Ibuprofen 400mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ibuprofen

Available from:

Galpharm International 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: 5017353502551 5017353502568 5017353502575

Patient Information leaflet

using
Ibuprofen 400mg
Caplets if you develop
these symptoms and seek medical attention
immediately. See also section 2
• Skin becomes sensitive to light - frequency
unknown.
Stomach and bowel problems including:
• indigestion or heartburn
• pains in your stomach (abdomen) or other
abnormal stomach problems
• pass blood in your stools or motions
• pass black tarry stools or motions
• vomit any blood or dark particles that look like
coffee grounds
• worsening of bowel problems (ulcerative
colitis or Crohn’s disease).
Blood disorders which can cause:
• unexplained or unusual bruising or bleeding
• sore throat or mouth ulcers
• fever (high temperature)
• extreme paleness or weakness and exhaustion.
Heart and circulation effects: Medicines such as
Ibuprofen 400mg Caplets may be associated with
a small increased risk of heart attack (myocardial
infarction), high blood pressure, heart failure,
swelling due to fluid build-up (oedema) or stroke.
Other side effects that may occur include:
Other stomach and intestine effects
including:
diarrhoea, flatulence, constipation and vomiting.
Liver problems that might be indicated by
yellowing of the skin and eyes (jaundice) and/or
pale coloured stools and dark urine.
Kidney problems that might be indicated by
passing less or more urine than normal, cloudy
urine, blood in the urine, pain in the back and/or
swelling (particularly of the legs) – very rarely
kidney failure.
Nervous system problems including
headache and aseptic meningitis (which can
have symptoms such as severe headache, stiff
neck, disorientation, fever and eye sensitivity to
light in those with existing auto-immune
disorders such as lupus).
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA
Yellow Card in the Google Play or Apple App Store.
By reporting side eff

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