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LEVETIRACETAM-LUPIN 750MG FILM-COATED TABLETS

Active substance(s): LEVETIRACETAM / LEVETIRACETAM / LEVETIRACETAM

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Package leaflet: Information for the patient
Levetiracetam-Lupin 250mg Film-coated Tablets
Levetiracetam-Lupin 500 mg Film-coated Tablets
Levetiracetam-Lupin 750 mg Film-coated Tablets
Levetiracetam-Lupin 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-Lupin is and what it is used for
2. What you need to know before you take Levetiracetam-Lupin
3. How to take Levetiracetam-Lupin
4. Possible side effects
5. How to store Levetiracetam-Lupin
6. Contents of the pack and other information
1. What Levetiracetam-Lupin is and what it is used for
Levetiracetam-Lupin contains the active substance levetiracetam, which is an antiepileptic medicine (a
medicine used to treat seizures in epilepsy).

225 mm

Levetiracetam-Lupin 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 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 then 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-Lupin
Do not take Levetiracetam-Lupin:
· if you are allergic to levetiracetam, other pyrrolidone derivatives or any of the other ingredients of this
medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Levetiracetam-Lupin:
· if you suffer from kidney problems, follow your doctor's instructions. He/she may decide if your dose
should be adjusted.
· A small number of people being treated with anti-epileptics such as levetiracetam have had thoughts
of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation,
please contact your doctor.

Pharmacode-4456 Std.

Other medicines and Levetiracetam-Lupin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is especially important to inform your doctor if you are taking:
· methotrexate (a medicine used to treat psoriasis, rheumatoid arthritis and some cancers)
· macragol (a medicine for constipation). You should not take macrogol for one hour before and one
hour after taking levetiracetam, as this may decrease its effect
· probenecid (a medicine for gout).

Driving and Using Machines:
Levetiracetam 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-Lupin 750mg tablets contains Sunset yellow (E110)
The coating on Levetiracetam-Lupin 750 mg tablets contains Sunset yellow (E110) per tablet which may
cause allergic reactions.
3. How to take Levetiracetam-Lupin
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 tablets must be taken twice
a day, once in the morning and once in the evening, at about the same time each day. The tablets can be
divided into equal doses.
Swallow levetiracetam tablets with a sufficient quantity of liquid (e.g a glass of water). You may take this
medicine with or without food.
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 first start taking levetiracetam, your doctor will prescribe you a lower dose (500 mg each day)
during 2 weeks before, giving you the lowest general dose of 1000 mg.
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 levetiracetam according to the
age, weight and dose.
Levetiracetam 100 mg/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 do not allow accurate dosage).
Duration of treatment:
· Levetiracetam is used as a chronic treatment. You should continue levetiracetam 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-Lupin than you should:
The possible side effects of an overdose of levetiracetam 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-Lupin:
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-Lupin:
If stopping treatment levetiracetam should be discontinued gradually to avoid an increase of seizures.
Should your doctor decide to stop your treatment with this medicine, he/she will instruct you about a
gradual withdrawal.
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.
The most frequently reported side effects are a sore nose or throat (nasopharyngitis), sleepiness
(somnolence), headache, fatigue and dizziness. At the beginning of treatment or at dose increase, side
effects like sleepiness, tiredness and dizziness may be more common. These effects should however
decrease over time.
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

134 mm

LEAFLET LEVETRACETUM TABS UK R5 (Front)
Market/Customer :

UK

Location :

Goa

Prepared On :

14/07/2017

Version No. :

01

Product name :

LEAFLET LEVETRACETUM TABS UK R5

Material code :

252998

Supercedes code :

243410

Component :

Leaflet

Pharmacode value :

4456

Open Size :

134 x 450 mm (W X H)

Gluing :

NA

Folded Size :

134 x 225 mm (W X H)

GSM :

40 gsm Bible Paper

Pantone Colours :
Reason for Change:

Black

Dieline (does not print)

Change in Textmatter

Unicorn Creation
D/Lupin/Regulatory/UK/Levetiracetam/

Pharmacode-4456 Std.

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 should not be used during pregnancy unless clearly necessary, as there is a risk of harm to
your unborn child.
Breast-feeding is not recommended during treatment as levetiracetam passes into breast milk.

450 mm

Children and adolescents
If you notice any slow-down in the growth or unexpected puberty development of your child, please
contact your doctor.
Levetiracetam is not intended for use on its own (monotherapy) in children and adolescents below 16
years.













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.
thinking about suicide or attempting suicide
severe abdominal pain that spreads to the back, which may be signs of a swollen pancreas

Tell your doctor straight away if you notice any of the following, as you may need medical attention
Uncommon (may affect up to 1 in 100 people):
· increased signs of infection such as fever, sore throat, mouth ulcers, which may be caused by a
reduction in white blood cells
Rare (may affect up to 1 in 1,000 people):
· signs of liver problems such as abdominal pain, fever, pale stools or dark urine, yellowing of the skin
and eyes
· sudden decrease in kidney function
· rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase
increase. Prevalence is significantly higher in Japanese patients when compared to non-Japanese
patients.
Other possible side effects
Very common (may affect more than 1 in 10 people):
· nasopharyngitis (sore nose or throat)
· 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 (weakness/tiredness)

Rare (may affect up to 1 in 1,000 people):
· decreased number of all blood cell types
· decreased blood sodium concentration
· infection
· 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)
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 Tablets
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 and blister after EXP.
The expiry date refers to the last day of that month.
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-Lupin Tablets contains
The active substance is levetiracetam. Each tablet contains 250 mg, 500 mg, 750 mg or 1000 mg
levetiracetam.
The other ingredients are:
Common Tablet Core:
Maize starch, colloidal anhydrous silica, croscarmellose sodium, povidone K30, microcrystalline
cellulose, talc and magnesium stearate.
Levetiracetam 250 mg Tablets film-coating contains: polyvinyl alcohol-part hydrolyzed, titanium dioxide
(E171), macrogol 3350, macrogol 6000, talc and Indigo carmine (E132).
Levetiracetam 500 mg Tablets film-coating contains: polyvinyl alcohol-part hydrolyzed, titanium dioxide
(E171), macrogol 3350, macrogol 6000, talc and iron oxide yellow (E172).
Levetiracetam 750 mg Tablets film-coating contains: polyvinyl alcohol-part hydrolyzed, titanium dioxide
(E171), macrogol 3350, macrogol 6000, talc, iron oxide yellow (E172), iron oxide red (E172) and Sunset
yellow (E110).
Levetiracetam 1000 mg Tablets film-coating contains: polyvinyl alcohol-part hydrolyzed, titanium dioxide
(E171), macrogol 3350, macrogol 6000 and talc.
What Levetiracetam-Lupin Tablets look like and contents of the pack:
·
·
·
·

Levetiracetam 250 mg tablets are blue, oblong shaped, biconvex film coated tablets marked with
“250” on one side and a score line on the other side.
Levetiracetam 500 mg tablets are yellow, oblong shaped, biconvex film coated tablet marked with
“500” on one side and a score line on the other side.
Levetiracetam 750 mg tablets are peach coloured, oblong shaped, biconvex film coated tablet marked
with “750” on one side and a score line on the other side.
Levetiracetam 1000 mg tablets are white to off white, oblong shaped, biconvex film coated tablet
marked with “1000” on one side and a score line on one side.

Levetiracetam tablets are available in blister packs containing 10, 20, 30, 50, 60, 100, 120 and 200 tablets
packaged in cartons.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Lupin (Europe) Ltd.
Victoria Court
Bexton Road
Knutsford
Cheshire, WA16 0PF
UK
This medicinal product is authorised in the Member States of the EEA under the following names:
Portugal
Levetiracetam-Lupin 250mg, 500mg, 750mg & 1000mg Comprimidos revestidos por
película
Czech Republic Letiramyl 250 mg, 500mg, 750mg, 1000mg potahované tablety
Hungary
Levetiracetam-Lupin 250mg, 500mg, 750mg & 1000mg Filmtabletta
Poland
Levetiracetam-Generics
Germany
Levetiracetam-Hormosan 250mg, 500mg, 750mg & 1000mg Filmtabletten
UK
Levetiracetam-Lupin 250mg, 500mg, 750mg & 1000mg Film-coated tablets
Italy
Levetiracetam Mylan Generics 250mg, 500mg, 750mg & 1000mg Compresse rivestite
con film
Spain
Levetiracetam-Lupin 250mg, 500mg, 750mg & 1000mg Comprimidos recubiertos con
pelicula

The leaflet was last revised in 07/2017
Manufacturer Code No. GO/DRUGS/654

ID#: 252998

134 mm

LEAFLET LEVETRACETUM TABS UK R5 (Back)
Market/Customer :

UK

Location :

Goa

Prepared On :

14/07/2017

Version No. :

01

Product name :

LEAFLET LEVETRACETUM TABS UK R5

Material code :

252998

Supercedes code :

243410

Component :

Leaflet

Pharmacode value :

4456

Open Size :

134 x 450 mm (W X H)

Gluing :

NA

Folded Size :

134 x 225 mm (W X H)

GSM :

40 gsm Bible Paper

Pantone Colours :
Reason for Change:

Black

Dieline (does not print)

Change in Textmatter

Unicorn Creation
D/Lupin/Regulatory/UK/Levetiracetam/

450 mm

Uncommon (may affect up to 1 in 100 people):
· decreased number of blood platelets, causing you to bruise or bleed more easily or for longer than
usual
· weight decrease, weight increase
· 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

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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