GEN-EZL-PIL-332.qxd:147 x 208    18/2/15

17:30

Page

Patient Information Leaflet    Chlorhexidine Gluconate 1% w/w

(incorporated as Chlorhexidine Gluconate tm    Solution 5% v/w)

ECZmOl 1% w/w Cream

Read all of this leaflet carefully because it contains important information for you.

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

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

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Eczmol cream is and what it is used for

2.    Before Eczmol cream is used

3.    How to use Eczmol cream

4.    Possible side effects

5.    How to store Eczmol cream

6.    Further information

1.    WHAT ECZMOL CREAM IS AND WHAT IT IS USED FOR

Eczmol cream contains skin moisturisers and an antiseptic called chlorhexidine gluconate.

It is used as a moisturiser to help prevent and treat the dryness and itching which are common features of skin complaints such as eczema and dermatitis.

Eczmol works by forming a barrier with the skin surface and trapping the moisture in deeper layers of the skin and reducing drying. The chlorhexidine gluconate helps combat germs on the skin that make certain types of eczema worse.

2.    BEFORE ECZMOL CREAM IS USED Do not use Eczmol cream:

•    If you are allergic (hypersensitive) to chlorhexidine gluconate or any of the other ingredients of Eczmol Cream.

Take special care with Eczmol cream:

•    Eczmol Cream may in rare cases cause severe allergic reactions, leading to a drop in blood pressure and even to unconsciousness. Early symptoms of a severe allergic reaction may be skin rash or asthma. If you notice these symptoms, stop using Eczmol Cream and contact your doctor as soon as possible (see under section 4: "Possible Side Effects").

•    Take care to avoid application to the ears and eyes, and any deep cuts involving the head or spine. Wash out with water if necessary. If any cream gets into the ears remove by very carefully swabbing.

•    If Eczmol cream comes into contact with fabrics and bleach is used to remove it, brown stains may develop.

•    If mixed with soap or detergents its effectiveness may be reduced.

•    If you have problems with the skin on the lower legs such as ulcers or a dry itchy rash (dermatitis).

In these cond it ions a sens itivity reacti on to Eczmol (e.g. ski n i rritat i on, rash) i s more common.

Taking or using other medicines

Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Eczmol cream may be used during pregnancy and breast feeding.

Ask your doctor or pharmacist for advice before taking any medicine when you are pregnant, think you may be pregnant, are planning to become pregnant, or are breast-feeding.

Driving and using machines

Eczmol cream should not affect your ability to drive or use machinery.

Important information about some of the ingredients of Eczmol cream

The ingredient cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis) which can cause an itchy rash.    25202402

GEN/EZL/PIL/332_03

GEN-EZL-PIL-332.qxd:147 x 208    18/2/15

17:30

Page

3.    HOW TO USE ECZMOL CREAM

Eczmol cream is for use on the skin only.

The same instructions apply to adults, the elderly and children:

For application to the skin:

•    Apply Eczmol to the affected areas.

•    Massage well into the skin until absorbed.

•    Repeat as often as required.

For use as a soap substitute:

•    Eczmol cream may be used as a moisturising cleanser in the bath or shower instead of ordinary soap or shower gel.

•    Keep the water temperature warm but not too hot as this can result in the removal of natural oils from the skin.

•    After washing, pat dry with a soft towel. Avoid rubbing too vigorously because this can aggravate dry skin conditions.

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

What to do if you accidentally swallow Eczmol cream

If you accidentally swallow the cream, contact your doctor or nearest hospital. If a significant quantity of the cream is accidentally swallowed the following symptoms may occur: a feeling of drunkenness, feeling sick, vomiting, slurred speech, a staggering walk and drowsiness. In the case of massive ingestion stomach upset and liver damage may result.

4.    POSSIBLE SIDE EFFECTS

Like all medicines Eczmol Cream can cause side effects, although not everybody gets them.

Serious side effects

If you get any of the following serious reactions stop using Eczmol Cream and get immediate medical help: Swelling of the face, lips, tongue or throat; a red itchy rash; wheezing or difficulty breathing; feeling faint and dizzy; a strange metallic taste in the mouth; collapse. You may be having an allergic reaction.

Other side effects

The following other side effects have been reported:

Irritation of the skin when the cream is first applied to that area. Skin may be dry, red, inflamed or itchy. Skin wheals, skin blisters, eczema.

If you develop a rash or your skin becomes itchy, red, dry or inflamed where you have used the product as a skin wash, stop using it and talk to your doctor or pharmacist.

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 ECZMOL CREAM

Keep out of the sight and reach of children.

Do not use after the expiry date stated on the packaging.

Keep at room temperature below 30°C.

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

The active ingredient is Chlorhexidine gluconate 1 % w/w.

The other ingredients are cetostearyl alcohol, macrogol cetostearyl ether, isopropyl alcohol, liquid paraffin, white soft paraffin and water.

What Eczmol cream looks like and contents of pack

Eczmol cream is a white thin cream available in 250ml bottles.

Marketing authorisation holder

Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK.

Manufacturer

Pharmasol Ltd, Walworth Industrial Estate, Andover, Hants SP10 5AZ, UK.

This leaflet was last revised in February 2015.

25202402    MP00864

GEN/EZL/PIL/332_03