Paracetamolum, Coffeinum, Phenylephrini hydrochloridum

Medicinal product name Febrisan 500 mg/25 mg/5 mg film-coated tablets
Pharmaceutical form Film-coated tablet
Strength 500 mg/25 mg/5 mg 
Information from the MAH on shortages No information on expected shortages
Legal status OTC OTC
Package leaflet MS Word document 18-02-2021
Summary of product characteristics MS Word document 18-02-2021
ATC code N02BE51 Analgesics

Important notice

Additional information regarding the use for persons aged 75+

If used as "ANALGESICS"
SubstanceClassComment
ParacetamolumASuitable for older persons. Maximum dose in regular use 2-3 g/day. Note paracetamol in OTC drugs and combination products. Overdose is hepatotoxic. Concurrent use with warfarin is possible if INR values are monitored.
CoffeinumASuitable for older persons.
Phenylephrini hydrochloridum No data on active substance.

Medicinal products (2)

Availability of medicinal product Wholesalers Package size, content Primary packaging Maximum admissible pharmacy price (€ incl. VAT) Product No. Labelling
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N12
(1 UD)
PVC/PVDC/Al blister    11-0019-01 Labelling text Labelling text Feb 4, 2016
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N24
(1 UD)
PVC/PVDC/Al blister 6.52  11-0019-02 Labelling text Labelling text Feb 4, 2016

Registration information

Marketing authorisation No. 11-0019
Date of authorisation Feb 1, 2011
MA valid until For unlimited time
Marketing authorisation holder, country Takeda GmbH, Germany