PACKAGE LEAFLET: INFORMATION FOR THE USER HYDROCORTISONE OINTMENT 1%

{Hydrocortisone}

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

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

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

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

See section 4.

•    You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

What is in this leaflet:

1.    What Hydrocortisone Ointment is and what it is used for

2.    What you need to know before you use Hydrocortisone Ointment

3.    How to use Hydrocortisone Ointment

4.    Possible side effects

5.    How to store Hydrocortisone Ointment

6.    Contents of the pack and other information

1.    What Hydrocortisone Ointment is and what it is used for

Hydrocortisone ointment is a topical anti-inflammatory used in the treatment of

•    Irritant dermatitis (inflammation of the skin)

•    Contact allergic dermatitis,

•    Insect bite reactions and

•    Mild to moderate eczema (inflammation of the skin).

2.    What you need to know before you use Hydrocortisone Ointment

Do not use Hydrocortisone Ointment

•    If you are allergic (hypersensitive) to hydrocortisone or any of the other ingredients of Hydrocortisone Ointment (See section 6, Further information)

•    If you are a child under 10 years old without medical supervision

•    On cut or infected skin such as cold sores, herpes, impetigo (bacterial skin infection), athlete's foot, chicken pox, ringworm or thrush.

•    On the eyes and face or ano-genital area

•    If you have acne

•    Under a water or air tight dressing as this may increase the absorption of hydrocortisone through the skin.

Warnings and precautions

•    Treatment of children should be restricted to no more than 7 days.

Other medicines and Hydrocortisone Ointment

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

Pregnancy and breast-feeding

Should not be used in pregnancy and breast-feeding without medical advice.

3.    How to use Hydrocortisone Ointment

Always use Hydrocortisone Ointment exactly as your doctor has told you.

You should check with your doctor or pharmacist if you are not sure.

For cutaneous (external) use only. Wash your hands after use unless the hands are the area being treated.

Use sparingly over a small area once or twice a day for a maximum period of one week.

If the condition is not improved after this time, consult your doctor.

If you use too much ointment

If you use too much ointment or if you or someone else accidently swallows some ointment, contact your doctor or go to your nearest hospital emergency department immediately, take the ointment with you so the doctor knows what you have taken.

4.    Possible Side Effects

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

Hydrocortisone preparations are usually well tolerated, but if any signs of hypersensitivity appear, application should stop immediately: this may include allergic contact dermatitis (rash which may be red, itchy and burning) or worsening of your condition.

Prolonged use of large amounts or treatment of extensive areas can result in features of Cushing's syndrome (symptoms include increased fat on the body, fragile or discoloured skin, weakening of bones, excessive hair growth, changes in periods in women, altered sexual function in men, increased thirst and urination, tiredness, irritability, anxiety or depression). If you experience these symptoms or are worried contact your doctor.

Other side effects:

•    Stretch marks may occur in areas where the skin may rub, for example at the joints and at folds in the skin.

•    Thinning of the skin, changes in skin pigmentation (colour) and hair growth.

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 Hydrocortisone Ointment

Keep out of the sight and reach of children.

Do not use Hydrocortisone Ointment after the expiry date stated on the carton. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer reguired.

These measures will help to protect the environment.

6.    Contents of the pack and other information What Hydrocortisone Ointment contains

The active substance is micronised hydrocortisone

The other ingredients are wool fat, liguid paraffin and white soft paraffin

What Hydrocortisone Ointment looks like and contents of the pack

A collapsible aluminium tube, with a membrane seal at the nozzle, internal epoxy lacguer, latex endseal band in the crimp seal area and a white plastic cap for reclosure after piercing membrane.

Hydrocortisone Ointment is provided in a 15 g tube.

Marketing Authorisation Holder

Co-Pharma Ltd Unit 4 Metro Centre,

Tolpits Lane, Watford,

Hertfordshire,

WD18 9SS

This medicinal product is authorised in the Member States of the EEA under the following names: Not applicable This leaflet was last revised 06/2015.

Manufacturer

Beltapharm SpA-via Stelvio,66 20095 Cusano Milanino-Milan -Italy