Ibuprofen 200mg tablets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

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下载 资料单张 (PIL)
28-09-2018
下载 产品特点 (SPC)
05-07-2018
下载 公众评估报告 (PAR)
01-12-2011

有效成分:

Ibuprofen

可用日期:

A A H Pharmaceuticals Ltd

ATC代码:

M01AE01

INN(国际名称):

Ibuprofen

剂量:

200mg

药物剂型:

Oral tablet

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 10010100; GTIN: 5012252102826

产品特点

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ibuprofen 200mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
mg/tablet
Ibuprofen
200mg
Each tablet contains 13.333mg lactose monohydrate.
For full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated Tablets (Tablets)
A white, pillow-shaped, film-coated, tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
P
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.
GSL
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
P and GSL:
For oral administration and short-term use only.
Undesirable effects may be minimised by using the lowest effective
dose for
the shortest duration necessary to control symptoms (see section 4.4).
Adults, the elderly and children over 12 years:
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.
One to two (200-400 mg) tablets to be taken up to three times a day,
as
required.
Leave at least four hours between doses and do not take more than 6
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
P and GSL
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-steroid
                                
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