FELDENE 5.0 mg/g Gel

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

PIROXICAM

Dostupno od:

Pfizer Limited

ATC koda:

M02AA07

INN (International ime):

PIROXICAM

Doziranje:

5.0 mg/g

Farmaceutski oblik:

Gel

Tip recepta:

Product subject to prescription which may be renewed (B)

Područje terapije:

Oxicams

Status autorizacije:

Authorised

Datum autorizacije:

1988-07-07

Uputa o lijeku

15:59
2016‑0001984/3
276989
Farmasierra
N/A
9.5 pt
Ireland
02
Leaflet
FPO
N/A
300 x 145 mm
Page:
PAR‑2016‑0001984
PROFILE
BLACK
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DATE:

08 AUG 2016 TIME:
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SMALLEST

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PACKAGE LEAFLET: INFORMATION FOR THE USER
IRELAND

FELDENE
®

5MG/G GEL
 piroxicam
READ ALL OF THIS LEAFLET CAREFULLY 
BEFORE YOU START USING 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 only. Do not pass it on to others. 
It may harm them, even if their signs 
of illness 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. See section 4.
WHAT IS IN THIS LEAFLET
1. What Feldene Gel is and what it is used for 
2.  What you need to know before you use 
Feldene Gel
3.  How to use Feldene Gel
4.  Possible side effects
5.  How to store Feldene Gel
6.  Contents of the pack and other 
information
1. WHAT FELDENE GEL IS AND WHAT IT 
IS USED FOR 
Feldene Gel is one of a group of medicines 
called non-steroidal anti-inflammatory drugs 
(NSAIDs). This means it will help to relieve 
pain and reduce swelling affecting joints and 
muscles when rubbed into the skin over the 
affected area.
Feldene Gel is for the treatment of rheumatism, 
sprains, strains and mild osteoarthritis of joints 
(knees, wrists, ankles etc).
2. WHAT YOU NEED TO KNOW BEFORE 
YOU USE FELDENE GEL 
DO NOT USE FELDENE GEL
•   if you have ever had an allergic reaction to 
piroxicam or any of the other ingredients  
of this medicine (listed in section 6), any 
other form of piroxicam, aspirin or any  
other medicines used to treat

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Feldene 5mg/g Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains 5 mg piroxicam (0.5% w/w).
Excipient with known effect: propylene glycol (E1520) 200 mg/g
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel for topical application.
Clear pale yellow gel
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Indications for Use: In the topical management of pain, inflammation, or stiffness associated with osteoarthritis, acute
musculoskeletal disorders such as bursitis, periarthritis, tendinitis, post-traumatic conditions, sprains and lower back
pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults: Apply 1g of the gel, (approximately 3 cms or 1 1/4 inches) to the affected area twice to four times daily.
In the elderly, who are more prone to adverse events, the lowest dose compatible with adequate safe clinical control
should be employed.
Occlusive dressings should not be used.
Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or if intolerance occurs.
Method of administration
Feldene Gel is for external use only.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Paediatric population
Use in children in the absence of experience_._
Use in patients whom asthma, rhinitis or urticaria are induced by aspirin or other non-steroidal anti-inflammatory
agents (NSAIDs).
Use on areas with open skin lesions, dermatoses or infection.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 31/07/2015_
_CRN 2166031_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Undesirable effects ma