Flodol Gel

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PIROXICAM

Available from:

Alta Care Laboratoires Piazza di Spagna 6, 00187 Roma, Italy

ATC code:

M02AA07

INN (International Name):

PIROXICAM 1 % (W/W)

Pharmaceutical form:

GEL

Composition:

PIROXICAM 1 % (W/W)

Prescription type:

POM

Therapeutic area:

TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN

Authorization status:

Authorised

Authorization date:

2007-09-10

Patient Information leaflet

1 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

FLODOL 1% GEL 50 G  
Piroxicam 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. 
Keep this leaflet. You may need to read it again. If you
have any further questions, ask your doctor. 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 any of the side effects gets
serious, or if you notice any side effects not listed
in this 
leaflet, please tell your doctor. 

1. 
WHAT FLODOL IS AND WHAT IT IS USED FOR 
FLODOL GEL is for the
treatment of rheumatism, sprains, strains and mild osteoarthritis of joints (knees, 
wrists, ankles etc). 

2. 
BEFORE YOU USE FLODOL 
DO NOT USE FLODOL   
If you are hypersensitive (allergic) to its
active substance or any of the other ingredients.  
If the use of NSAIDs induce symptoms of asthma 

TAKE SPECIAL CARE WITH FLODOL AND INFORM YOUR DOCTOR  
If you are pregnant or breastfeeding  

TAKING OTHER MEDICINES 
Please tell your doctor if you are
taking or have recently taken any other medicines,
including medicines 
obtained without a prescription. The effect
of FLODOL gel may be increased (have a synergic effect) if 
applied concurrently with the administration of other
oral anti-inflammatory medicinal products. 

3. 
HOW TO USE FLODOL 
Wash your hands well before and after applying FLODOL gel. 
Recommended dosage for adults only: Two to three applications
a day on the interested areas, accompanied 
by a light massage until completely absorbed.  
Following application of FLODOL GEL, occlusive dressings must
not be used. Avoid using the product on 
wounds and keep away from eyes and mucous membranes. 

If you have any further questions on the use of this product,
ask your doctor. 

4. POSSIBLE 
SIDE 
EFFECTS 
Immediately�

Summary of Product characteristics

 
          Page 1 of 3 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. TRADE NAME 

    FLODOL GEL 

    ATC CODE: 
     M02AA07 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION   

100g of gel contains: 
Active Ingredient: Piroxicam 1g 

Excipients: Carboxypolymethylene 1g; Ethylic alcohol
16g; Glycerine 4g; Polyethylenglycol 400 11g; 
Methyl p-hydroxybenzoate 0.007g; Propyl p-hydroxybenzoate 0.003g;
Essence of pine 0.1g; 
Monoethanolamine 0.3g; Purified water 66.5g. 

3. PHARMACEUTICAL FORM 

Gel. 

4. CLINICAL INFORMATION 

4.1. THERAPEUTIC INDICATIONS 

FLODOL GEL is a non-steroidal anti-inflammatory agent indicated for
a variety of conditions characterised 
by pain and inflammation, or stiffness. It is effective in the
treatment of osteoarthritis of superficial joints 
such as the knee, acute musculoskeletal injuries, periarthritis,
epicondylitis, tendinitis, and tenosynovitis. 

4.2. DOSES, DIRECTIONS AND ADMINISTRATION  

Recommended dosage for adults only: Two to three applications a
day on the interested areas, accompanied 
by a light massage until completely absorbed. The
treatment length is to be according to therapeutic needs. 
Following application of FLODOL GEL, occlusive dressings must not
be used.  

4.3. CONTRAINDICATIONS 

Hypersensitivity to the active ingredients or
any of the excipients of the product. Piroxicam is contra-
indicated in patients in whom NSAIDs induce symptoms of asthma. 

4.4. SPECIAL PRECAUTIONS FOR USE  

Piroxicam for topical use has a good compliance and there are no
systemic undesirable effects caused by the 
drug. However it is not advisable to use FLODOL GEL
in patients that manifest cross sensitivity to non-
steroidal anti-inflammatory or with known history of
hypersensitivity. 
Avoid using the product on wounds and
keep away from eyes and mucous membranes. 

4.5. INTERACTIONS