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 00173/0048.

Capasal Therapeutic Shampoo

PACKAGE LEAFLET Information for the user

CapasalTM Therapeutic Shampoo

salicylic acid, coconut oil, distilled coal tar

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 of the 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.

In this leaflet:

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

1. WHAT CAPASAL THERAPEUTIC SHAMPOO IS AND WHAT IT IS USED FOR

  • Capasal Therapeutic Shampoo is a treatment for dry, scaly scalp conditions such as:
    • seborrhoeic eczema / seborrhoeic dermatitis (patches of red, scaly, itchy skin);
    • pityriasis capitis (severe dandruff);
    • cradle cap (thick, yellowish, scaly scalp rash in babies and infants), and;
    • psoriasis (areas of raised, red, sometimes itchy, patches of skin, covered with silvery scales, without any blistering or tenderness).
  • Capasal Therapeutic Shampoo can also be used to remove other medicines applied to the scalp.
  • Capasal Therapeutic Shampoo is for use by adults, the elderly, children, infants and babies.
  • This product contains three active ingredients:
    • salicylic acid to remove scaly, flaky skin;
    • coconut oil to soften, moisturise and lubricate the scalp, and;
    • distilled coal tar to stop itching and restore normal skin development.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE CAPASAL THERAPEUTIC SHAMPOO

Do not use Capasal Therapeutic Shampoo

if you are allergic (hypersensitive) to salicylic acid, coconut oil, distilled coal tar or any of the other ingredients of Capasal Therapeutic Shampoo listed in Section 6.

Warnings and precautions

Take special care when using this product: Keep the undiluted shampoo, and the lather, away from the eyes.

Other medicines and Capasal Therapeutic 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 machinery

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

3. HOW TO USE CAPASAL THERAPEUTIC 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 Capasal Therapeutic Shampoo only to treat the scalp conditions that it is intended for.

Use as a shampoo until the scalp looks and feels better or as recommended by your doctor, pharmacist or nurse. Capasal 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, children, infants and babies:

  • Wet the hair thoroughly.
  • Apply a small amount of shampoo to the scalp (approximately a quantity the size of a fifty pence 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 product gets into the eyes

The product, or the lather, may cause irritation if it gets into the eyes. If this happens, rinse with plenty of water. If rinsing one eye, take care to avoid washing product into the other eye. If irritation persists, contact a doctor or hospital.

If you use more Capasal Therapeutic 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 Capasal Therapeutic 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, Capasal Therapeutic Shampoo can cause side effects, although not everybody gets them. This product has been specially designed for use on dry or problem skin, but in some rare cases it can cause irritant or allergic skin reactions on extremely sensitive skin. These rare effects tend to occur during or soon after the first few uses.

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 via the Yellow Card Scheme at: www.mhra. gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE CAPASAL THERAPEUTIC SHAMPOO

  • Keep this medicine out of the sight and reach of children.
  • Always replace the cap tightly after use.
  • Keep the bottle in the outer carton.
  • Keep away from direct sunlight.
  • 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 throw away any medicines you no longer use.

These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Capasal Therapeutic Shampoo contains:

The active ingredients are salicylic acid (0.5% w/w), coconut oil (1.0% w/w) and distilled coal tar (1.0% w/w).

The other ingredients are lauric acid diethanolamide, coco amido propyl dimethyl betaine, triethanolamine lauryl sulfate, ammonium sulfate, phenoxyethanol, and purified water.

What Capasal Therapeutic Shampoo looks like and contents of the pack

The product is a golden brown shampoo that smells of coal tar. The product is available in 250 ml plastic bottles fitted with dispensing caps. (30 ml bottles are also available to medical and allied professionals.)

The Marketing Authorisation holder is

Dermal Laboratories
Tatmore Place
Gosmore
Hitchin
Herts
SG4 7QR
UK

The Manufacturer is

Aeropak
Viking Road
Great Yarmouth
NR31 0NU
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: Capasal Therapeutic Shampoo, PL 00173/0048.

This is a service provided by the Royal National Institute of Blind People (RNIB).

FP38/20/1 202004