情報リーフレット
Page 1 of 3
C:Products/Tram caps/CMI 29feb12
29/2/12
LODAM
®
50 CAPSULES
_Tramadol hydrochloride_
CONSUMER MEDICINE INFORMATION
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Lodam 50. 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 Lodam 50
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 LODAM 50 IS USED
FOR
Lodam 50 is used to relieve
moderate to severe pain and
belongs to a group of medicines
called analgesics (pain relievers).
Your doctor may have prescribed
Lodam 50 for another reason. Ask
your doctor why Lodam 50 has
been prescribed for you.
This medicine is available only with
a doctor's prescription.
Lodam 50 is not normally
addictive although some cases
have been reported.
BEFORE YOU USE LODAM
50
_When you must not use it _
_ _
Do not use Lodam 50 if:
YOU HAVE A KNOWN ALLERGY
TO LODAM 50 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 LODAM 50 AFTER THE
EXPIRY DATE PRINTED ON THE PACK.
If you take this medicine after the
expiry da
完全なドキュメントを読む
製品の特徴
C:Products/Tram caps/PI Lodam 11mar09
11/3/09
Page 1 of 11
PRODUCT INFORMATION
LODAM 50 CAPSULES (TRAMADOL HYDROCHLORIDE 50 MG)
NAME OF THE MEDICINE
The product, Lodam 50 capsules, contains tramadol
hydrochloride (50 mg per
capsule) 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 croscarmellose
sodium, povidone,
cellulose – microcrystalline, silica – colloidal anhydrous,
magnesium stearate, gelatin,
titanium dioxide, quinoline yellow, iron oxide yellow,
Brilliant Blue FCF.
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.
C:Products/Tram caps/PI Lodam 11mar09
11/3/09
Page 2 of 11
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 tramad
完全なドキュメントを読む
情報リーフレット 