Tradol Plus 37.5 mg/325 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tramadol hydrochloride; Paracetamol

Available from:

Rowex Ltd

ATC code:

N02AJ; N02AJ13

INN (International Name):

Tramadol hydrochloride; Paracetamol

Dosage:

37.5mg/325 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

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

Therapeutic area:

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

Authorization status:

Not marketed

Authorization date:

2016-02-12

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TRADOL PLUS 37.5 MG/325 MG 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 Tradol Plus is and what it is used for
2. What you need to know before you take Tradol Plus
3. How to take Tradol Plus
4. Possible side effects
5.
How to store Tradol Plus
6.
Contents of the pack and other information
1.
WHAT TRADOL PLUS IS AND WHAT IT IS USED FOR
Tradol Plus is a combination of two analgesics (pain killers),
tramadol and paracetamol, which act
together to relieve pain.
Tradol Plus is indicated for the treatment of moderate to severe pain
when your doctor recommends
that a combination of tramadol and paracetamol is needed.
Tradol Plus should only be taken by adults and adolescents 12 years
and older.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRADOL PLUS
DO NOT TAKE TRADOL PLUS

if you are allergic to tramadol, paracetamol or any of the other
ingredients of this medicine (listed
in section 6)

in acute poisoning with alcohol, sleeping pills, pain relievers or
other psychotropic medicines
(medicines that affect mood and emotions)

if you are taking medicines called monoamine oxidase (MAO) inhibitors
(certain medicines used
to treat depression or Parkinson’s disease) or if you have taken
them in the last 14 days before
treatment with Tradol Plus

if you have a severe liver disease

if you have epilepsy that is not adequately controlled on your current
medicine.
WARNINGS AND PRECAUTIONS
Talk to your do

Summary of Product characteristics

Health Products Regulatory Authority
24 June 2020
CRN008MZD
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tradol Plus 37.5 mg/325 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of
paracetamol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, scored tablet of oblong shape (15 x 6.5 mm).
The score line is not intended for breaking the tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tradol Plus tablets are indicated for the symptomatic treatment of
moderate to severe pain.
The use of Tradol Plus 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 Tradol Plus 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 the 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 tablets of Tradol Plus 37.5 mg/325 mg is
recommended. Additional doses can be taken as needed, not
exceeding 8 tablets (equivalent to 300 mg of tramadol and 2600 mg of
paracetamol) per day.
The dosing interval should not be less than 6 hours.
Tramadol/paracetamol should under no circumstances be administered for
longer than is strictly necessary (see also section
4.4). 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 asses