ELOCOM LOTION

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

MOMETASONE FUROATE

Disponível em:

MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL

Código ATC:

D07AC13

Forma farmacêutica:

LOTION

Composição:

MOMETASONE FUROATE 1 MG/G

Via de administração:

TOPICAL

Tipo de prescrição:

Required

Fabricado por:

SCHERING-PLOUGH S.P.A., ITALY

Grupo terapêutico:

MOMETASONE

Área terapêutica:

MOMETASONE

Indicações terapêuticas:

The relief of the inflammatory and pruritic manifestations of corticosteroid - responsive dermatoses, such as psoriasis and atopic dermatitis.

Data de autorização:

2012-10-31

Folheto informativo - Bula

[Organon] Proprietary
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) - 1986
This medicine can be sold under doctor's prescription only
ELOCOM
® LOTION
Mometasone furoate 0.1%
Each gram contains 1 mg of mometasone furoate.
For a list of inactive ingredients see section 6 “FURTHER
INFORMATION”. See also section 2.5 “Important
information about some of the ingredients of ELOCOM LOTION”.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
This leaflet contains concise information about ELOCOM LOTION. If you
have any further questions,
refer to the doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
ailment seems similar to yours.
1. WHAT IS ELOCOM LOTION INTENDED FOR?
ELOCOM LOTION is used to reduce inflammation and itchiness caused by
certain
corticosteroid-responsive skin and scalp problems, such as psoriasis
or atopic dermatitis.
THERAPEUTIC GROUP: ELOCOM LOTION belongs to 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.
WHAT IS PSORIASIS?
Psoriasis is a skin disease in which itchy, scaly, pink patches
develop on the elbows, knees, scalp and
other parts of the body.
WHAT IS DERMATITIS?
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 USING ELOCOM
LOTION
2.1 DO NOT USE ELOCOM LOTION IF:
−
You are allergic (hypersensitive) to mometasone furoate or any of the
other ingredients of ELOCOM
LOTION (refer to sections 2.5 and 6), or to other similar medicines
−
You have skin or scalp problems as it could make them worse,
chickenpox, shingles, warts, other
skin infections, ulcerated skin, wounds, skin atrophy (thinning of the
skin)
Ask your doctor or pharmacist if you are not sure.
2.2 SPECIAL WARNINGS REGA

Características técnicas

[Organon] Confidential
SUMMARY OF PRODUCT CHARACTERISTICS
ELOCOM
® CREAM
ELOCOM
® OINTMENT
1.
NAME OF THE MEDICINAL PRODUCT
Elocom
®
Cream
Elocom
®
Ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mometasone furoate 0.1% w/w
Elocom Ointment- Excipients with known effect:
Propylene glycol stearate 2.0% w/w
For full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Cream
Ointment
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Elocom is indicated for the relief of the
inflammatory and pruritic manifestations of
corticosteroid-responsive dermatoses, such as psoriasis and atopic
dermatitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Apply a thin film of mometasone furoate cream or ointment to the
affected skin areas
once daily.
The duration of treatment of topical corticosteroids on the face
should be no more than
5 days.
Pediatrics population
As the safety and efficacy of Elocom in pediatric patients below 2
years of age have not been
established, its use in this age group is not recommended.
4.3
CONTRAINDICATIONS
Elocom is contraindicated in facial rosacea, acne vulgaris, skin
atrophy, perioral dermatitis,
perianal and genital pruritis, napkin eruptions, bacterial (e.g.
impetigo, pyodermas), viral
(e.g. herpes simplex, herpes zoster and chickenpox, verrucae vulgares,
condylomata
acuminata, molluscum contagiosum), parasitical and fungal (e.g.
candida or dermatophyte)
infections, varicella, tuberculosis, syphilis or post-vaccine
reactions. Elocom should not be
used on wounds or on skin which is ulcerated. Elocom should not be
used in patients who
are sensitive to mometasone furoate or to other corticosteroids or to
any of the excipients
listed in section 6.1.
[Organon] Confidential
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If irritation or sensitisation develop with the use of Elocom,
treatment should be
withdrawn and appropriate therapy instituted.
Should an infection develop, use of an appropriate antifungal or
antibacterial agent should
be instituted. If a favourable response does not occur