Tramadol/Paracetamol 37.5 mg/325 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tramadol hydrochloride; Paracetamol

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

N02AJ; N02AJ13

INN (International Name):

Tramadol hydrochloride; Paracetamol

Dosage:

37.5 mg/325 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Opioids in combination with non-opioid analgesics; opiods in combination with non-opiod analgesics

Authorization status:

Marketed

Authorization date:

2015-01-09

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRAMADOL/PARACETAMOL 37.5 MG / 325 MG, FILM-COATED 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 is and what it is used for
2.
What you need to know before you take Tramadol/Paracetamol
3.
How to take Tramadol/Paracetamol
4.
Possible side effects
5.
How to store Tramadol/Paracetamol
6.
Contents of the pack and other information.
1.
WHAT TRAMADOL/PARACETAMOL IS AND WHAT IS USED FOR
Tramadol/Paracetamol is used to treat moderate to severe pain when
your doctor recommends that a
combination of tramadol hydrochloride and paracetamol is needed.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMADOL/PARACETAMOL
DO NOT TAKE TRAMADOL/PARACETAMOL
if you are allergic to tramadol, paracetamol or any of the other
ingredients of this medicine (listed in Section 6).

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/Paracetamol.
MAOIs are used in the
treatment of depression or Parkinson’s disease.

if you have a severe liver disorder.

if you have epilepsy that is not adequately controlled by your current
medicine.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Tramadol/Paracetamol
if you:

take other medicines containing paracetamol

Summary of Product characteristics

Health Products Regulatory Authority
12 May 2022
CRN00CXH1
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tramadol/Paracetamol 37.5 mg/325 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 37.5 mg tramadol hydrochloride and
325 mg paracetamol
Excipient(s) with known effect: one film-coated tablet contains 3.6 mg
lactose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
6.4 mm x 15.5mm, yellow, oblong, biconvex, film coated tablet with T
on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tramadol/Paracetamol tablets are indicated for the symptomatic
treatment of moderate to severe pain.
The use of Tramadol/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
_Adults and adolescents (12 years and older)_
_ _
The use of Tramadol/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 individually adjusted according to intensity of
pain and response of the patient. The lowest effective dose
for analgesia should generally be selected.
An initial dose of two tablets of Tramadol/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/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/Paracetamol is required as
a result of the nature and severity of the illness, then careful,
regular monitoring should take place ( with breaks in the
treatment, where possible), to assess whether continuation of th