Selsun Shampoo 2.5% w/v

  • Name:

    Selsun Shampoo 2.5% w/v

  • Company:
    info
  • Active Ingredients:

    Selenium sulfide

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/03/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 15/3/2019

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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 15 March 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - manufacturer

Updated on 15 March 2019 SmPC

Reasons for updating

  • 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 4.8 - Undesirable effects

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

4.4       Special warnings and precautions for use

Gold, silver and other metallic jewellery should be removed prior to use, since discolouration may be caused.

Selsun is not to be ingested. In the event of accidental ingestion, take all appropriate measures immediately.

For external use only. 

Keep out of eyes; if Selsun gets into the eyes, wash thoroughly with cold water.

Do not leave the shampoo Selsun must not be left in contact with the hair or skin for more than the recommended duration as irritation, burning sensation or blistering may occur and do

Selsun is not to be used more often than recommended (see section 4.2).

Selsun must not be applied to or on infected or broken skin as this may cause systemic absorption of the selenium sulfide

4.5       Interaction with other medicinal products and other forms of interaction

If the hair has been damaged by chemical substances (like dyeing or bleaching products or as a result of a permanent wave or relaxing treatment) or if the hair is grey or white, discoloration of the hair may occur. In order to avoid discoloration of the hair it must be thoroughly rinsed immediately after use.

Selsun should be very thoroughly rinsed from the hair before dyeing, tinting, or permanent waving the hair. It should not be applied for a period of two days before or after any of these procedures.Selsun should not be applied for a period of two days before or after any of these procedures.

Gold, silver and other metallic jewelry should be removed prior to use of Selsun, since discolouration of the metals may occur.

4.6       Fertility, pregnancy and lactation

There are insufficient data available in pregnant women. Therefore, Selsun is not recommended for use in pregnant women.

 There are no adequate data from the use of selenium sulphide in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, foetal development and postnatal development.  Avoid use during pregnancy and in Selsun is not recommended for use while breastfeeding.

4.7       Effects on ability to drive and use machines

No studies on the effects on the ability to drive or use machines have been performed.

4.8       Undesirable effects

The following CIOMS frequency rating is used, when applicable: Very common 10%; Common 1 and < 10%; Uncommon 0.1 and < 1%; Rare 0.01 and < 0.1%; Very rare < 0.01%; Not known (cannot be estimated from available data).

Immune system disorder:

Frequency unknown: Hypersensitivity, rash and urticaria.

Skin and subcutaneous tissue disorders:

Frequency unknown: Irritation and sensitization, sometimes described as a burning sensation. Blistering can occur, especially if the shampoo is kept in contact with hair or skin for longer than the recommended duration.

Application to skin or scalp may produce irritation or sensitisation, sometimes described as a burning sensation.  Rarely, blistering can occur, especially if the shampoo is kept in contact with hair or skin for longer than the recommended duration.

Frequency unknown: Alopecia can occur.

Frequency unknown: Hair colour changes may occur; this can be avoided or minimized by thorough washing of the hair after treatment.

An increase in the amount of normal hair loss can occur. Discolouration of the hair may occur; this can be avoided or minimised by thorough washing of the hair after treatment.

Frequency unknown: Seborrhea (oiliness of hair and scalp) or application site dryness may occur.

As with other shampoos, oiliness or dryness of hair and scalp may occur.

Non-specific allergic reactions, including rash and urticaria, have been reported rarely.

Reporting of suspected adverse reactions

 

 

 

Updated on 7 August 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

Section 4.8: contact details updated for reporting of adverse events.
Section 6.1: new excipient 'sodium hydroxide' included

Updated on 7 August 2014 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 4 August 2014 PIL

Reasons for updating

  • Change to further information section

Updated on 4 August 2014 PIL

Reasons for updating

  • New PIL for new product

Updated on 20 May 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

Type IA B.II.f.a.1 variation to reduce the shelf life from 5 years to 3 years. This is to harmonise across all countries, not as the result of any other changes.

Updated on 6 March 2013 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

To update the list of excipients.

Updated on 4 October 2012 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

None provided

Updated on 1 October 2012 PIL

Reasons for updating

  • New PIL for new product