Targin 15 mg/7.5 mg prolonged-release tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

OXYCODONE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Saatavilla:

Mundipharma Pharmaceuticals Limited

ATC-koodi:

N02AA; N02AA55

INN (Kansainvälinen yleisnimi):

OXYCODONE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Annos:

15 mg / 7.5 milligram(s)

Lääkemuoto:

Prolonged-release tablet

Prescription tyyppi:

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

Terapeuttinen alue:

Natural opium alkaloids; oxycodone, combinations

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

2014-01-31

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
_TARGIN_ 15 MG/7.5_ _MG PROLONGED-RELEASE TABLETS
_TARGIN_ 30 MG/15_ _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.
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.
These tablets are only for use in adults.
How these tablets work
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE _TARGIN_
DO NOT TAKE _TARGIN_:
- if you are allergic to oxycodone hydrochloride, naloxone
hydrochloride or any of the other ingredients
of

Valmisteyhteenveto

Health Products Regulatory Authority
06 June 2023
CRN00D5YW
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Targin 15 mg/7.5 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 15 mg of oxycodone
hydrochloride equivalent to 13.5 mg oxycodone and 7.5 mg
naloxone hydrochloride as 8.24 mg of naloxone hydrochloride dihydrate
equivalent to 6.75 mg naloxone.
Excipient with known effect: Each prolonged-release tablet contains
53.0 mg lactose anhydrous
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
Grey, oblong tablets, with a nominal length of 9.5mm and with a film
coating, embossed “OXN” on one side and “15” on the
other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Severe pain, which can be adequately managed only with opioid
analgesics.
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
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 naïve 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.
Patients already receiving opioids may be started on higher doses
depending on their previous opioid experience.
The maximum daily dose of these tablets is 160 mg oxycodone
hydrochloride and 80 mg naloxone hydrochloride. The
maximum daily dose is reserved for patients who have previously been
maintained on a stable daily dose and who have
become