Hydrocortisone Cream 1%
PACKAGE LEAFLET: INFORMATION FOR THE USER
SKIN CALM CREAM Hydrocortisone Cream 1%
[Hydrocortisone]
Read all of this leaflet carefully before you start using this medicine.
• 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Skin Calm Cream is and what it is used for
2. Before you use Skin Calm Cream
3. How to use Skin Calm Cream
4. Possible side effects
5. How to store Skin Calm Cream
6. Further information
1. WHAT SKIN CALM CREAM IS AND WHAT IT IS USED FOR
Skin Calm Cream is a topical anti-inflammatory used in the treatment of
• irritant dermatitis (inflammation of the skin)
• contact allergic dermatitis
• insect bite reactions
• mild to moderate eczema (inflammation of the skin)
2. BEFORE YOU USE SKIN CALM CREAM Do not use Skin Calm Cream:
• if you are allergic (hypersensitive) to hydrocortisone or any of the other ingredients of Skin Calm Cream (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
Take special care with Skin Calm Cream
• Treatment of children should be restricted to no more than 7 days.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Should not be used in pregnancy and breastfeeding without medical advice.
3. HOW TO USE SKIN CALM CREAM
Always use Skin Calm Cream 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 cream
If you use too much cream or if you or someone else accidently swallows some cream, contact your doctor or go to your nearest hospital emergency department immediately, take the cream with you so the doctor knows what you have taken.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Skin Calm Cream 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 of treatment of extensive areas can result in features of Cushing 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 the folds in the skin.
• Thinning of the skin, changes in skin pigmentation (colour) and hair growth.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE SKIN CALM CREAM
Keep out the reach and sight of children.
Do not use Skin Calm Cream after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Medicines should not be disposed via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help protect the environment.
6. FURTHER INFORMATION
What Skin Calm Cream contains
The active substance is micronized hydrocortisone
The other ingredients are Cetomacrogol emulsifying wax, Chlorocresol, Liquid paraffin, Macrogol 300, White soft paraffin, Purified water.
What Skin Calm Cream looks like and contents of the pack
A collapsible aluminium tube, with a membrane seal at the nozzle, internal epoxy lacquer, latex endseal band in the crimp seal area and a white plastic cap for reclosure after piercing membrane.
Skin Calm Cream is provided in a 15g tube.
Marketing Authorisation Holder and Manufacturer
Co-Pharma Ltd
Unit 4 Metro Centre, Tolpits Lane, Watford, Hertfordshire, WD18 9SS
This medicinal product is authorized in the member states of the EEA under the following names: Not applicable