Tramadol/Paracetamol Accord 37.5mg/325mg Effervescent Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tramadol hydrochloride; Paracetamol

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

N02AJ13

INN (International Name):

Tramadol hydrochloride; Paracetamol

Dosage:

37.5 mg/325 milligram(s)

Pharmaceutical form:

Effervescent tablet

Therapeutic area:

opiods in combination with non-opiod analgesics

Authorization status:

Not marketed

Authorization date:

2021-12-03

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRAMADOL/PARACETAMOL ACCORD 37.5MG/325MG EFFERVESCENT TABLETS
tramadol hydrochloride/paracetamol
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 Tramadol/Paracetamol Accord 37.5mg/325mg Effervescent tablets are
and what they are
used for
2.
What you need to know before you take Tramadol/Paracetamol Accord
37.5mg/325mg
Effervescent tablets
3.
How to take Tramadol/Paracetamol Accord 37.5mg/325mg Effervescent
tablets
4.
Possible side effects
5.
How to store Tramadol/Paracetamol Accord 37.5mg/325mg Effervescent
tablets
6.
Contents of the pack and other information
1.
WHAT TRAMADOL/PARACETAMOL ACCORD 37.5MG/325MG EFFERVESCENT TABLETS ARE
AND WHAT
THEY ARE USED FOR
Tramadol/Paracetamol Accord 37.5mg/325mg Effervescent tablets are a
combination of two
analgesics, tramadol hydrochloride and paracetamol, which act together
to relieve your pain.
Tramadol/Paracetamol Accord 37.5mg/325mg Effervescent tablets are
intended for use in the
treatment of moderate to severe pain when your doctor recommends that
a combination of tramadol
hydrochloride and paracetamol is needed.
Tramadol/Paracetamol Accord 37.5mg/325mg Effervescent tablets should
only be taken by adults and
adolescents over 12 years.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMADOL/PARACETAMOL ACCORD
37.5MG/325MG
EFFERVESCENT TABLETS
DO NOT TAKE TRAMADOL/PARACETAMOL ACCORD 37.5MG/325MG EFFERVESCENT
TABLETS
-
if you are allergic to tramadol hydrochloride, paracetamol or peanut
or soya

Summary of Product characteristics

Health Products Regulatory Authority
10 May 2023
CRN00DFCJ
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tramadol/Paracetamol Accord 37.5mg/325mg Effervescent Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One effervescent tablet contains 37.5 mg tramadol hydrochloride and
325 mg paracetamol.
Excipients: Each effervescent tablet contains 0.33 mg of soya oil,
12.6 mg of sucrose and 10.06 mmol (or 231.49 mg) of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent Tablet.
White to off-white, round, flat, bevelled-edge tablets and plain on
both sides with mottled appearance and odour of orange.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tramadol/Paracetamol Accord 37.5mg/325mg Effervescent Tablets are
indicated for the symptomatic treatment of moderate
to severe pain.
The use of Tramadol/Paracetamol Accord 37.5mg/325mg Effervescent
Tablets should be restricted to patients whose moderate
to severe pain is considered to require a combination of tramadol
hydrochloride and paracetamol (see also section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The use of Tramadol/Paracetamol Accord 37.5mg/325mg Effervescent
Tablets should be restricted to patients whose moderate
to severe pain is considered to require a combination of tramadol
hydrochloride and paracetamol.
The dose should be adjusted to intensity of pain and the sensitivity
of the individual patient. The lowest effective dose for
analgesia should generally be selected.
The total dose of 8 tablets (equivalent to 300 mg tramadol
hydrochloride and 2600 mg paracetamol) per day should not be
exceeded. The dosing interval should not be less than six hours.
Adults and adolescents (12 years and older)
An initial dose of two effervescent tablets of Tramadol/Paracetamol
Accord 37.5mg/325mg Effervescent Tablets (equivalent to
75 mg tramadol hydrochloride and 650 mg paracetamol) is recommended.
Additional doses can be taken as needed, not
exceeding 8 effervescent tablets (equivalent