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Vermox Tablets

*
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

  • 90588_vermox100mgtabs_6s.jpeg

Updated on 13 April 2021

File name

ie-mockup-leaflet-vermox-tablets-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-tablet-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 02 February 2021

File name

ie-mockup-leaflet-2116-Jan2021.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 01 December 2020

File name

ie-leaflet-text-clean-vermox tablets-2084.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 01 December 2020

File name

ie-spc-clean-2084.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 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 14 August 2020

File name

ie-spc-vermox tablets-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-tablets-BV 1673.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-v7.0.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Supply through pharmacy only

Updated on 16 March 2017

File name

PIL_9310_236.pdf

Reasons for updating

  • New PIL for new product

Updated on 16 March 2017

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 16 March 2017

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Addition of marketing authorisation holder

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

MAH Transfer from McNeil Healthcare (Ireland) Ltd. to Johnson & Johnson (Ireland) Ltd.

Updated on 16 March 2017

Reasons for updating

  • Change to MA holder contact details

Updated on 08 December 2016

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 31 October 2016

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 10 February 2015

Reasons for updating

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

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

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 changed 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 2009 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 20019 CCDS, as these were not calculated using the formula detailed in SmPC guideline 2009.

Updated on 04 July 2011

Reasons for updating

  • Correction of spelling/typing errors

Updated on 03 June 2011

Reasons for updating

  • Change to section 4.9 - Overdose
  • 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

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Vermox 100mg Tablets

 

 

4.4       Special warnings and precautions for use:-

ADDED:

 

Sunset yellow (E110) may cause allergic reactions.

 

 

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).

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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 b

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; 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 blister 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 17 November 2010

Reasons for updating

  • 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

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 6.3 - Shelf life
  • 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 823/57/2

Shelf life changed from 5 years to 3 years.

Updated on 23 October 2009

Reasons for updating

  • Change of licence holder

Updated on 01 August 2009

Reasons for updating

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

Updated on 11 March 2009

Reasons for updating

  • 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

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 11 March 2009

Reasons for updating

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

Updated on 11 March 2009

Reasons for updating

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

Updated on 10 March 2009

Reasons for updating

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

Updated on 23 February 2007

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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

Change to section 3 – pharmaceutical form

Addition of text that half-score on tablet is only to facilitate breaking for ease of swallowing and not to divide into equal halves.

Change to section 10 – Date of revision of text

February 2007

Updated on 23 August 2006

Reasons for updating

  • Correction of spelling/typing errors

Updated on 08 November 2005

Reasons for updating

  • 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 08 November 2005

Reasons for updating

  • Change of inactive ingredient
  • Change to date of revision

Updated on 09 June 2005

Reasons for updating

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

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 17 December 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 16 December 2004

Reasons for updating

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

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