Levetiracetam 500 mg 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 Milpharm is and what it is used for
2. What you need to know before you take Levetiracetam Milpharm
3. How to take Levetiracetam Milpharm
4. Possible side effects
5. How to store Levetiracetam Milpharm
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 or pharmacist before taking Levetiracetam Milpharm:

• 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 Milpharm 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 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.

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 Milpharm, see a doctor as soon as possible.

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

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 as this may results 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 Milpharm 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.

Levetiracetam Milpharm 750 mg contains Sunset Yellow FCF (E110). It may cause allergic reactions.

Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more:

Recommended dose: between 1000 mg and 3,000 mg each day.

When you will first start taking Levetiracetam Milpharm, 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 1000 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 1000 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 Milpharm 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 Milpharm according to the age, weight and dose.

Levetiracetam Milpharm 100 mg/ml oral solution 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 50kg and when tablets don’t allow accurate dosage.

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

You may take Levetiracetam Milpharm with or without food. After oral administration the bitter taste of levetiracetam may be experienced.

• Levetiracetam Milpharm is used as a chronic treatment. You should continue Levetiracetam Milpharm 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 Milpharm 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, Levetiracetam Milpharm should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Levetiracetam Milpharm treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam Milpharm.

• 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), 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 a liver function test;
• 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 10000 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

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. Each film-coated tablet contains 250 mg/ 500 mg/ 750 mg/ 1000 mg levetiracetam.

The other ingredients are:

Tablet core: Maize starch, Silica colloidal anhydrous (E551), Povidone (K-30) (E1201), Talc (E553b), Magnesium stearate (E470b).

Film-coating:

250 mg: Hypromellose 3cp & 6cp (E464), titanium dioxide (E 171), macrogol 4000, indigo carmine aluminium lake (E132).

500 mg: Hypromellose 3cp & 6cp (E464), titanium Dioxide (E 171), macrogol 4000, iron oxide yellow (E172).

750 mg: Hypromellose 3cp & 6cp (E464), titanium Dioxide (E 171), macrogol 4000, indigo carmine aluminium lake (E132), sunset yellow aluminium lake (E110), iron oxide red. (E172)

1000 mg: Hypromellose 5 cp (E464), titanium dioxide (E 171), macrogol 400.

Film-coated tablet.

Levetiracetam Milpharm 250 mg film-coated tablets

Blue oval shaped biconvex film-coated tablets debossed with a deep break line separating ‘E’ and ‘10’ on one side and plain on the other side. The tablet can be divided into equal doses.

Levetiracetam Milpharm 500 mg film-coated tablets

Yellow oval shaped biconvex film-coated tablets debossed with a deep break line separating ‘E’ and ‘11’ on one side and plain on the other side. The tablet can be divided into equal doses.

Levetiracetam Milpharm 750 mg film-coated tablets

Orange oval shaped biconvex film-coated tablets debossed with a deep break line separating ‘E’ and ‘12’ on one side and plain on the other side. The tablet can be divided into equal doses.

Levetiracetam Milpharm 1000 mg film-coated tablets

White modified oval shaped, biconvex film-coated tablets debossed with a deep break line separating ‘E’ and ‘13’ on one side and plain on the other side. The tablet can be divided into equal doses.

Levetiracetam Milpharm film-coated tablets are packaged in blister pack or HDPE bottle.

Pack sizes:

Blister pack: 20, 30, 50, 60, 100, 200 and 500 film-coated tablets

Bottle pack: 30, 100, 200 and 500 film-coated tablets

Not all pack sizes may be marketed.

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