Nurofen Cold & Flu

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE

Available from:

Reckitt Benckiser Healthcare International Limited Thane Road, Nottingham NG90 2DB, United Kingdom

ATC code:

M01BX

INN (International Name):

IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE

Pharmaceutical form:

COATED TABLET

Composition:

IBUPROFEN 200 milligram(s) ; PSEUDOEPHEDRINE HYDROCHLORIDE 30 milligram(s)

Prescription type:

OTC

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2006-02-28

Patient Information leaflet

Reckitt Benckiser
0025 375 article 31 ibup
1.3.1 Package Leaflet
Ibuprofen Pseudoephedrine HCl 200mg 30mg Tablets
Page 1
Reckitt Benckiser
0025 375 article 31 ibup
1.3.1 Package Leaflet
Ibuprofen Pseudoephedrine HCl 200mg 30mg Tablets
Page 2

Summary of Product characteristics

Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nurofen Cold & Flu
Nurofen Sinus Relief
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients
Quantity
Ibuprofen BP
200mg
Pseudoephedrine
Hydrochloride
30mg
3
PHARMACEUTICAL FORM
Yellow film coated tablet. Printed in black with an identifying motif.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of symptoms cold and 'flu with associated congestion,
including
aches and pains, headache, fever, sore throat, blocked nose and
sinuses.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration and short-term use only.
Adults, the elderly and children over 12 years:
Undesirable effects may be minimised by using the lowest effective
dose for
the shortest duration necessary to control symptoms (see section 4.4).
The patient should consult a doctor if symptoms persist or worsen, or
if the
product is required for more than 10 days.
Take 1 or 2 tablets with water, up to three times a day as required.
Leave at least 4 hours between doses.
Do not take more than 6 tablets in any 24 hour period.
Page 2 of 10
Not to be given to children under 12 years.
4.3
CONTRAINDICATIONS
Hypersensitivity to ibuprofen or any of the excipients in the product.
Patients who have previously shown hypersensitivity reactions (e.g.
asthma,
rhinitis, angioedema, or urticaria) in response to aspirin or other
non-steroidal
anti-inflammatory drugs.
Active or history of recurrent peptic ulcer/haemorrhage (two or more
distinct
episodes of proven ulceration or bleeding).
History of gastrointestinal bleeding or perforation, related to
previous NSAIDs
therapy.
Severe heart failure (NYHA Class IV), renal failure or hepatic failure
(see
section 4.4)
Last trimester of pregnancy (see section 4.6)
Patients with serious cardiovascular disease, tachycardia,
hypertension, angina
pectoris,
hyperthyroidism,
diabetes,
phaeochromocytoma,
closed
angle
glaucoma, prostatic enlargement.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Undesirable effects may be minimi