Pregabalin Zentiva 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg capsules hard *
Pharmacy Only: Prescription

  • Company:

    Zentiva Pharma UK Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

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

Updated on 17 May 2022

File name

6283e3548daae.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to side-effects

Updated on 17 May 2022

File name

6283e2a6a1dad.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Text added to section 4.4

Women of childbearing potential/Contraception

Pregabalin Zentiva use in the first‑trimester of pregnancy may cause major birth defects in the unborn child. Pregabalin should not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus. Women of childbearing potential have to use effective contraception during treatment (see section 4.6).


Severe cutaneous adverse reactions

Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported rarely in association with pregabalin treatment. At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, pregabalin should be withdrawn immediately and an alternative treatment considered (as appropriate).

Text added to section 4.6

Pregabalin has been shown to cross the placenta in rats (see section 5.2). Pregabalin may cross the human placenta.


Major congenital malformations

Data from a Nordic observational study of more than 2 700 pregnancies exposed to pregabalin in the first trimester showed a higher prevalence of major congenital malformations (MCM) among the paediatric population (live or stillborn) exposed to pregabalin compared to the unexposed population (5.9% vs. 4.1%).


The risk of MCM among the paediatric population exposed to pregabalin in the first trimester was slightly higher compared to unexposed population (adjusted prevalence ratio and 95% confidence interval: 1.14 (0.96-1.35)), and compared to population exposed to lamotrigine (1.29 (1.01–1.65)) or to duloxetine (1.39 (1.07–1.82)).


The analyses on specific malformations showed higher risks of malformations of the nervous system, the eye, orofacial clefts, urinary malformations and genital malformations, but numbers were small and estimates imprecise.


toxic epidermal necrolysis added under rare side effect

Updated on 11 February 2022

File name

1.3.1 SPC combined clean_1644576625.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 10 February 2022

File name

67866 PIL_Pregabalin_GB (2)_1644532118.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 18 January 2022

File name

1.3.1-PIL combined clean_1642505883.pdf

Reasons for updating

  • Change to section 6 - what the product contains

Updated on 18 January 2022

File name

1.3.1 SPC combined clean_1642505558.pdf

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change of ink composition in section 6.1

Updated on 30 September 2021

File name

66801 PIL_Pregabalin_GB (5)-14-09-21_1633013771.pdf

Reasons for updating

  • New PIL for new product

Updated on 30 September 2021

File name

1.3.1 SPC combined clean_1633013522.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)