PHARMACY ACTION IBUPROFEN 400 ibuprofen 400 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ibuprofen, Quantity: 400 mg

Available from:

Generic Health Pty Ltd

INN (International Name):

Ibuprofen

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: sodium lauryl sulfate; povidone; colloidal anhydrous silica; macrogol 6000; stearic acid; croscarmellose sodium; titanium dioxide; purified water; purified talc; hypromellose; microcrystalline cellulose; lactose monohydrate

Administration route:

Oral

Units in package:

40, 12, 10, 50, 20, 30

Prescription type:

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

Therapeutic indications:

For the temporary relief of 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, arthritis, rheumatic pain and aches and pains associated with colds and flu. Reduces fever.

Product summary:

Visual Identification: white to off-white, pillow shaped, film coated tablets, plain on both sides; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-10-06

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
PHARMACY ACTION IBUPROFEN 400
(IBUPROFEN) FILM-COATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Pharmacy Action Ibuprofen 400.
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 pharmacist or
doctor has weighed the risks of
you taking Pharmacy Action
Ibuprofen 400 against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to
read it again.
WHAT PHARMACY ACTION
IBUPROFEN 400 IS USED FOR
Pharmacy Action Ibuprofen 400
is used for the temporary relief
of 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;
•
arthritis;
•
rheumatic pain; and
•
the aches and pains
associated with colds and flu.
It also reduces fever.
Ibuprofen belongs to a group of
medicines called non-steroidal
anti-inflammatory drugs (or
NSAIDs).
ASK YOUR PHARMACIST OR
DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT THIS
MEDICINE. Your pharmacist or
doctor may have given it to you
for another reason.
Pharmacy Action Ibuprofen 400
is only available from your
pharmacist.
Pharmacy Action Ibuprofen 400
is not addictive.
BEFORE YOU TAKE
PHARMACY ACTION
IBUPROFEN 400
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE PHARMACY ACTION
IBUPROFEN 400 IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
ibuprofen, aspirin or other
NSAIDs;
•
any of the ingredients listed
at the end of this leaflet.
Many medicines used to treat
headache, period pain and other
aches and pains contain aspirin
or NSAID medicines. If you are
not sure if you are taking any of
these medicines, ask your
pharmacist.
Some of the symptoms of an
allergic reaction may include:
•
asthma, wheezing or
s

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – PHARMACY ACTION
IBUPROFEN 400
(IBUPROFEN) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Ibuprofen.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Ibuprofen 400 mg.
List of excipients with known effect: lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
White to off-white, pillow-shaped, film coated tablets, plain on both
sides.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the temporary relief of 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, arthritis, rheumatic pain and
aches and pains associated with
colds and flu. Reduces fever.
4.2 DOSE AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN 12 YEARS AND OVER
The recommended dose is one tablet to be taken every 4 to 6 hours as
necessary. (Maximum 3 tablets
in 24 hours).
Do not exceed the recommended dose.
CHILDREN UNDER 12 YEARS
Pharmacy Action Ibuprofen 400 should not be administered to children
aged less than 12 years.
This product should not be used for more than 3 days at a time except
on medical advice, in which case
the patient should be reviewed regularly with regards to efficacy,
risk factors and ongoing need for
treatment. Excessive use can be harmful and increase the risk of heart
attack, stroke or liver damage.
Pharmacy Action Ibuprofen 400 v3.0
Page 2 of 11
(ibuprofen) film-coated tablet
4.3 CONTRAINDICATIONS
Ibuprofen is contraindicated for use in patients with:
•
known hypersensitivity or idiosyncratic reaction to ibuprofen (or any
of the inactive ingredients);
•
known hypersensitivity to aspirin and other NSAIDs;
•
asthma that is aspirin or NSAID sensitive;
•
active gastrointestinal bleeding or peptic ulceration;
•
renal impairment;
•
heart failure;
•
severe liver impairment;
•
undergoing treatment of perioperative pain in a setting of coronary
artery bypass surg