Medine.co.uk

Hydrocortisone 1.0% Cream

Document: leaflet MAH GENERIC_PL 00142-0609 change

Hydrocortisone 1% Cream

•    Please read this leaflet carefully before you start to take your medicine.

•    It gives you important information about your medicine.

•    If you want to know more, or you are not sure about anything, ask your pharmacist or doctor.

•    Keep the leaflet until you have finished the medicine.


WHAT’S IN YOUR MEDICINE

•    Hydrocortisone 1.0% Cream BP contains 1.0% w/w of the active ingredient Hydrocortisone.

•    The cream also contains cetomacrogol 1000, cetostearyl alcohol, chlorocresol, liquid paraffin, white soft paraffin, purified water.

•    Hydrocortisone 1.0% Cream BP is available in pack sizes of *.

•    Your cream is made by Actavis, Barnstaple, EX32 8NS, UK who are also the Marketing Authorisation holder.

ABOUT YOUR MEDICINE

Hydrocortisone is one of a group of medicines called mild topical corticosteroids. These medicines work by calming the inflammation that occurs during certain skin conditions or reactions.

Hydrocortisone 1.0% Cream BP may be used for treating various skin conditions including:

•    Eczema

•    Dermatitis, including intertrigo (irritation between skin folds)

•    Insect bite reactions

•    Inflammation of the external ear (otitis externa)

•    Prurigo nodularis- a long term skin problem where very itchy lumps appear

•    Neurodermatoses- long term skin problems where areas resembling lichen may appear

•    Nappy rash, where no infection exists, or if it does, it is being treated with appropriate antibiotics.

BEFORE USING YOUR MEDICINE

Do not use Hydrocortisone 1.0% Cream if you:

•    Have ever had an allergic reaction to hydrocortisone or any of the ingredients in the cream. An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. This product contains cetostearyl alcohol which may cause local skin reactions such as contact dermatitis and chlorocresol which may cause allergic reactions, in some people.

•    Are suffering from skin conditions caused by infections, which are not being treated with appropriate antibiotics, including impetigo, cold sores, chicken pox, herpes, ringworm, athlete’s foot or thrush.

•    Have scabies mite, rosacea (puffiness and reddening of the nose and cheek areas of the face) or dermatitis around the mouth area.

Take special care with Hydrocortisone 1.0% Cream if you:

•    Are treating a child. Long term use in children is not recommended. Do not use under a nappy or airtight dressing for more than five to seven days in young children.

•    Are applying the cream to the face. Avoid using the cream for longer than your doctor has told you to. Take particular care to keep the cream from getting in your eyes.

•    Have a skin infection. If the condition appears to be getting worse despite using antibiotics prescribed by your doctor, stop using the cream and contact your doctor.

•    Have psoriasis.

Pregnancy and Breast-feeding:

Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant

whilst using hydrocortisone, tell your doctor immediately.

Other precautions you should take:

If you see another doctor or go into hospital, let them know what medicines you are taking or using.

USING YOUR MEDICINE

Follow your doctor’s instructions. Check the pharmacy label to see how often to apply the cream and how much to apply. If you are still unsure ask your pharmacist or doctor.

The usual dosage(s) are described below.

For application to skin.

Adults

Gently apply a thin layer of cream to the affected area(s) two or three times daily.

Children

and

Infants

Gently apply a thin layer of cream to the affected area(s) two or three times daily.

Avoid using for more than five to seven days at a time .

If you use more Hydrocortisone 1.0% Cream than you should

•    Do not use the cream more often or for longer than your doctor tells you to.

•    Do not use larger quantities than told by your doctor or pharmacist, as this will increase the possibility of side effects.

•    If you accidentally use too much on a few occasions do not worry.

•    If you accidentally swallow some cream, small amounts are not harmful.

If you forget to use Hydrocortisone 1.0% Cream

If you forget to use the cream, apply it as soon as you remember, unless it is nearly time to apply the next dose.

AFTER APPLYING YOUR MEDICINE

Like all medicines, Hydrocortisone 1.0% Cream BP can sometimes cause unwanted side effects.

If the following happens, stop using Hydrocortisone 1.0% Cream BP and tell your doctor immediately or contact the casualty department at your nearest hospital:

•    An allergic reaction: swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.

•    contact dermatitis - localised rash or irritation to the skin

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

Using more than the correct amount of cream may:

•    Thin the skin so it damages easily

•    Allow the active ingredient to pass through the skin and affect other parts of the body, especially in infants and children, and during pregnancy, and if used under a nappy or airtight dressing.

In rare cases, a change in the colour of skin, or increased growth of hair in areas where the cream is used may occur.

If you feel unwell or have any unusual discomfort you do not understand, contact your doctor as soon as possible.

STORING YOUR MEDICINE

• Do not use the cream after the end of the expiry month (use by date) shown on the product packaging.

•    Store below 25°C. Do not freeze.

•    Do not transfer the cream to another container.

•    Keep Hydrocortisone 1.0% Cream BP out of the reach and sight of children in a secure place.

•    Remember that this medicine is for you only. Never give it to anyone else. It may harm them, even if their symptoms are the same as yours.

•    Return all unused medicines to your pharmacist for safe disposal.


If you would like a leaflet with larger text, please contact 01271 311257.

Further information:

More information on managing skin conditions may be obtained from:

National Eczema Society Unit 26, Imex Business Centre,

Balme Road Cleckheaton BD19 4EZ.

Skin Care Campaign 112 St Martins Lane London WC2N 4AZ

Date leaflet last revised: January 2012 *Pack sizes:15g, 30g and 50g

(Only the marketed pack size/s will be stated on the final version)