Nurofen Cold & Flu film-coated tablets Ibuprofen 200mg Pseudoephedrine hydrochloride 30mg

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Ibuprofen; PSEUDOEPHEDRINE HYDROCHLORIDE

Disponibbli minn:

PCO Manufacturing Ltd.

Kodiċi ATC:

M01AE; M01AE51

INN (Isem Internazzjonali):

Ibuprofen; PSEUDOEPHEDRINE HYDROCHLORIDE

Dożaġġ:

200 mg/30 milligram(s)

Għamla farmaċewtika:

Film-coated tablet

Tip ta 'preskrizzjoni:

Product not subject to medical prescription

Żona terapewtika:

Propionic acid derivatives; ibuprofen, combinations

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2014-11-24

Fuljett ta 'informazzjoni

_ _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NUROFEN
®
COLD & FLU FILM-COATED TABLETS
ibuprofen 200 mg
pseudoephedrine hydrochloride 30 mg
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.
Further 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 and 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 swelling of the lips, face,
tongu

Karatteristiċi tal-prodott

Health Products Regulatory Authority
25 November 2021
CRN00CMVD
Page 1 of 3
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
Active Ingredients
Quantity
Ibuprofen
200 mg
Pseudoephedrine Hydrochloride
30 mg
Excipient with known effect: Sunset yellow (E110)
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet
_Product imported from Greece and Poland:_
Yellow, circular, biconvex, tablets printed in black with an
identifying motif.
4 CLINICAL PARTICULARS
As per PA 0979/033/001
5 PHARMACOLOGICAL PROPERTIES
As per PA 0979/033/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Product imported from Greece
Core:
Tricalcium Phosphate
Microcrystalline Cellulose
Povidone
Croscarmellose Sodium
Magnesium stearate
Film Coating:
Hypromellose
Talc
Opaspray yellow M-1F-6168 or
Mastercoat Yellow FA 0156
Black printing Ink:
Black iron oxide (E172)
Propylene glycol
N-butyl alcohol
Dehydrated ethanol
Isopropyl alcohol
Shellac glaze
Product imported from Poland
Core:
Health Products Regulatory Authority
25 November 2021
CRN00CMVD
Page 2 of 3
Calcium phosphate
Microcrystalline cellulose
Povidone
Croscarmellose sodium
Magnesium stearate
Film coating:
Hypromellose
Talc
Opaspray yellow M-1F-6168 or
Mastercoat Yellow FA 0156 containing:
Titanium dioxide (E171)
Sunset yellow (E110)
Quinoline yellow (E104)
Printing ink:
Iron oxide black (E172)
Propylene glycol
Shellac
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 °C.
Store in the original package in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
A pack consisting of a blister containing 12 tablets. One or two
blisters packed in a cardboard carton (12 or 24 table