Package leaflet: Information for the patient

Levetiracetam Generics 250 mg Film-coated Tablets Levetiracetam Generics 500 mg Film-coated Tablets Levetiracetam Generics 750 mg Film-coated Tablets Levetiracetam Generics 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 Generics is and what it is used for

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

3.    How to take Levetiracetam Generics

4.    Possible side effects

5.    How to store Levetiracetam Generics

6.    Contents of the pack and other information

1.    What Levetiracetam Generics is and what it is used for

Levetiracetam Generics Film-coated Tablets contain the active substance levetiracetam, which is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Levetiracetam Generics 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 Generics 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 seizures with or without secondary generalization). Levetiracetam Generics 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 Generics

Do not take Levetiracetam Generics:

-    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 before taking Levetiracetam Generics:

-    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 have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal thoughts, please contact your doctor.

Children and adolescents

Levetiracetam is not intended for use on its own (monotherapy) in children and adolescents below 16 years.

Other medicines and Levetiracetam Generics

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.

It is especially important to inform your doctor if you are taking:

•    methotrexate (a medicine for psoriasis, inflammation and some cancers).

•    macrogol (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 (medicine for gout).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Levetiracetam Generics should not be used during pregnancy unless clearly necessary. A risk of birth defects for your unborn child cannot be completely ruled out. 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.

3. How to take Levetiracetam Generics

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 Generics 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 3000 mg each day.

When you first start taking Levetiracetam Generics, your doctor will prescribe you a lower dose for 2 weeks before giving you the lowest general dose.

Example: if your daily dose is 1000 mg, your reduced starting dose is 2 tablets of250 mg in the morning and 2 tablets of250 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 3000 mg each day.

Example: if your daily dose is 1000 mg, you might take 2 tablets of250 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.

An oral solution may be available which 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 dosing.

Method of administration:

Swallow Levetiracetam Generics tablets with a sufficient quantity of liquid (e.g. a glass of water). You may take this medicine with or without food.

The score line is only there to help you break the tablet if you have difficulty swallowing it whole. Duration of treatment:

•    Levetiracetam Generics is used as a chronic treatment. You should continue Levetiracetam Generics 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 Generics than you should

The possible side effects of an overdose of Levetiracetam Generics 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 Generics

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 Generics

If stopping treatment, as with other antiepileptic medicines, Levetiracetam Generics 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.

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 at the beginning of the treatment or at dosage increase. These effects should however decrease over time.

If you think you may have any of the following side effects, stop taking this medicine and contact your doctor or go to your nearest hospital emergency room immediately.

Uncommon: may affect up to 1 in 100 people

-    suicide attempt and suicidal ideation

-    decreased blood count (with signs such as sudden sore throat, fever, mouth ulcers, unexplained bruising or bleeding, tiredness).

Rare: may affect up to 1 in 1,000 people

-    suicide,

-    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 multiform), a widespread rash with blisters and peeling skin, particularly around the mouth nose, eyes, genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis).

-    severe allergic reactions (such as DRESS, anaphylactic reaction (severe and immediate allergic reaction), Quinke’s oedema (swelling of the face, lips, tongue and throat).

Other side effects include:

Very common: may affect more than 1 in 10 people

•    nasopharyngitis

•    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

•    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

•    infection

•    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)

•    decreased blood sodium concentration.

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

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 Generics

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.

This medicinal product 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 any medicines you no longer use. These measures will help to protect the environment.

6.    Contents of the pack and other information What Levetiracetam Generics contains

-    The active substance is levetiracetam. Each film-coated tablet contains either 250 mg, 500 mg, 750 mg or 1000 mg levetiracetam.

-    The other ingredients are: Tablet core: Povidone; cellulose, microcrystalline; croscarmellose sodium; magnesium stearate; sodium laurilsulfate; silica, colloidal anhydrous. Film coat: titanium dioxide (E171); polydextrose; hypromellose; triacetin; macrogol 8000, macrogol 400.

What Levetiracetam Generics looks like and contents of the pack

Film-coated Tablet

250 mg tablet: A white film-coated, round, biconvex, beveled-edge tablet debossed with “M” above the score and “613” below the score on one side of the tablet and blank on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

500 mg tablet: A white film-coated, oblong shaped, biconvex, beveled-edge tablet debossed with “M” on the left of the score and “615” on the right of the score on one side of the tablet and blank on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

750 mg tablet: A white film-coated, oblong shaped, biconvex, beveled-edge tablet debossed with “M” on the left of the score and “617” on the right of the score on one side of the tablet and blank on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

1000 mg tablet: A white film-coated, oblong shaped, biconvex, beveled-edge tablet debossed with “M” on the left of the score and “619” on the right of the score on one side of the tablet and blank on

the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Levetiracetam Generics Film-coated Tablets are packed in blister packs containing 20, 30, 60, 100 and 200 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Generics [UK] Ltd t/a Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

Manufacturer

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

This leaflet was last revised in 02/2016.

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