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Hydrocortisone Cream 1%

Document: leaflet MAH BRAND_PL 06464-0698 change

Patient Information Leaflet [Sovereign Medical logo]

Hydrocortistab Cream 1 %

(Hydrocortisone acetate)

Read all of this leaflet carefully before you start taking this medicine

-    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

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

In this leaflet:

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

2.    Before you use Hydrocortistab Cream 1 %

3.    How to use Hydrocortistab Cream 1 %

4.    Possible side effects

5.    How to store Hydrocortistab Cream 1 %

6.    Further information

1.    WHAT HYDROCORTISTAB CREAM 1 % IS AND WHAT IT IS USED FOR

The name of your medicine is Hydrocortistab Cream 1 %. Hydrocortistab Cream 1 % 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.

Hydrocortistab Cream 1 % is used to treat all types of eczema and dermatitis and insect bite reactions.

2.    BEFORE YOU USE HYDROCORTISTAB CREAM 1 %

Do not use this medicine if:

•    You are allergic to hydrocortisone or any of the other ingredients in Hydrocortistab Cream 1 % (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing);

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

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

•    You have a facial skin condition known as rosacea;

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

•    You have psoriasis (a skin condition).

Take special care 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 take this medicine.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines including those you have obtained without a prescription.

Pregnancy and breast-feeding

Tell your doctor before using this medicine if you are, or think you may be pregnant, or if you are breast-feeding.

3.    HOW TO USE HYDROCORTISTAB CREAM 1 %

Always use Hydrocortistab Cream 1 % exactly as your doctor has told you. You should 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 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, Hydrocortistab Cream 1 % 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 Hydrocortistab Cream 1 % 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.

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

5.    HOW TO STORE HYDROCORTISTAB CREAM 1 %

KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN

Do not store above 25°C.

Do not use any medicine after the “Use By” date on the carton and tube and keep them in their original pack.

6.    FURTHER INFORMATION

What Hydrocortistab Cream 1 % contains

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

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

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

Hydrocortistab Cream 1 % 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.

The Marketing Authorisation Holder and Manufacturer responsible for release:

Waymade PLC t/a Sovereign Medical,

Sovereign House,

Miles Gray Road,

Basildon,

Essex SS14 3FR.

[Sovereign Medical logo]


Date of preparation: April 2008