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LEVETIRACETAM HELM 500 MG FILM-COATED TABLETS.

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Levetiracetam Helm 250 mg film-coated tablets
Levetiracetam Helm 500 mg film-coated tablets
Levetiracetam Helm 750 mg film-coated tablets
Levetiracetam Helm 1000 mg film-coated tablets
Levetiracetam
Read all of this leaflet carefully before you start taking this medicine.
− 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. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
− If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
In this leaflet:
1.
2.
3.
4.
5.
6.

What Levetiracetam Helm is and what it is used for
Before you take Levetiracetam Helm
How to take Levetiracetam Helm
Possible side effects
How to store Levetiracetam Helm
Further information

1. WHAT LEVETIRACETAM HELM IS AND WHAT IT IS USED FOR
Levetiracetam Helm 250 mg film-coated tablets 500 mg film-coated tablets 750 mg film-coated tablets
1000 mg film-coated tablets are an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Levetiracetam Helm is used:
• on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial onset seizures with or without secondary generalisation.
• as an add-on to other antiepileptic medicines to treat:
partial onset seizures with or without generalisation in patients from one month of age
myoclonic seizures in patients from 12 years of age with juvenile myoclonic epilepsy
primary generalised tonic-clonic seizures in patients from 12 years of age with idiopathic generalised epilepsy
2.

BEFORE YOU TAKE LEVETIRACETAM HELM

Do not take Levetiracetam Helm
• if you are allergic (hypersensitive) to levetiracetam or any of the other ingredients of Levetiracetam Helm.
Take special care with Levetiracetam Helm
• 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.
• If you notice an increase in seizure severity (e.g. increased number), please contact your doc-



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

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Taking Levetiracetam Helm with food and drink
You may take Levetiracetam Helm with or without food. As a safety precaution, do not take Levetiracetam Helm with alcohol.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant or if you think you may be pregnant, please inform your doctor. Levetiracetam
Helm should not be used during pregnancy unless clearly necessary. The potential risk to your unborn
child is unknown. Levetiracetam Helm 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
Levetiracetam Helm may impair your ability to drive or operate any tools or machinery, as Levetiracetam Helm 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.
Only for Levetiracetam Helm 750 mg film-coated tablets:
Important information about some of the ingredients of Levetiracetam Helm:
Levetiracetam Helm 750 mg film-coated tablets contain the colouring agent sunset yellow aluminium lake (E110) which may cause allergic reactions.
3. HOW TO TAKE LEVETIRACETAM HELM
Always take Levetiracetam Helm exactly as your doctor has told you. You should check with your
doctor if you are not sure.
Levetiracetam Helm must be taken twice a day, once in the morning and once in the evening, at about
the same time each day.
Take the number of tablets following your doctor’s instructions.
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 Levetiracetam Helm, 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 infants (6 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 Levetiracetam Helm according to the age, weight and dose. Levetiracetam Helm100 mg/ml oral solution is a presentation more
appropriate to infants and children under the age of 6 years.
General dose: between 20 mg per kg bodyweight and 60 mg per kg bodyweight each day.
Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Helm according to the age, weight and dose. Levetiracetam Helm 100 mg/ml oral solution is a presentation more
appropriate to infants and children under the age of 6 years.
General dose: between 20 mg per kg bodyweight and 60 mg per kg bodyweight each day.
Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Helm according to the age, weight and dose. Levetiracetam Helm 100 mg/ml oral solution is a presentation more
appropriate to infants and children under the age of 6 years.
General dose: between 20 mg per kg bodyweight and 60 mg per kg bodyweight each day.
Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Helm according to the age, weight and dose. Levetiracetam Helm100 mg/ml oral solution is a presentation more
appropriate to infants and children under the age of 6 years.
General dose: between 20 mg per kg bodyweight and 60 mg per kg bodyweight each day.
Dose in infants (1 month to less than 6 months):
Levetiracetam Helm 100 mg/ml oral solution is a presentation more appropriate to infants.
Method of administration:
Swallow Levetiracetam Helm tablets with a sufficient quantity of liquid (e.g. a glass of water).
Duration of treatment:


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

If you take more Levetiracetam Helm than you should:
The possible side effects of an overdose of Levetiracetam Helm 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 Helm:
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 Helm:
Do not stop your treatment without your doctor’s advice as this could increase your seizures. Should
your doctor decide to stop your Levetiracetam Helm treatment, he/she will instruct you about the
gradual withdrawal of Levetiracetam Helm.
If stopping treatment, as with other antiepileptic medicines, Levetiracetam Helm should be discontinued gradually to avoid an increase of seizures.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Levetiracetam Helm can cause side effects, although not everybody gets them. Tell
your doctor if you have any of the following.

Some of the side effects like sleepiness, tiredness and dizziness may be more common at the beginning of the treatment or at dose increase. These effects should however decrease over time.
Other possible side effects include:
Very common (affects more than 1 user in 10):

somnolence (sleepiness);

asthenia/fatigue (tiredness).
Common (affects 1 to 10 users in 100):

infection, nasopharyngitis;

decreased number of blood platelets;

anorexia (loss of appetite), weight increase;

agitation, depression, emotional instability/mood swings, hostility or aggression, insomnia,

nervousness or irritability, personality disorders (behavioural problems), thinking abnormal

(slow thinking, unable to concentrate);

dizziness (sensation of unsteadiness), convulsion, headache, hyperkinesia (hyperactivity),
ataxia (impaired coordinated movements), tremor (involuntary trembling), amnesia (loss of
memory), balance disorder (equilibrium disorder), disturbance in attention (loss of
concentration), memory impairment (forgetfulness)

diplopia (double vision), vision blurred;

vertigo (sensation of rotation);

cough (increase of pre-existing cough);

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

rash, eczema, pruritus ;

myalgia (muscle pain);

accidental injury.
Not known (frequency cannot be estimated from the available data:

decreased number of red blood cells, and/or white blood cells;

weight loss;

abnormal behaviour, anger, anxiety, confusion, hallucination, mental disorder, suicide,
suicide attempt and suicidal ideation;

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

pancreatitis, hepatic failure, hepatitis, liver function test abnormal;

hair loss, blistering of the skin, mouth, eyes and genital area, skin eruption.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.

5. HOW TO STORE LEVETIRACETAM HELM
Keep out of the reach and sight of children.
Do not use after the expiry date stated on the carton box and blister after EXP. The expiry date refers
to the last day of the month.
250 mg and 500 mg film-coated tablets:
This medicinal product does not require any special storage conditions.
750 mg and 1000 mg film-coated tablets:
Store below 30°C.

6.

FURTHER INFORMATION

What Levetiracetam Helm contains
The active substance is levetiracetam.
Each film-coated tablet contains 250 mg levetiracetam.
Each film-coated tablet contains 500 mg levetiracetam.
Each film-coated tablet contains 750 mg levetiracetam.
Each film-coated tablet contains 1000 mg levetiracetam.
The other ingredients are:
Tablet core:
Maize starch
Povidone K 30
Talc
Colloidal silicon dioxide
Magnesium stearate (E 572)
Film-coating:
Polyvinyl alcohol-part. hydrolyzed
Titanium dioxide (E171)
Macrogol 3350
Talc
Indigo carmine aluminium lake (E132)
Film-coating:
Polyvinyl alcohol – part.hydrolyzed
Titanium Dioxide (E171)
Macrogol 3350
Talc
Iron Oxide Yellow (E172)
Film-coating:
Polyvinyl alcohol – part. hydrolyzed
Titanium Dioxide
Macrogol 3350
Talc
Sunset yellow aluminium lake (E110)
Iron Oxide Red (E172)
Film-coating:
Polyvinyl alcohol – part. hydrolyzed
Titan Dioxide (E171)
Macrogol 3350
Talc
What Levetiracetam Helm looks like and contents of the pack
The film-coated tablets are blue, oblong and debossed with the code “LEV 250” on one side and one
central score on both faces. The tablet can be divided into equal halves.
The film-coated tablets are yellow, oblong, scored and debossed with the code “LEV 500” on one side
and one central score on both faces. The tablet can be divided into equal halves.

The film-coated tablets are orange, oblong and debossed with the code “LEV 750” on one side and
one central score on both faces. The tablet can be divided into equal halves.
The film-coated tablets are white, oblong, scored and debossed with the code “LEV 100” on one side
and one central score on both faces. The tablet can be divided into equal halves.
The cardboard box contains 20, 30, 50, 60, 100 and 200 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Helm AG
Nordkanalstr. 28
20097 Hamburg
Germany
Manufacturer
Bluepharma Indústria Farmacêutica, S.A.
S. Martinho de Bispo
3045-016 Coimbra
Portugal
This medicinal product is authorised in the member states of the EEA under the following
names:
Germany:
Belgium:
Austria:
Spain:
Greece:
Netherlands:
United Kingdom:

Levetiracetam Helm 250 mg 500 mg 750 mg 1000 mg Filmtabletten
Levetiracetam Helm 250 mg 500 mg 750 mg 1000 mg comprimés pelliculés,
filmomhulde tabletten
Levetiracetam Helm 250 mg 500 mg 750 mg 1000 mg Filmtabletten
Levetiracetam Helm 250 mg 500 mg 750 mg 1000 mg comprimidos
recubiertos con película
Levetiracetam Helm 250 mg 500 mg 750 mg 1000 mg Επικαλυμμένα με
λεπτό υμένιο δισκία
Levetiracetam Helm 250 mg 500 mg 750 mg 1000 mg filmomhulde tabletten
Levetiracetam Helm 250 mg 500 mg 750 mg 1000 mg film-coated tablets

This leaflet was last approved in 10/2011.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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