Lepsitam

B. PATIENT INFORMATION LEAFLET

Patient Information Leaflet: Information for the Patient

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

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

• -You should keep this leaflet, so you can read it again later.
• -If you have any further questions, please 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 film-coated tablets are 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 (fits). Lepsitam is used to treat a form of epilepsy where seizures initially start 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 generalisation). 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 generalisation in patients from 1 month of age
• myoclonic seizures in patients from 12 years of age with juvenile myoclonic epilepsy
• primary generalised tonic-clonic seizures in patients from 12 years of age with idiopathic generalised epilepsy

2. Important information before taking Lepsitam

When not to take Lepsitam

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

Warnings and precautions

Before taking Lepsitam, tell your doctor:

• If kidney problems have 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 early puberty has been observed in a child, contact your doctor.
• Some patients taking antiepileptic medicines such as Lepsitam have had thoughts of harming themselves or ending their lives. If you experience any symptoms of depression and/or thoughts of harming yourself, contact your doctor.

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

• Unusual thoughts, irritability or more aggressive than usual reactions or significant changes in mood or behaviour noticed by you or your 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 the medicines you are taking now or have taken recently, and about any medicines you plan to take.
Do not take macrogol (a medicine used for constipation) for 1 hour before and 1 hour after taking levetiracetam, as it may reduce the effect of levetiracetam.

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 can be used during pregnancy, only if your doctor considers it necessary.
Do 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 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 a dose increase. Do not drive or operate machinery until you know how this medicine affects you.

Lepsitam 250mg and 750mg film-coated tablets contain orange yellow S (E110)

The colouring agent orange yellow S (E110) may cause an allergic reaction.

Lepsitam 1000mg film-coated tablets contain lactose

If you have been diagnosed with an 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 are unsure, consult your doctor.
Lepsitam must be taken twice a day, in the morning and evening, at approximately the same time each day.
Take the number of film-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 lowest 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 below 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 appropriate dose with tablets, and for patients who are unable to swallow tablets.

Method of administration:

Lepsitam film-coated tablets should be swallowed 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 experienced.

Duration of treatment:

• Lepsitam is used for long-term treatment. You should continue to take Lepsitam for as long as your doctor tells you to.
• Do not stop treatment without consulting your doctor, as this may increase the frequency of seizures.

Taking a higher dose of Lepsitam than prescribed

Possible side effects after an overdose of Lepsitam include drowsiness, agitation, aggression, decreased alertness, respiratory depression and coma.
If you have taken more tablets than prescribed, contact your doctor or pharmacist immediately. Your doctor will decide on the best possible treatment for the overdose.

Missing a dose of Lepsitam

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

Stopping treatment with Lepsitam:

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

4. Possible side effects

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

Seek immediate medical attention if you experience any of the following:

• 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 oedema)
• Flu-like symptoms and rash on the face and then on the rest of the body, with high fever, increased liver enzymes in blood tests, increased number of certain white blood cells (eosinophilia) and swollen lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms - DRESS)
• Reduced urine output, fatigue, nausea, vomiting, confusion and swelling of the feet, ankles or hands, as this may be a sign of sudden kidney failure
• A rash on the skin that may lead to blistering and looks like a target (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 lips, eyes, mouth, 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: confusion, drowsiness, amnesia (memory loss), memory disturbances (forgetfulness), behavioural disturbances or other neurological symptoms, including involuntary or uncontrolled movements. These may be signs of encephalopathy.

The most common side effects are: inflammation of the lining of the nose and throat, drowsiness, headache, fatigue and dizziness. At the beginning of treatment or after a dose increase, side effects such as drowsiness, fatigue or dizziness may occur. These effects should decrease over time.
Very common:may affect more than 1 in 10 people

• inflammation of the lining of the nose and throat;
• drowsiness; headache.

Common:may affect up to 1 in 10 people

• 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), diarrhoea, vomiting;
• rash;
• asthenia/fatigue (exhaustion).

Uncommon: may affect up to 1 in 100 people

• decreased platelet count, decreased white blood cell count;
• weight decrease; weight increase;
• abnormal behaviour, anger, disorientation, hallucinations, mental disturbances, suicidal thoughts and attempts, panic attacks, emotional instability/mood swings, agitation;
• paraesthesia (tingling), amnesia (memory loss), memory disturbances (forgetfulness), ataxia (disorder of coordination), attention disturbances;
• double vision, blurred vision;
• increased/liver enzyme abnormalities in liver function tests;
• hair loss, pruritus (itching), rash;
• injuries.

Rare: may affect up to 1 in 1,000 people

• infection;
• decreased count of all blood cell types;
• severe allergic reactions (DRESS, anaphylaxis, Quincke's oedema)
• decreased sodium levels in the blood;
• suicide, personality disorders (behavioural disturbances), thought disorders (slow thinking, inability to concentrate);
• delirium;
• encephalopathy (detailed description of symptoms in the "Seek immediate medical attention" section);
• involuntary muscle contractions of the head, trunk and limbs, difficulty controlling movements, hyperkinesia (overactivity);
• pancreatitis;
• liver dysfunction, hepatitis;
• sudden kidney failure;
• a rash on the skin that may lead to blistering and looks like a target (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 lips, eyes, mouth, 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 non-Japanese patients.
• paralysis or difficulty walking.

Reporting of 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 Drug Monitoring of 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
Side effects can also be reported to the marketing authorisation holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lepsitam

Keep the medicine out of the sight and reach of 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 month.
There are no special storage requirements.
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 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.
In addition, the medicine contains:
Core: calcium phosphate dihydrate, microcrystalline cellulose, crospovidone (type A), hydroxypropylcellulose
Lepsitam, 250 mg, film-coated tablets
Coating: hypromellose, titanium dioxide (E171), talc, propylene glycol (E1520), indigo carmine (E132), orange yellow S (E110), quinoline yellow (E104)
Lepsitam, 500 mg, film-coated tablets
Coating: hypromellose, titanium dioxide (E171), hydroxypropylcellulose, propylene glycol (E1520), sorbitan monooleate, potassium sorbate, vanilla, quinoline yellow (E104)
Lepsitam, 750 mg, film-coated tablets
Coating: hypromellose, macrogol 4000, titanium dioxide (E171), macrogol 4000, iron oxide red (E172), indigo carmine (E132), orange yellow S (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 packaged in white, non-transparent blisters of PVC/PE/PVDC/Aluminium in a cardboard box.
Lepsitam 250 mg film-coated tablets
Cardboard boxes contain 20, 30, 50, 60, 100 or 200 film-coated tablets.
Lepsitam 500 mg film-coated tablets
Cardboard boxes contain 10, 20, 30, 50, 60, 100, 120 and 200 film-coated tablets.
Lepsitam 750 mg film-coated tablets
Cardboard boxes contain 20, 30, 50, 60, 80, 100, 120 and 200 film-coated tablets.
Lepsitam 1000 mg film-coated tablets
Cardboard 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

Date of last revision of the leaflet: 06/2020