LEVETIRACETAM BROWN & BURK 500 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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.

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.

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 national reporting system, Yellow Card Scheme, Website: 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.

6. contents of the pack and other information

The active substance is levetiracetam. Each film-coated tablet contains 250 mg levetiracetam.

Each film-coated tablet contains 500 mg levetiracetam.

Each film-coated tablet contains 750 mg levetiracetam.

Each film-coated tablet contains 1000 mg levetiracetam.

The other ingredients are:

Tablet core: Maize starch, croscarmellose sodium, povidone (K-30) and magnesium stearate.

Tablet-coating:

For 250 mg film-coated tablets:

Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b) and indigo carmine AL (E132).

For 500 mg film-coated tablets:

Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b) and iron oxide yellow (E172).

For 750 mg film-coated tablets:

Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), iron oxide yellow (E172) and iron oxide red (E172).

For 1000 mg film-coated tablets:

Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521) and talc (E553b).

Light blue colored, oval shaped, biconvex, film coated tablets debossed with ‚ML‘ and ‚250‘ on either side of the breakline on one face and other face plain with approximate length of 12.90 mm and width 6.10 mm. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Light yellow to yellow colored, oval shaped, biconvex, film coated tablets debossed with ‚ML‘ and ‚500‘ on either side of the breakline on one face and other face plain with approximate length of 16.50 mm and width 7.80 mm.

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

Light orange colored, oval shaped, biconvex, film coated tablets debossed with ‘ML’ and ‘750’ on either side of the breakline on one face and other face plain with approximate length of 18.60 mm and width 8.70 mm.

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

White to off-white colored, oval shaped, biconvex, film coated tablets debossed with ‚ML‘ and ‚1000‘ on either side of the breakline on one face and other face plain with approximate length of 19.10 mm and width 10.20 mm.

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

Levetiracetam Brown & Burk film-coated tablets are packaged in blister pack.

Pack sizes:

Blister pack: 5, 10, 14, 15, 20, 28, 30, 50, 56, 60, 80, 90, 98, 100, 120, 150, 160, 180, 200 and 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Brown & Burk UK Ltd

5 Marryat Close Hounslow West Middlesex TW4 5DQ United Kingdom

This leaflet was last revised in 04/2021.

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