Occlusal

  • Name:

    Occlusal

  • Company:
    info
  • Active Ingredients:

    Salicylic Acid

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/03/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 22/3/2019

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Alliance Pharmaceuticals Ireland

Alliance Pharmaceuticals Ireland

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Medicine Name Anbesol Anaesthetic Antiseptic Oromucosal Solution Active Ingredients Cetylpyridinium Chloride, Chlorocresol, Lidocaine Hydrochloride
Medicine Name Haemopressin 1 mg powder and solvent for solution for injection Active Ingredients Terlipressin acetate
Medicine Name Naseptin Nasal Cream Active Ingredients Chlorhexidine Dihydrochloride, Neomycin sulfate
Medicine Name Nu-Seals 300 Active Ingredients Aspirin
Medicine Name Nu-Seals 75 Active Ingredients Aspirin
Medicine Name Occlusal Active Ingredients Salicylic Acid
Medicine Name Quinoderm 10% w/w + 0.5% w/w Cream Active Ingredients Benzoyl Peroxide, hydrous, Potassium hydroxyquinoline sulfate
Medicine Name Quinoderm 5% w/w + 0.5% w/w Cream Active Ingredients Benzoyl Peroxide, hydrous, Potassium hydroxyquinoline sulfate
Medicine Name Ranitidine 50mg/2ml Solution for Injection and Infusion Active Ingredients Ranitidine Hydrochloride
Medicine Name Syntometrine injection Active Ingredients Ergometrine Maleate, Oxytocin
1 - 0 of 11 items.Total: Infinity pages

When a pharmaceutical company changes any document, 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 27 March 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 22 March 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 22 March 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Supply through pharmacy only

Updated on 20 July 2018 SmPC

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 SmPC

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

Update section 4.8 to include adverse event reporting statement

Updated on 24 April 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 21 April 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 April 2015 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 11 March 2014 SmPC

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

Shelf life reduced from 3 years to 2 years

Updated on 25 January 2013 SmPC

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

Changes highlighted in red text:

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 4 May 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation

Updated on 9 November 2010 SmPC

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 7 January 2010 SmPC

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

Section 2: Qualitative and Quantitative Composition - Now contains the following red text

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 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 9 March 2009 SmPC

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

Section 6.3 The shelf life has changed from 2 to 3 years

Updated on 12 July 2005 SmPC

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 9 August 2004 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only