Levetiracetam Krka

Patient Information Leaflet

Levetiracetam Krka 250 mg film-coated tablets, 500 mg film-coated tablets, 1000 mg film-coated tablets

Levetiracetam
Generic medicine
Please read this leaflet carefully before you or your child starts taking this
medicine, as 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 effects, including those not listed in this leaflet, inform your doctor or pharmacist (See section 4).

Contents of this leaflet:

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

1. What Levetiracetam Krka is and what it is used for

Levetiracetam Krka is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Levetiracetam Krka is used:

• as monotherapy in adults and adolescents aged 16 years and older with newly diagnosed epilepsy, to treat a certain type of epilepsy. Epilepsy is a condition in which patients have repeated seizures. Levetiracetam is used for a type of epilepsy where seizures initially affect only one side of the brain, but may later 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 add-on therapy to other antiepileptic medicines to treat:
  • partial-onset seizures, with or without secondary generalization, in adults, adolescents, children and infants aged 1 month and older
  • myoclonic seizures (brief, shock-like jerks of a muscle or group of muscles) in adults and adolescents aged 12 years and older with juvenile myoclonic epilepsy
  • primary generalized tonic-clonic seizures (grand mal seizures, including loss of consciousness) in adults and adolescents aged 12 years and older with idiopathic generalized epilepsy (the type of epilepsy thought to have a genetic cause).

2. What you need to know before taking Levetiracetam Krka

Do not take Levetiracetam Krka:

• 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 Levetiracetam Krka.

• If you have kidney problems, follow your doctor's instructions. Your doctor may decide whether your dose needs to be adjusted.
• If you notice slowed growth or unexpected onset of puberty in the child, contact your doctor.
• A small number of people taking antiepileptic medicines such as Levetiracetam Krka have had thoughts of harming themselves or suicidal thoughts. If you experience any symptoms of depression and/or suicidal thoughts, contact your doctor.

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

• Unusual thoughts, feeling irritable, or more aggressive reactions than usual, or if you or your family and friends notice significant changes in mood or behaviour.

Children and adolescents

• Levetiracetam Krka is not indicated as monotherapy in children and adolescents under 16 years of age.

Other medicines and Levetiracetam Krka
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) within one hour before or one hour after taking levetiracetam, as it may cause loss of effectiveness.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Levetiracetam may be used during pregnancy only if, after careful evaluation, your doctor considers it necessary. You must not stop your treatment without discussing it with your doctor.
The risk of birth defects in the unborn child cannot be completely ruled out.
Breastfeeding is not recommended during treatment.

Driving and using machines
Levetiracetam Krka may impair your ability to drive or operate tools or machinery, as it may cause drowsiness. This is more likely at the beginning of treatment or after a dose increase. You must not drive or operate machinery until you are certain that your ability to perform these activities is not affected.

3. How to take Levetiracetam Krka

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

Monotherapy
Dosage for adults and adolescents (from 16 years of age)
Standard dose: between 1,000 mg and 3,000 mg per day.
When you first start taking Levetiracetam Krka, your doctor will prescribe a lower starting dose for 2 weeks before increasing to the lowest standard dose.
Example: If your daily dose is 1,000 mg, the initial reduced dose you should take is 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.

Adjunctive therapy
Dosage for adults and adolescents (from 12 to 17 years of age) weighing 50 kg or more
Standard dose: between 1,000 mg and 3,000 mg per day.
Example: If your daily dose is 1,000 mg, you should take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.

Dosage for infants (from 1 month to 23 months), children (from 2 to 11 years) and adolescents (from 12 to 17 years) weighing less than 50 kg
Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam based on age, weight, and required dose.
An oral solution is more suitable for infants and children under 6 years of age, for children and adolescents (from 6 to 17 years) weighing less than 50 kg, and when tablets do not allow precise dosing.

Method of administration
Swallow Levetiracetam Krka tablets with a sufficient amount of liquid (e.g. a glass of water). You may take Levetiracetam Krka with or without food. After oral administration, you may experience a bitter taste of levetiracetam.

Duration of treatment

• Levetiracetam Krka is used as a chronic treatment. Treatment with Levetiracetam Krka 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 Levetiracetam Krka than you should
Possible adverse effects of an overdose of Levetiracetam Krka include drowsiness, agitation, aggression, decreased attention, respiratory depression, and coma.
Contact your doctor if you have taken more tablets than prescribed. Your doctor will determine the most appropriate management for overdose.

If you forget to take Levetiracetam Krka
Contact your doctor if you have forgotten to take one or more doses.
Do not take a double dose to make up for the forgotten tablet.

If you stop taking Levetiracetam Krka
As with other antiepileptic medicines, Levetiracetam Krka should be discontinued gradually to avoid an increase in seizure frequency.
If your doctor decides to discontinue treatment with Levetiracetam Krka, they will provide instructions for gradual withdrawal.

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 gets them.
Contact your doctor immediately or go to the nearest emergency room if you experience:

• weakness, dizziness, lightheadedness, or difficulty breathing, as these may be signs of a severe allergic (anaphylactic) reaction,
• swelling of the face, lips, tongue, or throat (Quincke's oedema);
• flu-like symptoms and a rash on the face followed by a widespread rash with high fever, increased liver enzyme levels in blood tests, increased levels of 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 the legs, ankles, or feet, as these may indicate sudden kidney dysfunction;
• a skin rash that appears as blisters 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 close to you notices confusion, drowsiness, amnesia (memory loss), impaired memory (forgetfulness), abnormal behaviour, or other neurological signs including involuntary or uncontrolled movements. These could be symptoms of encephalopathy.

The most frequently reported side effects are nasopharyngitis, drowsiness (sleepiness), headache, fatigue, and dizziness. At the beginning of treatment or when the dose is increased, side effects such as increased drowsiness, fatigue, and dizziness may occur more frequently. However, these effects should decrease over time.

Very common: may affect more than 1 in 10 people

• nasopharyngitis;
• drowsiness, headache.

Common: may affect from 1 to 10 in 100 people

• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, restlessness or irritability;
• seizure, loss of balance (balance disorder), dizziness (sensation of instability), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (sensation of spinning);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• rash;
• asthenia/fatigue (tiredness).

Uncommon: may affect from 1 to 10 in 1,000 people

• decrease in the number of platelets in the blood, decrease in the number of white blood cells;
• weight loss, weight gain;
• suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, rage, confusion, panic attack, emotional instability/mood swings, agitation;
• amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordinated movements), paraesthesia (tingling), attention disorder (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated or abnormal liver function tests;
• hair loss, eczema, pruritus (itching);
• muscle weakness, myalgia (muscle pain);
• injury.

Rare: may affect from 1 to 10 in 10,000 people

• infection;
• decrease in all types of blood cells;
• severe allergic reactions (DRESS, anaphylactic reactions [severe and significant allergic reactions], Quincke's oedema [swelling of the face, lips, tongue, and throat]);
• reduced concentration of sodium in the blood;
• suicides, personality disorders (behavioural problems), thought disturbance (slow thinking, inability to concentrate);
• delirium;
• encephalopathy (see the subsection “Contact your doctor immediately” for a detailed description of symptoms);
• uncontrollable muscle spasms affecting the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• pancreatitis;
• liver failure, hepatitis;
• sudden decrease in kidney function;
• skin rash that may appear as blisters 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), 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 prevalence 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 can also report side effects directly via the national reporting system at https://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 Levetiracetam Krka

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 Exp. The expiry date refers to the last day of that month.
Store below 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Levetiracetam Krka contains
The active substance is called levetiracetam.
Each Levetiracetam Krka 250 mg film-coated tablet contains 250 mg of levetiracetam.
Each Levetiracetam Krka 500 mg film-coated tablet contains 500 mg of levetiracetam.
Each Levetiracetam Krka 1000 mg film-coated tablet contains 1000 mg of levetiracetam.

The other components are:
Tablet core: Maize starch, Anhydrous colloidal silica, Copovidone, Crospovidone, Magnesium stearate.
Coating: Hypromellose, Talc, Titanium dioxide (E 171), Macrogol, colourants*
*The colourants are:
250 mg film-coated tablet: indigo carmine lake (E 132).
500 mg film-coated tablet: yellow iron oxide (E 172).
1000 mg film-coated tablet: no additional colourant added.

Description of the appearance of Levetiracetam Krka and package contents
Levetiracetam Krka 250 mg film-coated tablets are light blue, oblong, 13.2 x 6.1 x 5.3 mm.
Levetiracetam Krka 500 mg film-coated tablets are light yellow, oblong, with a score line on both sides, 17.2 x 8.2 x 5.7 mm. The tablet can be divided into equal doses.
Levetiracetam Krka 1000 mg film-coated tablets are white, oblong, with a score line on both sides, 22.3 x 10.5 x 7.0 mm. The tablet can be divided into equal doses.

Carton packages contain 10, 30, 50, 60, 100 or 200 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local representative in Italy
KRKA Farmaceutici Milano S.r.l., Viale Achille Papa 30, 20149 Milano, Italy

Manufacturer
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This medicinal product is authorised in the European Economic Area Member States under the following names: