FELDENE GEL

Land: Maleisië

Taal: Engels

Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Werkstoffen:

PIROXICAM

Beschikbaar vanaf:

PFIZER (MALAYSIA) SDN. BHD.

INN (Algemene Internationale Benaming):

PIROXICAM

Eenheden in pakket:

25gm1Units Units

Geproduceerd door:

PT PFIZER (INDONESIA)

Bijsluiter

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
FELDENE
™
GEL
Piroxicam (5 mg)
1
PLD TITLE
:Feldene Gel
PLD DATE
:14 June 2019
COUNTRY
:Malaysia
REFERENCE DOCUMENT.
:Malaysia LPD dated 25
th
June 2014
REASON FOR CHANGE
:To update PRH address
:To update serial number
Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
FELDENE
™ GEL
Piroxicam (5 mg)
2
WHAT IS IN THIS LEAFLET
1.
What Feldene Gel is used for
2.
How Feldene Gel works
3.
Before you use Feldene Gel
4.
How to use Feldene Gel
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Feldene Gel
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT FELDENE GEL IS USED FOR
Feldene Gel is used for the
treatment of

osteoarthritis of joints

inflammation and swelling of
tendons and structures around a
joint

sprains and strains

low back pain
HOW FELDENE GEL WORKS
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.
BEFORE YOU USE FELDENE GEL
-
_When you must not use it _
_ _
Do not use Feldene Gel if you
have ever had an allergic reaction
to Feldene Gel or any other form
of piroxicam.
Feldene Gel should not be given
to patients in whom aspirin or
any other medicines used to treat
painful joints and muscles
(NSAIDS) induce symptoms like
difficulty in breathing,
inflammation of mucous
membrane of nose, swelling of
and itching of skin.
_Pregnancy and lactation _
Do not take Feldene Gel if you
are pregnant, trying to get
pregnant or think you may be
pregnant.
Do not take Feldene Gel if you
are breast-feeding. Ask your
doctor or pharmacist for advice
before taking any medicine.
-
_Before you start to use it_
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
from any of the f

Productkenmerken

Pfizer Confidential 1
LPD Title : Feldene Gel
Country : Malaysia
LPD Date : 29 August 2018
Reference : CDS version 7.0 dated 15 September 2016
Reason : To update administrative error in section 5.3 from CDS.
FELDENE*
0BPiroxicam
1BGEL
For external use only
1. TRADE NAME(S) OF THE MEDICINAL PRODUCT
FELDENE
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2BActive ingredient: anhydrous piroxicam
3. PHARMACEUTICAL FORM
Gel: 0.5% (5 mg per gram of gel) by weight anhydrous piroxicam
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
Piroxicam topical is indicated for a variety of conditions characterized by pain and
inflammation such as osteoarthritis (arthrosis, degenerative joint disease), post -traumatic or
acute musculoskeletal disorders including tendinitis, tenosynovitis, periart hritis, sprains,
strains and low back pain.
4.2 Posology and Method of Administration
This product is intended for external use only. A 1 gram dose of the 0.5% gel
(corresponding to 5 mg of piroxicam) should be applied to the affected site three or four
times per day.
After assessing the risk/benefit ratio in each individual patient, the lowest effective dose
for the shortest possible duration should be used. No occlusive dressing should be employed. Rub in the gel, leaving no residual material
on the skin.