Voltarol Emulgel 1% w/w Gel

Updated due to the deletion of GSK CH GMBH & Co as a Batch Release Site.

Update the the SPC following approval of a safety variation.

Contraindications

Addition of children under 14 years

Warnings

- Addition of flamabbility warning

- Remove of statement about concomitant use of NSAIDs

Driving

Removal of warning re dizziness

Excipients - warnings updated

To update the duration of use to 14 days.

Additional of the no mess cap for the 100 g pack.

Change to add an additional cap on the 100g pack size to allow for consumers to apply the product without using their hands to rub it in.

In section: 4.8 Undesirable effects

The following has been added.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

In section: 6.5       Nature and contents of container

Pack sizes has been added, 50g & 100g.

Section 4.4

“It should not be used with occlusion” added

Paragraph concerning excipients – slightly reworded

Section 7

Address changed to Camberley

Section 10

Date changed from Sept 2013 to August 2014

Section 2

Addition of benzyl benzoate to excipients list

Section 4.3

“isopropranol” changed to “isopropyl alcohol”

“Acetylsalicylic acid” changed to “aspirin”

Section 4.4

Under “Information concerning excipients” information added regarding irritant effect of benzyl benzoate.

Section 5.1

Section rewritten to include more information about mode of action and clinical data

Section 5.2

Section rewritten and split into subsections to include more information on absorption, distribution, biotransformation, elimination and activity in patients.

Section 5.3

Additional information added regarding preclinical experience with product.

Section 6.1

Addition of “(including benzyl benzoate)” after perfume.

Section 10

Date of revision changed from 16 November 2012 to 10 September 2013.

Section 4.3 

Add contraindications for last trimester of pregnancy and replace general statement about hypersensitivity to gel ingredients with specific statement referring to propylene glycol and isopropanol.

Section 4.4  

Add “The possibility of systemic adverse events from application of Voltarol Emulgel P cannot be excluded if the preparation is used on large areas of skin and over a prolonged period (see the product information on systemic forms of diclofenac).”

Discontinue the treatment if a skin rash develops after applying the product.

Voltarol Emulgel P can be used with non-occlusive bandages but should not be used with an airtight occlusive dressing.”

and “Voltarol Emulgel P contains propylene glycol, which may cause mild localised skin irritation in some people.”

Delete “It should not be used with occlusion”.  Replace “never be taken by mouth” with “not be ingested”

Section 4.5

Reword opening paragraph to “Since systemic absorption of diclofenac from topical application is very low, such interactions are very unlikely.”

Section 4.6
 

Change heading to “Fertility, pregnancy and lactation”
 

Previous information replaced with data to clarify recommendations associated with use in pregnancy and lactation, including contraindication in third trimester.

Section 4.7

Replace previous text with “Cutaneous application of Topical diclofenac has no influence on the ability to drive and use machines.”

Section 4.8

Frequencies for side effects have been added as per convention as well as table of reactions. 

Section 4.9
 

Add “However, undesirable effects, similar to those observed following an overdose of diclofenac tablets, can be expected if Voltarol Emulgel P is inadvertently ingested (1 tube of 100g contains the equivalent of 1000mg of diclofenac sodium).”

Add “Gastric decontamination and the use of activated charcoal should be considered, especially within a short time of ingestion.”

Section 4.2

Deletion of paragraph: Children: Not recommended

Addition of paragraph:  Children and adolescents below 14 years: There are insufficient data on efficacy and safety available for children and adolescents below 14 years of age (see also contraindications section 4.3). In children 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.

Section 4.3

Addition of paragraph: The use in children and adolescents aged less than 14 years is contraindicated.

Section 9

Date of last renewal changed from 31 October 2008 to 17 October 2008.

Section 10

Date changed from October 2010 to October 2011

Section 1

Addition of ‘1% w/w Gel’.

Section 2

Addition of  ‘Contains propylene glycol 5% w/w’. For full list of excipients see Section 6.1.

Section 4.2

New title added ‘Topical application’.

Section 4.5

Paragraph 1

The words ‘To date’ added at beginning of the paragraph.

Paragraph 2

The word ‘concentrations’ has been changed to ‘levels’.

Section 4.7

Paragraph: ‘Those who experience dizziness or other central nervous sytem disturbances, including visual disturbances, while taking NSAIDs should refrain from driving or operating machinery’ replaces ‘See side effects’.

Section 5.3

Addition of ‘Preclinical studies conducted with Voltarol Emulgel did not reveal any clinical relevant toxicological effects’ replaces ‘None known’.

Section 6.4

Wording changed from ‘Store below 30℃’ to ‘Do not store above 30℃’.

Section 6.5

Addition of words ‘available in packs of 10g and 30g’ at end of first paragraph.

Addition of words ‘available in packs of 30g’ at end of second paragraph.

Deletion of words ‘Both available in packs of 10g and 30g’.

Section 9

‘Date of first authorisation : 17 October 2003.  Date of last renewal: 31 October 2008’ replaces’ 17 October 2003’.

Section 10

Date change from 29 September 2008 to October 2010.

Voltarol Emulgel P ROI- changes to SPC September 2008

Section 6.5: addition of description of colour of polypropylene screw cap white or blue

Section 6.6: change in section heading name from Instructions for Use/Handling to Special precautions for disposal

Section 10: revision date change from Aug 2007 to September 2008

Section 6.5: Further information added regarding the aluminium laminated tubes Section 9: Date of last renewal added

Section 10: Revision date changed