Targinact 15 mg/7,5 mg, tablet 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) ; HYPROLOSE (E 463) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; STEARYLALCOHOL ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Oxycodone and naloxone

Product samenvatting:

Hulpstoffen: ETHYLCELLULOSE (E 462); HYPROLOSE (E 463); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); LACTOSE 1-WATER; MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); STEARYLALCOHOL; TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2013-12-30

Bijsluiter

NL PL Targinact 2,5 mg/ 1,25 mg, 15 mg/ 7,5 mg, 30 mg/ 15 mg
Versie 10 januari 2019
Pagina 1 van 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
TARGINACT 2,5 MG/1,25 MG, TABLET MET VERLENGDE AFGIFTE
TARGINACT 15 MG/7,5 MG, TABLET MET VERLENGDE AFGIFTE
TARGINACT 30 MG/15 MG, TABLET 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
Targinact 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 Targinact 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
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.
2.
WHAT YOU

Productkenmerken

NL SmPC Targinact 2,5 mg/ 1,25 mg, 15 mg/ 7,5 mg, 30 mg/ 15 mg
Versie 7 juni 2018
Pagina 1 van 16
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Targinact 2,5 mg/1,25 mg, tablet met verlengde afgifte
Targinact 15 mg/7,5 mg, tablet met verlengde afgifte
Targinact 30 mg/15 mg, tablet met verlengde afgifte
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION_ _
{Targinact 2.5 mg/1.25 mg}
Each prolonged-release tablet contains 2.5 mg of oxycodone
hydrochloride equivalent to 2.25 mg
oxycodone and 1.25 mg naloxone hydrochloride as 1.37 mg of naloxone
hydrochloride dihydrate
equivalent to 1.13 mg naloxone.
{Targinact 15 mg/7.5 mg}
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.
{Targinact_ _30 mg/15 mg}
Each prolonged-release tablet contains 30 mg of oxycodone
hydrochloride equivalent to 27 mg oxycodone
and 15 mg naloxone hydrochloride as 16.48 mg of naloxone hydrochloride
dihydrate equivalent to
13.5mg naloxone
{Targinact 2.5 mg/1.25 mg}
Excipient with known effect: Each prolonged-release tablet contains
34.1 mg lactose anhydrous
{Targinact 15 mg/7.5 mg}
Excipient with known effect: Each prolonged-release tablet contains
53.0 mg lactose anhydrous
{Targinact_ _30 mg/15 mg}
Excipient with known effect: Each prolonged-release tablet contains
36.5 mg lactose anhydrous
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet
_{Targinact 2.5 mg/1.25 mg} _
Light yellow, round tablets, 5mm in size, with a film coating.
_{Targinact 15 mg/7.5 mg} _
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.
_{Targinact 30 mg/15 mg} _
Brown, oblong tablets, with a nominal length of 9.5mm and with a film
coating, embossed “OXN” on one
side and “30” on the other.
NL SmPC Targinact 2,5 mg/ 1,25 mg, 15 mg/ 7,5 mg, 30 mg/ 15 mg
Versie