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LEVELANZ 750 MG FILM-COATED TABLETS

Active substance(s): LEVETIRACETAM

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Levetiracetam
SOLID 1000593584

v1.0

Package Leaflet: Information for the patient
Levelanz 750 mg film-coated tablets
Levetiracetam
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 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.
What is in this leaflet:
1. What Levelanz is and what it is used for
2. What you need to know before you take Levelanz
3. How to take Levelanz
4. Possible side effects
5. How to store Levelanz
6. Contents of the pack and other information
1.

WHAT LEVELANZ IS AND WHAT IT IS USED FOR

Levelanz 750 mg film-coated tablets are an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
Levelanz is used:
on its own in adults and adolescents 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:
o
partial onset seizures with or without generalisation in adults, adolescents, children
and infants from one month of age
o
myoclonic seizures in adults and adolescents from 12 years of age with juvenile
myoclonic epilepsy
o
primary generalised tonic-clonic seizures in adults and adolescents from 12 years of
age with idiopathic generalised epilepsy.
2.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVELANZ

Do not take Levelanz

This information is confidential

Levetiracetam
SOLID 1000593584

-

v1.0

If you are allergic (hypersensitive) to levetiracetam or any of the other ingredients of
this medicine (listed in Section 6).

Warnings and precautions
Talk to your doctor before taking Levelanz
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 doctor.
A small number of people being treated with anti-epileptics such as Levelanz have
had thoughts of harming or killing themselves. If you have any symptoms of depression
and/or suicidal ideation, please contact your doctor.
Other medicines and Levelanz
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Levelanz with food, drink and alcohol
You may take Levelanz with or without food. As a safety precaution, do not take Levelanz 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.
Levelanz 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.
Breast-feeding is not recommended during treatment.
Driving and using machines
Levelanz may impair your ability to drive or operate any tools or machinery, as Levelanz 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.
Levelanz contains Sunset Yellow FCF
Levelanz 750 mg film-coated tablets contains Sunset Yellow FCF Aluminium Lake (E110).
Sunset Yellow FCF (E110) colouring agent may cause allergic reactions.
3.

HOW TO TAKE LEVELANZ

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

This information is confidential

Levetiracetam
SOLID 1000593584

v1.0

Levelanz must be taken twice a day, once in the morning and once in the evening, at about the
same time each day. The scoreline is only to facilitate breaking for ease of swallowing and not to
divide into equal doses.
Take the number of tablets following your doctor’s instructions.
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 Levelanz, your doctor will prescribe you a lower dose during 2
weeks before giving you the lowest general dose.
Example: if your daily dose is 3,000 mg, you must take 2 tablets in the morning and 2 tablets 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 1,500 mg, you must take one tablet in the morning and one 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:
Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according
to the age, weight and dose. Any levetiracetam 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):
Any levetiracetam oral solution is a presentation more appropriate to infants.
Method of administration:
Swallow Levelanz with a sufficient quantity of liquid (e.g. a glass of water).
Duration of treatment:
- Levelanz is used as a chronic treatment. You should continue Levelanz 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 Levelanz treatment, he/she will instruct you about the
gradual withdrawal of Levelanz.
If you take more Levelanz than you should:
The possible side effects of an overdose of Levelanz 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 Levelanz:
This information is confidential

Levetiracetam
SOLID 1000593584

v1.0

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 Levelanz:
If stopping treatment, as with other antiepileptic medicines, Levelanz 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 or pharmacist.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
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.
Very common (may affect more than 1 user in 10):
- nasopharygitis;
- somnolence (sleepiness), headache.
Common (may affect 1 to 10 users in 100):
- anorexia (loss of appetite);
- depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
- convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness),
lethargy, 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 1,000):
- 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;
- liver function test abnormal;
- hair loss, eczema, pruritus;
- muscle weakness, myalgia (muscle pain);
- injury.
Rare (may affect 1 to 10 users in 10,000):
This information is confidential

Levetiracetam
SOLID 1000593584

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v1.0

infection;
decreased number of all blood cell types;
severe hypersensitivity reactions (DRESS);
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;
hepatic failure, hepatitis;
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).

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. By reporting side effects you can help provide more information on the safety of this medicine.

5.

HOW TO STORE LEVELANZ

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 blister and on the carton after
‘exp date’. 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 Levelanz contains
The active substance is called levetiracetam. Each tablet contains 750 mg of
levetiracetam.
-

The other ingredients are:

Tablet core: Pregelatinised starch (maize), sodium starch glycolate type A, povidone (K-30),
maize starch, silica colloidal anhydrous, magnesium stearate.

This information is confidential

Levetiracetam
SOLID 1000593584

v1.0

Film-coating: Hypromellose (6 cps), titanium dioxide (E171), macrogol 3350, talc, sunset yellow
FCF (E110), iron oxide red (E172).
What Levelanz looks like and contents of the pack
The film-coated tablets are orange, oval, biconvex, debossed with ‘750’ on one side and median
line on other side.
The cardboard boxes contain 28, 56 or 98 film-coated tablets. Not all pack sizes may be
marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
BGP Products Ltd.Abbott House

Vanwall Business Park
Vanwall Road
Maidenhead
Berkshire, SL6 4XE, UK
Manufacturer: (to be selected as appropriate)
Idifarma Desarrollo Farmaceutico S.L.
Polígono Mocholí
C/Noáin 1
31110 Noáin (Navarra)
SPAIN
OR
Abbott Logistics B.V.
Minervum 7201
4817 ZJ BREDA
The Netherlands
This medicinal product is authorised in the Member States of the EEA under the following
names:
United Kingdom:
Czech Republic:

LEVELANZ 750 mg film-coated tablets
LEVELANZ 750 mg film-coated tablets

Poland:

LEVELANZ 750 mg film-coated tablets

Romania:

LEVELANZ 750 mg film-coated tablets

This leaflet was last approved in {MM/YYYY}

This information is confidential

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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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