Pregabalin Zentiva k.s. 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg hard capsules
*Company:
Zentiva Pharma UK LimitedStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 10 February 2022
File name
PIL combined-clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 04 February 2022
File name
SPC clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Supply through pharmacy only
Updated on 16 February 2021
File name
SPC clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Update to text in 5.1
Paediatric population
The efficacy and safety of pregabalin as adjunctive treatment for epilepsy in paediatric patients below the age of 12 and adolescents has not been established. The adverse events observed in a pharmacokinetic and tolerability study that enrolled patients from 3 months to 16 years of age (n = 65) with partial onset seizures were similar to those observed in adults. Results of a 12-week placebo controlled study of 295 paediatric patients aged 4 to 16 years and a 14-day placebo-controlled study of 175 paediatric patients aged 1 month to younger than 4 years of age performed to evaluate the efficacy and safety of pregabalin as adjunctive therapy for the treatment of partial onset seizures and two 1 year open label safety studies in 54 and 431 paediatric patients respectively, from 3 months to 16 years of age with epilepsy indicate that the adverse events of pyrexia and upper respiratory infections were observed more frequently than in adult studies of patients with epilepsy (see sections 4.2, 4.8 and 5.2).
Update to table in 4.8
Not known - respiratory depression
Updated on 16 February 2021
File name
PIL combined - clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 22 September 2020
File name
Pregabalin.pdf
Reasons for updating
- New PIL for new product
Updated on 22 September 2020
File name
Pregabalin SPC.pdf
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
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