MATEVER 250 mg Фильм-Coated Таблетки

Содержание инструкции

1. Matever 250 mg film-coated tablets, 500 mg film-coated tablets, 750 mg film-coated tablets, 1000 mg film-coated tablets
   1. What is Matever and what it is used for
   2. What you need to know before you take Matever
   3. How to take Matever
   4. Possible side effects
   5. How to store Matever
   6. Contents of the pack and other information
2. Matever 100 mg/mL concentrate for solution for infusion
   1. What is Matever and what is it 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

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

Levetiracetam

Read this leaflet carefully before you take this medicine, or before your child takes this medicine, as 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 only for you. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
• 1. What Matever is and what it is used for
• 2. What you need to know before you take 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 is Matever and what it is used for

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

• alone in adults and adolescents starting from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition in which the patient has repeated attacks (seizures). Levetiracetam is used for the form of epilepsy in which the attacks initially affect a part of the brain, but may subsequently extend to larger 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 an addition to other antiepileptic medicines to treat:
• partial-onset seizures, with or without generalization, in adults, adolescents, children and infants starting from 1 month of age
• myoclonic seizures (brief shock-like spasms of a muscle or muscle group) in adults and adolescents starting from 12 years of age with juvenile myoclonic epilepsy
• primary generalized tonic-clonic seizures (major attacks, including loss of consciousness) in adults and adolescents starting from 12 years of age with idiopathic generalized epilepsy (the type of epilepsy that is thought to be due to genetic causes).

2. What you need to know before you take Matever

Do not take Matever

• If you are allergic to levetiracetam, pyrrolidone derivatives or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautionsTalk to your doctor before taking Matever
• If you have kidney problems follow your doctor’s instructions. The latter may decide whether the dose needs to be corrected.
• If you observe a slowing of growth or an unexpected development of puberty in the child, contact your doctor.
• A limited number of people treated with antiepileptics such as Matever have experienced self-harmful thoughts or suicidal ideas. If you have any symptoms of depression and/or suicidal ideas, contact your doctor.
• If you or a family member suffers from cardiac arrhythmia (visible on an electrocardiogram) or if you have a disease and/or are taking medicines that can cause irregular heartbeats or electrolyte imbalances. Inform your doctor or pharmacist if any of the following side effects worsen or last more than a few days:
• Abnormal thoughts, feeling of irritability or more aggressive reactions than usual, or if you or your family and friends notice the appearance of significant changes in mood or behavior.
• 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 remain present or worsen during treatment. If you experience any of these new symptoms during treatment with Matever, consult a doctor as soon as possible.

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

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Levetiracetam can be used during pregnancy, only if, after careful evaluation, this is
considered necessary by the doctor.
Do not stop your treatment without discussing it with your doctor.
A risk of birth defects for the fetus cannot be completely excluded. Breastfeeding is not
recommended during treatment.

Driving and using machines
Matever may reduce your ability to drive vehicles or use tools or machinery as it may cause
drowsiness. This is more likely at the beginning of treatment or after an increase in dose. You should not
drive or use machines until you have verified that your ability to perform these activities is not
affected.

Matever 250 mg, 750 mg film-coated tablets contain Sunset Yellow FCF (E110)
The dye Sunset Yellow FCF (E110) may cause allergic reactions.
The other dosages of Matever tablets do not contain this component.

Matever 1000 mg film-coated tablets contain lactose.
If your doctor has told you that you have an intolerance to some sugars (e.g. lactose), consult your
doctor before taking this medicine.
The other dosages of Matever tablets do not contain this component.

3. How to take Matever

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

Add-on 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 start taking Matever for the first time, your doctor will prescribe a lower dosefor 2 weeks before giving you the lowest daily dose. Example: if your daily dose is to be 1000 mg, your initial reduced dose is 1 tabletof 250 mg in the morning and 1 tablet of 250 mg in the evening and the dose will be gradually increasedto reach 1000 mg per day after 2 weeks.
• Adolescents (12 to 17 years) weighing 50 kg or less:The doctor will prescribe the pharmaceutical form of Matever most appropriate depending on weight and dose.
• Dose for infants (1 month to 23 months) and children (2 to 11 years) weighing less than 50 kg:The doctor will prescribe the pharmaceutical form of Matever most appropriate depending on age, weight and 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 and when
tablets do not allow for accurate dosing.
Method of administration:
Swallow Matever tablets with a sufficient amount of liquid (e.g. a glass of water). You can
take Matever with or without food. After oral administration, you may perceive the bitter taste of
levetiracetam.
Duration of treatment:

• Matever is used as chronic treatment. Treatment with Matever should last as long as prescribed by your doctor.
• Do not stop treatment without your doctor's advice as this could increase the number of seizures.

If you take more Matever than you should
Possible undesirable effects of an overdose of Matever are drowsiness, agitation, aggression,
decreased attention, respiratory inhibition and coma.
Contact your doctor if you have taken more tablets than you should have. The doctor will determine the best
possible 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 missed tablet

If you stop taking Matever
In case of discontinuation of treatment, as with any other antiepileptic medicine, Matever must be
discontinued gradually to avoid an increase in seizures.
If your doctor decides to stop treatment with Matever, he will give you instructions regarding
the gradual withdrawal of Matever.
If you have any questions about the use of Matever, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Immediately inform your doctor or go to the nearest emergency room if you experience:

• weakness, feeling dizzy or lightheaded, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic)
• swelling of the face, lips, tongue and throat (angioedema)
• flu-like symptoms and a rash on the face followed by a widespread rash with high fever, increased levels of liver enzymes observed in blood tests, and an increase in a type of white blood cells (eosinophilia) and enlarged lymph nodes (drug reaction with eosinophilia and systemic symptoms [DRESS, Drug Reaction with Eosinophilia and Systemic Symptoms])
• symptoms such as reduced urine output, fatigue, nausea, vomiting, confusion and swelling of legs, ankles or feet, as these may be a sign of sudden kidney failure
• a rash that may appear with blisters that look like small targets (dark central spots surrounded by a clearer area, with a dark ring around the edge) (erythema multiforme)
• a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• a more severe form of rash that causes skin peeling in more than 30% of the body surface area (toxic epidermal necrolysis)
• signs of severe mental changes or if someone around you notices signs of 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. These effects should, in any case, 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;
• convulsion, balance disorder, dizziness (feeling unstable), 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;
• attempted suicide and suicidal thoughts, mental disorder, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional lability/mood swings, agitation;
• amnesia (memory loss), impaired memory (forgetfulness), abnormal coordination/ataxia (impaired motor coordination), paresthesia (tingling), impaired attention (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/abnormal values in liver function tests;
• hair loss, eczema, 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], angioedema [swelling of the face, lips, tongue and throat]);
• decreased concentration of sodium in the blood;
• suicide, personality disorder (behavioral problems), altered thinking (slowed thinking, inability to concentrate);
• delirium;
• encephalopathy (see the subsection “Immediately inform your doctor” for a detailed description of the symptoms);
• seizures may worsen or occur more frequently;
• uncontrollable muscle spasms involving the head, trunk and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• altered heart rhythm (electrocardiogram);
• pancreatitis;
• liver failure, hepatitis;
• sudden kidney failure;
• a rash that may appear with blisters that look like small targets (dark central spots surrounded by a clearer area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form that causes skin peeling in more than 30% of the body surface area (toxic epidermal necrolysis);
• rhabdomyolysis (breakdown of muscle tissue) and increased blood creatine phosphokinase associated with it. The prevalence is significantly higher in Japanese patients than in non-Japanese patients;
• limping gait 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 than in non-Japanese patients.

Very rare:may affect up to 1 in 10,000 people

• repetitive unwanted thoughts or feelings or the urge to do something repeatedly (obsessive-compulsive disorder).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the 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 package after Scad.: and on the blister
after EXP:.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Matever contains
The active ingredient 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 ingredients 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), colorants*.
500 mg:
Coating: hypromellose (E464), titanium dioxide (E171), hydroxypropylcellulose (E463), glycol
propylene glycol (E1520), sorbic acid (E200), sorbitan monooleate (E494), vanillin, colorants*.
750 mg:
Coating: hypromellose (E464), macrogol/PEG 4000, titanium dioxide (E171), colorants*.
1000 mg:
Coating: hypromellose (E464), lactose monohydrate, macrogol/PEG 4000, titanium dioxide (E171).
* The colorants are:
250 mg tablets: indigotine aluminium lake (E132), sunset yellow FCF aluminium lake (E110), yellow
quinoline aluminium lake (E104)
500 mg tablets: yellow quinoline aluminium lake (E104)
750 mg tablets: sunset yellow FCF aluminium lake (E110), iron oxide red (E172), indigotine
aluminium lake (E132).
1000 mg tablets: (no additional colorants).

Description of the appearance of Matever and contents of the pack
Matever 250 mg: the film-coated tablets are blue, oval-shaped, biconvex.
Matever 500 mg: the film-coated tablets are yellow, oval-shaped, biconvex.
Matever 750 mg: the film-coated tablets are pink, oval-shaped, biconvex.
Matever 1000 mg: the film-coated tablets are white, oval-shaped, biconvex.
Opaque white aluminium/PVC/PE/PVDC blisters inserted in cardboard boxes.
Matever tablets are packaged in blisters inserted in cardboard boxes containing:

• 250 mg: 20, 30, 50, 60, 100 film-coated tablets and multi-packs of 200 (2 boxes of
• 100) film-coated tablets.
• 500 mg: 10, 20, 30, 50, 60, 100, 120 film-coated tablets and multi-packs of 200 (2 boxes of 100) film-coated tablets.
• 750 mg: 20, 30, 50, 60, 80, 100, 120 film-coated tablets and multi-packs of 200 (2 boxes of 100) film-coated tablets.
• 1000 mg: 10, 20, 30, 50, 60, 100 film-coated tablets and multi-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 medicine, contact the local representative of the marketing authorisation holder.

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

Lietuva
SIA ELVIM
Tel: +371 67808450

България
Pharmathen S.A.
Teл: +30 210 66 04 300

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

Česká republika
ARDEZ Pharma, spol. s r.o.
Tel.: +420 220 400 391

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

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

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

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

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

Eesti (Estonia)
SIA ELVIM
Tel: +371 67808450

Norge
Pharmathen S.A.
Tlf: +30 210 66 04 300

Ελλάδα
INNOVIS PHARMA ΑΕΒΕ
Τηλ: +30 210 66 64 805-806

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

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

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

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

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

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

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

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

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

Ísland
Alvogen ehf.
Tel: +354 522 2900

Slovenská republika
ARDEZ Pharma, spol. s r.o.
Tel.: +420 220 400 391

Italia
Ecupharma S.r.l.
Tel : +39-02-38238790

Suomi/Finland
Ailon Pharma Oy
Puh/Tel: +358 407024992

Κύπρος
The Star Medicines Importers Co. Ltd
Τηλ: +357 25371056

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

Latvija
SIA ELVIM
Tel: +371 67808450

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

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

Matever 100 mg/mL concentrate for solution for infusion

levetiracetam

Read this leaflet carefully before you take this medicine, or before your child takes this medicine
as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Matever is and what it is used for
• 2. What you need to know before you use 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 is Matever and what is it used for

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

• alone in adults and adolescents starting from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition in which the patient has repeated attacks (seizures). Levetiracetam is used for the form of epilepsy in which the attacks initially affect one part of the brain, but may subsequently extend to a wider area 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 an addition to other antiepileptic medicines to treat:
• partial-onset seizures, with or without generalization, in adults, adolescents and children starting from 4 years of age
• myoclonic seizures (brief shock-like spasms of a muscle or muscle group) in adults and adolescents starting from 12 years of age with juvenile myoclonic epilepsy
• primary generalized tonic-clonic seizures (major attacks, including loss of consciousness) in adults and adolescents and children starting from 12 years of age with idiopathic generalized epilepsy (the type of epilepsy that is thought to be due to genetic causes). Matever concentrate for infusion solution is an alternative for patients when the administration of the oral antiepileptic medicine Matever is temporarily not possible.

2. What you need to know before using Matever

Do not use 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 using 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 a slowing of growth or unexpected development of puberty in the child, contact your doctor.
• A limited number of people treated with antiepileptics such as Matever have experienced self-harmful thoughts or suicidal ideas. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.
• If you or a family member suffers from cardiac arrhythmia (visible on an electrocardiogram) or if you have a disease and/or are taking medicines that can cause irregular heartbeats or electrolyte imbalances.

Tell your doctor or pharmacist if any of the following side effects worsen or last for more than a few
days:

• Abnormal thoughts, feeling irritable or more aggressive than usual, or if you or your family and friends notice the appearance of significant changes in mood or behavior.
• 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 abilities, you may notice that seizures remain present or worsen during treatment.

If you experience any of these new symptoms during treatment with Matever, consult a doctor as
soon as possible.

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

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine. Levetiracetam may
be used during pregnancy, only if, after careful evaluation, this is considered necessary by the
doctor.
You must not stop your treatment without discussing it with your doctor.
A risk of birth defects for the fetus cannot be completely excluded.
Breastfeeding is not recommended during treatment.

Driving and using machines
Matever may reduce your ability to drive vehicles or use tools or machinery as it may
cause drowsiness. This is more likely at the beginning of treatment or after an increase in dose.
You should not drive or use machinery until you have verified that your ability to perform these activities
is not affected.

Matever contains sodium
This medicine contains 57.21 mg (main component of table salt) in each maximum
single dose. This is equivalent to 2.86% of the maximum recommended daily dose in adults.

3. How to use Matever

A doctor or nurse will administer Matever to you as an intravenous infusion.
Matever must be administered twice a day, 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. It can be switched from film-coated
tablets or oral solution to the intravenous formulation or vice versa directly without
dose adjustment. The total daily dose and frequency of administration remain identical.

Add-on therapy and monotherapy (starting 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 Matever, your doctor will prescribe a lower dosefor
2 weeks before giving you the lowest daily dose.

Dose for children (4 to 11 years) and adolescents (12 to 17 years) weighing less than 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 regarding the intravenous administration of levetiracetam for a period longer
than 4 days.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Immediately inform your doctor or go to the nearest emergency room if you experience:

• weakness, a feeling of lightheadedness or dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic)
• swelling of the face, lips, tongue and throat (angioedema)
• flu-like symptoms and a rash on the face followed by widespread rash with high fever, increased levels of liver enzymes observed in blood tests, and an increase in a type of white blood cells (eosinophilia) and enlarged lymph nodes (drug reaction with eosinophilia and systemic symptoms [DRESS, Drug Reaction with Eosinophilia and Systemic Symptoms])
• symptoms such as reduced urine output, fatigue, nausea, vomiting, confusion, and swelling of legs, ankles or feet, as these may be a sign of sudden decrease in kidney function
• a rash that may appear with blisters that look like small targets (dark central spots surrounded by a clearer area, with a dark ring around the edge) (erythema multiforme)
• a widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• a more severe form of rash that causes skin peeling in more than 30% of the body surface area (toxic epidermal necrolysis)
• signs of severe mental changes or if someone around you notices signs of 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. These effects should, in any case, decrease over time. Very common:may affect more than 1 in 10 people
• nasopharyngitis;
• drowsiness, headache.

Common:may affect up to 1 in 10 people

• anorexia (loss of appetite);
• depression, hostility or aggressiveness, anxiety, insomnia, nervousness or irritability;
• convulsions, balance disorders, dizziness (feeling unstable), 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;
• attempted suicide and suicidal ideation, mental disorder, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional lability/mood swings, agitation;
• amnesia (memory loss), impaired memory (forgetfulness), abnormal coordination/ataxia (impaired motor coordination), paresthesia (tingling), impaired attention (loss of concentration);
• diplopia (double vision), blurred vision;
• elevated/abnormal values in liver function tests;
• hair loss, eczema, 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], angioedema [swelling of the face, lips, tongue and throat]);
• decreased concentration of sodium in the blood;
• suicide, personality disorder (behavioral problems), altered thinking (slowed thinking, inability to concentrate);
• delirium;
• encephalopathy (see the subsection “Immediately inform your doctor” for a detailed description of the symptoms);
• seizures may worsen or occur more frequently;
• uncontrollable muscle spasms involving the head, trunk and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• altered heart rhythm (electrocardiogram);
• pancreatitis;
• liver failure, hepatitis;
• sudden decrease in kidney function;
• a rash that may form blisters and appear as small targets (dark central spots surrounded by a clearer area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form that causes skin peeling in more than 30% of the body surface area (toxic epidermal necrolysis);
• rhabdomyolysis (muscle tissue breakdown) and increased blood creatine phosphokinase associated with it. The prevalence 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, 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 feelings or an urge to do something repeatedly (obsessive-compulsive disorder).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the 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 which is stated on the vial and the package after Exp.:
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Matever contains
The active substance is called levetiracetam. Each mL of solution for infusion contains 100 mg of
levetiracetam.
The other ingredients are: sodium acetate trihydrate, glacial acetic acid, sodium chloride, water for
injections.

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

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

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

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

България
Pharmathen S.A.
Teл.: +30 210 66 04 300

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

Česká republika
ARDEZ Pharma, spol. s r.o.
Tel: +420 220 400 391

Magyarország
Onkogen Kft.
Tel.: +36 70 310 1163

Danmark
Orion Pharma A/S
Tlf: +45 49 12 66 00

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

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

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

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

Norge
Pharmathen S.A.
Tlf: +30 210 66 04 300

Ελλάδα
INNOVIS PHARMA ΑΕΒΕ
Τηλ: +30 210 66 64 805-806

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

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

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

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

Hrvatska
Makpharm d.o.o.
Tel: +385 1 4840 342

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

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

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

Slovenija
Lenis farmacevtika d.o.o
Tel.: +386 1 235 07 00

Ísland
Pharmathen S.A.
Sími: +30 210 66 04 300

Slovenská republika
ARDEZ Pharma, spol. s r.o.
Tel: +420 220 400 391

Italia
Ecupharma S.r.l.
Tel : +39-02-38238790

Suomi/Finland
Orion Corporation
Puh/Tel: +358 10 4261

Κύπρος
The Star Medicines Importers Co. Ltd
Τηλ: +357 25371056

Sverige
Orion Pharma AB
Tel: +46 8 623 6440

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

United Kingdom (Northern Ireland)
Pharmathen S.A.
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 correct use of Matever are provided in paragraph 3.
One 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 for single use only and any unused solution must be
discarded.
Validity during use: from a microbiological point of view, the product must be used immediately after
dilution. If not used immediately, the storage time during use and the conditions
prior to use are the responsibility of the user and should normally not exceed 24 hours
at a temperature between 2 and 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 stable when mixed with the following
diluents and stored in PVC bags at a controlled room temperature of 15-25°C for at least
24 hours.
Diluents:

• Sodium chloride 9 mg/mL (0.9%) injectable preparation
• Ringer's lactate injectable preparation
• Glucose 50 mg/mL (5%) injectable preparation