Nurofen Cold & Flu Film-Coated TabletsIbuprofen 200mgPseudoephedrine hydrochloride 30mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PSEUDOEPHEDRINE HYDROCHLORIDE; Ibuprofen

Available from:

Imbat Limited

ATC code:

M01AE; M01AE51

INN (International Name):

PSEUDOEPHEDRINE HYDROCHLORIDE; Ibuprofen

Dosage:

200/30 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Propionic acid derivatives; ibuprofen, combinations

Authorization status:

Authorised

Authorization date:

2017-07-21

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
NUROFEN
®
COLD & FLU FILM-COATED TABLETS
Ibuprofen 200mg
Pseudoephedrine Hydrochloride 30mg
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. However, you
still need to take Nurofen Cold & Flu Film-Coated Tablets
carefully to get the best results from them.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or
advice.

You must contact a doctor if your symptoms worsen or
do not improve after 3 days.

If any of the side-effects gets serious, or if you notice
any side-effect not listed in this leaflet, please tell your
doctor or pharmacist.
IN THIS LEAFLET:
1.
What Nurofen Cold & Flu Film-Coated Tablets are and
what they are used for
2.
Before you take Nurofen Cold & Flu Film-Coated Tablets
3.
How to take Nurofen Cold & Flu Film-Coated Tablets
4.
Possible side effects
5.
How to store Nurofen Cold & Flu Film-Coated Tablets
6.
Contents of the pack and other information
1.
WHAT NUROFEN COLD & FLU FILM-COATED
TABLETS ARE AND WHAT THEY ARE USED FOR?
Nurofen Cold & Flu Film-Coated Tablets contain two active
ingredients which work together to relieve the major
symptoms of cold & flu: ibuprofen relieves pain, reduces
inflammation and lowers temperature, whilst
Pseudoephedrine Hydrochloride is an effective decongestant
to ease nasal and sinus congestion. Nurofen Cold & Flu
Film-Coated Tablets rapidly relieves the headaches, aches
and the pain and fever commonly associated with colds and
flu and eases blocked noses, sinuses and the pain of sore
throats.
2.
BEFORE YOU TAKE NUROFEN COLD & FLU FILM-
COATED TABLETS
DO NOT TAKE NUROFEN COLD & FLU FILM-COATED TABLETS
IF YOU:

are allergic to ibuprofen, pseudoephedrine hydrochloride,
or any of the ingredients of Nurofen Cold & Flu Film-
Coated Tablets listed in Section 6

have experienced shortness of breath, worsening of
asthma, allergic rash or an itchy, runny nose or swellin

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nurofen Cold & Flu Film-Coated Tablets
Ibuprofen 200mg
Pseudoephedrine hydrochloride 30mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains the active ingredients 200mg ibuprofen and 30mg
pseudoephedrine hydrochloride.
Excipient with known effect: Sunset yellow (E110)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablets
_Product imported from the UK._
Yellow, circular, biconvex, tablets printed in black with an
identifying motif.
4 CLINICAL PARTICULARS
As per PA0979/033/001
This product contains sunset yellow (E110) which may cause allergic
reactions.
5 PHARMACOLOGICAL PROPERTIES
As per PA0979/033/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Core:
Calcium Phosphate
Microcrystalline Cellulose
Povidone
Croscarmellose Sodium
Magnesium stearate
Film Coating:
Hypromellose
Talc
Titanium dioxide
Quinoline yellow
Sunset yellow (contains Aluminium and E110)
Black printing Ink:
Shellac
Black iron oxide (E172)
Propylene glycol
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6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
blister and outer carton of the product as marketed in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25�