Last Updated on eMC 20-12-2016 View medicine  | McNeil Products Ltd Contact details

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.

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:07-12-2016

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Added text has been underlined and highlighted red, removed text has been struck through:

4.2 Posology and method of administration

For oral use

Adults, the elderly and children aged 12

 

16 years and over:

 

Two tablets, up to four times daily, as required. Do not take more

frequently than every four hours.

Children 6

 

10 to 12 15 years

 

One tablet, up to four times daily, as required. Do not take more

frequently than every four hours. Not to be used for more than five

days without the advice of a doctor. Parents or carers should seek

medical attention if the child’s condition deteriorates during treatment.

Children under 6

 

10 years

 

Benylin Four Flu Tablets are contraindicated in children under the age

of 6

 

10 years (see section 4.3).

 

Do not exceed the stated dose.

4.3 Contraindications

Known hypersensitivity to diphenhydramine, paracetamol,

pseudoephedrine or to any of the excipients.

Concomitant use of other sympathomimetic agents including those

given by other routes, beta-blockers (see section 4.5) and monoamine

oxidase inhibitors (MAOIs), or within 14 days of stopping MAOI

treatment (see section 4.5)

 

Cardiovascular disease including hypertension

Diabetes mellitus

Phaeochromocytoma

Hyperthyroidism

Closed angle glaucoma

Severe renal impairment

Not to be used in children under the age of 6

 

10 years.

 


Section 10 has been updated with the approval date.

Reasons for adding or updating:

  • Change to section 6.1 - List of Excipients

Date of revision of text on the SPC:03-07-2010

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Revision to section 6.1 inline with minor change to coating process

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:25-05-2010

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Change: To section 6.5. To remove reference to 3 strips of 8 tablets (the product is actually supplied as 2 strips of 12 tablets) and a further update to section 6.5 from a recently granted variation to remove non-child resistant foil from the licence. Also renewal of the marketing authorisation for an indefinite period.

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:30-07-2009

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Reason for change: To update sections 4.1 (Therapeutic indications), 4.2 (Posology and method of administration), 4.3 (Contraindications), 4.4 (Special warnings and precautions for use), 4.5 (Interaction with other medicinal products and other forms of interaction) and 4.8 (Undesirable effects) of the SPC in response to the MHRA’s letter of 18 February 2009, relating to recent advice from the UK Commission on Human Medicines (CHM) regarding appropriate use of OTC Cough and Cold products in children.

 

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC:23-03-2009

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



SPC changes resulting from MHRA review of paediatric cough & colds medicines:

http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/Safetywarningsandmessagesformedicines/CON038908

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Date of revision of text on the SPC:01-03-2008

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to MA as a result of integration

Reasons for adding or updating:

  • Change to section 10 (date of (partial) revision of the text

Date of revision of text on the SPC:01-08-2005

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 10 Change to date of revision of text

Reasons for adding or updating:

  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC