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TCP Liquid

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General Sale: Non-prescription

Updated on 19 April 2017

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale

Updated on 19 April 2017

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

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 13 April 2017

File name

PIL_15822_989.pdf

Reasons for updating

  • New PIL for new product

Updated on 13 April 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 21 September 2015

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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 18 September 2015

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 23 August 2013

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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 20 August 2013

Reasons for updating

  • New PIL for medicines.ie

Updated on 30 August 2012

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

None provided