Levetiracetam Almus: detailed information

Patient Information Leaflet

Levetiracetam Almus 250 mg film-coated tablets

Equivalent medicine
Please read this entire leaflet carefully before you or your child starts 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, consult 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, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Levetiracetam Almus is and what it is used for
What you need to know before taking Levetiracetam Almus
How to take Levetiracetam Almus
Possible side effects
How to store Levetiracetam Almus
Contents of the pack and other information

1. What Levetiracetam Almus is and what it is used for

Levetiracetam Almus (as it will be referred to in the rest of this leaflet) contains 250 mg of

levetiracetam in each film-coated tablet.

Levetiracetam Almus is an antiepileptic medicine (a medicine used to treat epileptic seizures).
It can be 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 of both sides of the brain (partial-onset seizures with or without secondary generalization). Levetiracetam has been prescribed by your doctor 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 (major 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 Almus

Do not take Levetiracetam Almus

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 Almus

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 Almus have experienced thoughts of self-harm or suicidal thoughts. 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 reactions than usual, or if you, your family, or friends notice the appearance of 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 types of seizures and loss of abilities, you may notice that seizures persist or worsen during treatment.

If you experience any of these new symptoms while taking Levetiracetam Almus, consult your doctor as soon as possible.
Children and adolescents

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

Other medicines and Levetiracetam Almus
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 a loss of effectiveness of levetiracetam.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before taking this medicine. Levetiracetam may be used during pregnancy only if, after careful evaluation, your doctor considers it necessary.
You must 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 Almus 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 an increase in dose. You must not drive or use machinery until you have determined that your ability to perform these activities is not impaired.

3. How to take Levetiracetam Almus

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

Take the number of tablets as instructed by your doctor.
Levetiracetam Almus must be taken twice daily, once in the morning and once in the evening, approximately at the same time each day.

Adjunctive therapy and monotherapy (from age 16 onwards)

Adults (≥ 18 years) and adolescents (12 to 17 years) with body weight of 50 kg or more: Recommended dose: between 1000 mg and 3000 mg per day. When you first start taking Levetiracetam Almus, your doctor will prescribe a lower starting dose for 2 weeks before increasing to the lowest daily dose. Example: if your daily dose is to be 1000 mg, your initial reduced dose is 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening, and the dose will be gradually increased to reach 1000 mg per day after 2 weeks.
Adolescents (12 to 17 years) with body weight below or equal to 50 kg: Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Almus according to body weight and required dose.
Dose for infants (1 month to 23 months) and children (2 to 11 years) with body weight below 50 kg: Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Almus according to age, body weight, and required dose.

Oral solution is the most suitable formulation for infants and children under 6 years of age, for children and adolescents (6 to 17 years) weighing less than 50 kg, and when tablets do not allow accurate dosing.

Method of administration
Swallow Levetiracetam Almus tablets with a sufficient amount of liquid (e.g. a glass of water).
You may take Levetiracetam Almus with or without food. After oral administration, you may experience a bitter taste of levetiracetam.

Duration of treatment

Levetiracetam Almus is used as a chronic treatment. Treatment with Levetiracetam Almus should continue for as long as prescribed by your doctor.
Do not stop treatment without consulting your doctor, as this may increase the frequency of seizures.

If you take more Levetiracetam Almus than you should
Possible adverse effects of an overdose of Levetiracetam Almus include drowsiness, agitation, aggression, decreased attention, respiratory depression, and coma.
Contact your doctor if you have taken more tablets than prescribed. Your doctor will determine the most appropriate treatment for overdose.

If you forget to take Levetiracetam Almus
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 Levetiracetam Almus
If treatment needs to be discontinued, Levetiracetam Almus should be gradually withdrawn to avoid an increase in seizure frequency. If your doctor decides to discontinue treatment with Levetiracetam Almus, they will provide you with instructions for the gradual discontinuation of Levetiracetam Almus.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Contact your doctor immediately or go to the nearest emergency room if you experience:

weakness, feeling faint or dizzy, 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 (Quincke's oedema)
flu-like symptoms and rash on the face followed by widespread rash with high fever, increased liver enzyme levels observed in blood tests, increase in 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 that 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)
widespread rash with blisters and skin peeling, especially 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 confusion, drowsiness, amnesia (memory loss), memory impairment (forgetfulness), abnormal behaviour, or other neurological signs including involuntary or uncontrollable 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, restlessness or irritability
seizure, balance disorder, dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking)
vertigo (spinning sensation)
cough
abdominal pain, diarrhoea, 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 thoughts, mental disorder, abnormal behaviour, 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], Quincke's oedema [swelling of face, lips, tongue, and throat])
decreased concentration of sodium in the blood
suicide, personality disorder (behavioural 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)
change in heart rhythm (electrocardiogram)
pancreatitis
liver failure, hepatitis
sudden worsening of kidney function
skin rash that 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), 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 the body surface (toxic epidermal necrolysis)
rhabdomyolysis (breakdown of muscle tissue) and associated increase in blood creatine phosphokinase. 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). 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 sensations, or an urge 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 Almus

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after Exp.: and on the blister after
EXP:.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Almus contains
The active substance is called levetiracetam.
Each tablet contains 250 mg of levetiracetam.
The other components are:
Tablet core: anhydrous colloidal silica, maize starch, magnesium stearate, talc, povidone K30.
Film coating: Opadry 85F20694: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, indigo carmine
aluminium lake (E132).
Levetiracetam Almus is packaged in blisters in cardboard boxes.
Each blister contains 10 tablets.
Description of the appearance of Levetiracetam Almus and the contents of the pack
The film-coated tablets of Levetiracetam Almus are blue, oval-shaped, scored and marked with “250” on one side.
The tablet can be divided into two equal doses.
The cardboard boxes contain 20 (2x10), 30 (3x10), 50 (5x10), 60 (6x10), 100 (10x10) and 200 (20x10) film-coated tablets, multiple packs of 2x50 (100) and 4x50 (200) film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Almus S.r.l.
Via Cesarea 11/10
16121 Genoa
Italy
E-mail: [email protected]
Manufacturer:
Laboratoires BTT
ZI de Krafft
67150 Erstein
France
Holsten Pharma GmbH
Hahnstraße 31-35
60528 Frankfurt am Main
Germany

Package leaflet: Information for the patient

Levetiracetam Almus 500 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before you or your child starts 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 adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Levetiracetam Almus is and what it is used for
What you need to know before taking Levetiracetam Almus
How to take Levetiracetam Almus
Possible side effects
How to store Levetiracetam Almus
Contents of the pack and other information

1. What Levetiracetam Almus is and what it is used for

Levetiracetam Almus (as it will be referred to throughout this patient information leaflet) contains 500 mg of

levetiracetam in each film-coated tablet.

Levetiracetam Almus is an antiepileptic medicine (a medicine used to treat epileptic seizures).
It can be 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 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 later spread to broader areas on both sides of the brain (partial-onset seizures with or without secondary generalization). Levetiracetam has been prescribed by your doctor to reduce the number of seizures.
as add-on therapy to other antiepileptic medicines to treat:
- partial-onset seizures, with or without generalization, in adults, adolescents, children, and infants aged 1 month and older
- myoclonic seizures (brief, shock-like muscle jerks of a single muscle or muscle group) 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 Almus

Do not take Levetiracetam Almus

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 Almus

If you have kidney problems, follow your doctor's instructions. Your doctor may decide whether the 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 Almus have experienced suicidal thoughts or self-harming thoughts. If you have any symptoms of depression and/or 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 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, especially 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 abilities, you may notice that seizures persist or worsen during treatment.

If you experience any of these new symptoms while taking Levetiracetam Almus, consult your doctor as soon as possible.
Children and adolescents

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

Other medicines and Levetiracetam Almus
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, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before taking this medicine. Levetiracetam may be used during pregnancy only if, after careful evaluation, your doctor considers it necessary.
You must 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 Almus 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.

3. How to take Levetiracetam Almus

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Take the number of tablets as instructed by your doctor.
Levetiracetam Almus should be taken twice daily, once in the morning and once in the evening, approximately
at the same time each day.

Adjunctive and monotherapy (from age 16 onwards)

Adults (≥ 18 years) and adolescents (12 to 17 years) weighing 50 kg or more: Recommended dose: between 1000 mg and 3000 mg per day. When you first start taking Levetiracetam Almus, your doctor will prescribe a lower starting dose for 2 weeks before increasing to the lowest daily dose. Example: if your daily dose is to be 1000 mg, your initial reduced dose is 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening, and the dose will be gradually increased to reach 1000 mg per day after 2 weeks.
Adolescents (12 to 17 years) weighing less than or equal to 50 kg: Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Almus according to weight and required dose.
Dose for infants (1 month to 23 months) and children (2 to 11 years) weighing less than 50 kg: Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Almus depending on age, weight, and dose.

Oral solution is the most suitable formulation for infants and children under 6 years of age,
for children and adolescents (6 to 17 years) weighing less than 50 kg, and when tablets do not
allow accurate dosing.

Duration of treatment

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

If you forget to take Levetiracetam Almus
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 tablet.

If you stop taking Levetiracetam Almus
If treatment needs to be discontinued, Levetiracetam Almus should be gradually withdrawn to
avoid an increase in seizures. If your doctor decides to stop treatment with
Levetiracetam Almus, they will provide you with instructions on how to gradually taper off 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 everybody will experience them.
Immediately contact your doctor or go to the nearest emergency room if you experience:

weakness, feeling faint or dizzy, or if you have difficulty breathing, as these may be signs of a serious allergic reaction (anaphylactic)
swelling of the face, lips, tongue, and throat (Quincke's edema)
flu-like symptoms and facial rash followed by widespread rash with high fever, increased liver enzyme levels observed in blood tests, increase in 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 appear as blistering lesions resembling small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
a widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
a more severe form of skin rash causing skin peeling affecting 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), impaired memory (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 tremors)
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
suicide attempt and suicidal ideation, mental disorder, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional 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 concentration of sodium in the blood
suicide, personality disorder (behavioral problems), thought disturbances (slowed thinking, inability to concentrate)
delirium
encephalopathy (see the subsection “Immediately contact your doctor” 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 worsening of kidney function
skin rash which may appear as blistering lesions resembling small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), a 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 affecting more than 30% of body surface area (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, low 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 certain actions repeatedly (obsessive-compulsive disorder)

5. How to store Levetiracetam Almus

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 carton after Exp.: and on the blister after EXP:.
The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Levetiracetam Almus contains
The active substance is called levetiracetam.
Each tablet contains 500 mg of levetiracetam.
The other components are:
Tablet core: anhydrous colloidal silica, maize starch, magnesium stearate, talc, povidone K30.
Coating: Opadry 85F32004: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).
Levetiracetam Almus is packaged in blisters contained in cardboard boxes.
Each blister contains 10 tablets.

Description of the appearance of Levetiracetam Almus and the contents of the packaging
Levetiracetam Almus film-coated tablets are yellow, oval-shaped, scored and marked with "500" on one side.
The tablet can be divided into two equal doses.
Cardboard boxes contain 10 (1x10), 20 (2x10), 30 (3x10), 50 (5x10), 60 (6x10), 100 (10x10), 120 (12x10) and 200 (20x10) film-coated tablets, as well as multiple packs of 2x50 (100) and 4x50 (200) film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Almus S.r.l.
Via Cesarea 11/10
16121 Genoa
Italy
E-mail: [email protected]

Manufacturer:
Laboratoires BTT
ZI de Krafft
67150 Erstein
France
Holsten Pharma GmbH
Hahnstraße 31-35
60528 Frankfurt am Main
Germany

Patient information leaflet: information for the patient

Levetiracetam Almus 750 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before you or your child starts 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, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Levetiracetam Almus is and what it is used for
What you need to know before taking Levetiracetam Almus
How to take Levetiracetam Almus
Possible side effects
How to store Levetiracetam Almus
Contents of the pack and other information

2. What Levetiracetam Almus is and what it is used for

Levetiracetam Almus (as it will be referred to in the rest of this leaflet) contains 750 mg of

levetiracetam in each film-coated tablet.

Levetiracetam Almus is an antiepileptic medicine (a medicine used to treat epileptic seizures).
It can be 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 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 Almus to reduce the number of seizures you experience.
in addition to other antiepileptic medicines to treat:
- partial-onset seizures, with or without generalization, in adults, adolescents, children and infants aged 1 month and older
- myoclonic seizures (brief, shock-like muscle jerks of a muscle or muscle group) 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 Almus

Do not take Levetiracetam Almus

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 Almus

If you have kidney problems, follow your doctor's instructions. Your doctor may decide whether the dose needs to be adjusted.
If you notice slowed growth or unexpected development of puberty in the child, contact your doctor.
A small number of people taking antiepileptic medicines such as Levetiracetam Almus have had suicidal thoughts or self-harming thoughts. If you experience any symptoms of depression and/or suicidal thoughts, contact your doctor.
If you or a family member has 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, your family, or friends notice the onset of 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 types of seizures and loss of acquired skills, you may notice that seizures persist or worsen during treatment.

If you experience any of these new symptoms while being treated with Levetiracetam Almus, consult your doctor as soon as possible.
Children and adolescents

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

Other medicines and Levetiracetam Almus
Tell 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 a loss of effectiveness of levetiracetam.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before taking this medicine.
Levetiracetam may be used during pregnancy only if, after careful evaluation, your doctor considers it necessary.
You must 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 Almus 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 are certain that your ability to perform these activities is not affected.
Levetiracetam Almus contains Sunset Yellow
Levetiracetam Almus 750 mg contains Sunset Yellow (E110), a colouring agent that may cause allergic reactions.

3. How to take Levetiracetam Almus

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Take the number of tablets as instructed by your doctor.
Levetiracetam Almus should be taken twice daily, once in the morning and once in the evening, approximately at the same time each day.

Adjunctive and monotherapy (from 16 years of age)

Adults (≥ 18 years) and adolescents (12 to 17 years) weighing 50 kg or more: Recommended dose: between 1000 mg and 3000 mg per day. When starting Levetiracetam Almus for the first time, your doctor will prescribe a lower dose for 2 weeks before increasing to the lowest daily dose. Example: if your daily dose is to be 1000 mg, your initial reduced dose is 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening, and the dose will be gradually increased to reach 1000 mg per day after 2 weeks.
Adolescents (12 to 17 years) weighing less than or equal to 50 kg: Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Almus based on weight and required dose.
Dose for infants (1 month to 23 months) and children (2 to 11 years) weighing less than 50 kg: Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Almus based on age, weight, and required dose.

Duration of treatment

Levetiracetam Almus is used as a chronic treatment. Treatment with Levetiracetam Almus 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 forget to take Levetiracetam Almus
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 Almus
If treatment needs to be discontinued, Levetiracetam Almus should be withdrawn gradually to avoid an increase in seizures. If your doctor decides to stop treatment with Levetiracetam Almus, they will provide you with instructions for gradually tapering off Levetiracetam Almus.

If you have any doubts about how to use 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, dizziness or lightheadedness, or have difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic reaction)
swelling of the face, lips, tongue, and 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, increase in 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 that may appear as blisters resembling small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) ( erythema multiforme )
widespread skin rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals ( Stevens-Johnson syndrome )
a more severe form of skin rash causing skin peeling affecting 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 behaviour, 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 (feeling of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking)
vertigo (sensation of spinning)
cough
abdominal pain, diarrhoea, 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 behaviour, hallucinations, anger, confusion, panic attack, emotional 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 important allergic reaction], Quincke's edema [swelling of face, lips, tongue, and throat])
decreased concentration of sodium in the blood
suicide, personality disorder (behavioural 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)
change in heart rhythm (electrocardiogram)
pancreatitis
liver failure, hepatitis
sudden worsening of kidney function
skin rash that may appear as blisters resembling small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) ( erythema multiforme ), widespread skin 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 affecting 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, low 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).

5. How to store Levetiracetam Almus

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 carton after "Exp." and on the blister after "EXP:".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Almus contains
The active substance is called levetiracetam.
Each tablet contains 750 mg of levetiracetam.
The other components are:
Tablet core: colloidal anhydrous silica, maize starch, magnesium stearate, talc, povidone K30.
Coating: Opadry 85F23452: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide red (E172), sunset yellow (E110).
Levetiracetam Almus is packaged in blisters in cardboard boxes.
Each blister contains 10 tablets.

Description of the appearance of Levetiracetam Almus and package contents
The film-coated tablets of Levetiracetam Almus are pink, oval-shaped, scored and marked with “750” on one side.
The tablet can be divided into two equal doses.
The cardboard boxes contain 20 (2x10), 30 (3x10), 50 (5x10), 60 (6x10), 80 (8x10), 100 (10x10) and 200 (20x10) film-coated tablets, or multiple pack sizes of 4x50 (200) film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Almus S.r.l.
Via Cesarea 11/10
16121 Genova
Italy
E-mail: [email protected]

Manufacturers:
Laboratoires BTT
ZI de Krafft
67150 Erstein
France
Holsten Pharma GmbH
Hahnstraße 31-35
60528 Frankfurt am Main
Germany

Patient Information Leaflet

Levetiracetam Almus 1000 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before you or your child starts 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, consult 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 adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Levetiracetam Almus is and what it is used for
What you need to know before taking Levetiracetam Almus
How to take Levetiracetam Almus
Possible side effects
How to store Levetiracetam Almus
Contents of the pack and other information

3. What Levetiracetam Almus is and what it is used for

Levetiracetam Almus (as it will be referred to throughout this patient information leaflet) contains 1000 mg of

levetiracetam in each film-coated tablet.

Levetiracetam Almus is an antiepileptic medicine (a medicine used to treat epileptic seizures).
It can be used:

as monotherapy in adults and adolescents 16 years of age and older 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 broader areas on both sides of the brain (partial-onset seizures with or without secondary generalization). Levetiracetam has been prescribed by your doctor to reduce the number of seizures.
in addition to other antiepileptic medicines to treat:
- partial-onset seizures, with or without generalization, in adults, adolescents, children, and infants from 1 month of age
- myoclonic seizures (brief, shock-like muscle jerks of a muscle or muscle group) in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy
- primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents 12 years of age 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 Almus

Do not take Levetiracetam Almus

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 Almus

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 Almus have experienced self-harming thoughts or suicidal ideas. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.
If you or a family member has a heart rhythm disorder (detectable 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 the onset of 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. In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations), which causes multiple seizure types 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 Almus, consult your doctor as soon as possible.
Children and adolescents

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

Other medicines and Levetiracetam Almus
Tell 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) one hour before or one hour after taking levetiracetam, as it may cause loss of effect of levetiracetam.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Levetiracetam may be used during pregnancy only if, after careful evaluation, your doctor considers it necessary.
You must 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 Almus 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 use machinery until you have determined that your ability to perform these activities is not impaired.

3. How to take Levetiracetam Almus

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take the number of tablets as prescribed by your doctor.
Levetiracetam Almus must be taken twice daily, once in the morning and once in the evening, approximately at the same time each day.

Adjunctive therapy and monotherapy (from 16 years of age)

Adults (≥ 18 years) and adolescents (12 to 17 years) weighing 50 kg or more: Recommended dose: between 1000 mg and 3000 mg per day. When you first start taking Levetiracetam Almus, your doctor will prescribe a lower dose for 2 weeks before increasing to the lowest daily dose. Example: if your daily dose is to be 1000 mg, your initial reduced dose is 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening, and the dose will be gradually increased to reach 1000 mg per day after 2 weeks.
Adolescents (12 to 17 years) weighing less than or equal to 50 kg: Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Almus based on weight and required dose.
Dose for infants (1 month to 23 months) and children (2 to 11 years) weighing less than 50 kg: Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Almus based on age, weight, and required dose.

The oral solution is the most suitable formulation for infants and children under 6 years of age, for children and adolescents (6 to 17 years) weighing less than 50 kg, and when tablets do not allow accurate dosing.

Duration of treatment

Levetiracetam Almus is used as a chronic treatment. Treatment with Levetiracetam Almus should continue for as long as prescribed by your doctor.
Do not stop treatment without consulting your doctor, as this could increase the number of seizures.

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

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Contact your doctor immediately or go to the nearest emergency room if you experience:

weakness, feeling faint or dizzy, or if you have difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction
swelling of the face, lips, tongue, or throat (angioedema, also known as Quincke's edema)
flu-like symptoms and a rash on the face followed by a widespread rash with high fever, increased liver enzyme levels 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 the legs, ankles, or feet, as these may indicate sudden worsening of kidney function
a skin rash that may appear as blistering lesions resembling small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) ( erythema multiforme )
a widespread rash with blisters and skin peeling, especially 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 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, 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 frequent. 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
seizures, balance disorder, dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking)
vertigo (spinning sensation)
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 thoughts, mental disorder, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional 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)
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 serious allergic reaction], angioedema [swelling of the face, lips, tongue, and throat])
decreased sodium levels in the blood
suicide, personality disorder (behavioral problems), disturbances in thinking (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 that may appear as blistering lesions resembling small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) ( erythema multiforme ), a 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 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
combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, and reduced 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

repetitive unwanted thoughts or urges to perform certain actions repeatedly (obsessive-compulsive disorder)

5. How to store Levetiracetam Almus

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after Exp.: and on the blister after
EXP:.
The expiry date refers to the last day of that month.
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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Levetiracetam Almus contains
The active substance is called levetiracetam.
Each tablet contains 1000 mg of levetiracetam.
The other components are:
Tablet core: anhydrous colloidal silica, maize starch, magnesium stearate, talc, povidone K30.
Coating: Opadry 85F18422: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.
Levetiracetam Almus is packaged in blisters within cardboard boxes.
Each blister contains 10 tablets.

Description of the appearance of Levetiracetam Almus and the contents of the pack
Levetiracetam Almus film-coated tablets are white, oval-shaped, scored and marked with "1000" on one side.
The tablet can be divided into two equal doses.
The cardboard boxes contain 10 (1x10), 20 (2x10), 30 (3x10), 50 (5x10), 60 (6x10), 100 (10x10) and 200 (20x10) film-coated tablets, and multiple packs of 2x50 (100) and 4x50 (200) film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Almus S.r.l.
Via Cesarea 11/10
16121 Genoa
Italy
E-mail: [email protected]

Manufacturer:
Laboratoires BTT
ZI de Krafft
67150 Erstein
France
Holsten Pharma GmbH
Hahnstraße 31-35
60528 Frankfurt am Main
Germany