Selsun Shampoo 2.5%

SANOFI

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, wash immediately with lots of 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

• Gold, silver and other metallic jewellery should be removed prior to use, as discolouration may occur

• Rinse thoroughly from the hair before dyeing, tinting, perming or chemical straightening

• It should not be used for 2 days before or after any of these hair treatments

• Take out hair grips and remove jewellery before use and avoid contact with metal surfaces

Pregnancy and Breast-feeding

You should not use Selsun Shampoo if you are pregnant, think you may be pregnant or are breast-feeding.

Ask your doctor or pharmacist for advice before using any medicine.

3. How to use Selsun Shampoo

Adults, (including elderly) and children over 5 years old

• Shake bottle well before use

• Wet the hair and then massage enough into your scalp to form a lather

• Leave for two to three minutes

• Rinse thoroughly

Selsun should be used twice a week for the first two weeks and then once a week for the next two weeks. After this first course of treatment, it should not be used more often than is needed to control your scalp condition.

Selsun Shampoo is not recommended for use in children under 5 years of age

If you accidentally swallow Selsun Shampoo,

seek medical advice immediately. Swallowing Selsun Shampoo can cause you to feel sick or be sick.

If you have any further questions on how to take this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Selsun Shampoo can cause side effects, although not everybody gets them.

Side effects may include:

• Skin rash or hives

• Irritation or sensitization of the skin or scalp, sometimes described as a burning sensation

• Increase in the amount of normal hair loss 2617.05

• Discolouration of hair, which may be avoided by thoroughly washing the hair after treatment

• Oiliness or dryness of hair and scalp.

• Rarely, blistering can occur, especially if the shampoo is kept in contact with the hair or skin for longer than the recommended duration

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

United Kingdom

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard Ireland

You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, iRl - Dublin 2;

Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Selsun Shampoo

Keep out of the reach and sight of children.

Do not store above 25°C.

Do not use Selsun Shampoo after the expiry date which is stamped on the pack. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further Information

What Selsun Shampoo contains

Each 100ml of shampoo contains 2.5 g of the active ingredient Selenium Sulphide (selenium disulphide Ph. Eur).

The other ingredients are bentonite, titanium dioxide, citric acid, sodium dihydrogen phosphate dihydrate, glyceryl monoricinoleate S, monoethanolamine lauryl sulphate, Empigen BB, perfume, sodium chloride, sodium hydroxide, purified water.

What Selsun Shampoo looks like and contents of the pack

Selsun Shampoo appears as a smooth beige suspension and it is available in plastic bottles containing 50ml, 100ml, or 150ml of shampoo.

Marketing Authorisation Holder

In the UK: Sanofi, One Onslow Street,

Guildford, Surrey, GU1 4YS, UK Tel: 0845 372 7101

email: uk-medicalinformation@sanofi.com In Ireland: Sanofi-Aventis Ireland Ltd. T/A SANOFI,

Citywest Business Campus, Dublin 24, Ireland

Tel: 01403 5600

email: IEmedinfo@sanofi.com

Manufacturer

Famar Nederland BV,

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