Adverse reactions : תופעות לוואי

4.8    Undesirable effects

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 (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000). 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.

System organ           Adverse drug reactions class
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               hyperglycaemia (most often observed in patients with diabetes) 
Rare                 hypoglycaemia (most often observed in patients with diabetes) Not known            hyponatraemia
Psychiatric disorders
Common              hostility, confusion and emotional lability, depression, anxiety, nervousness, thinking abnormal
Uncommon             agitation
Not known            suicidal ideation, 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
Uncommon             dysphagia
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 (ALT) and bilirubin Not known             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.

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.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form

http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic @moh.gov.il