Tramadol Hydrochloride/Paracetamol 37.5 mg/325 mg Film-Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; Tramadol hydrochloride

Available from:

Athlone Laboratories Ltd

ATC code:

N02AX; N02AX52

INN (International Name):

Paracetamol; Tramadol hydrochloride

Dosage:

37.5/325 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other opioids; tramadol, combinations

Authorization status:

Not marketed

Authorization date:

2016-06-10

Patient Information leaflet

0010
IE/H/823/001/IB/004G
CCF21114
PACKAGE LEAFLET: INFORMATION FOR THE USER
CONTAINS PARACETAMOL
TRAMADOL HYDROCHLORIDE/PARACETAMOL 37.5MG/325MG FILM-COATED TABLETS
TRAMADOL HYDROCHLORIDE/PARACETAMOL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
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.
•
You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1.
What Tramadol Hydrochloride/Paracetamol Tablets are and what they are
used for
2.
What you need to know before you take Tramadol
Hydrochloride/Paracetamol Tablets
3.
How to take Tramadol Hydrochloride/Paracetamol Tablets
4.
Possible side effects
5.
How to store Tramadol Hydrochloride/Paracetamol Tablets
6.
Contents of the pack and other information
1.
WHAT TRAMADOL HYDROCHLORIDE/PARACETAMOL TABLETS ARE AND
WHAT THEY ARE USED FOR
Tramadol Hydrochloride/Paracetamol tablets are used to treat moderate
to severe pain when
you doctor recommends that a combination of paracetamol and tramadol
hydrochloride is
needed.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMADOL
HYDROCHLORIDE/PARACETAMOL TABLETS
Do not take Tramadol Hydrochloride/Paracetamol film coated tablets:
•
if you are hypersensitive or have had an allergic reaction (for
instance skin rash,
swelling of the face, wheezing or difficulty breathing) to tramadol,
paracetamol or any
of the other ingredients (see section 6) in Tramadol
Hydrochloride/Paracetamol tablets.
•
in cases of acute alcohol poisoning.
•
if you are taking sleeping pills, pain relievers or medicines that
affect mood and
emotions.
•
if you are also taking medicines called monoamine oxidase inhibitors
(MAOIs) or have
taken MAOIs in the last 14 days before treatment with Tramadol
Hydrochloride/
Paracetamol tablets. MAOIs are used in the treatment of depres

Summary of Product characteristics

Health Products Regulatory Authority
14 June 2022
CRN00CVZ6
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tramadol Hydrochloride/Paracetamol 37.5 mg/325 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 37.5mg tramadol hydrochloride and
325mg paracetamol
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Pale yellow film-coated tablet, marked with “325” on one side and
’37.5’ on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tramadol Hydrochloride/Paracetamol tablets are indicated for the
symptomatic treatment of moderate to severe pain.
The use of Tramadol Hydrochloride/Paracetamol should be restricted to
patients whose moderate to severe
pain is considered to require a combination of tramadol and
paracetamol (see also Section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
_ _
The use of Tramadol Hydrochloride/Paracetamol should be restricted to
patients whose moderate to severe pain is considered
to require a combination of tramadol 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 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 tablets of Tramadol Hydrochloride/ Paracetamol
is recommended. Additional doses can be taken as
needed, not exceeding 8 tablets (equivalent to 300 mg tramadol and
2600 mg paracetamol) per day. The dosing interval
should not be less than six hours.
Tramadol Hydrochloride/Paracetamol should under no circumstances be
administered for longer than is strictly necessary (see
also section 4.4 – Special warnings and precautions for use). If
repeated use or long term treatment with Tramadol
Hydrochloride/Paracetamol is