Selsun Shampoo 2.5% w/v

Product Information *

  • Company:

    SANOFI
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Supply through pharmacy only

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 11 June 2021

File name

1.3.1 selsun shampoo patient leaflet_1623423418.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 11 June 2021

File name

1.3.1 selsun shampoo smpc_1623423218.pdf

Reasons for updating

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

Updated on 06 July 2020

File name

1.3.1 selsun patient leaflet_1590985893.pdf

Reasons for updating

  • XPIL Removed

Updated on 01 June 2020

File name

1.3.1 selsun patient leaflet_1590985893.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

Type IA.5in Change in name of manufacturer – Delpharm Bladel B.V.

Updated on 15 March 2019

File name

PIL Selsun IE785_1552655828.pdf

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

File name

SPC Selsun Shampoo IE785 _1552655987.pdf

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 07 August 2014

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 07 August 2014

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 04 August 2014

File name

PIL_15505_7.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 August 2014

Reasons for updating

  • Change to further information section

Updated on 20 May 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

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 06 March 2013

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 04 October 2012

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 01 October 2012

Reasons for updating

  • New PIL for new product