Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Elocom, 1 mg/g, cream
Mometasone furoate
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet for possible future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Elocom is and what it is used for
Important information before using Elocom
How to use Elocom
Possible side effects
How to store Elocom
Contents of the pack and other information

1. What Elocom is and what it is used for

Elocom cream contains the active substance mometasone furoate. Mometasone furoate is a synthetic corticosteroid with potent anti-inflammatory action; when applied topically, it exerts anti-inflammatory, antipruritic (anti-itch), and vasoconstrictive effects.
Elocom cream is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, such as psoriasis and atopic dermatitis.

2. Important information before using Elocom

When not to use Elocom:

if the patient is allergic to mometasone furoate, other corticosteroids, or any of the other ingredients of this medicine (listed in section 6);
in acne vulgaris,
in rosacea,
in skin atrophy,
in perioral dermatitis,
in bacterial infections (e.g. impetigo, pyoderma), viral infections (e.g. herpes simplex, herpes zoster, varicella, common warts, plantar warts, molluscum contagiosum), parasitic or fungal skin infections (e.g. those caused by dermatophytes or yeasts),
in post-vaccination reactions,
in cutaneous tuberculosis,
in syphilitic skin lesions,
in anal or genital pruritus,
in diaper dermatitis,
on damaged skin or skin with ulcers.

Warnings and precautions
Before starting treatment with Elocom, consult your doctor or pharmacist.
If symptoms of irritation or allergy occur after applying the medicine, contact your doctor immediately.
If infections occur, the doctor will initiate appropriate antibacterial or antifungal treatment. If there is no rapid and positive response to treatment, corticosteroid therapy should be discontinued until the infection has resolved.
Due to the increased risk of systemic adverse effects of corticosteroids, avoid using Elocom over large areas of the body, under occlusive dressings, for prolonged periods, or on the face and in skin folds, especially in children. If application to the face is necessary, treatment should not exceed 5 days.
All adverse effects associated with systemic corticosteroid therapy, including suppression of adrenal cortex function, may also occur with topical corticosteroids, particularly in infants and children.
In children, due to a higher body surface area to body weight ratio compared to adults, there is a greater likelihood of systemic adverse effects of corticosteroids, such as hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome.
Do not use the medicine on skin covered by diapers, as diapers may act like occlusive dressings and increase transdermal absorption of mometasone furoate.
Use the lowest effective dose that controls symptoms, especially in children. Prolonged corticosteroid treatment may impair growth and development in children.
Topically applied Elocom is not intended for ophthalmic use (including the eyelid area) due to the very rare risk of glaucoma or subcapsular cataract.
Patients with psoriasis should use this medicine with particular caution.
Use of the medicine in psoriasis may lead to relapse due to development of tolerance, generalized pustular psoriasis, or systemic toxic effects related to disruption of skin integrity.
As with other potent topical corticosteroids, abrupt discontinuation of treatment should be avoided. After sudden withdrawal, intense redness, burning, and stinging pain (so-called "rebound effect") may occur. In such cases, contact your doctor.
Like other corticosteroid-containing medicines, Elocom may alter the appearance of certain skin lesions, which could make diagnosis more difficult for the physician, and may also delay wound healing.
Consult your doctor even if the above warnings refer to conditions that occurred in the past.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.

Elocom with other medicines
No data available.
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
The safety of Elocom during pregnancy has not been established.
Elocom may be used during pregnancy only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the mother and fetus. However, the medicine should not be used over large areas of the body or for prolonged periods. Animal studies have shown that corticosteroids may harm the fetus.

Breastfeeding
It is not known whether topically administered corticosteroids are absorbed through the skin in sufficient amounts to pass into breast milk.
Use of Elocom in breastfeeding women is possible only if the doctor decides after carefully weighing the risk of adverse effects in the infant against the benefit of treatment for the mother.
If prolonged therapy is deemed necessary by the doctor, breastfeeding should be discontinued.

Driving and operating machinery
Elocom has no effect on the ability to drive or operate machinery.

3. How to use Elocom

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.
Affected skin areas are usually treated once daily with a thin layer of cream.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.

Use in children
Elocom should be used with caution in children aged 2 years and older, although the safety and efficacy of Elocom have not been established for treatment periods longer than 3 weeks.
There are insufficient data on the use of this medicine in children under 2 years of age.
The lowest effective dose needed to control disease symptoms should be used.
Prolonged corticosteroid treatment may impair growth and development in children.

Use of a higher than recommended dose of Elocom
Cases of overdose have not been reported so far.
Prolonged topical use of corticosteroids may lead to suppression of the hypothalamic-pituitary-adrenal (HPA) axis and consequently to adrenal insufficiency.
In case of overdose, the physician will apply appropriate symptomatic and supportive treatment. Acute symptoms of corticosteroid overdose are usually reversible. In cases of chronic intoxication, the physician will recommend gradual withdrawal of the medicine.

Missed dose of Elocom
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been observed during the use of corticosteroids applied to the skin:

Very rare (occur in less than 1 patient in 10,000): folliculitis, burning sensation, itching.
Frequency unknown (frequency cannot be determined from available data): infections, carbuncle, paresthesia, contact dermatitis, hypopigmentation, excessive hair growth, striae, acneiform eruptions, skin atrophy, pain at application site, application site reactions, blurred vision.

When applied over large areas of skin for prolonged periods, especially when using occlusive dressings, systemic absorption of the drug may occur.
The following adverse reactions have been observed during local use of corticosteroids:
dry skin, skin irritation, dermatitis, perioral dermatitis, maceration, miliaria, and appearance of dilated small blood vessels (telangiectasia).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions allows additional information on the safety of the medicine to be collected.

5. How to store Elocom

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Keep the container tightly closed.
Do not use containers that are damaged or show signs of tampering.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
After first opening, the product remains stable for 4 weeks.

6. Contents of the pack and other information

What Elocom contains:

The active substance is mometasone furoate. Each gram of cream contains 1 mg of mometasone furoate.
The other ingredients are: hexylene glycol, purified water, concentrated phosphoric acid (for pH adjustment), hydrogenated soybean lecithin, sodium starch octenyl succinate, titanium dioxide (E 171), white wax, and white vaseline.

What Elocom looks like and contents of the pack
Elocom is a cream.
Packaging:
An aluminium tube internally coated with epoxy resin, with a polyethylene cap, containing 30 g of cream,
packaged in a cardboard box.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Spain, country of export:
Organon Salud, S.L.
Paseo de la Castellana, 77
28046 Madrid, Spain
Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Spain, country of export: 797894.7
Parallel Import Authorisation Number: 277/15