Nurofen Plus Tablets Ibuprofen 200 mg Codeine Phosphate Hemihydrate 12.8 mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibuprofen; Codeine phosphate hemihydrate

Available from:

PCO Manufacturing Ltd.

ATC code:

N02AJ; N02AJ08

INN (International Name):

Ibuprofen; Codeine phosphate hemihydrate

Dosage:

200/12.8 milligram(s)

Pharmaceutical form:

Film-coated tablet

Administration route:

Oral use

Units in package:

Blister packs containing 12 or 24 tablets

Prescription type:

Product not subject to medical prescription

Manufactured by:

Reckitt Benckiser Healthcare International Ltd

Therapeutic group:

NSAID

Therapeutic area:

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

Therapeutic indications:

For the relief of pain in such conditions as: rheumatic and muscular pain, backache, migraine, dental pain, dysmenorrhoea, feverishness, symptoms of cold and flu.

Authorization status:

Authorised

Authorization date:

2015-05-29

Patient Information leaflet

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TABLETS
IBUPROFEN 200 MG
CODEINE PHOSPHATE HEMIHYDRATE 12.8 MG
ADVANCED DUAL ACTION 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 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 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. Further Information
1.
WHAT NUROFEN PLUS TABLETS ARE AND WHAT ARE THEY USED FOR?
Nurofen Plus Tablets contains 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 TABLETS
Do not take Nurofen Plus Tablets if you:
–
Are allergic to ibuprofen, codeine, or any of the ingredients of
Nurofen Plus listed in
Section 6
–
Have experienced shortness of breath, wor

Summary of Product characteristics

Health Products Regulatory Authority
06 December 2023
CRN00DXS9
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nurofen Plus Tablets Ibuprofen 200 mg Codeine Phosphate Hemihydrate
12.8 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains ibuprofen 200 mg and codeine phosphate
hemihydrate 12.8 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet (Tablet)
_Product imported from Poland_
Nurofen Plus is a white film-coated, biconvex capsule-shaped tablet
embossed with the logo ‘N+’ on one side.
4 CLINICAL PARTICULARS
As per PA0979/034/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0979/034/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Product imported from the UK
Tablet core:
Microcrystalline cellulose
Sodium starch glycolate
Starch Pregelatinised
Hypromellose
Film coating:
Hypromellose
Opaspray white M-1-7111B
Talc
Product imported from Poland
Tablet core
Microcrystalline cellulose
Sodium starch glycollate
Starch Pregelatinised
Hypromellose
Tablet coating
Hypromellose
Talc
Opaspray white M-1-7111B (containing: hypromellose and titanium
dioxide (E171),)
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
06 December 2023
CRN00DXS9
Page 2 of 2
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container 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
Blister packs containing 12 or 24 tablets in a cardboard carton (OTC
pack sizes).
Not all pack sizes may be marketed.
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
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODU