VOLTAROL EMULGEL EXTRA STRENGTH 2 %w/w Gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DICLOFENAC DIETHYLAMINE

Available from:

Novartis Consumer Health UK Limited

INN (International Name):

DICLOFENAC DIETHYLAMINE

Dosage:

2 %w/w

Pharmaceutical form:

Gel

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

 
Novartis Consumer Health  

VOLTAROL EMULGEL EXTRA STRENGTH 2% W/W GEL. 

diclofenac sodium (as diclofenac diethylammonium) 

PATIENT INFORMATION LEAFLET (PIL)  
Author(s): 
Julie Jennings 
Document status: 
Final  
Effective date: 
Thursday, 13 February 2014 
Next Update date: 

Number of pages: 
6 
Property of Novartis Consumer Health 
Confidential 
May not be used, divulged, published or otherwise disclosed 
without the consent of Novartis Consumer Health 
Novartis Consumer Health 
CONFIDENTIAL 
Page 2 
PIL 

Voltarol Forte Emulgel 2.32 %

PACKAGE LEAFLET: INFORMATION FOR THE USER 

VOLTAROL EMULGEL EXTRA STRENGTH 2% W/W GEL  
diclofenac sodium (as diclofenac diethylammonium) 
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.  
Always  use  VOLTAROL  EMULGEL  EXTRA  STRENGTH  2%  W/W  GEL  exactly  as  your  doctor  or 
pharmacist has told you. You should check with your doctor
or pharmacist if you are not sure. 

  This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, 
even if their signs of illness are the same as yours. 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 the 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 after 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. 

WHERE TO FIND INFORMATION IN THIS LEAFLET 
1 
What VOLTAROL EMULGEL EXTRA STRENGTH 2% W/W GEL is and what it is
used for .............. 2 
2 
What you need to know about VOLTAROL EMUL

Summary of Product characteristics

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).
Excipients:
Propylene glycol (50 mg/g gel)
Butylhydroxytoluene (0.2 mg/g gel).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gel
White, pleasantly perfumed, homogeneous, non-greasy emulsion in an aqueous gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the local symptomatic relief of pain and inflammation in:
trauma of the tendons, ligaments, muscles and joints, e.g. due to sprains, strains and bruises.
localised forms of soft tissue rheumatism.
in adults and adolescents 14 years and over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Topical application
_Adults and adolescents 14 years and over:_
Voltarol Emulgel Extra Strength 2% w/w Gel provides lasting pain relief of up to 12 hours (applied 2 times daily -
morning and evening). It should be rubbed gently into the skin at the affected area.
The amount needed depends on the size of the painful area: 2 g to 4 g (a quantity ranging in size from a cherry to a
walnut) of gel is sufficient to treat an area of about 400-800 cm². After application, the hands should be washed, unless
they are the site being treated.
It is recommended that treatment should be reviewed after 14 days
Patients should consult their doctor if the condition does not improve within 7 days, or if it gets worse.
In adolescents aged 14 years and over, if this product is required for more than 7 days for pain relief or if the symptoms
worsen the patient/parents of the adolescent is/are advised to consult a doctor.
_Use in the elderly: _The usual adult dose may�