What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

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Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00173/5001R .

Psoriderm Scalp Lotion Shampoo

PACKAGE LEAFLET Information for the user

Psoriderm™ Scalp Lotion Shampoo

distilled coal tar 2.5% w/v

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Keep this leaflet. You may need to read it again. Ask your doctor, pharmacist or nurse if you need more information or advice. If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. You must talk to a doctor if your skin condition is not improving or if it feels worse after 4 weeks.

What is in this leaflet:

1. What Psoriderm Scalp Lotion Shampoo is and what it is used for
2. What you need to know before you use Psoriderm Scalp Lotion Shampoo
3. How to use Psoriderm Scalp Lotion Shampoo
4. Possible side effects
5. How to store Psoriderm Scalp Lotion Shampoo
6. Contents of the pack and other information

1. WHAT PSORIDERM SCALP LOTION SHAMPOO IS AND WHAT IT IS USED FOR

  • Psoriderm Scalp Lotion Shampoo is a shampoo treatment for scalp psoriasis (areas of raised, red, sometimes itchy, patches of skin, covered with silvery scales without any blistering or tenderness).
  • The shampoo is for use by adults, the elderly and children.
  • This product contains the active ingredient distilled coal tar, which stops itching and restores normal skin development.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE PSORIDERM SCALP LOTION SHAMPOO

Do not use Psoriderm Scalp Lotion Shampoo:

  • if you are allergic (hypersensitive) to distilled coal tar, or any of the other ingredients of this medicine listed in Section 6;
  • on psoriasis that feels and looks sore and angry, or on pustular psoriasis (which is very tender, inflamed, and involves small blisters filled with pus);
  • on infected skin.

Warnings and Precautions

Take special care when using this product: Keep the undiluted shampoo, and the lather, away from the eyes, mouth and the inside of your nose.

Other medicines and Psoriderm Scalp Lotion Shampoo

This product is not known to affect, or to be affected by, any other medicines.

Pregnancy and breast-feeding

This product can be used during pregnancy and whilst breast-feeding. The ingredients have been in widespread use in this and similar preparations for many years, without reports of problems. However, safety trials have not been conducted.

Driving and using machines

Using this product is not known to affect your ability to drive or use machinery.

3. HOW TO USE PSORIDERM SCALP LOTION SHAMPOO

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

Use this product only as a shampoo to treat scalp psoriasis.

Use as a shampoo until the scalp looks and feels better or as recommended by your doctor, pharmacist or nurse. Psoriderm can be used daily if required, reducing frequency of use to once or twice a week as your condition improves. Thereafter, occasional use may be necessary.

For adults, the elderly and children:

  • Wet the hair thoroughly.
  • Apply a small amount of shampoo to the scalp. (approximately a quantity the size of a fifty pence piece / two Euro piece for short hair, adjusting up depending on length/ thickness of hair).
  • With the tips of the fingers, massage in thoroughly.
  • Leave on for a few minutes.
  • Remove as much lather as possible with the hands (this is important as it will take the scales with it).
  • Rinse out.
  • If necessary, repeat the steps above.
  • Rinse out well under running water, then dry the hair as normal.

If the shampoo gets into the eyes, nose or mouth

This product, or the lather, may cause irritation if it gets into the eyes, nose or mouth. If this happens, rinse the affected areas with plenty of water.

If rinsing one eye, take care to avoid washing product into the other eye. If irritation persists, tell your doctor, pharmacist or nurse.

If you use more Psoriderm Scalp Lotion Shampoo than you should

Do not worry if you use too much shampoo, simply rinse hair under running water and continue as instructed above.

If you forget to use Psoriderm Scalp Lotion Shampoo

Do not worry if you occasionally forget to use this product, just carry on using it when you remember.

If there is no improvement after 4 weeks, or if your scalp condition seems to look or feel worse, discontinue use of the product and consult your doctor, pharmacist or nurse.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

  • The following can occur rarely, in which case you should stop using the product:
    • skin irritation;
    • acne-like eruptions;
    • skin photo-sensitivity (sensitivity to sunlight).
  • In rare cases, it may stain the skin, hair or fabric.

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. You can also report side effects directly (see details below).

By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

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

Ireland

HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: [email protected]

5. HOW TO STORE PSORIDERM SCALP LOTION SHAMPOO

  • Keep this medicine out of the sight and reach of children.
  • Always replace the cap tightly after use.
  • Do not store the product above 25°C.
  • Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP. The expiry date refers to the last day of that month.
  • Do not throw away any unused medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Psoriderm Scalp Lotion Shampoo contains:

The active ingredient is distilled coal tar (2.5% w/v).

The other ingredients are lecithin, trolamine laurilsulfate, lauric acid diethanolamide, ammonium sulfate, disodium edetate, sodium chloride, phenoxyethanol and purified water.

What Psoriderm Scalp Lotion Shampoo looks like and contents of the pack

  • The product is a golden brown shampoo.
  • The shampoo is available in white plastic bottles containing 250ml fitted with screw caps.

The Marketing Authorisation holder is

Dermal Laboratories
Tatmore Place
Gosmore
Hitchin
Herts
SG4 7QR
UK

The Manufacturer is

Fleet Laboratories Ltd
94 Rickmansworth Road
Watford
Herts
WD18 7JJ
UK

This leaflet was last revised in February 2020.

To listen to or request a copy of this leaflet in Braille, large print or audio, please call free of charge: 0800 198 5000 (UK only).

Please be ready to give the following information: Psoriderm Scalp Lotion Shampoo, 00173/5001. This is a service provided by the Royal National Institute of Blind People (RNIB).

OP4/20/1 202000