Paracetamolum, Codeini phosphas hemihydricus

Medicinal product name Co-Codamol 500 mg/8 mg tablets
Pharmaceutical form Tablet
Strength 500 mg/8 mg 
Information from the MAH on shortages No information on expected shortages
Legal status OTC OTC
Package leaflet MS Word document 18-07-2019
Summary of product characteristics MS Word document 18-07-2019
ATC code N02AJ06 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.
Codeini phosphas hemihydricusDAvoid use in older persons. Opioid. Sedative. Prodrug. Genotype affects the response. Significant adverse effects include constipation, nausea, urinary difficulties and gallbladder problems. Increases risk of falling. Take interactions into account.

Medicinal products (1)

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 N20
(500 mg/8 mg)
PVC blister 4.70  00-0255-01 Labelling text Labelling text Aug 1, 2019

Registration information

Marketing authorisation No. 00-0255
Date of authorisation Mar 15, 2000
MA valid until For unlimited time
Marketing authorisation holder, country Actavis Group PTC ehf., Iceland