OxyNorm 20mg, Capsules

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

OXYCODONE HYDROCHLORIDE

Boleh didapati daripada:

MUNDIPHARMA PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

OXYCODONE HYDROCHLORIDE

Unit dalam pakej:

28Capsule Capsules

Dikeluarkan oleh:

Bard Pharmaceuticals Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
OXYNORM
® CAPSULES
Oxycodone hydrochloride (5mg, 10mg, 20mg)
1
WHAT IS IN THIS LEAFLET
1.
What OxyNorm®
is used for
2.
How OxyNorm®works
3.
Before you use OxyNorm®
4.
How to use OxyNorm®
5.
While you are taking it
6.
Side effects
7.
Storage and Disposal of OxyNorm®
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT OXYNORM®
IS USED FOR
These capsules have been prescribed
for you by your doctor to relieve
moderate to severe pain..
_ _
HOW OXYNORM®
WORKS
They contain the active ingredient
oxycodone which belongs to a group of
medicines called strong analgesics or
‘painkillers’.
BEFORE YOU TAKE OXYNORM®
_-When you must not use it _
Do not take OxyNorm
®
capsules if you:
-
are allergic (hypersensitive) to
oxycodone or any of the ingredients
of the capsules (see section 7
‘Product description’) or have
previously had an allergic reaction
when taking other strong analgesics
or painkillers (such as morphine or
other opioids);
-
have breathing problems, such as
obstructive airways disease, acute
asthma or breathing more slowly or
weakly than expected;
-
have a heart problem after long-term
lung disease (cor pulmonale), suffer
from irregular or fast heartbeats or
changes in the way the heart beats
(cardiac arrhythmias), have
decreased heart rate;
-
have a condition where the small
bowel does not work properly
(paralytic ileus), your stomach
empties more slowly than it should
(delayed gastric emptying) or you
have sudden pain in your abdomen,
persistent constipation;
-
have severe kidney problems;
-
have just drunk a large amount of
alcohol, regularly drink large
amounts of alcohol or have
confusion and shaking due to
stopping drinking alcohol;
-
have a head injury, a brain tumour
or have raised pressure within the
head, brain or spinal cord;
-
are severely drowsy or have a
reduced level of consciousness;
-
suffer from convulsion, fits or
seizures, have too much carbon
dioxide in the blood (hypercabia);
-
are

Ciri produk

OxyNorm ® Capsules
Composition
Oxycodone hydrochloride Ph Eur
Oxycodone hydrochloride is a white, crystalline odourless powder readily soluble in water, sparingly
soluble in ethanol and nearly insoluble in ether. The chemical name is 4,5α -epoxy -14-hydroxy -3-
methoxy -17-methylmorphinan -6-one hydrochloride (CAS No: 124 -90-3). The molecular formula is C 18
H21NO 4 HCl and molecular weight is 351.83.
The inactive ingredients in OxyNorm ® capsules are: microcrystalline cellulose and magnesium stea rate.
The capsule shells contain sodium lauryl sulfate and gelatin. Capsule shell is derived from animal origin
(bovine source).
The capsule shells also contain the following colouring materials: Strength
Colouring material 5 mg 10 mg 20 mg
Indigo carmine CI73015 (E132) • • •
Iron oxide red CI77491 (E172) • • •
Iron oxide yellow CI77492 (E172) • • •
Sunset yellow FCF CI15985 (E110) •
Titanium dioxide (E171) • • •
Therapeutic properties
Oxycodone is a full opioid agonist with no antagonist properties whose principal therapeutic action is
analgesia. It has affinity for kappa, mu and delta opiate receptors in the brain and spinal cord.
Oxycodone is similar to morphine in its action. Other pharmacological actions of oxycodone are in the
CNS (respiratory depression, antitussive, anxiolytic, sedative and miosis), smooth muscle (constipation,
reduction in gastric, biliary and pancreatic secretions, spasm of sphincter of Oddi and transient
eleva tions in serum amylase) and cardiovascular system (release of histamine and/ or peripheral
vasodilation, possibly causing pruritus, flushing, red eyes, sweating and/or orthostatic
hypotension).
Pharmacokinetics
Elimination and Metabolism
Oxycodone has an elimination half life of approximately 3 hours and is metabolised principally to
noroxycodone and oxymorphone. Oxymorphone has some analgesic activity but is present in plasma in
low concentrations and is not considered to contribute to oxycodone’s ph armacological effect.