Lepsitam

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

Read the contents of the leaflet before taking the medicine.

• -Keep this leaflet, you may need to read it again.
• -If you have any further questions, 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, please inform 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 and then may spread to larger areas of both hemispheres of the brain (partial seizures with or without secondary generalization). The doctor has prescribed Lepsitam to reduce the number of seizures.
• in patients who are already taking another antiepileptic medicine for the treatment of:
• patients from 1 month of age for the treatment of partial seizures with or without secondary generalization
• patients from 12 years of age with juvenile myoclonic epilepsy for the treatment of myoclonic seizures (short, shock-like muscle contractions of single muscles or muscle groups),
• patients from 12 years of age with idiopathic generalized epilepsy (a type of epilepsy that is likely to have a genetic basis) for the treatment of primary generalized tonic-clonic seizures (large seizures, including loss of consciousness).

2. Important information before taking Lepsitam

When not to take Lepsitam

• In case of hypersensitivity to levetiracetam, pyrrolidine derivatives, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Lepsitam, consult your doctor:

• If kidney disease has been diagnosed in the patient, Lepsitam should be used in accordance with the doctor's recommendations. The doctor may decide to adjust the dosage.
• If any slowing of growth or unexpected premature puberty of the child has been observed, contact your doctor.
• In some patients treated with antiepileptic medicines, such as Lepsitam, thoughts of self-harm or suicidal thoughts have occurred. In case of symptoms of depression and/or suicidal thoughts, contact your doctor.

Tell your doctor or pharmacist if any of the following side effects get worse or persist for more than a few days:

• Unusual thoughts, irritability, or more aggressive reactions than usual, or significant mood changes or behavior 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

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.
Do not take macrogol (a medicine used for constipation) one hour before and one 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 child, consult your doctor before taking this medicine.
Lepsitam may be used during pregnancy, only if the doctor considers it necessary after careful evaluation.
Do not stop treatment with this medicine without discussing it with your doctor.
The risk of congenital malformations cannot be completely excluded.
Breastfeeding is not recommended during treatment.

Driving and using machines

Lepsitam may impair 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 of the medicine. It is not recommended to drive or operate machines until the effect of the medicine on the patient's ability to perform these activities has been established.

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

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

Lepsitam 1000mg coated tablets contain lactose

If the patient has previously been diagnosed with intolerance to some sugars (e.g., lactose), the patient should consult a doctor before taking the medicine.

3. How to take Lepsitam

Always take Lepsitam exactly as your doctor has told you. If you are not sure, ask your doctor.
Lepsitam must be taken twice a day, in the morning and evening, at approximately the same time every day.
Take the number of coated tablets as recommended 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 the patient is taking the medicine for the first time, the doctor will initially recommend a lower dosefor 2 weeks, and then the 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 of age), and adolescents (from 12 to 17 years of age) with a body weight of less than 50 kg

The doctor will recommend the most suitable form of Lepsitam, depending on the 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 appropriate 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. Treatment with Lepsitam should be continued for as long as the doctor recommends.
• Do not stop treatment without consulting your doctor, as this may increase the frequency of seizures.

Using 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 a higher dose of coated tablets than recommended has been taken, consult a doctor or pharmacist immediately. The doctor will recommend the best possible treatment for overdose.

Missing a dose of Lepsitam

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

Stopping treatment with Lepsitam:

If treatment with Lepsitam is to be stopped, the medicine should be discontinued gradually, in order to avoid increasing the frequency of epileptic seizures.
If the doctor decides to stop treatment with Lepsitam, they will also inform you how to gradually discontinue the medicine Lepsitam.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Inform your doctor or contact the nearest hospital emergency department immediately 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 rest of the 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 may lead to the formation of blisters and looks like small targets (a dark spot surrounded by a lighter area and a dark ring around it) (erythema multiforme)
• Widespread rash with blisters and peeling skin, mainly on the lips, eyes, nose, and genitals (Stevens-Johnson syndrome)
• A more severe form of rash that causes skin peeling over more than 30% of the body surface (toxic epidermal necrolysis)
• Signs of serious mental changes or if the patient notices: confusion, drowsiness, amnesia (memory loss), memory disturbances (forgetfulness), behavioral disturbances, or other neurological symptoms, including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most common 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; headaches.

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

• loss of appetite;
• 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 disturbances, suicidal thoughts and attempts, panic attacks, emotional instability/mood swings, agitation;
• paresthesia (tingling), amnesia (memory loss), memory disturbances (forgetfulness), ataxia (coordination disorder), attention disturbances;
• 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 count 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;
• suicidal thoughts, personality disorders (behavioral disorders), thought disorders (slow thinking, inability to concentrate);
• delirium;
• encephalopathy (a detailed description of the symptoms is given in the subsection "Inform your doctor immediately");
• involuntary muscle contractions of the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (overactivity);
• pancreatitis;
• liver dysfunction, hepatitis;
• sudden worsening of kidney function;
• a skin rash that may lead to the formation of blisters and looks like small targets (a dark spot surrounded by a lighter area and a dark ring around it) (erythema multiforme), widespread rash with blisters and peeling skin, mainly on the lips, eyes, nose, and genitals (Stevens-Johnson syndrome), and a more severe form of rash that causes 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, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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

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 and blister after “Expiry Date” and (or) “EXP”. The expiry date refers to the last day of that month.
There are no special storage precautions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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), yellow orange (E110), quinoline yellow (E104)
Lepsitam, 500 mg, coated tablets
Coating: hypromellose, titanium dioxide (E171), hydroxypropylcellulose, propylene glycol (E1520), sorbitan monooleate, sorbic acid, 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 (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, opaque blisters of PVC/PE/PVDC/Aluminum 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, or 200 coated tablets.
Lepsitam 750 mg coated tablets
Cardboard boxes contain 20, 30, 50, 60, 80, 100, 120, or 200 coated tablets.
Lepsitam 1000 mg coated tablets
Cardboard boxes contain 10, 20, 30, 50, 60, 100, or 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