Tramadol/ Paracetamol Aurobindo 37.5mg/325mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PARACETAMOL, TRAMADOL HYDROCHLORIDE

Available from:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC code:

N02AJ13

INN (International Name):

PARACETAMOL 325 mg TRAMADOL HYDROCHLORIDE 37.5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

PARACETAMOL 325 mg TRAMADOL HYDROCHLORIDE 37.5 mg

Prescription type:

POM

Therapeutic area:

ANALGESICS

Authorization status:

Authorised

Authorization date:

2013-04-16

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
TRAMADOL/ PARACETAMOL AUROBINDO 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 Tramadol/ Paracetamol Aurobindo is and what it is used for
2.
What you need to know before you take Tramadol/ Paracetamol Aurobindo
3.
How to take Tramadol/ Paracetamol Aurobindo
4.
Possible side effects
5.
How to store Tramadol/ Paracetamol Aurobindo
6.
Contents of the pack and other information
1.
WHAT TRAMADOL/ PARACETAMOL AUROBINDO IS AND WHAT IT IS USED FOR
Tramadol/ Paracetamol Aurobindo is a combination of two analgesics,
tramadol and paracetamol,
which act together to relieve your pain.
Tramadol/ Paracetamol Aurobindo is 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 Aurobindo should only be taken by adults and
adolescents over 12 years.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMADOL/ PARACETAMOL AUROBINDO
_ _
DO NOT TAKE TRAMADOL/ PARACETAMOL AUROBINDO:
•
if you are allergic to tramadol hydrochloride, paracetamol or any of
the other ingredients of this
medicine (listed in section 6)
•
in
acute
poisoningwith
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
disease or have taken them in
the last

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tramadol/ Paracetamol Aurobindo 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 tablets
Light yellow, oblong shaped biconvex film coated tablets debossed with
“I 03” on one side and
plain on the other side. The size is approximately 15.5 mm x 6.35mm
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tramadol
Hydrochloride/Paracetamol
tablets
are
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 also Section
5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
Adults and adolescents (12 years and older)
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 individually adjusted according to intensity of
pain and response of the
patient.
An initial dose of two tablets of Tramadol Hydrochloride/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 Hydrochloride/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
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repeated use or long term treatment with Tramadol
Hydrochloride/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
ne