Ibuprofen FAIR-MED 600mg film-coated tablet

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IBUPROFEN

Available from:

FAIR-MED HEALTHCARE GmbH Planckstr. 13, 22765 Hamburg, Germany

ATC code:

M01AE01

INN (International Name):

IBUPROFEN 600 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

IBUPROFEN 600 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Withdrawn

Authorization date:

2013-03-01

Patient Information leaflet

Page 1 of 9 
PACKAGE LEAFLET: INFORMATION FOR THE USER 
IBUPROFEN FAIR-MED600 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 or pharmacist. 
- This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if 
their symptoms are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side 
effects not listed in this leaflet. 

WHAT IS IN THIS LEAFLET: 
1. What Ibuprofen FAIR-MED is and what it is used for 
2. What you need to know before you take Ibuprofen FAIR-MED 
3. How to take Ibuprofen FAIR-MED 
4. Possible side effects 
5. How to store Ibuprofen FAIR-MED 
6. Contents of the pack and other information 

1. WHAT IBUPROFEN FAIR-MED IS AND WHAT IT IS USED FOR 

Ibuprofen FAIR-MEDbelongs to a group of medicines called Non-Steroidal
Anti-Inflammatory 
Drugs (NSAIDs). These medicines provide relief by changing how the
body responds to pain and 
swelling. 

Ibuprofen FAIR-MED is used for the symptomatic treatment of pain and
inflammation in  arthritic 
diseases, (e.g. rheumatoid arthritis), degenerative arthritic
conditions (e.g. osteoarthritis) and in 
painful swelling and inflammation after soft tissue injuries. 

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN FAIR-MED 

DO NOT TAKE IBUPROFEN FAIR-MED 
- if you are allergic to ibuprofen or any of the other ingredients of
this medicine (listed in section 6) 
- if you have ever suffered from shortness of breath, asthma, a runny
nose, swelling or hives after 
using acetylsalicylic acid (known as aspirin) or other similar
painkillers (NSAIDs) 
-  if you have (or have had two or more episodes of ) a stomach
ulcer or bleeding of the stomach 
-  if you have a history of gastro-i

Summary of Product characteristics

Page 1 of 15 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. NAME OF THE MEDICINAL PRODUCT 

Ibuprofen FAIR-MED 600 mg film-coated tablet 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each film-coated tablet contains 600 mg ibuprofen 

Ibuprofen FAIR-MED contains 42mg lactose. 

For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL FORM 

Film-coated tablet. 

White coloured, film coated pillow shaped tablets de-bossed with
‘237’ on one side and plain on the 
other. 

4. CLINICAL PARTICULARS 

4.1 THERAPEUTIC INDICATIONS 

Symptomatic treatment of pain and inflammation in arthritic
diseases (e.g. rheumatoid arthritis), 
degenerative arthritic conditions (e.g. osteoarthritis) and in painful
swelling and inflammation after 
soft tissue injuries. 

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 

Posology 

Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration 
necessary to control symptoms (see section 4.4). 

The ibuprofen dose depends on the patient’s age and body weight.
The recommended dose range 
for adults lies between 1200 mg and 2400 mg ibuprofen per day. The
maximum single daily dose 
for adults should not exceed 800 mg of ibuprofen. 

AGE 
SINGLE DOSE IN MG 
MAXIMUM DAILY DOSE 
IN MG 
Adults  
600 mg ibuprofen 
1200-2400 mg 
ibuprofen 

_RHEUMATIC DISEASES _
_Adults:_ 
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The usual dose is 600 mg 3 times a day. Maintenance doses of 600
mg-1200 mg daily may be 
effective in some patients. In acute and severe conditions the dose
may be increased to a maximum 
of 2400 mg in divided doses. 
In rheumatic diseases the use of Ibuprofen FAIR-MED can be required
for a longer period. The 
treating physician decides on the duration of treatment. 
_ _
SPECIAL PATIENT GROUPS 
Paediatric population: 
Ibuprofen FAIR-MED is contraindicated in children and adolescents. 
_ _

_ELDERLY _
NSAIDs should be used with particular caution in elderly pa