Pregabalin Zentiva k.s. 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg hard capsules *

  • Company:

    Zentiva Pharma UK Limited
  • Status:

    No Recent Update
  • Legal Category:

    Supply through pharmacy only
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 16 February 2021

File name

SPC clean_1613508271.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_1613507985.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 22 September 2020

File name

Pregabalin_1600771777.pdf

Reasons for updating

  • New PIL for new product

Updated on 22 September 2020

File name

Pregabalin SPC_1600771647.pdf

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section