Targin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Naloxone hydrochloride dihydrate 10.9mg equivalent to Naloxone hydrochloride anhydrous 10 mg; Oxycodone hydrochloride 20mg;  

Available from:

Mundipharma New Zealand Ltd

INN (International Name):

Naloxone hydrochloride dihydrate 10.9 mg (=Naloxone hydrochloride anhydrous 10 mg)

Dosage:

20/10mg

Pharmaceutical form:

Modified release tablet

Composition:

Active: Naloxone hydrochloride dihydrate 10.9mg equivalent to Naloxone hydrochloride anhydrous 10 mg Oxycodone hydrochloride 20mg   Excipient: Ethylcellulose Lactose monohydrate Magnesium stearate Opadry pink 85F24151 Povidone Purified talc   Stearyl alcohol

Units in package:

Blister pack, PVC/aluminium, 20 tablets

Class:

Class B3 Controlled Drug

Prescription type:

Class B3 Controlled Drug

Manufactured by:

Sanofi Chimie

Therapeutic indications:

The management of moderate to severe chronic pain unresponsive to non-narcotic analgesia. The naloxone component in a fixed combination with oxycodone is indicated for the therapy and/or prophylaxis of opioid-induced constipation.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/aluminium - 20 tablets - 60 months from date of manufacture stored at or below 25°C - Blister pack, PVC/aluminium - 28 tablets - 60 months from date of manufacture stored at or below 25°C - Blister pack, PVC/aluminium - 60 tablets - 60 months from date of manufacture stored at or below 25°C

Authorization date:

2008-11-12

Patient Information leaflet

TARGIN
®
 TABLETS 
1 
TARGIN
®
 TABLETS 
_Oxycodone hydrochloride and naloxone hydrochloride dihydrate _
CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 
This leaflet answers some common 
questions about TARGIN tablets. 
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 this medicine 
against the benefits they expect it 
will have for you. 
IF YOU HAVE ANY CONCERNS ABOUT 
TAKING THIS MEDICINE, ASK YOUR 
DOCTOR OR PHARMACIST. 
KEEP THIS LEAFLET WITH THE MEDICINE. 
You may need to read it again. 
WHAT TARGIN TABLETS 
ARE TAKEN FOR 
TARGIN tablets contain two 
different medicines called oxycodone 
hydrochloride and naloxone 
hydrochloride dihydrate.  Oxycodone 
belongs to a group of medicines 
called opioid analgesics.  Naloxone is 
a medicine which, when taken orally, 
can block some of the effects of 
opioids in the gut, such as 
constipation. 
TARGIN tablets are used to relieve 
moderate to severe persistent pain 
when other forms of treatment have 
not been effective and naloxone in 
TARGIN tablets will help prevent 
and treat opioid-induced 
constipation.  Opioid analgesics such 
as oxycodone hydrochloride have 
been used to treat pain for many 
years. 
Your doctor, however, may prescribe 
it for another purpose. 
Ask your doctor if you have any 
questions about why this medicine 
has been prescribed for you. 
As with all strong painkillers, your 
body may become used to you taking 
TARGIN tablets.  Taking it may 
result in physical dependence.  
Physical dependence means that you 
may experience withdrawal 
symptoms if you stop taking 
oxycodone suddenly, so it is 
important to take it exactl

Summary of Product characteristics

NEW ZEALAND DATA SHEET 
TARGIN
®
 Tablets 
– TARG007 

26 February 2013 

TARGIN

 TABLETS

Oxycodone hydrochloride and naloxone hydrochloride dihydrate
controlled release 
tablets 

PRESENTATION 

TARGIN

 controlled release tablets are available
as oblong, unscored, film-coated 
tablets as follows: 


  5 mg anhydrous oxycodone hydrochloride/2.5 mg
anhydrous naloxone hydrochloride 
(as the dihydrate) (light blue, marked “OXN” on one side
and “5” on the other) 

  10 mg anhydrous oxycodone hydrochloride/5 mg
anhydrous naloxone hydrochloride 
(as the dihydrate) (white, marked “OXN” on one
side and “10” on the other) 

  20 mg anhydrous oxycodone hydrochloride/10 mg
anhydrous naloxone 
hydrochloride
(as the dihydrate) (pink, marked “OXN” on one side and “20” on the 
other) 

  40 mg anhydrous oxycodone hydrochloride/20 mg
anhydrous naloxone 
hydrochl
oride
(as the dihydrate) (yellow, marked “OXN” on one side and “40” on the 
other) 

USES 

ACTIONS 

Oxycodone is a full opioid receptor agonist whose
principal therapeutic action is 
analgesia.  It has an affinity for endogenous mu, kappa and
delta opiate receptors in the 
brain, spinal cord
and peripheral organs (e.g. intestine).  Binding of oxycodone
to 
endogenous opioid receptors in
the central nervous system (CNS) results in pain relief.  
Oxycodone is
similar to morphine in its action.  Other pharmacological actions of 
oxycodone are
in the CNS (respiratory depression, antitussive, anxiolytic, sedative
and 
miosis), smooth muscle
(constipation, reduced gastric, biliary and
pancreatic secretions, 
sphincter of Oddi spasm, and transient elevations in
serum amylase), and 
cardiovascular system _via_ histamine release and peripheral vasodilation
(pruritus, 
flushing, red eyes, sweating and or