ITALEPT 500 mg Film-Coated Tablets

Зміст інструкції

1. ITALEPT 500 mg film-coated tablets, 1000 mg film-coated tablets
   1. What ITALEPT is and what it is used for
   2. What you need to know before taking ITALEPT
   3. How to take ITALEPT
   4. Possible side effects
   5. How to store ITALEPT
   6. Package Contents and Other Information
2. ITALEPT 100 mg/ml oral solution
   1. What ITALEPT is and what it is used for
   2. What you need to know before taking ITALEPT
   3. How to take ITALEPT
   4. Possible side effects
   5. How to store ITALEPT
   6. Contents of the pack and other information

ITALEPT 500 mg film-coated tablets, 1000 mg film-coated tablets

Levetiracetam
Generic medicine

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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ITALEPT is and what it is used for

ITALEPT500 mg 1000 mg film-coated tablets is an antiepileptic medicine (a medicine used
to treat seizures in epilepsy).

ITALEPTis used:

• alone in adults and adolescents starting from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition in which patients have recurrent seizures (convulsions). Levetiracetam is used for the form of epilepsy in which the seizures initially affect only one part of the brain, but may subsequently spread to larger areas of both sides of the brain (partial-onset seizures with or without secondary generalization). Levetiracetam has been given to you by your doctor to reduce the number of seizures.
• as an addition to other antiepileptic medicines to treat:
• partial-onset seizures, with or without secondary generalization, in adults, adolescents, children and infants starting from one month of age;
• myoclonic seizures (brief, shock-like spasm of a muscle or muscle group) in adults and adolescents starting from 12 years of age with juvenile myoclonic epilepsy;
• primary generalized tonic-clonic seizures (major attacks, including loss of consciousness) in adults and adolescents starting from 12 years of age with idiopathic generalized epilepsy (the type of epilepsy that is thought to have a genetic cause).

2. What you need to know before taking ITALEPT

Do not take ITALEPT

• if you are allergic (hypersensitive) 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 ITALEPT

• If you have kidney problems, follow your doctor's instructions. The latter may decide whether your dose needs to be adjusted.
• If you notice a slowing of growth or unexpected development of puberty in the child, inform your doctor.
• If you notice an increase in the severity of seizures (e.g. an increase in the number), contact your doctor.
• A limited number of people treated with antiepileptics such as ITALEPThave experienced self-harming thoughts or suicidal ideas. If you have any symptoms of depression and/or suicidal thoughts, consult your doctor.

Children and adolescents
ITALEPT alone (monotherapy) is not indicated in children and adolescents under 16 years of age.

Other medicines and ITALEPT
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those available without a prescription.
Do not take macrogol (a medicine used as a laxative) one hour before and one hour after taking
levetiracetam because a loss of the latter's efficacy may occur.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you may be pregnant or are planning to
become pregnant, ask your doctor for advice before taking this medicine.

ITALEPTshould not be used during pregnancy unless strictly necessary. A risk of
birth defects for the fetus cannot be completely excluded. ITALEPThas shown adverse
effects on reproduction in animal studies at dose levels higher than those needed to
control seizures. Breastfeeding is not recommended during treatment.

Driving and using machines
ITALEPTcan reduce the ability to drive vehicles or use tools or machinery, as ITALEPTcan
cause drowsiness. This is more likely at the beginning of treatment or after a dose increase.
Do not drive or use machinery until it has been verified that your ability to perform these activities
is not affected.

3. How to take ITALEPT

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

ITALEPTmust be taken twice a day, once in the morning and once in the evening, at approximately the same
time each day.
Take the number of tablets following your doctor's instructions.

Monotherapy
Dosage for adults and adolescents (from 16 years of age)
Usual dose: between 1000 mg and 3000 mg per day. When you start taking ITALEPTfor the first
time, your doctor will prescribe a lower dosefor 2 weeks before giving you the usual lowest dose.
Example: if your daily dose is 1000 mg, your initial reduced dose is 2 x 250 mg tablets in the
morning and 2 x 250 mg tablets in the evening.

Add-on therapy
Dosage for adults and adolescents (12 to 17 years) weighing 50 kg or more
Usual dose: between 1000 mg and 3000 mg per day.
Example: if your daily dose is 1000 mg, you may take 2 x 250 mg tablets in the morning and 2
x 250 mg tablets in the evening.
Dosage for young children (1 to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing
less than 50 kg
The doctor will prescribe the pharmaceutical form of ITALEPTmost appropriate depending on age, weight and
dose.

ITALEPT100 mg/ml oral solution is a more suitable presentation for infants and children under 6 years
of age and for children and adolescents (6 to 17 years) weighing less than 50 kg and when tablets do not
allow for accurate dosing.

Method of administration
Swallow the tablets of ITALEPTwith a sufficient amount of liquid (e.g. a glass of water).
ITALEPT can be taken with or without food.

Duration of treatment
ITALEPTis used as chronic treatment. You must continue to take ITALEPTas long as it has been
prescribed by your doctor.
Do not stop treatment without consulting your doctor, as otherwise the seizures may increase.

If you take more ITALEPT than you should
The possible side effects of an overdose of ITALEPTare drowsiness, agitation, aggression,
decreased attention, respiratory inhibition and coma.
Contact your doctor if you have taken more tablets than you should have. The doctor will establish the best
possible treatment for the overdose.

If you forget to take ITALEPT
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 tablet.

If you stop taking ITALEPT
If your doctor decides to stop treatment with ITALEPT, they will give you instructions regarding the
gradual discontinuation of ITALEPT.
In case of discontinuation of treatment, as with any other antiepileptic drug, ITALEPTmust be
discontinued gradually to avoid an increase in seizures.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most frequently reported adverse reactions are nasopharyngitis, drowsiness, headache, fatigue and dizziness. Some of the side effects such as drowsiness, fatigue and dizziness may be more common at the beginning of treatment or when the dose is increased. These effects should, in any case, 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 aggressiveness, anxiety, insomnia, nervousness or irritability;
• convulsion, balance disorders, dizziness (feeling of instability), lethargy, 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 1000 people

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

Rare: may affect up to 1 in 10,000 people

• infection;
• decreased number of all types of blood cells;
• severe hypersensitivity reactions (DRESS), anaphylactic reaction [severe and important allergic reaction], angioedema [swelling of the face, lips, tongue and throat]);
• decreased concentration of sodium in the blood;
• suicide, personality disorder (behavioural problems), altered thinking (slowed thinking, inability to concentrate);
• uncontrollable muscle spasms involving the head, trunk and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• pancreatitis;
• liver failure, hepatitis;
• skin rash that may form blisters and appear as small targets (dark central spot surrounded by a lighter area, with a dark ring around the edge) ( erythema multiforme), a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome) and a more severe form that causes peeling of the skin in more than 30% of the body surface ( toxic epidermal necrolysis).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the system
http://www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store ITALEPT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the package and on the blister after SCAD. The
expiry date refers to the last day of the month.

Film-coated tablets 500 mg
This medicine does not require any special storage conditions.

Film-coated tablets 1000 mg
Do not store at a temperature above 30 °C.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What ITALEPT contains
The active ingredient is called levetiracetam.
Each film-coated tablet contains 500 mg of levetiracetam.
Each film-coated tablet contains 1000 mg of levetiracetam.
The excipients are:
Tablet core:
corn starch
povidone K 30
talc
colloidal silicon dioxide
magnesium stearate (E 572)
Film coating:
partially hydrolyzed polyvinyl alcohol
titanium dioxide (E171)
macrogol 3350
talc
yellow iron oxide (E172)
Film coating:
partially hydrolyzed polyvinyl alcohol
titanium dioxide (E171)
macrogol 3350
talc

Description of the appearance of ITALEPT and package contents
The film-coated tablets are yellow, oblong in shape, with a break line, with the inscription “LEV 500”
embossed on one side and a central break line on both sides. The tablet can be divided into two
equal halves.
The film-coated tablets are white, oblong in shape, with a break line, with the inscription “LEV
1000” embossed on one side and a central break line on both sides. The tablet can be divided into
two equal halves.
The cardboard box contains

Film-coated tablets 500 mg
60 film-coated tablets

Film-coated tablets 1000 mg
30 film-coated tablets
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00040 Pomezia (Roma) - Italy

Manufacturer
Bluepharma Indústria Farmacêutica, S.A.

• S. Martinho de Bispo 3045-016 Coimbra Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following
denominations:
Italy:ITALEPT 500 mg - 1000 mg film-coated tablets

ITALEPT 100 mg/ml oral solution

Levetiracetam
Generic medicine

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ITALEPT is and what it is used for

ITALEPT100 mg/ml oral solution is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

ITALEPTis used:

• alone in adults and adolescents starting from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition in which patients have repeated seizures (convulsions). Levetiracetam is used for the form of epilepsy in which seizures initially affect only one part of the brain, but may subsequently expand to larger areas of both sides of the brain (partial-onset seizures with or without secondary generalization). Levetiracetam has been given to you by your doctor to reduce the number of seizures.
• as an addition to other antiepileptic medicines to treat:
• partial-onset seizures, with or without secondary generalization, in adults, adolescents, children and infants starting from one month of age;
• myoclonic seizures (brief, shock-like spasms of a muscle or muscle group) in adults and adolescents starting from 12 years of age with juvenile myoclonic epilepsy;
• primary generalized tonic-clonic seizures (major attacks, including loss of consciousness) in adults and adolescents starting from 12 years of age with idiopathic generalized epilepsy (the type of epilepsy that is thought to have a genetic cause).

2. What you need to know before taking ITALEPT

Do not take ITALEPT

• if you are allergic (hypersensitive) 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 before taking ITALEPT

• If you have kidney problems, follow your doctor's instructions. The latter may decide whether your dose

needs to be adjusted.

• If you notice a slowing of growth or an unexpected development of puberty in the child, inform your doctor.
• If you notice an increase in the severity of seizures (e.g. an increase in the number), contact your doctor.
• A limited number of people treated with antiepileptics such as ITALEPThave experienced self-harming thoughts or suicidal ideas. If you have any symptoms of depression and/or suicidal thoughts, consult your doctor.

Children and adolescents
ITALEPT is not indicated in children and adolescents under 16 years of age alone (as monotherapy).

Other medicines and ITALEPT
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Do not take macrogol (a medicine used as a laxative) for one hour before and for one hour after taking levetiracetam because it may cause a loss of the latter's effect.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you may be pregnant, or if you are planning to become pregnant, ask your doctor for advice before taking this medicine.

ITALEPTshould not be used during pregnancy unless strictly necessary. A risk of birth defects for the fetus cannot be completely excluded. ITALEPThas shown undesirable effects on reproduction in animal studies at dose levels higher than those needed to control seizures. Breastfeeding is not recommended during treatment.

Driving and using machines
ITALEPTcan reduce the ability to drive vehicles or use tools or machinery, as ITALEPTcan cause drowsiness. This is more likely at the beginning of treatment or after an increase in the dose.
Do not drive or use machinery until it has been verified that your ability to perform these activities is not affected.

ITALEPT contains propylparahydroxybenzoate, methylparahydroxybenzoate and maltitol
ITALEPToral solution contains methylparahydroxybenzoate (E218) and propylparahydroxybenzoate (E216), which may cause allergic reactions (including delayed reactions).

ITALEPToral solution also contains maltitol. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take ITALEPT

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
ITALEPT must be taken twice a day, once in the morning and once in the evening, approximately at the same
time each day.
Take the oral solution following the doctor's instructions.

Monotherapy
Dose for adults and adolescents (starting from 16 years of age)
Usual dose: between 10 ml (1000 mg) and 30 ml (3000 mg) per day, divided into 2 administrations
daily. When you start taking ITALEPT for the first time, your doctor will prescribe a lower
dosefor 2 weeks before giving you the usual lowest dose.

Add-on therapy
Dose for adults and adolescents (from 12 to 17 years) with a weight of 50 kg or more
Usual dose: between 10 ml (1000 mg) and 30 ml (3000 mg) per day, divided into 2 administrations
daily.

Dose for young children (from 6 to 23 months), children (from 2 to 11 years) and adolescents (from 12 to 17 years) with
weight less than 50 kg
The doctor will prescribe the pharmaceutical form of ITALEPT most appropriate according to age, weight and
dose.
Usual dose: between 0.2 ml (20 mg) and 0.6 ml (60 mg) per kg of body weight per day, divided into 2
daily administrations. The exact amount of oral solution must be administered using the
syringe provided in the cardboard box.

Dose for infants (from 1 month to less than 6 months)
Usual dose: between 0.14 ml (14 mg) and 0.42 ml (42 mg) per kg of body weight per day, divided into
2 daily administrations. The exact amount of oral solution must be administered using
the syringe provided in the cardboard box.

Method of administration
ITALEPT oral solution can be diluted in a glass of water or in a baby bottle. It can be taken with or
without food.
Instructions for use:

• Open the bottle: press the closing cap and turn counterclockwise (figure 1).

• Insert the adapter into the neck of the bottle (figure 2). Make sure it is well fixed.
• Take the syringe and insert it into the opening of the adapter (figure 2).

2

• Turn the bottle upside down (figure 3).

3

• Fill the syringe with a small amount of solution by pulling the plunger down (figure 4), then press the plunger up to remove any possible bubbles (figure 5). Pull the plunger down to the graduation line corresponding to the amount in milliliters (ml) prescribed by your doctor (figure 6).
• Turn the bottle upright.
• Remove the syringe from the adapter (figure 6).

45

• Pour the contents of the syringe into a glass of water or a baby bottle by pressing the plunger all the way down (figure 7).

7

• Drink the entire contents of the glass/bottle.
• Close the bottle with the plastic screw cap.

8

• Wash the syringe with water only (figure 8).

Duration of treatment
ITALEPT is used as a chronic treatment. You must continue to take ITALEPT as long as it has been
prescribed by your doctor.
Do not stop treatment without consulting your doctor, as otherwise the seizures may increase.

If you take more ITALEPT than you should
The possible side effects of an overdose of ITALEPT are drowsiness, agitation, aggressiveness,
decreased attention, inhibition of breathing and coma.
Contact your doctor if you have taken more ITALEPT than you should. The doctor will establish the best
possible treatment for the overdose.

If you forget to take ITALEPT
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 taking ITALEPT
If your doctor decides to stop treatment with ITALEPT, they will give you instructions regarding the
gradual discontinuation of ITALEPT.
In case of interruption of treatment, as with any other antiepileptic drug, ITALEPT must be
discontinued gradually to avoid an increase in seizures.
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.
The most frequently reported adverse reactions are nasopharyngitis, drowsiness, headache, fatigue and dizziness. Some of the side effects such as drowsiness, fatigue and dizziness
may be more common at the beginning of treatment or when the dose is increased. These effects
should, in any case, 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 aggressiveness, anxiety, insomnia, nervousness or irritability;
• convulsion, balance disorders, dizziness (feeling of instability), lethargy, tremor (involuntary tremors);
• 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 1000 people

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

Rare: may affect up to 1 in 10,000 people

• infection;
• decreased number of all types of blood cells;
• severe hypersensitivity reactions (DRESS, anaphylactic reactions [severe and important allergic reactions], angioedema [swelling of the face, lips, tongue and throat]);
• decreased concentration of sodium in the blood;
• suicide, personality disorder (behavioral problems), alterations in thinking (slowness of thought, inability to concentrate);
• uncontrollable muscle spasms involving the head, trunk and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• pancreatitis;
• liver failure, hepatitis;
• skin rash that may form blisters and appear as small targets (dark central spot surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form that causes peeling of the skin in more than 30% of the body surface area (toxic epidermal necrolysis).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the system
http://www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store ITALEPT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and the bottle after Exp. The
expiry date refers to the last day of the month. Do not use after 7 months from the first opening of the
bottle.
Store in the original package, because the medicine is sensitive to light.
Store in an upright position.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ITALEPT contains
The active ingredient is levetiracetam.
Each ml contains 100 mg of levetiracetam.
The excipients are: Sodium citrate, Citric acid monohydrate, Methyl parahydroxybenzoate (E218), Propyl
parahydroxybenzoate (E216), Ammonium glycyrrhizate, Glycerol (E422), Liquid maltitol (E965), Acesulfame
potassium (E950), Grapefruit aroma, Purified water.

Description of the appearance of ITALEPT and contents of the pack
ITALEPT 100 mg/ml oral solution is a clear liquid.
300 ml of solution in an amber glass bottle with a child-resistant closure, in a cardboard box
also containing a 10 ml oral syringe (with graduations every 0.25 ml) and an adapter for
the syringe.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00040 Pomezia (Roma)
Italy

Manufacturer
Bluepharma Indústria Farmacêutica, S.A.

• S. Martinho de Bispo 3045-016 Coimbra Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Italy:ITALEPT 100mg/ml oral solution