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.

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 00173/0183.


Doublebase Gel

PACKAGE LEAFLET

Information for the user

Doublebase™ Gel

isopropyl myristate 15% w/w, liquid paraffin 15% w/w

Please read all of this leaflet carefully before you start using this medicine.

Keep this leaflet. You may need to read it again.

Ask your doctor, nurse or pharmacist if you need more information or advice.

In this leaflet:

1. What Doublebase Gel is and what it is used for
2. Before you use Doublebase Gel
3. How to use Doublebase Gel
4. Possible side effects
5. How to store Doublebase Gel
6. Further information
7. General advice on looking after dry skin conditions

1. WHAT DOUBLEBASE GEL IS AND WHAT IT IS USED FOR

  • Doublebase Gel is a treatment for application to your skin.
  • It helps treat dry or chapped skin conditions that may also be itchy, red and sore. Common examples include:
    • psoriasis (scaly, pink patches of skin), elderly pruritus (itchy skin due to ageing), ichthyosis (abnormal scaly skin), various forms of eczema, dermatitis and other dry skin disorders.
  • All age groups can use Doublebase Gel, including babies.
  • The active ingredients in this product are isopropyl myristate and liquid paraffin.
    These are known as emollients. The product helps to:
    • soften, moisturise and protect your skin by trapping moisture in the skin and restoring the normal protective function of the skin.
    • prevent the skin-drying and irritant effects that can be caused by washing and bathing and by the soaps, foaming additives and fragrances used in ordinary cleansing products.
  • This product can be used in addition to any other emollients or treatments your doctor, pharmacist or nurse may have given or prescribed for you to treat your dry skin condition.

2. BEFORE YOU USE DOUBLEBASE GEL

Do not use Doublebase Gel if you are allergic (hypersensitive) to isopropyl myristate, liquid paraffin or any of the other ingredients of Doublebase Gel listed in Section 6.

Using other medicines

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

Pregnancy and breast-feeding

This product can be used during pregnancy and while 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.

Important Safety Information

Paraffin is a common, important and very effective ingredient in emollient products applied to the skin. However, care should be taken as emollients which soak into medical dressings or fabrics (clothing, pyjamas, bed linen, etc.) can increase the flammability of these items. Patients using emollients (and their parents/carers) should take particular care to avoid these materials coming into contact with naked flames or lit cigarettes, etc. As a precaution, dressings and clothing, etc., should be changed frequently and laundered thoroughly.

3. HOW TO USE DOUBLEBASE GEL

This product is only for application to the skin.

For maximum benefit you should apply the gel on a regular basis and as often as required.

  • Before using the 500 g and 1 kg bottles, turn the top of the pump dispenser in the direction of the ‘open’ arrow to unlock it. After unlocking, you will need to press down the pump dispenser several times to prime the pump before any product is dispensed.
  • Apply Doublebase Gel to the affected areas of the skin on a regular basis and as often as required.
  • Use a few gentle strokes to smooth the gel across the skin in the same direction as hair growth (like stroking a cat or dog). If necessary, allow time for any excess to soak in.
    Do not rub the skin vigorously.
  • This product can also be used before and after washing, showering or having a bath to help condition your skin and stop it from drying further.
  • If you are applying another treatment to the same areas of skin as Doublebase Gel, try to avoid mixing the two products. This can be achieved by applying the treatments alternately, leaving sufficient time to allow the previous application to soak in.

If you forget to use Doublebase Gel

Do not worry if you occasionally forget to use it, just carry on using the gel as described the next time you require it.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Doublebase Gel can cause side effects, although not everybody gets them.

This product has been specially designed for use on dry or problem skin. However, in rare cases it can cause skin irritation (mild rashes) or allergic skin reactions on extremely sensitive skin.

These rare effects tend to occur during or soon after the first few uses.

Stop using this gel and tell your doctor, nurse or pharmacist:

  • if your skin condition seems to look or feel worse.
  • if any of the side effects get serious, or you notice any other side effects not mentioned in this leaflet.

If this product is accidentally swallowed, its oily ingredients may cause diarrhoea.

If this happens:

  • treat the symptoms as you would deal with any case of diarrhoea.
  • drink plenty of water.
  • do not attempt to cause vomiting.

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

5. HOW TO STORE THIS PRODUCT

  • Keep out of the sight and reach of children.
  • Do not use Doublebase Gel after the expiry date shown on the container.
    The expiry date refers to the last day of that month.
  • Do not store above 25°C.
  • Do not freeze the product.
  • If using a tube, replace cap after use.
  • Occasionally, in the 500 g and 1 kg bottles a small pocket of air may form around the bottom end of the pump’s dip tube, making it harder to pump the gel out. This may be resolved by tapping the base of the bottle firmly on a hard surface two or three times, so the gel can settle at the bottom around the end of the dip tube. The pump should then be pumped SLOWLY.

6. FURTHER INFORMATION

What Doublebase Gel contains:

The active ingredients are isopropyl myristate (15% w/w) and liquid paraffin (15% w/w).

The other ingredients are glycerol, carbomer, sorbitan laurate, trolamine, phenoxyethanol and purified water.

What Doublebase Gel looks like and contents of the pack

  • The gel is available in a plastic tube containing 100 g or plastic pump bottles containing 500 g and 1 kg. (25 g packs are also available to the medical and allied professions.)
  • The product has the appearance of a white gel. It contains no dye or fragrance.

The Marketing Authorisation holder is

Dermal Laboratories
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 July 2017.

7. GENERAL ADVICE ON LOOKING AFTER DRY SKIN CONDITIONS

  • Emollients help soften, moisturise and protect the skin. They play a central role in the treatment and management of dry skin conditions. For maximum effect, they should be applied regularly and as often as needed.
  • When bathing, try to use warm, not hot, water and avoid staying in the bath for long periods. This could make dry skin conditions worse.
  • Try to avoid using normal soaps or bath additives (even those labelled “moisturising”). This is because they tend to dry and irritate the skin. Avoid using products containing fragrances, as these can also cause skin problems. You should try to use a fragrance-free emollient “soap substitute” instead. This type of product will not foam or lather but will be better for your dry skin condition.

Breaking the itch-scratch cycle

Some dry skin conditions like eczema and dermatitis are itchy, and can be quite sore. Although scratching relieves the itching for a short while, it further damages the skin. Badly scratched skin easily gets infected. This makes it itchier and the urge to scratch becomes even greater. It is better if scratching can be avoided by reducing the itching. The regular use of emollients or moisturisers can help with this.

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: Doublebase Gel, 00173/0183.

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

IP13/17/2 201635