Ibuprofen 200mg capsules

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:

200mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5017353503800

Patient Information leaflet

using Ibuprofen 200mg Capsules 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 200mg Capsules
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 e

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ibuprofen 200mg Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 200mg
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
White and pink capsule printed with “IBU 200”.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Rheumatic or muscular pain, pain of non-serious arthritic conditions,
backache, neuralgia, migraine, headache, dental pain, dysmenorrhea
(period
pain), 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: _
The minimum effective dose should be used for the shortest time
necessary to
relieve symptoms.
Swallow 200mg – 400mg (1-2 capsules), preferably with water, up to
three
times a day, as required. Leave at least four hours between doses and
do not
take more than 1200mg (6 capsules) in any 24 hour period.
If in adults this medicinal product is required for more than 10 days,
or if
symptoms worsen the patient should consult a doctor.
If in children and adolescents between 12 and 18 years this medicinal
product
is required for more than 3 days, of if symptoms worsen a doctor
should be
consulted.
Not to be given to children under 12 years.
Undesirable effects may be minimised by using the lowest effective
dose for
the shortest duration necessary to control symptoms (see section 4.4).
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,
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 upper gastrointestinal bleeding or perforation, related to
previous
NSAIDs therapy.
Severe heart failure
(NYHA Class IV)
, renal failure or hepatic failure (see section
4.4 Special Warnings and Preca