CHEMMART TRAMADOL SR tramadol hydrochloride 200 mg oral tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tramadol hydrochloride

Available from:

Southern Cross Pharma Pty Ltd

INN (International Name):

Tramadol hydrochloride

Authorization status:

Registered

Patient Information leaflet

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Page 1 of 7
CHEMMART TRAMADOL SR
MODIFIED RELEASE TABLETS
[TRAMADOL HYDROCHLORIDE]
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about this medicine.
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 being given
CHEMMART TRAMADOL SR against the benefits it is expected to have for
you.
If you have any concerns about being given this medicine, ask your
doctor or pharmacist.
Keep this leaflet. You may need to read it again.
WHAT CHEMMART TRAMADOL SR IS USED FOR
CHEMMART TRAMADOL SR is used to relieve moderate to severe pain. It
belongs to the
group of medicines called analgesics (pain relievers). CHEMMART
TRAMADOL SR
tablets are designed to release the active ingredient for pain relief
gradually over several
hours.
BEFORE TAKING CHEMMART TRAMADOL SR FOR THE FIRST TIME
_Tell your doctor if: _

you are allergic to any of the ingredients in CHEMMART TRAMADOL SR
(see
"Product Description”)

you are known to be sensitive to opioids

you have lung or breathing problems

you are taking any medicines for depression, or mental or psychiatric
disorder or to
help you sleep

you are taking medication known as selective serotonin reuptake
inhibitors (SSRI's),
tricyclic anti-depressants, quinidine, phenothiazines or anti
psychotics

you have had any fits or convulsions, or take medicines for epilepsy

you are taking the medicine carbamazepine (one Brand name is Tegretol)
C:Products/Tram SR/Resub/CMI CM 6mar09 6/3/09
Page 2 of 7

you have any disorder of the kidney, liver or pancreas, including any
related to
alcohol intake - for example, cirrhosis of the liver

you have a stomach problem

you have a severe headache or have had a head injury

you have, or have had, any drug or alcohol dependence

you are taking any other medicine, including those you b

Summary of Product characteristics

Product Information- Australia
CHEMMART TRAMADOL SR TABLETS
NAME OF THE MEDICINE
Tramadol hydrochloride
Chemical Name:
(1_RS_,2_RS_)-2-[(dimethylamino)methyl)]-1-(3-methoxyphenyl)cyclohexanol
hydrochloride.
Structural Formula:
Molecular formula:
C
16
H
25
NO
2
.HCl
Molecular Weight:
299.84
CAS Registry Number: 53611-16-8
DESCRIPTION
Tramadol hydrochloride is an odourless, white to off white crystalline
powder that is readily
soluble in both water and ethanol. The water/n-octanol partition
coefficient is 1.35 at pH 7.
The excipients contained in each of the three strengths of CHEMMART
TRAMADOL SR include
calcium hydrogen phosphate, hyprolose, colloidal anhydrous silica and
magnesium stearate.
PHARMACOLOGY
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.
PHARMACODYNAMICS
Although the mode of action is not completely understood, at least two
complementary
mechanisms appear applicable: binding to mu-opioid receptors and
inhibition of reuptake of
noradrenaline and serotonin. The opioid-like activity of tramadol
derives from low affinity binding
of the parent compound to mu-opioid receptors and higher affinity
binding of the principal active
metabolite, mono _O_-desmethyltramadol, denoted M1, to mu-opioid
receptors. In animal models,
M1 is up to six times more potent than tramadol in producing analgesia
and 200 times more
potent in mu-opioid binding. The contribution of tramadol to human
analgesia, relative to M1, is
unknown.
Both human and animal studies have shown that antinociception induced
by tramadol is only
partially antagonised by the opiate antagonist naloxone. In addition,
tramadol has been
shown to
inhibit reuptake of noradrenaline and serotonin _in vitro_, as have
some other opioid
analgesics.
These latter mechanisms may contribute independently to the overall
analgesic profile of
tramadol.
The analgesic effect is dose dependent, but the relationship between
serum conce