Nurofen Plus Tablets; Ibuprofen 200mg Codeine Phosphate Hemihydrate 12.8mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CODEINE PHOSPHATE, HEMIHYDRATE, IBUPROFEN

Available from:

Reckitt Benckiser Ireland Ltd 7 Riverwalk Citywest Business Campus Dublin 24 , Ireland

ATC code:

N02AJ

INN (International Name):

CODEINE PHOSPHATE HEMIHYDRATE 12.8 mg IBUPROFEN 200 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

CODEINE PHOSPHATE HEMIHYDRATE 12.8 mg IBUPROFEN 200 mg

Prescription type:

OTC

Therapeutic area:

ANALGESICS

Authorization status:

Authorised

Authorization date:

2006-02-28

Patient Information leaflet

NUROFEN PLUS TABLETS
Ibuprofen 200mg
Codeine Phosphate Hemihydrate 12.8mg
ADVANCE DUAL ACTION POWEFUL 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. 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, worsening of asthma, allergic
rash or

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. TRADE NAME OF THE MEDICINAL PRODUCT
Nurofen Plus Tablets
Ibuprofen 200mg
Codeine Phosphate Hemihydrate 12.8mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Ibuprofen 200.0 mg and Codeine Phosphate
Hemihydrate 12.8 mg.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated Tablet (Tablet)
Nurofen Plus is a white film coated, biconvex capsule-shaped tablet
embossed with the logo ‘N+’
on one side.
4. CLINICAL PARTICULARS
4.1.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.
This product is indicated in patients older than 12 years of age for
the treatment of acute moderate
pain which is not considered to be relieved by other analgesics such
as paracetamol or ibuprofen alone.
4.2.POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
Codeine should be used at the lowest effective dose for the shortest
period of time. This dose may
be taken up to 4 times daily at intervals of not less than 6 hours.
The maximum daily dose should not
exceed 6 tablets in 24 hours.
The duration of treatment should be limited to 3 days and if no
effective pain relief is achieved the
patients/carers should be advised to seek the views of a physician.
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms
(see section 4.4).
Adults, the elderly and children over 12 years;
Initially two tablets, then if necessary one or two tablets every 6
hours.
Paediatric population:
Children aged less than 12 years:
Ibuprofen + Codeine combination solid dose strength products should
not be used in children below
the age of 12 years because of the risk of opioid toxicity due to the
variable and unpredictable
metabolism of codeine to morphine (see sections 4.3 & 4.4).
Nurofen Plus is contraindicated in children below the age of 12 years
for the symptomatic treatment
of cough and/or cold (see section 4.3