer

Pharmathen S.A.
6, Dervenakion Str.
15351 Pallini Attiki
Greece
And
Pharmathen International S.A.
Industrial Park Sapes
Rodopi Prefecture
Block No 5, Rodopi 69300
Greece

Date of last revision of the leaflet: 06/2020