Nervica 25/Nervica 75/Nervica 150 Adverse Reactions

The most commonly reported adverse reactions were dizziness and somnolence. Adverse reactions were usually mild to moderate in intensity. In all controlled studies, the discontinuation rate due to adverse reactions was 12% for patients receiving Pregabalin and 5% for patients receiving placebo. The most common adverse reactions resulting in discontinuation from Pregabalin treatment groups were dizziness and somnolence.
All adverse reactions, which occurred at an incidence greater than placebo and in more than one patient, are listed 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), not known (cannot be estimated from the available data).
Additional reactions reported from postmarketing experience are included in italics in the list as follows. (See Table 2.)

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After discontinuation of short-term and long-term treatment with Pregabalin withdrawal symptoms have been observed in some patients. The following reactions have been mentioned: insomnia, headache, nausea, anxiety, diarrhea, flu syndrome, convulsions, nervousness, depression, pain, hyperhidrosis and dizziness, suggestive of physical dependence. The patient should be informed about this at the start of the treatment.
Concerning discontinuation of long-term treatment of Pregabalin, data suggest that the incidence and severity of withdrawal symptoms may be dose-related.
Pediatric population: The Pregabalin safety profile observed in three pediatric studies in patients with partial seizures with or without secondary generalization (12-week efficacy and safety study in patients with partial onset seizures, n=295; pharmacokinetic and tolerability study, n=65; and 1 year open label follow on safety study, n=54) was similar to that observed in the adult studies of patients with epilepsy. The most common adverse events observed in the 12-week study with Pregabalin treatment were somnolence, pyrexia, upper respiratory tract infection, increased appetite, weight increased, and nasopharyngitis.
Seek medical attention immediately at the first sign of any adverse drug reaction.