LOCOID CRELO
Active substance: HYDROCORTISONE BUTYRATE MICRONISED
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Patient Information Leaflet
Hydrocortisone butyrate 0.1% w/w
Locoid Crelo
136497
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. any of the side effects gets serious, or if you notice any side effects not listed in If this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Locoid Crelo is and what it is used for 2. Before you use Locoid Crelo 3. How to use Locoid Crelo 4. Possible side effects 5. How to store Locoid Crelo 6. Further information The active substance in Locoid Crelo (hydrocortisone butyrate) is a corticosteroid which when made up as an emulsion is for use on the skin. This is known as topical application. Topical corticosteroids are ranked as mildly potent, moderately potent, potent and very potent; Locoid Crelo is classed as potent. Topical corticosteroids are able to reduce the inflammation caused by a variety of skin conditions, and so allow it to get better. They can also affect the cause of the condition, which can lead to its healing. Locoid Crelo is used to treat a variety of skin conditions especially those affecting the scalp, hairy or facial skin, such as eczema and dermatitis (itching) of all types including atopic (childhood) eczema, photodermatitis (itching caused by exposure to light) and dermatitis caused by skin irritants and allergies. It can also be used in the treatment of psoriasis, a condition resulting in thickening of areas of the skin. It is important that you follow your doctors instructions particularly in psoriasis, and use it only on small areas on the scalp, hands or feet. The original symptoms may return if you stop using Locoid Crelo prematurely.
1. WHAT LOCOID CRELO IS AND WHAT IT IS USED FOR
Do not use Locoid Crelo if:
2. BEFORE YOU USE LOCOID CRELO
you are allergic (hypersensitive) to hydrocortisone butyrate or any of the other ingredients of Locoid Crelo. See section 6 Further Information for a list of other ingredients and see also the end of this section for some important information on some of the ingredients. your skin disorder is caused by an untreated bacterial, viral (e.g. cold sores, herpes, chicken pox), fungal (e.g. athletes foot), yeast or parasitic (e.g. ringworm) infection. Locoid Crelo may worsen or hide these disorders. Your doctor will check these. you have skin problems associated with syphilis (a sexually transmitted disease) or tuberculosis. skin around your mouth is inflamed (perioral dermatitis). It might be the the result of previous treatment with corticosteroids. you have pimples or spots (acne). you have redness of the facial skin.
Take special care with Locoid Crelo if you intend to:
treat facial skin, thin skin (e.g. skin of your genitals). These areas of your skin are particularly sensitive to corticosteroids. You should not apply to your eyes or your eyelids. use Locoid Crelo at skin folds, under an airtight dressing or on large areas of your skin. If you are using Locoid Crelo under bandages, it should only be on small areas for a short time, and only on the advice of your doctor. Bandages and dressings should not be used on babies or children. treat your child. In infants, Locoid Crelo should not normally be used for more than seven days. use it for psoriasis. Topical corticosteroids can be effective in psoriasis in the short term. The condition may relapse or significantly worsen on stopping treatment and there is a risk of widespread pustular psoriasis. This is a condition where the psoriasis spreads and becomes very inflamed. In order to minimise side effects Locoid Crelo should only be used on small areas of psoriasis (e.g. scalp, hands and feet). If your doctor has prescribed Locoid Crelo to treat psoriasis, you should let your doctor review your progress regularly as such treatment needs careful supervision.
Taking 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
You should not use Locoid Crelo if you are pregnant or breastfeeding unless clearly necessary. There may be a small risk of harm to your baby if you use any corticosteroid emulsion whilst pregnant, so if your doctor does prescribe it for you knowing you are pregnant, you should not use it in large amounts for a long time. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Locoid Crelo is unlikely to affect your ability to drive or use machines.
Important information about some of the ingredients of Locoid Crelo
Locoid Crelo contains cetostearyl alcohol and butylhydroxytoluene that may cause
local skin reactions (e.g. contact dermatitis). It also contains propylene glycol which may cause skin irritation. The butylhydroxytoluene may cause irritation to the eyes and mucous membranes (e.g. nose). The propyl parahydroxybenzoate (E216) and butyl parahydroxybenzoate (E218) may cause allergic reactions (possibly delayed).
Instructions for proper use
3. HOW TO USE LOCOID CRELO
Apply a thin layer of Locoid Crelo to the affected skin. Gently massage the emulsion into the affected area. On advice of your doctor you may have to apply Locoid Crelo under an airtight dressing in order to obtain a better result.
Dosage
Always use Locoid Crelo exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. If your skin problem does not improve, you should go back to your doctor. The usual dose of Locoid Crelo is no more than twice daily. Thickened areas of psoriasis on elbows and knees may be treated with Locoid Crelo under a dressing, but only if your doctor has told you so.
If you use more Locoid Crelo than you should If you forget to use Locoid Crelo If you stop using Locoid Crelo
If you have used too much Locoid Crelo the side effects (as described in Section 4) can occur. Contact your doctor or pharmacist immediately. Do not use a double dose to make up for a forgotten dose. The original symptoms may return if you stop using Locoid Crelo prematurely. If you have any further questions on the use of this product, ask your doctor or pharmacist. A small number of people may be hypersensitive (allergic) to the constituents of Locoid Crelo. If your skin condition seems to get worse, the skin becomes red, itchy or irritated, tell your doctor or pharmacist if this becomes troublesome. If Locoid Crelo is used in moist skin areas (e.g. skin folds) the skin may become thin and damaged. Tell your doctor if this happens. Like all medicines, Locoid Crelo can cause side effects, although not everybody gets them. Locoid Crelo may cause the following: Rare side effects (likely to affect more than 1 in 10,000 patients and less than 1 in 1000 patients) Thinning of the skin, redness of the skin, bruising and stretch marks. Facial spots, redness of the skin around the mouth. Worsening of the skin condition after treatment has stopped. Discolouration of skin. Very rare side effects (likely to affect less than 1 in 10,000 patients) Suppression of the release of the stress hormones. 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. Locoid Crelo should be stored in the original packaging and not above 25C. Do not refrigerate or freeze. Keep out of the reach and sight of children. Do not use Locoid Crelo after the expiry date which is stated on the tube after EXP. The expiry date refers to the last day of that month
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE LOCOID CRELO
What Locoid Crelo contains
6. FURTHER INFORMATION
The active substance is hydrocortisone butyrate. Locoid Crelo contains 0.1% hydrocortisone butyrate. The other ingredients are macrogol 25 cetostearyl ether, cetostearyl alcohol, white soft paraffin, hard paraffin, borage oil, butylhydroxytoluene, propylene glycol, sodium citrate (E331), citric acid (E330), propyl parahydroxybenzoate (E216), butyl parahydroxybenzoate (E218), and purified water.
What Locoid Crelo looks like and contents of the pack Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder: Astellas Pharma Ltd., 2000 Hillswood Drive, Chertsey, Surrey, KT16 0RS, UK. Manufacturer: Temmler Italia S.r.l., Via Delle Industrie 2, 20061, Carugate (MI), Italy
Locoid Crelo is a white emulsion and is supplied in 100 gram bottles.
Further support and information for skin conditions such as eczema can be gained from: National Eczema Society Hill House, Highgate Hill, London, N19 5NA, UK Information Centre Tel: 0870 2413604 This leaflet was last approved in September 2012.
Hydrocortisone butyrate 0.1% w/w
Locoid Crelo
136497
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. any of the side effects gets serious, or if you notice any side effects not listed in If this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Locoid Crelo is and what it is used for 2. Before you use Locoid Crelo 3. How to use Locoid Crelo 4. Possible side effects 5. How to store Locoid Crelo 6. Further information The active substance in Locoid Crelo (hydrocortisone butyrate) is a corticosteroid which when made up as an emulsion is for use on the skin. This is known as topical application. Topical corticosteroids are ranked as mildly potent, moderately potent, potent and very potent; Locoid Crelo is classed as potent. Topical corticosteroids are able to reduce the inflammation caused by a variety of skin conditions, and so allow it to get better. They can also affect the cause of the condition, which can lead to its healing. Locoid Crelo is used to treat a variety of skin conditions especially those affecting the scalp, hairy or facial skin, such as eczema and dermatitis (itching) of all types including atopic (childhood) eczema, photodermatitis (itching caused by exposure to light) and dermatitis caused by skin irritants and allergies. It can also be used in the treatment of psoriasis, a condition resulting in thickening of areas of the skin. It is important that you follow your doctors instructions particularly in psoriasis, and use it only on small areas on the scalp, hands or feet. The original symptoms may return if you stop using Locoid Crelo prematurely.
1. WHAT LOCOID CRELO IS AND WHAT IT IS USED FOR
Do not use Locoid Crelo if:
2. BEFORE YOU USE LOCOID CRELO
you are allergic (hypersensitive) to hydrocortisone butyrate or any of the other ingredients of Locoid Crelo. See section 6 Further Information for a list of other ingredients and see also the end of this section for some important information on some of the ingredients. your skin disorder is caused by an untreated bacterial, viral (e.g. cold sores, herpes, chicken pox), fungal (e.g. athletes foot), yeast or parasitic (e.g. ringworm) infection. Locoid Crelo may worsen or hide these disorders. Your doctor will check these. you have skin problems associated with syphilis (a sexually transmitted disease) or tuberculosis. skin around your mouth is inflamed (perioral dermatitis). It might be the the result of previous treatment with corticosteroids. you have pimples or spots (acne). you have redness of the facial skin.
Take special care with Locoid Crelo if you intend to:
treat facial skin, thin skin (e.g. skin of your genitals). These areas of your skin are particularly sensitive to corticosteroids. You should not apply to your eyes or your eyelids. use Locoid Crelo at skin folds, under an airtight dressing or on large areas of your skin. If you are using Locoid Crelo under bandages, it should only be on small areas for a short time, and only on the advice of your doctor. Bandages and dressings should not be used on babies or children. treat your child. In infants, Locoid Crelo should not normally be used for more than seven days. use it for psoriasis. Topical corticosteroids can be effective in psoriasis in the short term. The condition may relapse or significantly worsen on stopping treatment and there is a risk of widespread pustular psoriasis. This is a condition where the psoriasis spreads and becomes very inflamed. In order to minimise side effects Locoid Crelo should only be used on small areas of psoriasis (e.g. scalp, hands and feet). If your doctor has prescribed Locoid Crelo to treat psoriasis, you should let your doctor review your progress regularly as such treatment needs careful supervision.
Taking 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
You should not use Locoid Crelo if you are pregnant or breastfeeding unless clearly necessary. There may be a small risk of harm to your baby if you use any corticosteroid emulsion whilst pregnant, so if your doctor does prescribe it for you knowing you are pregnant, you should not use it in large amounts for a long time. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Locoid Crelo is unlikely to affect your ability to drive or use machines.
Important information about some of the ingredients of Locoid Crelo
Locoid Crelo contains cetostearyl alcohol and butylhydroxytoluene that may cause
local skin reactions (e.g. contact dermatitis). It also contains propylene glycol which may cause skin irritation. The butylhydroxytoluene may cause irritation to the eyes and mucous membranes (e.g. nose). The propyl parahydroxybenzoate (E216) and butyl parahydroxybenzoate (E218) may cause allergic reactions (possibly delayed).
Instructions for proper use
3. HOW TO USE LOCOID CRELO
Apply a thin layer of Locoid Crelo to the affected skin. Gently massage the emulsion into the affected area. On advice of your doctor you may have to apply Locoid Crelo under an airtight dressing in order to obtain a better result.
Dosage
Always use Locoid Crelo exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. If your skin problem does not improve, you should go back to your doctor. The usual dose of Locoid Crelo is no more than twice daily. Thickened areas of psoriasis on elbows and knees may be treated with Locoid Crelo under a dressing, but only if your doctor has told you so.
If you use more Locoid Crelo than you should If you forget to use Locoid Crelo If you stop using Locoid Crelo
If you have used too much Locoid Crelo the side effects (as described in Section 4) can occur. Contact your doctor or pharmacist immediately. Do not use a double dose to make up for a forgotten dose. The original symptoms may return if you stop using Locoid Crelo prematurely. If you have any further questions on the use of this product, ask your doctor or pharmacist. A small number of people may be hypersensitive (allergic) to the constituents of Locoid Crelo. If your skin condition seems to get worse, the skin becomes red, itchy or irritated, tell your doctor or pharmacist if this becomes troublesome. If Locoid Crelo is used in moist skin areas (e.g. skin folds) the skin may become thin and damaged. Tell your doctor if this happens. Like all medicines, Locoid Crelo can cause side effects, although not everybody gets them. Locoid Crelo may cause the following: Rare side effects (likely to affect more than 1 in 10,000 patients and less than 1 in 1000 patients) Thinning of the skin, redness of the skin, bruising and stretch marks. Facial spots, redness of the skin around the mouth. Worsening of the skin condition after treatment has stopped. Discolouration of skin. Very rare side effects (likely to affect less than 1 in 10,000 patients) Suppression of the release of the stress hormones. 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. Locoid Crelo should be stored in the original packaging and not above 25C. Do not refrigerate or freeze. Keep out of the reach and sight of children. Do not use Locoid Crelo after the expiry date which is stated on the tube after EXP. The expiry date refers to the last day of that month
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE LOCOID CRELO
What Locoid Crelo contains
6. FURTHER INFORMATION
The active substance is hydrocortisone butyrate. Locoid Crelo contains 0.1% hydrocortisone butyrate. The other ingredients are macrogol 25 cetostearyl ether, cetostearyl alcohol, white soft paraffin, hard paraffin, borage oil, butylhydroxytoluene, propylene glycol, sodium citrate (E331), citric acid (E330), propyl parahydroxybenzoate (E216), butyl parahydroxybenzoate (E218), and purified water.
What Locoid Crelo looks like and contents of the pack Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder: Astellas Pharma Ltd., 2000 Hillswood Drive, Chertsey, Surrey, KT16 0RS, UK. Manufacturer: Temmler Italia S.r.l., Via Delle Industrie 2, 20061, Carugate (MI), Italy
Locoid Crelo is a white emulsion and is supplied in 100 gram bottles.
Further support and information for skin conditions such as eczema can be gained from: National Eczema Society Hill House, Highgate Hill, London, N19 5NA, UK Information Centre Tel: 0870 2413604 This leaflet was last approved in September 2012.
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
