Lepsitam

Lepsitam, 250 mg, film-coated tablets
Lepsitam, 500 mg, film-coated tablets
Lepsitam, 750 mg, film-coated tablets
Lepsitam, 1000 mg, film-coated tablets
levetiracetam
Please read the entire leaflet before taking this medicine.

• Keep this leaflet for future reference.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Lepsitam is and what it is 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 Lepsitam is and what it is used for
Lepsitam film-coated tablets belong to a group of medicines called antiepileptic drugs (medicines used to treat seizures in epilepsy).
Lepsitam is used:

• as monotherapy (single medicine treatment) in patients aged 16 years and older with newly diagnosed epilepsy for a specific type of seizure. Epilepsy is a condition in which patients experience recurrent seizures (fits). Lepsitam is used to treat a type of epilepsy in which seizures start in one part of the brain but may then spread to larger areas of both brain hemispheres (secondarily generalized partial seizures or partial seizures without secondary generalization). Your doctor has prescribed Lepsitam to help reduce the number of seizures.
• in patients already taking another antiepileptic medicine for the treatment of:
  • partial seizures with or without secondary generalization in patients aged 1 month and older,
  • juvenile myoclonic epilepsy in patients aged 12 years and older, to treat myoclonic seizures (brief, shock-like jerks of a muscle or group of muscles),
  • idiopathic generalized epilepsy (a type of epilepsy likely to have a genetic basis) in patients aged 12 years and older, to treat primary generalized tonic-clonic seizures (major seizures, including loss of consciousness).

2. Important information before taking Lepsitam

When not to take Lepsitam

• If the patient is allergic to levetiracetam, pyrrolidone 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 the patient has kidney disease, Lepsitam should be used according to the doctor’s recommendations. The doctor may decide to adjust the dosage.
• If any growth retardation or unexpected early puberty in a child is observed, contact the doctor.
• In some patients treated with antiepileptic medicines such as Lepsitam, thoughts of self-harm or suicidal thoughts have occurred. If symptoms of depression and/or suicidal thoughts occur, contact your doctor immediately.

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

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

Children and adolescents
Lepsitam is not indicated as monotherapy (as the sole medicine) in children and adolescents under 16 years of age.
Lepsitam and other medicines
Tell your doctor or pharmacist if you are currently taking, have recently taken, or plan to take any other medicines.
Do not take macrogol (a medicine used for constipation) within one hour before or one hour after taking levetiracetam, as it may interfere with the action of levetiracetam.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before taking this medicine.
Lepsitam may be used during pregnancy only if, after careful evaluation, the doctor considers it necessary.
Do not stop treatment with this medicine without discussing it with the doctor managing the patient’s care.
A risk of congenital malformations in the unborn child cannot be completely ruled out.
Breastfeeding is not recommended during treatment.
Driving and operating machinery
Lepsitam may impair the ability to drive or operate tools or machinery, as it may cause drowsiness. This is more likely at the beginning of treatment or after an increase in dose. Driving and operating machinery should be avoided until the effect of the medicine on the patient’s ability to perform these activities has been established.
Lepsitam 250 mg and 750 mg film-coated tablets contain sunset yellow FCF (E110)
Sunset yellow (E110) may cause allergic reactions.
Lepsitam 1000 mg film-coated tablets contain lactose
If the patient has previously been diagnosed with intolerance to certain sugars (e.g. lactose), the patient should consult their doctor before taking this medicine.

3. How to take Lepsitam

Lepsitam must always be taken as prescribed by the doctor. If in doubt, consult your doctor.
Lepsitam should be taken twice daily, in the morning and evening, approximately at the same time each day.
Take the number of coated tablets as prescribed by your doctor.

Monotherapy

• Dose in adults and adolescents (aged 16 years and older): The usual dose is 1000 mg to 3000 mg per day.
  If the patient is taking the medication for the first time, the doctor will initially prescribe a lower dose for 2 weeks, followed by the lowest usually recommended dose.
  For example, if the daily dose is to be 1000 mg, the initial lower dose would be 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening.

Adjunctive therapy

• Dose in adults and adolescents (aged 12 to 17 years) with body weight of 50 kg or more:
  The usual dose is 1000 mg to 3000 mg per day.
  For example, if the daily dose is 1000 mg, the patient may take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.

• Dose in infants and children (aged 1 to 23 months), children (aged 2 to 11 years), and adolescents (aged 12 to 17 years) with body weight less than 50 kg:
  The doctor will prescribe the most appropriate formulation of Lepsitam depending on age, body weight, and required dose.
  Levetiracetam 100 mg/ml oral solution is more suitable for infants and children under 6 years of age, for children and adolescents (aged 6 to 17 years) with body weight below 50 kg, when the exact dose cannot be achieved with tablets, and for patients unable to swallow tablets.

Administration method:
Lepsitam coated tablets should be swallowed with sufficient liquid (e.g. a glass of water). Lepsitam may be taken with or without food. A bitter taste may be experienced after oral administration of levetiracetam.

Duration of treatment:

• Lepsitam is intended for long-term treatment. Continue taking Lepsitam for as long as directed by your doctor.
• Do not discontinue treatment without consulting your doctor, as this may lead to increased seizure frequency.

Overdose of Lepsitam
Possible adverse effects following overdose of Lepsitam may include drowsiness, agitation, aggression, decreased alertness, respiratory depression, and coma.
If an overdose of coated tablets has been taken, seek immediate medical advice from a doctor or pharmacist. The doctor will advise on the best possible treatment for overdose.

Missed dose of Lepsitam
Contact your doctor if one or more doses have been missed.
Do not take a double dose to make up for a missed coated tablet.

Discontinuation of Lepsitam:
If treatment with Lepsitam needs to be discontinued, the medication should be withdrawn gradually to avoid increased seizure frequency.
If your doctor decides to discontinue Lepsitam, they will provide instructions on how to taper the medication gradually.

If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should immediately inform a doctor or contact the nearest hospital emergency department if the patient experiences:

• Weakness, dizziness, or difficulty breathing, as these symptoms may indicate a severe allergic reaction (anaphylactic reaction)
• Swelling of the face, lips, tongue, or throat (angioedema / Quincke's edema)
• Flu-like symptoms and rash on the face spreading to the whole body, accompanied by high fever, increased liver enzyme activity observed in blood tests, elevated levels of certain white blood cells (eosinophilia), and enlarged lymph nodes (drug rash with eosinophilia and systemic symptoms – DRESS syndrome)
• Symptoms such as reduced urine output, fatigue, nausea, vomiting, confusion, and swelling of legs, ankles, or feet, as these may indicate sudden worsening of kidney function
• Skin rash which may lead to blister formation and appear as small target-like lesions (a dark center surrounded by a lighter area and a dark ring around it) (erythema multiforme)
• Widespread rash with blisters and peeling skin, mainly affecting areas around the mouth, eyes, nose, and genitals (Stevens-Johnson syndrome)
• A more severe form of rash causing skin detachment affecting more than 30% of the body surface (toxic epidermal necrolysis)
• Signs of serious mental disturbances or observation in the patient of: confusion, drowsiness, amnesia (memory loss), memory impairment (forgetfulness), behavioral changes, or other neurological symptoms, including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most commonly reported adverse effects are: inflammation of the mucous membranes of the nose and throat, drowsiness, headache, fatigue, and dizziness. These symptoms may occur at the beginning of treatment or after an increase in dose. These effects should gradually decrease over time.

Very common: may affect more than 1 in 10 patients

• Inflammation of the mucous membranes of the nose and throat
• Drowsiness
• Headache

Common: may affect up to 1 in 10 patients

• Loss of appetite
• Depression, feelings of hostility or aggression, anxiety, insomnia, restlessness, or irritability
• Seizures, balance disorders, dizziness (sensation of unsteadiness), lethargy (lack of energy and motivation), tremors (involuntary shaking)
• Dizziness (sensation of spinning)
• Cough
• Abdominal pain, nausea, dyspepsia (indigestion), diarrhea, vomiting
• Rash
• Asthenia/fatigue (tiredness)

Uncommon: may affect up to 1 in 100 patients

• Decreased platelet count, decreased white blood cell count
• Decreased body weight; increased body weight
• Abnormal behavior, feelings of anger, disorientation, hallucinations, mental disturbances, suicidal thoughts and attempts, panic attacks, emotional lability/mood changes, agitation
• Paresthesia (tingling sensations), memory loss (amnesia), memory disorders (forgetfulness), ataxia (impaired coordination of movements), difficulty concentrating
• Double vision, blurred vision
• Elevated/abnormal liver function test results
• Hair loss, rash, itching
• Injuries

Rare: may affect up to 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 blood
• Suicide, personality disorders (behavioral disturbances), thought disorders (slowed thinking, inability to concentrate)
• Delirium
• Encephalopathy (a detailed description of symptoms is provided in the section "You should immediately inform a doctor")
• Involuntary muscle contractions of the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (excessive motor activity)
• Pancreatitis
• Liver function disorders, hepatitis
• Sudden worsening of kidney function
• Skin rash which may lead to blister formation and appear as small target-like lesions (a dark center surrounded by a lighter area and a dark ring around it) (erythema multiforme), widespread rash with blisters and peeling skin mainly affecting areas around the mouth, eyes, nose, and genitals (Stevens-Johnson syndrome), and a more severe form of rash causing skin detachment affecting more than 30% of the body surface (toxic epidermal necrolysis)
• Rhabdomyolysis (breakdown of skeletal muscles) and associated increase in blood creatine phosphokinase activity. Occurrence is significantly more frequent in Japanese patients compared to other (non-Japanese) patients.
• Weakness or difficulty walking

Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the 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 stated on the carton and blister pack following
"Expiry date" and (or) "EXP". The expiry date refers to the last day of the specified month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
what to do with medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Lepsitam contains
The active substance is levetiracetam.
Each Lepsitam 250 mg film-coated tablet contains 250 mg of levetiracetam.
Each Lepsitam 500 mg film-coated tablet contains 500 mg of levetiracetam.
Each Lepsitam 750 mg film-coated tablet contains 750 mg of levetiracetam.
Each Lepsitam 1000 mg film-coated tablet contains 1000 mg of levetiracetam.

The other ingredients are:
Tablet core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, crospovidone (type A), hydroxypropylcellulose

Lepsitam 250 mg film-coated tablets
Coating: hypromellose, titanium dioxide (E171), talc, propylene glycol (E1520), indigotine (E132), sunset yellow FCF (E110), quinoline yellow (E104)

Lepsitam 500 mg film-coated tablets
Coating: hypromellose, titanium dioxide (E171), hydroxypropylcellulose, propylene glycol (E1520), sorbitol monooleate, sorbic acid, vanillin, quinoline yellow (E104)

Lepsitam 750 mg film-coated tablets
Coating: hypromellose, macrogol 4000, titanium dioxide (E171), macrogol 4000, red iron oxide (E172), indigotine (E132), sunset yellow FCF (E110)

Lepsitam 1000 mg film-coated tablets
Coating: titanium dioxide (E171), lactose monohydrate, hypromellose, macrogol 4000

What Lepsitam looks like and contents of the pack
Lepsitam 250 mg film-coated tablets are blue, elongated, biconvex film-coated tablets.
Lepsitam 500 mg film-coated tablets are yellow, elongated, biconvex film-coated tablets.
Lepsitam 750 mg film-coated tablets are pink, elongated, biconvex film-coated tablets.
Lepsitam 1000 mg film-coated tablets are white, elongated, biconvex film-coated tablets.

The film-coated tablets are packed in white, opaque blisters made of PVC/PE/PVDC/Aluminium, contained in cardboard boxes.

Lepsitam 250 mg film-coated tablets
Carton boxes contain 20, 30, 50, 60, 100 or 200 film-coated tablets.

Lepsitam 500 mg film-coated tablets
Carton boxes contain 10, 20, 30, 50, 60, 100, 120 and 200 film-coated tablets.

Lepsitam 750 mg film-coated tablets
Carton boxes contain 20, 30, 50, 60, 80, 100, 120 and 200 film-coated tablets.

Lepsitam 1000 mg film-coated tablets
Carton boxes contain 10, 20, 30, 50, 60, 100 and 200 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation 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