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Hydrocortistab Ointment 1%

Document: leaflet MAH BRAND_PL 06464-0699 change

797-TBC

Patient Information Leaflet


^SOVEREIGN

■Mi MEDICAL


Hydrocortistab Ointment


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

Keep this leaflet; you may need to refer to it again.

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

This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

In this leaflet:

1.    What is in your medicine and what is it used for?

2.    Before you use your medicine

3.    How to use your medicine

4.    Possible side effects

5.    Looking after your medicine


1. What is in your medicine and what is it used for?

The name of your medicine is Hydrocortistab Ointment 1%.

The active ingredient is hydrocortisone.

The inactive ingredient is white soft paraffin.

Hydrocortistab Ointment is a soft, white to off-white ointment, with a faint characteristic odour, free from extraneous matter. It is available in a tube containing either 15 g, 30 g or 50 g of ointment.

The Marketing Authorisation Holder is: Waymade PLC t/a Sovereign Medical, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR.

Manufacturer Responsible for Release: Waymade PLC, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR.

Hydrocortistab Ointment belongs to a group of medicines called topical corticosteroids which relieve inflammation of the skin. Hydrocortistab Ointment is used for the treatment of eczema and dermatitis of all types including atopic eczema, photodermatitis, otitis externa, primary irritant and allergic dermatitis, intertrigo, prurigo nodularis, seborrhoeic dermatitis and insect bite reactions.


2. Before you use your medicine

You should not use this medicine, but tell your doctor first if:

•    you are allergic to any of the ingredients listed above

•    you have an untreated infection of the skin

•    you have urticaria, rosacea, ulcers and local infection.

Taking other medicines

Hydrocortistab Ointment is not known to interact with any other medicines.


3.    How to use your medicine

Check that the tube seal is not broken before use. Use the point on the cap to break the seal. Follow your doctor’s directions. Read the label to see how often you should use your medicine. A pharmacist will help you if you are not sure.

The usual dose for Adults and Children is: apply sparingly twice daily.

Important Information

•    Use sparingly

•    Avoid prolonged, continuous use, particularly in children and especially on the face.

What to do if you use too much

If you accidentally use too much ointment it is unlikely to cause any harm. If anyone accidentally swallows any ointment, rinse out the mouth and seek medical advice. Take the product and packaging with you.

4.    Possible side effects

Very occasionally you may get an allergic reaction after using this product. If you experience a skin rash, reddening of the skin or itching of the skin, stop using the ointment and see your doctor at once.

If you use Hydrocortistab Ointment for a long period of time you may get thinning of the skin and other skin changes (such as broken blood vessels and stretch marks) especially in areas such as the folds of the skin, the face and the nappy area or in areas where an occlusive dressing is used after using the ointment. Very occasionally, this may lead to an imbalance in your hormones.

If concerned or if anything else unusual happens, talk to a pharmacist or doctor.


5. Looking after your medicine

Do not store above 25°C.

Keep this ointment in a safe place away from the reach of children, preferably in a locked cupboard. Do not use any medicine after the “Use By” date on the carton and tube and keep them in their original pack.

Remember: This medicine has been prescribed to you personally by your doctor. Do not give it to anybody, even if their symptoms are the same as yours. There are important reasons why it could harm them.


Date of preparation: August 2006


^SOVEREIGN

■MB MEDICAL