Targinact 60 mg/30 mg, tabletten met verlengde afgifte

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

NALOXONHYDROCHLORIDE 2-WATER SAMENSTELLING overeenkomend met ; ; NALOXON ; OXYCODONHYDROCHLORIDE SAMENSTELLING overeenkomend met ; ; OXYCODON

Beschikbaar vanaf:

Mundipharma Pharmaceuticals B.V.

ATC-code:

N02AA55

INN (Algemene Internationale Benaming):

NALOXONHYDROCHLORIDE 2-WATER COMPOSITION corresponding to ; ; NALOXONE ; OXYCODONHYDROCHLORIDE COMPOSITION corresponding to ; ; OXYCODONE

farmaceutische vorm:

Tablet met verlengde afgifte

Samenstelling:

ETHYLCELLULOSE (E 462) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; STEARYLALCOHOL ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Oxycodone and naloxone

Product samenvatting:

Hulpstoffen: ETHYLCELLULOSE (E 462); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); LACTOSE 1-WATER; MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); POVIDON K 30 (E 1201); STEARYLALCOHOL; TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2017-05-18

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
TARGINACT 60 MG/30 MG TABLETTEN MET VERLENGDE AFGIFTE
TARGINACT 80 MG/40 MG TABLETTEN MET VERLENGDE AFGIFTE
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 Targinact is and what it is used for
2.
What you need to know before you take Targinact
3.
How to take Targinact
4.
Possible side effects
5.
How to store Targinact
6.
Contents of the pack and other information
1.
WHAT TARGINACT IS AND WHAT IT IS USED FOR
How Targinact works
Targinact contains oxycodone hydrochloride and naloxone hydrochloride
as active substances. Oxycodone
hydrochloride is responsible for the pain-killing effect of Targinact,
and is a potent analgesic (“painkiller”)
of the opioid group. The second active substance of Targinact,
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 Targinact for the treatment of severe pain,
which can be adequately managed only
with opioid analgesics. Naloxone hydrochloride is added to counteract
constipation.
Targinact tablets are only for use in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TARGINACT
DO NOT TAKE TARGINACT

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

Productkenmerken

1.
NAME OF THE MEDICINAL PRODUCT
Targinact 60 mg/30 mg, tabletten met verlengde afgifte
Targinact 80 mg/40 mg, tabletten met verlengde afgifte
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Targinact 60 mg/30 mg
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.
Targinact 80 mg/40 mg
Each prolonged-release tablet contains 80 mg of oxycodone
hydrochloride equivalent to 72 mg oxycodone
and 40 mg naloxone hydrochloride as 43.6 mg of naloxone hydrochloride
dihydrate, equivalent to 36 mg
naloxone.
Targinact 60 mg/30 mg
Excipient with known effect: Each prolonged-release tablet contains
77.1 mg lactose (as monohydrate)
Targinact 80 mg/40 mg
Excipient with known effect: Each prolonged-release tablet contains
45.2 mg lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet
Targinact 60 mg/30 mg
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.
Targinact 80 mg/40 mg
Brown, capsule shaped tablets, with a nominal length of 14 mm and with
a film coating, embossed “OXN”
on one side and “80” 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.
Targinact is indicated in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The analgesic efficacy of Targinact is equivalent to oxycodone
hydrochloride prolonged-release
formulations.
Versie 7 juni 2018
Pagina 2 van 15
The dosage should be adjusted to the intensity of pain and the
sensitivity of the individual patient. Unless
otherwise prescribed, Targinact should be administered as follows:
_Adults _
_ _
Th