Ibuprofen 400mg tablets

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Ibuprofen

제공처:

Mawdsley-Brooks & Company Ltd

ATC 코드:

M01AE01

INN (International Name):

Ibuprofen

복용량:

400mg

약제 형태:

Oral tablet

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 10010100

환자 정보 전단

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

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ibuprofen 400mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
mg/tablet
Ibuprofen
400mg
Each tablet contains 26.667mg lactose monohydrate.
For full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet for oral use
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of pain of non-serious arthritic conditions and for the
relief of
rheumatic or muscular pain, backache, neuralgia, headache including
migraine
headache, dental pain, dysmenorrhoea, feverishness and the 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:
Undesirable effects may be minimised by using the lowest effective
dose for
the shortest duration necessary to control symptoms (see section 4.4).
The
patient should consult a doctor if symptoms persist or worsen, or if
the product
is required for more than 10 days.
One tablet to be taken up to three times a day, as required.
Leave at least four hours between doses and do not take more than 3
tablets
(1200mg) in any 24 hour period.
Adolescents (12-18 years old):
If this medicinal product is required for more than 3 days, or if
symptoms
worsen a doctor should be consulted.
Children under 12 years:
Not suitable for children under 12 years.
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 ibuprofen, 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 (NYHA Class IV), renal failure or hepatic failure
(see
section 4.4).
Last trimester of pregnancy (see section 4.6).
Children u