Elocon 0.1% w/w Scalp Lotion, Cutaneous Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mometasone furoate

Available from:

Merck Sharp & Dohme Ireland (Human Health) Limited

ATC code:

D07AC; D07AC13

INN (International Name):

Mometasone furoate

Dosage:

0.1 percent weight/weight

Pharmaceutical form:

Cutaneous solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Corticosteroids, potent (group III); mometasone

Authorization status:

Not marketed

Authorization date:

1993-12-20

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ELOCON® 0.1% W/W SCALP LOTION
Cutaneous Solution
0.1% w/w mometasone furoate (equivalent to 1.0 mg/g)
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 any of the side effects get serious, or if you notice any side
effects not listed in
this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Elocon is and what it is used for
2. Before you use Elocon
3. How to use Elocon
4. Possible side effects
5. How to store Elocon
6. Further information
1. WHAT ELOCON IS AND WHAT IT IS USED FOR
Elocon Scalp Lotion is one of a group of medicines called topical
corticosteroids. It is
classified as a “potent corticosteroid”. These medicines are put
on the surface of the
skin to reduce the redness and itchiness caused by certain skin
problems.
In adults and children, Elocon Scalp Lotion is used to reduce redness
and itchiness
caused by certain conditions affecting the scalp, called psoriasis or
dermatitis.
Psoriasis is a skin disease in which itchy, scaly, pink patches
develop on the elbows,
knees, scalp and other parts of the body. Dermatitis is a condition
brought on by the
skin reacting to outside agents e.g. detergents, causing the skin to
become red and itchy.
2. BEFORE YOU USE ELOCON
DO NOT USE ELOCON
-
if you are allergic (hypersensitive) to mometasone furoate, any of the
other
ingredients of Elocon or to other similar medicines.
-
on any other scalp problems as it could make them worse especially
chickenpox,
shingles, ulcerated skin, wounds, skin atrophy (thinning of the skin)
or other
infections of the scalp. Ask your doctor or pharmacist if you are not
sure.
-
to treat scalp infections in children under one year of age, including
dermatitis.
TAKE SPECIAL CARE WITH ELOCON
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Summary of Product characteristics

Health Products Regulatory Authority
05 November 2020
CRN009MVN
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Elocon 0.1% w/w Scalp Lotion, Cutaneous Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Mometasone Furoate 0.1% w/w (equivalent to 1.0mg/g)
Propylene glycol 30.0% w/w (equivalent to 300mg/g)
Excipients with known effect
This medicine contains 300.0 mg propylene glycol (E1520) in each
milliliter of the lotion which is equivalent to 9.0 g of
propylene glycol per unit.( 30ml bottle).
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cutaneous solution.
A colourless to light yellow, smooth, viscous, cutaneous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Elocon Scalp Lotion is indicated for the topical management of
corticosteroid responsive dermatoses of the scalp, such as
psoriasis and seborrhoeic dermatitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
A small quantity should be applied once daily to the affected areas of
the scalp and massaged gently until the medication
disappears.
Use of topical corticosteroids in children should be limited to the
least amount compatible with an effective therapeutic
regimen. Safe use in children for more than 6 weeks has not been
established. There is limited data in children under 2 years.
4.3 CONTRAINDICATIONS
Use in the presence of untreated infections of bacterial (e.g.
impetigo, pyodermas), viral (e.g. herpes simplex, herpes zoster,
chickenpox, verrucae vulgares, condylomata acuminata, molluscum
contagiosum), tuberculous or fungal origin (e.g. candida or
dermatophyte) of the scalp.
Dermatoses in children under one year of age, including dermatitis.
Hypersensitivity to the preparation.
Elocon is contraindicated in skin atrophy.
Health Products Regulatory Authority
05 November 2020
CRN009MVN
Page 2 of 6
Elocon should not be used on wounds or on skin which is ulcerated.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Local and systemic toxicity, including suppression of adrenocortical
function may occur