Levetiracetam Aristo Pharma

Package leaflet: Information for the patient

Levetiracetam Aristo Pharma 100 mg/ml oral solution

Levetiracetam
Generic medicine
Please read this leaflet carefully before you or your child start taking 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Levetiracetam Aristo Pharma is and what it is used for

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

• as monotherapy in adults and adolescents from the age of 16 years with newly diagnosed epilepsy, to treat a certain type of epilepsy. Epilepsy is a condition in which patients have repeated attacks (seizures). Levetiracetam is used for the type of epilepsy in which the seizure initially affects 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). 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 from 1 month of age
• myoclonic seizures (brief, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy
• primary generalized tonic-clonic seizures (grand mal 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 need to know before taking Levetiracetam Aristo Pharma

Do not take Levetiracetam Aristo Pharma

• 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 Aristo Pharma

• 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 Aristo Pharma have experienced self-harming thoughts or suicidal ideation. 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 or your family and friends notice significant changes in mood or behaviour.
• Worsening of epilepsy: Seizures may rarely worsen or occur more frequently, mainly 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 Aristo Pharma,
consult a doctor as soon as possible.
Children and adolescents

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

Other medicines and Levetiracetam Aristo Pharma
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 reduce the effect of levetiracetam.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, inform
your doctor before taking this medicine.
Levetiracetam may be used during pregnancy only if, after careful evaluation, your doctor considers
it necessary.
Do not stop your treatment without discussing it with your doctor.
A risk of birth defects for 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 Aristo Pharma may reduce your ability to drive or use 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 have determined that your ability to perform these
activities is not impaired.
Levetiracetam Aristo Pharma contains methyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate, sodium, maltitol, benzyl alcohol, propylene glycol, and potassium
Levetiracetam Aristo Pharma oral solution contains methyl 4-hydroxybenzoate (E 218) and
propyl 4-hydroxybenzoate (E 216), which may cause allergic reactions (including delayed-type
reactions).
Levetiracetam Aristo Pharma oral solution also contains maltitol. If your doctor has diagnosed you
with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains 2.3 mg of sodium (the main component of table salt) per ml. This is
equivalent to 0.1% of the maximum daily recommended dietary intake of sodium for an adult.
This medicine contains 0.0083 mg of benzyl alcohol per ml. Benzyl alcohol may cause allergic
reactions.
Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing
problems (gasping syndrome), in young children. Do not administer to neonates up to 4 weeks of
age unless advised by a doctor.
Do not use for more than one week in young children (under 3 years of age) unless otherwise
recommended by a doctor or pharmacist.
Ask your doctor or pharmacist for advice if you are pregnant or breastfeeding, as large amounts
of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic
acidosis).
Ask your doctor or pharmacist for advice if you have liver or kidney disease, as large amounts of
benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic
acidosis).
This medicine contains 3.435 mg of propylene glycol per ml. If the 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.
This medicine contains 2.9 mg of potassium per ml. This should be taken into account in patients
with impaired renal function and in patients on a potassium-controlled diet.

3. How to take Levetiracetam Aristo Pharma

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Levetiracetam Aristo Pharma 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 16 years of age)
Adults (≥ 18 years) and adolescents (from 16 years of age):
Measure the appropriate dose using the 10 ml syringe provided in the package for patients aged 4 years and older.
Recommended dose: Levetiracetam Aristo Pharma should be taken twice daily, in two equal doses, each ranging between 5 ml (500 mg) and 15 ml (1500 mg).
When you first start taking Levetiracetam Aristo Pharma, your doctor will prescribe a lower dose for 2 weeks before increasing to the lowest daily maintenance dose.

Adjunctive therapy
Dose for adults and adolescents (aged 12 to 17 years):
Measure the appropriate dose using the 10 ml syringe provided in the package for patients aged 4 years and older.
Recommended dose: Levetiracetam Aristo Pharma should be taken twice daily, in two equal doses, each ranging between 5 ml (500 mg) and 15 ml (1500 mg).

Dose for children aged 6 months and above:
Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Aristo Pharma depending 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 older than 4 years, measure the appropriate dose using the 10 ml syringe provided in the package.

Recommended dose: Levetiracetam Aristo Pharma should be taken twice daily, in two equal doses, each ranging between 0.1 ml (10 mg) and 0.3 ml (30 mg) per kg of the child's body weight (see table below for examples of doses).

Dose for children aged 6 months and above:

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 Aristo Pharma should be taken twice daily, in two equal doses, each
ranging between 0.07 ml (7 mg) and 0.21 ml (21 mg) per kg of the infant's body weight (see the table below for some examples of doses).
Dose for infants (from 1 month to less than 6 months):

Administration method:
After measuring the correct dose with the appropriate syringe, Levetiracetam Aristo Pharma oral solution may be diluted in a glass of water or a feeding bottle. Levetiracetam Aristo Pharma may be taken with or without food. After oral administration, you may perceive the bitter taste of levetiracetam.

Instructions on how to use the syringe:

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

Follow this procedure the first time Levetiracetam Aristo Pharma is administered:

• Remove the adapter from the oral administration syringe (Figure 2).
• Insert the adapter into the top of the bottle (Figure 3). Make sure it is securely fixed in place. It is not necessary to remove the adapter after use.

Follow this procedure for each administration of Levetiracetam Aristo Pharma:

• Insert the oral administration syringe into the opening of the adapter (Figure 4).
• Invert the bottle (Figure 5).

• Hold the inverted bottle in one hand while filling the oral administration syringe with the other.
• Pull the plunger down to fill the oral administration syringe with a small amount of solution (Figure 5A).
• Then push the plunger upward to remove any air bubbles (Figure 5B).
• Pull the plunger down to the mark on the oral syringe corresponding to the millilitres (mL) prescribed by your doctor (Figure 5C). The plunger may rise up within the syringe barrel during the first dose. Therefore, ensure the plunger remains in position until the dosing syringe is removed from the bottle.

• 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 pushing the plunger fully down (Figure 7).

• Drink the entire contents of the glass/bottle.
• Close the bottle with the plastic screw cap (there is no need to remove the adapter).
• To clean the syringe, rinse it only with cold water, moving the plunger up and down several times to draw in and expel water, without separating the two components (Figure 8).
• Store the bottle, the oral administration syringe, and the instruction leaflet inside the carton.

Duration of treatment:

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

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

If you stop treatment with Levetiracetam Aristo Pharma:
If treatment needs to be discontinued, Levetiracetam Aristo Pharma should be stopped gradually to avoid an increase in seizures. If your doctor decides to stop treatment with Levetiracetam Aristo Pharma, they will provide you with instructions on how to taper off the medication gradually.

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 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 reaction (anaphylactic)
• swelling of the face, lips, tongue and throat (angioedema, Quincke's edema)
• flu-like symptoms and rash on the face followed by widespread rash with high temperature, increased liver enzyme levels observed in blood tests, increase in a type of white blood cells (eosinophilia), lymph node enlargement 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 decrease in kidney function
• a skin rash which may present as blisters appearing like small targets (dark spots in the center surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
• widespread rash with blisters and skin peeling, 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 body surface area (toxic epidermal necrolysis)
• signs of serious mental disturbances or if someone around you notices confusion, drowsiness, amnesia (memory loss), memory impairment (forgetfulness), abnormal behavior or other neurological signs, including involuntary or uncontrolled movements. These could be symptoms of encephalopathy.

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

• nasopharyngitis;
• somnolence, 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 (feeling of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary tremors);
• vertigo (spinning sensation);
• cough;
• abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea;
• rash;
• asthenia/fatigue (tiredness).

Uncommon: may affect up to 1 in 100 people

• decreased number of platelets in the blood, decreased number of white blood cells in the blood;
• weight loss, weight gain;
• suicide attempt and suicidal ideation, mental disorder, abnormal behavior, hallucinations, anger, confusion, panic attack, affective lability/mood swings, agitation;
• amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired motor coordination), paresthesia (tingling), attention disturbance (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/abnormal liver function test results;
• hair loss, eczema, pruritus (itching);
• muscle weakness, myalgia (muscle pain);
• injury.

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

• infection;
• decreased number of all types of blood cells;
• severe allergic reactions (DRESS, anaphylactic reaction [severe and significant allergic reaction], angioedema [swelling of face, lips, tongue and throat]);
• decreased sodium concentration in the blood;
• suicide, personality disorders (behavioral problems), abnormal thought disturbances (slowed 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);
• changes in heart rhythm (electrocardiogram);
• pancreatitis;
• liver failure, hepatitis;
• sudden decrease in kidney function;
• skin rash which may form blisters appearing like small targets (dark spots in the center surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling over more than 30% of body surface area (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of muscle tissue) and associated increase in blood creatine phosphokinase levels. 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, low level of consciousness (may be signs of a disorder called neuroleptic malignant syndrome). Prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

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

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

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 Aristo Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the bottle after
Exp.:. The expiry date refers to the last day of that month.
Do not use more than 6 months after first opening the bottle.
This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Levetiracetam Aristo Pharma 100 mg/ml contains

• The active substance is called levetiracetam. Each ml contains 100 mg of levetiracetam.
• The other components are: sodium citrate (E331), anhydrous citric acid (E330), water, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), ammonium glycyrrhizinate, glycerol (E420), maltitol (E 965), acesulfame potassium (E 950), flavouring Fantasie (anisyl, gamma-butyrolactone, diacetyl, delta-dodecalactone, ethyl butyrate, 4-(p-Hydroxyphenyl)-2-butanone, maltol, menthol, methylcyclopentenolone, propylene glycol E1520, 4-(2,6,6-Trimethylcyclohexane-1-enyl)but-2-en-4-one, gamma-undecalactone), flavouring Contramarum (acetyl methyl carbinol, benzyl alcohol, butyric acid, cocoa powder extract, delta decalactone, dihydrocoumarin, delta dodecalactone, ethyl butyrate, ethyl maltol, ethyl propionate, heliotropine, 60% v/v extract of Holy Herb leaves, triacetin, aniline, propylene glycol-1,2, water).

Description of the appearance of Levetiracetam Aristo Pharma 100 mg/ml and contents of the pack
Clear solution, colourless to slightly brownish.
The 300 ml glass bottle of Levetiracetam Aristo Pharma (for children from 4 years of age,
adolescents and adults) is packaged in a cardboard box containing a 10 ml oral dosing syringe
(graduated every 0.25 ml) and a syringe adapter.
The 150 ml glass bottle of Levetiracetam Aristo Pharma (for infants and young children from
6 months up to less than 4 years of age) is packaged in a cardboard box containing a 3 ml oral dosing syringe
(graduated every 0.1 ml) and a syringe adapter.
The 150 ml glass bottle of Levetiracetam Aristo Pharma (for infants from 1 month up to less than 6 months
of age) is packaged in a cardboard box containing a 1 ml oral dosing syringe (graduated every 0.05 ml)
and a syringe adapter.
Pack sizes of 150 ml and 300 ml of oral solution.
Hospital packs of 1500 ml (10 x 150 ml or 5 x 300 ml) of oral solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Aristo Pharma GmbH
Wallenroder Straße 8 – 10,
13435 Berlin,
Germany
Marketing Authorisation Holder in Italy:
Aristo Pharma Italy srl
[email protected]