Land: Israel
Språk: engelska
Källa: Ministry of Health
MOMETASONE FUROATE
ORGANON PHARMA ISRAEL LTD., ISRAEL
D07AC13
CREAM
MOMETASONE FUROATE 0.1 %
DERMAL
Required
ORGANON LLC, USA
MOMETASONE
MOMETASONE
For the relief of the inflammatory and pruritic manifestations of corticosteroid - responsive dermatoses such as psoriasis and atopic dermatitis.
2023-04-30
[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 Läs hela dokumentet
[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 Läs hela dokumentet