BRUFEN? PAIN ibuprofen 400 mg film-coated tablet blister pack

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

ibuprofen, Quantity: 400 mg

Tilgængelig fra:

Viatris Pty Ltd

Lægemiddelform:

Tablet, film coated

Sammensætning:

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

Indgivelsesvej:

Oral

Enheder i pakken:

20, 12, 36, 48, 28, 10, 24, 30, 6, 40, 50

Recept type:

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

Terapeutiske indikationer:

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.

Produkt oversigt:

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

Autorisation status:

Registered

Autorisation dato:

2023-01-03

Indlægsseddel

BRUFEN
® PAIN
B
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F
E
N
®
P
A
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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.
1.
WHY AM I USING BRUFEN
® PAIN?
Brufen
®
Pain contains the active ingredient ibuprofen. Brufen
®
Pain 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.
For more information, see Section 1. Why am I using Brufen® Pain? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BRUFEN
® PAIN?
Do not use if you have allergy to ibuprofen, aspirin, NSAIDs or any of
the ingredients listed at the end of the CMI.
Talk to your doctor or pharmacist if you have any other medical
conditions, take any other medicines, or are pregnant or plan to
become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use
Brufen® Pain? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Brufen
®
Pain 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 BRUFEN
® PAIN?
•
Adults and Children from 12 years: One tablet every 4 to 6 hours as
necessary. Do not take more than 3 tablets in 24 hours.
•
Do not give to children under 12.
•
Do not exceed recommended dose. Excessive use can be harmful and
increase the risk of heart attack, stroke or liver damage.
More instructions can be found in Section 4. How do I use Brufen®
Pain?in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING BRUFEN
® PAIN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Brufen
®
Pain.
•
If you become pregnant while taking this medicine tell your doctor
immed

Produktets egenskaber

AUSTRALIAN PRODUCT INFORMATION
BRUFEN
® PAIN
_Ibuprofen tablets _
1
NAME OF THE MEDICINE
Ibuprofen
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400 mg of ibuprofen as the active ingredient.
Excipients with known effect: contains sugars (as lactose).
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.
PREGNANCY
See Section 4.3 CONTRAINDICATIONS and Section 4.6 FERTILITY, PREGNANCY
AND
LACTATION.
CHILDREN UNDER 12 YEARS
Brufen
®
Pain 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.
4.3
CONTRAINDICATIONS
Ibuprofen is contraindicated for use in patients with:
BRUFEN
®
PAIN – PRODUCT INFORMATION
2
•
known hypersensitivity or idiosyncratic reaction to ibuprofen (or any
of the inactive ingredients)
•
known hypersitivity 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 settin