Brufen 600mg film-coated tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Ibuprofen

可用日期:

Mylan IRE Healthcare Limited

ATC代码:

M01AE; M01AE01

INN（国际名称）:

Ibuprofen

剂量:

600 milligram(s)

药物剂型:

Film-coated tablet

给药途径:

Oral use

每包单位数:

Pack size: 60 tablets

处方类型:

Product subject to prescription which may be renewed (B)

厂商:

FAMAR S.A.

治疗组:

Propionic acid derivatives

治疗领域:

Propionic acid derivatives; ibuprofen

疗效迹象:

It is indicated in the symptomatic management of various arthroses such as rheumatoid arthritis (including juvenile rheumatoid arthritis or Still’s disease) and osteoarthritis, fibrositis, ankylosing spondylitis and other muscular syndromes, such as low back pain, soft tissue trauma and various inflammations of tendon, joint capsules and ligaments. It is also used as an analgesic in the relief of mild to moderate pain.

授权状态:

Marketed

授权日期:

1982-06-01

资料单张

Package leaflet: Information for the user
BRUFEN
® 600 MG FILM-COATED TABLETS
ibuprofen
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions ask your doctor, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it to
others it may
harm them even if their signs of illness are the same as yours.
•
If you get side effects talk to your doctor, pharmacist or nurse. This
includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What Brufen is and what it is used for
2.
What you need to know before you take Brufen
3.
How to take Brufen
4.
Possible side effects
5.
How to store Brufen
6.
Contents of the pack and other information
The full name of your medicine is BRUFEN 600MG FILM-COATED TABLETS. In
this leaflet, the
shorter name Brufen is used.
1. WHAT BRUFEN IS AND WHAT IT IS USED FOR
Brufen belong to a group of medicines called anti-inflammatory pain
killers.
The active ingredient in Brufen is ibuprofen and each tablet contains
600mg of
ibuprofen.
They can be used to relieve pain and inflammation in conditions such
as osteoarthritis,
rheumatoid arthritis (including juvenile rheumatoid arthritis or
Still's disease), arthritis of
the spine (ankylosing spondylitis), swollen joints, frozen shoulder,
bursitis, tendonitis,
tenosynovitis, lower back pain, sprains and strains.
Brufen can also be used to treat other painful conditions such as
toothache, pain after
operations, period pain and headache, including migraine.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BRUFEN
DO NOT TAKE BRUFEN
•
if you are allergic to ibuprofen or any of the ingredients of this
medicine (listed in
Section 6)
•
if you previously experienced stomach bleeding or perforation after
taking
ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs)
•
if you currently have a peptic ulcer (ulcer in your stom

产品特点

Health Products Regulatory Authority
11 November 2022
CRN00D7DJ
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brufen 600mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 600 mg of ibuprofen.
Excipient(s) with known effect: each tablet contains 40mg of lactose
monohydrate.
For the full list of the excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
A white, pillow-shaped, film-coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Brufen is indicated in the symptomatic management of various arthroses
such as rheumatoid arthritis (including juvenile
rheumatoid arthritis or Still’s disease) and osteoarthritis,
fibrositis, ankylosing spondylitis and other muscular syndromes, such
as low back pain, soft tissue trauma and various inflammations of
tendon, joint capsules and ligaments.
Brufen is also used as an analgesic in the relief of mild to moderate
pain.
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 AND ADOLESCENTS OLDER THAN 12 YEARS (≥ 40KG) The recommended
dosage of Brufen is 1200-1800 mg daily in divided
doses. Some patients can be maintained on 600-1200 mg daily. The total
daily dose should not exceed 2400 mg.
PAEDIATRIC POPULATION
Brufen 600mg film-coated tablets are not suitable for use inchildren
under 12 years of age.
ELDERLY
No specific dosage modifications are required for elderly patients,
unless renal or hepatic function is impaired, in which case,
dosage should be assessed individually.
NSAIDs should be used with particular caution in elderly patients who
are more prone to adverse events. The lowest dose
compatible with adequate safe clinical control should be employed.
(See also Section 4.4). Treatment should be reviewed at
regular intervals and discontinued if no benefit is seen or
intolerance occurs.
RENAL IMPAIRMENT
No dose reduction is required in patients with mild t