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Johnson & Johnson (Ireland) Ltd

Airton Road, Tallaght, Dublin 24, Ireland
Telephone: +353 1 466 5200
Fax: +353 1 466 53160
Medical Information Direct Line: 1 800 22 00 44
Medical Information e-mail: crc@its.jnj.com
Customer Care direct line: 1 800 22 00 44
Summary of Product Characteristics last updated on medicines.ie: 16/03/2017
SPC Vermox Tablets

When a pharmaceutical company changes an SPC or PIL, 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 16/03/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
  • Addition of marketing authorisation holder
Date of revision of text on the SPC:   01-Mar-2017
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 10/02/2015 and displayed until 16/03/2017
Reasons for adding or 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
Date of revision of text on the SPC:   17-Dec-2014
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

Section 4.3:

In persons with a known hypersensitivity to the drug or its components.

changed to:
In persons with a known hypersensitivity to the active substance or to any of the excipients listed in section 6.1

Section 4.5:

Deleted: 

In the latter case, determination of plasma concentrations are recommended in order to allow dose adjustments.

Section 4.8:

Added text about reporting side effects

Section 4.9:

Deleted:

Within the first hour after ingestion, gastric lavage may be performed.

Section 5.2:

Following oral administration, approximately 20% of the dose reaches the systemic circulation,
changed to:
Following oral administration, <10% of the dose reaches the systemic circulation,
Deleted: 
Updated on 18/07/2011 and displayed until 10/02/2015
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   11-Jul-2011
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 03/06/2011 and displayed until 18/07/2011
Reasons for adding or 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
Date of revision of text on the SPC:   31-May-2011
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 17/11/2010 and displayed until 03/06/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   15-Oct-2010
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 29/10/2009 and displayed until 17/11/2010
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
Date of revision of text on the SPC:   15-Sep-2009
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 11/03/2009 and displayed until 29/10/2009
Reasons for adding or 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
Date of revision of text on the SPC:   02/2009
Legal Category:   prescription 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 23/02/2007 and displayed until 11/03/2009
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   02/2007
Legal Category:   retail sale 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 08/11/2005 and displayed until 23/02/2007
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Updated on 26/05/2005 and displayed until 08/11/2005
Reasons for adding or 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
Updated on 16/12/2004 and displayed until 26/05/2005
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Updated on 05/06/2003 and displayed until 16/12/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Mebendazole