Paracetamolum, Codeini phosphas hemihydricus

Medicinal product name Ultracod 500 mg + 30 mg tablets
Pharmaceutical form Tablet
Strength 500 mg/30 mg 
Information from the MAH on shortages Not notified
Legal status Rx Prescription (Pr.)
Package leafletPDF 14-09-2022 (Sep 14, 2022)
ATC code N02AJ06 Analgesics
Information for Marketing authorisation holdersView

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 N30
(500 mg/30 mg)
PVC/PVDC/Al blister 14.04  I000331-01 Outer Outer May 27, 2019
Outer Outer Nov 16, 2018
Inner Inner Nov 16, 2018

Registration information

Authorisations for distribution of parallel imported medicines no. I000331
Authorisation for distribution of parallel imported medicines revoked Dec 20, 2022
Permitted to distribute until Jun 20, 2023
Marketing authorisation holder, country Zentiva, k.s., Czech Republic
Parallel importer, country Sabiedrība ar ierobežotu atbildību “ELPIS”, Latvia
Country of medicines exporter Poland