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Benylin Chesty Coughs (Non-Drowsy)

Last Updated on eMC 07-Oct-2016 View document  | 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.

Updated on 07-Oct-2016 and displayed until Current

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 28-Sep-2016

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Text that has been struck through and highlighted in red has been removed, text that has been underlined and highlighted in blue has been added:

5.1 Pharmacodynamic properties

Pharmacotherapeutic Group: Cough and cold preparations, Expectorants. ATC Code:

R05CA10

Guaifenesin is thought to exert its pharmacological action by stimulating receptors in the

gastric mucosa. This increases the output from secretory glands of the gastrointestinal

system and in reflex increases the flow of fluids from glands lining the respiratory tract.

The result is an increase in volume and decrease in viscosity of bronchial secretions.

Other actions may include stimulating vagal nerve endings in bronchial secretory glands

and stimulating certain centres in the brain which in turn enhance respiratory fluid flow.

Guaifenesin produces its expectorant action within 24 hours.

Menthol has mild local anaesthetic

 

, and decongestant and antitussive properties.

 

10

 

DATE OF REVISION OF THE TEXT

 

 

 

 

09 May 2016 28 September 2016

 

 

 

 

Updated on 27-May-2016 and displayed until 07-Oct-2016

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 09-May-2016

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 2 removed text “BENYLIN Chesty Coughs (Non-drowsy)” and “in each 5 ml.”

Added text “Also contains:

Ethanol 0.2595ml/5ml

Glucose 3492 mg/5ml

Sucrose 999 mg/5ml

Sodium 16.42 mg/5ml

Ponceau 4R (E124)

For full list of excipients, see Section 6.1.”

Section 4.2 replaced “Benylin Chesty Coughs (Non Drowsy)” with “This product”

Section 4.3 replaced “Benylin Chesty Coughs (Non Drowsy)” with “This product”

Section 4.4 replaced “Benylin Chesty Coughs (Non Drowsy)” with “This product” and replaced “be not” with “not be”

Added text “Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

This medicinal product contains 5 vol % ethanol (alcohol), i.e. up to 200 mg per 5ml dose, equivalent to approximately 5 ml beer, 2 ml wine per 5 ml dose. This can be harmful for those suffering from alcoholism. The ethanol content should be taken into account in pregnant or breastfeeding women, children and high-risk groups such as patients with liver disease or epilepsy.

This product contains 16.42mg of sodium per 5ml. This should be taken into consideration by those on a controlled sodium diet.

This product contains Ponceau 4R (E124) red colouring which may cause allergic reactions.”

Section 4.5 replaced “Benylin Chesty Coughs (Non Drowsy)” with “This product”

Section 4.6 added “Fertility” to the title and added text “There are no or limited amount of data from the use of Guaifenesin in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3)” replaced “Benylin Chesty Coughs (Non Drowsy)” with “This product” removed “Benylin Chesty Coughs (Non Drowsy)” and added “This product is not recommended during pregnancy and in women of childbearing potential not using contraception” and removed text “like most medicines, should not be used during pregnancy unless the potential benefit of treatment to the mother outweighs the possible risks to the developing foetus”

Added “Breastfeeding” as a subtitle, removed text “with no effect expected on the infant” and added “There is insufficient information on the effects of Guaifenesin in newborns/infants. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from this product, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility

There is insufficient information available to determine whether guaifenesin has the potential to impair fertility”

 

Section 4.7 Replaced “No special comment - unlikely to produce an effect” with “This product has no or negligible influence on the ability to drive or operate machinery”

 

Section 4.8 replaced “Side effects resulting from guaifenesin administration are very rare.

Adverse reactions to menthol at the low concentration present in BENYLIN Chesty Coughs (Non-drowsy) are not anticipated” with “The safety of guaifenesin/menthol is based on available data from clinical trials and adverse drug reactions (ADRs) identified during post-marketing experience are included.

The frequencies are provided according to the following convention:

Very common ≥1/10

Common ≥1/100 and < 1/10

Uncommon ≥1/1,000 and <1/100

Rare ≥1/10,000 and <1/1,000

Very rare <1/10,000, including isolated reports

Not known (cannot be estimated from the available data)

ADRs are presented for frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies if available or 2) when incidence cannot be estimated, frequency category is listed as ‘Not known’

Adverse Drug Reactions identified During Clinical trials, Epidemiology studies and Post-Marketing Experience with Guaifenesin. Frequency Category Estimated from Clinical Trials or Epidemiology Studies.

Body system

Incidence

Reported adverse

event

Immune System

Disorders

Not known

Hypersensitivity

reactions

(hypersensitivity,

pruritus and

urticaria)

Rash

Gastrointestinal

Disorders

Not known

Abdominal pain

upper

Diarrhoea

Nausea

Vomiting

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 the Yellow

Card Scheme at: www.mhra.gov.uk/yellowcard

 

Section 4.9 replaced “The symptoms and signs of overdose” with “The effects of acute toxicity from Guaifenesin” and added text “When taken in excess, guaifenesin may cause renal calculi”

 

Section 6 added text “E211”

 

Section 6.6 replaced “None applicable” with “No special requirements. Any unused product or waste material should be disposed of in accordance with local requirements”

 

Section 10 replaced date with “09 May 2016”

Updated on 05-Jan-2015 and displayed until 27-May-2016

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 12-Dec-2014

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

section 5.1  to amend the word 'reflexly' to 'in reflex'

section 5.2 to add the following text
' Menthol is well absorbed from the gastrointestinal tract following oral administration'.

section 10 to amend revision text date to 12th Dec 2014

Updated on 21-Apr-2010 and displayed until 05-Jan-2015

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: 05-Mar-2010

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Change to section 6.5

 

(1) To register an alternative cap 2-piece HDPE plastic child-resistant cap fitted with a polyterephtalate ethylene faced aluminium/expanded polyethylene laminated wad for the medicinal product as requested by the MHRA.

(2) To register the deletion of obsolete presentations (involving non-CRC caps that are no longer allowable) and pack sizes (30ml) that are no more appropriate are to be removed.

Updated on 08-Jun-2009 and displayed until 21-Apr-2010

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product

Date of revision of text on the SPC: 27-May-2009

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Registration of an alternative brand name on the licence

Updated on 12-May-2009 and displayed until 08-Jun-2009

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: 02-Apr-2009

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Update to Childrens Cough and Cold medicinal products as requested by the MHRA:

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

Updated on 21-Oct-2008 and displayed until 12-May-2009

Reasons for adding or updating:

  • Introduction of new pack/pack size

Date of revision of text on the SPC: 09-Sep-2008

Legal Category:GSL

Black Triangle (CHM): NO

Updated on 21-Aug-2008 and displayed until 21-Oct-2008

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container

Date of revision of text on the SPC: 13-Aug-2008

Legal Category:GSL

Black Triangle (CHM): NO

Updated on 03-Apr-2008 and displayed until 21-Aug-2008

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

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

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to MA as a result of integration

Updated on 14-Sep-2006 and displayed until 03-Apr-2008

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-Apr-2006

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 10 Change to date of revision of test

Updated on 30-Sep-2004 and displayed until 14-Sep-2006

Reasons for adding or updating:

  • Improved Electronic Presentation

Updated on 28-Sep-2004 and displayed until 29-Sep-2004

Reasons for adding or updating:

  • Improved Electronic Presentation
  • SPC Submitted in error

Updated on 29-Sep-2003 and displayed until 28-Sep-2004

Reasons for adding or updating:

  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 7 - Marketing Authorisation Holder

Updated on 19-Sep-2002 and displayed until 29-Sep-2003

Reasons for adding or updating:

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

Updated on 29-Aug-2001 and displayed until 19-Sep-2002

Reasons for adding or updating:

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

Company contact details

McNeil Products Ltd

Company image
Address

Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG

Medical Information e-mail
Medical Information Direct Line

01344 864042

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?

Active ingredients

guaifenesin, levomenthol

Legal categories

GSL - General Sales List

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