Tramadol hydrochloride/Paracetamol 37.5 mg/325 mg Film-coated Tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Tramadol hydrochloride; Paracetamol 90% dcl (compap l)

Disponible desde:

Generics (UK) Limited

Código ATC:

N02AJ; N02AJ13

Designación común internacional (DCI):

Tramadol hydrochloride; Paracetamol 90% dcl (compap l)

Dosis:

37.5/325 milligram(s)

formulario farmacéutico:

Film-coated tablet

tipo de receta:

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

Área terapéutica:

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

Estado de Autorización:

Not marketed

Fecha de autorización:

2014-03-07

Información para el usuario

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRAMADOL HYDROCHLORIDE/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 hydrochloride/Paracetamol is and what it is used for
2.
What you need to know before you take Tramadol
hydrochloride/Paracetamol
3.
How to take Tramadol hydrochloride/Paracetamol
4.
Possible side effects
5.
How to store Tramadol hydrochloride/Paracetamol
6.
Contents of the pack and other information
1.
WHAT TRAMADOL HYDROCHLORIDE/PARACETAMOL IS AND WHAT IT IS USED FOR Tramadol hydrochloride/Paracetamol is a combination of two
analgesics, tramadol and paracetamol, which
act together to relieve your pain.
Tramadol hydrochloride/Paracetamol is used for the treatment of
moderate to severe pain when your doctor
decides that a combination of tramadol and paracetamol is necessary. Tramadol hydrochloride/Paracetamol should only be taken by adults and
adolescents 12 years of age and
over.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMADOL
HYDROCHLORIDE/PARACETAMOL
DO NOT TAKE TRAMADOL HYDROCHLORIDE/PARACETAMOL:
-
if you are allergic to paracetamol, tramadol 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 taking medicines called monoamine oxidase inhibitors
(MAOIs) or have taken MAOIs in
the last 14 days before treatment with Tramadol
h

Ficha técnica

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
Each film-coated tablet contains 37.5 mg tramadol hydrochloride and
325 mg paracetamol.
Excipient with known effect:
Each film-coated tablet contains 2.651 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
An oblong, light yellow film-coated tablet debossed with “P/T” on
one side and “M” on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tramadol hydrochloride/Paracetamol is 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
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 of tramadol and 2600
mg of paracetamol) per day should not be
exceeded. The dosing interval should not be less than 6 hours.
_Adults and adolescents (12 years and older)_
An initial dose of two tablets of Tramadol hydrochloride/Paracetamol
(equivalent to 75 mg of tramadol and 650 mg of
paracetamol) is recommended. Additional dose 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 hydrochloride/Paracetamol should under no circumstances be
taken for longer than is strictly necessary (see
section 4.4). If repeated use or long term treatment with Tramadol
hydroch