Oxycodon HCl CF 5 mg, harde capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

OXYCODONHYDROCHLORIDE SAMENSTELLING overeenkomend met ; OXYCODON

Beschikbaar vanaf:

Centrafarm B.V. Nieuwe Donk 3 4879 AC ETTEN LEUR

ATC-code:

N02AA05

INN (Algemene Internationale Benaming):

OXYCODONHYDROCHLORIDE COMPOSITION corresponding to ; OXYCODONE

farmaceutische vorm:

Capsule, hard

Samenstelling:

AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN (E 132) ; KALIUMHYDROXIDE (E 525) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Oxycodone

Product samenvatting:

Hulpstoffen: AMMONIA (E 527); CELLULOSE, MICROKRISTALLIJN (E 460); GELATINE (E 441); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); INDIGOKARMIJN (E 132); KALIUMHYDROXIDE (E 525); MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); PROPYLEENGLYCOL (E 1520); SCHELLAK (E 904); TITAANDIOXIDE (E 171); ZWARTE INKT;

Autorisatie datum:

2017-11-03

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
OXYCODON HCL CF 5 MG, HARDE CAPSULES
OXYCODON HCL CF 10 MG, HARDE CAPSULES
OXYDOCON HCL CF 20 MG, HARDE CAPSULES
For adults and adolescents over 12 years of age.
Oxycodone 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 [Product name] is and what it is used for
2. What you need to know before you take [Product name]
3. How to take [Product name]
4. Possible side effects
5. How to store [Product name]
6. Contents of the pack and other information
1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[Product name] is a centrally acting, strong painkiller from the group
of opioids.
[Product name] is used to treat severe pain, which can only be
adequately managed with
opioid analgesics.
For adults and adolescents over 12 years of age.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [PRODUCT NAME]
DO NOT TAKE [PRODUCT NAME]

if you are allergic to oxycodone hydrochloride or any of the other
ingredients of this
medicine (listed in section 6)

if you suffer from severely depressed breathing (respiratory
depression) with too little
oxygen in the blood (hypoxia) and/or too much carbon dioxide
(hypercapnia) in the blood

if
you
suffer from
severe
chronic
obstructive lung
disease,
cor
pulmonale (cardiac
changes due to chronic overload of lung circulation) or acute, severe
bronchial asthma

if you suffer from intestinal paralysis (paralytic ileus)

if your doctor has told you not to take strong pain killer (opioid)
WARNINGS AND PRECAUTIONS
Talk

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Oxycodon HCl CF 5 mg, harde capsules
Oxycodon HCl CF 10 mg, harde capsules
Oxycodon HCl CF 20 mg, harde capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
[Product name] 5 mg capsules:
Each
hard
capsule
contains
5 mg
oxycodone
hydrochloride
corresponding
to
4.5 mg
oxycodone.
[Product name] 10 mg capsules:
Each
hard
capsule
contains
10 mg
oxycodone
hydrochloride
corresponding
to
9 mg
oxycodone.
[Product name] 20 mg capsules:
Each
hard
capsule
contains
20 mg
oxycodone
hydrochloride
corresponding
to
18 mg
oxycodone.
Excipient(s) with known effect
Each hard capsule contains up to 0.003 mg sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Capsule, hard
[Product name] 5 mg capsules:
Hard capsules, size 4, 14.4 mm in length, with a dark pink body marked
with ‘5’ and a brown
cap marked with ‘OXY’.
[Product name] 10 mg capsules:
Hard capsules, size 4, 14.4 mm in length, with a white body marked
with ‘10’ and a brown
cap marked with ‘OXY’.
[Product name] 20 mg capsules:
Hard capsules, size 4, 14.4 mm in length, with a light pink body
marked with ‘20’ and a brown
cap marked with ‘OXY’.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Severe pain, which can only be adequately managed with opioid
analgesics.
For adults and adolescents over 12 years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Some patients who receive a retarded oxycodone preparation according
to a fixed schedule
require fast-release analgesics as an on-demand medication for
controlling breakthrough
pain. can be used for the treatment of these
breakthroughs.
2
capsules are available for dosage adjustment and for
the treatment of
breakthrough pain.
Posology
The dose depends on the intensity of pain and the patient’s
individual susceptibility to the
treatment. In general, the lowest effective analgesic dose should be
chosen. The following
general dose recommendations apply:
Adults and adolescents