Derma Care Hydrocortisone 1% Cream
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CORTOPIN HYDROCORTISONE CREAM 1%
1% Hydrocortisone
Read all of this leaflet because it contains important information for you.
This medicine is available without a prescription. However, you still need to use this product carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve after 7 days
• 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 Cortopin Hydrocortisone Cream is and what it is used for
2. Before you use Cortopin Hydrocortisone Cream
3. Howto use Cortopin Hydrocortisone Cream
4. Possible side effects
5. Howto store Cortopin Hydrocortisone Cream
6. Further information
WHAT CORTOPIN HYDROCORTISONE CREAM IS AND WHAT IT IS USED FOR
Cortopin Hydrocortisone Cream is a smooth white cream for application to the skin only. It contains hydrocortisone which belongs to a group of medicines called corticosteroids. Cortopin Hydrocortisone Cream is used to reduce inflammation in a variety of inflammatory skin conditions, such as:
• mild to moderate eczema
• dermatitis caused by irritants or allergens
• insect bite reactions
Hydrocortisone should not be confused with anabolic steroids, used by some body builders and taken as tablets or injections. 2. BEFORE YOU USE CORTOPIN HYDROCORTISONE CREAM
Do not use Cortopin Hydrocortisone Cream:
• if you are allergic to hydrocortisone or to any of the other ingredients of Cortopin Hydrocortisone Cream (see Section 6 and end of Section 2).
• if you have a bacterial infection (e.g. impetigo), viral infection (e.g. cold sores ‘herpes simplex’, chicken pox) or fungal infection (e.g. tinea, also called ‘athlete’s foot’, ringworm or thrush) of the skin.
• on your face or near your eyes, on the anal or genital region, or on broken skin.
Take special care with Cortopin Hydrocortisone Cream
Cortopin Hydrocortisone Cream is not suitable for use in the following:
• allergic skin reactions including temporary red or raised areas on your skin (short lived ‘wheal and flare’ reactions)
• conditions involving the deeper skin layers, such as granulomas
• psoriasis (long term scaly skin condition); only use this product on medical advice and with careful supervision by your doctor.
Do not cover the area with a plaster or dressing of any kind after application of Cortopin Hydrocortisone Cream.
Take great care to apply the cream sparingly to the skin of infants or children, especially in the nappy area which can be covered for long periods. Covering the treated area can increase absorption. Treatment for infants must not exceed 7 days.
Do not apply the product to your face for long periods of time.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Tell your doctor if you are or may be pregnant. Ask your doctor for advice before taking any medicine during pregnancy. There is a very small risk of abnormalities in the unborn child if this product is used during pregnancy.
If you are breast-feeding, do not apply the product to your chest area.
Important information about some of the ingredients
Cortopin Hydrocortisone Cream contains
• chlorocresol - may cause allergic reactions
• cetomacrogol emulsifying wax - which contains cetostearyl alcohol - may cause local skin reactions (e.g. contact dermatitis).
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3. HOW TO USE CORTOPIN HYDROCORTISONE CREAM
FOR EXTERNAL USE ONLY
Always use Cortopin Hydrocortisone Cream exactly as instructed in this leaflet. If you are not sure, ask your doctor or pharmacist. Do not exceed the stated dose.
Not for use by children under 10 years of age without medical advice.
For application to the surface of the skin only:
1. Wash your hands thoroughly before use.
2. Apply the cream sparingly to the affected area, once or twice a day for a maximum of 7 days. Massage the cream gently into the affected area to help absorption into the skin.
3. Once applied, do not cover the area with a dressing or plaster.
If the condition has not improved after 7 days, or worsens, consult your doctor.
If you use more Cortopin Hydrocortisone Cream than you should
If you or a child accidentally swallow the cream, contact your doctor or nearest hospital immediately. Take the packet with you to help identification.
If you forget to use Cortopin Hydrocortisone Cream
If you miss a treatment, apply the cream as soon as you remember, and apply the remaining doses for that day at evenly spaced intervals.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Cortopin Hydrocortisone Cream can cause side effects, although not everybody gets them.
You may notice the following:
• rash, itchy skin, swelling of the lips, eyes, tongue, or difficulty in breathing may be signs of an allergic reaction. Stop using Cortopin Hydrocortisone Cream immediately.
• ‘stretch marks’ may appear, especially in skin folds such as the groin or armpits.
If any of the side effects become severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE CORTOPIN HYDROCORTISONE CREAM
Keep out of the reach and sight of children. Do not store above 25°C. Store in the original package and keep the tube in the outer carton. Do not use Cortopin Hydrocortisone Cream after the expiry date which is stated on the tube/carton.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Cortopin Hydrocortisone Cream contains:
• The active substance is hydrocortisone and the cream contains 10 mg in every 1g (1%).
• The other ingredients are Cetomacrogol Emulsifying Wax, chlorocresol, liquid paraffin, Macrogol 300, white soft paraffin and purified water (see end of Section 2 for further information).
What Cortopin Hydrocortisone Cream looks like and contents of the pack
The product is a smooth, white cream and is available in aluminium tubes containing 15g.
Marketing Authorisation Holder and Manufacturer
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
PL 04917/0019
This leaflet was last updated in 06/2008
23LF00703PW
II
PATIENT INFORMATION LEAFLET
HYDROCORTISONE CREAM 1%
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 Hydrocortisone Cream is and what it is used for
2. Before you use Hydrocortisone Cream
3. Howto use Hydrocortisone Cream
4. Possible side effects
5. Howto store Hydrocortisone Cream
6. Further information
1.
WHAT HYDROCORTISONE CREAM IS AND WHAT IT IS USED FOR
Hydrocortisone Cream is a smooth white cream for application to the skin only. It contains hydrocortisone which belongs to a group of medicines called corticosteroids. Hydrocortisone Cream is used to reduce inflammation in a variety of inflammatory skin conditions including eczema and dermatitis of all types, such as:
• inherited skin inflammation, scaliness or itchiness (atopic eczema)
• light-sensitive skin (photodermatitis)
• dermatitis between folds of skin (intertrigo)
• dermatitis caused by irritants or allergens
• lumps in the skin with itching (prurigo nodularis)
• scaly or crusty skin, ‘cradle cap’ (seborrhoeic dermatitis)
• insect bite reactions.
BEFORE YOU USE HYDROCORTISONE CREAM
Do not use Hydrocortisone Cream if you:
• are allergic to hydrocortisone or to any of the other ingredients of Hydrocortisone Cream (see Section 6 and end of Section 2).
• have a bacterial infection (e.g. impetigo), viral infection (e.g. herpes simplex) or fungal infection (e.g. tinea, also called ‘athlete’s foot’, ringworm or thrush) of the skin.
Take special care with Hydrocortisone Cream
Hydrocortisone Cream is not suitable for use in the following:
• allergic skin reactions including temporary red or raised areas on your skin (short lived ‘wheal and flare’ reactions)
• conditions involving the deeper skin layers, such as granulomas
• psoriasis (long term scaly skin condition); only use this product on medical advice and with careful supervision by your doctor.
Take great care to apply the cream sparingly to the skin of infants or children, especially in the nappy area which can be covered for long periods. Covering the treated area can increase absorption. Treatment for infants must not exceed 7 days.
Your doctor may advise the use of antimicrobial medicine at the same time as Hydrocortisone Cream if the area has become infected.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Tell your doctor if you are or may be pregnant. Ask your doctor for advice before taking any medicine during pregnancy. There is a very small risk of abnormalities in the unborn child if this product is used during pregnancy.
If you are breast-feeding, do not apply the product to your chest area.
Important information about some of the ingredients
Hydrocortisone Cream contains
• chlorocresol - may cause allergic reactions
II
• cetomacrogol emulsifying wax - which contains cetosteryl alcohol - may cause local skin reactions (e.g. contact dermatitis).
23LF00569PW
-Q-
3.
HOWTO USE HYDROCORTISONE CREAM
FOR EXTERNAL USE ONLY
Always use Hydrocortisone Cream exactly as your doctor has told you. Your doctor will tell you how much to apply and how often, but you must check with your doctor if you are not sure.
Do not exceed the stated dose.
For application to the surface of the skin only:
1. Wash your hands thoroughly before use.
2. Apply the cream sparingly to the affected area, one to four times a day. Massage the cream gently into the affected area to help absorption into the skin.
3. Once applied, do not cover the area with a dressing or plaster.
Increase the intervals between applications as the condition improves. Treatment may be reduced to two to three times a week, or restarted when your symptoms return.
If you use more Hydrocortisone Cream than you should
If you or a child accidentally swallow the cream, contact your doctor or nearest hospital immediately. Take the packet with you to help identification.
If you forget to use Hydrocortisone Cream
If you miss a treatment, apply the cream as soon as you remember, and apply the remaining doses for that day at evenly spaced intervals.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Hydrocortisone Cream can cause side effects, although not everybody gets them.
You may notice the following:
• rash, itchy skin, swelling of the lips, eyes, tongue, or difficulty in breathing may be signs of an allergic reaction. Stop using Hydrocortisone Cream immediately.
• ‘stretch marks’ may appear, especially in skin folds such as the groin or armpits.
If any of the side effects become severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE HYDROCORTISONE CREAM
Keep out of the reach and sight of children. Do not store above 250C. Store in the original package and keep the tube in the outer carton. Do not use Hydrocortisone Cream after the expiry date which is stated on the tube/carton.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Hydrocortisone Cream contains:
• The active substance is hydrocortisone and the cream contains 10 mg in every 1g (1%).
• The other ingredients are Cetomacrogol Emulsifying Wax, chlorocresol, liquid paraffin, Macrogol 300, white soft paraffin and purified water (see end of Section 2 for further information).
What Hydrocortisone Cream looks like and contents of the pack
The product is a homogenous, white cream and is available in aluminium tubes containing 5g, 10g, 15g, 20g, 30g or 50g.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
PL 04917/0019
This leaflet was last updated in 09/2009
23LF00569PW