Levetiracetam aurovitas

Package leaflet: Information for the user

Levetiracetam Aurovitas 250 mg, film-coated tablets
Levetiracetam Aurovitas 500 mg, film-coated tablets
Levetiracetam Aurovitas 750 mg, film-coated tablets
Levetiracetam Aurovitas 1000 mg, film-coated tablets
Levetiracetamum
Please read the entire leaflet carefully before taking this medicine or giving it to a child, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, 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 similar.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

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

Levetiracetam Aurovitas film-coated tablets is an antiepileptic medicine (a medicine used to treat epileptic seizures).
Levetiracetam Aurovitas is used:

• as monotherapy (as the only medicine) in the treatment of adults and adolescents aged 16 years and older with newly diagnosed epilepsy, for certain types of epilepsy. Epilepsy is a condition in which patients experience recurrent seizures (fits). Levetiracetam is used to treat a type of epilepsy where seizures start in one part of the brain and may then spread to larger areas of both brain hemispheres (secondarily generalized partial seizures or partial seizures without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures;
• as an add-on therapy in addition to another antiepileptic medicine:
• in adults, adolescents, children and infants from 1 month of age, for the treatment of partial seizures with or without secondary generalization;
• in adults and adolescents aged 12 years and older, for the treatment of juvenile myoclonic epilepsy, specifically myoclonic seizures (brief, shock-like jerks of a muscle or group of muscles);
• in adults and adolescents aged 12 years and older, for the treatment of idiopathic generalized epilepsy (a type of epilepsy likely to have a genetic basis), specifically for primary generalized tonic-clonic seizures (major seizures, including loss of consciousness).

2. Important information before using Levetiracetam Aurovitas

When not to use Levetiracetam Aurovitas

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

Warnings and precautions
Before starting treatment with Levetiracetam Aurovitas, discuss the following with your doctor:

• If the patient has kidney disease, Levetiracetam Aurovitas should be used according to the doctor's recommendations. The doctor may decide to adjust the dosage.
• If any growth retardation or unexpected premature puberty in a child is observed, contact the doctor.
• In some patients treated with antiepileptic medicines such as Levetiracetam Aurovitas, thoughts about self-harm or suicidal thoughts have occurred. If symptoms of depression and/or suicidal thoughts occur, contact the doctor.
• If the patient has a family history or previous personal history of irregular heart rhythm (seen on electrocardiogram), or if the patient has a disease and/or is taking medicines that may predispose to irregular heart rhythm or electrolyte imbalances.

Inform your doctor or pharmacist if any of the following adverse effects become severe or persist for more than a few days:

• Abnormal thoughts, irritability, more aggressive behaviour than usual, or significant changes in mood or behaviour noticed by the patient or their family and friends.
• Worsening of epilepsy. In rare cases, seizures may increase in frequency or severity, especially during the first month after starting treatment or increasing the dose. In a very rare early-onset form of epilepsy (epilepsy associated with SCN8A gene mutations) causing various seizure types and loss of skills, the patient may notice that seizures continue or worsen during treatment.

If any of these new symptoms appear while taking Levetiracetam Aurovitas, contact your doctor as soon as possible.
Children and adolescents

• The use of Levetiracetam Aurovitas as monotherapy (Levetiracetam Aurovitas used alone) is not recommended in children and adolescents under 16 years of age.

Levetiracetam Aurovitas and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Do not take macrogol (a medicine used for constipation) within one hour before or one hour after taking levetiracetam, as this may reduce the effectiveness of levetiracetam.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Levetiracetam may be used during pregnancy only if, after careful assessment, the treating doctor considers it necessary. Do not discontinue treatment without discussing it with your doctor.
A risk of congenital malformations in the unborn child cannot be completely ruled out. Results from two studies do not suggest an increased risk of autism or intellectual disability in children born to mothers treated with levetiracetam during pregnancy. However, available data on the effects of levetiracetam on neurodevelopment in children are limited.
Breastfeeding is not recommended during treatment.
Driving and operating machinery
Levetiracetam Aurovitas may impair the ability to drive or operate tools or machinery, as treatment with Levetiracetam Aurovitas may cause drowsiness. This is more likely at the beginning of treatment or after a dose increase. Driving and operating machinery should be avoided until the effect of the medicine on the patient's ability to perform these activities is known.
Levetiracetam Aurovitas 750 mg film-coated tablets contain the colouring agent sunset yellow (E 110), which may cause allergic reactions.

3. How to take Levetiracetam Aurovitas

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If in doubt,
please consult your doctor or pharmacist.
Take the number of tablets as directed by your doctor.
Levetiracetam Aurovitas must be taken twice daily, in the morning and evening, approximately at the
same time each day.

Adjunctive therapy and monotherapy (from age 16)
Adults (aged ≥ 18) and adolescents (aged 12 to 17 years) weighing 50 kg or less:
Recommended dose: 1000 mg to 3000 mg per day.
If the patient is taking Levetiracetam Aurovitas for the first time, the doctor will initially prescribe a
lower dose for 2 weeks, before increasing to the lowest maintenance daily 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, with the dose gradually increased so that after 2
weeks the daily dose of 1000 mg is reached.

Adolescents (aged 12 to 17 years) weighing 50 kg or less:
The doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Aurovitas based
on body weight and dose.

Dose in infants and children (aged 1 to 23 months) and children (aged 2 to 11 years) weighing less than 50 kg:
The doctor will recommend the most appropriate form of Levetiracetam Aurovitas depending on age,
body weight, and required dose.
Levetiracetam Aurovitas 100 mg/ml oral solution is the more suitable formulation for infants and
children under 6 years of age, as well as for children and adolescents (aged 6 to 17 years) weighing less
than 50 kg, and also when the correct dose cannot be administered using tablets.

Method of administration:
Levetiracetam Aurovitas tablets should be swallowed whole with sufficient fluid (e.g. a glass of water).
Levetiracetam Aurovitas may be taken with or without food. After oral administration, levetiracetam
may leave a bitter taste.

Duration of treatment:

• Levetiracetam Aurovitas is used for long-term treatment. Continue taking Levetiracetam Aurovitas for as long as your doctor prescribes.
• Do not stop treatment without consulting your doctor, as this may
  lead to an increase in seizure frequency.

Taking more Levetiracetam Aurovitas than prescribed
Possible adverse effects after overdose of Levetiracetam Aurovitas include drowsiness, agitation,
aggression, reduced alertness, respiratory depression, and coma.
If you have taken more than the prescribed dose, seek immediate medical advice from your doctor or
pharmacist. Your doctor will advise on the best possible treatment for overdose.

If you forget to take Levetiracetam Aurovitas
Contact 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 tablet.

Stopping Levetiracetam Aurovitas
If treatment with Levetiracetam Aurovitas is to be discontinued, the medicine should be withdrawn
gradually to avoid an increase in seizure frequency. If your doctor decides to stop treatment with
Levetiracetam Aurovitas, they will also advise you on how to taper the dose gradually.

If you have any further 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 everybody will experience them.
You should contact a doctor immediately or go to the nearest hospital emergency department if the patient experiences:

• weakness, dizziness or breathing difficulties, as these symptoms may indicate a severe allergic reaction (anaphylaxis);
• swelling of the face, lips, tongue or throat (angioedema);
• flu-like symptoms and rash on the face followed by a rash spreading over the whole body, accompanied by high fever, increased liver enzyme activity observed in blood tests, increase in certain white blood cells (eosinophilia), swollen lymph nodes and involvement of other organs (drug rash with eosinophilia and systemic symptoms - DRESS syndrome);
• symptoms such as reduced urine output, fatigue, nausea, vomiting, confusion, and swelling of the legs, ankles or feet, as these may indicate sudden worsening of kidney function;
• skin rash which may lead to blistering and resemble target lesions (a dark centre surrounded by a lighter area and a dark ring around it) (erythema multiforme);
• widespread rash with blisters and peeling skin, occurring mainly 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 changes, or if the patient shows signs of disorientation, drowsiness, amnesia (memory loss), memory impairment (forgetfulness), behavioural disturbances 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 mucous membranes of the nose and throat, drowsiness, headache, fatigue and dizziness. At the beginning of treatment or after an increase in dose, side effects such as drowsiness, fatigue or dizziness may occur more frequently. These effects should gradually diminish over time.
Very common: may affect more than 1 in 10 people

• inflammation of the mucous membranes of the nose and throat;
• drowsiness, headache.

Common: may affect up to 1 in 10 people

• loss of appetite;
• depression, feeling of hostility or aggression, anxiety, insomnia, nervousness or irritability;
• seizures, loss of balance, dizziness (feeling of swaying), lethargy (lack of energy and motivation), tremor (involuntary shaking);
• vertigo (spinning sensation);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• rash;
• asthenia/fatigue (tiredness).

Uncommon: may affect up to 1 in 100 people

• decreased platelet count, decreased white blood cell count;
• weight loss, weight gain;
• suicidal thoughts and attempts, mental disorders, abnormal behaviour, hallucinations, feeling of anger, disorientation, panic attacks, emotional lability/mood changes, agitation;
• amnesia (memory loss), memory disturbances (forgetfulness), ataxia (impaired coordination of movement), paresthesia (tingling sensation), difficulty concentrating;
• double vision, blurred vision;
• increased/abnormal liver function test results;
• hair loss, acne, itching;
• muscle weakness, muscle pain;
• injuries.

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

• infection;
• decreased count of all types of blood cells;
• severe allergic reactions (drug rash with eosinophilia and systemic symptoms - DRESS syndrome), angioedema (swelling of the face, lips, tongue and throat);
• decreased sodium levels in the blood;
• suicide, personality disorders (behavioural disturbances), thought disorders (slow thinking, inability to concentrate);
• delirium;
• encephalopathy (a detailed description of symptoms is provided in the section "Contact a doctor immediately");
• seizures may worsen or occur more frequently;
• involuntary muscle contractions of the head, trunk and limbs, difficulty controlling movements, hyperkinesia (overactivity);
• change in heart rhythm (electrocardiographic findings);
• pancreatitis;
• liver function disorders, hepatitis;
• sudden worsening of kidney function;
• skin rash which may lead to blistering and resemble target lesions (a dark centre surrounded by a lighter area and a dark ring around it) (erythema multiforme), widespread rash with blisters and peeling skin, occurring mainly 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 serum creatine kinase activity. Occurrence is significantly more frequent in Japanese patients compared to non-Japanese patients;
• limping or difficulty walking;
• occurrence of fever, muscle rigidity, unstable blood pressure and heart rate, disorientation and reduced level of consciousness at the same time (these may be symptoms of a disorder known as neuroleptic malignant syndrome). The frequency of occurrence is significantly higher in Japanese patients compared to non-Japanese patients.

Very rare: may affect up to 1 in 10,000 people

• recurrent unwanted thoughts or impulses, or an inner compulsion to repeatedly perform the same action (obsessive-compulsive disorder).

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring Adverse Drug Reactions, 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.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Levetiracetam Aurovitas

Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the blister pack, carton and
container after EXP. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures help protect
the environment.

6. Contents of the package and other information

What Levetiracetam Aurovitas contains
The active substance is levetiracetam. Each film-coated tablet contains 250 mg, or 500 mg, or 750 mg, or 1000 mg of levetiracetam, respectively.
Other ingredients are:
Tablet core: maize starch, colloidal anhydrous silica (E 551), povidone (K-30) (E 1201), talc (E 553b), magnesium stearate (E 470b).
Coating composition:
250 mg: hypromellose 3cP, hypromellose 6cP (E 464), titanium dioxide (E 171), macrogol 4000, indigo carmine (E 132).
500 mg: hypromellose 3cP, hypromellose 6cP (E 464), titanium dioxide (E 171), macrogol 4000, iron oxide yellow (E 172).
750 mg: hypromellose 3cP, hypromellose 6cP (E 464), titanium dioxide (E 171), macrogol 4000, iron oxide red (E 172), indigo carmine (E 132), sunset yellow (E 110).
1000 mg: hypromellose 5cP (E 464), titanium dioxide (E 171), macrogol 400.

What Levetiracetam Aurovitas looks like and contents of the pack
Film-coated tablet.
Levetiracetam Aurovitas, 250 mg, film-coated tablets
Blue, oval, biconvex film-coated tablets with a scored line dividing the embossings "E" and "10" on one side and smooth on the other side. The tablet can be divided into equal doses.
Levetiracetam Aurovitas, 500 mg, film-coated tablets
Yellow, oval, biconvex film-coated tablets with a scored line dividing the embossings "E" and "11" on one side and smooth on the other side. The tablet can be divided into equal doses.
Levetiracetam Aurovitas, 750 mg, film-coated tablets
Orange, oval, biconvex film-coated tablets with a scored line dividing the embossings "E" and "12" on one side and smooth on the other side. The tablet can be divided into equal doses.
Levetiracetam Aurovitas, 1000 mg, film-coated tablets
White, oval, biconvex film-coated tablets with a scored line dividing the embossings "E" and "13" on one side and smooth on the other side. The tablet can be divided into equal doses.

Levetiracetam Aurovitas film-coated tablets are packed in PVC/PE/PVDC/Aluminium blisters or HDPE containers with PP closure, placed in a cardboard box.
Pack sizes:
Blister pack: 20, 30, 50, 60, 100, 200 and 500 film-coated tablets.
HDPE container: 30, 100, 200 and 500 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
France: Levetiracetam Arrow Lab 250 mg/500 mg/1000 mg, comprimé pelliculé sécable
Germany: Levetiracetam Aurobindo 250 mg/500 mg/750 mg/1000 mg Filmtabletten
Italy: Levetiracetam Aurobindo 500 mg/1000 mg compresse rivestite con film
Netherlands: Levetiracetam Aurobindo 250 mg/500 mg/750 mg/1000 mg, filmomhulde tabletten
Poland: Levetiracetam Aurovitas
Romania: Levetiracetam Aurobindo 500 mg/1000 mg comprimate filmate