Capasal Therapeutic Shampoo
*Company:
Dermal Laboratories (Ireland) LtdStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 12 June 2024
File name
CAPX-IPHA.PIL. FP33-24-1.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 12 June 2024
File name
CAPX-IPHA.SPC.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- 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
In Section 2 Qualitative and Quantitative composition:
the following text has been added:
“Excipients with known effect:
Sodium benzoate (E 211)
In section 4.3 Contra-indications
Revised text:
From “Not to be used in case of sensitivity to any of the ingredients” to “Not to be used in cases of hypersensitivity to the active substances or to any of the excipients listed in section 6.1.”
In section 4.4 Special warnings and precautions for use
Additional text added after “ for external use only:”
“This medicine contains 0.15mg of sodium benzoate (E 211) per gram of shampoo. Sodium benzoate (E 211) may cause local irritation. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old). Absorption of sodium benzoate through the immature skin of neonates is significant”
In Section 6.1 List of Excipients: the following text has been updated
Additional text to be added:
Coco amido propyl dimethyl betaine to add “(contains sodium benzoate as a preservative)”
Triethanolamine lauryl sulfate to add “(trolamine lauril sulfate) (contains methylchloroisothiazolinone /methylisothiazolinone (3:1) as a preservative)”
In Section 10 Date of revision of the text:
The date has changed to:
“June 2024”
Updated on 23 January 2023
File name
CAPX-IPHA.SPC.pdf
Reasons for updating
- Document format updated
Legal category:Supply through pharmacy only
Updated on 17 December 2020
File name
CAPX-IPHA.SPC.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 22 July 2020
File name
CAPX-IPHA.PIL.FP33-20-1-Apk.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 22 July 2020
File name
CAPX-IPHA.SPC.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
- Updated inline with QRD template and/or excipient guideline
Legal category:Supply through pharmacy only
Updated on 31 August 2018
File name
CAPX-IPHA.SPC.04.08.15.06.08.15.pdf
Reasons for updating
- File format updated to PDF
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
File format updated to PDF
Updated on 06 August 2015
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 06 August 2015
Reasons for updating
- Correction of spelling/typing errors
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 05 March 2015
File name
PIL_14749_232.pdf
Reasons for updating
- New PIL for new product
Updated on 05 March 2015
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
Free text change information supplied by the pharmaceutical company
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; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:medsafety@hpra.ie.
In section 10 Date of revision of the text, the date has changed to "February 2015"
Updated on 05 March 2015
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 13 May 2014
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
- 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
In section 6.1 (List of excipients) "Sulphate" has been replaced with "Sulfate" in "Triethanolamine Lauryl Sulfate Solution" and "Ammonium Sulfate"
In section 10 (Date of revision of the text) the date has changed to "March 2014"
Updated on 13 May 2014
Reasons for updating
- Change to further information section
- Change to date of revision
- Removal/change of distributor
Updated on 16 November 2011
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 26 October 2011
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
Free text change information supplied by the pharmaceutical company
In section 10 (Date of Revision of the Text) the date has changed to "August 2011"
Updated on 11 August 2010
Reasons for updating
- New PIL for medicines.ie
Updated on 20 August 2009
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
In section 6.4 (Special precautions for storage) : the following text has been deleted "Keep away from direct sunlight"
In section 10 (Date of revision of the text) : the date has changed to "July 2009"
Updated on 07 February 2006
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 12 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only
Updated on 12 June 2003
Reasons for updating
- Change to section 4.1 - Therapeutic indications
Legal category:Supply through pharmacy only