Oxycodone Controlled Release Tablets

Nazione: Nuova Zelanda

Lingua: inglese

Fonte: Medsafe (Medicines Safety Authority)

Principio attivo:

Oxycodone hydrochloride 30mg;  

Commercializzato da:

Boucher & Muir (New Zealand) Limited t/a BNM Group

INN (Nome Internazionale):

Oxycodone hydrochloride 30 mg

Dosaggio:

30 mg

Forma farmaceutica:

Modified release tablet

Composizione:

Active: Oxycodone hydrochloride 30mg   Excipient: Ammonio methacrylate copolymer Ferrous oxide Hypromellose Iron oxide black Lactose monohydrate Macrogol 400 Magnesium stearate Povidone Purified talc   Purified water Stearyl alcohol Titanium dioxide Triacetin

Tipo di ricetta:

Class B3 Controlled Drug

Prodotto da:

Siegfried Ltd

Indicazioni terapeutiche:

Management of moderate to severe chronic pain unresponsive to non-narcotic analgesia.

Dettagli prodotto:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC film with aluminium foil - 20 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC film with aluminium foil - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC film with aluminium foil - 100 tablets - 36 months from date of manufacture stored at or below 25°C

Data dell'autorizzazione:

2015-01-05

Foglio illustrativo

1
OXYCODONE CONTROLLED RELEASE TABLETS (MATRIX FORMULATION)
06072018
Consumer Medicine Information
OXYCODONE
CONTROLLED RELEASE TABLETS
Oxycodone hydrochloride
C
ONTROLLED RELEASE tablets (Matrix Formulation)
5mg, 10 mg, 20 mg, 40 mg & 80 mg
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start taking Oxycodone
Controlled Release
Tablets.
This leaflet answers some common questions about Oxycodone Controlled
Release
Tablets. It does not contain all the available information. The most
up-to-date Consumer
Medicine Information can be downloaded from www.medsafe.govt.nz.
Reading this leaflet does not take the place of talking to your doctor
or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking
Oxycodone Controlled Release Tablets against the benefits this
medicine is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT OXYCODONE CONTROLLED RELEASE TABLETS ARE
USED FOR
Oxycodone Controlled Release Tablets contain oxycodone hydrochloride.
Oxycodone
belongs to a group of medicines called opioid analgesics which are
strong medicines used
to treat or prevent pain.
Oxycodone Controlled Release Tablets are used to relieve moderate to
severe persistent
pain when other forms of treatment have not been effective.
Your doctor may have prescribed this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR
YOU.
2
OXYCODONE CONTROLLED RELEASE TABLETS (MATRIX FORMULATION)
06072018
Oxycodone Controlled Release Tablets are only available with a
doctor's prescription.
As with all strong painkillers, your body may become used to you
taking Oxycodone
Controlled Release Tablets. Taking it may result in physical
dependence. Physical
dependence means that you may experience withdrawal symptoms if you
stop taking
oxycodone suddenly, so it is important to take it exactly as directed
by your doc

Scheda tecnica

1
OXYCODONE CONTROLLED RELEASE TABLETS (MATRIX FORMULATION)
OXYCODONE HYDROCHLORIDE MODIFIED RELEASE TABLETS 5MG, 10MG, 15MG,
20MG, 30MG, 40MG, 60MG & 80MG
06072017
Page 1 of 18
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
OXYCODONE CONTROLLED RELEASE TABLETS (MATRIX FORMULATION)
5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg & 80 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxycodone hydrochloride 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg
& 80 mg
Excipient with known effect: lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oxycodone Controlled Release Tablets 5 MG – Light blue, round,
biconvex, controlled
release tablets with black imprint ‘5’ on one side and a diameter
of approx. 7.1 mm.
Oxycodone Controlled Release Tablets 10 MG – White, round, biconvex,
controlled
release tablets with black imprint ‘10’ on one side and a diameter
of approx. 7.1 mm.
Oxycodone Controlled Release Tablets 15 MG* – Grey, round, biconvex,
controlled
release tablets with a diameter of approx. 7.1 mm.
Oxycodone Controlled Release Tablets 20 MG – Light pink, round,
biconvex controlled
release tablets with black imprint ‘20’ on one side and a diameter
of approx. 7.1 mm.
Oxycodone Controlled Release Tablets 30 MG* – Brown, round,
biconvex, controlled
release tablets with a diameter of approx. 7.1 mm.
Oxycodone Controlled Release Tablets 40 MG –
Light
orange
to ochre, round,
biconvex, controlled release tablets with black imprint ‘40’ on
one side and a diameter
of
approx. 7.1 mm.
Oxycodone Controlled Release Tablets 60 MG* – Pink-red, round,
biconvex, controlled
release tablets with a diameter of approx. 8.8 mm.
Oxycodone Controlled Release Tablets 80 MG – Green, round, biconvex,
controlled
release tablets with white imprint ‘80’ on one side and a diameter
of approx. 8.8 mm.
_*Not available in New Zealand._
2
OXYCODONE CONTROLLED RELEASE TABLETS (MATRIX FORMULATION)
OXYCODONE HYDROCHLORIDE MODIFIED RELEASE TABLETS 5MG, 10MG, 15MG,
20MG, 30MG, 40MG, 60MG & 80MG