GABIX Capsule

In patients with known hypersensitivity to gabapentin or any of the components of the product.

Neuropathic Pain

Common: Dizziness, somnolence

Less common: Diarrhoea, dry mouth, peripheral edema, weight gain, abnormal gait, amnesia, ataxia, abnormal thinking, rash and amblyopia.

Rare: Accidental injury, asthenia, back pain, constipation, flatulence, nausea, confusion, hyperesthesia, vertigo, dyspnea and pharyngitis.

Epilepsy (Adults) Common: Dizziness, somnolence.

Less common: Ataxia, fatigue, nystagmus, tremor, diplopia, amblyopia, abnormal vision, dysarthria, amnesia, asthenia, paraesthesia, arthralgia, purpura, dyspepsia, anxiety, weight increase, urinary tract infection and pharyngitis.

Uncommon: Leucopenia, nervousness, rhinitis and male sexual dysfunction (impotence).

Rare: Urinary incontinence, pancreatitis, elevated liver function tests, erythema multiforme and Stevens Johnson Syndrome, confusion, depression, emotional lability, hostility, abnormal thinking and psychoses/hallucinations, blood glucose fluctuations in patients with diabetes, myalgia, headache, nausea and/or vomiting.

Epilepsy (Children 3-12 years)

Common: Emotional lability, nervousness and thinking abnormally. All reports of these events were rated as mild or moderate and discontinuation or dose reduction was infrequent.

Uncommon: Somnolence, fatigue, weight increase, hostility, emotional lability, dizziness, hyperkinesia, nausea/vomiting, viral infection, fever, bronchitis, respiratory infection.

Adverse events associated with both epilepsy and neuropathic pain include: acute kidney failure, allergic reaction including urticaria, alopecia, angioedema, chest pain, hepatitis, jaundice, movement disorders such as choreoathetosis, dyskinesia and dystonia, palpitation, thrombocytopenia, and tinnitus.

Adverse events following the abrupt discontinuation of gabapentin have also been reported. The most frequently reported events are anxiety, insomnia, nausea, pain and sweating.

Please see the package insert about the details.

- Naproxen

- Hydrocodone

- Morphine

- Phenytoin, Valproic acid, Carbamazepine or Phenobarbitone

- Antacid

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Gabapentin should be used during pregnancy only the potential benefit justifies the potential risk to the fetus.

Nursing Mother

Gabapentin is secreted into breast milk following oral administration. The effect on the nursing infant is unknown. Therefore, gabapentin should be used in nursing women only if the potential benefits clearly outweigh the risks.

- Gabapentin should not be abruptly discontinued because of the possibility of increasing seizure frequency.

- Caution is recommended in patients with a history of psychotic illness.

- Gabapentin should not be considered a treatment of absence seizures and may exacerbate these seizures in some patients. Consequently, gabapentin should be used with caution in patients who have mixed seizure disorders that include absence seizures.

- Patients should be advised neither to drive a car nor to operate complex machinery until they have gained sufficient experience on gabapentin.

- Suicidal ideation and behavior have been reported in patients treated with anti-epileptic agents in several indications. Therefore, patients should be monitored for signs of suicidal ideation and behaviors and appropriate treatment should be considered.

Gabapentin is structurally related to the neurotransmitter gamma-amino butyric acid (GABA) but is mechanism of action is different from that of several drugs that interact with GABA synapses. Gabapentin has proven affinity for special site in brain tissues such as neocortex and hippocampus. Though exact mechanism of its CNS depressant and anticonvulsant activity is not fully understood.