Targin 60 mg/30 mg prolonged-release tablets

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

OXYCODONE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Предлага се от:

Mundipharma Pharmaceuticals Limited

АТС код:

N02AA; N02AA55

INN (Международно Name):

OXYCODONE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

дозиране:

60 mg/30 milligram(s)

Лекарствена форма:

Prolonged-release tablet

Вид предписание :

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

Терапевтична област:

Natural opium alkaloids; oxycodone, combinations

Статус Оторизация:

Marketed

Дата Оторизация:

2016-02-16

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE USER
_TARGIN_ 60 MG/30 MG PROLONGED-RELEASE TABLETS
_TARGIN_ 80 MG/40 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
How
_TARGIN_
works
_TARGIN_
contains 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.
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.
_TARGIN _
are only for use in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE _TARGIN_
DO NOT TAKE _TARGIN_
•
if you are allergic to oxycodone hydrochloride, naloxone
hydrorochloride or any of the other
ingredients of this medicine (listed in section 6),
•
if your breathing is not able to supply enough oxygen to the blood,
and get rid of carbon dioxide
produced in the body (re

Данни за продукта

Health Products Regulatory Authority
06 June 2023
CRN00D5YW
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Targin 60 mg/30 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged‑release tablet contains 60 mg of oxycodone
hydrochloride equivalent to 54 mg oxycodone and 30 mg
naloxone hydrochloride as 32.7 mg of naloxone hydrochloride dihydrate,
equivalent to 27 mg naloxone.
Excipient with known effect: Each prolonged‑release tablet contains
77.1 mg lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged‑release tablet
Red, capsule shaped tablets, with a nominal length of 14 mm and with a
film coating, embossed “OXN” on one side and “60”
on the other side.
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,
Targin 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.
Patients already receiving opioids may be started on higher doses
depending on their previous opioid experience.
The maximum daily dose 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