Oxycodon HCl Apotex 5 mg, tablet met verlengde afgifte

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

OXYCODONHYDROCHLORIDE SAMENSTELLING overeenkomend met ; OXYCODON

Beschikbaar vanaf:

Apotex Europe BV

ATC-code:

N02AA05

INN (Algemene Internationale Benaming):

OXYCODONHYDROCHLORIDE COMPOSITION corresponding to ; OXYCODONE

farmaceutische vorm:

Tablet met verlengde afgifte

Samenstelling:

BRILJANTBLAUW FCF ALUMINIUMLAK (E133) ; ETHYLCELLULOSE (E 462) ; HYPROLOSE (E 463) ; HYPROMELLOSE (Release controlling polymer)(E 464) ; LACTOSE 0-WATER ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Oxycodone

Product samenvatting:

Hulpstoffen: BRILJANTBLAUW FCF ALUMINIUMLAK (E133); ETHYLCELLULOSE (E 462); HYPROLOSE (E 463); HYPROMELLOSE (Release controlling polymer)(E 464); LACTOSE 0-WATER; MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Autorisatie datum:

2011-06-27

Bijsluiter

OXYCODON HCL APOTEX 5, 10, 20, 40 & 80 MG PROLONGED-RELEASE TABLETS
–
RVG 104271-2-3-4-5
MODULE 1.3
Product Information
Version: 2019-01-10
MODULE 1.3.1
Package Leaflet
Replaces : 2018-11-29
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
OXYCODON HCL APOTEX 5 MG, TABLETTEN MET VERLENGDE AFGIFTE
OXYCODON HCL APOTEX 10 MG, TABLETTEN MET VERLENGDE AFGIFTE
OXYCODON HCL APOTEX 20 MG, TABLETTEN MET VERLENGDE AFGIFTE
OXYCODON HCL APOTEX 40 MG, TABLETTEN MET VERLENGDE AFGIFTE
OXYCODON HCL APOTEX 80 MG, TABLETTEN MET VERLENGDE AFGIFTE
OXYCODONE HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 {Oxycodone Hydrochloride} is and what it is used for
2. What you should know before you take {Oxycodone Hydrochloride}
3. How to take {Oxycodone Hydrochloride}
4. Possible side effects
5. How to store {Oxycodone Hydrochloride}
6. Contents of the pack and other information
1.
WHAT {OXYCODONE HYDROCHLORIDE} IS AND WHAT IT IS USED FOR
{Oxycodone
Hydrochloride}
prolonged-release
tablets
contain
the
active
ingredient
oxycodone hydrochloride which belongs to a group of medicines called
opioids. These are
strong painkillers. Medicines which are used to relieve pain are
called analgesics.
{Oxycodone Hydrochloride} is used to relieve severe pain which can
only be controlled by
opioid analgesics.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE {OXYCODONE HYDROCHLORIDE}
DO NOT TAKE {OXYCODONE HYDROCHLORIDE} IF:

If you are allergic to oxycodone hydrochloride or any of the other
ingredients of this
medicine (lis

Productkenmerken

OXYCODON HCL APOTEX 5, 10, 20, 40 & 80 MG PROLONGED-RELEASE TABLETS
–
RVG 104271-2-3-4-5
MODULE 1.3
Product Information
Version: 2019-01-10
MODULE 1.3.1
Summary of Product Characteristics
Replaces:
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Oxycodon HCl Apotex 5 mg, tabletten met verlengde afgifte
Oxycodon HCl Apotex 10 mg, tabletten met verlengde afgifte
Oxycodon HCl Apotex 20 mg, tabletten met verlengde afgifte
Oxycodon HCl Apotex 40 mg, tabletten met verlengde afgifte
Oxycodon HCl Apotex 80 mg, tabletten met verlengde afgifte
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
<{Oxycodone Hydrochloride} 5 mg prolonged-release tablet:> Each
prolonged-release tablet
contains 5 mg oxycodone hydrochloride.
<{Oxycodone
Hydrochloride}
10
mg
prolonged-release
tablet:>
Each
prolonged-release
tablet contains 10 mg oxycodone hydrochloride.
<{Oxycodone
Hydrochloride}
20
mg
prolonged-release
tablet:>
Each
prolonged-release
tablet contains 20 mg oxycodone hydrochloride.
<{Oxycodone
Hydrochloride}
40
mg
prolonged-release
tablet:>
Each
prolonged-release
tablet contains 40 mg oxycodone hydrochloride.
<{Oxycodone
Hydrochloride}
80
mg
prolonged-release
tablet:>
Each
prolonged-release
tablet contains 80 mg oxycodone hydrochloride.
Excipient with known effect: Anhydrous lactose.
Each tablet contains 37.07 mg anhydrous
lactose.
Each tablet contains 34.07 mg anhydrous
lactose.
Each tablet contains 41.50 mg anhydrous
lactose.
Each tablet contains 64.0 mg anhydrous
lactose.
Each tablet contains 89.0 mg anhydrous
lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet
<{Oxycodone Hydrochloride} 5 mg prolonged-release tablet:> Light blue,
round, biconvex
prolonged-release tablet, engraved ‘APO’ on one side, ‘OCD’
over ‘5’on the other side.
OXYCODON HCL APOTEX 5, 10, 20, 40 & 80 MG PROLONGED-RELEASE TABLETS
–
RVG 104271-2-3-4-5
MODULE