BRUFEN 600 Milligram Film Coated Tablet

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

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下载 资料单张 (PIL)
07-06-2024
下载 产品特点 (SPC)
07-06-2024

有效成分:

IBUPROFEN

可用日期:

Abbott Laboratories Ireland Ltd

INN(国际名称):

IBUPROFEN

剂量:

600 Milligram

药物剂型:

Film Coated Tablet

处方类型:

Product subject to prescription which may be renewed (B)

授权状态:

Authorised

授权日期:

0000-00-00

资料单张

                                 
Patient Information Leaflet  
 
BRUFEN 600 MG FILM-COATED TABLETS 
Ibuprofen 
 
 
IMPORTANT INFORMATION 
Please read this leaflet carefully before you start taking your
medicine. 
Keep this leaflet as you may need to read it again. 
This leaflet provides a summary of the information currently
available on Brufen 600mg Tablets.  
For further information or advice ask your doctor or pharmacist. 
This medicine is for you and should never be given to anyone else,
even if they appear to have 
the same symptoms as you. 
Tell your doctor or pharmacist if you experience any side effects. 
 
In this leaflet: 
1.  What are Brufen 600mg Tablets and what are they used for? 
2.  What should you know before taking Brufen 600mg Tablets? 
3.  How should you take Brufen 600mg Tablets? 
4.  Possible side effects of Brufen 600mg Tablets 
5.  How should you store Brufen 600mg Tablets? 
6.  Further information about  Brufen 600mg Tablets 
 
 
1. WHAT ARE BRUFEN 600MG TABLETS AND WHAT ARE THEY USED FOR? 
 
Brufen 600mg Tablets belong to a group of medicines called
anti-inflammatory pain killers. 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 600mg Tablets can also be used to treat other painful
conditions such as toothache, pain 
after operations, period pain and headache, including migraine.  
 
The active ingredient in Brufen 600mg Tablets is ibuprofen and each
tablet contains 600mg of 
ibuprofen. 
 
2. WHAT SHOULD YOU KNOW BEFORE TAKING BRUFEN 600MG TABLETS? 
 
DO NOT TAKE BRUFEN 600MG TABLETS IF;
 
•  you are sensitive (allergic) to any of the ingredients in the
tablets.  These are listed in 
Section 6 
•  you previously experience
                                
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产品特点

                                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.
Excipients: each tablet contains 40.0mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (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
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control
symptoms (see section 4.4, _special warnings and special precautions for use_).
Adults: 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.
Children: The recommended dose of Brufen is 20-30 mg/kg bodyweight daily in divided doses but in juvenile
rheumatoid arthritis, the daily dosage may be increased to 40 mg/kg bodyweight in severe cases.
In children weighing less than 30 kg, the total daily dose of Brufen should not exceed 500 mg (the liquid formulation
should be used).
Elderly: No specific dosage modifications are required for elderly patients, unless renal or hepatic function is impaired,
in which case, dosage should be assessed indivi
                                
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