GABAPENTIN ROSEMONT

The adverse reactions observed during clinical studies conducted in epilepsy (adjunctive and monotherapy) and neuropathic pain have been provided in a single list below by class and frequency (very common (≥1/10); common (≥1/100 to< 1/10); uncommon (≥1/1000 to < 1/100); rare (≥1/10000 to < 1/1000); very rare (< 1/10000). Where an adverse reaction was seen at different frequencies in clinical studies, it was assigned to the highest frequency reported.

Additional reactions reported from post-marketing experience are included as frequency Not known (cannot be estimated from the available data) in italics in the list below.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Under treatment with gabapentin cases of acute pancreatitis were reported. Causality with gabapentin is unclear (see section 4.4).

In patients on haemodialysis due to end-stage renal failure, myopathy with elevated creatine kinase levels has been reported.

Respiratory tract infections, otitis media, convulsions and bronchitis were reported only in clinical studies in children. Additionally, in clinical studies in children, aggressive behaviour and hyperkinesias were reported commonly.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting systems.

Ireland
HPRA Pharmacovigilance
Earlsfort Terrace

Dublin 2
IRL
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: http://www.hpra.ie/
e-mail: medsafety@hpra.ie

The adverse reactions observed during clinical studies conducted in epilepsy (adjunctive and monotherapy) and neuropathic pain have been provided in a single list below by class and frequency (very common (≥1/10); common (≥1/100 to< 1/10); uncommon (≥1/1000 to < 1/100); rare (≥1/10000 to < 1/1000); very rare (< 1/10000). Where an adverse reaction was seen at different frequencies in clinical studies, it was assigned to the highest frequency reported.

Additional reactions reported from post-marketing experience are included as frequency Not known (cannot be estimated from the available data) in italics in the list below.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Body System	Adverse drug reactions
Infections and infestations
Very Common	Viral infection
Common	Pneumonia, respiratory infection, urinary tract infection, infection, otitis media
Blood and the lymphatic system disorders
Common	leucopenia
Not known	thrombocytopenia
Immune system disorders
Uncommon	allergic reactions (e.g. urticaria)
Not known	hypersensitivity syndrome, a systemic reaction with a variable presentation that can include fever, rash, hepatitis, lymphadenopathy, eosinophilia, and sometimes other signs and symptoms, anaphylaxis (see section 4.4)
Metabolism and Nutrition Disorders
Common	anorexia, increased appetite
Uncommon	hyperglycemia (most often observed in patients with diabetes)
Rare	hypoglycemia (most often observed in patients with diabetes)
Not known	hyponatremia
Psychiatric disorders
Common	hostility, confusion and emotional lability, depression, anxiety, nervousness, thinking abnormal
Uncommon	agitation
Not known	hallucinations
Nervous system disorders
Very Common	somnolence, dizziness, ataxia
Common	convulsions, hyperkinesias, dysarthria, amnesia, tremor, insomnia, headache, sensations such as paresthesia, hypaesthesia, coordination abnormal, nystagmus, increased, decreased, or absent reflexes
Uncommon	hypokinesia, mental impairment
Rare	loss of consciousness
Not known	other movement disorders (e.g. choreoathetosis, dyskinesia, dystonia)
Eye disorders
Common	visual disturbances such as amblyopia, diplopia
Ear and Labyrinth disorders
Common	vertigo
Not known	tinnitus
Cardiac disorders
Uncommon	palpitations
Vascular disorders
Common	hypertension, vasodilatation
Respiratory, thoracic and mediastinal disorders
Common	dyspnoea, bronchitis, pharyngitis, cough, rhinitis
Rare	respiratory depression
Gastrointestinal disorders
Common	vomiting, nausea, dental abnormalities, gingivitis, diarrhoea, abdominal pain, dyspepsia, constipation, dry mouth or throat, flatulence
Not known	pancreatitis
Hepatobiliary disorders
Not known	hepatitis, jaundice
Skin and subcutaneous tissue disorders
Common	facial oedema, purpura most often described as bruises resulting from physical trauma, rash, pruritus, acne
Not known	Stevens-Johnson syndrome, angioedema, erythema multiforme, alopecia, drug rash with eosinophilia and systemic symptoms (see section 4.4)
Musculoskeletal and connective tissue disorders
Common	arthralgia, myalgia, back pain, twitching
Not known	rhabdomyolysis, myoclonus
Renal and urinary disorder
Not known	acute renal failure, incontinence
Reproductive system and breast disorders
Common	impotence
Not known	breast hypertrophy, gynaecomastia, sexual dysfunction (including changes in libido, ejaculation disorders and anorgasmia)
General disorders and administration site conditions
Very Common	fatigue, fever
Common	peripheral oedema, abnormal gait, asthenia, pain, malaise, flu syndrome
Uncommon	generalized oedema
Not known	withdrawal reactions (mostly anxiety, insomnia, nausea, pains, sweating), chest pain. Sudden unexplained deaths have been reported where a causal relationship to treatment with gabapentin has not been established.
Investigations
Common	WBC (white blood cell count) decreased, weight gain
Uncommon	elevated liver function tests SGOT (AST), SGPT (<?xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /><st1:stockticker w:st="on">ALT</st1:stockticker>) and bilirubin
Not known	blood glucose fluctuations in patients with diabetes, blood creatine phosphokinase increased
Injury, poisoning and procedural complications
Common	accidental injury, fracture, abrasion
Uncommon	fall

Under treatment with gabapentin cases of acute pancreatitis were reported. Causality with gabapentin is unclear (see section 4.4).

In patients on haemodialysis due to end-stage renal failure, myopathy with elevated creatine kinase levels has been reported. Respiratory tract infections, otitis media, convulsions and bronchitis were reported only in clinical studies in children. Additionally, in clinical studies in children, aggressive behaviour and hyperkinesias were reported commonly.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting systems.

Ireland
HPRA Pharmacovigilance
Earlsfort Terrace

Dublin 2
IRL
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: http://www.hpra.ie/
e-mail: medsafety@hpra.ie