Locoid Scalp Lotion
Warnings and precautions
S0844 LEAFLET Locoid 20151221
PACKAGE LEAFLET: INFORMATION FOR USER LOCOID SCALP LOTION
(hydrocortisone 17-butyrate)
Your medicine is known as Locoid Scalp Lotion but will be referred to as Locoid throughout the following leaflet.
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.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• 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.
What is in this leaflet:
1. What Locoid is and what it is used for
2. What you need to know before you use Locoid
3. How to use Locoid
4. Possible side effects
5. How to store Locoid
6. Contents of the pack and other information
1. WHAT LOCOID IS AND WHAT IT IS USED FOR
Locoid contains the active substance hydrocortisone butyrate. This is a corticosteroid which when made up as a lotion 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 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 is indicated in adults, children and infants. It is used to treat a variety of skin conditions such as eczema and dermatitis (itching) of all types, but it is used in particular in the treatment of psoriasis of the scalp. This is a condition resulting in thickening of areas of the scalp. It can also be used for the treatment of seborrhoea capitis, a condition causing redness and inflammation of the scalp, and scaling of the scalp with crusted patches, often with severe dandruff. It is not suitable for treating large areas of psoriasis of the scalp. You should let your doctor review your progress regularly as treatment of psoriasis needs careful supervision. The original symptoms may return if you stop using Locoid prematurely.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE LOCOID
Do not use Locoid:
• if you are allergic to hydrocortisone butyrate or any of the other ingredients of this medicine (listed in section 6).
• if your skin disorder is caused by an untreated bacterial, viral (e.g. cold sores, herpes, chicken pox), fungal (e.g. athlete’s foot), yeast or parasitic (e.g. ringworm) infection. Locoid may worsen or hide these disorders.
Your doctor will check these.
• if you have skin problems associated with syphilis (a sexually transmitted disease) or tuberculosis.
• if the skin around your mouth is inflamed (perioral dermatitis). It might be the result of previous treatment with corticosteroids.
• if you have pimples or spots (acne).
• if you have redness of the facial skin.
• if for treating areas other than the scalp.
Talk to your doctor before using Locoid. This is especially important 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 at skin folds, under an airtight dressing or on large areas of your skin. If you are using Locoid 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 (see further information below).
• 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 should only be used on small areas of psoriasis.
If your doctor has prescribed Locoid to treat psoriasis, you should let your doctor review your progress regularly as such treatment needs careful supervision.
Children and adolescents
Long term treatment of children should be avoided where possible. In infants treatment should be limited if possible to a maximum of seven days.
Other medicines and Locoid
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Pregnancy and breast-feeding
You should not use Locoid if you are pregnant or breast-feeding unless clearly necessary. There may be a small risk of harm to your baby if you use any corticosteroid lotion 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.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
Locoid is unlikely to affect your ability to drive or use machines.
3. HOW TO USE LOCOID
Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure. If your scalp problem does not improve, you should go back to your doctor.
The recommended dose of Locoid is no more than twice daily. Do not use Locoid near a naked flame.
This medicine is for cutaneous use. Apply a thin layer of Locoid to the affected skin. Gently massage the lotion into the affected area.
On advice of your doctor you may have to apply Locoid under an airtight dressing in order to obtain a better result.
If you use more Locoid than you should
If you have used too much Locoid the side effects (as described in Section 4) can occur. Contact your doctor, pharmacist or nurse immediately.
If you forget to use Locoid
Do not use a double dose to make up for a forgotten dose.
If you stop using Locoid
The original symptoms may return if you stop using Locoid prematurely.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
A small number of people may be hypersensitive (allergic) to the constituents of Locoid. If your skin condition seems to get worse, the skin becomes red, itchy or irritated, tell your doctor, pharmacist or nurse if this becomes troublesome.
If Locoid is used in moist skin areas (e.g. skin folds) the skin may become thin and damaged. Tell your doctor if this happens.
Locoid may cause the following:
Rare side effects (may affect up to 1 in 1,000 people)
• 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 (may affect up to 1 in 10,000 people)
• Suppression of the release of the stress hormones.
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 LOCOID
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 25°C.
• Do not use after the expiry date printed on the carton or bottle label.
• 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.
What Locoid contains
• Locoid contains 0.1%w/v of the active ingredient, hydrocortisone 17-butyrate.
• Locoid also includes the following: isopropyl alcohol, glycerol, povidone K90, anhydrous citric acid, sodium citrate and purified water.
What Locoid looks like and contents of the pack
Locoid is clear colourless topical solution and is available in bottles containing 100ml.
Product Licence holder
Procured from within the EU and repackaged by the PL holder:
S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley,
HA0 1DX.
Manufacturer
This product is manufactured by:
• Astellas Pharma Europe B.V., Hogemaat, 2, 7942 JG, Meppel, Netherlands.
• Temmler Italia S.r.l., Via delle Industrie 2, 20061 Carugate, Milan, Italy.
|POMl PL 19488/0844
Leaflet revision date: 21 December 2015
Locoid is a registered trade mark of Yamanouchi Europe B V,
The Netherlands.
S0844 LEAFLET Locoid 20151221
Further support and information for skin conditions such as eczema can be gained from:
National Eczema Society
11 Murray Street, London, NW1 9RE, UK.
Helpline Tel: 0800 089 1122
S0844 LEAFLET Hydrocortisone 20151221
PACKAGE LEAFLET: INFORMATION FOR USER HYDROCORTISONE BUTYRATE 0.1% w/v SCALP LOTION
Your medicine is known as Hydrocortisone Butyrate 0.1% w/v Scalp Lotion but will be referred to as Hydrocortisone throughout the following leaflet.
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.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• 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.
What is in this leaflet:
1. What Hydrocortisone is and what it is used for
2. What you need to know before you use Hydrocortisone
3. How to use Hydrocortisone
4. Possible side effects
5. How to store Hydrocortisone
6. Contents of the pack and other information
1. WHAT HYDROCORTISONE IS AND WHAT IT IS USED FOR
Hydrocortisone contains the active substance hydrocortisone butyrate. This is a corticosteroid which when made up as a lotion 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; Hydrocortisone 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.
Hydrocortisone is indicated in adults, children and infants. It is used to treat a variety of skin conditions such as eczema and dermatitis (itching) of all types, but it is used in particular in the treatment of psoriasis of the scalp. This is a condition resulting in thickening of areas of the scalp. It can also be used for the treatment of seborrhoea capitis, a condition causing redness and inflammation of the scalp, and scaling of the scalp with crusted patches, often with severe dandruff. It is not suitable for treating large areas of psoriasis of the scalp. You should let your doctor review your progress regularly as treatment of psoriasis needs careful supervision. The original symptoms may return if you stop using Hydrocortisone prematurely.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE HYDROCORTISONE
Do not use Hydrocortisone:
• if you are allergic to hydrocortisone butyrate or any of the other ingredients of this medicine (listed in section 6).
• if your skin disorder is caused by an untreated bacterial, viral (e.g. cold sores, herpes, chicken pox), fungal (e.g. athlete’s foot), yeast or parasitic (e.g. ringworm) infection.
Hydrocortisone may worsen or hide these disorders.
Your doctor will check these.
• if you have skin problems associated with syphilis (a sexually transmitted disease) or tuberculosis.
• if the skin around your mouth is inflamed (perioral dermatitis). It might be the result of previous treatment with corticosteroids.
• if you have pimples or spots (acne).
• if you have redness of the facial skin.
• if for treating areas other than the scalp.
Talk to your doctor before using Hydrocortisone. This is especially important 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 Hydrocortisone at skin folds, under an airtight dressing or on large areas of your skin. If you are using Hydrocortisone 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 (see further information below).
• 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 minimize side effects Hydrocortisone should only be used on small areas of psoriasis.
If your doctor has prescribed Hydrocortisone to treat psoriasis, you should let your doctor review your progress regularly as such treatment needs careful supervision.
Children and adolescents
Long term treatment of children should be avoided where possible. In infants treatment should be limited if possible to a maximum of seven days.
Other medicines and Hydrocortisone
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Pregnancy and breast-feeding
You should not use Hydrocortisone 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 lotion 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.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
Hydrocortisone is unlikely to affect your ability to drive or use machines.
3. HOW TO USE HYDROCORTISONE
Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure. If your scalp problem does not improve, you should go back to your doctor.
The recommended dose of Hydrocortisone is no more than twice daily. Do not use Hydrocortisone near a naked flame.
This medicine is for cutaneous use. Apply a thin layer of Hydrocortisone to the affected skin. Gently massage the lotion into the affected area.
On advice of your doctor you may have to apply Hydrocortisone under an airtight dressing in order to obtain a better result.
If you use more Hydrocortisone than you should
If you have used too much Hydrocortisone the side effects (as described in Section 4) can occur. Contact your doctor, pharmacist or nurse immediately.
If you forget to use Hydrocortisone
Do not use a double dose to make up for a forgotten dose.
If you stop using Hydrocortisone
The original symptoms may return if you stop using Hydrocortisone prematurely.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
A small number of people may be hypersensitive (allergic) to the constituents of Hydrocortisone. If your skin condition seems to get worse, the skin becomes red, itchy or irritated, tell your doctor, pharmacist or nurse if this becomes troublesome.
If Hydrocortisone is used in moist skin areas (e.g. skin folds) the skin may become thin and damaged. Tell your doctor if this happens.
Hydrocortisone may cause the following:
Rare side effects (may affect up to 1 in 1,000 people)
• 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 (may affect up to 1 in 10,000 people)
• Suppression of the release of the stress hormones.
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
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 25°C.
• Do not use after the expiry date printed on the carton or bottle label.
• 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.
What Hydrocortisone contains
• Hydrocortisone contains 0.1%w/v of the active ingredient, hydrocortisone 17-butyrate.
• Hydrocortisone also includes the following: isopropyl alcohol, glycerol, povidone K90, anhydrous citric acid, sodium citrate and purified water.
What Hydrocortisone looks like and contents of the pack
Hydrocortisone is clear colourless topical solution and is available in bottles containing 100ml.
Product Licence holder
Procured from within the EU and repackaged by the PL holder:
S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley,
HA0 1DX.
Manufacturer
This product is manufactured by:
• Astellas Pharma Europe B.V., Hogemaat, 2, 7942 JG, Meppel, Netherlands.
• Temmler Italia S.r.l., Via delle Industrie 2, 20061 Carugate, Milan, Italy.
|POMl PL 19488/0844
Leaflet revision date: 21 December 2015
S0844 LEAFLET Hydrocortisone 20151221
Further support and information for skin conditions such as eczema can be gained from:
National Eczema Society
11 Murray Street, London, NW1 9RE, UK.
Helpline Tel: 0800 089 1122