Ibuprofen 400mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ibuprofen

Available from:

Zentiva Pharma 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 Tablets 400mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen BP 400.0mg
Excipient(s) with known effect
Sucrose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatic and muscular pain, backache, neuralgia, migraine, headache,
dental
pain, dysmenorrhoea, feverishness, symptoms of cold and influenza.
Pain of non-serious arthritic conditions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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_: One tablet up to
three times a
day as required. The dose should not be repeated more frequently than
every
four hours and no more than three tablets in any 24-hour period.
If in adolescents this medicinal product is required for more than 3
days, or if
symptoms worsen a doctor should be consulted.
_Paediatric population_: Do not give to children under 12 years except
on the
advice of a doctor.
Method of administration
For oral use. The tablets should be swallowed with or after food.
4.3
CONTRAINDICATIONS
Ibuprofen is contraindicated in patients with a hypersensitivity to
the
active substance or to any of the excipients listed in section 6.1.
Ibuprofen should not be used in patients who have previously shown
hypersensitivity
reactions (e.g. asthma, rhinitis, or urticaria) after taking
ibuprofen, aspirin, or other
non-steroidal anti-inflammatory drugs.
Ibuprofen is also contraindicated in patients with a history of
gastrointestinal bleeding or perforation, related to previous NSAID
therapy.
Ibuprofen should not be used in patients with active, or history of,
recurrent
peptic ulcer or gastrointestinal haemorrhage (two or more distinct
episodes
of proven ulceration or bleeding).
Ibuprofen should not be given to patients with conditions involving an
increased tendency to bleeding.
Ibuprofen is also contra