Levetiracetam Aurobindo Pharma Italia: detailed information

Package leaflet: Information for the user

Levetiracetam Aurobindo Pharma Italia 100 mg/ml oral solution

Equivalent medicine
Please read all of this leaflet carefully before you or your child take this medicine because 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Levetiracetam Aurobindo Pharma Italia is and what it is used for
What you need to know before taking Levetiracetam Aurobindo Pharma Italia
How to take Levetiracetam Aurobindo Pharma Italia
Possible side effects
How to store Levetiracetam Aurobindo Pharma Italia
Contents of the pack and other information

1. What Levetiracetam Aurobindo Pharma Italia is and what it is used for

Levetiracetam Aurobindo Pharma Italia is an antiepileptic medicine (a medicine used to treat
epileptic seizures).
Levetiracetam Aurobindo Pharma Italia is used:

as monotherapy in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a specific type of epilepsy. Epilepsy is a condition in which patients experience repeated seizures. Levetiracetam is used for the type of epilepsy in which the seizure starts in only one part of the brain but may subsequently spread to wider areas on both sides of the brain (partial-onset seizures with or without secondary generalization). Levetiracetam has been prescribed by your doctor 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 from 1 month of age;
- myoclonic seizures (brief, shock-like jerks of a muscle or muscle group) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;
- primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalized epilepsy (the type of epilepsy believed to have a genetic cause).

2. What you should know before taking Levetiracetam Aurobindo Pharma Italia

Do not use Levetiracetam Aurobindo Pharma Italia

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Levetiracetam Aurobindo Pharma Italia.

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 development of puberty in a child, contact your doctor.
A small number of people taking antiepileptic medicines such as Levetiracetam Aurobindo Pharma Italia have experienced suicidal thoughts or self-harming thoughts. If you experience any symptoms of depression and/or have suicidal thoughts, contact your doctor.
If you or a family member has a cardiac arrhythmia (visible on electrocardiogram), or if you have a disease and/or are taking medicines that may cause irregular heartbeats or electrolyte imbalances.

Inform your doctor or pharmacist if any of the following side effects worsen or last longer than a few days:

Unusual thoughts, feeling irritable, or more aggressive reactions than usual, or if you, your family, or friends notice the onset of significant changes in mood or behaviour.
Worsening of epilepsy. Seizures may rarely worsen or occur more frequently, especially during the first month after starting treatment or increasing the dose. In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations), which causes multiple seizure types and loss of developmental skills, you may notice that seizures persist or worsen during treatment.

If you experience any of these new symptoms while being treated with Levetiracetam Aurobindo Pharma Italia, consult a doctor as soon as possible.
Children and adolescents

Levetiracetam Aurobindo Pharma Italia used alone (monotherapy) is not indicated in children and adolescents under 16 years of age.

Other medicines and Levetiracetam Aurobindo Pharma Italia
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 a loss of effectiveness of levetiracetam.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Levetiracetam Aurobindo Pharma Italia may be used during pregnancy only if, after careful evaluation, your doctor considers it necessary. You should not stop your treatment without discussing it with your doctor first. The risk of birth defects in the unborn child cannot be completely ruled out.
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 impact of levetiracetam on children's neurological development are limited.
Breastfeeding is not recommended during treatment.
Driving and using machines
Levetiracetam Aurobindo Pharma Italia may reduce 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 use machinery until you have determined that your ability to perform these activities is not impaired.
Levetiracetam Aurobindo Pharma Italia contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216)
Levetiracetam Aurobindo Pharma Italia oral solution contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (including delayed reactions).
Levetiracetam Aurobindo Pharma Italia oral solution also contains maltitol. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Propylene glycol
This medicine contains 20.27 mg of propylene glycol per 1 ml of dosage unit. If your child is less than 4 weeks old, talk to your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.
Levetiracetam Aurobindo Pharma Italia 100 mg/ml oral solution contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dosage unit, i.e. it is essentially 'sodium-free'.

3. How to take Levetiracetam Aurobindo Pharma Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Levetiracetam Aurobindo Pharma Italia should be taken twice daily, once in the morning and once in the
evening, approximately at the same time each day.
Take the oral solution as instructed by your doctor.
Monotherapy (from age 16 onwards)
Adults (≥18 years) and adolescents (from age 16 onwards):
Measure the appropriate dose using the 10 ml syringe provided in the package for patients from 4 years of
age.
Recommended dose:
Levetiracetam Aurobindo Pharma Italia is taken twice daily in two equally divided doses, each ranging from
5 ml (500 mg) to 15 ml (1500 mg).
When starting Levetiracetam Aurobindo Pharma Italia for the first time, your doctor will prescribe a lower dose for 2 weeks before increasing to the lowest daily dose.
Adjunctive therapy
Dose for adults and adolescents (from 12 to 17 years of age):
Measure the appropriate dose using the 10 ml syringe provided in the package for patients from 4 years of
age.
Recommended dose:
Levetiracetam Aurobindo Pharma Italia is taken twice daily in two equally divided doses, each ranging from
5 ml (500 mg) to 15 ml (1500 mg).
Dose for children from 6 months of age onwards:
Your doctor will prescribe the most appropriate formulation of Levetiracetam Aurobindo Pharma Italia based
on the child's age, weight, and required dose.
For children from 6 months to 4 years of age, measure the appropriate dose using the 3 ml syringe provided
in the package.
For children above 4 years of age, measure the appropriate dose using the 10 ml syringe provided in the
package.
Recommended dose: Levetiracetam Aurobindo Pharma Italia is taken twice daily in two equally divided
doses, each ranging from 0.1 ml (10 mg) to 0.3 ml (30 mg) per kg of the child's body weight (see the
following table for dose examples).
Dose for children from 6 months of age onwards:

Weight	Initial dose: 0.1 ml/kg twice daily	Maximum dose: 0.3 ml/kg twice daily
6 kg	0.6 ml twice daily	1.8 ml twice daily
8 kg	0.8 ml twice daily	2.4 ml twice daily
10 kg	1 ml twice daily	3 ml twice daily
15 kg	1.5 ml twice daily	4.5 ml twice daily
20 kg	2 ml twice daily	6 ml twice daily
25 kg	2.5 ml twice daily	7.5 ml twice daily
50 kg and above	5 ml twice daily	15 ml twice daily

Dose for infants (from 1 month to less than 6 months):
For infants from 1 month to less than 6 months, measure the appropriate dose using the 1 ml syringe
provided in the package.
Recommended dose: Levetiracetam Aurobindo Pharma Italia is taken twice daily, in equally divided doses,
each ranging from 0.07 ml (7 mg) to 0.21 ml (21 mg) per kg of body weight (see the table below for dose
examples).
Dose for infants (from 1 month to less than 6 months):

Weight	Initial dose: 0.07 ml/kg twice daily	Maximum dose: 0.21 ml/kg twice daily
4 kg	0.3 ml twice daily	0.85 ml twice daily
5 kg	0.35 ml twice daily	1.05 ml twice daily
6 kg	0.45 ml twice daily	1.25 ml twice daily
7 kg	0.5 ml twice daily	1.5 ml twice daily

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

Instructions for use:

Open the bottle: press down on the cap and turn it counterclockwise (Figure 1).
Separate the adapter from the syringe (Figure 2). Insert the syringe adapter into the neck of the bottle (Figure 3). Make sure it is securely fixed.
Take the syringe and insert it into the opening of the adapter (Figure 4). Invert the bottle (Figure 5).
Fill the syringe with a small amount of solution by pulling the plunger downward (Figure 5A), then push the plunger upward to remove any possible air bubbles (Figure 5B). Pull the plunger downward until the mark corresponding to the amount in millilitres (mL) prescribed by your doctor is reached (Figure 5C).
Turn the bottle upright (Figure 6A). Remove the syringe from the adapter (Figure 6B).
Pour the contents of the syringe into a glass of water or a feeding bottle by pressing the plunger fully down (Figure 7).
Drink the entire contents of the glass/bottle.
Close the bottle with the plastic screw cap.
Do not use or apply solvents when cleaning the syringe; clean the syringe gently with water only after use.
Avoid applying force and clean the syringe gently after cleaning (Figure 8).

Duration of treatment:

Levetiracetam Aurobindo Pharma Italia is used as a chronic treatment. Treatment with Levetiracetam Aurobindo Pharma Italia should continue for as long as prescribed by your doctor.
Do not stop treatment without consulting your doctor, as this may increase the frequency of seizures.

If you take more Levetiracetam Aurobindo Pharma Italia than you should:
Possible adverse effects of an overdose of Levetiracetam Aurobindo Pharma Italia include drowsiness, agitation, aggression, decreased attention, respiratory depression, and coma.
Contact your doctor if you have taken more Levetiracetam Aurobindo Pharma Italia than you should. Your doctor will determine the most appropriate treatment for the overdose.

If you forget to take Levetiracetam Aurobindo Pharma Italia:
Contact your doctor if you have forgotten to take one or more doses. Do not take a double dose to make up for the missed dose.

If you stop taking Levetiracetam Aurobindo Pharma Italia:
If treatment interruption is necessary, Levetiracetam Aurobindo Pharma Italia should be discontinued gradually to avoid an increase in seizures. If your doctor decides to discontinue treatment with Levetiracetam Aurobindo Pharma Italia, they will provide you with instructions for the gradual discontinuation of the medication.

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

weakness, feeling faint or dizzy, or have difficulty breathing, as these may be signs of a severe allergic (anaphylactic) reaction;
swelling of the face, lips, tongue, or throat (Quincke's edema);
flu-like symptoms and a rash on the face followed by widespread rash with high fever, increased liver enzyme levels observed in blood tests, increase in a type of white blood cells (eosinophilia), swollen lymph nodes, and involvement of other organs (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 legs, ankles, or feet, as these may indicate sudden kidney dysfunction;
a skin rash that may present as blisters appearing like small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
widespread rash with blisters and skin peeling, particularly 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 severe mental disturbances, or if someone around you notices confusion, drowsiness, amnesia (memory loss), impaired memory (forgetfulness), abnormal behavior, or other neurological signs, including involuntary or uncontrolled movements. These could be symptoms of encephalopathy.

The most commonly reported side effects are: nasopharyngitis, drowsiness, headache, fatigue, and dizziness. At the beginning of treatment or when the dose is increased, side effects such as drowsiness, fatigue, and dizziness may be more frequent. However, these effects should decrease over time.
Very common: may affect more than 1 in 10 people

nasopharyngitis;
drowsiness, headache.

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

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

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

infection;
decreased count of all types of blood cells;
severe allergic reactions (DRESS, anaphylactic reaction [severe and serious allergic reaction], Quincke's edema [swelling of face, lips, tongue, and throat]);
low sodium levels in the blood;
suicide, personality disorders (behavioral problems), thought disturbance (slow thinking, inability to concentrate);
delirium;
encephalopathy (see the section "Contact your doctor immediately" for a detailed description of symptoms);
seizures may worsen or occur more frequently;
uncontrollable muscle spasms involving the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
change in heart rhythm (electrocardiogram);
pancreatitis;
liver failure, hepatitis;
sudden decrease in kidney function;
skin rash that may form blisters and appear as small targets (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a very extensive rash with blisters and skin peeling, particularly 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;
combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, and reduced level of consciousness (may be signs of a condition called neuroleptic malignant syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

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

repetitive unwanted thoughts or urges to perform actions repeatedly (obsessive-compulsive disorder).

Reporting of side effects
If you experience any side effect, 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 Aurobindo Pharma Italia

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use more than 7 months after first opening the bottle.
Do not dispose of medicines 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 Aurobindo Pharma Italia Contains

The active substance is levetiracetam. Each ml contains 100 mg of levetiracetam.
The excipients are: liquid maltitol (E965), glycerol (E422), propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), citric acid monohydrate, acesulfame potassium (E950), Mafco Magnasweet (glycerin and ammonium glycyrrhizinate), grape flavour (flavouring agents, propylene glycol, ascorbic acid), purified water.

Description of the Appearance of Levetiracetam Aurobindo Pharma Italia and Contents of the Package
Levetiracetam Aurobindo Pharma Italia 100 mg/ml oral solution is a clear, colourless liquid with a grape flavour.

300 ml of solution in an amber glass bottle (Type III) of Levetiracetam Aurobindo Pharma Italia (for children aged 4 years or older, adolescents and adults), with a white child-resistant closure, in a cardboard carton containing also a 10 ml graduated syringe (marked every 0.25 ml) and a syringe adapter.

150 ml of solution in an amber glass bottle (Type III) of Levetiracetam Aurobindo Pharma Italia (for infants and children from 6 months up to but less than 4 years of age), with a white child-resistant closure, in a cardboard carton containing also a 3 ml graduated syringe (marked every 0.1 ml) and a syringe adapter.

150 ml of solution in an amber glass bottle (Type III) of Levetiracetam Aurobindo Pharma Italia (for children from 1 month up to but less than 6 months of age), with a white child-resistant closure, in a cardboard carton containing also a 1 ml graduated syringe (marked every 0.05 ml) and a syringe adapter.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102
21047 - Saronno (VA)
Italy

Manufacturers
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
Portugal: Levetiracetam Aurovitas
Spain: Levetiracetam Aurovitas 100 mg/ml solución oral EFG