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Vermox 100mg/5ml Oral Suspension

*
Pharmacy Only: Non-prescription

  • Company:

    Kenvue

  • Status:

    No Recent Update

  • Legal Category:

    Supply through pharmacy only

  • Active Ingredient(s):

    Mebendazole

    *Additional information is available within the SPC or upon request to the company

  • 89881_vermoxoralsuspension_30ml.jpeg

Updated on 13 April 2021

File name

ie-mockup-leaflet-vermox-suspension-bv2127.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 3 - dose and frequency
  • Change to section 6 - date of revision

Updated on 13 April 2021

File name

ie-spc-clean-vermox-suspension-rfi-2127.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 19 January 2021

File name

ie-mockup-leaflet-vermox-suspension-1657.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 19 January 2021

File name

m1-3-1-spc-clean-1657.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 01 December 2020

File name

ie-leaflet-text-clean-2083-rfi.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • 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 01 December 2020

File name

ie-spc-clean-2083-rfi.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 14 August 2020

File name

ie-spc-vermox suspension-BV1673.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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 14 August 2020

File name

ie-mockup-leaflet-vermox-suspension-BV1673.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 18 June 2019

File name

ie-spc-clean-1248.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Supply through pharmacy only

Updated on 08 September 2016

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 08 September 2016

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

Section 6.3 - 5 years was changed to 3 years

Section 10 - date changed to 22 August 2016
(please note that this was a Type IAin application and so the change was implemented on 22nd August 2016, however the official approval letter from the HPRA was received on 1st September 2016)

Updated on 10 February 2015

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Updated on 19 December 2014

File name

PIL_9572_727.pdf

Reasons for updating

  • New PIL for new product

Updated on 19 December 2014

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 18 July 2011

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

4.8       Undesirable effects


The legend at the end of the table has been corrected from:

a ADR frequency data derived from Clinical Trials or Epidemiological Studies

b ADRs not observed in Clinical Trials and frequency calculated using “Rule 3”, as detailed in SmPC guideline 2009. 6279 patients exposed in clinical trials and epidemiological studies, divided by 3 (frequency = 1/2092). Note: frequencies differ from those reported in august 20019 CCDS, as these were not calculated using the formula detailed in SmPC guideline 2009.


to:

a ADR frequency data derived from Clinical Trials or Epidemiological Studies

b ADRs not observed in Clinical Trials and frequency calculated using “Rule 3”, as detailed in SmPC guideline 2009. 6279 patients exposed in clinical trials and epidemiological studies, divided by 3 (frequency = 1/2092). Note: frequencies differ from those reported in August 2009 CCDS, as these were not calculated using the formula detailed in SmPC guideline 2009.

Updated on 12 July 2011

Reasons for updating

  • Change to side-effects

Updated on 03 June 2011

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Vermox 100mg/5ml Oral Suspension

 

 

4.4.      Special warnings and precautions for use:-

ADDED (paragraph):

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

Methyl (E218) and propyl (E216) parahydroxybenzoate may cause allergic reactions which could possibly be delayed.

 

 

4.8       Undesirable effects:-

ADDED (paragraph):

Throughout this section adverse reactions are reported. Adverse reactions are adverse events that were considered to be reasonably associated with the use of mebendazole based on the comprehensive assessment of the available adverse event information. A causal relationship with mebendazole cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

 

ADDED (in red):

AMENDED (in blue)

Very common (≥ 1/10); Common (≥ 1/100 and < 1/10); Uncommon (≥ 1/1000 and < 1/100); Rare (≥ 1/10,000 and < 1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data).

 

Table 1: Adverse Drug Reactions Reported in Clinical Trials and Post-Marketing Experience for Mebendazole

System Organ Class

Adverse Drug Reactions

Frequency Category

Common
(³ 1/100 to < 1/10)

 

Uncommon
(³ 1/1000 to < 1/100)

Rare
(≥ 1/10,000 and < 1/1000)

Blood and lymphatic system disorders

 

 

Neutropoenia b

 

Immune system disorders

 

 

Hypersensitivity including anaphylactic reaction and anaphylactoid reaction b

Nervous system disorders

 

 

Convulsions b,

Dizziness a

Gastro-intestinal disorders

Abdominal pain a

Abdominal discomfort a;
Diarrhoea a;
Flatulence a

 

Hepato-biliary disorders

 

 

Hepatitis b;
Abnormal liver function tests b

Skin and sub-cutaneous tissue disorders

 

 

Rash a , Toxic epidermal necrolysis b;
Stevens-Johnson syndrome b;
Exanthema b; Angioedema b; Urticaria b;
Alopoecia b

a ADR frequency data derived from Clinical Trials or Epidemiological Studies

b ADRs not observed in Clinical Trials and frequency calculated using “Rule 3”, as detailed in SmPC guideline 2009. 6279 patients exposed in clinical trials and epidemiological studies, divided by 3 (frequency = 1/2092). Note: frequencies differ from those reported in august 20019 CCDS, as these were not calculated using the formula detailed in SmPC guideline 2009.

 

4.9       Overdose:-

            ADDED (in red)

In patients treated at dosages substantially higher than recommended or for prolonged periods of time, the following adverse reactions have been reported rarely: alopecia, reversible liver function disturbances, hepatitis, agranulocytosis, neutropenia and glomerulonephritis. With the exception of agranulocytosis and glomerulonephritis, these also have been reported in patients who were treated with mebendazole at standard dosages (see Section 4.8).

 

6.4       Special precautions for storage:-

ADDED (in red)

Do not store above 25°C. 

Keep bottle in the outer carton in order to protect from light.

Updated on 31 May 2011

Reasons for updating

  • Change to side-effects
  • Change due to user-testing of patient information

Updated on 18 November 2010

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

 

Re-format of section 4.8 to align with CCDS with consequantial change to section 4.9.

Replacement of section 5.2 with CCDS text plus addition of ATC code and pharmacotherapeutic

classification to section 5.1.

Updated on 29 October 2009

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

PA holder changed to: McNeil Healthcare (Ireland) Ltd.
New PA number: PA 823/57/1

Updated on 23 October 2009

Reasons for updating

  • Change of licence holder

Updated on 01 August 2009

Reasons for updating

  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 17 March 2009

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 7 - Marketing authorisation holder
  • 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

1.

NAME OF THE MEDICINAL PRODUCT

Name changed in line with directive requirements to state the name, strength and pharmaceutical form.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Quantitative information for some other excipients added

7.

MARKETING AUTHORISATION HOLDER

Change of address

10.

DATE OF REVISION OF THE TEXT

 

Changed to February 2009

 

Updated on 18 August 2006

Reasons for updating

  • Improved electronic presentation

Legal category:Supply through pharmacy only

Updated on 09 June 2005

Reasons for updating

  • Change to drug interactions
  • Change to side-effects
  • Change of active ingredient

Updated on 07 June 2005

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Supply through pharmacy only

Updated on 26 May 2005

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Supply through pharmacy only

Updated on 28 April 2005

Reasons for updating

  • New PIL for medicines.ie

Updated on 25 April 2005

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 16 July 2003

Reasons for updating

  • Improved electronic presentation

Legal category:Supply through pharmacy only

Updated on 05 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only