Cuprofen Maximum Strength 400mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ibuprofen

Available from:

Reckitt Benckiser Healthcare (UK) Ltd

ATC code:

M01AE01

INN (International Name):

Ibuprofen

Dosage:

400mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5012509973339 5012509973346 5012509974183 5012509980443

Patient Information leaflet

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FOR ADULTS AND CHILDREN & ADOLESCENTS BETWEEN 12 AND 18 YEARS:
• Take one tablet with water up to three times a day as required.
• To be taken preferably with food.
• Leave at least 4 hours between doses.
• Do not take more than three tablets in any 24 hour period.
• Do not exceed the stated dose.
CHILDREN UNDER 12 YEARS:
• Not suitable for children under 12 years.
IF YOU HAVE TAKEN MORE MEDICINE THAN YOU SHOULD, OR IF CHILDREN HAVE
TAKEN THIS MEDICINE BY ACCIDENT, ALWAYS
CONTACT A DOCTOR OR NEAREST HOSPITAL TO GET AN OPINION OF THE RISK AND
ADVICE ON ACTION TO BE TAKEN.
The symptoms can include nausea, stomach pain, vomiting (may be blood
streaked), headache, ringing in the ears, confusion
and shaky eye movement. At high doses, drowsiness, chest pain,
palpitations, loss of consciousness, convulsions (mainly in
children), weakness and dizziness, blood in urine, cold body feeling,
and breathing problems have been reported.
POSSIBLE SIDE EFFECTS
As with all medicines, these tablets can have side effects in some
people. The elderly are more likely to suffer such effects.
If you suffer from any of the following at any time during your
treatment STOP TAKING the medicine and seek immediate medical help:
• Passing blood in your faeces (stools/motions).
• Passing black tarry stools.
• Vomiting any blood or dark particles that look like coffee
grounds.
• Allergic reactions, which can include the following: bruising or
facial swelling; swelling of the lips, throat and tongue
causing difficulty swallowing or breathing; breathing problems, e.g.
unexplained wheezing, shortness of breath, asthma or
worsening of asthma; skin reactions, e.g. skin rashes, itching,
urticaria (hives) which can be severe with blistering and
peeling of the skin; rapid heart rate/palpitations, collapsing or low
blood pressure. Seek medical help immediately.
• Severe skin reaction known as DRESS syndrome. Symptoms of DRESS
include: skin rash, fever, swelling of lymph
nodes and an increase of eosinophils (a

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cuprofen Tablets 400 mg
Ibuprofen Tablets BP 400 mg
Cuprofen Maximum Strength Tablets
Own label: UniChem Extra Strength Ibuprofen 400mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 400 mg
Excipients with known effect:
Lactose
See Section 6.1 for full list of excipients
3
PHARMACEUTICAL FORM
Film-coated tablets (tablets)
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of rheumatic, muscular, dental and period pains and
pain in
backache, neuralgia, migraine and headache, and for the symptomatic
relief of
colds, flu and feverishness.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration and short-term use only.
ADULTS, THE ELDERLY AND CHILDREN AND ADOLESCENTS BETWEEN 12 AND 18
YEARS:
Undesirable effects may be minimised by using the effective dose for
the shortest
duration necessary to control symptoms (see section 4.4).
If in children and adolescents this medicinal product is required for
more than
3 days, or if symptoms worsen a doctor should be consulted.
Adults should consult a doctor if symptoms persist or worsen, or if
the product is
required for more than 10 days.
CHILDREN AND ADOLESCENTS BETWEEN 12 AND 18 YEARS: One tablet up to
three times as
day as required.
ADULTS: One tablet up to three times as day as required.
Leave at least four hours between doses and do not take more than 3
tablets in any 24
hour period.
To be taken preferably after food.
CHILDREN UNDER 12 YEARS:
Not to be given to children under 12 years of age.
4.3
CONTRAINDICATIONS
Hypersensitivity to ibuprofen or any of the excipients in the product.
Patients who have previously shown hypersensitivity reactions (e.g.
asthma, rhinitis,
angioedema or urticaria) in response to aspirin or other non steroidal
anti-
inflammatory drugs.
Active or history of recurrent peptic ulcer/haemorrhage (two or more
distinct
episodes of proven ulceration or bleeding).
History of gastrointestinal bleeding or perforation, relating to
previous NSAIDs
thera