Occlusal
*Company:
Alliance Pharmaceuticals IrelandStatus:
UpdatedLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 23 December 2024
File name
Occlusal PIL UK ROI 006.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 20 December 2024
File name
Occlusal SPC ROI 010.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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
CMDh position is that a causal relationship between cutaneous formulations of salicylic acid (topical use) and increased risk of use during pregnancy is at least a reasonable possibility and therefore section 4.6 of the product information of salicylic acid containing products should be updated to bring in line with the CMDh/PRAC recommendation following the assessment of PSUSA/00002680/202312.
Updated on 27 March 2019
File name
Occlusal PIL UK ROI 005.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 22 March 2019
File name
Occlusal PIL UK ROI 005.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 22 March 2019
File name
Occlusal SPC ROI 009.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Supply through pharmacy only
Updated on 20 July 2018
File name
Occlusal SPC ROI 008.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 update to PDF
Updated on 24 April 2015
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 24 April 2015
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 21 April 2015
File name
PIL_14341_304.pdf
Reasons for updating
- New PIL for new product
Updated on 21 April 2015
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 11 March 2014
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 25 January 2013
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
4.8 Undesirable effects
Undesirable effects are listed by MedDRA System Organ Classes.
Assessment of undesirable effects is based on the following frequency groupings:
Very common: ≥1/10
Common: ≥1/100 to <1/10
Uncommon: ≥1/1,000 to <1/100
Rare: ≥1/10,000 to <1/1,000
Very rare: <1/10,000
Not known: cannot be estimated from the available data
System Organ Class
|
Undesirable Effect |
Frequency |
Skin and subcutaneous tissue disorders
|
skin irritation* |
Not known |
Injury, poisoning and procedural complications
|
salicylism (including tinnitus) |
Not known |
* A localised irritant reaction may occur if Occlusal is applied to normal skin surrounding the wart. This may normally be controlled by temporarily discontinuing the use of Occlusal and by being careful to apply the solution only to the wart itself when treatment is resumed.
Updated on 04 May 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change to information about pregnancy or lactation
Updated on 09 November 2010
Reasons for updating
- 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 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- 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
Changes highlighted in red text:
4.3 Contraindications
Hypersensitivity to salicylic acid or to any of the excipients.
Occlusal should not be used by diabetics or patients with impaired blood circulation. Do not use if the wart or surrounding skin is inflamed or broken. Do not use on moles, birthmarks, unusual warts with hair growth, on facial warts, or in the anal or perineal region.
4.4 Special warnings and precautions for use
Occlusal is for external use only. Do not permit contact with eyes or mucous membranes. If contact occurs flush with water for 15 minutes. Do not allow contact with normal skin around wart. Avoid using on areas of broken or damaged skin. Discontinue treatment if excessive irritation occurs. Excessive prolonged use of topical salicylic acid may result in symptoms of salicylism and must therefore be avoided.
4.5 Interaction with other medicinal products and other forms of interaction
There are no known interactions when used as indicated. However, topical salicylic acid may increase the absorption of other topically applied medicines. Concomitant use of Occlusal and other topical medicines on the treated wart should therefore be avoided.
4.6 Fertility, pregnancy and lactation
Whilst there are no known contra-indications to use of Occlusal during pregnancy and lactation, the safety has not been established. Occlusal should therefore be used with caution or following professional advice.
4.7 Effects on ability to drive and use machines
None known.
4.9 Overdose
Symptoms of systemic salicylate poisoning have been reported after the application of salicylic acid to large areas of skin and for prolonged periods. Salicylism may also occur in the unlikely event of large quantities being ingested. Salicylism is unlikely to occur if Occlusal is used as indicated.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Wart and anticorn preparations
ATC code: D11FA
Salicylic acid has bacteriostatic and fungicidal actions, but it is its keratolytic properties which are important for this medicinal product. When applied externally it produces slow and painless destruction of the epithelium. Salicylic acid is usually applied in the form of a paint in a collodian base (10 to 17%) or as a plaster (20 to 50%) to destroy warts or corns.
5.2 Pharmacokinetic properties
Salicylic acid may be percutaneously absorbed. However, there is no evidence of any systemic absorption from the use of Occlusal.
5.3 Preclinical safety data
No other information relevant to the prescriber other than that already stated in other sections of the SPC.
Updated on 07 January 2010
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 7 - Marketing authorisation holder
- Change to section 9 - Date of renewal of authorisation
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Contains Salicylic Acid 26% w/w
For a full list of excipients, see section 6.1
Section 7. Marketing Authorisation Holder - Now contains the following red text
Alliance Pharmaceuticals Ltd
Avonbridge House
Bath Road
Chippenham
Wiltshire SN15 2BB
England.
Section 9. Date of First Authorisation/Renewal of the Authorisation
Date of first authorisation: 31 May 1994
Date of last renewal: 31 May 2009
Updated on 21 July 2009
Reasons for updating
- New PIL for medicines.ie
Updated on 09 March 2009
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 12 July 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 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 09 August 2004
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only