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LEVETIRACETAM-LUPIN 1000MG FILM-COATED TABLETS

Active substance(s): LEVETIRACETAM

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Package leaflet: Information for the patient
Levetiracetam-Lupin 250 mg 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).
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.
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.
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).
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.
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)
Sunset yellow (E110) colouring agent 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.
Example: if your daily dose is 1,000 mg, your reduced starting dose is 2 tablets of 250 mg in
the morning and 2 tablets of 250 mg 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 1,000 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.

450 mm

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.
If you notice any of the following serious side effects, stop taking this medicine and contact
your doctor or go to your nearest hospital emergency department immediately
Uncommon (may affect up to 1 in 100 people):
· thinking about suicide or attempting suicide
· Rare (may affect up to 1 in 1,000 people):severe immediate allergic reaction causing a
rash, swelling of the face, lips, tongue and throat
· 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)
· 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):
· delayed allergic reaction causing rash with fever and possibly swollen or tender lymph
glands
· signs of liver problems such as abdominal pain, fever, pale stools or dark urine, yellowing
of the skin and eyes
Other possible side effects
Very common (may affect more than 1 in 10 people):
· nasopharyngitis (common cold)
· 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)
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
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
Hungary Levetiracetam-Lupin 250mg, 500mg, 750mg & 1000mg Filmtabletta
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
The leaflet was last revised in 08/2016
Manufacturer Code No. GO/DRUGS/654
ID#: 248335

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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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