Nurofen Plus Tablets Ibuprofen 200mg Codeine Phosphate Hemihydrate 12.8mg

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Codeine phosphate hemihydrate; Ibuprofen

Beszerezhető a:

Imbat Limited

ATC-kód:

N02AJ; N02AJ08

INN (nemzetközi neve):

Codeine phosphate hemihydrate; Ibuprofen

Adagolás:

200 mg/12.8 milligram(s)

Gyógyszerészeti forma:

Film-coated tablet

Recept típusa:

Product not subject to medical prescription

Terápiás terület:

Opioids in combination with non-opioid analgesics; codeine and ibuprofen

Engedélyezési státusz:

Authorised

Engedély dátuma:

2009-10-30

Betegtájékoztató

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
NUROFEN
® PLUS TABLETS
IBUPROFEN 200MG
CODEINE PHOSPHATE HEMIHYDRATE 12.8MG
Your medicine is available using the above name, but will be
referred to as ‘Nurofen Plus Tablets’ throughout this leaflet.
ADVANCED DUAL ACTION FOR POWERFUL RELIEF
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. However, you
will still need to take Nurofen Plus Tablets carefully to get the
best results from them.

Keep this leaflet. You may need to read it again.

Ask you 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 Plus Tablets are and what are they used
for
2.
What you need to know before you take Nurofen Plus
Tablets
3.
How to take Nurofen Plus Tablets
4.
Possible side effects
5.
How to store Nurofen Plus Tablets
6.
Contents of the pack and other information
1.
WHAT NUROFEN PLUS TABLETS ARE AND WHAT
ARE THEY USED FOR
Nurofen Plus Tablets contain two active ingredients – each
tackles pain in a different way: Ibuprofen belongs to a group
of medicines known as non-steroidal anti-inflammatory drugs
(NSAIDs) and works to relieve inflammation and pain at
source. The product also contains Codeine. Codeine belongs
to a group of medicines called opioid analgesics which act to
relieve pain. It can be used on its own or in combination with
other pain killers such as paracetamol. Together they change
the body’s response to pain and swelling to provide relief.
Nurofen Plus Tablets have been specially formulated for use
when you need pain relief for example RHEUMATIC AND
MUSCULAR PAIN, MIGRAINE, CRAMPING PERIOD PAIN, DENTAL
PAIN, BACKACHE, FEVER AND SYMPTOMS OF COLD & FLU.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
NUROFEN PLUS TABL

Termékjellemzők

Health Products Regulatory Authority
30 July 2019
CRN0091PH
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nurofen Plus Tablets Ibuprofen 200mg Codeine Phosphate Hemihydrate
12.8mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Ibuprofen 200mg and Codeine Phosphate Hemihydrate
12.8mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet (Tablet)
_Product imported from the UK:_
Nurofen Plus are white, film-coated torpedo-shaped tablets embossed
with ‘N+’ on one side and plain on the other.
4 CLINICAL PARTICULARS
As per PA0979/034/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0979/034/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Microcrystalline cellulose
Sodium starch glycolate
Hypromellose
Pregelatinised starch
Talc
Opaspray white M-1-7111B
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
blister strips and outer carton of the product as marketed 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 light.
6.5 NATURE AND CONTENTS OF CONTAINER
Rebox containing blister strips of 12 or 24 tablets.
Pack size: 12 or 24 tablets.
Not all pack sizes may be marketed.
Health Products Regulatory Authority
30 July 2019
CRN0091PH
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Imbat Limited
Unit L2
North Ring Business Park
Santry
Dublin 9
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1151/126/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 30
th
October 2009
10 DATE OF REVISION OF THE TEXT
November 2015