Ibuprofen 400mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ibuprofen

Available from:

IVAX Pharmaceuticals 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

Patient Information leaflet

PATIENT INFORMATION LEAFLET FOR
IBUPROFEN TABLETS 400MG
_Read this leaflet carefully before taking your medicine. It does not
contain all the information about _
_your medicine that you may need to know, so please ask your doctor or
pharmacist if you have any _
_questions. This leaflet only applies to Ibuprofen Tablets 400mg. _
_ _
1. WHAT THESE TABLETS DO
Ibuprofen is a type of painkiller called a ‘non-steroidal
anti-inflammatory drug’ (NSAID). It is used to
relieve rheumatic and muscular pain, backache, neuralgia, migraine,
headache, dental pain, period
pains, feverishness and the symptoms of cold and flu.
2. CHECK BEFORE YOU TAKE
DO NOT TAKE THESE TABLETS IF YOU:

Are allergic to Ibuprofen or any of the other ingredients listed in
section 6

Have a history of allergy to aspirin, ibuprofen or NSAID’s which
includes attacks of asthma,
swelling of the nose and throat, skin rashes or a runny nose

Have an active or a history of recurrent peptic ulcers (more than two)

Are over six months pregnant

Are already taking aspirin at doses of above 75mg daily or taking any
other NSAID

Have severe liver, kidney or heart problems

Have a history of gastro intestinal bleeding or perforation related to
the use of NSAID’s
WARNINGS AND PRECAUTIONS
Anti-inflammatory pain-killer medicines like ibuprofen may be
associated with a small increased risk
of heart attack or stroke particularly when used at high doses. Do not
exceed the recommended dose
or duration of treatment.
If you have heart problems including heart failure, angina (chest
pain), or if you have had a heart
attack, bypass surgery, peripheral artery disease (poor circulation in
the legs or feet due to narrow or
blocked arteries), or any kind of stroke (including ‘mini-stroke’
or transient ischaemic attack ‘TIA’)
or think that you may be at risk have high blood pressure, diabetes,
high cholesterol, have a family
history of heart disease or stroke, or if you are a smoker.
TAKE SPECIAL CARE AND TELL YOUR DOCTOR IF YOU:

Suffering

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ibuprofen 400mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Ibuprofen 400mg
For excipients, see 6.1
3
PHARMACEUTICAL FORM
Film-Coated tablets
White film coated capsule shaped tablets (caplets) with letter 'I'
marked on
one face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatic
or
muscular
pain,
pain
of
non-serious
arthritic
conditions,
backache,
neuralgia,
migraine,
headache,
dental
pain,
dysmenorrhoea,
feverishness, symptoms of colds and influenza.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration and short-term use only.
Adults, the elderly and children over 12 years: One tablet up to 3
times a day,
as required. Leave at least 4 hours between each dose.
The lowest effective dose should be used for the shortest duration
necessary to
relieve symptoms. The patient should consult a doctor if symptoms
persist or
worsen, or if the product is required for more than 10 days. Leave at
least four
hours between doses and do not take more than 1200mg in any 24 hour
period.
If this medicinal product is required for more than 3 days in children
and
adolescents between the age of 12 to 18 years or if symptoms worsen a
doctor
should be consulted.
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, related to previous NSAIDs therapy.
Severe heart failure, renal failure or hepatic failure (see section
4.4)
Last trimester of pregnancy (see section 4.6)
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Undesirable effects may be minimised by using the lowest effective
dose
for the shortest duration necessary to control sym