OxyNorm 5mg/5ml Oral Solution

Country: Malaysia

Language: English

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

Active ingredient:

OXYCODONE HYDROCHLORIDE

Available from:

MUNDIPHARMA PHARMACEUTICALS SDN. BHD.

INN (International Name):

OXYCODONE HYDROCHLORIDE

Units in package:

100ml mL; 250ml mL

Manufactured by:

Mundipharma Pharmaceuticals Ltd.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
OXYNORM
® ORAL SOLUTION
Oxycodone Hydrochloride (5mg/5ml, 10mg/ml)
WHAT IS IN THIS LEAFLET
1.
What Oxynorm® oral solution is
used for
2.
How Oxynorm® oral solution works
3.
Before you use Oxynorm® oral
solution
4.
How to use Oxynorm® oral solution
5.
While you are taking it
6.
Side effects
7.
Storage and Disposal of Oxynorm®
oral solution
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT OXYNORM® ORAL SOLUTION IS
USED FOR
The oral solution has been prescribed
for you by your doctor to relieve
moderate to severe pain. It contains the
active ingredient oxycodone which
belongs to a group of medicines called
strong analgesics or ‘painkillers’.
HOW OXYNORM® ORAL SOLUTION WORKS
Oxycodone is a full opioid agonist with
no antagonist properties. It has an
affinity for kappa, mu and delta opiate
receptors in the brain and spinal cord.
Oxycodone is similar to morphine in its
action. The therapeutic effect is mainly
analgesic, antianxiety and sedative.
BEFORE YOU TAKE OXYNORM® ORAL
SOLUTION
_-When you must not use it _
Do not take Oxynorm® oral solution if
you:
-
are allergic (hypersensitive) to
oxycodone or any of the ingredients
of the oral solutions (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
chronic obstructive airways disease,
chronic bronchial asthma or
breathingmore slowly or weakly than
expected; symptoms may include
breathlessness or coughing
-
have a head injury;
-
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 a heart problem after long-term
lung disease (cor pulmonale);
-
have severe kidney problems;
-
have moderate to severe liver
problems;
-
have too much c

Summary of Product characteristics

1
OXYNORM® ORAL SOLUTION 5MG/5ML
OXYNORM® CONCENTRATE ORAL SOLUTION 10MG/ML
NAME OF THE MEDICINAL PRODUCT
OXYNORM® Oral Solution 5mg/5ml
OXYNORM® Concentrate Oral Solution 10mg/ml
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml OXYNORM® Oral Solution 5mg/5ml contains oxycodone base 4.5
mg as oxycodone hydrochloride 5 mg.
Excipient with known effect:
Each 5 ml OXYNORM® Oral Solution 5mg/5ml contains 5 mg sodium
benzoate.
Each 1 ml OXYNORM® Concentrate Oral Solution 10mg/ml contains
oxycodone base 9 mg as oxycodone
hydrochloride 10 mg.
Excipients with known effect:
Each 1 ml OXYNORM® Concentrate Oral Solution 10mg/ml contains 1 mg
sodium benzoate. It also contains 0.1 mg
sunset yellow (E 110), which may cause allergic reactions.
PHARMACEUTICAL FORM
OXYNORM® Oral Solution 5mg/5ml is a clear colourless/straw-coloured
solution.
OXYNORM® Concentrate Oral Solution 10mg/ml is a clear, orange
solution.
CLINICAL PARTICULARS
THERAPEUTIC INDICATION
The management of opioid responsive, moderate to severe pain.
POSOLOGY AND METHOD OF ADMINISTRATION
_Route of administration: _
Oral
_Post-operative pain: _
In common with other strong opioids, the need for continued treatment
should be assessed at regular intervals.
_Elderly and adults over 18 years: _
OXYNORM® oral solutions 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® oral solutions. 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.
The usual starting dose for opioid naïve patients or patients
presenting with severe pain uncontrolled by weaker
opioids is 5 mg, 4-6 hourly. The dose should then be carefully
titrated, as frequently as o