GB 724-7539-APIL

Package leaflet: Information for the user

Hydrocortisone 1% Cream

(Hydrocortisone acetate)

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

•    Please keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Hydrocortisone 1% Cream is and what it is used for

2.    What you need to know before you use Hydrocortisone 1 % Cream

3.    How to use Hydrocortisone 1 % Cream

4.    Possible side effects

5.    How to store Hydrocortisone 1% Cream

6.    Contents of the pack and other information

1.    What Hydrocortisone 1% Cream is and what it is used for

The name of your medicine is Hydrocortisone 1% Cream.

Hydrocortisone 1% Cream contains the active ingredient hydrocortisone which belongs to a group of medicines called corticosteroids or 'steroids'. Steroids like hydrocortisone are applied to the skin to reduce inflammation. Hydrocortisone 1% Cream is used to treat all types of eczema and dermatitis and insect bite reactions

2.    What you need to know before you use Hydrocortisone 1% Cream

Do not use Hydrocortisone 1% Cream:

•    if you are allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6) (allergic reactions include mild symptoms such as itching and/or rash.

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More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing).

•    If you have an infection of the skin which has not been treated;

•    If you have pale or reddened patches of skin - (usually as a result of an allergy; this is a condition known as urticaria);

•    If you have a facial skin condition known as rosacea;

•    If you have ulcers or an infection at the site of treatment;

•    If you have psoriasis (a skin condition).

Warnings and precautions

Talk to your doctor or pharmacist before

using Hydrocortisone 1% Cream if you:

•    have TB (tuberculosis);

•    have diabetes

If any of the above applies to you, or you are not sure please tell your doctor or pharmacist before you use this medicine.

Other medicines and Hydrocortisone 1% Cream

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

3. How to use Hydrocortisone 1% Cream

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Check that the tube seal is not broken before use. Use the point on the cap to break the seal.

For adults and children

Apply sparingly to the affected area of skin

two or three times daily.

Important Information

•    Use sparingly

•    Avoid using the cream continuously for a long time, particularly in children and on the face.

If you use more Hydrocortisone 1% Cream than you should

If you accidentally use too much cream it is not likely to cause any harm.

If anyone accidentally swallows any cream, rinse out the mouth and seek medical advice. Take the product and packaging with you.

4.    Possible side effects

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

If you notice;

•    a skin rash,

•    reddening of the skin or itching of the skin stop using the cream and tell your doctor immediately. These may be signs of an allergic reaction.

Other side effects may include:

•    spread of infection;

•    permanent 'stretch-mark' like marks;

•    thinning of the skin;

•    changes in hair growth;

•    acne;

•    oily skin;

•    slight loss of colour in the skin.

If you use Hydrocortisone 1 % Cream for a long time, very occasionally, this may lead to problems with your hormones. This mainly happens if it is used in areas such as the folds of the skin, the face and the nappy area, or in areas where a dressing is used to cover the area after using the cream.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects via the Yellow Card Scheme at: www.mhra.aov.uk/vellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Hydrocortisone 1% Cream

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Do not use any medicine after the expiry date on the carton and tube and keep them in their original pack.

Do not throw away any medicines via wastewater or household waste.

Ask your pharmacist how to throw away medicines you no longer use.

These measures will help protect the environment.

6. Contents of the pack and other information

What Hydrocortisone 1% Cream contains

The active ingredient is hydrocortisone acetate present at a concentration of 1 %.

The other inactive ingredients are: cetomacrogol emulsifying wax, liquid paraffin, white soft paraffin, chlorocresol and purified water.

What Hydrocortisone 1% Cream looks like and the contents of the pack

Hydrocortisone 1% Cream is a soft, white cream, with a faint characteristic odour.

It is available in a tube containing either 15 g, 30 g or 50 g of cream.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sovereign Medical, Sovereign House,

Miles Gray Road, Basildon,

Essex SS14 3FR UK

Manufacturer

Waymade Pic, Sovereign House,

Miles Gray Road, Basildon,

Essex SS14 3FR UK

This leaflet was last revised in:

March 2016

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