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LEVETIRACETAM HETERO 1000 MG FILM-COATED TABLETS

Active substance(s): LEVETIRACETAM FORM I

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Package leaflet: Information for the user

Warnings and precautions

Monotherapy

Levetiracetam Hetero 1000 mg Film-Coated Tablets
Levetiracetam

Talk to your doctor, pharmacist or nurse before taking
Levetiracetam 1000 mg.

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

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

When you will first start taking Levetiracetam 1000 mg,
you doctor will prescribe you a lower dose during 2
weeks before giving you the lowest general dose.

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

Example: if your daily dose is 2,000 mg, you must take 1
tablet in the morning and 1 tablet in the evening.

If you notice an increase in seizure severity (e.g.
increased number), please contact your doctor.

Add-on therapy

Read all of this leaflet carefully before you 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,
pharmacist or nurse.
- 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,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet
1.What Levetiracetam 1000 mg is and what it is used for
2.What you need to know before you take
Levetiracetam 1000 mg
3.How to take Levetiracetam 1000 mg
4.Possible side effects
5.How to store Levetiracetam 1000 mg
6.Contents of the pack and other information

1. What Levetiracetam 1000 mg is and what it is
used for
Levetiracetam Hetero 1000 mg Film-Coated Tablets are an
antiepileptic medicine (a medicine used to treat seizures
in epilepsy).
Levetiracetam 1000 mg 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.

Other medicines and Levetiracetam 1000 mg
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Levetiracetam 1000 mg with food and drink
You may take Levetiracetam 1000 mg with or without
food. As a safety precaution, do not take Levetiracetam
1000 mg with alcohol.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
Levetiracetam 1000 mg should not be used during
pregnancy unless clearly necessary. The potential risk to
your unborn child is unknown. Levetiracetam has shown
unwanted reproductive effects in animal studies at dose
levels higher than you would need to control your
seizures.

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 2,000 mg, you must take 1
tablet in the morning and 1 tablet in the evening.
Dose in infants (6 to 23 months), children (2 to 11
years) and adolescents (12 to 17 years) weighing less
than 50 kg:
You doctor will prescribe the most appropriate
pharmaceutical form of levetiracetam according to the
age, weight and dose.
Levetiracetam 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.
Dose in infants (1 month to less than 6 months):
Levetiracetam 100 mg/ml oral solution is a presentation
more appropriate to infants.
Method of administration:
Swallow Levetiracetam 1000 mg tablets with a sufficient
quantity of liquid (e.g. a glass of water).

Breast-feeding is not recommended during treatment.

The tablet can be divided into equal doses.

Driving and using machines
Levetiracetam 1000 mg may impair your ability to drive
or operate any tools or machinery, as Levetiracetam 1000
mg 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.

Duration of treatment:

3.How to take Levetiracetam 1000 mg

2. What you need to know before you take
Levetiracetam 1000 mg

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

Do not take Levetiracetam 1000 mg :

Levetiracetam 1000 mg must be taken twice a day, once
in the morning and once in the evening, at about the same
time each day.

• if you are allergic to levetiracetam or any of the
other ingredients of this medicine (listed in section
6).

Size: 260 x 245 mm

A small number of people being treated with antiepileptics such as Levetiracetam 1000 mg have had
thoughts of harming or killing themselves. If you have
any symptoms of depression and/or suicidal ideation,
please contact your doctor.

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

Take the number of tablets following your doctor's
instructions.

• Levetiracetam 1000 mg is used as a chronic treatment.
You should continue Levetiracetam 1000 mg 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. Should
your doctor decide to stop your Levetiracetam 1000
mg treatment, he/she will instruct you about the
gradual withdrawal of Levetiracetam 1000 mg.
If you take more Levetiracetam 1000 mg than you
should
The possible side effects of an overdose of Levetiracetam
1000 mg 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.

Do not take a double dose to make up for a forgotten
tablet.
If you stop taking Levetiracetam 1000 mg
If stopping treatment, as with other antiepileptic
medicines, Levetiracetam 1000 mg should be
discontinued gradually to avoid an increase of seizures.
If you have any further questions on the use of this
medicine, ask your doctor pharmacist or nurse.

4.Possible side effects

• weight decrease, weight increase;
• suicide attempt and suicidal ideation, mental disorder,
abnormal behaviour, hallucination, anger, confusion,
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;
• liver function test abnormal;
• hair loss, eczema, pruritus;
• muscle weakness, myalgia (muscle pain);

Tablet core:
Maize starch, Croscarmellose sodium, Povidone (K 30),
Silica colloidal anhydrous, Talc and Magnesium Stearate.
Tablet coating:
Polyvinyl alcohol, Titanium dioxide (E171).Macrogol
3350 and Talc.
What Levetiracetam 1000 mg looks like and contents
of the pack
Levetiracetam Hetero 1000 mg Film-Coated Tablets are white
coloured, oblong shaped, scored on one side, film-coated
tablets debossed with “H” on one side and “91” on the
other side.

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

• injury.

Tell your doctor if you have any of the following and
they worry you.

Rare:

Levetiracetam 1000 mg are available in blister packs
containing 10, 20, 30, 50, 60, 80, 100, 120 or 200 filmcoated tablets.

• infection;

Not all pack sizes may be marketed.

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.

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Hetero Europe S.L.
Viladecans Business Park Edificio Brasil
Catalunya 83-85
08840 Viladecans (Barcelona)
Spain

The frequency of possible side effects listed below is
defined using the following convention:

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

Common (affects 1 to 10 users in 100)

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

Uncommon (affects 1 to 10 users in 1,000)

• pancreatitis;

Rare (affects 1 to 10 users in 10,000)

• hepatic failure, hepatitis;

Very rare (affects less than 1 user in 10,000)

• blistering of the skin, mouth, eyes and genital area,
skin eruption.

Very common (affects more than 1 user in 10)

Not known (frequency cannot be estimated from the
available data)
Very common:
• nasopharyngitis;

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

Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola, PLA 3000
Malta
This medicinal product is authorised in the Member
States of the EEA under the following names:
Portugal

: Levetiracetam Hetero 1000 mg
comprimido revestido por película

Spain

: Levetiracetam Hetero 1000 mg
comprimidos recubiertos con
película EFG

• somnolence (sleepiness), headache.

5.How to store Levetiracetam 1000 mg

Common:
• anorexia (loss of appetite);

Keep this medicine out of the sight and reach of children.

The Netherlands : Levetiracetam Hetero 1000 mg,
filmomhulde tabletten

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

This medicinal product does not require any special
storage conditions.

Germany

• convulsion, balance disorder (equilibrium disorder),
dizziness (sensation of unsteadiness), lethargy, tremor
(involuntary trembling);

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.

United Kingdom :

• vertigo (sensation of rotation);

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.

This leaflet was last revised in 07/2014.

• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion),
vomiting, nausea;
• rash;
• asthenia/fatigue (tiredness).
Uncommon:
• decreased number of blood platelets, decreased
number of white blood cells;

6.

Contents of the pack and other information

What Levetiracetam 1000 mg contains
The active substance is levetiracetam. Each Film-coated
tablet contains 1000 mg of levetiracetam.
The other ingredients are:

: Levetiracetam Hetero 1000 mg
Filmtabletten
Levetiracetam Hetero 1000 mg
Film-coated tablets

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If you forget to take Levetiracetam 1000 mg
Contact your doctor if you have missed one or more
doses.

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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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