OxyNorm 5mg 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) _
1
OXYNORM
® CAPSULES
Oxycodone hydrochloride (5mg, 10mg)
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 taking a t

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
H
21
NO
4
HCl and molecular weight is 351.83.
The inactive ingredients in _OXYNORM_
® capsules are: microcrystalline cellulose and magnesium
stearate.
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
Indigo carmine CI73015 (E132)
•
•
Iron oxide red CI77491 (E172)
•
•
Iron oxide yellow CI77492 (E172)
•
•
Sunset yellow FCF CI15985 (E110)
•
Titanium dioxide (E171)
•
•
INDICATION
The management of opioid responsive, moderate to severe pain.
ADMINISTRATION AND DOSAGE
_OXYNORM_
® capsules are for oral use and should be swallowed whole and not
opened, chewed
or crushed.
_Adults and elderly over 18 years: _
Prior to initiation and titration of doses, refer to the _Warnings and
Precautions _section for
information on special risk groups such as females and the elderly.
_OXYNORM_
® capsules should be taken at 4-6 hourly intervals. The dosage is
dependent on the
severity of the pain, and the patient’s previous history of
analgesic requirements.
Generally, the lowest effective dose for analgesia should be selected
Increasing severity of pain will require an increased dosage of
_OXYNORM_
® capsules. The correct
dosage for any individual patient is that which controls the pain and
is well tolerated throughout
the dosing period. Patients should be titrated to pain relief unless
unmanageable adverse drug
reactions prevent this.
_OXYNORM_
® capsules will generally be used in a short term trial (4-6 weeks) to
determine if the
pain is opioid responsive, before transferring to a