Locoid Scalp Lotion
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Package leaflet: Information for the user
Locoid® Scalp Lotion
Hydrocortisone butyrate 0.1% w/w
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 Scalp Lotion is and what it is used for
2. What you need to know before you use Locoid Scalp Lotion
3. How to use Locoid Scalp Lotion
4. Possible side effects
5. How to store Locoid Scalp Lotion
6. Contents of the pack and other information
1. WHAT LOCOID SCALP LOTION IS AND WHAT IT IS USED FOR
Locoid Scalp Lotion 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 Scalp Lotion 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 Scalp Lotion 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 Scalp Lotion prematurely.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE LOCOID SCALP LOTION
Do not use Locoid Scalp Lotion:
• 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 Scalp Lotion 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.
Warnings and precautions
Talk to your doctor before using Locoid Scalp Lotion. 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 Scalp Lotion at skin folds, under an airtight dressing or on large areas of your skin. If you are using Locoid Scalp Lotion 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 Scalp Lotion should only be used on small areas of psoriasis. If your doctor has prescribed Locoid Scalp Lotion 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 Scalp Lotion
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 Scalp Lotion 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 Scalp Lotion is unlikely to affect your ability to drive or use machines.
3. HOW TO USE LOCOID SCALP LOTION
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 Scalp Lotion is no more than twice daily. Do not use Locoid Scalp Lotion near a naked flame.
This medicine is for cutaneous use. Apply a thin layer of Locoid Scalp Lotion to the affected skin. Gently massage the lotion into the affected area.
On advice of your doctor you may have to apply Locoid Scalp Lotion under an airtight dressing in order to obtain a better result.
If you use more Locoid Scalp Lotion than you should
If you have used too much Locoid Scalp Lotion the side effects (as described in Section 4) can occur. Contact your doctor, pharmacist or nurse immediately.
If you forget to use Locoid Scalp Lotion
Do not use a double dose to make up for a forgotten dose.
If you stop using Locoid Scalp Lotion
The original symptoms may return if you stop using Locoid Scalp Lotion prematurely.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
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 Scalp Lotion. 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 Scalp Lotion is used in moist skin areas (e.g. skin folds) the skin may become thin and damaged. Tell your doctor if this happens.
Locoid Scalp Lotion 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.
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 SCALP LOTION
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the tube (EXP). The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original packaging. Do not refrigerate or freeze.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Locoid Scalp Lotion contains
• The active substance is hydrocortisone butyrate. Locoid Scalp Lotion contains 0.1% hydrocortisone butyrate.
• The other ingredients are isopropyl alcohol, glycerol, povidone, citric acid, sodium citrate and purified water.
What Locoid Scalp Lotion looks like and contents of the pack
Locoid Scalp Lotion is a clear, colourless lotion and is supplied in 100 ml plastic squeeze bottles.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder:
Astellas Pharma Ltd.,
2000 Hillswood Drive, Chertsey, Surrey, KT16 0RS, UK.
Manufacturer:
Astellas Pharma Europe B.V.,
Sylviusweg 62, 2333 Be, Leiden, The Netherlands. or
Temmler Italia S.r.l., Via delle Industrie 2, 20061, Carugate (MI), Italy.
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 revised in March 2015.
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