Nurofen Plus

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Codeine phosphate hemihydrate 12.8mg;  ;  ; Ibuprofen 200mg;  

Available from:

Reckitt Benckiser (New Zealand) Limited

INN (International Name):

Codeine phosphate hemihydrate 12.8 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Codeine phosphate hemihydrate 12.8mg     Ibuprofen 200mg   Excipient: Hypromellose   Microcrystalline cellulose Opaspray white M-1-7111B Purified talc Sodium starch glycolate Starch

Units in package:

Blister pack, PVC/PVDC & Aluminium foil (not marketed), 2 tablets

Class:

Restricted

Prescription type:

Prescription

Manufactured by:

Weifa AS

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC & Aluminium foil - 2 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC & Aluminium foil - 12 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC & Aluminium foil - 24 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC & Aluminium foil - 30 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2003-12-10

Patient Information leaflet

New Zealand Consumer Medicine Information
WARNINGS
LIMITATIONS OF USE
Nurofen Plus should only be used when your doctor decides that other
treatment
options are not able to effectively manage your pain or you cannot
tolerate them._ _
HAZARDOUS AND HARMFUL USE
Nurofen Plus poses risks of abuse, misuse and addiction which can lead
to overdose
and death. Your doctor will monitor you regularly during treatment.
_ _
LIFE THREATENING RESPIRATORY DEPRESSION
Nurofen Plus can cause life-threatening or fatal breathing problems
(slow, shallow,
unusual or no breathing) even when used as recommended. These problems
can
occur at any time, but the risk is higher when first starting Nurofen
Plus and after a
dose increase, if you are older, or have an existing problem with your
lungs. Your
doctor will monitor you and change the dose as appropriate.
USE OF OTHER MEDICINES WHILE TAKING NUROFEN PLUS
USING NUROFEN PLUS WITH OTHER MEDICINES THAT CAN MAKE YOU FEEL DROWSY
SUCH
AS SLEEPING TABLETS (E.G. BENZODIAZEPINES), OTHER PAIN RELIEVERS,
ANTIHISTAMINES,
ANTIDEPRESSANTS, ANTIPSYCHOTICS, GABAPENTINOIDS (E.G. GABAPENTIN AND
PREGABALIN), CANNABIS OIL AND ALCOHOL MAY RESULT IN SEVERE DROWSINESS,
DECREASED AWARENESS, BREATHING DIFFICULTIES, COMA AND DEATH. Your
doctor will
minimise the dose and duration of use and monitor you for signs and
symptoms of
breathing difficulties and sedation. You must not drink alcohol while
using Nurofen
Plus.
NUROFEN PLUS
_IBUPROFEN 200MG AND CODEINE PHOSPHATE HEMIHYDRATE 12.8MG _
Tablet, film coated
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using NUROFEN
PLUS.
1
This leaflet answers some common questions about NUROFEN PLUS. It does
not
contain all the available information. It 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 using
Nurofen Plus against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.

Summary of Product characteristics

Nurofen Plus – 18
th
December 2023
NEW ZEALAND DATA SHEET
NUROFEN PLUS
WARNINGS
_LIMITATIONS OF USE_
Because of the risks associated with the use of opioids, Nurofen Plus
should only be used
in patients for whom other treatment options, including non-opioid
analgesics, are
ineffective, not tolerated or otherwise inadequate to provide
appropriate management of
pain (see _section 4.4 Special Warnings and Precautions for Use_)._ _
_HAZARDOUS AND HARMFUL USE_
Nurofen Plus poses risks of hazardous and harmful use which can lead
to overdose and
death. Assess the patient's risk of hazardous and harmful use before
prescribing and
monitor the patient regularly during treatment (see _section 4.4.
Special Warnings and _
_Precautions for Use_).
_ _
_LIFE THREATENING RESPIRATORY DEPRESSION_
Serious, life-threatening or fatal respiratory depression may occur
with the use of Nurofen
Plus. Be aware of situations which increase the risk of respiratory
depression, modify
dosing in patients at risk and monitor patients closely, especially on
initiation or following a
dose increase (see _section 4.4 Special Warnings and Precautions for
Use_).
_CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS) _
_DEPRESSANTS, INCLUDING ALCOHOL_
Concomitant use of opioids with benzodiazepines, gabapentinoids,
antihistamines, tricyclic
antidepressants, antipsychotics, cannabis or other central nervous
system (CNS)
depressants, including alcohol, may result in profound sedation,
respiratory depression,
coma, and death. Limit dosages and durations to the minimum required;
and monitor
patients for signs and symptoms of respiratory depression and
sedation. Caution patients
not to drink alcohol while taking Nurofen Plus.
1. TRADE NAME OF THE MEDICINAL PRODUCT
NUROFEN PLUS
Ibuprofen 200mg
Codeine Phosphate Hemihydrate 12.8mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains ibuprofen 200.0 mg and codeine phosphate
hemihydrate 12.8 mg.
For a full list of excipients, see section 6.1.
Nurofen Plus – 18
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December 2023