TARGIN PROLONGED RELEASE TABLETS 10MG5MG

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

Boleh didapati daripada:

MUNDIPHARMA PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

Unit dalam pakej:

28tablet Tablets

Dikeluarkan oleh:

Bard Pharmaceuticals Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
TARGIN® PROLONGED RELEASE TABLET
Oxycodone hydrochloride / Naloxone hydrochloride (5mg/2.5mg, 10mg/5mg,
20mg/10mg, 40mg/20mg)
1
WHAT IS IN THIS LEAFLET
1.
What
_Targin_
_® _
tablet is used for
2.
How
_Targin_
_® _
tablet works
3.
Before you use
_Targin_
_® _
tablet
4.
How to use
_Targin_
_® _
tablet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Targin_
_® _
tablet
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of revision
WHAT _TARGIN_
_® _
TABLET IS USED FOR
_Targin_
®
tablet is used to relieve moderate
to severe chronic pain when other forms
of treatment have not been effective and
to bring relief from constipation which is
a typical side effect of treatment with
opioid analgesics.
_Targin_
®
tablets are also used to
relieve the symptoms of severe to
very severe restless legs syndrome in
people who can't be treated with
dopamine medicines.
HOW _TARGIN_
_® _
TABLET WORKS
_Targin_
®
tablet contains two different
medicines called oxycodone
hydrochloride and naloxone
hydrochloride. Oxycodone belongs to a
group of medicines called opioid
analgesics, which are strong pain killers
and is responsible for the pain-killing
effect of the tablets. Naloxone is intended
to bring relief from constipation.
Constipation is a typical side effect of
treatment with strong painkillers
BEFORE YOU USE _TARGIN_
_® _
TABLET
_- When you must not use it _

Do not take
_Targin® _
tablets if you are
allergic to oxycodone, naloxone, opiod
painkillers, or any of the ingredients
listed at the end of this leaflet.

Do not take Targin® tablets if you
-
have any breathing problems such as
severe asthma, respiratory depression
(breathing slows or weakens) or other
obstructive airways disease.
-
are severely drowsy or have a reduced
level of consciousness
-
have heart problems due to long term
lung disease (Cor pulmonale).
-
have a condition where your stomach
empties more slowly than it should or
any condition that obstr

Ciri produk

Page 1 of 29
_FOR HOSPITAL USE ONLY _
_THIS PRODUCT MAY BE HABIT-FORMING UPON PROLONGED USE _
PRODUCT INFORMATION - TARGIN
_®_
_ _PROLONGED-RELEASE
TABLETS
1.
NAME OF THE MEDICINE
Oxycodone hydrochloride and naloxone hydrochloride dihydrate.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_TARGIN_
®
5 mg/2.5 mg prolonged-release tablet contains 5 mg of oxycodone
hydrochloride equivalent to
4.5 mg oxycodone, and 2.73 mg of naloxone hydrochloride dihydrate
equivalent to 2.5 mg naloxone
hydrochloride and 2.25 mg naloxone;
_TARGIN_
®
10 mg/5 mg prolonged-release tablet contains 10 mg of oxycodone
hydrochloride equivalent
to 9.0 mg oxycodone, and 5.45 mg of naloxone hydrochloride dihydrate
equivalent to 5.0 mg naloxone
hydrochloride and 4.5 mg naloxone;
_TARGIN_
®
20 mg/10 mg prolonged-release tablet contains 20 mg of oxycodone
hydrochloride equivalent
to 18.0 mg oxycodone, and 10.9 mg of naloxone hydrochloride dihydrate
equivalent to 10.0 mg
naloxone hydrochloride and 9.0 mg naloxone;
_TARGIN_
®
40 mg/20 mg prolonged-release tablet contains 40 mg of oxycodone
hydrochloride equivalent
to 36.0 mg oxycodone, and 21.8 mg of naloxone hydrochloride dihydrate
equivalent to 20.0 mg
naloxone hydrochloride and 18.0 mg naloxone;
The
inactive
ingredients
in
_TARGIN_
®
5
mg/2.5
mg
tablets
are
lactose
monohydrate,
hydroxypropylcellulose, ethylcellulose, stearyl alcohol, talc and
magnesium stearate. The inactive
ingredients in
_TARGIN_
®
10 mg/5 mg, 20mg/10 mg and 40mg/20 mg tablets are lactose monohydrate,
povidone K30, ethylcellulose, stearyl alcohol, talc and magnesium
stearate. All tablets are coated with
polyvinyl alcohol, titanium dioxide (E171), macrogol 3350 and talc.
The tablet coat also contains
brilliant blue FCF aluminium lake E133 (5mg/2.5 mg tablets), iron
oxide red E172 (20mg/10 mg
tablets) and iron oxide yellow E172 (40mg/20 mg tablets)
3.
PHARMACEUTICAL
FORM
_TARGIN_

tablets are available as oblong, unscored film-coated tablets in
blister pack sizes of
28 tablets
as follows:
5 mg/2.5 mg light blue, marked �