Targin

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

Compra'l ara

Descargar Fitxa tècnica (SPC)
11-06-2024

ingredients actius:

Naloxone hydrochloride; Oxycodone hydrochloride

Disponible des:

Mundipharma Pty Ltd

clase:

Medicine Registered

Informació per a l'usuari

                                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 exactly as
directed by your doctor.
This medicine is only available with
a doctor's prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE TARGIN TABLETS IF
YOU:
•
have moderate or severe liver
problems or disease
•
suffer from shallow breathing or
have any other breathing
problems such as severe asthma,
                                
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Fitxa tècnica

                                TARGIN
®
 tablets PI 28 December 11 (mfptargi11211) 
Supersedes PI 20311 
 
Page 1 of 22_ _
PRODUCT  INFORMATION 
 
TARGIN
® 
TABLETS (5/2.5 MG, 10/5 MG, 20/10 MG, 40/20 MG) 
 
 
NAME OF THE MEDICINE 
Oxycodone hydrochloride and naloxone hydrochloride dihydrate. 
 
 
DESCRIPTION 
Oxycodone hydrochloride is a white,
crystalline,  odourless powder readily soluble in water, 
sparingly soluble in ethanol and nearly insoluble in ether.
 The chemical name is 4,5
a-epoxy-
14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride (CAS No.: 124-90-3).
 The 
molecular formula is C
18
H
21
NO
4
.HCl and molecular weight is 351.83.  The pKa is 8.9 and
the 
Partition Coefficient Log P is 0.7.
 The structural formula for oxycodone hydrochloride is: 
 
 
 
Naloxone hydrochloride dihydrate is an
off-white powder soluble in water.  The chemical 
name is 17-allyl-4,5
a-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride dihydrate (CAS 
No.: 51481-60-8).  It is a synthetic congener of oxymorphone,
with molecular formula 
C
19
H
21
NO
4
.HCl.2(H
2
O) and molecular weight 399.87.  The pKa is 7.9 and
the Partition 
Coefficient Log P is 1.5.
 The structural formula for naloxone hydrochloride dihydrate is: 
 
The inactive ingredients in TARGIN
®
  5/2.5  mg  tablets are lactose, hydroxypropylcellulose, 
ethylcellulose, stearyl alcohol, talc
and magnesium stearate.  The inactive ingredients in 
TARGIN
®
  10/5  mg, 20/10  mg and 40/20  mg tablets are lactose,
povidone, 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 
CI42090 (5/2.5 mg tablets), iron oxide red CI77491
(20/10 mg tablets) and iron oxide yellow 
CI77492 (40/20 mg tablets). 
 
TARGIN
®
 tablets PI 28 
                                
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