Matever

Patient Information Leaflet

Matever 250 mg film-coated tablets, 500 mg film-coated tablets, 750 mg film-coated tablets, 1000 mg film-coated tablets

Levetiracetam
Please read this 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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
  Contents of this leaflet:

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

1. What Matever is and what it is used for

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

• as monotherapy in adults and adolescents 16 years of age and older with newly diagnosed epilepsy, to treat a specific type of epilepsy. Epilepsy is a condition in which the patient has repeated attacks (seizures). Levetiracetam is used for the type of epilepsy in which seizures initially affect 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 to you 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 spasms 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 (grand mal seizures, including loss of consciousness) in adults and adolescents 12 years of age and older with idiopathic generalized epilepsy (the type of epilepsy thought to be due to genetic causes).

2. What you need to know before taking Matever

Do not take Matever

• 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 Matever
• 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 Matever have experienced suicidal thoughts or self-harming 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 can 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 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 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 Matever, consult a doctor as soon as possible.

Children and adolescents
Matever as monotherapy (used alone) is not indicated in children or adolescents under 16 years of age.
Other medicines and Matever
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) one hour before or one hour after taking levetiracetam, as it may cause loss of effectiveness of levetiracetam.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice 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 in the unborn child cannot be completely ruled out. Breastfeeding is not recommended during treatment.
Driving and using machines
Matever may reduce your ability to drive or operate tools or machinery, as it may cause drowsiness. This is more likely at the beginning of treatment or after a dose increase. Do not drive or operate machinery until you are certain that your ability to perform these activities is not impaired.
Matever 250 mg, 750 mg film-coated tablets contain Sunset Yellow FCF (E110)
The colouring agent Sunset Yellow FCF (E110) may cause allergic reactions.
Other strengths of Matever tablets do not contain this ingredient.
Matever 1000 mg film-coated tablets contain lactose.
If your doctor has told you that you have an intolerance to certain sugars (e.g. lactose), consult your doctor before taking this medicine.
Other strengths of Matever tablets do not contain this ingredient.

3. How to take Matever

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.
Matever should 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 starting Matever for the first time, 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 Matever formulation 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 Matever formulation based on age, weight, and required dose.

Levetiracetam 100 mg/mL oral solution is the most suitable formulation for infants and children under
6 years of age, and for children and adolescents (6 to 17 years) weighing less than 50 kg, when
tablets do not allow accurate dosing.
Method of administration:
Swallow Matever tablets with a sufficient amount of liquid (e.g. a glass of water). You may
take Matever with or without food. After oral administration, a bitter taste of levetiracetam may be perceived.
Duration of treatment:

• Matever is used as a chronic treatment. Treatment with Matever 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 Matever than you should
Possible adverse effects of Matever overdose include somnolence, agitation, aggression,
reduced attention, respiratory depression, and coma.
Contact your doctor if you have taken more tablets than you should have. Your doctor will determine the best
treatment for the overdose.
If you forget to take Matever
Contact your doctor if you have forgotten to take one or more doses.
Do not take a double dose to make up for the forgotten tablet.
If you stop taking Matever
If treatment is to be discontinued, as with any other antiepileptic medicine, Matever should be
gradually withdrawn to avoid an increase in seizures.
If your doctor decides to stop treatment with Matever, they will provide you with instructions on how to gradually discontinue Matever.
If you have any questions about the use of Matever, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Immediately contact your doctor or go to the nearest emergency room if you experience:

• weakness, feeling faint or dizzy, or have difficulty breathing, as these may be signs of a severe allergic (anaphylactic) reaction
• swelling of the face, lips, tongue, or 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, 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 forming small target-like spots (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 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), 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 were nasopharyngitis, somnolence, headache, fatigue, and dizziness. At the beginning of treatment or when the dose is increased, side effects such as somnolence, fatigue, and dizziness may be more common. However, these effects should decrease over time.

Very common: may affect more than 1 in 10 people

• nasopharyngitis
• somnolence, headache

Common: may affect up to 1 in 10 people

• anorexia (loss of appetite)
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability
• seizure, balance disorder, dizziness (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
• 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 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 serious 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 section “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 abnormalities)
• pancreatitis
• liver failure, hepatitis
• sudden worsening of kidney function
• skin rash that may appear as blisters forming small target-like spots (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), 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 incidence is significantly higher in Japanese patients compared to non-Japanese patients
• limping gait or difficulty walking
• combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, reduced level of consciousness (may be signs of a condition called neuroleptic malignant syndrome). The incidence 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 effects, including those not listed in this leaflet, please consult your doctor or pharmacist. You may 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 Matever

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 Matever Contains
The active substance is called levetiracetam.
Each Matever 250 mg tablet contains 250 mg of levetiracetam.
Each Matever 500 mg tablet contains 500 mg of levetiracetam.
Each Matever 750 mg tablet contains 750 mg of levetiracetam.
Each Matever 1000 mg tablet contains 1000 mg of levetiracetam.

The other components are:
Tablet core: dibasic calcium phosphate dihydrate, microcrystalline cellulose, crospovidone type A,
hydroxypropylcellulose (L).

250 mg:
Coating: hypromellose (E464), titanium dioxide (E171), talc, propylene glycol (E1520), colourants*.

500 mg:
Coating: hypromellose (E464), titanium dioxide (E171), hydroxypropylcellulose (E463), propylene
glycol (E1520), sorbic acid (E200), sorbitan monooleate (E494), vanillin, colourants*.

750 mg:
Coating: hypromellose (E464), macrogol/PEG 4000, titanium dioxide (E171), colourants*.

1000 mg:
Coating: hypromellose (E464), lactose monohydrate, macrogol/PEG 4000, titanium dioxide (E171).

* The colourants are:
250 mg tablets: indigo carmine aluminium lake (E132), sunset yellow FCF aluminium lake (E110), quinoline yellow aluminium lake (E104).
500 mg tablets: quinoline yellow aluminium lake (E104).
750 mg tablets: sunset yellow FCF aluminium lake (E110), red iron oxide (E172), indigo carmine aluminium lake (E132).
1000 mg tablets: (no additional colourants).

Description of the Appearance of Matever and Contents of the Package
Matever 250 mg: film-coated tablets are blue, oval-shaped, biconvex.
Matever 500 mg: film-coated tablets are yellow, oval-shaped, biconvex.
Matever 750 mg: film-coated tablets are pink, oval-shaped, biconvex.
Matever 1000 mg: film-coated tablets are white, oval-shaped, biconvex.

Opaque white aluminium/PVC/PE/PVDC blisters packed in cardboard boxes.
Matever tablets are packaged in blisters within cardboard boxes containing:

• 250 mg: 20, 30, 50, 60, 100 film-coated tablets and multiple packs of 200 (2 boxes of 100) film-coated tablets.
• 500 mg: 10, 20, 30, 50, 60, 100, 120 film-coated tablets and multiple packs of 200 (2 boxes of 100) film-coated tablets.
• 750 mg: 20, 30, 50, 60, 80, 100, 120 film-coated tablets and multiple packs of 200 (2 boxes of 100) film-coated tablets.
• 1000 mg: 10, 20, 30, 50, 60, 100 film-coated tablets and multiple packs of 200 (2 boxes of 100) film-coated tablets.
  Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharmathen S.A., 6 Dervenakion Str., 15351 Pallini, Attiki, Greece.

Manufacturer
Pharmathen S.A.
6 Dervenakion Str.
15351 Pallini, Attiki
Greece
or
Pharmathen International S.A.
Industrial Park Sapes,
Rodopi Prefecture, Block No 5,
Rodopi 69300,
Greece

For further information on this medicinal product, please contact the local representative of the marketing authorisation holder.

België/Belgique/Belgien Lietuva
Pharmathen S.A. SIA ELVIM
Tél/Tel: +30 210 66 04 300 Tel: +371 67808450

България Luxembourg/Luxemburg
Pharmathen S.A. Pharmathen S.A.
Teл: +30 210 66 04 300 Tel.: +30 210 66 04 300

Česká republika Magyarország
ARDEZ Pharma, spol. s r.o. Pharmathen S.A.
Tel.: +420 220 400 391 Tel.: +30 210 66 04 300

Danmark Malta
Pharmathen S.A. Pharmathen S.A.
Tel.: +30 210 66 04 300 Tel: +30 210 66 04 300

Deutschland Nederland
Pharmathen S.A. Pharmathen S.A.
Tel.: +30 210 66 04 300 Tel: +30 210 66 04 300

Eesti (Estonia) Norge
SIA ELVIM Pharmathen S.A.
Tel: +371 67808450 Tlf: +30 210 66 04 300

Ελλάδα Österreich
INNOVIS PHARMA ΑΕΒΕ Pharmathen S.A.
Τηλ: +30 210 66 64 805-806 Tel: +30 210 66 04 300

España Polska
Pharmathen S.A. Pharmathen S.A.
Tel: +30 210 66 04 300 Tel.: +30 210 66 04 300

France Portugal
Pharmathen S.A. Pharmathen S.A.
Tél: +30 210 66 04 300 Tel: +30 210 66 04 300

Hrvatska România
Pharmathen S.A. Pharmathen S.A.
Tel: +30 210 66 04 300 Tel: +30 210 66 04 300

Ireland Slovenija
Pharmathen S.A. Pharmathen S.A.
Tel.: +30 210 66 04 300 Tel: +30 210 66 04 300

Ísland Slovenská republika
Alvogen ehf. ARDEZ Pharma, spol. s r.o.
Tel: +354 522 2900 Tel.: +420 220 400 391

Italia Suomi/Finland
Ecupharma S.r.l. Ailon Pharma Oy
Tel : +39-02-38238790 Puh/Tel: +358 407024992

Κύπρος Sverige
The Star Medicines Importers Co. Ltd Pharmathen S.A.
Τηλ: +357 25371056 Tel: +30 210 66 04 300

Latvija United Kingdom (Northern Ireland)
SIA ELVIM Pharmathen S.A.
Tel: +371 67808450 Tel.: +30 210 66 04 300

Other Sources of Information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu

Package leaflet: information for the user

Matever 100 mg/mL concentrate for solution for infusion

levetiracetam
Please read this leaflet carefully before you or your child are given 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

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

1. What Matever is and what it is used for

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

• as monotherapy in adults and adolescents from the age of 16 years with newly diagnosed epilepsy, to treat a certain type of epilepsy. Epilepsy is a condition in which the patient has repeated attacks (seizures). Levetiracetam is used for the type of epilepsy in which seizures initially affect one part of the brain, but may subsequently spread to a wider area on both sides of the brain (partial-onset seizures with or without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures.
• as add-on therapy to other antiepileptic medicines to treat:
• partial-onset seizures, with or without secondary generalization, in adults, adolescents and children from 4 years 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, adolescents and children from 12 years of age with idiopathic generalized epilepsy (the type of epilepsy thought to be due to genetic causes). Matever concentrate for solution for infusion is an alternative for patients when oral administration of the antiepileptic medicine Matever is temporarily not possible.

2. What you need to know before taking Matever

Do not take Matever

• 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 Matever

• If you have kidney problems, follow your doctor's instructions. Your doctor may decide whether your dose needs to be adjusted.
• If you observe slowed growth or unexpected onset of puberty in the child, contact your doctor.
• A small number of people taking antiepileptic medicines such as Matever have had thoughts about harming themselves or about suicide. If you experience 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 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, especially during the first month after starting treatment or increasing the dose. In a very rare early-onset form of epilepsy (epilepsy associated with SCN8A mutations), which causes multiple types of seizures and loss of acquired abilities, you may notice that seizures persist or worsen during treatment.

If you experience any of these new symptoms while taking Matever, consult a doctor as
soon as possible.
Children and adolescents
Matever used alone (monotherapy) is not indicated in children or adolescents under 16 years of age.
Other medicines and Matever
Inform 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) 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, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist 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 in the unborn child cannot be completely ruled out.
Breastfeeding is not recommended during treatment.
Driving and using machines
Matever 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.
Matever contains sodium
This medicine contains 57.21 mg of sodium (the main component of table salt) in each maximum
single dose. This corresponds to 2.86% of the maximum recommended daily intake for adults.

3. How to use Matever

A doctor or nurse will administer Matever to you as an intravenous infusion.
Matever must be administered twice daily, once in the morning and once in the evening, approximately at the same time each day.
The intravenous formulation is an alternative to oral administration. You may switch directly from film-coated tablets or oral solution to the intravenous formulation, or vice versa, without dose adjustment. The total daily dose and frequency of administration remain unchanged.
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 starting Matever for the first time, your doctor will prescribe a lower dose for 2 weeks before increasing to the lowest daily dose.
Dose for children (4 to 11 years) and adolescents (12 to 17 years) with body weight below 50 kg:
Typical dose: between 20 mg per kg of body weight and 60 mg per kg of body weight per day.
Method and route of administration
Matever is for intravenous use. The recommended dose must be diluted in at least 100 mL of a compatible diluent and infused over 15 minutes.
More detailed instructions for appropriate use of Matever are provided for doctors and nurses in section 6.
Duration of treatment
There is no experience with intravenous administration of levetiracetam for periods longer than 4 days.
If you stop treatment with Matever:
As with any other antiepileptic medicine, Matever should be discontinued gradually to avoid an increase in seizures.
If your doctor decides to stop treatment with Matever, they will give you instructions for gradually stopping Matever.
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 everyone will experience them.
Immediately contact your doctor 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 (anaphylactic) reaction
• 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 that may appear as blistering lesions resembling "target" lesions (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 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 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 disorders, dizziness (feeling 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
• 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 the face, lips, tongue, and throat])
• decreased concentration of sodium in the blood (hyponatremia)
• suicide, personality disorder (behavioral problems), thought disturbances (slowed thinking, inability to concentrate)
• delirium
• encephalopathy (see the section "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 abnormalities)
• pancreatitis
• liver failure, hepatitis
• sudden worsening of kidney function
• skin rash that may form blisters and appear as "target" lesions (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 affecting 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, and 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 urges to perform actions repeatedly (obsessive-compulsive disorder)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/web/guest/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Matever

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and carton 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 Matever contains
The active substance is called levetiracetam. Each mL of infusion solution contains 100 mg of
levetiracetam.
The other components are: sodium acetate trihydrate, glacial acetic acid, sodium chloride, water for injectable preparations.

Description of the appearance of Matever and contents of the pack
Matever concentrate for solution for infusion is a clear, colourless, sterile liquid.
Matever concentrate for solution for infusion is packaged in a cardboard box containing 10 vials of 5 mL each.

Marketing Authorisation Holder and Manufacturer
Pharmathen S.A., 6 Dervenakion Str., 15351 Pallini, Attiki, Greece.
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
Pharmathen S.A. Pharmathen S.A.
Tél/Tel: +30 210 66 04 300 Tel: +30 210 66 04 300

България Luxembourg/Luxemburg
Pharmathen S.A. Pharmathen S.A.
Teл.: +30 210 66 04 300 Tél/Tel: +30 210 66 04 300

Česká republika Magyarország
ARDEZ Pharma, spol. s r.o. Onkogen Kft.
Tel: +420 220 400 391 Tel.: +36 70 310 1163

Danmark Malta
Orion Pharma A/S Pharmathen S.A.
Tlf: +45 49 12 66 00 Tel: +30 210 66 04 300

Deutschland Nederland
Pharmathen S.A. Pharmathen S.A.
Tel.: +30 210 66 04 300 Tel.: +30 210 66 04 300

Eesti (Estonia) Norge
Pharmathen S.A. Pharmathen S.A.
Tel: +30 210 66 04 300 Tlf: +30 210 66 04 300

Ελλάδα Österreich
INNOVIS PHARMA ΑΕΒΕ Pharmathen S.A.
Τηλ: +30 210 66 64 805-806 Tel: +30 210 66 04 300

España Polska
Pharmathen S.A. Pharmathen S.A.
Tel: +30 210 66 04 300 Tel.: +30 210 66 04 300

France Portugal
Pharmathen S.A. Pharmathen S.A.
Tél: +30 210 66 04 300 Tel: +30 210 66 04 300

Hrvatska România
Makpharm d.o.o. Pharmathen S.A.
Tel: +385 1 4840 342 Tel: +30 210 66 04 300

Ireland Slovenija
Pharmathen S.A. Lenis farmacevtika d.o.o
Tel: +30 210 66 04 300 Tel.: +386 1 235 07 00

Ísland Slovenská republika
Pharmathen S.A. ARDEZ Pharma, spol. s r.o.
Sími: +30 210 66 04 300 Tel: +420 220 400 391

Italia Suomi/Finland
Ecupharma S.r.l. Orion Corporation
Tel: +39-02-38238790 Puh/Tel: +358 10 4261

Κύπρος Sverige
The Star Medicines Importers Co. Ltd Orion Pharma AB
Τηλ: +357 25371056 Tel: +46 8 623 6440

Latvija United Kingdom (Northern Ireland)
Pharmathen S.A. Pharmathen S.A.
Tel: +30 210 66 04 300 Tel: +30 210 66 04 300

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu

The following information is intended exclusively for healthcare professionals:

Instructions for the correct use of Matever are provided in section 3.
A vial of Matever concentrate contains 500 mg of levetiracetam (5 mL of concentrate at 100 mg/mL). See Table 1 for the recommended preparation and administration of Matever concentrate to achieve a total daily dose of 500 mg, 1000 mg, 2000 mg, or 3000 mg divided into two doses.
Table 1. Preparation and administration of Matever concentrate

This medicinal product is intended for single use and any unused solution must be discarded.
In-use stability: From a microbiological point of view, the product should be used immediately after dilution. If not used immediately, the in-use storage time and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at a temperature of 2 to 8°C, unless the dilution has been carried out under controlled and validated aseptic conditions.
Matever concentrate has been shown to be physically and chemically compatible and stable for at least 24 hours when mixed with the following diluents and stored in PVC bags at a controlled room temperature of 15–25°C.
Diluents:

• Sodium chloride 9 mg/mL (0.9%) solution for injection
• Sodium lactate Ringer's solution for injection
• Dextrose 50 mg/mL (5%) solution for injection