Microlax Rectal Solution
*Company:
KenvueStatus:
UpdatedLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 29 April 2024
File name
ie-pil-microlax-2381.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 29 April 2024
File name
ie-spc-v10-Microlax-2381.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 08 November 2022
File name
ie-PIL-updated.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 21 June 2022
File name
ie-pl-microlax-clean-2241.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 21 June 2022
File name
ie-spc-clean-2241.pdf
Reasons for updating
- 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 23 October 2020
File name
ie-pl-microlax-2058.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 18 June 2019
File name
ie-spc v8 MAC02 1697.pdf
Reasons for updating
- File format updated to PDF
Legal category:Supply through pharmacy only
Updated on 06 March 2019
File name
ie-mockup-pl-clean updated-1885.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 27 March 2018
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 27 March 2018
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
Free text change information supplied by the pharmaceutical company
|
PA Transfer from McNeil Healthcare (Ireland) Ltd to Johnson & Johnson (Ireland) Ltd. Change in PA number. Note the address and contact details remain the same. |
Updated on 23 March 2018
File name
PIL_10741_37.pdf
Reasons for updating
- New PIL for new product
Updated on 23 March 2018
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 19 April 2016
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 4.5 replaced "None known" with "Risk of intestinal necrosis with sorbitol and sodium polystyrene sulphonate (oral/rectal administration)"
Section 10 replaced date with "April 2016"
Updated on 26 June 2015
Reasons for updating
- Change to section 4.3 - Contraindications
- 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 4.9 - Overdose
- 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 4.3:
Hypersensitivity to any of the ingredients.
changed to:
Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
Section 4.4:
The following has been added:
Lubricate the nozzle tip with some of the contents to aid insertion.
Seek medical advice if symptoms persist and avoid prolonged use. Microlax contains sorbic acid which may cause local skin reactions, e.g. contact dermatitis which is a local irritation at the site of use.
Section 4.6:
No problems have been reported.
changed to:
As there is no relevant data available to evaluate the potential for foetal malformation or other foetotoxic effects when administered during pregnancy Microlax Rectal Solution should only be used as directed by a physician at the time of delivery
It is not known whether sodium citrate, sodium lauryl sulphoacetate are excreted in human milk.
Section 4.7:
N/A
changed to:
Microlax has no or negligible influence on the ability to drive or use machines.
Section 4.8:
Occasionally, slight rectal burning has been observed. Individual cases of hypersensitivity have been reported.
Changed to:
Adverse drug reactions identified during post-marketing experience with sodium citrate/ sodium lauryl sulfoacetate are included in the table below.
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
Not known (cannot be estimated from the available data)
|
Table 1: Adverse Drug Reactions Identified During post-Marketing Experience with sodium citrate/sodium lauryl sulfoacetate by Frequency Category estimated from clinical trials or epidemiology studies
|
||
|
Body system |
Incidence |
Reported adverse event |
|
Gastrointestinal Disorders |
Not known |
Abdominal paina Anorectal discomfort Loose stool |
|
Immune System Disorders |
Not known |
Hypersensitivity reactions (e.g. Urticaria) |
a: Includes the PTs Abdominal discomfort, Abdominal pain, and Abdominal pain upper
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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:medsafety@hpra.ie.
Section 4.9:
Overdose is unlikely given the physical limitations of the route of administration.
Change to:
No symptoms of overdose have been identified from post-marketing data and scientific literature for this product, when used intrarectally.
Updated on 23 June 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to information about driving or using machinery
Updated on 23 December 2014
Reasons for updating
- Introduction of new pack/pack size
Updated on 13 September 2011
Reasons for updating
- Change due to user-testing of patient information
Updated on 01 July 2011
Reasons for updating
- Change of manufacturer
Updated on 24 August 2009
Reasons for updating
- Change to marketing authorisation holder
- Change of trade or active ingredient name
Updated on 09 September 2008
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
5.2 Pharmacokinetic Properties
The ingredients contained in the preparation are not likely to be systemically absorbed, distributed or metabolised. The ingredients are excreted in faeces.
5.3 Preclinical Safety Data
No preclinical data of clinical relevance are available.
Updated on 01 May 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
Updated on 28 August 2007
Reasons for updating
- Change to section 6.1 - List of excipients
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 28 February 2006
Reasons for updating
- New PIL for medicines.ie
Updated on 29 July 2005
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 11 August 2004
Reasons for updating
- Improved electronic presentation
Legal category:Supply through pharmacy only
Updated on 29 December 2003
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through pharmacy only
Updated on 10 July 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only