SELSUN Shampoo Ref.[27681] Active ingredients: Selenium sulfide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Aventis Pharma Limited (trading as Sanofi), 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, United Kingdom

4.3. Contraindications

Hypersensitivity to any of the ingredients.

Do not allow contact with broken or severely inflamed skin.

4.4. Special warnings and precautions for use

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

Do not leave the shampoo in contact with the hair or skin for more than the recommended duration as irritation, burning sensation or blistering may occur and do not use more often than recommended (see Section 4.2).

Selsun is not to be ingested.

In the event of accidental ingestion, take all appropriate measures immediately.

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.

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

4.6. Pregnancy and lactation

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 during pregnancy and 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

Immune system disorder

Frequency unknown:

Hypersensitivity, rash and urticarial.

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.

Alopecia can occur.

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

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

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

6.2. Incompatibilities

None known.

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