LEVETIRACETAM MYLAN 500 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

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 Mylan is and what it is used for

• 2. What you need to know before you take Levetiracetam Mylan

• 3. How to take Levetiracetam Mylan

• 4. Possible side effects

• 5. How to store Levetiracetam Mylan

• 6. Contents of the pack and other information

1. what levetiracetam mylan is and what it is used for

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 then extend to larger areas on both sides of the brain (partial onset seizures 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 mylan- 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 Mylan:

• – If you suffer from kidney problems, follow your doctor’s instruc­tions. He/she may decide if your dose should be adjusted.

A small number of people being treated with anti-epileptics such as Levetiracetam Mylan have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal thoughts, please contact your doctor.

• – If you have a family or medical history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or take a treatment that make(s) you prone to heartbeat irregularities or salt imbalances.

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.

• - Aggravation of epilepsy

Your seizures may rarely become worse or happen more often, mainly during the first month after the start of the treatment or increase of the dose. If you experience any of these new symptoms while taking Levetiracetam, see a doctor as soon as possible.

Children and adolescents

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

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

Other medicines and Levetiracetam Mylan

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.

Pregnancy

Levetiracetam Mylan 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

Breast-feeding is not recommended during treatment as Levetiracetam Mylan passes into breast milk.

Driving and using machines

Levetiracetam Mylan 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 mylan

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 Mylan must be taken twice a day, once in the morning and once in the evening, at about the same time each day.

Swallow Levetiracetam Mylan tablets with a sufficient quantity of liquid (e.g. a glass of water). You may take this medicine with or without food. After taking the tablets you may feel the bitter taste of levetiracetam.

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

Monotherapy

Dose in adults and adolescents (from 16 years of age):

General dose: between 1,000 mg and 3,000 mg each day.

When you first start taking Levetiracetam Mylan, your doctor will prescribe you a lower dose (500 mg each day) during 2 weeks before giving you the lowest general dose of 1,000 mg.

Example: if your daily dose is 1,000 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 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.

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.

Duration of treatment:

• Levetiracetam Mylan is used as a chronic treatment. You should continue Levetiracetam Mylan

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 Mylan than you should

The possible side effects of an overdose of Levetiracetam Mylan 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 Mylan

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 Mylan

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

This medicine contains less than 1 mmol per tablet, that is to say ‘essentially sodium-free’.

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.

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.
• thinking about suicide or attempting suicide
• severe abdominal pain that spreads to the back, which may be signs of a swollen pancreas.

Tell your doctor straight away if you notice any of the following, as you may need medical attention.

Uncommon (may affect up to 1 in 100 people):

• increased signs of infection such as sore throat, fever, mouth ulcers, which may be caused by a reduction in white blood cells

Rare (may affect up to 1 in 1,000 people)

• signs of liver problems such as abdominal pain, fever, pale stools or dark urine, yellowing of the skin and eyes
• rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase increase. Prevalence is significantly higher in Japanese patients when compared to nonJapanese patients.

Other side effects include:

Very common: may affect more than 1 in 10 people

• nasopharyngitis (sore nose or 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 (weakness/tired­ness).

Uncommon: may affect up to 1 in 100 people

• decreased number of blood platelets, causing you to bruise or bleed more easily or for longer than usual
• 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

• decreased number of all blood cell types
• infection
• suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate)
• delirium
• encephalopathy (see sub-section “Tell your doctor immediately” for a detailed description of symptoms)
• seizures may become worse or happen more often
• uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity)
• change of the heart rhythm (Electrocardiogram)

decreased blood sodium concentration. 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 Yellow Card Scheme at or search for MHRA Yellow Card in the 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 mylan

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, bottle 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.

Bottles: Use within 3 months of opening. Once open keep bottle tightly closed.

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

What Levetiracetam Mylan looks like and contents of the pack

250 mg tablet: A white film-coated, round, biconvex, beveled-edge tablet marked with “M” above the score and “613” below the score on one side of the tablet and blank on the other side.

500 mg tablet : A white film-coated, oblong shaped, biconvex, beveled-edge tablet marked 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.

750 mg tablet: A white film-coated, oblong shaped, biconvex, beveled-edge tablet marked 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.

1000 mg tablet: A white film-coated, oblong shaped, biconvex, beveled-edge tablet marked 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.

Levetiracetam Mylan Film-coated Tablets are packed in blister packs containing 20, 30, 50, 60, 90, 100, 120 and 200 film-coated tablets and perforated unit-dose blisters of 30 × 1 and 60 × 1 film-coated tablets. Levetiracetam Mylan Film-coated Tablets are packed in bottles containing 60, 100, 120, 200 and 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

Manufacturer

McDermott Laboratories Limited t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange

Road, Dublin 13, Ireland.

Mylan Hungary Kft/Mylan Hungary Ltd., Mylan utca 1.,Komarom, 2900,Hungary (only for 500 mg and

1000 mg)

This leaflet was last revised in 08/2021.

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