NUROFEN PLUS tablet blister pack (reformulation)

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

ibuprofen, Quantity: 200 mg; codeine phosphate hemihydrate, Quantity: 12.8 mg

Prieinama:

Reckitt Benckiser Pty Ltd

INN (Tarptautinis Pavadinimas):

codeine phosphate hemihydrate,Ibuprofen

Vaisto forma:

Tablet, film coated

Sudėtis:

Excipient Ingredients: hypromellose; sodium starch glycollate; microcrystalline cellulose; purified talc; pregelatinised maize starch; titanium dioxide; purified water; industrial methylated spirit

Vartojimo būdas:

Oral

Vienetai pakuotėje:

4, 12, 24, 30, 6

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

For the temporary relief of acute moderate pain and inflammation in patients over the age of 12 years ( see also Contraindications and Paediatric use)

Produkto santrauka:

Visual Identification: A white, film-coated biconvex capsule-shaped tablet embossed with the logo 'N+" on one side; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Autorizacija statusas:

Licence status A

Leidimo data:

2005-02-17

Pakuotės lapelis

NUROFEN
® PLUS TABLETS
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING NUROFEN PLUS?
Nurofen Plus contains the active ingredients Ibuprofen and Codeine
phosphate. Nurofen Plus is used to provide temporary relief of
acute moderate pain and inflammation. For more information, see
Section 1. Why am I using Nurofen Plus? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NUROFEN PLUS?
Do not use if you have ever had an allergic reaction to Nurofen Plus
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, or are pregnant or plan to become
pregnant.
You may develop addiction, dependence and tolerance. For more
information, see Section 2. What should I know before I use
Nurofen Plus? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Nurofen Plus and affect how it
works. A list of these medicines is in Section 3. What if I am
taking other medicines? in the full CMI.
4.
HOW DO I USE NUROFEN PLUS?
•
The usual dose of Nurofen Plus is 2 tablets then, if necessary 1 or 2
tablets every 4 to 6 hours.
More instructions can be found in Section 4. How do I use Nurofen
Plus? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NUROFEN PLUS?
THINGS YOU
SHOULD DO
•
REMIND ANY DOCTOR, DENTIST OR PHARMACIST YOU VISIT THAT YOU ARE USING
NUROFEN PLUS.
•
TALK TO YOU DOCTOR ABOUT PAIN CONTROL IF NUROFEN PLUS IS NOT HELPING.
•
TELL YOUR DOCTOR IF YOU BECOME PREGNANT WHILE TAKING NUROFEN PLUS.
THINGS YOU
SHOULD NOT DO
•
Do not take more than 6 tablets in 24 hours.
•
Do not give Nurofen Plus to children under the age of 12 years
•
Do not take Nurofen Plus for more than three days at a time
DRIVING
OR USING

Prekės savybės

Nurofen Plus PI September 2021
AUSTRALIAN PRODUCT INFORMATION – NUROFEN PLUS TABLETS
(IBUPROFEN, CODEINE PHOSPHATE HEMIHYDRATE)
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
NAME OF THE MEDICINE
Ibuprofen and codeine phosphate hemihydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains ibuprofen 200 mg and codeine phosphate
hemihydrate 12.8 mg.
For the full list of excipients, see Section 6.1 List of Excipients.
Nurofen