KEPPRA 1000 mg FILM-COATED TABLETS

4. Possible side effects

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

Tell your doctor immediately, or go to the casualty department at your nearest hospital if you experience:

• weakness, dizziness or difficulty breathing, as these may be signs of a severe allergic reaction
• swelling of the face, lips, tongue or throat (Quincke’s oedema)
• symptoms of flu and rash on the face followed by a prolonged rash with high fever, elevated liver enzymes in blood tests and an increased number of a type of white blood cells (eosinophilia) and swollen lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS)
• symptoms such as low urine output, tiredness, nausea, vomiting, confusion and swelling of the feet, ankles, face, hands or fingers, as these may be signs of acute kidney injury
• a rash that may form blisters and may look like small targets (central red spot surrounded by a paler area, with a red 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 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 (drowsiness), amnesia (loss of memory), memory impairment (memory loss), abnormal behaviour, hallucinations, aggression, restlessness, depressed mood or personality disorders

The most frequently reported side effects are nasopharyngitis, somnolence (feeling drowsy), headache, fatigue and dizziness. Side effects like somnolence, fatigue and dizziness may be more frequent at the beginning of treatment or when the dose is increased. However, these effects should decrease over time.

Very common:may affect more than 1 in 10 people

• nasopharyngitis
• headache, somnolence (feeling drowsy)

Common:may affect up to 1 in 10 people

• loss of appetite (anorexia)
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability
• seizures, balance disorder, dizziness (feeling unsteady), lethargy (lack of energy and enthusiasm), tremor (shaking, usually of the hands)
• vertigo (spinning sensation)
• cough
• abdominal pain, diarrhoea, dyspepsia (indigestion, heartburn), vomiting, nausea
• skin rash
• asthenia/fatigue (feeling weak)

Uncommon:may affect up to 1 in 100 people

• decreased number of platelets, decreased number of white blood cells
• weight loss, weight gain
• suicidal ideation and attempt, mental disorders, abnormal behaviour, hallucinations, anger, confusion, panic attacks, mood swings, depression, restlessness, aggression
• amnesia (loss of memory), memory impairment (memory loss), abnormal coordination/ataxia (impaired coordination of movements), paraesthesia (tingling), attention abnormality (lack of concentration)
• diplopia (double vision), blurred vision
• abnormal liver function tests
• hair loss, eczema, pruritus (itching)
• muscle weakness, muscle pain
• injury

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

• infection
• decrease of all blood cell types
• severe allergic reactions (DRESS, anaphylactic reaction, Quincke’s oedema)
• low sodium levels in the blood
• suicide, personality disorders (behavioural problems), abnormal thinking (slow thinking, difficulty in concentrating)
• delirium
• encephalopathy (see section “Tell your doctor immediately” for a detailed description of the symptoms)
• seizures may worsen or become more frequent
• uncontrolled muscle spasms affecting the face, trunk and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity)
• abnormal heart rate (electrocardiogram)
• pancreatitis (inflammation of the pancreas)
• liver failure, hepatitis (inflammation of the liver)
• sudden decrease in kidney function
• skin rash which may form blisters and may look like small targets (central red spot surrounded by a paler area, with a red 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 increased creatine phosphokinase in the blood. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients
• limping or difficulty walking
• a combination of fever, muscle stiffness, unstable blood pressure and heart rate, confusion, low level of consciousness (these may be signs of a condition called malignant neuroleptic syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients

Reporting of side effects