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Novartis Consumer Health
Novartis Consumer Health UK Ltd, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, UK
Telephone: +44 (0)1276 687300
Fax: +44 (0)1276 687284
Medical Information Direct Line: +44 (0)1403 323 046
Medical Information e-mail: medicalaffairs.uk@novartis.com
Customer Care direct line: +44 (0)1276 687290
Medical Information Fax: +44 (0)1403 324 024

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 04/08/2011
SPC Voltarol Emulgel P

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 04/08/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   17-Mar-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 3

Addition of: White to practically white, soft, homogeneous, cream-like

 

Section 4.2

Change from : ‘Adults and children 12 years and over’ to ‘Adults and children 14 years and over.’

 

New paragraph:

Children:  There are insufficient data on efficacy and safety available for the 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.

 

Deletion of: Children: Not for use in children under 12 years of age.

 

Section 4.3

Addition of:

The use in children and adolescents aged less than 14 years is contraindicated.

 

Section 4.4

Deletion of the word ‘Precautions’.

 

Section 6.5

Addition of words : ‘with two alternate shapes of cap and thread’ between ‘screw cap in white or blue’ and ‘incorporating a moulded feature’.

 

Section 10

Change of date from 7 May 2010 to 17 March 2011.
Updated on 05/08/2010 and displayed until 04/08/2011
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   07-May-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 21/07/2010 and displayed until 05/08/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07-May-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.2

Deletion of “ Not to be used for more than 7 days unless recommended by a doctor”

Insertion of new text relating to extension of use to 14 days:

 

The maximum daily dose is 16g. Therefore the maximum weekly dose is 112g.

 

For arthritis pain it may be necessary to apply the gel for up to 7 days (to allow its effect to build up on the joint) before an improvement in pain is noticed.  The gel can be used for up to 14 days under pharmacy supervision.

 

If symptoms do not improve by day 7, or if they worsen within the first 7 days, a consultation with a doctor is recommended. Consultation with a doctor is recommended if more than two major joints in the body are affected.  Do not use for more than 14 days unless recommended by a doctor.

 

Section 4.7

Deletion of “see side-effects”. Addition of “Voltarol Emulgel P has no or negligible influence on the ability to drive and use machines”. 

 

Section 6.4

Addition of new text relating to the pump dispenser presentation:

The pump dispenser is a pressurised container. It should be protected from direct sunlight and must not be pierced or burned even when empty.

 

Section 6.5

Paragraph 1

Addition of pack size 100g.

 

Paragraph 2

Additional pack size ‘100g’ available.

 

Paragraph 3

Description of additional pump dispenser available as a 75ml pack

 

Section 10

Date change from 22 December 2008 to 7 May 2010

 

 
Updated on 30/01/2009 and displayed until 21/07/2010
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   22-Dec-2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Voltarol Emulgel P - changes to SPC – December 2008

 

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

 

Section 10: revision date change from May 2007 to 22 December 2008

 
Updated on 01/08/2008 and displayed until 30/01/2009
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Date of revision of text on the SPC:  
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  diclofenac diethylammonium