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Chefaro Ireland Ltd

Chefaro Ireland, 1st Floor, 32 Vauxhall Bridge Road, London, SW1V2SA, UK
Telephone: +44 (0)203 598 9601
E-mail: omegaroi@professionalinformation.co.uk
WWW: www.omegapharma.ie
Medical Information Direct Line: +44 (0)1748 827 299
Summary of Product Characteristics last updated on medicines.ie: 19/04/2017
SPC TCP Liquid

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 19/04/2017 and displayed until Current
Reasons for adding or updating:
  • 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:   12-Apr-2017
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company

In section 7, the MAH address has been changed.

In section 10, the date of revision of text has been updated.
Updated on 21/09/2015 and displayed until 19/04/2017
Reasons for adding or updating:
  • 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:   18-Sep-2015
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company



4.4       Special warnings and precautions for use

If symptoms persist for more than 14 days a doctor should be consulted. Use in allergic skin conditions should be avoided.

            Avoid contact with eyes.

            Sickness can occur after accidental oral intake.

4.8       Undesirable effects

The following convention has been utilised for the classification of undesirable effects: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000), not known (cannot be estimated from available data).

The risk of undesirable effect is low with appropriate use.

Body System Class

Undesirable Effect

Frequency

Nervous system disorders

Mouth paresthesia, dysgeusia

Not known

Skin and subcutaneous tissue disorders

Blisters, buccal ulcer, swelling, burns, redness, pruritus, dry skin, skin necrosis, skin peeling, pain

Not known

 

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: http://www.hpra.ie/;  e-mail: medsafety@hpra.ie

Updated on 23/08/2013 and displayed until 21/09/2015
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   21-Nov-2011
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company

In section 7 (Marketing Authorisation Holder), the address of the MAH has been updated.
Updated on 30/08/2012 and displayed until 23/08/2013
Reasons for adding or updating:
  • New SPC for medicines.ie
Date of revision of text on the SPC:  
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Phenol
   Halogenated phenols