Tramadol hydrochloride/Paracetamol Amneal 37.5 mg/ 325 mg, film-coated tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Tramadol hydrochloride; Paracetamol

Tilgjengelig fra:

Amneal Pharma Europe Limited

ATC-kode:

N02AX; N02AX52

INN (International Name):

Tramadol hydrochloride; Paracetamol

Dosering :

37.5/325 milligram(s)

Legemiddelform:

Film-coated tablet

Resept typen:

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

Terapeutisk område:

Other opioids; tramadol, combinations

Autorisasjon status:

Not marketed

Autorisasjon dato:

2017-11-10

Informasjon til brukeren

Paracetamol 325 mg and Tramadol hydrochloride 37.5 mg Tablets
1.3.1-package-leaflet
12-September-2017
Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
37.5MG/325MG, 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

is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store

6. Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
This medicine is a combination of two analgesics, tramadol and
paracetamol, which act
together to relieve your pain.
This medicine is 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.
This medicine should only be taken by adults and adolescents over 12
years.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE

if you have had an allergic reaction (for instance skin rash, swelling
of the face, wheezing or
difficulty breathing) after taking tramadol or 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 also taking MAO inhibitors (certain medicines used for
treatment of depression or
Parkinson’s disea

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tramadol hydrochloride/Paracetamol Amneal 37.5 mg/ 325 mg, film-coated
tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 37.5 mg tramadol hydrochloride and 325
mg paracetamol
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Light yellow, film coated, capsule shaped tablets about 15.98 X 7.14
mm, engraved “AN506” on one side and plain on
the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tramadol hydrochloride/Paracetamol Amneal are indicated for the
symptomatic treatment of moderate to severe pain.
The use of Tramadol hydrochloride/Paracetamol Amneal 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 Amneal 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 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 Tramadol hydrochloride/Paracetamol
Amneal 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 Amneal 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/Parace