Levetiracetam Doc Generici

Package leaflet: Information for the patient

LEVETIRACETAM DOCgen 100 mg/ml oral solution

Levetiracetam
Generic medicine
Read this entire leaflet carefully before you or your child takes 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 could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What LEVETIRACETAM DOCgen is and what it is used for

Levetiracetam 100 mg/ml oral solution is an antiepileptic medicine (a medicine used to treat epileptic seizures).
LEVETIRACETAM DOCgen is used:

• as monotherapy in adults and adolescents aged 16 years and older with newly diagnosed epilepsy, to treat a specific type of epilepsy. Epilepsy is a condition in which patients experience repeated seizures (convulsions). 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 epileptic 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 spasms 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 attacks, 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 DOCgen

Do not take LEVETIRACETAM DOCgen

• 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 or pharmacist before taking LEVETIRACETAM DOCgen

• 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 DOCgen 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 heart rhythm disorder (visible on electrocardiogram), or if you have a disease and/or are taking medicines that may cause irregular heartbeat 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 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 existing abilities, you may notice that seizures persist or worsen during treatment. If you experience any of these new symptoms while taking LEVETIRACETAM DOCgen, consult a doctor as soon as possible.

Children and adolescents

• LEVETIRACETAM DOCgen used alone (monotherapy) is not indicated in children and adolescents under 16 years of age.

Other medicines and LEVETIRACETAM DOCgen
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 loss of effectiveness of levetiracetam.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or 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 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 DOCgen may impair 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 have determined that your ability to perform these activities is not affected.

LEVETIRACETAM DOCgen contains methyl 4-hydroxybenzoate (E218), liquid maltitol (E965), sodium, and benzyl alcohol
LEVETIRACETAM DOCgen oral solution contains methyl 4-hydroxybenzoate, which may cause allergic reactions (including delayed reactions).
LEVETIRACETAM DOCgen oral solution also contains liquid maltitol. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e. essentially 'sodium-free'.
This medicine contains 0.0016 mg of benzyl alcohol per ml. Benzyl alcohol may cause allergic reactions.
Do not use this medicine for more than one week in young children (under 3 years of age) unless 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 DOCgen

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
LEVETIRACETAM DOCgen 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 supplied in the package for patients aged 4 years and older.
Recommended dose: LEVETIRACETAM DOCgen 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 DOCgen, your doctor will prescribe a lower starting dose for 2 weeks before increasing to the lowest daily maintenance dose.

Adjunctive therapy
Dose for adults and adolescents (from 12 to 17 years of age):
Measure the appropriate dose using the 10 ml syringe supplied in the package for patients aged 4 years and older.
Recommended dose: LEVETIRACETAM DOCgen 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 age, body weight, and required dose.

• For children from 6 months to 4 years of age, measure the appropriate dose using the 3 ml syringe supplied in the package.
• For children older than 4 years, measure the appropriate dose using the 10 ml syringe supplied in the package.
  Recommended dose: LEVETIRACETAM DOCgen 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 body weight (see table below for examples of doses).

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.
Recommended dose: LEVETIRACETAM DOCgen should be taken twice daily, in two equal doses, each ranging from 0.07 ml (7 mg) to 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 DOCgen oral solution
may be diluted in a glass of water or in a baby bottle. LEVETIRACETAM DOCgen 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. Make sure it is securely attached.
• Take the syringe and insert it into the opening of the adapter. Turn the bottle upside down (Figure 3).
• Fill the syringe with a small amount of solution by pulling the plunger down (Figure 4A), then push the plunger upward to remove any air bubbles (Figure 4B). Pull the plunger down to the graduation mark corresponding to the amount in millilitres (ml) prescribed by your doctor (Figure 4C).
• Turn the bottle upright. Remove the syringe from the adapter.
• Empty the syringe into a glass of water or a baby bottle by pressing the plunger fully down (Figure 5).
• Drink the entire contents of the glass/baby bottle.
• Close the bottle with the child-resistant cap.
• Wash the syringe with water only (Figure 6).

Duration of treatment:

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

If you forget to take LEVETIRACETAM DOCgen:
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 DOCgen:
If treatment needs to be discontinued, LEVETIRACETAM DOCgen should be stopped gradually to avoid an increase in seizures.
If your doctor decides to discontinue treatment with LEVETIRACETAM DOCgen, they will provide you with instructions on how to taper off LEVETIRACETAM DOCgen 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, lightheadedness or dizziness, or if you have difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic)
• swelling of the face, lips, tongue and throat (angioedema, also known as 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, and 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 be signs of sudden decrease in kidney function
• a skin rash which 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 )
• a widespread skin rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome )
• a more severe form of skin 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 signs of 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 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 common. 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 (sensation of spinning);
• cough;
• abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea;
• 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 or 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], angioedema [swelling of face, lips, tongue and throat]);
• decreased sodium concentration in the blood;
• suicide, personality disorder (behavioral problems), thought disturbances (slowed thinking, inability to concentrate);
• delirium;
• encephalopathy (see the subsection “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 present as blisters appearing like small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) ( erythema multiforme ), a widespread skin rash with blisters and peeling of the skin, 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, reduced level of consciousness (may be signs of a disorder 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 DOCgen

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.
This medicine requires no 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 medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What LEVETIRACETAM DOCgen contains
The active substance is levetiracetam. Each ml of solution contains 100 mg of levetiracetam.
The other components are: sodium citrate (for pH adjustment), monohydrate citric acid (for pH
adjustment), methyl parahydroxybenzoate (E218), glycerol (E422), acesulfame potassium
(E950), maltitol liquid (E965), raspberry flavour (containing benzyl alcohol).
Description of the appearance of LEVETIRACETAM DOCgen and contents of the pack
LEVETIRACETAM DOCgen 100 mg/ml oral solution is a clear liquid.
The 300 ml glass bottle of LEVETIRACETAM DOCgen (for children from 4 years of age,
adolescents and adults) is packaged in a cardboard box containing a 10 ml oral syringe (graduated
every 0.25 ml) and a syringe adapter.
The 150 ml glass bottle of LEVETIRACETAM DOCgen (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 syringe
(graduated every 0.1 ml) and a syringe adapter.
The 150 ml glass bottle of LEVETIRACETAM DOCgen (for infants from 1 month up to less than 6 months of
age) is packaged in a cardboard box containing a 1 ml oral syringe (graduated every 0.05 ml) and a syringe adapter.
It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder
DOC Generici Srl, Via Turati 40, 20121 Milano
Manufacturer
Remedica Ltd, Aharnon Street, Limassol Industrial Estate, Limassol, Cyprus
Galenica Pharmaceutical Industry S.A., 3rd Km Old National Road Chalkida Athens, Chalcis, 341 00 Greece