PHARMACY ACTION PARACETAMOL & IBUPROFEN film coated tablet blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

지금 구매하세요

환자 정보 전단 환자 정보 전단 (PIL)
09-09-2021
제품 특성 요약 제품 특성 요약 (SPC)
19-10-2016
공공 평가 보고서 공공 평가 보고서 (PAR)
24-11-2017

유효 성분:

ibuprofen, Quantity: 200 mg; paracetamol, Quantity: 500 mg

제공처:

Generic Health Pty Ltd

INN (International Name):

Ibuprofen,Paracetamol

약제 형태:

Tablet, film coated

구성:

Excipient Ingredients: hypromellose; crospovidone; pregelatinised maize starch; titanium dioxide; microcrystalline cellulose; colloidal anhydrous silica; purified talc; magnesium stearate; povidone; purified water; polysorbate 80; polyvinyl alcohol; macrogol 3350; mica

관리 경로:

Oral

패키지 단위:

10, 6, 8, 16, 20, 12, 4, 5, 24, 30

처방전 유형:

(S2) Pharmacy Medicine, (S3) Pharmacist Only Medicine

치료 징후:

Temporary relief of acute (short term) pain and / or inflammation associated with headache, migraine headache, tension headache, sinus pain, toothache, dental procedures, backache, muscular aches and pains, period pain, sore throat, tennis elbow, rheumatic pain and arthritis, and the aches and pains associated with colds and flu. Reduces fever.

제품 요약:

Visual Identification: White to off-white, oval shaped, biconvex, film-coated pearlescent tablets plain on both sides.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

승인 상태:

Licence status A

승인 날짜:

2016-10-19

환자 정보 전단

                                CONSUMER MEDICINE INFORMATION
PHARMACY ACTION
PARACETAMOL & IBUPROFEN
(PARACETAMOL AND IBUPROFEN) FILM-COATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
PHARMACY ACTION
Paracetamol & Ibuprofen. 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 or
pharmacist has weighed the
risks of you taking PHARMACY
ACTION Paracetamol &
Ibuprofen against the benefits
this medicine is expected to
have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR PHARMACIST OR
DOCTOR.
Keep this information with the
medicine. You may need to read
it again.
WHAT PHARMACY
ACTION PARACETAMOL &
IBUPROFEN IS USED FOR
PHARMACY ACTION
Paracetamol & Ibuprofen
contains two ingredients,
paracetamol and ibuprofen, that
together deliver temporary relief
of acute (short term) pain and/or
inflammation associated with
back pain, dental pain, period
pain, migraine headache, cold
and flu symptoms, tension
headache, muscular pain,
headache, sore throat,
rheumatic pain and non-serious
arthritic pain.
Paracetamol works to stop the
pain messages from getting
through to the brain.
Paracetamol also acts in the
brain to reduce fever.
Ibuprofen belongs to a family of
medicines called non-steroidal
anti-inflammatory drugs
(NSAIDS). This group of
medicines work by relieving
pain, inflammation (swelling,
redness, soreness) and fever.
Your doctor or pharmacist may
have given you this medicine for
another use.
PHARMACY ACTION
PARACETAMOL & IBUPROFEN IS
NOT RECOMMENDED FOR CHILDREN
UNDER 12 YEARS OF AGE.
IF YOU WANT MORE INFORMATION,
ASK YOUR DOCTOR OR
PHARMACIST.
BEFORE YOU TAKE
PHARMACY ACTION
PARACETAMOL & IBUPROFEN
_WHEN YOU MUST NOT TAKE IT _
You should not take
PHARMACY ACTION
Paracetamol & Ibuprofen if you
are allergic to:
•
paracetamol or ibuprofen,
aspirin, other NSAIDs;
•
any of the ingredients listed
under ‘Product Description’.
The symptoms of an allergic
reaction may include:

                                
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제품 특성 요약

                                AUSTRALIAN PRODUCT INFORMATION – PHARMACY ACTION
PARACETAMOL & IBUPROFEN
(PARACETAMOL AND IBUPROFEN) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Paracetamol and ibuprofen.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500 mg and Ibuprofen 200 mg.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Pharmacy Action Paracetamol & Ibuprofen tablets are white to off
white, oval shaped, biconvex, film-
coated pearlescent tablets plain on both sides.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Temporary relief of acute (short term) pain and/or inflammation
associated with headache, migraine
headache, tension headache, sinus pain, toothache, dental procedures,
backache, muscular aches and
pains, period pain, sore throat, tennis elbow, rheumatic pain and
arthritis, and the aches and pains
associated with colds and flu. Reduces fever.
4.2 DOSE AND METHOD OF ADMINISTRATION
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms (see
SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
Adults under 65 and children over 12 years: Take 1 tablet three times
a day when necessary (every 8
hours). Maximum 3 tablets in 24 hours.
Keep to the recommended dose. Do not take for more than 3 days at a
time (2 days for adolescents
aged 12 to 17 years) unless on medical advice, in which case the
patient should be reviewed regularly
with regard to efficacy, risk factors and ongoing need for treatment.
Do not give to children under 12 years of age.
Not recommended for adults 65 years and over.
Pregnancy: see Section 4.3 Contraindications and Section 4.6
Fertility, pregnancy and lactation
Pharmacy Action Paracetamol & Ibuprofen v3.0
Page 2 of 15
(paracetamol and ibuprofen) film-coated tablet
_Monitoring advice: _if symptoms persist please consult your
healthcare professional.
4.3 CONTRAINDICATIONS
•
Known
hypersensitivity
or
idiosyncratic
reaction
to
ibuprofen,
paracetamol,
or
any
other
ingredients in the product listed in 
                                
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