Levetiracetam Eg Stada Italia

Patient Information Leaflet: Information for the Patient

LEVETIRACETAM EG STADA ITALIA 100 mg/ml oral solution

Equivalent medicine
Please read 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

1. What LEVETIRACETAM EG STADA ITALIA is and what it is used for

Levetiracetam is an antiepileptic medicine (a medicine used to treat epileptic seizures).
LEVETIRACETAM EG STADA ITALIA is used:

• as monotherapy in adults and adolescents aged 16 years and older with newly diagnosed epilepsy, to treat a certain type of epilepsy. Epilepsy is a condition in which patients have recurrent seizures. Levetiracetam is used for that type of epilepsy in which seizures initially involve only one side of the brain, but may subsequently spread to broader 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 (epileptic attacks) you experience;
• as an add-on to other antiepileptic medicines to treat:
  • partial onset seizures, with or without secondary generalization, in adults, adolescents, children and infants aged 1 month and older;
  • myoclonic seizures (brief, shock-like jerks of a muscle or group of muscles) in adults and adolescents aged 12 years and older with juvenile myoclonic epilepsy;
  • primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents aged 12 years and older with idiopathic generalized epilepsy (the type of epilepsy believed to have a genetic cause).

2. What you need to know before taking LEVETIRACETAM EG STADA ITALIA

Do not take LEVETIRACETAM EG STADA ITALIA:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking LEVETIRACETAM EG STADA 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 onset of puberty in a child, contact your doctor.
• A small number of people taking antiepileptic medicines such as LEVETIRACETAM EG STADA ITALIA have experienced suicidal thoughts or self-harming behaviour. If you experience any symptoms of depression and/or have suicidal thoughts, contact your doctor.
• If you or a family member has a heart rhythm disorder (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 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, especially during the first month after starting treatment or increasing the dose. If you develop any of these new symptoms while taking LEVETIRACETAM EG STADA ITALIA, consult a doctor as soon as possible.

Children and adolescents
LEVETIRACETAM EG STADA ITALIA used alone (monotherapy) is not indicated in children and
adolescents under 16 years of age.
Other medicines and LEVETIRACETAM EG STADA ITALIA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicine.
Do not take macrogol (a medicine used as a laxative) within one hour before or one hour after taking
levetiracetam, as it may cause loss of effectiveness of levetiracetam.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult 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 treatment without discussing it with your doctor. A risk of birth defects for the
foetus 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 EG STADA 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. Do not drive or operate machinery until you are sure that your ability to perform these activities is not impaired.
LEVETIRACETAM EG STADA ITALIA contains methyl parahydroxybenzoate (E218), liquid maltitol (E965), sodium and benzyl alcohol
LEVETIRACETAM EG STADA ITALIA oral solution contains methyl parahydroxybenzoate, which may
cause allergic reactions (including delayed reactions).
LEVETIRACETAM EG STADA ITALIA oral solution also contains liquid maltitol. If your doctor has informed you of an intolerance to certain sugars, contact them before taking this
medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e. essentially ‘sodium-free’.
Each ml of this medicine contains 0.0016 mg of benzyl alcohol. Benzyl alcohol may cause allergic reactions.
Do not use for more than one week in young children (under 3 years), unless otherwise advised
by your doctor or pharmacist.
Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts
of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).
Consult your doctor or pharmacist if you have liver or kidney disease. This is because large
amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).

3. How to take LEVETIRACETAM EG STADA ITALIA

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
LEVETIRACETAM EG STADA 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 directed by your doctor.

Monotherapy (from 16 years of age onwards)
Adults (≥ 18 years) and adolescents (from 16 years of age onwards):
Measure the appropriate dose using the 10 ml syringe provided in the package, for patients aged 4 years and older.
Typical dose: LEVETIRACETAM EG STADA ITALIA 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 EG STADA ITALIA, your doctor will prescribe a lower starting dose for 2 weeks before increasing to the lowest typical 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 aged 4 years and older.
Typical dose: LEVETIRACETAM EG STADA ITALIA 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 older:
Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam 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.
  Typical dose: LEVETIRACETAM EG STADA ITALIA 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 some examples of dosing).

Dose for children aged 6 months and older:

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.
Typical dose: LEVETIRACETAM EG STADA ITALIA 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 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 EG STADA ITALIA oral solution may be diluted in a glass of water or in a baby bottle. LEVETIRACETAM EG STADA ITALIA may be taken regardless of food intake. After oral administration, a bitter taste of levetiracetam may be perceived.

Instructions for use:

• Open the bottle: press the cap and turn counterclockwise (Figure 1).
• Separate the adapter from the syringe (Figure 2). Insert the syringe adapter into the neck of the bottle. Make sure it is securely attached.
• Take the syringe and insert it into the opening of the adapter. Invert the bottle (Figure 3).
• Fill the syringe with a small amount of solution by pulling the plunger down (Figure 4 a), then push the plunger upward to remove any possible air bubbles (Figure 4 b). Pull the plunger down to the graduation mark corresponding to the amount in millilitres (ml) prescribed by your doctor (Figure 4 c).
• Turn the bottle upright. Remove the syringe from the adapter.
• Pour the contents of the syringe into a glass of water or into a baby bottle by pressing the plunger fully down (Figure 5).
• Drink the entire contents of the glass/bottle.
• Close the bottle with the child-resistant cap.
• Wash the syringe with water only (Figure 6).

Duration of treatment:

• LEVETIRACETAM EG STADA ITALIA is used as a chronic treatment. Treatment with LEVETIRACETAM EG STADA ITALIA 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 EG STADA ITALIA than you should
Possible adverse effects of an overdose of LEVETIRACETAM EG STADA ITALIA include drowsiness, agitation, aggression, decreased attention, respiratory depression, and coma.
Contact your doctor if you have taken more LEVETIRACETAM EG STADA ITALIA than you should have. Your doctor will determine the most appropriate treatment for the overdose.

If you forget to take LEVETIRACETAM EG STADA 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 EG STADA ITALIA
If treatment needs to be discontinued, LEVETIRACETAM EG STADA ITALIA should be stopped gradually to avoid an increase in seizures. If your doctor decides to discontinue treatment with LEVETIRACETAM EG STADA ITALIA, they will provide you with instructions on how to gradually stop the medication.

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 everyone 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, or throat (Quincke's edema);
• flu-like symptoms and rash on the face followed by widespread rash with high fever, increased liver enzyme levels observed in blood tests, increased levels of a type of white blood cells (eosinophilia), and swollen lymph nodes (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 worsening of 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);
• a widespread rash with blisters and peeling of the skin, 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 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 commonly reported side effects 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 frequent. 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 shaking);
• vertigo (sensation of spinning);
• cough;
• abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling weak).

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;
• suicidal 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);
• trauma.

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], Quincke's edema [swelling of face, lips, tongue, and throat]);
• decreased sodium concentration in the blood;
• suicide, personality disorder (behavioral problems), thought disorders (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 abnormalities);
• pancreatitis;
• liver failure, hepatitis;
• sudden worsening of kidney function;
• 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, 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 levels. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
• limping or difficulty walking.

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 EG STADA ITALIA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or bottle after the wording
EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After first opening: do not store above 25°C.
Do not use more than 7 months after first opening the bottle.
Do not dispose of any medicine 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 EG STADA ITALIA contains
The active substance is levetiracetam.
Each ml of solution contains 100 mg of levetiracetam.
The other components are: sodium citrate (for pH adjustment), citric acid (for pH adjustment), methyl p-hydroxybenzoate (E218), glycerol (E422), acesulfame potassium (E950), maltitol liquid (E965), raspberry flavouring (containing benzyl alcohol).

Description of the appearance of LEVETIRACETAM EG STADA ITALIA and contents of the pack
LEVETIRACETAM EG STADA ITALIA 100 mg/ml oral solution is a clear liquid.
The 300 ml glass bottle of LEVETIRACETAM EG STADA ITALIA (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 EG STADA ITALIA (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 EG STADA ITALIA (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.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
EG S.p.A., Via Pavia 6, 20136 Milano, Italy

Manufacturers
Remedica Ltd, Aharnon Street, Limassol Industrial Estate - Limassol 3056 – Cyprus
STADA Arzneimittel AG, Stadastrasse 2 - 18, 61118 Bad Vilbel – Germany
STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Wien – Austria
Galenica Pharmaceutical Industry S.A., 3rd Km Old National Road Chalkida Athens, Chalcis 34100 – Greece

This medicinal product is authorized in the European Economic Area countries under the following names:
DE Levetiracetam AL 100 mg/ml Lösung zum Einnehmen
AT Levetiracetam STADA 100 mg/ml Lösung zum Einnehmen
DK Levetiracetam STADA TBC
ES Levetiracetam STADA 100 mg/ml solución oral EFG
FI Levetiracetam STADA 100 mg/ml oraaliliuos
FR LEVETIRACETAM EG 100 mg/ml, solution buvable
IS Levetiracetam STADA 100 mg/ml mixtúra, lausn
IT LEVETIRACETAM EG STADA ITALIA
PT Levetiracetam Ciclum
SE Levetiracetam STADA 100 mg/ml oral lösning