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LEVETIRACETAM CIPLA 750 MG FILM-COATED TABLETS

Active substance(s): LEVETIRACETAM / LEVETIRACETAM / LEVETIRACETAM

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Package leaflet: Information for the patient
Levetiracetam Cipla 750 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 pharmacist. This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet
1.What Levetiracetam Cipla is and what it is used for
2. What you need to know before you take Levetiracetam Cipla
3. How to take Levetiracetam Cipla
4. Possible side effects
5. How to store Levetiracetam Cipla
6. Contents of the pack and other information

1. What Levetiracetam Cipla is and what it is used for
Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Levetiracetam Cipla 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 Cipla 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 Cipla has been
given to you by your doctor to reduce the number of fits.
• As an add-on to other antiepileptic medicines to treat:
o partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of
age
o 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
o 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 Cipla
Do not take Levetiracetam Cipla
• If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in
Section 6)
Warnings and precautions
Talk to your doctor before taking Levetiracetam Cipla
• 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.
• A small number of people being treated with anti-epileptics such as Levetiracetam Cipla 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
Levetiracetam Cipla is not indicated in children and adolescents below 16 years on its own (monotherapy).
Other medicines and Levetiracetam Cipla
Tell your doctor or pharmacist if you are taking or 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 Cipla 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 Cipla should not be used during pregnancy unless clearly necessary. The potential risk to your unborn child
is unknown.
Levetiracetam Cipla 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 Cipla 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.

3. How to take Levetiracetam Cipla
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 Cipla 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):
General dose: between 1000 mg and 3,000 mg each day.
When you will first start taking Levetiracetam Cipla, 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 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:
General dose: between 1000 mg and 3,000 mg each day.
Example: if your daily dose is 1,500 mg, you must take one tablet in the morning and one tablet 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.
A 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 adolescent (from 6 to 17 years) weighing less than 50kg and when tablets don’t allow accurate dosage.
Method of administration:
Swallow Levetiracetam Cipla tablets with a sufficient quantity of liquid (e.g. a glass of water). You may take
Levetiracetam Cipla with or without food.
Duration of treatment:
• Levetiracetam Cipla is used as a chronic treatment. You should continue Levetiracetam Cipla 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 Cipla than you should:
The possible side effects of an overdose of Levetiracetam Cipla 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.
21055137

If you forget to take Levetiracetam Cipla:

2D
Code
Area

21055137

Levetiracetam Cipla 750 mg
film-coated tablets

2D
Code
Area

21055137

Levetiracetam Cipla 750 mg
film-coated tablets

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

Date: 17-10-2016

If you stop taking Levetiracetam Cipla:
If stopping treatment, Levetiracetam Cipla should be discontinued gradually to avoid an increase of seizures. Should your
doctor decide to stop your Levetiracetam Cipla treatment, he/she will instruct you about the gradual withdrawal of
Levetiracetam Cipla.
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 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.
Very common: may affect more than 1 user in 10 people
• nasopharyngitis;
• Somnolence (sleepiness), headache.
Common: may affect 1 to 10 users in 100 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 1 to 10 users in 1000 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 1 to 10 users in 10,000 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;
• severe reduction in number of white blood cells which makes infections more likely; 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;
• 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).
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 Yellow Card Scheme at Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Levetiracetam Cipla
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 box and blister after EXP:. The expiry date
refers to the last day of the 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 Cipla contains
The active substance is called Levetiracetam. Each tablet contains 750 mg of Levetiracetam.
The other ingredients are:
Tablet core: Croscarmellose sodium, Maize starch, Povidone K- 30, Silica colloidal anhydrous, Magnesium stearate.
Film-coating: Hypromellose 6cP (E464), Titanium dioxide (E171) , Macrogol 400, Iron oxide Red (E172 ), Indigo
Carmine Aluminium Lake (E132 )
What Levetiracetam Cipla looks like and contents of the pack
Levetiracetam Cipla 750mg film-coated tablets are light pink, capsule shaped, biconvex, length: 19.4 mm to 19.8 mm,
width: 8.0 mm to 8.4 mm and thickness: 6.3 mm to 6.9, mm, film-coated tablets plain on both sides.
Aluminium/PVC/PE/PVDC blisters placed into cardboard boxes containing 10, 20, 30, 50, 60, 100, 120 and 200
film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Cipla (EU) Limited,
Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom
Manufacturer
Cipla (EU) Limited, 20 Balderton Street, London W1K 6TL,United Kingdom
S&D Pharma CZ, spol. s r.o., Theodor 28, 273 08 Pchery (Pharmos a.s. facility), Czech Republic
Cipla Europe NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium

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This leaflet was last revised in 10/2016

Date: 17-10-2016

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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