CIPLA PAIN RELIEF IBUPROFEN PLUS film-coated tablet blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

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

제공처:

Cipla Australia Pty Ltd

INN (International Name):

codeine phosphate hemihydrate,Ibuprofen

약제 형태:

Tablet, film coated

구성:

Excipient Ingredients: glyceryl behenate; magnesium stearate; maize starch; lactose monohydrate; purified water; colloidal anhydrous silica; titanium dioxide; hypromellose; macrogol 6000

관리 경로:

Oral

패키지 단위:

12, 30, 24, 10, 20, 15

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

CIPLA PAIN RELIEF IBUPROFEN PLUS is used for temporary relief of acute moderate pain and inflammation

제품 요약:

Visual Identification: White to off-white capsule shaped, biconvex, film coated tablets with central breakline on one side and plain on the other side.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Licence status A

승인 날짜:

2008-10-14

환자 정보 전단

CIPLA PAIN RELIEF IBUPROFEN PLUS
1
CIPLA PAIN RELIEF IBUPROFEN PLUS
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 CIPLA PAIN RELIEF IBUPROFEN PLUS?
CIPLA PAIN RELIEF IBUPROFEN PLUS contains the active ingredients
Ibuprofen and Codeine phosphate. CIPLA PAIN RELIEF
IBUPROFEN PLUS is used to relieve pain, inflammation (swelling,
redness, soreness) and fever when other analgesics have
proven not to be effective.
For more information, see Section 1. Why am I using CIPLA PAIN RELIEF
IBUPROFEN PLUS? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CIPLA PAIN RELIEF IBUPROFEN PLUS?
Do not use if you have ever had an allergic reaction to CIPLA PAIN
RELIEF IBUPROFEN 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 OR ARE BREASTFEEDING. Do not use at all
during the last three months of pregnancy,
For more information, see Section 2. What should I know before I use
CIPLA PAIN RELIEF IBUPROFEN PLUS? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CIPLA PAIN RELIEF IBUPROFEN 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 CIPLA PAIN RELIEF IBUPROFEN PLUS?
The usual dose of CIPLA PAIN RELIEF IBUPROFEN PLUS for adults and
children over 12 years of age is 2 tablets followed by, if
necessary 1 or 2 tablets every 4 hours. Do not take more CIPLA PAIN
RELIEF IBUPROFEN PLUS than 6 tablets in 24 hours. More
instructions can be found in Section 4. How do I use CIPLA PAIN RELIEF
IBUPROFEN PLUS? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CIPLA PAIN RELIEF IBUPROFEN PLUS?
THINGS YOU
SHOULD DO

제품 특성 요약

AUSTRALIAN PRODUCT INFORMATION - CIPLA PAIN RELIEF IBUPROFEN PLUS
(IBUPROFEN, CODEINE PHOSPHATE HEMIHYDRATE) TABLET
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, CIPLA PAIN
RELIEF IBUPROFEN 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 _
CIPLA PAIN RELIEF IBUPROFEN 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 CIPLA PAIN
RELIEF IBUPROFEN 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 CIPLA PAIN
RELIEF IBUPROFEN PLUS.
1
NAME OF THE MEDICINE
Ibuprofen and codeine phosphate hemihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Ibuprofen 200mg, codeine phosphate 12.8mg.
CIPLA PAIN RELIEF IBUPROFE