Selsun Shampoo 2.5% w/v

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Selenium disulfide

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

D11AC; D11AC03

INN (International Name):

Selenium disulfide

Dosage:

2.5 percent weight/volume

Pharmaceutical form:

Shampoo

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Medicated shampoos; selenium compounds

Authorization status:

Marketed

Authorization date:

1983-04-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SELSUN ® 2.5% W/V SHAMPOO (SELENIUM SULPHIDE)
MEDICAL TREATMENT
FOR DANDRUFF
Read all of this leaflet carefully because it contains important
information for you.
This medicine is available without prescription. However, you still
need to use Selsun carefully to get
the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If any of the side effects gets serious, or if you notice any side
effect not listed in this leaflet, please
tell your doctor or pharmacist._ _
IN THIS LEAFLET:
1.
What Selsun Shampoo is and what it is used for
2.
Before you use Selsun Shampoo
3.
How to use Selsun Shampoo
4.
Possible side effects
5.
How to store Selsun Shampoo
6.
Further information
1. WHAT SELSUN SHAMPOO IS AND WHAT IT IS USED FOR
SELSUN SHAMPOO IS A MEDICATED SHAMPOO USED TO TREAT DANDRUFF AND
SEBORRHOEIC
DERMATITIS (A GREASY, CRUSTING, ITCHING SCALP CAUSED BY EXCESS OIL).
It works against dandruff in two ways:
• By reducing greasiness of the scalp and
• By slowing down growth of the layer of skin cells on the scalp
that cause dandruff
2. BEFORE YOU USE SELSUN SHAMPOO
DO NOT USE SELSUN SHAMPOO IF:
• You are allergic (hypersensitive) to the active ingredient
selenium sulphide, or any of the
other ingredients of Selsun Shampoo
• You have broken or severely inflamed skin on your scalp
TAKE SPECIAL CARE WITH SELSUN SHAMPOO
USER PRECAUTIONS
•
Avoid contact with the eyes. If the shampoo does get in your eyes, you
can
experience severe eye irritation that may lead to injury. If this
occurs, rinse
immediately with lots of cold water.
•
In case of eye contact, if severe eye pain, eye swelling, change in
vision develop and
persist after rinsing with water talk to your doctor or pharmacist
(see section 4).
•
Selsun is not to be ingested or eaten.
•
Do not leave the shampoo in contact with the hair or skin for more
than the
recommended duration as irritation, burning sensation or blistering

Summary of Product characteristics

Health Products Regulatory Authority
09 June 2021
CRN009ZRL
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Selsun Shampoo 2.5% w/v
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100ml of suspension contains 2.5 g (2.5% w/v) of Selenium
disulphide Ph. Eur.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Shampoo.
Beige to pale yellow to pale orange uniform suspension; free from
large particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Simple Dandruff and seborrhoeic dematitis of the scalp.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Apply topically to the scalp.
_Adults and the elderly:_
After thoroughly wetting the hair massage Selsun in to form a lather.
Rinse after 2 to 3 minutes. Usage should be twice a
week for the first tow weeks and then once a week for the next two
weeks to control the condition. After this initial course of
treatment Selsun should not be used more often than necessary.
_Children aged 5-14 years:_
As for adults.
_Children under 5 years of age:_
Not recommended.
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.
This shampoo is an irritant to the eyes. It should therefore be kept
away from the eyes.
If the shampoo comes in contact with the eyes, they should rinse
thoroughly with cold water.
Exposure of Selsun to eyes may result in ocular injuries such as
corneal abrasion (see section 4.8).
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.
Selsun is not to be ingested. In the event of accidental ingestion,
take all appropriate measures immediately.
Selsun is not to be used more often than recommended.
Health Products Regulatory Authority
09 June 2021
CRN009ZRL
Page 2 of 4
Selsun must not be applied to or on infected or broken skin as this
may cause systemic absorption of the selenium sulfi