Patient leaflet - LEVETIRACETAM TORRENT 1000 MG FILM-COATED TABLETS
= 1. what levetiracetam torrent is and what it is used for
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2. What you need to know before you take Levetiracetam Torrent
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3. How to take Levetiracetam Torrent
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4. Possible side effects
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5. How to store Levetiracetam Torrent
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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, to treat a 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 generalised 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
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– If you are allergic to levetiracetam, pyrrolidone derivatives, Sunset Yellow FCF 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 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.
Tell your doctor or pharmacist if any of the following side effects gets serious or last longer than a few days:
- Abnormal thoughts, feeling irritable or reacting more aggressively than usually, or if you or your family and friends notice important changes in mood or behaviour.
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 can be used during pregnancy, only if after careful assessment it is considered necessary by your doctor. You should not stop your treatment without discussing this with your doctor.
A risk of birth defects for your unborn child cannot be completely excluded.
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.
Only for Levetiracetam Torrent 750 mg film-coated tablets:
Levetiracetam Torrent contains Sunset Yellow FCF (E110)
Levetiracetam 750 mg film-coated tablets contain the colouring agent Sunset Yellow FCF aluminium lake (E110) which may cause allergic reactions.
Further information about the ingredients of this medicine
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.
3. how to take levetiracetam torrent
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 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.
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 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.
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.
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;
- suicide attempt and suicidal ideation;
- liver failure (a yellowish color of skin and eyes, bleeding easily, fluid buildup in the legs), hepatitis (poor appetite, vomiting, abdominal pain);
- unusual aches, pains or weakness in your muscles which go on for longer than you might expect, these could be symptoms of rhabdomyolysis (a condition which causes the breakdown of muscle tissue which can result in kidney damage). Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.
The most frequently reported side effects are nasopharyngitis (swelling of the nasal passages and the back of the throat), 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.
Very common: may affect more than 1 in 10 people
- nasopharyngitis (swelling of the nasal passages and the back of the 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 (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;
- mental disorder, hallucination, anger, confusion, panic attack, emotional instability/mood swings, agitation;
- 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;
- injury.
Rare: may affect up to 1 to 1,000 people
- infection;
- decreased number of all blood cell types;
- decreased blood sodium concentration;
- personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate);
- delirium;
- seizures may become worse or happen more often;
- hyperkinesia (hyperactivity);
- pancreatitis;
- limp or difficulty walking.
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 or search for MHRA Yellow Card in Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
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:
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– The active substance is called levetiracetam.
Levetiracetam Torrent 250 mg film-coated tablets
Each film-coated tablet contains 250 mg of levetiracetam.
Levetiracetam Torrent 500 mg film-coated tablets
Each film-coated tablet contains 500 mg of levetiracetam.
Levetiracetam Torrent 750 mg film-coated tablets
Each film-coated tablet contains 750 mg of levetiracetam.
Levetiracetam Torrent 1000 mg film-coated tablets
Each film-coated tablet contains 1000 mg of levetiracetam.
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– The other ingredients are:
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 × 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.
Levetiracetam Torrent 500 mg
The film-coated tablets are yellow colored, oval shaped, 16.2 × 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.
Levetiracetam Torrent 750 mg
The film-coated tablets are orange colored, oval shaped, 18.8 × 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.
Levetiracetam Torrent 1000 mg
The film-coated tablets are white colored, oval shaped, 20.1 × 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.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Torrent Pharma (UK) Ltd.
3rd Floor, Nexus Building,
4 Gatwick Road,
Crawley,
West Sussex,
RH10 9BG,
United Kingdom
Telephone: (01293) 574180
E-mail:
This leaflet was last revised in 03/2021.
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