Levetiracetam aurovitas

Package leaflet: information for the patient

Levetiracetam Aurovitas, 100 mg/ml, oral solution
Levetiracetamum
Please read carefully the entire leaflet before taking the medicine or giving it to a child, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• 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. It may harm other people, even if their symptoms are the same.
• 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. Important information 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 is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Levetiracetam Aurovitas is used:

• as monotherapy (using Levetiracetam Aurovitas alone) in the treatment of adults and adolescents aged 16 years and older with newly diagnosed epilepsy, for certain types of seizures. Epilepsy is a condition in which patients have recurrent seizures (convulsions). Levetiracetam is used to treat partial-onset seizures, which may secondarily generalize or remain without secondary generalization, meaning seizures that start in one part of the brain and may then spread to larger areas of both brain hemispheres. Your doctor has prescribed levetiracetam to reduce the number of seizures;
• as an add-on therapy to other antiepileptic medicines:
• in adults, adolescents, children and infants from 1 month of age, for the treatment of partial-onset 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 single muscles or muscle groups);
• 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 taking Levetiracetam Aurovitas

When not to use Levetiracetam Aurovitas

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

Warnings and precautions
Before starting treatment with Levetiracetam Aurovitas, consult 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 you notice any growth retardation or unexpected early puberty in a child, contact your 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 your doctor immediately.
• If the patient has a family history of, or previously experienced, irregular heart rhythm (as seen on electrocardiogram), or if the patient has a disease and/or is taking medicines that may predispose to irregular heart rhythm or electrolyte imbalance.

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

• Abnormal thoughts, irritability, more aggressive reactions than usual, or significant changes in mood or behaviour noticed by the patient or by family and friends.
• Worsening of epilepsy. In rare cases, seizures may increase in frequency or severity, especially during the first month of treatment or after increasing the dose. If any of these new symptoms occur while taking Levetiracetam Aurovitas, contact your doctor as soon as possible.

Children and adolescents

• The use of Levetiracetam Aurovitas as monotherapy (Levetiracetam Aurovitas 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 you are currently taking, have recently taken, or plan to take.
Do not take macrogol (a medicine used for constipation) one hour before or one hour after taking levetiracetam, as this may interfere with the effectiveness of levetiracetam.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, you should consult your doctor or pharmacist before taking this medicine.
Levetiracetam may be used during pregnancy only if, after careful evaluation, the treating doctor considers it necessary. Do not stop treatment without discussing it with your doctor.
A risk of congenital malformations in the unborn child cannot be completely ruled out.
Breastfeeding is not recommended during treatment.

Driving and operating machinery
Levetiracetam Aurovitas may impair the ability to drive or operate tools or machinery, as the medicine may cause drowsiness. This is more likely at the beginning of treatment or after an increase in dose. Do not drive or operate machinery until you know how this medicine affects your ability to perform these activities.

Levetiracetam Aurovitas contains methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216) and maltitol
Levetiracetam Aurovitas oral solution contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (delayed-type).
Levetiracetam Aurovitas oral solution contains maltitol. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Levetiracetam Aurovitas, 100 mg/ml, oral solution contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per unit volume, meaning the medicine is considered "sodium-free".

3. How to take Levetiracetam Aurovitas

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult
your doctor or pharmacist.
Levetiracetam Aurovitas should be taken twice daily, in the morning and evening, approximately
at the same time each day.
The oral solution should be taken according to the doctor's instructions.

Monotherapy (from age 16 onwards)
Adults (≥ 18 years) and adolescents (from age 16):
Measure the appropriate dose using the 10 ml syringe supplied with the packaging intended for
patients aged 4 years and older.
Recommended dose: Levetiracetam Aurovitas is taken twice daily, in two equal doses, each dose
ranging from 5 ml (500 mg) to 15 ml (1500 mg).
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 daily maintenance dose.

Adjunctive therapy
Dosage in adults and adolescents (aged 12 to 17 years):
Measure the appropriate dose using the 10 ml syringe supplied with the packaging intended for
patients aged 4 years and older.
Recommended dose: Levetiracetam Aurovitas is taken twice daily, in two equal doses, each dose
ranging from 5 ml (500 mg) to 15 ml (1500 mg).

Dosage in children from 6 months of age:
The doctor will recommend the most appropriate formulation of Levetiracetam Aurovitas depending
on the child's age, body weight, and required dose.

• For children aged 6 months to under 4 years, measure the appropriate dose using the 3 ml
  syringe supplied with the packaging.
• For children aged 4 years and older, measure the appropriate dose using the 10 ml syringe
  supplied with the packaging.
  Recommended dose: Levetiracetam Aurovitas is taken twice daily, in two equal doses, each dose
  ranging from 0.1 ml (10 mg) to 0.3 ml (30 mg) per kilogram of the child's body weight (see table
  below for examples of dosing).

Dosing in children from 6 months of age and older

Dosage for infants (aged 1 to below 6 months):
For infants aged 1 month to below 6 months, the appropriate dose should be measured using the 1 ml syringe provided in the package.
Recommended dose: Levetiracetam Aurovitas should be administered twice daily in two equal doses, each dose ranging between 0.07 ml (7 mg) and 0.21 ml (21 mg) per kilogram of the infant's body weight (see the table below for examples of dosing).
Dosing in infants (aged 1 to below 6 months):

Method of administration:
After measuring the appropriate dose using the correct syringe, Levetiracetam Aurovitas oral solution may be diluted in a glass of water or in a baby feeding bottle. Levetiracetam Aurovitas may be taken with or without food. After oral administration, levetiracetam may leave a bitter taste.

Instructions for preparing the medicine for use:

• Open the bottle: press down on the cap and turn it counterclockwise (Figure 1)

• Separate the connector from the syringe (Figure 2). Place the connector into the neck of the bottle (Figure 3). Make sure it is securely attached.

• Push the dosing syringe firmly into the opening of the connector (Figure 4). Turn the bottle upside down (Figure 5)

• Draw a small amount of the solution into the syringe by pulling the plunger down (Figure 5A), then push the plunger to expel any air bubbles from the syringe (Figure 5B). Pull the plunger down to the mark corresponding to the dose prescribed by the doctor in millilitres (ml) (Figure 5C).

• Turn the bottle upright (Figure 6A). Remove the syringe from the connector (Figure 6B).

• Empty the contents of the syringe into a glass of water or a baby feeding bottle by pressing the syringe plunger (Figure 7).

• Drink the entire contents of the glass or feeding bottle.
• Close the bottle with the plastic cap.
• Rinse the syringe with water (Figure 8).

Duration of treatment:

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

Overdose of Levetiracetam Aurovitas:
Possible adverse effects after overdose of Levetiracetam Aurovitas include drowsiness, agitation, aggression, decreased alertness, respiratory depression, and coma.
If an overdose 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 Levetiracetam Aurovitas:
If one or more doses of the medicine have been missed, contact your doctor. Do not take a double dose to make up for a missed dose.

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, they will also advise you on how to taper the medicine gradually.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should immediately inform your 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 (anaphylaxis);
• swelling of the face, lips, tongue or throat (Quincke's oedema);
• 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), 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 the legs, ankles or feet, as these may indicate sudden worsening of kidney function;
• skin rash which may lead to blistering and appear as small target-like lesions (a dark spot surrounded by a lighter area and a dark ring around it) (erythema multiforme);
• extensive rash with blisters and peeling skin, occurring mainly around the mouth, eyes, nose and genital organs (Stevens-Johnson syndrome);
• a more severe form of rash causing skin detachment from over 30% of the body surface (toxic epidermal necrolysis);
• signs of serious mental changes, or if the patient shows signs of disorientation, drowsiness, amnesia (loss of memory), memory disturbances (forgetfulness), behavioural disturbances or other neurological symptoms including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most commonly reported adverse reactions are: inflammation of the mucous membranes of the nose and throat, somnolence, headache, fatigue and dizziness. At the beginning of treatment or when increasing the dose, adverse reactions such as somnolence, fatigue or dizziness may occur more frequently. These effects should diminish over time.
Very common: may affect more than 1 in 10 patients

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

Common: may affect up to 1 in 10 patients

• loss of appetite;
• depression, feeling of hostility or aggression, anxiety, insomnia, nervousness or irritability;
• seizures, impaired balance, dizziness (feeling of unsteadiness), 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 patients

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

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

• infection;
• decreased number of all types of blood cells;
• severe hypersensitivity reactions (drug rash with eosinophilia and systemic symptoms - DRESS syndrome, Quincke's oedema (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 "You should immediately inform your doctor");
• seizures may worsen or occur more frequently;
• involuntary contractions of head, trunk and limb muscles, difficulty controlling movements, hyperkinesia (overactivity);
• change in heart rhythm (electrocardiographic examination);
• pancreatitis;
• liver function disorders, hepatitis;
• sudden worsening of kidney function;
• skin rash which may lead to blistering and appear as small target-like lesions (a dark spot surrounded by a lighter area and a dark ring around it) (erythema multiforme), extensive rash with blisters and peeling skin, occurring mainly around the mouth, eyes, nose and genital organs (Stevens-Johnson syndrome), and a more severe form of rash causing skin detachment from over 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of striated muscles) and associated increase in creatine phosphokinase activity in blood. Occurrence is significantly more frequent in Japanese patients compared to non-Japanese patients;
• limping or difficulty walking;
• concurrent occurrence of fever, muscle rigidity, unstable blood pressure and heart rate, disorientation, low level of consciousness (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.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Levetiracetam Aurovitas

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the stated month.
No special precautions for storage of this medicinal product.
Do not use more than 7 months after first opening the bottle.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Levetiracetam Aurovitas contains

• The active substance is levetiracetam. Each ml contains 100 mg of levetiracetam.
• Other ingredients are: liquid maltitol (E 965), glycerol (E 422), propylene glycol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), citric acid monohydrate, sodium citrate, acesulfame potassium (E 950), Mafco Magnasweet containing: glycerine and ammonium glycyrrhizinate, grape flavour containing: flavours, propylene glycol, ascorbic acid, purified water.

What Levetiracetam Aurovitas looks like and contents of the pack
Levetiracetam Aurovitas 100 mg/ml oral solution is a clear, colourless liquid with a grape flavour.

300 ml of Levetiracetam Aurovitas oral solution in an amber glass bottle (Type III) (for children from 4 years of age and older, adolescents and adults) with a white child-resistant closure, packaged in a cardboard box containing also a 10 ml oral syringe (graduated every 0.25 ml) and a syringe adapter.

150 ml of Levetiracetam Aurovitas oral solution in an amber glass bottle (Type III) (for infants and young children from 6 months up to below 4 years of age) with a white child-resistant closure, packaged in a cardboard box containing also a 3 ml oral syringe (graduated every 0.1 ml) and a syringe adapter.

150 ml of Levetiracetam Aurovitas oral solution in an amber glass bottle (Type III) (for infants from 1 month up to below 6 months of age) with a white child-resistant closure, packaged in a cardboard box containing also a 1 ml oral syringe (graduated every 0.05 ml) and a syringe adapter.

Not all pack sizes may be marketed.

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

Manufacturer/Importer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Levetiracetam Aurobindo Pharma Italia
Malta: Levetiracetam Aurobindo 100 mg/ml oral solution
Poland: Levetiracetam Aurovitas
Portugal: Levetiracetam Aurovitas
Spain: Levetiracetam Aurovitas 100 mg/ml solución oral EFG