Daktacort Cream
Out of date information, search anotherS655 LEAFLET Daktacort 20130207
PACKAGE LEAFLET: INFORMATION FOR USER DAKTACORT CREAM (hydrocortisone and miconazole nitrate)
Your medicine is known as Daktacort cream and will be referred to as Daktacort cream throughout the following leaflet.
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 you get side effects and they become serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
In this leaflet:
1. What Daktacort cream is and what it is used for
2. Before you use Daktacort cream
3. How to use Daktacort cream
4. Possible side effects
5. How to store Daktacort cream
6. Further information
1. WHAT DAKTACORT CREAM IS AND WHAT IT IS USED FOR
Daktacort cream is a medicine which is used to treat inflamed conditions of the skin such as eczema and dermatitis which may be caused by infection with certain fungi and bacteria.
The cream contains the following ingredients:
• Miconazole nitrate - an antifungal which works by destroying both the fungus that causes the infection and some of the associated bacteria which may also be present
• Hydrocortisone - a mild ‘topical steroid' which reduces inflammation, swelling, redness and itching of the skin
2. BEFORE YOU USE DAKTACORT CREAM
Do not use Daktacort cream if:
• You are allergic to anything in Daktacort cream (listed in section 6 below)
• You have any other skin problems such as cold sores, herpes, chicken pox or shingles. Only use it for the skin problem that you showed the doctor
Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Daktacort cream.
Take special care with Daktacort cream
Check with your doctor or pharmacist before using this medicine if:
• The inflamed skin is on your face. You should not use Daktacort cream on your face, unless your doctor has told you to
• The cream is to be used by children:
• The cream should not be used on young children for long periods of time (such as every day for several weeks)
• The cream should not be used on large areas of a child's body or under a baby's nappy unless your doctor has told you
Elderly patients
Medicines like Daktacort cream can cause thinning of the skin when used for a long time without a break. Because thinning of the skin happens naturally in older people, this medicine should be used sparingly for no more than a few weeks in elderly patients. Only use it for as long as your doctor tells you.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines.
• Medicines that thin your blood (anticoagulants) such as warfarin. Your doctor may want to check that the anticoagulants are still working properly
If you are pregnant or breast-feeding
Ask your doctor for advice before using this medicine if you are pregnant or breast-feeding. Your doctor will decide if you can use Daktacort cream.
Driving and using machines
Daktacort cream is not likely to affect you being able to drive or use any tools or machines.
Important information about some of the ingredients of Daktacort cream
• Benzoic acid (E210) and butylated hydroxyanisole (E320) can mildly irritate the skin, eyes and mucosal membranes
3. HOW TO USE DAKTACORT CREAM
Always use Daktacort cream exactly as your doctor has told you. Daktacort cream is for use on your skin only. You should check with your doctor or pharmacist if you are not sure.
How to apply the cream
• Each tube of Daktacort cream is sealed. Use the cap to pierce the tube
• Wash the infected area and dry it well
• As many skin conditions are infectious, you should keep a towel and flannel for your own use. Do not share them so that you do not infect anyone else
• Apply a small amount of Daktacort cream to the affected area and rub it in gently until the cream has disappeared
• Unless the infected skin is on your hands, wash your hands carefully after applying the cream to avoid spreading the infection to other parts of the body or to other people. Clothing which comes into contact with the infected areas should be washed and changed frequently
How much to apply - adults and children
• Unless your doctor tells you differently, apply a small amount of Daktacort cream to the affected area 2 or 3 times each day
• If your skin problem does not improve in 7 days, tell your doctor If you swallow Daktacort cream
If anyone accidentally swallows Daktacort cream, contact a doctor or go to your nearest hospital casualty department straight away.
If you forget a dose
• Do not apply the missed dose of cream
• Apply the next dose of cream as usual and keep using the cream as your doctor has told you
• Do not use a double dose of cream to make up for a missed dose
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Daktacort cream can cause side effects, although not everybody gets them. Stop using Daktacort cream and tell your doctor straight away if you notice the following. You may need medical treatment.
• Sudden swelling of the face, lips, tongue, wheezing or shortness of breath.
• Severe irritation or reddening of the skin where the cream has been used, or other signs of severe allergy.
Tell your doctor or pharmacist if you notice or suspect any of the following side effects:
Uncommon side effects (affects fewer than 1 in 100 people)
• Skin irritation
• Burning sensation
• Itchy skin
• Hives (also known as nettle rash, or urticaria)
• Irritability
Frequency not known
• Lighter patches of skin
• Sensitivity reactions (such as rash) at the application site. Inflammation (contact dermatitis). If this occurs stop using the medicine
If you get side effects and they become serious or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE DAKTACORT CREAM
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Store in a refrigerator (2-8°C).
• Do not use the cream after the expiry date printed on the packet. Always return any medicine that you do not use to your pharmacist.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
• 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 Daktacort cream contains
• Each gram contains 20 mg of the active ingredient, miconazole nitrate (2% w/w), and 10mg of the active ingredient hydrocortisone (1% w/w/)
• Daktacort Cream also contains the following inactive ingredients: Tefose 63, labrafil M1944 CS, paraffin liquid, benzoic acid, butylated hydroxyanisole, disodium edetate and purified water.
What Daktacort cream looks like and contents of the pack
Daktacort Cream is a white cream.
Daktacort Cream is available in a 15g tube.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Famar ABE, 49km Athens-Lamia, Avlona, Attica, Greece.
|POM | PL No: 19488/0655
Leaflet revision date: 7th February 2013
Daktacort is a registered trade mark of Janssen-Cilag, UK.
S655 LEAFLET Daktacort 20130207