Topvex 25/Topvex 50/Topvex 100 Adverse Reactions

The adverse events considered at least possibly related to the treatment are listed as follows by body system, organ class and frequency (wherever applicable). Frequencies are defined as very common (>1/10), common (>1/100, =1/10), uncommon (>1/1000, =1/100), rare (>1/10000, =1/1000), very rare (=1/10000) or frequency unknown.
Blood and lymphatic system disorders: Less frequent: Leucopenia.
Frequency unknown: Purpura. Anaemia and thrombocytopenia, alone or in combination with leucopenia. Thrombotic events have been reported although a causal association with Topiramate has not been established.
Immune system disorders: Frequency unknown: Viral infection.
Metabolism and nutritional disorders: Less frequent: Weight decrease, anorexia.
Psychiatric disorders: Frequent: Somnolence, nervousness, psychomotor slowing, difficulty with memory not otherwise specified, confusion, difficulty with concentration/attention, anorexia, depression, mood problems, personality changes, insomnia.
Less frequent: Agitation, cognitive problems not otherwise specific, emotional lability, apathy, psychosis/psychotic symptoms, hallucination, aggressive reaction/behaviour, suicidal ideas or attempts.
Nervous system disorders: Frequent: Paresthesia, ataxia, dizziness, speech disorders/related speech problems, language problems, tremor, hyperkinesias.
Co-ordination problems.
Eye disorders: Frequent: Abnormal vision, diplopia, nystagmus, acute and secondary angle closure glaucoma.
Rare: Conjunctivitis.
Ear and labyrinth disorders: Rare: Tinnitus.
Vascular disorders: Frequency unknown: Hypotension and postural hypotension.
Respiratory, thoracic and mediastinal disorders: Less frequent: Pharyngitis.
Frequency unknown: Rhinitis, pneumonia, Dyspnoea.
Gastro-intestinal disorders: Frequent: Nausea.
Less frequent: Constipation, dyspepsia, abdominal pain.
Frequency unknown: Increased saliva production.
Hepato-biliary disorders: Frequency unknown: Hepatic failure, hepatitis.
Skin and subcutaneous tissue disorders: Less frequent: Gingivitis, increased sweating.
Rare: Pruritus.
Frequency unknown: Bullous skin and mucosal reactions, including erythema multiforme, pemphigus, Stevens-Johnson syndrome and toxic epidermal necrolysis.
Renal and urinary disorders: Less frequent: Nephrolithiasis (kidney stones).
Rare: Dysuria, urinary frequency, incontinence.
Frequency unknown: Renal failure, haematuria.
General disorders and administration site conditions: Frequent: Asthenia, fatigue.
Frequency unknown: Injury.