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LEVETIRACETAM MILPHARM 500 MG FILM-COATED TABLETS

Active substance(s): LEVETIRACETAM

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Levetiracetam Milpharm 250 mg film-coated tablets
Levetiracetam Milpharm 500 mg film-coated tablets
Levetiracetam Milpharm 750 mg film-coated tablets
Levetiracetam Milpharm 1000 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 Levetiracetam Milpharm is and what it is used for
2. What you need to know before you take Levetiracetam
Milpharm
3. How to take Levetiracetam Milpharm
4. Possible side effects
5. How to store Levetiracetam Milpharm
6. Contents of the pack and other information
1. What Levetiracetam Milpharm is and what it is used for
Levetiracetam Milpharm film-coated tablet are an antiepileptic
medicine (a medicine used to treat seizures in epilepsy).
Levetiracetam Milpharm 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:
• partial onset seizures with or without generalisation in adults,
adolescents, children and infants from one month of age
• myoclonic seizures in adults and adolescents from 12 years
of age with juvenile myoclonic epilepsy.
• primary generalised tonic-clonic seizures in adults and
adolescents from 12 years of age with idiopathic generalised
epilepsy.

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Levetiracetam Milpharm

Package Leaflet: Information for the patient

Levetiracetam Milpharm

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

Important information about some of the ingredients of
Levetiracetam Milpharm:
Levetiracetam Milpharm 750 mg contains Sunset Yellow FCF
(E110). Sunset Yellow FCF (E110) colouring agent may cause
allergic reactions.
3. How to take Levetiracetam Milpharm
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
Levetiracetam Milpharm 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 Milpharm, your doctor
will prescribe you a lower dose during 2 weeks before giving you
the lowest general dose.
250 mg
Example: if your daily dose is 1,000 mg, you must take 2 tablets in
the morning and 2 tablets in the evening.
500 mg
Example: if your daily dose is 2,000 mg, you must take 2 tablets in
the morning and 2 tablets in the evening.
750 mg
Example: if your daily dose is 3,000 mg, you must take 2 tablets in
the morning and 2 tablets in the evening.
1000 mg
Example: if your daily dose is 2,000 mg, you must take 1 tablet in
the morning and 1 tablet 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.
250 mg
Example: if your daily dose is 1,000 mg, you must take 2 tablets in
the morning and 2 tablets in the evening.

2. What you need to know before you take Levetiracetam
Milpharm

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

Do not take Levetiracetam Milpharm:
• If you are allergic (hypersensitive) to levetiracetam or any of the
other ingredients of this medicine (listed in Section 6).

750 mg
Example: if your daily dose is 1,500 mg, you must take one tablet in
the morning and one tablet in the evening.

Warnings and Precautions
Talk to your doctor before taking Levetiracetam Milpharm

1000 mg
Example: if your daily dose is 2,000 mg, you must take one tablet in
the morning and one tablet in the evening.







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 Levetiracetam Milpharm 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 Levetiracetam Milpharm
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Levetiracetam Milpharm with food, drink and alcohol
You may take Levetiracetam Milpharm with or without food. As a
safety precaution, do not take Levetiracetam Milpharm 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 Milpharm should not be used during pregnancy
unless clearly necessary. A risk of birth defects for your unborn
child cannot be completely excluded. 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:
Levetiracetam Milpharm may impair your ability to drive or operate
any tools or machinery, as Levetiracetam Milpharm 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.

Black

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.
An 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.
250 mg
Example: a general dose of 20 mg per kg bodyweight each day,
you must give your 25 kg child 1 tablet in the morning and 1 tablet
in the evening.
Dose in infants (1 month to less than 6 months):
An Levetiracetam 100 mg/ml oral solution is a presentation more
appropriate to infants.
Method of administration:
Swallow Levetiracetam Milpharm tablets with a sufficient quantity of
liquid (e.g. a glass of water).
Duration of treatment:
• Levetiracetam Milpharm is used as a chronic treatment. You
should continue Levetiracetam Milpharm 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 Milpharm treatment, he/she will instruct you
about the gradual withdrawal of Levetiracetam Milpharm.
If you take more Levetiracetam Milpharm than you should:
The possible side effects of an overdose of Levetiracetam
Milpharm 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 Milpharm:
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 Milpharm:
If stopping treatment, as with other antiepileptic medicines,
Levetiracetam Milpharm 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
• nasopharyngitis;
• somnolence (sleepiness), headache.

6. Contents of the pack and other information
What Levetiracetam Milpharm contains
The active substance is called levetiracetam. Each film-coated
tablet contains 250 mg/ 500 mg/ 750 mg/ 1000 mg levetiracetam.
The other ingredients are:
Tablet core: Maize starch, silica colloidal anhydrous (E551),
povidone (K-30) (E1201), talc (E553b), magnesium stearate
(E470b).
Film-coating:
250 mg: Hypromellose 3cp & 6cp (E464), titanium dioxide (E 171),
macrogol 4000, indigo carmine aluminium lake (E132).
500 mg: Hypromellose 3cp & 6cp (E464), titanium dioxide (E 171),
macrogol 4000, iron oxide yellow (E172).
750 mg: Hypromellose 3cp & 6cp (E464), titanium dioxide (E 171),
macrogol 4000, indigo carmine aluminium lake (E132), sunset
yellow aluminium lake (E110), iron oxide red. (E172).
1000 mg: Hypromellose 5 cp (E464), titanium dioxide (E 171),
macrogol 400.

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).

What Levetiracetam Milpharm looks like and contents of the
pack
Film-coated tablet.

Uncommon: may affect 1 to 10 users in 1000
• 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.

Levetiracetam Milpharm 750 mg film-coated tablets
Orange oval shaped biconvex film-coated tablets debossed with a
deep break line separating ‘E’ and ‘12’ on one side and plain on the
other side. The tablet can be divided into equal halves.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet.
Also you can help to make sure that medicines remain as safe as
possible by reporting any unwanted side effects via the internet at
www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone
0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to
Fridays) or fill in a paper form available from your local pharmacy.
5. How to store Levetiracetam Milpharm
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage
conditions.
Do not use this medicine after the expiry date which is stated on
the carton box, blister & bottle label 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.

Levetiracetam Milpharm 500 mg film-coated tablets
Yellow oval shaped biconvex film-coated tablets debossed with a
deep break line separating ‘E’ and ‘11’ on one side and plain on the
other side. The tablet can be divided into equal halves.

Levetiracetam Milpharm 1000 mg film-coated tablets
White modified oval shaped, biconvex film-coated tablets debossed
with break line separating ‘E’ and ‘13’ on one side and plain on the
other side. The tablet can be divided into equal halves.
Levetiracetam Milpharm film-coated tablets are packaged in
PVC/PE/PVdC – Aluminium foil blister pack or HDPE bottle with
polypropylene cap pack.
Pack size:
Blister pack: 20, 30, 50, 60, 100, 200 and 500 film-coated tablets
Bottle pack: 30, 100, 200 and 500 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
This medicinal product is authorised in the Member States of
the EEA under the following names:
France:

Levetiracetam Arrow Lab 250mg/ 500mg/
1000mg, comprimé pelliculé sécable
Germany
Levetiracetam Aurobindo 250mg/ 500mg/ 750mg/
1000mg Filmtabletten
Ireland
Levetiracetam Aurobindo 250mg/ 500mg/ 750mg/
1000mg film-coated tablets
Italy
Levetiracetam Aurobindo 500mg/ 1000mg
compresse rivestite con film
Netherlands
Levetiracetam Aurobindo 250mg/ 500mg/ 750mg/
1000mg, filmomhulde tabletten
Poland
Levetiracetam Aurobindo
Romania
Levetiracetam Aurobindo 250mg/ 500mg/
1000mg comprimat filmate
Spain
Levetiracetam Aurobindo 250mg/ 500mg/
1000mg comprimidos recubiertos con película
United Kingdom Levetiracetam Milpharm 250mg/ 500mg/ 750mg/
1000mg film-coated tablets
This leaflet was last revised in 08/2014.

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Rare: may affect 1 to 10 users in 10,000
• 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).

Levetiracetam Milpharm 250 mg film-coated tablets
Blue oval shaped biconvex film-coated tablets debossed with a
deep break line separating ‘E’ and ‘10’ on one side and plain on the
other side. The tablet can be divided into equal halves.

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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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