TRAMADOL AMNEAL tramadol hydrochloride 50mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tramadol hydrochloride

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Tramadol hydrochloride

Authorization status:

Registered

Patient Information leaflet

Page 1 of 3
Tramadol Amneal v2
TRAMADOL AMNEAL CAPSULES
_Tramadol hydrochloride_
CONSUMER MEDICINE INFORMATION
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tramadol Amneal.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Tramadol
Amneal against the benefits this
medicine is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT TRAMADOL AMNEAL
IS USED FOR
Tramadol Amneal is used to relieve
moderate to severe pain and
belongs to a group of medicines
called analgesics (pain relievers).
Your doctor may have prescribed
Tramadol Amneal for another
reason. Ask your doctor why
Tramadol Amneal has been
prescribed for you.
This medicine is available only with
a doctor's prescription.
Tramadol Amneal is not normally
addictive although some cases
have been reported.
BEFORE YOU USE
TRAMADOL AMNEAL
_When you must not use it _
_ _
DO NOT USE TRAMADOL AMNEAL IF:

YOU HAVE A KNOWN ALLERGY
TO TRAMADOL AMNEAL OR
ANY OF THE INGREDIENTS
LISTED AT THE END OF THIS
LEAFLET.
Some of the symptoms of
an allergic reaction may
include skin rash, itching,
difficulty breathing and
swelling of the face
(including lips, tongue,
throat etc)

YOU ARE TAKING MEDICINE
FOR DEPRESSION
CONTAINING A "MONOAMINE
OXIDASE INHIBITOR" (SUCH
AS NARDIL, PARNATE), OR
HAVE TAKEN ONE WITHIN THE
PAST TWO WEEKS.
DO NOT USE TRAMADOL AMNEAL
AFTER THE EXPIRY DATE PRINTED ON
THE PACK.
If you take this medicine after the
expiry date has passed, it may not
work as well.
DO NOT USE TRAMADOL AMNEAL IF
THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
DO NOT GIVE TRAMADOL AMNEAL TO
CHILDREN.
There is no experience with the use
of Tramadol Amneal in children.
If you are not sure whether you
should be using Tramadol Amneal,
talk to your doctor.
_ _
_Before you use it _
_ _
Y

Summary of Product characteristics

_Tramadol AMNEAL capsules Product Information _
_Amneal Pharma Australia Pty Ltd _
Tramadol AMNEAL PI v3.0
Page 1 of 12
PRODUCT INFORMATION
TRAMADOL AMNEAL 50 MG CAPSULES
NAME OF THE MEDICINE
The product, Tramadol AMNEAL 50 mg capsules, contains tramadol
hydrochloride
as the active ingredient.
The chemical structure of tramadol hydrochloride is:
CAS number: 36282-47-0
DESCRIPTION AND COMPOSITION
The chemical name of tramadol hydrochloride is (1_RS_,2_RS_)-2-
[(dimethylamino)methyl)]-1-(3-methoxyphenyl)cyclohexanol
hydrochloride.
Molecular formula: C
16
H
25
NO
2
.HCl. MW: 299.84.
Tramadol hydrochloride is an odourless, white to off white crystalline
powder that is
readily soluble in both water and ethanol and has a pKa of 9.41. The
water/n-octanol
partition coefficient is 1.35 at pH 7.
The excipients contained in the product include microcrystalline
cellulose, gelatin,
indigo carmine aluminium lake, iron oxide yellow, magnesium stearate,
methyl
hydroxybenzoate, propyl hydroxybenzoate, colloidal anhydrous silica,
sodium lauryl
sulphate, sodium starch glycollate, and titanium dioxide.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS: Tramadol is a centrally acting synthetic analgesic
of the
aminocyclohexanol group with opioid-like effects. It is not derived
from natural
sources, nor is it chemically related to opiates.
_Tramadol AMNEAL capsules Product Information _
_Amneal Pharma Australia Pty Ltd _
Tramadol AMNEAL PI v3.0
Page 2 of 12
Although the mode of action is not completely understood, at least two
complementary mechanisms appear applicable: binding to _µ_-opioid
receptors and
inhibition of re-uptake of noradrenaline and serotonin. The opioid
like activity of
tramadol derives from low affinity binding of the parent compound to
_µ_-opioid
receptors and higher affinity binding of the principal active
metabolite, mono O-
desmethyl tramadol, denoted M1, to _µ_-opioid receptors. In animal
models, M1 is up
to six times more potent than tramadol in producing analgesia and 200
times more
potent in _µ_-opioid binding. The