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Matever (levetiracetam) – Package leaflet - N03AX14

Updated on site: 08-Oct-2017

Medication nameMatever
ATC CodeN03AX14
Substancelevetiracetam
ManufacturerPharmathen S.A.

Package leaflet: Information for the patient

Matever 250 mg film-coated tablets

Matever 500 mg film-coated tablets

Matever 750 mg film-coated tablets

Matever 1000 mg film-coated tablets

Levetiracetam

Read all of this leaflet carefully before you or your child start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

 

effects not listed in this leaflet. See section 4.

What is in 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 Matever is and what it is used for

Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Matever is used:

on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition where the patients have repeated fits (seizures). Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation). Levetiracetam has been given to you by your doctor to reduce the number of fits.

as an add-on to other antiepileptic medicines to treat:

partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age

myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy

primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

2.What you need to know before you take 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 suffer from kidney problems, follow your doctor’s instructions. He/she may decide if your dose should be adjusted.

If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor.

A small number of people being treated with anti-epileptics such as Matever have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.

Children and adolescents

Matever is not indicated in children and adolescents below 16 years on its own (monotherapy).

Other medicines and Matever

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may results in a loss of its effect.

Pregnancy and breast-feeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Matever should not be used during pregnancy unless clearly necessary. A risk of birth defects for your unborn child cannot be completely excluded. Matever has shown unwanted reproductive effects in animal studies at dose levels higher than you would need to control your seizures.

Breast-feeding is not recommended during treatment.

Driving and using machines

Matever may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy. This is more likely at the beginning of treatment or after an increase in the dose. You should not drive or use machines until it is established that your ability to perform such activities is not affected.

Matever 250mg, 750 mg tablets contain Sunset Yellow FCF (E110).

Sunset Yellow FCF (E110) colouring agent may cause allergic reactions.

The other strengths of Matever tablets do not contain this ingredient.

Matever 1000 mg tablets contain lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product

The other strengths of Matever tablets do not contain this ingredient.

3.How to take Matever

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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 about the same time each day.

Monotherapy

Dose in adults and adolescents (from 16 years of age):

General dose: between 1,000 mg and 3,000 mg each day.

When you will first start taking Matever, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.

Example: if your daily dose is 1,000 mg, your reduced starting dose is 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.

Add-on therapy

Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more:

General dose: between 1,000 mg and 3,000 mg each day.

Example: if your daily dose is 1,000 mg, you might take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.

Dose in infants (1 month to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of Matever according to the age, weight and dose.

Levetiracetam 100mg/ml oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescents (from 6 to 17 years) weighing less than 50 kg and when tablets don’t allow accurate dosage.

Method of administration

Swallow Matever tablets with a sufficient quantity of liquid (e.g. a glass of water). You may take Matever with or without food.

Duration of treatment

Matever is used as a chronic treatment. You should continue Matever treatment for as long as your doctor has told you.

Do not stop your treatment without your doctor’s advice as this could increase your seizures.

If you take more Matever than you should

The possible side effects of an overdose of Matever are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.

Contact your doctor if you took more tablets than you should. Your doctor will establish the best possible treatment of overdose.

If you forget to take Matever

Contact your doctor if you have missed one or more doses.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Matever

If stopping treatment Matever should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Matever treatment, he/she will instruct you about the gradual withdrawal of Matever.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.Possible side effects

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

Tell your doctor immediately, or go to your nearest emergency department, if you experience:

weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction

swelling of the face, lips, tongue and throat (Quincke’s oedema)

flu-like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS])

symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function

a skin rash which may form blisters and look like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)

a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)

a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)

signs of serious mental changes or if someone around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements. These could be symptoms of an encephalopathy.

The most frequently reported side effects are nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common. These effects should however decrease over time.

Very common: may affect more than 1 user in 10 people

nasopharyngitis;

somnolence (sleepiness), headache.

Common: may affect 1 to 10 users in 100 people

anorexia (loss of appetite);

depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;

convulsion, balance disorder (equilibrium disorder),dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary trembling);

vertigo (sensation of rotation);

cough;

abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;

rash;

asthenia/fatigue (tiredness).

Uncommon: may affect 1 to 10 users in 1000 people

decreased number of blood platelets, decreased number of white blood cells;

weight decrease, weight increase;

suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, confusion, panic attack, emotional instability/mood swings, agitation;

amnesia (loss of memory),memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);

diplopia (double vision), vision blurred;

elevated/abnormal values in a liver function test;

hair loss, eczema, pruritus;

muscle weakness, myalgia (muscle pain);

injury.

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

infection;

decreased number of all blood cell types;

severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke’s oedema [swelling of the face, lips, tongue and throat]);

decreased blood sodium concentration;

suicide, personality disorders (behavioural problems),thinking abnormal (slow thinking, unable to concentrate);

uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);

pancreatitis;

liver failure, hepatitis;

sudden decrease in kidney function;

skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens– Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis).

rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase increase. Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. 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 box and 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 throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Matever contains

The active substance is called levetiracetam.

One tablet of Matever 250 mg contains 250 mg of levetiracetam.

One tablet of Matever 500 mg contains 500 mg of levetiracetam.

One tablet of Matever 750 mg contains 750 mg of levetiracetam.

One tablet of Matever 1000 mg contains 1000 mg of levetiracetam.

The other ingredients are:

Tablet core: calcium hydrogen phosphate dihydrate, cellulose microcrystalline, crospovidone type A, hydroxypropylcellulose (L).

250 mg:

Film-coating: hypromellose (E464), titanium dioxide (E171), talc, propylene glycol (E1520) colourants*.

500 mg:

Film-coating: hypromellose (E464), titanium dioxide (E171), hydroxypropyl cellulose (E463), propylene glycol (E1520), sorbic acid (E200), sorbitan monooleate (E494), vanillin, colourants*.

750 mg:

Film-coating: hypromellose (E464), iron oxide red (E172), macrogol/PEG 4000, titanium dioxide (E171), colourants*.

1000 mg:

Film-coating: hypromellose (E464), lactose monohydrate,macrogol/PEG 4000, titanium dioxide (E171).

* The colourants are:

250 mg tablet: indigo carmine aluminium lake (E132), sunset yellow FCF aluminium lake (E110), quinoline yellow aluminium lake (E104)

500 mg tablet: quinoline yellow aluminium lake (E104)

750 mg tablet: indigo carmine aluminium lake (E132), sunset yellow FCF aluminium lake (E110) 1000 mg tablet: (no additional colourant).

What Matever looks like and contents of the pack

Matever 250 mg: The film-coated tablets are blue, oblong, biconvex.

Matever 500 mg; The film-coated tablets are yellow, oblong, biconvex.

Matever 750 mg; The film-coated tablets are pink, oblong, biconvex.

Matever 1000 mg: The film-coated tablets are white, oblong, biconvex.

White opaque PVC/PE/PVDC-Aluminium foil blister in cardboard boxes.

Matever tablets are packaged in blister packs supplied in cardboard boxes containing:

250 mg: 20, 30, 50, 60, 100 and multipack of 200 (2 packs of 100) film-coated tablets.

500 mg: 10, 20, 30, 50, 60, 100, 120 and multipack of 200 (2 packs of 100) film-coated tablets.

750 mg: 20, 30, 50, 60, 80, 100, 120 and multipack of 200 (2 packs of 100) film-coated tablets.

1000 mg: 10, 20, 30, 50, 60, 100 and multipack of 200 (2 packs of 100) film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Pharmathen S.A., 6 Dervenakion Str., 15351 Pallini, Attiki, Greece

For any information about this medicine, 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

ACEpharma Ltd.

Pharmathen S.A.

Teл.: +359 2862 9152

Tel: +30 210 66 04 300

Česká republika

Magyarország

Genericon s.r.o.

Pharmathen S.A.

Tel: +420 221 512 176

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.

Glenmark Pharmaceuticals B.V.

Tel.: +30 210 66 04 300

Tel: 0031 76 596 1937

Eesti (Estonia)

Norge

SIA ELVIM

Pharmathen S.A.

Tel: +371 67808450

Tlf: +30 210 66 04 300

Ελλάδα

Österreich

ΦΑΡΜΑΤΕΝ ΕΛΛΑΣ 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

Aspire Pharma Limited

Pharmathen S.A.

Tel: +44(0)1730 231148

Tel: +30 210 66 04 300

Ísland

Slovenská republika

Alvogen ehf.

Genericon s.r.o.

Tel: +354 522 2900

Tel: +420 221 512 176

Italia

Suomi/Finland

Ecupharma S.r.l

Pharmathen S.A.

Tel : +39-02-38238790

Puh/Tel: +30 210 66 04 300

Κύπρος

Sverige

C.V. MEDILINE LTD

Pharmathen S.A.

Τηλ: +357 25761699

Tel: +30 210 66 04 300

Latvija

United Kingdom

SIA ELVIM

Aspire Pharma Limited

Tel: +371 67808450

Tel: +44(0)1730 231148

This leaflet was last revised in

 

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

Package leaflet: Information for the patient

Matever 100 mg/ml concentrate for solution for infusion

Levetiracetam

Read all of this leaflet carefully before you or your child start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Matever is and what it is used for

2.What you need to know before you are given Matever

3.How Matever is given

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 seizures in epilepsy).

Matever is used:

on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition where the patients have repeated fits (seizures). Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalisation). Levetiracetam has been given to you by your doctor to reduce the number of fits.

as an add-on to other antiepileptic medicines to treat:

partial onset seizures with or without generalisation in adults, adolescents and children from 4 years of age

myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy.

primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

Matever concentrate is an alternative for patients when administration of the antiepileptic oral Matever medicine is temporarily not feasible.

2. What you need to know before you are given 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 you are given Matever

If you suffer from kidney problems, follow your doctor's instructions. He/she may decide if your dose should be adjusted

If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor.

A small number of people being treated with anti-epileptics such as Matever have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.

Children and adolescents

Matever is not indicated in children and adolescents below 16 years on it’s own (monotherapy)

Other medicines and Matever

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may results in a reduction of its effect.

Pregnancy and breast-feeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Matever should not be used during pregnancy unless clearly necessary. A risk of birth defects for your unborn child cannot be completely excluded. Matever has shown unwanted reproductive effects in animal studies at dose levels higher than you would need to control your seizures.

Breast-feeding is not recommended during treatment.

Driving and using machines

Matever may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy. This is more likely at the beginning of treatment or after an increase in the dose. You should not drive or use machines until it is established that your ability to perform such activities is not affected.

Matever contains sodium

One maximum single dose of Matever concentrate contains 2.49 mmol (or 57.21mg) of sodium (0.8 mmol (or 19 mg) of sodium per vial). This should be taken into consideration if you are on a controlled sodium diet.

3.How Matever is given

A doctor or a nurse will administer you Matever as an intravenous infusion.

Matever must be administered twice a day, once in the morning and once in the evening, at about the same time each day.

The intravenous formulation is an alternative to your oral administration. You can switch from the film-coated tablets or from the oral solution to the intravenous formulation or reverse directly without dose adaptation. Your total daily dose and frequency of administration remain identical.

Monotherapy

Dose in adults and adolescents (from 16 years of age):

General dose: between 1000 mg and 3,000 mg each day.

When you will first start taking Matever, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.

Add-on therapy

Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more:

General dose: between 1,000 mg and 3,000 mg each day.

Dose in children (4 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:

General dose: between 20 mg per kg bodyweight and 60 mg per kg bodyweight each 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.

For doctors and nurses, more detailed direction for the proper use of Matever is provided in section 6.

Duration of treatment

There is no experience with administration of intravenous levetiracetam for a longer period than 4 days.

If you stop using Matever

If stopping treatment, as with other antiepileptic medicines, Matever should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Matever treatment, he/she will instruct you about the gradual withdrawal of Matever.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Tell your doctor immediately, or go to your nearest emergency department, if you experience:

weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction

swelling of the face, lips, tongue and throat (Quincke’s oedema)

flu-like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS])

symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function

a skin rash which may form blisters and look like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)

a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)

a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)

signs of serious mental changes or if someone around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements. These could be symptoms of an encephalopathy.

The most frequently reported adverse reactions were nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common. These effects should however decrease over time.

Very common: may affect more than 1 user in 10 people

nasopharyngitis;

somnolence (sleepiness), headache.

Common: may affect 1 to 10 users in 100 people

anorexia (loss of appetite);

depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;

convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary trembling);

vertigo (sensation of rotation);

cough;

abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;

rash;

asthenia/fatigue (tiredness).

Uncommon: may affect 1 to 10 users in 1000 people

decreased number of blood platelets, decreased number of white blood cells;

weight decrease, weight increase;

suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, confusion, panic attack, emotional instability/mood swings, agitation;

amnesia (loss of memory),memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);

diplopia (double vision), vision blurred;

elevated/abnormal values in a liver function test;

hair loss, eczema, pruritus;

muscle weakness, myalgia (muscle pain);

injury.

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

infection;

decreased number of all blood cell types;

severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke’s oedema [swelling of the face, lips, tongue and throat]);

decreased blood sodium concentration;

suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate);

uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);

pancreatitis;

liver failure, hepatitis;

sudden decrease in kidney function;

skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens- Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis).rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase increase. Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. 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 carton box after EXP:. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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.

What Matever looks like and contents of the pack

Matever concentrate for solution for infusion (Matever concentrate) is a clear, colorless, sterile liquid. Matever concentrate 5 ml vial is packed in a cardboard box of 10 vials.

Marketing Authorisation Holder and Manufacturer

Pharmathen S.A. 6, Dervenakion str.

15351 Pallini, Attiki Greece

For any information about this medicine, 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

Pharmathen S.A.

Pharmathen S.A.

Tel: +30 210 66 04 300

Tel.: +30 210 66 04 300

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

ΦΑΡΜΑΤΕΝ ΕΛΛΑΣ 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

Panpharma

Generis Farmacêutica, S.A.

Tél: +33 299 979 212

Tel: +351 214 967 120

Hrvatska

România

Pharmathen S.A.

Pharmathen S.A.

Tel: +30 210 66 04 300

Tel: +30 210 66 04 300

Ireland

Slovenija

Aspire Pharma Limited

Lenis farmacevtika d.o.o

Tel: +44(0)1730 231148

Tel.: +386 1 235 07 00

Ísland

Slovenská republika

Pharmathen S.A.

Pharmathen S.A.

Sími: +30 210 66 04 300

Tel: +30 210 66 04 300

Italia

Suomi/Finland

Ecupharma S.r.l

Orion Pharma.

Tel : +39-02-38238790

Puh/Tel: +358 10 4261

Κύπρος

Sverige

C.V. MEDILINE LTD

 

Τηλ: +357 25761699

Orion PharmaAB

 

Tel: 08- 623 64 40

Latvija

United Kingdom

Pharmathen S.A.

Aspire Pharma Limited

Tel: +30 210 66 04 300

Tel: +44(0)1730 231148

This leaflet was last revised in

 

Other sources of information

 

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.

The following information is intended for healthcare professionals only:

Directions for the proper use of Matever is provided in section 3.

One vial of Matever concentrate contains 500mg levetiracetam (5ml concentrate of 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 in two divided doses.

Table 1. Preparation and administration of Matever concentrate

Dose

Withdrawal Volume

Volume of

Infusion

Frequency of

Total Daily

 

 

Diluent

Time

administration

Dose

250 mg

2.5 ml (half 5 ml vial)

100 ml

15 minutes

Twice daily

500 mg/day

500 mg

5 ml (one 5 ml vial)

100 ml

15 minutes

Twice daily

1000 mg/day

1000 mg

10 ml (two 5 ml vials)

ml

15 minutes

Twice daily

2000 mg/day

1500 mg

15 ml (three 5 ml vials)

ml

15 minutes

Twice daily

3000 mg/day

This medicinal product is for single use only any unused solution should be discarded.

In use shelf life: from a microbiological point of view, the product should be used immediately after dilution. If not used immediately, in-use storage time and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Matever concentrate was found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in PVC bags at controlled room temperature 15- 25°C.

Diluents:

Sodium chloride (0.9 %) injection

Lactated Ringer's injection

Dextrose 5 % injection

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