Paracetamol/codeine Accord – Medicinal Product Register of Latvia

Paracetamolum, Codeini phosphas hemihydricus

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Medicinal product name	Paracetamol/codeine Accord 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 leaflet	25-05-2023
Summary of product characteristics	25-05-2023
ATC code	N02AJ06 – Analgesics
Information for Marketing authorisation holders	View

Product information leaflet and summary of product characteristics in MS Word format.

Package leaflet	25-05-2023
Summary of product characteristics	25-05-2023

Important notice

Additional information regarding the use for persons aged 75+

If used as "ANALGESICS"
Substance	Class	Comment
Paracetamolum	A	Suitable for older adults. Maximum dose in regular use 2–3 grams per day. Consider paracetamol in OTC drugs and combination products. Overdose is hepatotoxic. Concurrent use of over 2 grams with warfarin is possible only if INR values are monitored.
Codeini phosphas hemihydricus	D	Avoid use in older adults. Sedative. Prodrug. Genotype affects the response. Increases the risk of confusion and falling. Start a laxative to prevent constipation. Consider potential interactions.

Medicinal products (7)

Display only medicinal products with a declared price

Display only medicinal products available in wholesalers' stock

Availability of medicinal product	Wholesalers	Package size, content	Primary packaging	Product No.	Labelling
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N10 (500 mg/30 mg)	PVC/Al/paper blister	23-0100-01	Labelling text May 25, 2023 Labelling text May 25, 2023
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N16 (500 mg/30 mg)	PVC/Al/paper blister	23-0100-02	Labelling text May 25, 2023 Labelling text May 25, 2023
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N20 (500 mg/30 mg)	PVC/Al/paper blister	23-0100-03	Labelling text May 25, 2023 Labelling text May 25, 2023
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N30 (500 mg/30 mg)	PVC/Al/paper blister	23-0100-04	Labelling text May 25, 2023 Labelling text May 25, 2023
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N50 (500 mg/30 mg)	PVC/Al/paper blister	23-0100-05	Labelling text May 25, 2023 Labelling text May 25, 2023
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N90 (500 mg/30 mg)	PVC/Al/paper blister	23-0100-06	Labelling text May 25, 2023 Labelling text May 25, 2023
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N100 (500 mg/30 mg)	PVC/Al/paper blister	23-0100-07	Labelling text May 25, 2023 Labelling text May 25, 2023

Registration information

Marketing authorisation No.	23-0100
Date of authorisation	May 30, 2023
Marketing authorisation holder, country	Accord Healthcare B.V., Netherlands

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Icon explanation

– Medicine is available
– Medicine is not available
– Distribution permitted for a limited time span
– Without a prescription
– Prescription medicine

– Medicine is listed on the Latvian National Health Service (NHS) list of state reimbursed medicines. (source of the information – the NHS)
– Reference medicine on the NHS List of state reimbursed medicines
– Lowest cost medicine within its therapeutic effectiveness class in cases where no reference medicine is available
- – Next lowest cost medicine after or (in ascending order)

Class A A (green): Suitable for the older persons. The medicinal substance can be used as in younger patients. Changes due to aging do not affect the dose or frequency of administration, and the adverse reaction profile is not different from that of younger patients.

Class B B (grey): There is little research evidence, practical experience or efficacy in older persons.

Class C C (yellow): Suitable for older persons, with specific cautions. The medicinal substance can be used by older persons, but the dose might either have to be reduced, or the frequency of administration decreased due to mild or moderate renal insufficiency or a significant risk of interactions or adverse reactions.

Class D D (red): Avoid use in older persons. Use is possible only in exceptional cases or on a one-off basis. Changes due to aging predispose older persons to adverse or dangerous reactions to the drug. The risk of adverse reactions typically exceeds the benefits.

Meds75+ data source is Finnish Medicines Agency Fimea (licensed under CC BY 4.0).
Data updated on May 18, 2024.