Targin 5 mg/2.5 mg prolonged-release tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

OXYCODONE HYDROCHLORIDE; Naloxone hydrochloride dihydrate

可用日期:

Mundipharma Pharmaceuticals Limited

ATC代码:

N02AA; N02AA55

INN（国际名称）:

OXYCODONE HYDROCHLORIDE; Naloxone hydrochloride dihydrate

剂量:

5 mg/2.5 milligram(s)

药物剂型:

Prolonged-release tablet

处方类型:

Product subject to prescription which may not be renewed (A)

治疗领域:

Natural opium alkaloids; oxycodone, combinations

授权状态:

Marketed

授权日期:

2009-09-25

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
_TARGIN_ 5 MG/2.5 MG PROLONGED-RELEASE TABLETS
_TARGIN_ 10 MG/5 MG PROLONGED-RELEASE TABLETS
_TARGIN_ 20 MG/10 MG PROLONGED-RELEASE TABLETS
_TARGIN_ 40 MG/20 MG PROLONGED-RELEASE TABLETS
Oxycodone hydrochloride / naloxone hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What
_TARGIN_
is and what it is used for
2.
What you need to know before you take
_TARGIN_
3.
How to take
_TARGIN_
4.
Possible side effects
5.
How to store
_TARGIN_
6.
Contents of the pack and other information
1.
WHAT _TARGIN_ IS AND WHAT IT IS USED FOR
_TARGIN_
is a prolonged-release tablet, which means that its active substances
are released over an extended
period. Their action lasts for 12 hours.
These tablets are only for use in adults.
Pain relief
You have been prescribed
_TARGIN_
for the treatment of severe pain, which can be adequately managed only
with opioid analgesics. Naloxone hydrochloride is added to counteract
constipation.
How these tablets work in pain relief
These tablets contain oxycodone hydrochloride and naloxone
hydrochloride as active substances. Oxycodone
hydrochloride is responsible for the pain-killing effect of
_TARGIN_
, and is a potent analgesic (“painkiller”) of
the opioid group. The second active substance of
_TARGIN_
, naloxone hydrochloride, is intended to counteract
constipation.
Bowel
dysfunction
(e.g.
constipation)
is
a
typical
side
effect
of
treatment
with
opioid
painkillers.
Restless legs syndrome
You have been prescribed
_TARGIN_
for the

产品特点

Health Products Regulatory Authority
06 June 2023
CRN00D5YW
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Targin 5 mg/2.5 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged‑release tablet contains 5 mg of oxycodone
hydrochloride equivalent to 4.5 mg oxycodone and 2.5 mg
naloxone hydrochloride as 2.73 mg of naloxone hydrochloride dihydrate
equivalent to 2.25 mg naloxone.
Excipient with known effect: Each prolonged‑release tablet contains
68.2 mg lactose anhydrous
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged‑release tablet
Blue oblong tablets, with a nominal length of 9.5 mm and with a film
coating, embossed “OXN” on one side and “5” on the
other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Severe pain, which can be adequately managed only with opioid
analgesics.
Second line symptomatic treatment of patients with severe to very
severe idiopathic restless legs syndrome after failure of
dopaminergic therapy.
The opioid antagonist naloxone is added to counteract opioid‑induced
constipation by blocking the action of oxycodone at
opioid receptors locally in the gut.
_TARGIN_is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Analgesia
The analgesic efficacy of _TARGIN_ is equivalent to oxycodone
hydrochloride prolonged‑release formulations.
The dosage should be adjusted to the intensity of pain and the
sensitivity of the individual patient. Unless otherwise prescribed,
these tablets should be administered as follows:
_Adults_
The usual starting dose for an opioid naive patient is 10 mg/5 mg of
oxycodone hydrochloride/naloxone hydrochloride at
12 hourly intervals.
Lower strengths are available to facilitate dose titration when
initiating opioid therapy and for individual dose adjustment.
Health Products Regulatory Authority
06 June 2023
CRN00D5YW
Page 2 of 17
Patients already receiving opioids may be started on higher doses
depending on their previous opioid exper