NUROFEN COLD & FLU WITH DECONGESTANT tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ibuprofen, Quantity: 200 mg; pseudoephedrine hydrochloride, Quantity: 30 mg

Available from:

Reckitt Benckiser Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; hypromellose; calcium phosphate; povidone; purified talc; microcrystalline cellulose; croscarmellose sodium; titanium dioxide; purified water; sunset yellow FCF; quinoline yellow; industrial methylated spirit; propylene glycol; butan-1-ol; isopropyl alcohol; ethanol absolute; iron oxide black; ethanol; Shellac; strong ammonia solution; sulfuric acid

Administration route:

Oral

Units in package:

4, 24, 4 Trial Pack, 6

Prescription type:

(S3) Pharmacist Only Medicine

Therapeutic indications:

For the relief of the symptoms of colds and flu with associated congestion, including aches and pains, headache, fever, sore throat, runny nose, blocked nose and sinuses.

Product summary:

Visual Identification: Yellow, film coated tablet; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1998-08-24

Patient Information leaflet

Nurofen Cold and Flu
1
NUROFEN® COLD AND FLU
ACTIVE INGREDIENTS: _Ibuprofen 200mg and pseudoephedrine hydrochloride
30mg _
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using
Nurofen Cold and Flu. YOU SHOULD ALSO SPEAK TO YOUR
DOCTOR OR PHARMACIST IF YOU WOULD LIKE FURTHER
INFORMATION OR IF YOU HAVE ANY CONCERNS OR QUESTIONS
ABOUT USING NUROFEN COLD AND FLU.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1.
Why am I using Nurofen Cold and Flu?
2.
What should I know before I use Nurofen Cold and
Flu?
3.
What if I am taking other medicines?
4.
How do I use Nurofen Cold and Flu?
5.
What should I know while using Nurofen Cold and
Flu?
6.
Are there any side effects?
7.
Product details
1.
WHY AM I USING NUROFEN COLD AND FLU?
NUROFEN COLD AND FLU CONTAINS THE ACTIVE INGREDIENTS
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE.
Ibuprofen is used for the relief of the symptoms of colds
and flu, including aches and pains, headache, fever and
sore throat. It belongs to a group of medicines called non-
steroidal anti-inflammatory drugs (NSAIDs).
Pseudoephedrine is used for the relief of the congestion
associated with colds and flu including runny nose, blocked
nose and sinuses. It belongs to a group of medicines called
sympathomimetic decongestants and works by reducing
congestion in the upper respiratory tract, making it easier
to breathe.
NUROFEN COLD AND FLU IS USED FOR THE FAST EFFECTIVE
TEMPORARY RELIEF OF THE SYMPTOMS OF COLDS AND FLU.
2.
WHAT SHOULD I KNOW BEFORE I USE
NUROFEN COLD AND FLU?
WARNINGS
DO NOT USE NUROFEN COLD AND FLU IF:
•
you are allergic to any medicine containing
pseudoephedrine, ibuprofen, aspirin or other NSAIDs,
or any of the ingredients listed at the end of this
leaflet.
Some of 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
-
rash, itching or hives on the skin
Always check the ingredients to make sure you can use
this medicine.
DO NOT USE NU

Summary of Product characteristics

NUROFEN
®
Cold and Flu with Decongestant Tablets Product Information (PI)
-
1 -
AUSTRALIAN PRODUCT INFORMATION – NUROFEN
® COLD AND
FLU WITH DECONGESTANT TABLETS (IBUPROFEN,
PSEUDOEPHEDRINE HYDROCHLORIDE)
1
NAME OF THE MEDICINE
NUROFEN
®
Cold and Flu with Decongestant Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredients in NUROFEN
®
Cold and Flu with Decongestant Tablets are
Ibuprofen 200mg and pseudoephedrine hydrochloride 30mg.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Nurofen Cold and Flu with Decongestant Tablet is a round tablet with a
yellow-coloured
film-coating inscribed with a black logo of a letter ‘N’ in a
letter ‘C’’.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For the temporary relief of the symptoms of colds and flu with
associated congestion,
including aches and pains, headaches, fever, sore throat, runny nose,
blocked nose and
sinuses.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The lowest effective dose should be used for the shortest duration
necessary to relieve
symptoms (see section 4.4)
Adults and children 12 years and over:
Initial dose of 2 tablets then, if necessary, 1 or 2 tablets every 4
hours. Not to be given to
children under 12 years.
Do not exceed 6 tablets in any 24 hour period.
Do not use for a period of more than three 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.
Children: Do not use in children under 12 years of age.
Pregnancy: see Section 4.3 Contraindications and Section 4.6
Fertility, pregnancy and
lactation
Method of administration: For oral administration
NUROFEN
®
Cold and Flu with Decongestant Tablets Product Information (PI)
-
2 -
4.3
C
ONTRAINDICATIONS
Known hypersensitivity to ibuprofen, pseudoephedrine hydrochloride or
any of the
excipients.
Hypersensitivity (e.g. asthma, rhinitis or urticaria) to aspirin or
other non-steroidal anti-
inflammatory drugs.
Use wit