Feldene 5mg/g Gel

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Piroxicam

Tilgjengelig fra:

Pfizer Healthcare Ireland

ATC-kode:

M02AA; M02AA07

INN (International Name):

Piroxicam

Dosering :

5.0 milligram(s)/gram

Legemiddelform:

Gel

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Antiinflammatory preparations, non-steroids for topical use; piroxicam

Autorisasjon status:

Not marketed

Autorisasjon dato:

1988-07-07

Informasjon til brukeren

Page 1 of 6
2020-0061718, 2020-0061785, 2020-0061957
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 painful joints and muscles. This may have been
itching,
reddening of the skin or difficulty in breathing.

on broken, damaged, infected or diseased skin.

if you are under 12 years of age.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Feldene Gel. Medicines
are not always
suitable for everyone. Your doctor needs to know
BEFORE
you use Feldene Gel if you suffer
from or have suffered in the past fro

Preparatomtale

Health Products Regulatory Authority
20 August 2021
CRN009Z80
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Feldene 5mg/g Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains 5mg piroxicam (0.5% w/w).
Excipients with known effect:
Feldene Gel contains 200 mg/g propylene glycol, 10 mg/g benzyl alcohol
and 240 mg/g anhydrous ethanol.
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, tendonitis, 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
20 August 2021
CRN009Z80
Page 2 of 5
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Undesirable effects may be reduced by using the minimum effective dose
for the shortest possible duration. Patients treated
with NSAIDs long term should undergo regular medical supervision to
monitor for adverse events.
Piroxicam