Benylin Four Flu Tablets

Product Information *

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 18 September 2020

File name

BEN02 2074 SPC V12_1600421029.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 18 September 2020

File name

ie-mockup-pl-benylinfourflu-2074_1600420703.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 23 December 2019

File name

ie-mockup-pl-benylin4flutablets-1933_1577091096.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 23 December 2019

File name

BEN02 1933 SPC V11.1_1577090949.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 13 September 2019

File name

401360964_360138C_PIL_BenylinFourFluTablets_IE_r6 - 1625_1568358153.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - driving and using machines
  • Change to section 3 - dose and frequency
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 13 September 2019

File name

BEN02 1625 SPC V10_1568357271.pdf

Reasons for 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - 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 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 05 December 2018

File name

ie-mockup-pl-benylinfourflutablets-1778_1543991530.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 05 December 2018

File name

ie-spc-clean-1778_1543991643.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 19 January 2017

Reasons for 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

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

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


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.

 

 

 

 

10        DATE OF REVISION OF THE TEXT

 

            06-January-2017


Updated on 19 January 2017

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 13 January 2017

File name

PIL_9059_146.pdf

Reasons for updating

  • New PIL for new product

Updated on 13 January 2017

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 08 April 2013

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 21 July 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 21 July 2011

Reasons for updating

  • Change of manufacturer

Updated on 02 June 2010

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 01 June 2010

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.3 additional warnings for use in children 6-12 years.

Updated on 25 August 2008

Reasons for updating

  • Change to marketing authorisation holder

Updated on 22 August 2008

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 7:
McNeil Healthcare (Ireland) Ltd.
Airton Road
Tallaght
Dublin 24
Ireland
 

Updated on 28 February 2006

Reasons for updating

  • Correction of spelling/typing errors

Updated on 04 October 2004

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Supply through pharmacy only

Updated on 30 September 2004

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Supply through pharmacy only

Updated on 28 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 11 August 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only