Voltarol Emulgel Extra Strength 2% w/w gel

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Diclofenac sodium

Beschikbaar vanaf:

IMED Healthcare Ltd.

ATC-code:

M02AA; M02AA15

INN (Algemene Internationale Benaming):

Diclofenac sodium

farmaceutische vorm:

Gel

Therapeutisch gebied:

Antiinflammatory preparations, non-steroids for topical use; diclofenac

Autorisatie datum:

2024-01-26

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
VOLTAROL
® EMULGEL
® EXTRA STRENGTH 2% W/W GEL
diclofenac diethylammounium 2.32% w/w corresponding to
diclofenac sodium 2% w/w (20mg/g)
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU. This medicine is available
without prescription. However, you still need to use VOLTAROL
EMULGEL EXTRA STRENGTH 2% W/W GEL carefully to get the
best results from it.
Always use this medicine exactly as described in this leaflet.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or
advice.

You must contact a doctor if your signs of illness worsen or
do not improve within 7 days.

If you get any side effects which worry you (even side
effects not listed in this leaflet), talk to your doctor or
pharmacist.
WHAT IS IN THIS LEAFLET
1.
What VOLTAROL EMULGEL EXTRA STRENGTH 2% W/W GEL is
and what it is used for
2.
What you need to know before you use VOLTAROL EMULGEL
EXTRA STRENGTH 2% W/W GEL
3.
How to use VOLTAROL EMULGEL EXTRA STRENGTH 2% W/W
GEL
4.
Possible side effects
5.
How to store VOLTAROL EMULGEL EXTRA STRENGTH 2% W/W
GEL
6.
Contents of the pack and other information
1.
WHAT VOLTAROL EMULGEL EXTRA STRENGTH 2% W/W GEL IS
AND WHAT IT IS USED FOR
VOLTAROL EMULGEL EXTRA STRENGTH 2% W/W GEL contains the
active substance diclofenac which belongs to a group of
medicines called non-steroidal anti-inflammatory drugs
(NSAIDs). It is specially formulated for rubbing into the skin
and has enhanced skin permeation. The active substance
targets deep inflamed tissues.
VOLTAROL EMULGEL EXTRA STRENGTH 2% W/W GEL is used to
relieve pain and reduce inflammation and swelling in a
number of painful conditions affecting the joints and muscles,
e.g. sprains, strains and bruises, relieving pain quickly,
including moderate to strong pain,
and helping recovery to normal function.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VOLTAROL
EMULGEL EXTRA STRENGTH 2% W/W GEL
DO NOT USE VOLTAROL EMULGEL EXTRA STRENGTH 2% W/W GEL

Productkenmerken

Health Products Regulatory Authority
26 January 2024
CRN00DWZS
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Voltarol Emulgel Extra Strength 2% w/w gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains diclofenac diethylammonium 2.32% w/w corresponding to
diclofenac sodium 2 % w/w (20mg/g).
Excipient(s) of known affect:
Propylene glycol (50 mg/g gel) Buthylhydroxytoluene (0.2 mg/g gel).
Perfume eucalyptus sting (containing limonene and linalool)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel
_Product imported from Romania:_
White, pleasantly perfumed, homogeneous, non-greasy gel.
4 CLINICAL PARTICULARS
As per PA0678/140/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0678/140/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Butylhydroxytoluene
Carbomers
Cocoyl caprylocaprate
Diethylamine Isopropyl alcohol Liquid paraffin
Macrogol cetostearyl ether
Oleyl alcohol
Propylene glycol
Perfume eucalyptus sting (containing limonene and linalool) Purified
water
6.2 INCOMPATIBILITIES
Not Applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the tube and outer package of the product on the market
in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30° C. Keep the tube in the outer carton.
Health Products Regulatory Authority
26 January 2024
CRN00DWZS
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
For the screw cap:
Aluminium laminated tube [low density polyethylene / aluminium / high
density polyethylene (internal layer) or
LDPE/aluminium/LLDPE, HDPE and Antiblock Masterbatch blend (internal
layer)] fitted with a high density polyethylene
shoulder and closed by a moulded seal. The tube is closed with a
polypropylene screw cap, in blue or white, incorporating a
moulded feature used to insert, twist and remove the seal before first
use.
Pack size: 50g
For the flip-top cap:
Aluminium laminated tube [low density polyethylene / aluminium / high
density polyethylene (internal layer) or
LDPE/al