TRUST IBUPROFEN PLUS CODEINE film coated tablet blister pack

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

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

Dostępny od:

Pharmacor Pty Ltd

INN (International Nazwa):

codeine phosphate hemihydrate,Ibuprofen

Forma farmaceutyczna:

Tablet, film coated

Skład:

Excipient Ingredients: colloidal anhydrous silica; croscarmellose sodium; pregelatinised maize starch; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 400

Droga podania:

Oral

Sztuk w opakowaniu:

12, 24, 18, 10, 15, 30, 20

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

For temporary relief of acute moderate pain and inflammation in patients over the age of 12 years

Podsumowanie produktu:

Visual Identification: white to off-white capsule-shaped, biconvex, film-coated tablet; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status autoryzacji:

Registered

Data autoryzacji:

2010-09-01

Ulotka dla pacjenta

Trust Ibuprofen Plus Codeine (V – 03)
1
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
1. WHY AM I USING
TRUST IBUPROFEN PLUS CODEINE?
2. WHAT SHOULD I KNOW BEFORE I USE TRUST IBUPROFEN PLUS CODEINE?
3. WHAT IF I AM TAKING OTHER MEDICINES?
4. HOW DO I USE TRUST IBUPROFEN PLUS CODEINE?
5. WHAT SHOULD I KNOW WHILE USING TRUST IBUPROFEN PLUS CODEINE?
6. ARE THERE ANY SIDE EFFECTS?
TRUST IBUPROFEN PLUS CODEINE
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.
Trust Ibuprofen Plus Codeine contains the active ingredients Ibuprofen
and Codeine phosphate. Trust Ibuprofen Plus
Codeine is used to provide temporary relief of acute moderate pain and
inflammation.
For more information, see Section 1. Why am I using Trust Ibuprofen
Plus Codeine? in the full CMI.
Do not use if you have ever had an allergic reaction to Trust
Ibuprofen Plus Codeine 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
Trust Ibuprofen Plus Codeine? in the full CMI.
Some medicines may interfere with Trust Ibuprofen Plus Codeine 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.
•
The usual dose of Trust Ibuprofen Plus Codeine 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 Trust Ibuprofen
Plus Codeine?
in the full CMI.
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Trust Ibuprofen Plus Codeine.
•
Talk to you doctor about pain control if Trust Ibuprofen Plus Codeine
is not helping.
•
Tell your doctor if yo

Charakterystyka produktu

Trust Ibuprofen Plus Codeine (V - 03)
Page 1 of 23
AUSTRALIAN PRODUCT INFORMATION
TRUST IBUPROFEN PLUS CODEINE
(IBUPROFEN, CODEINE PHOSPHATE HEMIHYDRATE) TABLETS
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, TRUST
IBUPROFEN PLUS
CODEINE 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 _
TRUST IBUPROFEN PLUS CODEINE 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 TRUST IBUPROFEN PLUS CODEINE. 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
patie
nts
for
signs
and
symptoms of respiratory depression and sedation. Caution patients not
to drink
alcohol while taking TRUST IBUPROFEN PLUS CODEINE.
1
NAME OF THE MEDICINE
Ibuprofen and codeine phosphate hemihydrate
Trust Ibuprofen Plus Codeine (V - 03)
Page 2 of 23
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Trust Ibupr