Paracetamol/Codeine phosphate hemihydrate Accord 500 mg/30 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; Codeine phosphate hemihydrate

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

N02AJ06

INN (International Name):

Paracetamol; Codeine phosphate hemihydrate

Pharmaceutical form:

Tablet

Therapeutic area:

codeine and paracetamol

Authorization status:

Not marketed

Authorization date:

2023-06-16

Patient Information leaflet

PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PARACETAMOL/CODEINE PHOSPHATE HEMIHYDRATE ACCORD 500 MG/30 MG TABLETS
paracetamol/codeine phosphate hemihydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Paracetamol/Codeine phosphate hemihydrate Accord is and what it
is used for
2.
What you need to know before you take Paracetamol/Codeine phosphate
hemihydrate Accord
3.
How to take Paracetamol/Codeine phosphate hemihydrate Accord
4.
Possible side effects
5.
How to store Paracetamol/Codeine phosphate hemihydrate Accord
6.
Contents of the pack and other information
1.
WHAT PARACETAMOL/CODEINE PHOSPHATE HEMIHYDRATE ACCORD IS AND WHAT IT
IS USED FOR
Paracetamol/Codeine phosphate hemihydrate Accord belongs to a group of
medicines called analgesics
(painkillers) and is used in adult patients (18 years of age and
older) for the relief of severe pain.
Paracetamol/Codeine phosphate hemihydrate Accord can be used in
patients from 12 years of age and
older for the short-term relief of moderate pain that is not relieved
by other painkillers such as
paracetamol or ibuprofen alone.
This product contains paracetamol and codeine.
Paracetamol is an analgesic that can be used to relieve pain.
Codeine belongs to a group of medicines called opioid analgesics which
act to relieve pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL/CODEINE PHOSPHATE
HEMIHYDRATE
ACCORD
DO NOT TAKE PARACETAMOL/CODEINE PHOSPHATE HEMIHYDRATE ACCORD:
•
For pain relief in children and adolescents (0-18 y

Summary of Product characteristics

Health Products Regulatory Authority
16 June 2023
CRN00CDVN
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol/Codeine phosphate hemihydrate Accord 500 mg/30 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg paracetamol and 30 mg codeine phosphate
hemihydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, oval (17 mm x 8.5 mm) biconvex tablet marked 'LK' on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Paracetamol/Codeine phosphate hemihydrate Accord is indicated in adult
patients (18 years of age and older) for the relief of
severe pain.
Paracetamol/Codeine phosphate hemihydrate Accord is indicated in
patients from 12 years of age and older for the treatment
of acute moderate pain which is not considered to be relieved by other
analgesics such as paracetamol or ibuprofen (alone).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Paracetamol/Codeine phosphate hemihydrate Accord should be used at the
lowest effective dose for the shortest period of
time. This dose may be taken, up to 4 times a day. Maximum daily dose
of codeine should not exceed 240 mg.
The duration of treatment should be limited to 3 days and if no
effective pain relief is achieved the patients/carers should be
advised to seek the views of a physician.
Adults (18 years and over):
One‐two tablets at intervals of not less than 6 hours to a maximum
of four doses in any 24 hours.
Do not exceed eight tablets in 24 hours.
Elderly:
The initial dosage should be reduced to half the recommended dosage
and should be titrated to the individuals need and
overall medical condition.
Paediatric Population
_Adolescents aged 16 to 18 years: _
The dose should primarily be based on the codeine component and body
weight. Recommended single codeine dose is 0.5 ‐ 1
mg codeine/kg, every 6 hours, maximum 4 times daily.
The Paracetamol/Codeine phosphate hemihydrate Accord dose should be
adjusted so that the paracetamol component does
not exceed 15 m