Pregabalin Zentiva 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg capsules hard
*Company:
Zentiva Pharma UK LimitedStatus:
No Recent UpdateLegal 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 29 May 2024
File name
72006 PIL_Pregabalin_IE-prague.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 29 May 2024
File name
1.3.1 SPC combined clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Section 4.4
Withdrawal symptoms
After discontinuation of short-term and long-term treatment with pregabalin withdrawal symptoms have been observed. The following symptoms have been reported: insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, suicidal ideation, pain, convulsion, hyperhidrosis and dizziness. The occurrence of withdrawal symptoms following discontinuation of pregabalin may indicate drug dependence (see section 4.8). The patient should be informed about this at the start of the treatment. If pregabalin should be discontinued, it is recommended this should be done gradually over a minimum of 1 week independent of the indication (see section 4.2).
Section 4.8
After discontinuation of short-term and long-term treatment with pregabalin withdrawal symptoms have been observed. The following symptoms have been reported: insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, convulsions, nervousness, depression, suicidal ideation, pain, hyperhidrosis and dizziness. These symptoms may indicate drug dependence. The patient should be informed about this at the start of the treatment.
Updated on 13 February 2023
File name
70129 PIL_Pregabalin_GB-IE (1)-Prague.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
Free text change information supplied by the pharmaceutical company
Change to storage conditions
Updated on 13 February 2023
File name
1.3.1 SPC combined clean.pdf
Reasons for updating
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to storage conditions in section 6.4
Updated on 17 May 2022
File name
1.3.1-PIL combined clean.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
1.3.1 SPC combined clean.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.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).pdf
Reasons for updating
- Improved presentation of PIL
Updated on 18 January 2022
File name
1.3.1-PIL combined clean.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.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.pdf
Reasons for updating
- New PIL for new product
Updated on 30 September 2021
File name
1.3.1 SPC combined clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)