Patient Information Leaflet

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

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 ointment contains the active substance mometasone furoate. Mometasone furoate is a synthetic corticosteroid with potent anti-inflammatory activity; when applied topically, it exerts anti-inflammatory, antipruritic (anti-itch), and vasoconstrictive effects.
Elocom ointment 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, shingles, chickenpox, 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 itching;
in diaper dermatitis;
on damaged skin or skin with ulcers.

Warnings and precautions
Before starting to use Elocom, discuss this with your doctor or pharmacist.
If irritation or allergic reactions occur after applying the medicine, contact your doctor immediately.
If infections develop, your doctor will prescribe 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 facial skin and in skin folds, especially in children. If application to the face is necessary, treatment should not exceed 5 days.
All adverse effects reported 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 an increased risk of systemic adverse effects of corticosteroids, such as hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome.
Do not apply the medicine to skin covered by diapers, as diapers may act similarly to occlusive dressings and increase percutaneous absorption of mometasone furoate.
Use the lowest effective dose required to control 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 a very rare risk of developing glaucoma or subcapsular cataract.
Particular caution should be exercised by patients with psoriasis.
Using the medicine in psoriasis may lead to relapse due to development of tolerance, generalized pustular psoriasis, or systemic toxic effects associated with impaired skin integrity.
As with other potent topical corticosteroids, abrupt discontinuation of treatment should be avoided. After sudden withdrawal, intense redness, burning, and stinging pain ("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 may make it difficult for the doctor to establish an accurate diagnosis, and may also delay 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 your doctor.

Elocom and 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 they plan to take.

Pregnancy and breastfeeding

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

Pregnancy
The safety of using Elocom during pregnancy has not been established.
Elocom should be used during pregnancy only if, in the opinion of the doctor, 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 to such an extent that they may pass into breast milk.
Use of Elocom in breastfeeding women is possible only if decided by the doctor after careful consideration of the risk of adverse effects in infants versus 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 does not affect the ability to drive or operate machinery.

Elocom cream contains stearic acid propylene glycol ester
Due to the presence of stearic acid propylene glycol ester, the medicine may cause skin irritation.

3. How to use Elocom

This medicine should always be used as directed by a physician. If in doubt, consult your
doctor or pharmacist.
Affected skin areas are usually treated once daily with a thin layer of ointment.
The oint combustible is recommended for the treatment of dry, scaly, and cracked lesions.
If you feel the medicine's effect 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 use longer than 3 weeks.
There are insufficient data on the use of the medicine in children under 2 years of age.
The lowest effective dose needed to control symptoms should be used.
Prolonged corticosteroid treatment may impair growth and development in children.

Use of a higher than recommended dose of Elocom
There have been no reported cases of overdose.
Long-term topical use of corticosteroids may lead to suppression of the hypothalamic-pituitary-adrenal (HPA) axis and, consequently, adrenal insufficiency.
In case of overdose, the doctor will administer appropriate symptomatic and supportive treatment.
Acute corticosteroid overdose symptoms are usually reversible. In cases of chronic toxicity, the doctor will recommend gradual discontinuation 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 (occurring in less than 1 patient out of 10,000): folliculitis, burning sensation, pruritus.
Frequency unknown (cannot be estimated from available data): infections, abscess, paresthesia, contact dermatitis, hypopigmentation, hypertrichosis, striae, acneiform eruptions, skin atrophy, pain at application site, application site reactions, blurred vision.

When the medicine was applied over a large skin surface for prolonged periods, especially when using occlusive dressings, systemic absorption of the drug occurred.
The following adverse reactions have been observed during local application of corticosteroids:
dry skin, skin irritation, dermatitis, perioral dermatitis, maceration, hyperhidrosis, 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, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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 helps to provide more information on the safety of the medicine.

5. How to store Elocom

Keep the medicine out of sight and reach of children.
Do not store above 25°C.
Keep the container tightly closed.
Do not use if the packaging is damaged or shows signs of tampering.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month indicated.
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.

6. Contents of the package and other information

What Elocom contains

The active substance is mometasone furoate. 1 gram of ointment contains 1 mg of mometasone furoate.
The other ingredients are: hexylene glycol, purified water, concentrated phosphoric acid, propylene glycol stearate, white wax, and white vaseline. This medicine contains 20 mg of propylene glycol stearate in each gram of ointment, equivalent to 600 mg of propylene glycol stearate per unit (30 g tube).

What Elocom looks like and contents of the pack
Elocom is an ointment.
Packaging of the medicine
An aluminium tube with an internal epoxy resin coating, containing 30 g of ointment, fitted with a protective membrane and a PE cap, packed in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Spain, the 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:
Delfarma Sp. z o.o., ul. Świętej Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged by:
Delfarma Sp. z o.o., ul. Świętej Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing authorisation number in Spain, the country of export: 797977.7
Parallel import licence number: 302/14