Patient leaflet - Levetiracetam ratiopharm
B. PACKAGE LEAFLET
Package Leaflet: Information for the patient
Levetiracetam ratiopharm 250 mg film-coated tablets Levetiracetam ratiopharm 500 mg film-coated tablets Levetiracetam ratiopharm 750 mg film-coated tablets Levetiracetam ratiopharm 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 Levetiracetam ratiopharm is and what it is used for
-
2. What you need to know before you take Levetiracetam ratiopharm
-
3. How to take Levetiracetam ratiopharm
-
4. Possible side effects
-
5. How to store Levetiracetam ratiopharm
-
6. Contents of the pack and other information
1. What Levetiracetam ratiopharm is and what it is used for
Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Levetiracetam ratiopharm 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 Levetiracetam ratiopharm
Do not take Levetiracetam ratiopharm
- If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in Section 6).
Warnings and precautions
Talk to your doctor before taking Levetiracetam ratiopharm
- 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 Levetiracetam ratiopharm
have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.
- If you have a family or medical history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or take a treatment that make(s) you prone to heartbeat irregularities or salt imbalances.
Tell your doctor or pharmacist if any of the following side effects gets serious or last longer than a few days:
- Abnormal thoughts, feeling irritable or reacting more aggressively than usually, or if you or your family and friends notice important changes in mood or behaviour.
- Aggravation of epilepsy
Your seizures may rarely become worse or happen more often, mainly during the first month after the start of the treatment or increase of the dose. If you experience any of these new symptoms while taking Levetiracetam ratiopharm, see a doctor as soon as possible.
Children and adolescents
- Levetiracetam ratiopharm is not indicated in children and adolescents below 16 years on its own (monotherapy).
Other medicines and Levetiracetam ratiopharm
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. Levetiracetam can be used during pregnancy, only if after careful assessment it is considered necessary by your doctor.
You should not stop your treatment without discussing this with your doctor.
A risk of birth defects for your unborn child cannot be completely excluded. Breast-feeding is not recommended during treatment.
Driving and using machines
Levetiracetam ratiopharm 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.
3. How to take Levetiracetam ratiopharm
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.
Levetiracetam ratiopharm must be taken twice a day, once in the morning and once in the evening, at about 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:
General dose: between 1000 mg and 3,000 mg each day.
When you will first start taking Levetiracetam ratiopharm, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.
Example: if your daily dose is intended to be 1000 mg, your reduced starting 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 incremented to reach 1000 mg daily after 2 weeks.
- Adolescents (12 to 17 years) weighing 50 kg or less:
Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam ratiopharm according to weight and dose.
Dose in infants (1 month to 23 months) and children (2 to 11 years) weighing less than 50 kg:
Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam ratiopharm according to the age, weight and dose.
Levetiracetam ratiopharm 100 mg/ml oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children and adolescent (from 6 to 17 years) weighing less than 50 kg and when tablets don’t allow accurate dosage.
Method of administration
Swallow Levetiracetam ratiopharm film-coated tablets with a sufficient quantity of liquid (e.g. a glass of water). You may take Levetiracetam ratiopharm with or without food. After oral administration the bitter taste of levetiracetam may be experienced.
Duration of treatment
- Levetiracetam ratiopharm is used as a chronic treatment. You should continue Levetiracetam ratiopharm 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 Levetiracetam ratiopharm than you should
The possible side effects of an overdose of Levetiracetam ratiopharm 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 Levetiracetam ratiopharm
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 Levetiracetam ratiopharm
If stopping treatment, Levetiracetam ratiopharm should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Levetiracetam ratiopharm treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam ratiopharm.
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 in 10 people
- nasopharyngitis;
- somnolence (sleepiness), 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 (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 up to 1 in 100 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 up to 1 in 1000 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);
delirium;
encephalopathy (see sub-section “Tell your doctor immediately” for a detailed description of symptoms);
seizures may become worse or happen more often;
uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);
change of the heart rhythm (Electrocardiogram);
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.
limp or difficulty walking
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 Levetiracetam ratiopharm
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton box and blister after EXP.
The expiry date refers to the last day of the 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 Levetiracetam ratiopharm contains
The active substance is called levetiracetam.
One film-coated tablet of Levetiracetam ratiopharm 250 mg contains 250 mg levetiracetam.
One film-coated tablet of Levetiracetam ratiopharm 500 mg contains 500 mg levetiracetam.
One film-coated tablet of Levetiracetam ratiopharm 750 mg contains 750 mg levetiracetam.
One film-coated tablet of Levetiracetam ratiopharm 1000 mg contains 1000 mg levetiracetam.
The other ingredients are:
Tablet core :
Macrogol 6000, Colloidal anhydrous silica, Crospovidone, Cellulose powdered, Magnesium stearate.
Film-coating :
Levetiracetam ratiopharm 250 mg
Poly(vinyl alcohol), Titanium dioxide (E171), Macrogol, Talc, Blue indigo carmine aluminium lake (E132)
Levetiracetam ratiopharm 500 mg
Hypromellose (E464), Microcrystalline cellulose (E460), Macrogol 40 stearate type I, Anatase
titanium dioxide (E171), Yellow Iron Oxide (E 172)
Levetiracetam ratiopharm 750 mg
Hypromellose (E464), Microcrystalline cellulose (E460), Macrogol 40 stearate type I, Anatase
titanium dioxide (E171), Yellow Iron Oxide (E172), Red Iron Oxide (E172)
Levetiracetam ratiopharm 1000 mg
Hypromellose (E464), Microcrystalline cellulose (E460), Macrogol 40 stearate type I, Titanium dioxide (E171)
What Levetiracetam ratiopharm looks like and contents of the pack
Levetiracetam ratiopharm 250 mg
Film-coated tablets are blue, oblong and scored on one side and are supplied in packs of 20, 30, 50, 60 or 100 film-coated tablets or multipacks of 200 (2 packs of 100) film-coated tablets.
Levetiracetam ratiopharm 500 mg
Film-coated tablets are yellow, oval and scored on one side and are supplied in packs of 10, 20, 30, 50, 60 or 100 film-coated tablets or multipacks of 120 (2 packs of 60) or 200 (2 packs of 100) film-coated tablets.
Levetiracetam ratiopharm 750 mg
Film-coated tablets are light red coloured, oblong and scored on both sides and are supplied in packs of 20, 30, 50, 60, 80 or 100 film-coated tablets or multipacks of 200 (2 packs of 100) film-coated tablets.
Levetiracetam ratiopharm 1000 mg
Film-coated tablets are white, oblong and scored on both sides and are supplied in packs of 10, 20, 30, 50, 60 or 100 film-coated tablets or multipacks of 200 (2 packs of 100) film-coated tablets.
The tablets can be divided into equal halves.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
ratiopharm GmbH
Graf-Arco-StraBe 3
89079 Ulm
Germany
Email:
Manufacturer
Merckle GmbH
Ludwig-Merckle-StraBe 3
89143 Blaubeuren
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
| België/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG Tel./Tél.: +32 38207373 | Lietuva UAB Teva Baltics Tel: +370 52660203 |
| Efc^rapufl TeBa OapMa EAfl Ten: +359 24899585 | Luxembourg/Luxemburg ratiopharm GmbH Allemagne/Deutschland Tél/Tel: +49 73140202 |
| Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111 | Magyarország Teva Gyógyszergyár Zrt. Tel: +36 12886400 |
| Danmark Teva Denmark A/S Tlf: +45 44985511 | Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117 |
| Deutschland ratiopharm GmbH Tel: +49 73140202 | Nederland Teva Nederland B.V. Tel.: +31 8000228400 |
| Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801 | Norge Teva Norway AS Tlf: +47 66775590 |
| EXÁáóa Specifar A.B.E.E. Tql: +30 2118805000 | Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070 |
| España ratiopharm España, S.A. Tel: +34 913873280 | Polska Teva Pharmaceuticals Polska Sp.z.o.o Tel: +48 223459300 |
| France Teva Santé Tél: +33 155917800 | Portugal ratiopharm, Comércio e Indústria de Produtos Farmaceuticos Lda. Tel: +351 214767550 |
| Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720000 | Romania Teva Pharmaceuticals S.R.L. Tel: +40 212306524 |
| Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117 | Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890390 |
| Ísland Teva Pharma Iceland ehf. Sími: +354 5503300 | Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911 |
Italia
Teva Italia S.r.l.
Tel: +39 028917981
Kûnpoç
Specifar A.B.E.E.
EUaôa
Tql: +30 2118805000
Latvija
UAB Teva Baltics filiale Latvijä
Tel: +371 67323666
Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900
Sverige
Teva Sweden AB
Tel: +46 42121100
United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117
This leaflet was last revised in {month/YYYY}.
Detailed information on this medicine is available on the European Medicines Agency web site:
Package Leaflet: Information for the patient
Levetiracetam ratiopharm 100 mg/ml oral solution.
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 Levetiracetam ratiopharm is and what it is used for
-
2. What you need to know before you take Levetiracetam ratiopharm
-
3. How to take Levetiracetam ratiopharm
-
4. Possible side effects
-
5. How to store Levetiracetam ratiopharm
-
6. Contents of the pack and other information
1. What Levetiracetam ratiopharm is and what it is used for
Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Levetiracetam ratiopharm 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 Levetiracetam ratiopharm
Do not take Levetiracetam ratiopharm
- If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in Section 6).
Warnings and precautions
Talk to your doctor before taking Levetiracetam ratiopharm
- 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 Levetiracetam ratiopharm have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.
- If you have a family or medical history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or take a treatment that make(s) you prone to heartbeat irregularities or salt imbalances.
Tell your doctor or pharmacist if any of the following side effects gets serious or last longer than a few days:
- Abnormal thoughts, feeling irritable or reacting more aggressively than usually, or if you or your family and friends notice important changes in mood or behaviour.
- Aggravation of epilepsy
Your seizures may rarely become worse or happen more often, mainly during the first month after the start of the treatment or increase of the dose. If you experience any of these new symptoms while taking Levetiracetam ratiopharm, see a doctor as soon as possible.
Children and adolescents
- Levetiracetam ratiopharm is not indicated in children and adolescents below 16 years on its own (monotherapy)
Other medicines and Levetiracetam ratiopharm
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. Levetiracetam can be used during pregnancy, only if after careful assessment it is considered necessary by your doctor.
You should not stop your treatment without discussing this with your doctor.
A risk of birth defects for your unborn child cannot be completely excluded.
Breast-feeding is not recommended during treatment.
Driving and using machines
Levetiracetam ratiopharm 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.
Levetiracetam ratiopharm contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, potassium and sodium.
Levetiracetam ratiopharm oral solution includes methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
This medicine contains 1.2 mmol (or 46.65 mg) potassium per 15 ml. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
This medicine contains less than 1 mmol sodium (23 mg) per 15 ml that is to say essentially ‘sodium-free’.
3. How to take Levetiracetam ratiopharm
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Levetiracetam ratiopharm must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Take the oral solution following your doctor’s instructions.
Monotherapy (from 16 years of age)
Adults (>18 years) and adolescents (from 16 years of age):
Measure the appropriate dosage using the 10 ml syringe included in the package for patients 4 years and above.
General dose: Levetiracetam ratiopharm is taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500 mg) and 15 ml (1500 mg).
When you will first start taking Levetiracetam ratiopharm, 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):
Measure the appropriate dosage using the 10 ml syringe included in the package for patients of 4 years and above.
General dose: Levetiracetam ratiopharm is taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500mg) and 15 ml (1500mg).
Dose in children 6 months and older:
Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam ratiopharm according to the age, weight and dose.
For children 6 months to 4 years , measure the appropriate dosage using the 3 ml syringe included in the package.
For children above 4 years , measure the appropriate dosage using the 10 ml syringe included in the package.
General dose: Levetiracetam ratiopharm is taken twice daily, in two equally divided doses, each individual dose being measured between 0.1 ml (10 mg) and 0.3 ml (30 mg), per kg bodyweight of the child. (see table below for dose examples).
Dose in children 6 months and older
| Weight | Starting dose: 0.1 ml/kg twice daily | Maximum dose: 0.3 ml/kg twice daily |
| 6 kg | 0.6 ml twice daily | 1.8 ml twice daily |
| 8 kg | 0.8 ml twice daily | 2.4 ml twice daily |
| 10 kg | 1 ml twice daily | 3 ml twice daily |
| 15 kg | 1.5 ml twice daily | 4.5 ml twice daily |
| 20 kg | 2 ml twice daily | 6 ml twice daily |
| 25 kg | 2.5 ml twice daily | 7.5 ml twice daily |
| From 50 kg | 5 ml twice daily | 15 ml twice daily |
Dose in infants (1 month to less than 6 months):
For infants 1 month to less than 6 months, measure the appropriate dosage using the 1 ml syringe included in the package.
General dose: Levetiracetam ratiopharm is taken twice daily, in two equally divided doses, each individual dose being measured between 0.07 ml (7 mg) and 0.21 ml (21 mg), per kg bodyweight of the infant. (see table below for dose examples).
Dose in infants (1 month to less than 6 months):
| Weight | Starting dose: 0.07 ml/kg twice daily | Maximum dose: 0.21 ml/kg twice daily |
| 4 kg | 0.3 ml twice daily | 0.85 ml twice daily |
| 5 kg | 0.35 ml twice daily | 1.05 ml twice daily |
| 6 kg | 0.45 ml twice daily | 1.25 ml twice daily |
| 7 kg | 0.5 ml twice daily | 1.5 ml twice daily |
Method of administration
After measuring the correct dose with an appropriate syringe, Levetiracetam ratiopharm oral solution may be diluted in a glass of water or baby’s bottle. You may take Levetiracetam ratiopharm with or without food. After oral administration the bitter taste of levetiracetam may be experienced.
Instructions for use:
- Open the bottle: press the cap and turn it anticlockwise.
- Take the syringe and put it in the opening of the bottle.
For this the piston must be completely pushed into the syringe
(figure ©)
©
Hold bottle and syringe securely tight. Then turn bottle and syringe upside down (figure ®).
®
Fill the syringe with the liquid by pulling the piston to the graduation mark corresponding to the quantity in millilitre (ml) prescribed by your doctor.
You can read the corresponding millilitre at the beginning of the thicker part of the piston figure ®).
®
If bubbles occur push the piston into the syringe again and fill the syringe once more slowly.
Move bottle and the filled syringe back in starting position.
Remove the filled syringe from the bottle (figure @).
Empty the contents of the syringe in a glass of water by pushing the piston into the syringe (figure ©).
- Close the bottle with the plastic screw cap after every usage.
- Drink the whole contents of the glass.
- Wash the syringe afterwards with clear water by filling and emptying the syringe repeatedly.
Duration of treatment
- Levetiracetam ratiopharm is used as a chronic treatment. You should continue Levetiracetam ratiopharm 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 Levetiracetam ratiopharm than you should
The possible side effects of an overdose of Levetiracetam ratiopharm are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
Contact your doctor if you took more Levetiracetam ratiopharm than you should. Your doctor will establish the best possible treatment of overdose.
If you forget to take Levetiracetam ratiopharm
Contact your doctor if you have missed one or more doses.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Levetiracetam ratiopharm
If stopping treatment, Levetiracetam ratiopharm should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Levetiracetam ratiopharm treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam ratiopharm.
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 in 10 people nasopharyngitis;
- somnolence (sleepiness), 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 (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 up to 1 in 100 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 up to 1 in 1000 people
- infection;
5. How to store Levetiracetam ratiopharm
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and bottle after EXP.
The expiry date refers to the last day of the month.
Keep the bottle in the outer carton in order to protect from light.
Do not use after 4 months of first opening the bottle.
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 Levetiracetam ratiopharm contains
The active substance is called levetiracetam. Each ml contains 100 mg of levetiracetam.
The other ingredients are: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), citric acid monohydrate, sodium hydroxide, purified water, acesulfame potassium (E 950), grape flavour.
What Levetiracetam ratiopharm looks like and contents of the pack
Levetiracetam ratiopharm 250 mg
Film-coated tablets are blue, oblong and scored on one side and are supplied in packs of 20, 30, 50, 60 or 100 film-coated tablets or multipacks of 200 (2 packs of 100) film-coated tablets.
Levetiracetam ratiopharm 500 mg
Film-coated tablets are yellow, oval and scored on one side and are supplied in packs of 10, 20, 30, 50, 60 or 100 film-coated tablets or multipacks of 120 (2 packs of 60) or 200 (2 packs of 100) film-coated tablets.
Levetiracetam ratiopharm 750 mg
Film-coated tablets are light red coloured, oblong and scored on both sides and are supplied in packs of 20, 30, 50, 60, 80 or 100 film-coated tablets or multipacks of 200 (2 packs of 100) film-coated tablets.
Levetiracetam ratiopharm 1000 mg
Film-coated tablets are white, oblong and scored on both sides and are supplied in packs of 10, 20, 30, 50, 60 or 100 film-coated tablets or multipacks of 200 (2 packs of 100) film-coated tablets.
The tablets can be divided into equal halves.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
ratiopharm GmbH
Graf-Arco-StraBe 3
89079 Ulm
Germany
Email:
Manufacturer
Merckle GmbH
Ludwig-Merckle-StraBe 3
89143 Blaubeuren
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
| België/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG Tel./Tél.: +32 38207373 | Lietuva UAB Teva Baltics Tel: +370 52660203 |
| Efc^rapufl TeBa OapMa EAfl Ten: +359 24899585 | Luxembourg/Luxemburg ratiopharm GmbH Allemagne/Deutschland Tél/Tel: +49 73140202 |
| Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111 | Magyarország Teva Gyógyszergyár Zrt. Tel: +36 12886400 |
| Danmark Teva Denmark A/S Tlf: +45 44985511 | Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117 |
| Deutschland ratiopharm GmbH Tel: +49 73140202 | Nederland Teva Nederland B.V. Tel.: +31 8000228400 |
| Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801 | Norge Teva Norway AS Tlf: +47 66775590 |
| EXÁáóa Specifar A.B.E.E. Tql: +30 2118805000 | Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070 |
| España ratiopharm España, S.A. Tel: +34 913873280 | Polska Teva Pharmaceuticals Polska Sp.z.o.o Tel: +48 223459300 |
| France Teva Santé Tél: +33 155917800 | Portugal ratiopharm, Comércio e Indústria de Produtos Farmaceuticos Lda. Tel: +351 214767550 |
| Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720000 | Romania Teva Pharmaceuticals S.R.L. Tel: +40 212306524 |
| Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117 | Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890390 |
| Ísland Teva Pharma Iceland ehf. Sími: +354 5503300 | Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911 |
Italia
Teva Italia S.r.l.
Tel: +39 028917981
Kûnpoç
Specifar A.B.E.E.
EUaôa
Tql: +30 2118805000
Latvija
UAB Teva Baltics filiale Latvijä
Tel: +371 67323666
Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900
Sverige
Teva Sweden AB
Tel: +46 42121100
United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117
This leaflet was last revised in {month/YYYY}.
Detailed information on this medicine is available on the European Medicines Agency web site:
Package Leaflet: Information for the patient
Levetiracetam ratiopharm 100 mg/ml oral solution.
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 Levetiracetam ratiopharm is and what it is used for
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2. What you need to know before you take Levetiracetam ratiopharm
-
3. How to take Levetiracetam ratiopharm
-
4. Possible side effects
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5. How to store Levetiracetam ratiopharm
-
6. Contents of the pack and other information
1. What Levetiracetam ratiopharm is and what it is used for
Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Levetiracetam ratiopharm 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 Levetiracetam ratiopharm
Do not take Levetiracetam ratiopharm
- If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in Section 6).
Warnings and precautions
Talk to your doctor before taking Levetiracetam ratiopharm
- 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 Levetiracetam ratiopharm have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.
- If you have a family or medical history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or take a treatment that make(s) you prone to heartbeat irregularities or salt imbalances.
Tell your doctor or pharmacist if any of the following side effects gets serious or last longer than a few days:
- Abnormal thoughts, feeling irritable or reacting more aggressively than usually, or if you or your family and friends notice important changes in mood or behaviour.
- Aggravation of epilepsy
Your seizures may rarely become worse or happen more often, mainly during the first month after the start of the treatment or increase of the dose. If you experience any of these new symptoms while taking Levetiracetam ratiopharm, see a doctor as soon as possible.
Children and adolescents
- Levetiracetam ratiopharm is not indicated in children and adolescents below 16 years on its own (monotherapy)
Other medicines and Levetiracetam ratiopharm
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. Levetiracetam can be used during pregnancy, only if after careful assessment it is considered necessary by your doctor.
You should not stop your treatment without discussing this with your doctor.
A risk of birth defects for your unborn child cannot be completely excluded.
Breast-feeding is not recommended during treatment.
Driving and using machines
Levetiracetam ratiopharm 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.
Levetiracetam ratiopharm contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, potassium and sodium.
Levetiracetam ratiopharm oral solution includes methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
This medicine contains 1.2 mmol (or 46.65 mg) potassium per 15 ml. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
This medicine contains less than 1 mmol sodium (23 mg) per 15 ml that is to say essentially ‘sodium-free’.
3. How to take Levetiracetam ratiopharm
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Levetiracetam ratiopharm must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Take the oral solution following your doctor’s instructions.
Monotherapy (from 16 years of age)
Adults (>18 years) and adolescents (from 16 years of age):
Measure the appropriate dosage using the 10 ml syringe included in the package for patients 4 years and above.
General dose: Levetiracetam ratiopharm is taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500 mg) and 15 ml (1500 mg).
When you will first start taking Levetiracetam ratiopharm, 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):
Measure the appropriate dosage using the 10 ml syringe included in the package for patients of 4 years and above.
General dose: Levetiracetam ratiopharm is taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500mg) and 15 ml (1500mg).
Dose in children 6 months and older:
Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam ratiopharm according to the age, weight and dose.
For children 6 months to 4 years , measure the appropriate dosage using the 3 ml syringe included in the package.
For children above 4 years , measure the appropriate dosage using the 10 ml syringe included in the package.
General dose: Levetiracetam ratiopharm is taken twice daily, in two equally divided doses, each individual dose being measured between 0.1 ml (10 mg) and 0.3 ml (30 mg), per kg bodyweight of the child. (see table below for dose examples).
Dose in children 6 months and older
| Weight | Starting dose: 0.1 ml/kg twice daily | Maximum dose: 0.3 ml/kg twice daily |
| 6 kg | 0.6 ml twice daily | 1.8 ml twice daily |
| 8 kg | 0.8 ml twice daily | 2.4 ml twice daily |
| 10 kg | 1 ml twice daily | 3 ml twice daily |
| 15 kg | 1.5 ml twice daily | 4.5 ml twice daily |
| 20 kg | 2 ml twice daily | 6 ml twice daily |
| 25 kg | 2.5 ml twice daily | 7.5 ml twice daily |
| From 50 kg | 5 ml twice daily | 15 ml twice daily |
Dose in infants (1 month to less than 6 months):
For infants 1 month to less than 6 months, measure the appropriate dosage using the 1 ml syringe included in the package.
General dose: Levetiracetam ratiopharm is taken twice daily, in two equally divided doses, each individual dose being measured between 0.07 ml (7 mg) and 0.21 ml (21 mg), per kg bodyweight of the infant. (see table below for dose examples).
Dose in infants (1 month to less than 6 months):
| Weight | Starting dose: 0.07 ml/kg twice daily | Maximum dose: 0.21 ml/kg twice daily |
| 4 kg | 0.3 ml twice daily | 0.85 ml twice daily |
| 5 kg | 0.35 ml twice daily | 1.05 ml twice daily |
| 6 kg | 0.45 ml twice daily | 1.25 ml twice daily |
| 7 kg | 0.5 ml twice daily | 1.5 ml twice daily |
Method of administration
After measuring the correct dose with an appropriate syringe, Levetiracetam ratiopharm oral solution may be diluted in a glass of water or baby’s bottle. You may take Levetiracetam ratiopharm with or without food. After oral administration the bitter taste of levetiracetam may be experienced.
Instructions for use:
- Open the bottle: press the cap and turn it anticlockwise.
- Take the syringe and put it in the opening of the bottle.
For this the piston must be completely pushed into the syringe
(figure ©)
©
Hold bottle and syringe securely tight. Then turn bottle and syringe upside down (figure ®).
®
Fill the syringe with the liquid by pulling the piston to the graduation mark corresponding to the quantity in millilitre (ml) prescribed by your doctor.
You can read the corresponding millilitre at the beginning of the thicker part of the piston figure ®).
®
If bubbles occur push the piston into the syringe again and fill the syringe once more slowly.
Move bottle and the filled syringe back in starting position.
Remove the filled syringe from the bottle (figure @).
Empty the contents of the syringe in a glass of water by pushing the piston into the syringe (figure ©).
- Close the bottle with the plastic screw cap after every usage.
- Drink the whole contents of the glass.
- Wash the syringe afterwards with clear water by filling and emptying the syringe repeatedly.
Duration of treatment
- Levetiracetam ratiopharm is used as a chronic treatment. You should continue Levetiracetam ratiopharm 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 Levetiracetam ratiopharm than you should
The possible side effects of an overdose of Levetiracetam ratiopharm are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
Contact your doctor if you took more Levetiracetam ratiopharm than you should. Your doctor will establish the best possible treatment of overdose.
If you forget to take Levetiracetam ratiopharm
Contact your doctor if you have missed one or more doses.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Levetiracetam ratiopharm
If stopping treatment, Levetiracetam ratiopharm should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Levetiracetam ratiopharm treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam ratiopharm.
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 in 10 people nasopharyngitis;
- somnolence (sleepiness), 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 (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 up to 1 in 100 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 up to 1 in 1000 people
- infection;