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PREGABALIN safety information

No increased incidence pregabalin of tumours was observed in rats at exposures (plasma AUC) up to 25 times the expected Version: pfplyric10113 Supersedes: pfplyric10611 human exposure at the maximum recommended clinical dose of 600 mg/day .
In mice, no increased incidence of tumours was found at exposures similar to the expected maximum human exposure, but an increased incidence of haemangiosarcoma was observed at exposures 6 to 33 pregabalin times the expected maximum human exposure .
The precise non-genotoxic mechanism of pregabalin-induced tumour pregabalin formation is not fully characterised .
However, available data show that platelet changes associated with the formation of this tumour in mice are not seen in rats, monkeys pregabalin or humans .
Although long-term data in humans are limited, these findings in lyrica side effects constipation pregabalin qtc prolongation pregabalin urinary frequency lyrical mice are thought not to pose a risk Effects on Ability to Drive and Use Machines Pregabalin may cause dizziness and somnolence and therefore may have an influence on the ability to drive or use machines .
Patients are advised not to drive, operate complex machinery or engage in other potentially hazardous activities until it is known whether this medication affects their ability to perform these pregabalin activities .
INTERACTIONS WITH OTHER MEDICINES Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (<2% of a pregabalin dose recovered in urine as metabolites), does not inhibit drug metabolism in vitro, and is not bound to plasma proteins, pregabalin is unlikely to produce, or be subject to, pharmacokinetic interactions .
Accordingly, in in vivo studies no clinically relevant pharmacokinetic interactions were observed between pregabalin and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, pregabalin lorazepam, oxycodone or ethanol .

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