TRAMADOL/PARACETAMOL TEVA 37.5/325 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TRAMADOL HYDROCHLORIDE, PARACETAMOL

Available from:

Teva Pharma B.V.

ATC code:

N02AJ13

INN (International Name):

TRAMADOL HYDROCHLORIDE, PARACETAMOL

Dosage:

37.5/325 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

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

Therapeutic area:

opiods in combination with non-opiod analgesics

Authorization status:

Authorised

Authorization date:

2010-11-19

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 
TRAMADOL/PARACETAMOL TEVA 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. Do not pass it on to others. It may harm them, even if 
their symptoms 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. 
1. WHAT TRAMADOL/PARACETAMOL TEVA IS AND WHAT IT IS USED FOR 
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TRAMADOL/PARACETAMOL TEVA 
3. HOW TO TAKE TRAMADOL/PARACETAMOL TEVA 
4. POSSIBLE SIDE EFFECTS 
5. HOW TO STORE TRAMADOL/PARACETAMOL TEVA 
6. CONTENTS OF THE PACK AND OTHER INFORMATION 

1. 
WHAT TRAMADOL/PARACETAMOL TEVA IS AND WHAT IT IS USED FOR 

Tramadol/Paracetamol Teva is a combination of two analgesics, tramadol and paracetamol, which act 
together to relieve your pain. 

Tramadol/Paracetamol Teva is intended
for use in the treatment of moderate
to severe pain when your 
doctor recommends that a combination of tramadol and paracetamol is
needed. 

Tramadol/Paracetamol Teva should only be taken
by adults and adolescents over 12 years. 

2. 
BEFORE YOU TAKE TRAMADOL/PARACETAMOL TEVA 

DO NOT TAKE TRAMADOL/PARACETAMOL TEVA 
• if you are allergic to 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  medicin

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tramadol/Paracetamol Teva 37.5mg / 325mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 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
Peach, capsule shaped, film
-
coated tablet engraved with T37.5 on one side and A325 on the other
side
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tramadol/Paracetamol Teva 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 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 the
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 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
assess whether continuation of the treatment is necessary.
_Paediatric population_
The effective and safe use of tramadol/paracetamol has not been
established in children below the age of 12 years.
Treatm