Nurofen Plus tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ibuprofen; Codeine phosphate

Available from:

Reckitt Benckiser Healthcare (UK) Ltd

ATC code:

N02AJ08

INN (International Name):

Ibuprofen; Codeine phosphate

Dosage:

200mg ; 12.8mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

Schedule 5 (CD Inv)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5000167016642 5000167016635 5000167094305 5000158101043

Patient Information leaflet

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00000000
Nurofen
Adult
Stronger Pain
Plus
24 / 32Capsule
RB307491
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Generic RB
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TR1346702
Paper White
UK
01/05/18
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- RR - 01/05/18 13:37:15
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• IF YOU HAVE HEART PROBLEMS, HAVE HAD A STROKE OR THINK
THAT YOU MIGHT BE AT RISK OF THESE CONDITIONS (for
example if you have high blood pressure, diabetes, high
cholesterol or are a smoker), you should discuss your
treatment with your doctor or pharmacist.
• Codeine is transformed to morphine in the liver by an
enzyme. Morphine is the substance that produces pain
relief. Some people have a variation of this enzyme and this
can affec

Summary of Product characteristics

OBJECT 1
NUROFEN PLUS
Summary of Product Characteristics Updated 22-May-2018 | Reckitt
Benckiser Healthcare (UK) Ltd
1. Name of the medicinal product
Nurofen Plus
2. Qualitative and quantitative composition
Active constituents:
Ibuprofen Ph Eur
200.0 mg
Codeine phosphate Ph Eur
12.8 mg
3. Pharmaceutical form
Tablet
4. Clinical particulars
4.1 Therapeutic indications
Nurofen Plus (which contains codeine) is indicated in patients older
than 12 years of age for the short
term treatment of acute, moderate pain (such as rheumatic and muscular
pain, backache, migraine,
headache, neuralgia, period pain and dental pain) which is not
considered to be relieved by other
analgesics such as paracetamol, ibuprofen or aspirin alone.
4.2 Posology and method of administration
POSOLOGY:
Recommended dosage:
_ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS OF AGE: _
One or two tablets every four to six hours.
_CHILDREN AGED 12-18 YEARS:_
One or two tablets every four to six hours.
_CHILDREN UNDER 12 YEARS:_
Nurofen plus (which contains Codeine) 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 and 4.4).
_ELDERLY:_
No special dosage modifications are required for elderly patients,
unless renal or hepatic function is
impaired, in which case dosage should be assessed individually.
Do not take more than 6 tablets in 24 hours.
Leave at least four hours between doses and do not take more than
1200mg in any 24 hour period.
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.
For short term use only. Codeine should be used at the lowest
effective dose for the shortest period of
time necessary to relieve symptoms. The patient should consult a
doctor if symptoms persist or worsen, or
if the product is required for more than 3 days.
METHOD OF ADMINISTRATION
For oral administration
4.3 Contraindic