TARGIN PROLONGED RELEASE TABLETS 40MG/20MG

Nazione: Malesia

Lingua: inglese

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

Principio attivo:

OXYCODONE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Commercializzato da:

MUNDIPHARMA PHARMACEUTICALS SDN. BHD.

INN (Nome Internazionale):

OXYCODONE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Confezione:

28tablet Tablets

Prodotto da:

Bard Pharmaceuticals Limited

Foglio illustrativo

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 obstructs the
stomach/bowel or affects bowel transit
(moveme

Scheda tecnica

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 �