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LEVETIRACETAM TORRENT 750 MG FILM-COATED TABLETS

Active substance(s): LEVETIRACETAM / LEVETIRACETAM / LEVETIRACETAM

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The most frequently reported side effects are nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. At the
beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common. These effects
should however decrease over time.

Package Leaflet: Information for the patient
Levetiracetam Torrent 250 mg film-coated tablets
Levetiracetam Torrent 500 mg film-coated tablets
Levetiracetam Torrent 750 mg film-coated tablets
Levetiracetam Torrent 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 Torrent is and what it is used for
2. What you need to know before you take Levetiracetam Torrent
3. How to take Levetiracetam Torrent
4. Possible side effects
5. How to store Levetiracetam Torrent
6. Contents of the pack and other information
1. What LEVETIRACETAM TORRENT is and what it is used for
Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).


Levetiracetam is used: on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, certain form of
epilepsy. Epilepsy is a condition where the 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 thereafter 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 generalized epilepsy (the type of epilepsy that is thought to have a genetic cause).

2. What you need to know before you take LEVETIRACETAM TORRENT
Do not take Levetiracetam Torrent

If you are allergic to levetiracetam, pyrrolidone derivatives, Sunset Yellow aluminium lake (E110) (only for Levetiracetam Torrent
750 mg film-coated tablets) 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

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

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.

Very common: may affect more than 1 in 10 people

nasopharyngitis

somnolence (sleepiness), headache.
Common: mayaffect 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 (tiredness);
Uncommon: may affect up to 1 in 100 people

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;

elevated/abnormal values in a liver function test;

hair loss, eczema, pruritus;

muscle weakness, myalgia (muscle pain);

injury.
Rare: may affect up to 1 to 1000 people

infection;

decreased number of all blood cell types;

severe allergic reactions (DRESS anaphylactic reaction [severe and important allergic reaction], Quincke’s oedema [swelling of the
face, lips, tongue and throat]);

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

liver failure, hepatitis;

sudden decrease in kidney function;

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).

rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase increase. Prevalence is significantly
higher in Japanese patients when compared to non-Japanese patients.
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 www. mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the
safety of this medicine.

Children and adolescents
Levetiracetam Torrent is not indicated in children and adolescents below 16 years on its own (monotherapy).
Other medicines and Levetiracetam Torrent:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may results in a loss
of its effect.
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 for advice before taking
this medicine. Levetiracetam 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 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.

5. How to store LEVETIRACETAM TORRENT
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton box and blister after EXP.
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 Levetiracetam Torrent contains:
The active substance is called levetiracetam.
Levetiracetam Torrent 250 mg film-coated tablets
Each film-coated tablet contains 250 mg of levetiracetam.

Only for Levetiracetam Torrent 750 mg film-coated tablets:
Levetiracetam Torrent contains Sunset Yellow aluminium lake (E110)
Levetiracetam 750 mg film-coated tablets contain the colouring agent Sunset Yellow aluminium lake (E110) which may cause allergic
reactions.

Levetiracetam Torrent 500 mg film-coated tablets
Each film-coated tablet contains 500 mg of levetiracetam.

3. How to take LEVETIRACETAM TORRENT

Levetiracetam Torrent 750 mg film-coated tablets
Each film-coated tablet contains 750 mg of levetiracetam.

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 Torrent 1000 mg film-coated tablets
Each film-coated tablet contains 1000 mg of levetiracetam.

Levetiracetam must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Monotherapy
Dose in adults and adolescents (from 16 years of age):
The recommended dose is: between 1,000 mg and 3,000 mg each day.
When you will first start taking Levetiracetam, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest
general dose.
Example: if your daily dose is 1000 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:
The recommended dose is: 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 100mg/ml oral solution is a formulation more appropriate to infants and children under the age of 6 years and to children
and adolescent (from 6 to 17 years) weighing less than 50kg and when tablets don’t allow accurate dosage.
Method of administration:
Swallow Levetiracetam tablets with a sufficient quantity of liquid (e.g. a glass of water). You may take Levetiracetam Torrent with or
without food.
The tablet can be divided into equal doses.

-

The other ingredients are:
Levetiracetam Torrent 250 mg
Tablet core: Maize starch, Sodium starch glycolate (Type A), Silica Colloidal Anhydrous, Povidone (K-30), Talc, Magnesium Stearate
Film-coating: Hypromellose, Titanium Dioxide (E171), Macrogol 400, Indigo Carmine aluminium lake (E132)
Levetiracetam Torrent 500 mg
Tablet core: Maize starch, Sodium starch glycolate (Type A), Silica Colloidal Anhydrous, Povidone (K-30), Talc, Magnesium Stearate
Film-coating: Hypromellose, Titanium Dioxide (E171), Macrogol 400, Ferric Oxide Yellow (E172)
Levetiracetam Torrent 750 mg
Tablet core: Maize starch, Sodium starch glycolate (Type A), Silica Colloidal Anhydrous, Povidone (K-30), Talc, Magnesium Stearate
Film-coating: Hypromellose, Titanium Dioxide (E171), Macrogol 400, Ferric Oxide Red (E 172), Sunset Yellow aluminium lake (E
110)
Levetiracetam Torrent 1000 mg
Tablet core: Maize starch, Sodium starch glycolate (Type A), Silica Colloidal Anhydrous, Povidone (K-30), Talc, Magnesium Stearate
Film-coating: Hypromellose, Titanium Dioxide (E171), Macrogol 400

Levetiracetam film-coated tablets are packed in blisters in cardboard boxes.
What Levetiracetam Torrent looks like and contents of the pack
Levetiracetam Torrent 250 mg
The film-coated tablets are blue colored, oval shaped, 12.9 x 6.1 mm, and debossed with break line separating ‘250’ and ‘MG’ on one side
and ‘1014’ on other side.
The cardboard boxes contain 28, 30, 50, 60, 100 and 200 film-coated tablets.

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.

Levetiracetam Torrent 500 mg
The film-coated tablets are yellow colored, oval shaped, 16.2 x 7.3 mm, and debossed with breakline separating ‘500’ and ‘MG’ on one
side and ‘1015’ on other side.
The cardboard boxes contain 28, 30, 50, 60, 100 and 200 film-coated tablets.

If you take more Levetiracetam Torrent 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.

Levetiracetam Torrent 750 mg
The film-coated tablets are orange colored, oval shaped, 18.8 x 8.8. mm, and debossed with breakline separating ‘750’ and ‘MG’ on one
side and ‘1016’ on other side.
The cardboard boxes contain 28, 30, 50, 60, 100 and 200 film-coated tablets.

If you forget to take Levetiracetam Torrent:
Contact your doctor if you have missed one or more doses.
Do not take a double dose to make up for a forgotten tablet.

Levetiracetam Torrent 1000 mg
The film-coated tablets are white colored, oval shaped, 20.1 x 9.8 mm, and debossed with breakline separating ‘1000’ and ‘MG’ on one
side and ‘1017’ on other side.
The cardboard boxes contain 28, 30, 50, 60, 100 and 200 film-coated tablets.

If you stop taking Levetiracetam Torrent:
If stopping treatment, Levetiracetam should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop
your Levetiracetam Torrent treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam Torrent
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.
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
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.

LOCATION : Baddi
SIZE

COUNTRY : UK

: 180 x 490 mm_Front/Back Side

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Torrent Pharma (UK) Ltd.
Unit 4, Charlwood Court,
County Oak Way
Crawley
West Sussex. RH11 7XA
United Kingdom
Telephone: (01293) 574180
Fax: (01293) 533003
E-mail: drugsafety@torrentpharma.co.uk
This medicinal product is authorised in the Member States of the EEA under the following names:
Germany:
Levetiracetam Heumann 250/500/750/1000 mg Filmtabletten
Italy:
Levetiracetam Torrent
Lithuania:
Levetiracetamas Torrent 250/500/750/1000 mg plévele dengtos tabletés
Romania:
Levetiracetam Torrent 250/500/750/1000 mg comprimate filmate
United Kingdom:
Levetiracetam Torrent 250/500/750/1000 mg film-coated tablets
This leaflet was last revised in 01/2017

8061422-7803

Supersedes A / W No.:
CODE : 8061422-7803

DATE : 10-01-2017

REMARK : Folding Length 35 mm
SUBSTRATE :
Activities

Department

Prepared By Pkg.Dev
Reviewed By Pkg.Dev
Approved By Quality

Name

Signature

Date

Colour Black

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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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