Israel - English - Ministry of Health
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
This medicine can be sold under doctor's prescription only
Mometasone furoate 0.1%
For a list of inactive ingredients please refer to sections 2.5 and 6.
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, 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 ailment seems similar to yours.
This medicine is not intended for children under the age of 2 years.
1. WHAT IS ELOCOM AND WHAT IT IS USED FOR?
1.1 What is ELOCOM?
Therapeutic group: ELOCOM Lotion belongs to a group of medicines called topical corticosteroids.
Topical corticosteroids have anti-inflammatory activity. These medicines are put on the surface of the skin
to reduce the redness and itchiness caused by certain skin problems.
1.2 What is ELOCOM Lotion used 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 in adults and children.
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 YOU USE ELOCOM
2.1 Do not use ELOCOM if you:
Are allergic (hypersensitive) to mometasone furoate, any of the other ingredients of ELOCOM
Lotion, or to similar medicines (refer to sections 2.5 and 6).
Have any other skin or scalp problems as it could make them worse especially: rosacea (a skin
condition affecting the face); acne; skin atrophy (thinning of the skin); dermatitis around the mouth;
perianal and genital itching; nappy rash; cold sores; chickenpox; shingles; warts; ulcerated skin;
wounds; skin tuberculosis; post-vaccination reactions; other skin infections.
If you think that one of these is relevant to you, do not use ELOCOM until you have consulted your
2.2 Special warnings concerning use of ELOCOM
ELOCOM may not be suitable for you, or you may need to be monitored regularly while taking it if any of the
following apply to you:
If your skin or scalp becomes irritated or sensitive after using ELOCOM, you should stop using it and tell
If you think that you have developed an infection on your skin or scalp whilst using ELOCOM, you should
tell your doctor as he may need to give you another type of medicine to use.
Do not apply on large surface areas of the skin or on open wounds.
If you are being treated for psoriasis – you may need to be monitored regularly.
The use of ELOCOM for children under 2 years is not recommended.
Special caution is required when using this medicine in children and adolescents. Use in these age
groups must be carried out under medical surveillance.
If you are not sure if any of the above apply to you, talk to your doctor before taking ELOCOM to see if
this medicine is suitable for you.
Do not light a cigarette or be exposed to fire until complete drying of the product.
2.3 Taking other medicines
If you are taking or have recently taken other medicines, including non-prescription medicines and
nutritional supplements, you should inform the attending doctor or pharmacist.
2.4 Pregnancy and breast-feeding
Do not use this medicine without consulting your doctor before starting treatment if you are pregnant or
2.5 Important information about some of the ingredients of ELOCOM
ELOCOM Lotion contains propylene glycol, which can cause skin irritation.
3. HOW DO YOU USE ELOCOM?
Always use ELOCOM exactly as your doctor has told you. You should check with your doctor or pharmacist
if you are not sure.
ELOCOM is not intended for use in children under the age of 2 years.
Do not use this medicine frequently, or for a long period, without consulting a doctor. Your doctor will
determine the dosage and duration of the treatment.
A few drops of ELOCOM Lotion should be gently massaged into the affected area of the skin or scalp once
a day. Massage gently and thoroughly until absorption of the medication. Apply with the aid of your finger
and then wash your finger thoroughly.
Do not exceed the recommended dose. Do not swallow, for external use only.
You should always follow these instructions when using ELOCOM:
Do not use ELOCOM on your face or in children for more than 5 days.
Do not put ELOCOM under your child’s diaper, as this makes it easier for the active drug to pass through
the skin and possibly cause some unwanted effects.
You should check with your doctor before covering the treated areas with a bandage or plaster. Treated
areas on the face or in children should not be covered with a bandage or plaster.
You should not use a large amount of ELOCOM Lotion on large areas of the body for a long time (for
example every day for many weeks or months).
Do not use in or around the eyes, including eye-lids, because of the very rare risk of glaucoma or cataract.
Avoid contact with mucous membranes (e.g. in mouth and nose). In case of contact wash thoroughly.
If you use more ELOCOM than you should
If you (or somebody else) accidentally swallows ELOCOM Lotion, it should not produce any problems.
However, if you are worried, you should see your doctor.
If you use ELOCOM Lotion more often than you should, or on large areas of the body, it can affect some of
your hormones levels. In children, this may affect their growth and development.
If you have not used ELOCOM Lotion as you were told to do, and have used it too often and/or for a long
time, you should tell your doctor.
If you forget to use ELOCOM
It is important to use ELOCOM as the doctor has prescribed. If you forget to use ELOCOM Lotion at the
right time, use it as soon as you remember, then carry on as before.
If you stop using ELOCOM
If you have been using ELOCOM Lotion for a long time and your skin or scalp problem seems to have got
better, you should not suddenly stop using ELOCOM Lotion. If you do, you may find that your skin and
scalp becomes red and you may notice stinging and burning. To avoid this, you should speak to your doctor
as he will gradually reduce how often you need to use ELOCOM Lotion until you stop treatment altogether.
Even if there is an improvement in your health, do not discontinue use of this medicine before consulting
your doctor. If you have additional questions regarding the use of this medicine, consult the doctor or
4. POSSIBLE SIDE EFFECTS
Like all medicines, ELOCOM can cause side effects, in some of the users.
Do not be alarmed by reading the list of side effects, you may experience none of them.
A few people may find that they suffer from some of the following side effects after using ELOCOM:
allergic skin reactions, bacterial and secondary skin infections, acne, inflammation and/or infection of the
hair follicles, thinning of the skin, red marks with associated prickly heat, loss of skin colour, burning,
stinging, itching, tingling, excessive hair growth, softening of the skin and stretch marks.
Other side effects that may occur with topical corticosteroids are dry skin, skin irritation, dermatitis,
dermatitis around the mouth, and dilated capillary blood vessels.
If a side effect appears, if one of the side effects gets serious or if you suffer from a side effect not
mentioned in this leaflet, consult your doctor.
Side effects can be reported to the Ministry of Health by using the link "Adverse Drug Reactions Report" at
the home page of the Ministry of Health's web site (www.health.gov.il) which refers to the online side effects
or by using the link:
5. HOW TO STORE ELOCOM?
Avoid Poisoning! This medicine, as all other medicines, must be stored in a safe place out of the reach
and sight of children and/or infants, in order to avoid poisoning. Do not induce vomiting unless explicitly
instructed to do so by a doctor!
Do not take medicines in the dark! Check the label and the dose each time you take your medicine.
Wear glasses if you need them.
Do not use ELOCOM after the expiry date (exp. date) which is stated on the pack. The expiry date refers
to the last day of the indicated month. In case of doubt, consult the pharmacist who dispensed the
medicine to you.
Store not above 25°C.
After first opening, use within 3 months.
Do not store different medications in the same package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
6.1 What ELOCOM Lotion contains
The active substance is mometasone furoate 0.1% (1mg/g).
The other ingredients are: isopropyl alcohol, propylene glycol, hydroxypropyl cellulose, sodium
dihydrogen phosphate dihydrate, purified water. May contain phosphoric acid.
6.2 What ELOCOM Lotion looks like and contents of the pack
ELOCOM Lotion is a colorless, to off-white lotion.
Merck Sharp & Dohme Corp., New-Jersey, USA.
6.4 License holder:
Merck Sharp & Dohme (Israel-1996) Company Ltd., P.O.Box 7121, Petah-Tikva 49170.
This Leaflet was checked and approved by the Ministry of Health on: March 2016.
Drug registration no. listed in the official registry of the Ministry of Health:
Cream, Ointment and Lotion
Physicians' Prescribing Information
DESCRIPTION OF THE PRODUCT
mometasone furoate (SCH 32088; Figure 1.1), a synthetic 17-heterocyclic
properties, which is presently being therapeutically used for the treatment
of corticosteroid responsive dermatoses, such as psoriasis and atopic
Mometasone furoate (see Figure
-methylpregna-1,4-diene-3,20-dione 17-(2)-furoate, is a synthetic, anti-
analog of beclomethasone, but with a 21-chloro group and a novel (2)-
Molecular Weight (MW) is 521.44.
mometasone furoate in a cream base of white soft paraffin, hexylene
hydrogenated soybean lecithin, titanium dioxide, phosphoric acid.
mometasone furoate in an ointment base of hexylene glycol, propylene
glycol stearate, white wax, white petrolatum, purified water and phosphoric
acid to adjust the pH.
Each gram of Elocom Lotion 0.1% contains: 1 mg of mometasone furoate
purified water. May also contain phosphoric acid to adjust the pH.
The pharmacodynamic activity of mometasone furoate cream, ointment
and lotion is directly related to its active component, mometasone furoate,
and the vehicles.
inflammatory, antipruritic, and vasoconstrictive properties. The mechanism
of the anti-inflammatory activity of the topical steroids, in general, is
unclear. Corticosteroids, however, are thought to act by the induction of
phospholipase A2 inhibitory proteins, collectively called lipocortins. It is
postulated that these proteins control the biosynthesis of potent mediators
of inflammation, such as prostaglandins and leukotrienes, by inhibiting the
release of their common precursor arachidonic acid. Arachidonic acid is
released from membrane phospholipids by phospholipase A2.
Mometasone furoate is a potent inhibitor of the in vitro production of three
inflammatory cytokines that are involved in initiating and maintaining the
inflammatory state: interleukin 1 (IL-1), interleukin 6 (IL-6), and tumor
PRECLINICAL PHARMACOKINETICS AND METABOLISM
Several studies were conducted to investigate for mometasone furoate the
absorption, distribution, metabolism and excretion following various routes
of administration and in different species. Mometasone furoate and/or its
metabolites are rapidly and extensively distributed in the rat. Mometasone
furoate undergoes extensive first-pass metabolism and is excreted as
metabolites mostly via the bile, and to a limited extent into the urine.
PRECLINICAL SAFETY DATA
No toxicological effects unique to mometasone furoate exposure were
demonstrated during the course of preclinical testing. All observed effects
are typical of this class of compounds and are related to exaggerated
pharmacologic effects of glucocorticoids.
Preclinical studies demonstrate that mometasone furoate is devoid of
androgenic, anti-androgenic, estrogenic or anti-estrogenic activity but, like
other glucocorticoids, it exhibits some anti-uterotrophic activity and delays
vaginal opening in animal models at high oral doses of 56 mg/kg/day and
Mometasone furoate was non-mutagenic in the mouse-lymphoma assay
and the Salmonella/E. coli/mammalian microsome mutagenicity bioassay.
At cytotoxic doses only, mometasone furoate produced an increase in
chromosome aberrations in vitro in Chinese hamster ovary cell (CHO)
cultures in the non-activation phase, but not in the presence of rat liver S9
aberrations in vitro in a Chinese hamster lung cell (CHL) chromosomal-
aberrations assay or in vivo in the mouse bone-marrow erythrocyte-
micronucleus assay, in the rat bone-marrow clastogenicity assay, and the
mouse male germ-cell clastogenicity assay. Mometasone furoate also did
not induce unscheduled DNA synthesis in vivo in rat hepatocytes, The
finding of simple chromosomal aberrations in the non-activation phase of
the CHO assay is considered to be related to cytotoxicity and is not
considered to be of significance in the risk assessment of mometasone
furoate because of the negative results in the S9 phase of this assay, the
negative results in a second in vitro chromal aberrations assay (CHL
assay), and the negative results in three in vivo chromosomal aberrations
In studies of reproductive function, subcutaneous mometasone furoate
was well tolerated at doses up to 7.5 µg/kg. At 15 µg/kg, mometasone
furoate caused prolonged gestation and prolonged and difficult labor
occurred with a reduction in offspring survival and body weight or body
weight gain. There was no effect on fertility.
Like other glucocorticoids, mometasone furoate is a teratogen in rodents
and rabbits. Teratology studies were conducted in rats, mice and rabbits
umbilical hernia in rats, cleft palate in mice, and gall bladder agenesis,
reductions in maternal body weight gains, effects on fetal growth (lower
fetal body weight and/or delayed ossification) in rats, rabbits and mice,
and reduced offspring survival in mice .
In an oral teratology study in rabbits, at 700 µg/kg, increased incidences of
malformations (hydrocephaly or domed head) were observed. Pregnancy
failure was observed in most rabbits at 2800 µg/kg.
The carcinogenicity and toxicological potential of inhaled Mometasone
Furoate (aerosol with CFC propellant and surfactant) at concentrations of
0.25 to 2.0 ug/I was investigated in studies in mice and rats of up to 24
response relationship was detected for any of the tumor types.
determined by many factors including the vehicle and the integrity of the
corticosteroids can be absorbed from normal intact skin. Inflammation
absorption. Occlusive dressings substantially increase the percutaneous
absorption of topical corticosteroids.
The percutaneous absorption of
H-mometasone furoate was studied in
man following topical application of cream (0.1%) and ointment (0.1%)
formulations. Results showed that only about 0.4% and 0.7% of the
steroid, respectively, were systemically absorbed following 8 hours of
contact, without occlusion, through intact skin of normal volunteers .The
percutaneous absorption of
H-mometasone furoate also was studied in
ointment 0.1% formulation over a 100cm
area. Results showed that only
1.3% of mometasone was absorbed systemically following 12 hours of
anticipated with the lotion formulation.
In studies of the effects of mometasone furoate cream and ointment on
the hypothalamic-pituitary-adrenal axis (HPA), 15 grams were applied
twice daily for 7 days to 6 patients with psoriasis or atopic dermatitis. The
cream or ointment was applied without occlusion to at least 30% of the
body surface. The results suggest that the drug caused a slight lowering of
adrenal corticosteroid secretion, although in no case did plasma cortisol
levels go below the lower limit of the normal range.
Mometasone furoate lotion was applied at 15 ml twice daily (30 ml per
day) to diseased skin (patients with scalp and body psoriasis) of four
patients for seven days, to study its effects on the hypothalamic-pituitary-
adrenal (HPA) axis. Plasma cortisol levels for each of the four patients
remained well within the normal range and changed little from baseline
In a study involving 24 children (6 months to 13 years of age) with
moderate to severe atopic eczema, mometasone furoate cream was
applied once daily for three to six weeks. Occlusive dressings were not
used. The plasma cortisol levels for all patients remained within or above
the normal range during the course of treatment. Clinical laboratory values
of the children generally remained within the normal range. There were
some laboratory values that were outside the normal range during the
course of treatment; however, the investigator did not consider these
values to be of clinical significance or indicative of specific organ system
occlusion for three weeks in 24 psoriasis patients. Plasma cortisol levels
remained within normal limits for all patients.
Due to the negligible absorption of mometasone furoate following topical
administration, the pharmacokinetics of the drug was evaluated following
intravenous administration of mometasone furoate. The apparent volume
of distribution was 917 liters, indicating that any absorbed mometasone
furoate would be extensively distributed in human plasma, mometasone
furoate is over 99% bound.
metabolism to multiple metabolites. The multiple metabolites are more
polar than mometasone furoate, and because of their polarity, are not
mometasone furoate was 976 ml/min, confirming extensive metabolism.
modeling, the effective plasma elimination half-life is 5.8 hours. Any
absorbed drug is excreted as metabolites mostly via the bile, and to a
limited extent, into the urine.
INDICATIONS AND USAGE
Mometasone furoate cream, ointment and lotion are indicated for the relief
of the inflammatory and pruritic manifestations of corticosteroid-responsive
dermatoses, such as psoriasis, atopic dermatitis.
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
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 ingredients in this
If irritation develops, topical corticosteroids should be discontinued and
appropriate therapy instituted.
In the presence of a dermatological infection, use of an appropriate
discontinued until the infection is adequately controlled.
hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential
Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can
also be produced in some patients by systemic absorption of topical
corticosteroids while on treatment. Patients applying a topical steroid to a
periodically for evidence of HPA axis suppression.
corticosteroids, including adrenal suppression, may also occur with topical
corticosteroids, especially in infants and children.
Pediatric patients may be more susceptible to systemic toxicity from
equivalent doses due to their larger skin surface to body mass ratios.
As the safety and efficacy of Elocom in pediatric patients below 2 years of
Local and systemic toxicity is common especially following long continued
use on large areas of damaged skin, in flexures and with polythene
occlusion. If used in childhood, or on the face, occlusion should not be
used. If used on the face, courses should be limited to 5 days and
occlusion should not be used. Long term continuous therapy should be
avoided in all patients irrespective of age.
Topical steroids may be hazardous in psoriasis for a number of reasons
including rebound relapses following development of tolerance, risk of
centralised pustular psoriasis and development of local or systemic toxicity
due to impaired barrier function of the skin. If used in psoriasis careful
patient supervision is important.
As with all potent topical glucocorticoids, avoid sudden discontinuation of
treatment. When long term topical treatment with potent glucocorticoids is
stopped, a rebound phenomenon can develop which takes the form of a
treatment on an intermittent basis before discontinuing treatment.
Glucocorticoids can change the appearance of some lesions and make it
difficult to establish an adequate diagnosis and can also delay the healing.
Elocom ointment and lotion contains propylene glycol which may cause
Elocom topical preparations are not for ophthalmic use, including the
eyelids, because of the very rare risk of glaucoma simplex or subcapsular
Pregnancy and lactation:
performed only on the physician's order. Then however, the application on
large body surface areas or over a prolonged period should be avoided.
There is inadequate evidence of safety in human pregnancy. Topical
abnormalities of fetal development including cleft palate and intra-uterine
growth retardation. There are no adequate and well-controlled studies with
Elocom in pregnant women and therefore the risk of such effects to the
considered. There may therefore be a very small risk of such effects in the
human fetus. Like other topically applied glucocorticoids, Elocom should
be used in pregnant women only if the potential benefit justifies the
potential risk to the mother or the fetus.
It is not known whether topical administration of corticosteroids could
result in sufficient systemic absorption to produce detectable quantities in
breast milk. Elocom should be administered to nursing mothers only after
careful consideration of the benefit/risk relationship. If treatment with
higher doses or long term application is indicated, breast-feeding should
Table 1: Treatment-related adverse reactions reported with Elocom by body system
Very common (
1/10); common (
1/100, <1/10); uncommon (
1/10,000, <1/1,000); very rare (<1/10 000,); not known (cannot be estimated
from available data)
Infections and infestations
Nervous system disorders
Skin and subcutaneous
Dermatitis contact, skin hypopigmentation,
hypertrichosis, skin striae, dermatitis acneiform,
General disorders and
Application site pain, application site reactions
maceration of the skin, miliaria and telangiectasiae.
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-
induced hypothalamic-pituitary-adrenal axis suppression and Cushing's syndrome
than mature patients because of a larger skin surface area to body weight ratio.
Chronic corticosteroids therapy may interfere with the growth and development of
DRUG ABUSE AND DEPENDENCE
insufficiency which is usually reversible.
If HPA axis suppression is noted, an attempt should be made to withdraw
the drug, to reduce the frequency of application or to substitute a less
The steroid content of each container is so low as to have little or no toxic
effect in the unlikely event of accidental oral ingestion.
INTERFERENCE WITH LABORATORY TESTS
DOSAGE AND ADMINISTRATION
Apply a thin film of mometasone furoate cream of ointment or a few drops
of mometasone furoate lotion to the affected skin areas once daily.
Store below 25
Elocom ointment: after first opening, use within 1 month.
Elocom lotion and cream: after first opening, use within 3 months.
Elocom ointment and cream: Schering-Plough Labo N.V., Heist-op-den-
Elocom lotion: Merck Sharp & Dohme Corp., New-Jersey, USA.
9 REGISTRATION HOLDER
Merck Sharp & Dohme (Israel-1996) Company Ltd, P.O.B. 7121 Petach-
The format of this leaflet was determined by the Ministry of Health and its
content was checked and approved in December 2014.