Ibuprofen FAIR-MED 400mg 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 400 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

IBUPROFEN 400 mg

Prescription type:

OTC

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Withdrawn

Authorization date:

2013-03-01

Patient Information leaflet

Page 1 of 10 

PACKAGE LEAFLET: INFORMATION FOR THE USER 
IBUPROFEN FAIR-MED200 MG FILM-COATED TABLETS 
IBUPROFEN FAIR-MED400 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 effect, talk to your doctor or pharmacist.
This includes any possible side effects 
not listed in this leaflet. 

READ ALL OF THIS LEAFLET CAREFULLY  BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU 
Always take this medicine exactly as described in this leaflet or as
your doctor,  pharmacist or nurse 
have told you. 
-Keep this leaflet. You may need to read it again. 
-Ask your pharmacist if you need more information or advice.  
-If  you get any side effects talk to your doctor or pharmacist. This
includes any possible side 
effects not listed in this leaflet. 
- You must contact a doctor if your symptoms worsen or do not
improve after 3 days if you have 
fever or migraine headache and after 4 days for the treatment of pain.

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 
high temperature.  

Ibuprofen FAIR-MED is used for the symptomatic treatment of: mild to
moderate p

Summary of Product characteristics

Page 1 of 16 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. NAME OF THE MEDICINAL PRODUCT 

Ibuprofen FAIR-MED 200 mg film-coated tablet 
Ibuprofen FAIR-MED 400 mg film-coated tablet 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each film-coated tablet contains 200 mg ibuprofen. 
Each film-coated tablet contains 400 mg ibuprofen 

Ibuprofen FAIR-MED contains 14mg lactose. 
Ibuprofen FAIR-MED contains 28mg lactose. 

For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL FORM 

Film-coated tablet. 

200mg 
White coloured, film coated pillow shaped tablets debossed with
‘235’ on one side 
and plain on the other. 
400mg 
White coloured, film coated pillow shaped tablets debossed with
‘236’ on one side 
and plain on the other. 

4. CLINICAL PARTICULARS 

4.1 THERAPEUTIC INDICATIONS 

For the symptomatic treatment of mild to moderate pain, such as
headache, acute 
migraine headache with or without aura,  period pain, dental pain,
and fever and pain 
in the common cold._ _

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)._ _
200 mg strength: Suitable for adult and children from 20kg (around 6
years old) 
400 mg strength: Suitable for adults and adolescents from 40 kg (12
years and older) 

If this product is required for more than 3 days in the case of fever
or migraine 
headache, or for more than 4 days for pain relief, or if the
symptoms worsen the 
patient is advised to consult a doctor. 
Page 2 of 16 

ADULTS AND ADOLESCENTS ≥40 KG:  
Initial dose, 200 mg or 400 mg ibuprofen. If necessary additional
doses of 200 mg or 
400 mg of ibuprofen can be taken. The respective dosing interval
should be chosen in 
line with the observed symptoms and the maximum recommended daily
dose. It 
should not be below 6 hours for the 400 mg dose and not below