Voltarol Emulgel 1% w/w Gel

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Diclofenac sodium

Beschikbaar vanaf:

PCO Manufacturing Ltd.

ATC-code:

M02AA15

INN (Algemene Internationale Benaming):

Diclofenac sodium

Dosering:

1 percent weight/weight

farmaceutische vorm:

Gel

Therapeutisch gebied:

diclofenac

Autorisatie datum:

2019-03-22

Bijsluiter

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PACKAGE LEAFLET: INFORMATION FOR THE USER
VOLTAROL
® EMULGEL
® 1% W/W GEL
diclofenac diethylammonium
diclofenac diethylammonium 1.16% w/w corresponding to
diclofenac sodium 1% w/w
For joint, back and muscular pain relief
Relieves pain, reduces inflammation, cooling effect
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 1% w/w Gel carefully to get the
best results from it.
−
Keep this leaflet. You may need to read it again. Note that
this leaflet is revised on a regular basis with the latest
information on your medicine. Please refer to the date at the
end of this leaflet.
−
Ask your pharmacist if you need more information or advice.
−
You must contact a doctor if your symptoms worsen or do
not improve within 7 days.
−
If any of the side effects gets serious, or if you notice any
side effect not listed in this leaflet, please tell your doctor or
pharmacist.
WHAT IS IN THIS LEAFLET
1.
What Voltarol Emulgel 1% w/w Gel is and what it is used for
2.
What you need to know before you use Voltarol Emulgel
1% w/w Gel
3.
How to use Voltarol Emulgel 1% w/w Gel
4.
Possible side effects
5.
How to store Voltarol Emulgel 1% w/w Gel
6.
Contents of the pack and other information
1.
WHAT VOLTAROL EMULGEL 1% W/W GEL IS AND WHAT IT IS
USED FOR
Voltarol Emulgel 1% w/w Gel contains the active ingredient
diclofenac which is from the group of medicines called non-
steroidal anti-inflammatory drugs (NSAIDs).
Voltarol Emulgel 1% w/w Gel is used in adults, the elderly and
adolescents aged 14 years and over to relieve pain and reduce
swelling in a number of painful conditions affecting the joints and
muscles, e.g. sprains, strains and bruises. It is also used to
relieve the pain of muscular rheumatism.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VOLTAROL
EMULGEL 1% W/W GEL
DO NOT USE VOLTAROL EMULGEL 1% W/W GEL IF YOU:
•
are allergic (hypersensitive) to diclofenac, propylene glycol,
benzy

Productkenmerken

Health Products Regulatory Authority
03 March 2022
CRN00CT0L
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Voltarol Emulgel 1% w/w Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains: Voltarol Emulgel contains diclofenac diethylammonium 1.16%
w/w corresponding to diclofenac sodium 1% w/w.
Excipients with known effect: propylene glycol and benzyl benzoate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel
_Product imported from Germany_
Voltarol Emulgel is a white to slightly milky gel
4 CLINICAL PARTICULARS
As per PA0678/140/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0678/140/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
diethylamine,
Carbomer 974 P,
cetomacrogol,
cocoyl caprylocaprate,
isopropyl alcohol,
liquid paraffin,
propylene glycol,
purified water,
perfume crème (containing benzyl benzoate)
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.
After first opening: 16 weeks.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30 °C.
Keep the tube in the outer carton in order to protect from light.
Health Products Regulatory Authority
03 March 2022
CRN00CT0L
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Sealed tubes closed with a screw cap incorporating a built-in point to
pierce the seal before first use.
Available in packs of 50 g and 100 g.
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/442/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 22
nd
March 2019
10 DATE OF REVISION OF THE TEXT
March 2022