Leaflet: information for the user

Levetiracetam Aurovitas 100 mg/ml oral solution EFG

levetiracetam

Read this leaflet carefully before you or your child start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isLevetiracetam Aurovitasand what it is used for

2. What you need to know before starting to takeLevetiracetam Aurovitas

3. How to takeLevetiracetam Aurovitas

4. Possible side effects

5. Storage ofLevetiracetam Aurovitas

6. Contents of the pack and additional information

Levetiracetam is an antiepileptic medication (a medication for the treatment of seizures in epilepsy).

Levetiracetam Aurovitas is used:

• alone in adults and adolescents 16 years of age or older with recently diagnosed epilepsy to treat a form of epilepsy. Epilepsy is a disease where patients have seizures (crises). Levetiracetam is used for the form of epilepsy in which the seizures initially affect only one side of the brain, but may later extend to wider areas in both sides of the brain (partial onset seizures with or without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures.
• concurrently with other antiepileptic medications to treat:
• partial onset seizures with or without generalization in adults, adolescents, children, and infants from 1 month of age.
• myoclonic seizures (shock-like, short, muscle or group of muscles) in adults and adolescents 12 years of age or older with juvenile myoclonic epilepsy.
• primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents 12 years of age or older with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

Do not takeLevetiracetam Aurovitas

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

Warnings and precautions

Consult your doctor before starting to take levetiracetam:

• If you have kidney problems, follow your doctor's instructions, who will decide if you need to adjust your dose.
• If you notice any decrease in your child's growth or an unexpected onset of puberty, contact your doctor.
• A small number of people taking antiepileptic medications, such as levetiracetam, have had thoughts of self-harm or suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.
• If you have a family or medical history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or treatment that makes you prone to irregular heartbeats or electrolyte imbalances.

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

• Abnormal thoughts, feeling irritable, or reacting more aggressively than normal, or if you or your family and friends notice significant changes in mood or behavior.
• Worsening of epilepsy

In rare cases, seizures may worsen or occur more frequently, mainly during the first month after starting treatment or increasing the dose. If you experience any of these new symptoms while taking Levetiracetam Aurovitas, see a doctor as soon as possible.

In a very rare form of early-onset epilepsy (SCN8A mutation-associated epilepsy) that causes multiple types of seizures and loss of skills, you may notice that seizures persist or worsen during treatment.

If you experience any of these new symptoms while taking levetiracetam, see a doctor as soon as possible.

Children and adolescents

• Monotherapy with levetiracetam is not indicated in children and adolescents under 16 years old.

Use of Levetiracetam Aurovitas with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Do not take macrogol (laxative medication) within one hour before and one hour after taking levetiracetam, as it may reduce its effect.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Levetiracetam can only be used during pregnancy if, after careful evaluation, your doctor considers it necessary. Do not stop your treatment without discussing it with your doctor first.No risk of birth defects for the baby can be completely excluded.

It is not recommended to breastfeed naturally during treatment.

Driving and operating machinery

Levetiracetam may affect your ability to drive or operate tools or machinery, as it may cause drowsiness. This is more likely at the start of treatment or when increasing the dose. Do not drive or use machinery until it is confirmed that your ability to perform these activities is not impaired.

Levetiracetam Aurovitascontains parahydroxybenzoic acid methyl ester (E 218) and parahydroxybenzoic acid propyl ester (E 216)

Levetiracetam oral solution, containing parahydroxybenzoic acid methyl ester (E218) and parahydroxybenzoic acid propyl ester (E216), may cause allergic reactions (possibly delayed).

Levetiracetam oral solution also contains maltitol. If your doctor informs you that you have an intolerance to some sugars, contact your doctor before taking this medication.

Propylene glycol

This medication contains 20.27 mg of propylene glycol per ml of oral solution. If the baby is under 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications containing propylene glycol or alcohol.

Levetiracetam Aurovitas 100 mg/ml oral solution EFG contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per ml; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Levetiracetam should be taken twice a day, once in the morning and once at night, approximately at the same time each day.

Take the oral solution according to your doctor's instructions.

Monotherapy(from 16 years of age)

Adults (≥ 18 years) and adolescents (from 16 years of age):

Measure the appropriate dose using the 10 ml syringe included in the package for patients 4 years of age and older.

Recommended dose: Levetiracetam is taken twice a day, divided into two equal doses, each of between 5 ml (500 mg) and 15 ml (1,500 mg).

When starting to take levetiracetam, your doctor will prescribe a lower dose for two weeks before administering the daily minimum dose.

Concomitant therapy

Dose in adults and adolescents (12 to 17 years):

Measure the appropriate dose using the 10 ml syringe included in the package for patients 4 years of age and older.

Recommended dose:

Levetiracetam is taken twice a day, divided into two equal doses, each of between 5 ml (500 mg) and 15 ml (1,500 mg).

Dose in children 6 months of age and older:

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam based on age, weight, and dose.

For children 6 months to 4 years:, measure the appropriate dose using the 3 ml syringe included in the package.

For children over 4 years:, measure the appropriate dose using the 10 ml syringe included in the package.

Recommended dose: Levetiracetam is taken twice a day, divided into two equal doses, each of between 0.1 ml (10 mg) and 0.3 ml (30 mg) per kilogram of body weight of the child (see examples of doses in the table below).

Dose in children 6 months of age and older:

Dosage in infants (1 month to less than 6 months):

For infants 1 month to less than 6 months:, measure the appropriate dose using the 1 ml syringe included in the package.

Recommended dose: Levetiracetam is taken twice a day, divided into two equal doses, each of between 0.07 ml (7 mg) and 0.21 ml (21 mg) per kilogram of body weight of the infant (see examples of doses in the table below).

Dosage in infants (1 month to less than 6 months):

Administration form:

After measuring the correct dose with an appropriate syringe, levetiracetam can be taken by diluting the oral solution in a glass of water or in a bottle. Levetiracetam can be taken with or without food. After oral administration of levetiracetam, its bitter taste may be appreciated.

Instructions for correct administration:

• Open the bottle: press the cap and unscrew in the opposite direction to the clock hands (figure 1)

• Separate the adapter from the syringe (figure 2). Insert the 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). Place the bottle upside down (figure 5).

• Fill the syringe with a small amount of solution by lowering the plunger (figure 5A) and then raising it to eliminate any possible bubbles (figure 5B). Lower the plunger to the graduation mark corresponding to the dose in milliliters (ml) prescribed by your doctor (figure 5C).

• Place the bottle right side up (figure 6A). Remove the syringe from the adapter (figure 6B).

• Empty the contents of the syringe into a glass of water or a bottle by lowering the plunger to the end of the syringe (figure 7).

• Drink the contents of the glass or bottle entirely.
• Close the bottle with the plastic screw cap.
• Wash the syringe only with water (figure 8).

Treatment duration:

• Levetiracetam is used as a chronic treatment. You should continue treatment with levetiracetam for the time indicated by your doctor.
• Do not stop treatment without your doctor's recommendation, as this may increase your seizures.

If you take more Levetiracetam Aurovitas than you should:

The possible adverse effects of a levetiracetam overdose are drowsiness, agitation, aggression, decreased alertness, respiratory inhibition, and coma.

Contact your doctor if you have taken more oral solution than you should. Your doctor will establish the best possible treatment for the overdose.

If you forgot to take Levetiracetam Aurovitas:

Contact your doctor if you have missed one or more doses. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Levetiracetam Aurovitas:

The discontinuation of treatment with levetiracetam should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with levetiracetam, they will give you instructions for the gradual withdrawal of levetiracetam.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, levetiracetam may cause side effects, although not everyone will experience them.

Inform your doctor immediately, or go to the emergency service of your nearest hospital if you experience:

• weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylaxis);
• swelling of the face, lips, tongue, or throat (Quincke's edema);
• flu-like symptoms and a rash on the face followed by a prolonged rash with high temperature, elevated liver enzyme levels in blood tests, and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (drug reaction with eosinophilia and systemic symptoms (DRESS));
• symptoms such as low urine output, fatigue, nausea, vomiting, confusion, and swelling of the legs, arms, or feet, as it may be a sign of sudden kidney function decline;
• a skin rash that can form blisters and may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
• a generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome);
• a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis);
• signs of severe mental changes or if someone around you notices signs of confusion, drowsiness (drowsiness), amnesia (memory loss), memory decline (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported side effects are nasopharyngitis, drowsiness (feeling sleepy), headache, fatigue, and dizziness. Side effects such as feeling sleepy, feeling weak, and dizziness may be more frequent when starting treatment or increasing the dose. However, these side effects should decrease over time.

Very common: may affect more than 1 in 10 people

• nasopharyngitis;
• drowsiness (feeling sleepy), headache.

Common: may affect up to 1 in 10 people

• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, nervousness, or irritability;
• seizures, balance disorder, dizziness (feeling unsteady), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (feeling of rotation);
• cough;
• abdominal pain, diarrhea, indigestion, vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling weak).

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 changes, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory decline (forgetfulness), abnormal coordination/ataxia (coordinated movement altered), paresthesia (tingling), attention alterations (loss of concentration);
• diplopia (double vision), blurred vision;
• abnormal liver function test results;
• hair loss, eczema, 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, anaphylaxis (severe and life-threatening allergic reaction), Quincke's edema (swelling of the face, lips, tongue, and throat));
• decreased sodium concentration in blood;
• suicide, personality disorders (behavior problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see "Inform your doctor immediately" for a detailed description of symptoms);
• seizures may worsen or occur more frequently;
• involuntary muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• electrocardiogram changes;
• pancreatitis (inflammation of the pancreas);
• liver insufficiency, hepatitis (inflammation of the liver);
• sudden decline in kidney function;
• skin rash, which may lead to blisters that may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), a generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis);
• rhabdomyolysis (muscle tissue breakdown) and elevated creatine phosphokinase blood levels associated. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
• gait disturbance or difficulty walking,

• combination of fever, muscle rigidity, unstable blood pressure, and heart rate, confusion, low 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

• unwanted thoughts or feelings and repeated or the urge to do something over and over (obsessive-compulsive disorder).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Do not use after 7 months of opening the container.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofLevetiracetam Aurovitas

• The active ingredient is levetiracetam. Each ml contains 100 mg of levetiracetam.
• The other components 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 (glycerin, ammonium glycyrrhizate), grape flavor (flavorings, propylene glycol, ascorbic acid), purified water.

Appearance of the product and contents of the package

Levetiracetam Aurovitas 100 mg/ml oral solution EFG is a transparent, colorless liquid with a grape flavor.

The 300 ml (type III) glass bottle of Levetiracetam Aurovitas (for children from 4 years of age, adolescents, and adults) with a white child-resistant cap, is packaged in a cardboard box accompanied by a 10 ml oral syringe (graduated every 0.25 ml) and a syringe adapter.

The 150 ml (type III) glass bottle of Levetiracetam Aurovitas (for infants and small children from 6 months to less than 4 years of age) with a white child-resistant cap, is packaged in a cardboard box accompanied by a 3 ml oral syringe (graduated every 0.1 ml) and a syringe adapter.

The 150 ml (type III) glass bottle of Levetiracetam Aurovitas (for infants from 1 month to less than 6 months of age) with a white child-resistant cap, is packaged in a cardboard box accompanied by a 1 ml oral syringe (graduated every 0.05 ml) and a syringe adapter.

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain:Levetiracetam Aurovitas 100 mg/ml oral solution EFG

Italy:Levetiracetam Aurobindo Pharma Italia

Malta:Levetiracetam Aurobindo 100 mg/ml oral solution

Portugal: Levetiracetam Aurovitas

Last review date of this leaflet:November 2023

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)