Type IB application has been approved for Peyona:

• Update from ml to mL (section 1, 2, 4.2, 4.9, 6.5, 6.6)
• Inclusion of the sodium content statement (section 4.4 of the SmPC)
  • 4.4     Special warnings and precautions for use

The following statement  has been added

• Sodium content
• ​This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free’
• Update to the relevant PV reporting details for UK + IE in line with EU guidance (section 4.8)
• Update to date of revision of text from Nov 2018 to Oct 2020 (section 10

Changed from 09/2017 to November 2018

Information on the safe use of Peyona (caffeine citrate) 20mg/ml solution for infusion and oral solution

Peyona (caffeine citrate) 20 mg/ml Solution for Infusion and Oral Solution Laminated Card

A Type IA Variation was submitted to change the name of product manufacturer & batch release site registered on the licence.

10.     DATE OF REVISION OF THE TEXT  February 2015 changed to August 2017

Section 4.2 – Hepatic and renal impairment – The safety of caffeine citrate in patients with renal impairment has not been established – has been removed

Section 4.4 – Renal and hepatic impairment - In a post-authorisation safety study, the frequency of adverse reactions in a small number of very premature infants with renal/hepatic impairment appeared to be higher as compared to premature infants without organ impairment – has been added

(see sections 4.2,4.8 and 5.2) has been amended to add 4.8

Section 4.8 – and - had been removed

Convulsion, arrhythmia, metabolism and nutrition disorders such as hyperglycaemia, and obtained from a post-authorisation safety study – has been added

Changes to the side effects table include – Hyperglycaemia , common

Hyperglycaemia changed to Hypoglycaemia

Convulsion, Uncommon

Convulsion removed from frequency unknown

Tachycardia , common

Arrhythmia, Uncommon

Tachycardia also associated with – removed

New section added - Other special populations

In a post-authorisation safety study on 506 preterm infants treated with Peyona, safety data have been collected in 31 very premature infants with renal/hepatic impairment. Adverse reactions appeared to be more frequent in this subgroup with organ impairment than in other observed infants without organ impairment. Cardiac disorders (tachycardia, including one single case of arrhythmia) were mostly reported.

Section - Reporting of suspected adverse reactions

the national reporting system listed in Appendix V has been replaced by UK: Yellow Card Scheme at www.mhra.gov.uk/yellowcard .

ROI: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax:

+353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie

Section 6.5 – Nature and contents of container - Type I clear glass 3 ml ampoule – removed

Section 8 – Marketing Authorisation Number(s) - 1 ml ampoules EU/1/09/528/001 3 ml ampoules – removed

Section 10 -  Date of revision of the Text – February 2015