LOCOID SCALP LOTION

Active substance: HYDROCORTISONE BUTYRATE MICRONISED

View full screen / Print PDF » Download PDF ⇩

Transcript
Patient Information Leaflet

Locoid® Scalp Lotion
Hydrocortisone butyrate 0.1% w/w

138998

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.
T
•  his 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.
I
• f 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 Locoid Scalp Lotion is and what it is used for
2. 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. Further information

1. WHAT LOCOID SCALP LOTION IS AND WHAT IT IS USED FOR
The active substance in Locoid Scalp Lotion (hydrocortisone butyrate) 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 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. BEFORE YOU USE LOCOID SCALP LOTION
Do not use Locoid Scalp Lotion if:
•  ou are allergic (hypersensitive) to hydrocortisone butyrate or any of the
y
other ingredients of Locoid Scalp Lotion. See section 6 “Further Information”
for a list of other ingredients.
•  our skin disorder is caused by an untreated bacterial, viral (e.g. cold
y
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.
•  ou have skin problems associated with syphilis (a sexually transmitted
y
disease) or tuberculosis.
•  he skin around your mouth is inflamed (perioral dermatitis). It might be
t
the result of previous treatment with corticosteroids.
• you have pimples or spots (acne).
• you have redness of the facial skin.
• for treating areas other than the scalp.
Take special care with Locoid Scalp Lotion if you intend to:
t
•  reat 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.
u
•  se 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.
t
•  reat your child. In infants, Locoid Scalp Lotion should not normally be used
for more than seven days.
•  se it for psoriasis. Topical corticosteroids can be effective in psoriasis in the
u
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.
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 Scalp Lotion 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Locoid Scalp Lotion is unlikely to affect your ability to drive or use machines.

el

Black

3. HOW TO USE LOCOID SCALP LOTION
Instructions for proper 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.
Dosage
Always use Locoid Scalp Lotion exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure. If your scalp problem
does not improve, you should go back to your doctor.
The usual dose of Locoid Scalp Lotion is no more than twice daily. Do not use
Locoid Scalp Lotion near a naked flame.
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 or pharmacist 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 or
pharmacist.

4. POSSIBLE SIDE EFFECTS
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 or pharmacist 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.
Like all medicines, Locoid Scalp Lotion can cause side effects, although not
everybody gets them.
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.
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.

5. HOW TO STORE LOCOID SCALP LOTION
Locoid Scalp Lotion should be stored in the original packaging and not above
25°C. Do not refrigerate or freeze.
Keep out of the reach and sight of children.
Do not use Locoid Scalp Lotion after the expiry date which is stated on the tube
after EXP. The expiry date refers to the last day of that month.

6. FURTHER INFORMATION
What Locoid Scalp Lotion contains
•  he active substance is hydrocortisone butyrate. Locoid Scalp Lotion
T
contains 0.1% hydrocortisone butyrate.
•  he other ingredients are isopropyl alcohol, glycerol, povidone, citric acid,
T
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
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 January 2013.

138998

Expand view ⇕

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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)