Nurofen 200 mg coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibuprofen

Available from:

PCO Manufacturing Ltd.

ATC code:

M01AE01

INN (International Name):

Ibuprofen

Dosage:

200 milligram(s)

Pharmaceutical form:

Coated tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

ibuprofen

Authorization status:

Authorised

Authorization date:

2017-08-25

Patient Information leaflet

_ _
_ _
200 MG COATED TABLETS
ibuprofen
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 200 mg 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 200 mg Coated Tablets are and what they are used
for
2.
Before you take Nurofen 200 mg Coated Tablets
3.
How to take Nurofen 200 mg Coated Tablets
4.
Possible side effects
5.
How to store Nurofen 200 mg Coated Tablets
6.
Further Information
1.
WHAT NUROFEN 200 MG COATED TABLETS ARE AND WHAT
THEY ARE USED FOR
Nurofen 200 mg Coated Tablets contain ibuprofen which belongs to a
group of medicines known as non-steroidal anti-inflammatory drugs
(NSAIDs). NSAIDs provide relief by changing the body’s response to
pain, swelling and high temperature. Each tablet contains 200 mg
ibuprofen. Nurofen 200 mg Coated Tablets provide fast and effective
relief from HEADACHES, DENTAL PAIN, PERIOD PAIN, BACKACHE, MUSCULAR
PAIN, FOR THE SYMPTOMATIC TREATMENT OF OSTEOARTHRITIS, COLD AND FLU
SYMPTOMS AND FEVER.
2.
BEFORE YOU TAKE NUROFEN 200 MG COATED TABLETS:
Do not take Nurofen 200 mg Coated Tablets if you:
–
are allergic to ibuprofen, or any of the ingredients of Nurofen
200mg 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,
tongue or throat when taking ibuprofen, codeine, aspirin or other
similar medicines.
–
are already taking non-steroidal anti-inflammatory medication
(NSAIDs)
–
have ever had stomach bleeding or perforation after taking
ibuprofen, aspirin

Summary of Product characteristics

Health Products Regulatory Authority
04 July 2023
CRN00DK5H
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nurofen 200 mg coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains ibuprofen 200 mg.
Excipient(s) with known effect: Each tablet contains sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet.
_Product imported from the Czech Republic and Lithuania_
White, biconvex, coated tablets with "NUROFEN" printed in black on one
side.
4 CLINICAL PARTICULARS
As per PA0979/032/006
5 PHARMACOLOGICAL PROPERTIES
As per PA0979/032/006
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Sodium Citrate
Croscarmellose Sodium
Stearic Acid
Colloidal anhydrous silica
Sodium Laurilsulphate
Sucrose
Talc
Carmellose Sodium
Titanium Dioxide
Acacia spray dried
Macrogol 6000
Black Printing Ink
(iron oxide black (E172), propylene glycol (E1520), 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 blister and outer package of the product on the market
in the country of origin.
Health Products Regulatory Authority
04 July 2023
CRN00DK5H
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 °C.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister containing 12 tablets packed into cardboard cartons,
containing 12, 24 or 48 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
PPA0465/430/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 25
th
August 2017
Date of last renewal: 25
th
June 2021
10 DATE OF REVISION OF THE TEXT
July 2023