Nurofen Express Maximum Strength 400 mg tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
06-12-2023
Summary of Product characteristics
(SPC)
06-12-2023
Active ingredient:
Ibuprofen
Available from:
PCO Manufacturing Ltd.
ATC code:
M01AE01
INN (International Name):
Ibuprofen
Dosage:
400 milligram(s)
Pharmaceutical form:
Coated tablet
Prescription type:
Product not subject to medical prescription
Therapeutic area:
ibuprofen
Authorization status:
Authorised
Authorization date:
2017-08-04
Patient Information leaflet
_ _
_ _
EXPRESS
MAXIMUM STRENGTH
ibuprofen (as sodium dihydrate)
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 Express Maximum Strength 400 mg Tablets carefully to
get the best results from it.
–
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
effects not listed in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1.
What Nurofen Express Maximum Strength 400 mg Tablets are and
what they are used for
2.
Before you take Nurofen Express Maximum Strength 400 mg
Tablets
3.
How to take Nurofen Express Maximum Strength 400 mg Tablets
4.
Possible side effects
5.
How to store Nurofen Express Maximum Strength 400 mg Tablets
6.
Further information
1.
WHAT NUROFEN EXPRESS MAXIMUM STRENGTH 400 MG TABLETS ARE
AND WHAT THEY ARE USED FOR
The active ingredient (which makes the medicine work) in Nurofen
Express Maximum Strength 400 mg Tablets is ibuprofen 400 mg (as
sodium dihydrate 512 mg). Ibuprofen belongs to a group of medicines
called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These
medicines work by changing how the body responds to pain, swelling
and high temperature.
Nurofen Express Maximum Strength 400 mg Tablets are used for the
relief of fever and mild to moderate pain such as:
•
headaches, period pain and dental pain
•
muscle pain and backache
•
symptoms of colds and flu, and high temperature (fever)
2.
BEFORE YOU TAKE NUROFEN EXPRESS MAXIMUM STRENGTH 400 MG
TABLETS
DO NOT TAKE THESE TABLETS IF YOU:
•
are allergic (hypersensitive) to ibuprofen or any of the other
ingredients (see Section 6: Further Information)
•
are allergic (hypersensitive) to aspirin or to other painkillers
•
have or ever had
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
06 December 2023
CRN00DXSC
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nurofen Express Maximum Strength 400 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Ibuprofen 400 mg (as sodium dihydrate)
Excipients with known effect: Each tablet contains sucrose and sodium.
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Coated Tablet.
_Product imported from Lithuania:_
A white to off-white, biconvex, round, sugar coated tablet with an
identifying logo in red on one face.
4 CLINICAL PARTICULARS
As per PA0979/032/011
5 PHARMACOLOGICAL PROPERTIES
As per PA0979/032/011
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Croscarmellose sodium (E468)
Xylitol (E967)
Microcrystalline cellulose (E460)
Magnesium stearate (E572)
Colloidal anhydrous silica (E551)
Carmellose sodium (E466)
Talc (E553b)
Acacia spray dried (E414)
Sucrose
Titanium dioxide (E171)
Macrogol 6000 powder
Red print ink*
*(containing: Shellac (E904), iron oxide red (E172), ammonium
hydroxide (E257) and simethicone)
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.
Health Products Regulatory Authority
06 December 2023
CRN00DXSC
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
The blisters are packed into cardboard cartons. Each pack may contain
12 or 24 tablets.
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/430/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 4
th
August 2017
10 DATE OF REVISI
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