Levetiracetam Zentiva 250mg Film-Coated Tablets

• 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.

1. What Levetiracetam is and what it is used for
2. What you need to know before you take Levetiracetam
3. How to take Levetiracetam
4. Possible side effects
5. How to store Levetiracetam
6. Contents of the pack and other information

• if you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6).

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.
• 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 usual, 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. In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations) that causes multiple types of seizures and loss of skills you may notice that the seizures remain present or are becoming worse during your treatment.

If you experience any of these new symptoms while taking Levetiracetam, see a doctor as soon as possible.

• Levetiracetam is not indicated in children and adolescents below 16 years on its own (monotherapy).

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 a laxative) for one hour before and one hour after taking levetiracetam as this may result in a loss of its effect.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist 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.

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.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

• Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more
  Recommended dose: 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 daily dose.
  Example: if your daily dose is intended to be 1 000 mg, your reduced starting dose is 1 tablet of 250 mg in the morning and 1 tablet of 250 mg in the evening, and the dose will be gradually incremented to reach 1 000 mg daily after 2 weeks.
• Adolescents (12 to 17 years) weighing 50 kg or less
  Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam according to weight and dose.
• Dose in infants (1 month to 23 months) and children (2 to 11 years) weighing less than 50 kg
  Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam according to the age, weight and dose.

Oral solution is a formulation more appropriate for infants and children under the age of 6 years and for children and adolescents (from 6 to 17 years) weighing less than 50 kg and when tablets don’t allow accurate dosage.

Swallow Levetiracetam tablets with a sufficient quantity of liquid (e.g. a glass of water).

You may take levetiracetam with or without food. You may feel a bitter taste of Levetiracetam after oral use.

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

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.

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.

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 stopping treatment, as with other antiepileptic medicines, levetiracetam should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your levetiracetam treatment, he/she will instruct you about the gradual withdrawal of levetiracetam.

• 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 and the involvement of other body organs (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.

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 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):

• 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 liver function tests
• hair loss, eczema, pruritus
• muscle weakness, myalgia (muscle pain)
• injury

Rare (may affect up to 1 in 1 000 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
• 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)
• 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
• limp or difficulty walking
• combination of fever, muscle stiffness, unstable blood pressure and heart rate, confusion, low level of consciousness (may be signs of a disorder called neuroleptic malignant syndrome). Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.

Very rare: may affect up to 1 in 10 000 people

• repeated unwanted thoughts or sensations or the urge to do something over and over again (Obsessive Compulsive Disorder).

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: www.mhra.gov.uk/yellowcard 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.

The active substance is levetiracetam.

Levetiracetam Zentiva 250 mg: each film-coated tablet contains 250 mg levetiracetam.

Levetiracetam Zentiva 500 mg: each film-coated tablet contains 500 mg levetiracetam.

Levetiracetam Zentiva 750 mg: each film-coated tablet contains 750 mg levetiracetam.

Levetiracetam Zentiva 1 000 mg: each film-coated tablet contains 1 000 mg levetiracetam.

The other ingredients are:

Tablet core: povidone 30, croscarmellose sodium, silica, colloidal anhydrous, sodium stearyl fumarate.

Tablet coating: hypromellose 2910/5, macrogol 6000, talc, titanium dioxide (E-171), simeticone emulsion (water, purified 67.4 %, simeticone 30.0 %, methylcellulose 2.5 %, sorbic acid 0.1 %).

Levetiracetam Zentiva 250 mg also contains indigo carmine aluminium lake (E-132).

Levetiracetam Zentiva 500 mg also contains iron oxide yellow (E-172).

Levetiracetam Zentiva 750 mg also contains iron oxide red (E-172), iron oxide yellow (E-172).

Levetiracetam Zentiva 250 mg: blue oblong film-coated tablet, with length approx.

12.6 mm and width approx. 6.1 mm, scored on both sides.

Levetiracetam Zentiva 500 mg: yellow oblong film-coated tablet, with length approx.

16.1 mm and width approx. 7.6 mm, scored on both sides.

Levetiracetam Zentiva 750 mg: orange oblong film-coated tablet, with length approx.

18.6 mm and width approx. 8.6 mm, scored on both sides.

Levetiracetam Zentiva 1 000 mg: white to off-white oblong, film-coated tablet, with length approx. 19.1 mm and width approx. 10.1 mm, scored on both sides.

Levetiracetam Zentiva 250 mg, 500 mg, 750 mg, 1 000 mg are packed in PVC/Alu blisters with 20, 30, 60, 100 or 200 tablets.

It means 2, 3, 6, 10, 20 blisters, each containing 10 tablets in one folding box.

Levetiracetam Zentiva 250 mg and 500 mg are packed in a HDPE bottle with a PE cap with a safety lock insert with 100 or 200 tablets.

Levetiracetam Zentiva 750 mg and 1 000 mg are packed in a HDPE bottle with PE cap with a safety lock insert with 100 tablets or in PET bottle with PP cap with 200 tablets.

Not all pack sizes may be marketed.