IBUPANE paracetamol 500 mg and ibuprofen 200 mg film coated tablet blister

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Alphapharm Pty Ltd

INN (International Name):

Ibuprofen,Paracetamol

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

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

Prescription type:

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

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.

Product summary:

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: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2016-01-19

Patient Information leaflet

IBUPANE
®
_paracetamol and ibuprofen_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about IBUPANE tablets.
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
IBUPANE tablets 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 ARE IBUPANE
TABLETS USED FOR
IBUPANE tablets contains two
ingredients paracetamol and
ibuprofen that together deliver
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.
•
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.
IBUPANE tablets are not
recommended for children under 12
years of age.
IF YOU WANT MORE INFORMATION, ASK
YOUR DOCTOR OR PHARMACIST.
BEFORE YOU TAKE
IBUPANE TABLETS
_WHEN YOU MUST NOT TAKE IT_
YOU SHOULD NOT TAKE IBUPANE
TABLETS IF YOU ARE ALLERGIC TO:
•
Paracetamol
•
Ibuprofen
•
Aspirin
•
Other NSAIDs or any of the
ingredients listed under "Product
Description".
The symptoms of an allergic reaction
may include:
•
Shortness of breath
•
Wheezing or difficulty breathing
•
Swelling of the face, lips, tongue
or other parts of the body

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
IBUPANE
_paracetamol / ibuprofen tablet _
1
NAME OF THE MEDICINE
Paracetamol and ibuprofen
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg paracetamol and 200 mg ibuprofen as the
active ingredients.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Tablets are white to off white, oval shaped, biconvex, film-coated
pearlescent tablets plain on both side.
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
Adults and children over 12 years: Take 1 tablet three times a day
when necessary (every 8 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).
Do not give to children under 12 years of age.
4.3
CONTRAINDICATIONS
•
Known hypersensitivity or idiosyncratic reaction to ibuprofen,
paracetamol, or any other ingredients
in the product listed in the description section above
•
Hypersensitivity to aspirin or other NSAIDs or analgesic drugs
•
Asthma
•
Pregnancy
•
History of, or active gastrointestinal bleeding or peptic ulceration,
or other stomach disorder
•
Impaired hepatic function, impaired renal function or heart failure
•
Conditions that predispose to renal failure
•
Taking other products containing ibuprofen, paracetamol, aspirin,
salicylates or with other anti-
inflammatory medicines (see
SECTION 4.5 INTERACTIONS WITH OTHER MEDICINES AND
OTHER FORMS OF INTERACTIONS
)
•
Children under 12 years
Refer to
SECTION 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF
INTERACTIONS
for additional information.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
IBU