ELOCOM CREAM

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

MOMETASONE FUROATE

Disponible des:

ORGANON PHARMA ISRAEL LTD., ISRAEL

Codi ATC:

D07AC13

formulario farmacéutico:

CREAM

Composición:

MOMETASONE FUROATE 0.1 %

Vía de administración:

DERMAL

tipo de receta:

Required

Fabricat per:

ORGANON LLC, USA

Grupo terapéutico:

MOMETASONE

Área terapéutica:

MOMETASONE

indicaciones terapéuticas:

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

Data d'autorització:

2023-04-30

Informació per a l'usuari

[Organon] Proprietary
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) 1986
This medicine can be sold under doctor's prescription only
ELOCOM
® CREAM
ELOCOM
® OINTMENT
Mometasone furoate 0.1%
Each gram of cream contains:
1 mg of mometasone furoate
Mometasone furoate 0.1%
Each gram of ointment 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 OINTMENT
”.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
This leaflet contains summary information about ELOCOM. 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 ELOCOM IS INTENDED FOR?
ELOCOM is used for the relief of the inflammatory and pruritic
manifestations of corticosteroid - responsive
dermatoses such as psoriasis and atopic dermatitis
THERAPEUTIC GROUP: ELOCOM
CREAM and ELOCOM OINTMENT belong to a group of medicines called
topical corticosteroids.
It is classified as a “potent corticosteroid”.
T
hese medicines are put on the surface of
the skin to reduce 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
2.1 DO NOT USE ELOCOM IF:
−
you are allergic (hypersensitive) to mometasone furoate or any of the
other ingredients of ELOCOM
(refer to sections 2.5 and 6), or to other similar medicines.
−
you have any other skin problems as it could make them worse,
especially: rosacea (a skin
condition affecting the face); acne; skin atrophy (thinning of the
skin); d

Fitxa tècnica

[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