Patient Information Leaflet

Warning! Keep this leaflet! 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, as you may need to read it again.
If you have any questions, please 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 similar.
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 is Elocom and what is it 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 is Elocom and what is it used for
Elocom ointment contains the active substance mometasone furoate. Mometasone furoate is a synthetic corticosteroid with potent anti-inflammatory, antipruritic, and vasoconstrictive properties when applied topically.
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 you are 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 skin 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, discuss it with your doctor or pharmacist.
If irritation or allergic reactions occur after application, contact your doctor immediately.
If an infection develops, your doctor should initiate appropriate antibacterial or antifungal treatment. If there is no rapid improvement, corticosteroid treatment should be discontinued until the infection has resolved.
Due to the increased risk of systemic corticosteroid side effects, 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.
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 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 Elocom 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 cataracts.
Patients with psoriasis should use this medicine with particular caution.
Treatment of psoriasis with Elocom may lead to disease recurrence due to tolerance development, generalized pustular psoriasis, or systemic toxic effects related to skin barrier disruption.
As with other potent topical corticosteroids, abrupt discontinuation of treatment should be avoided. Sudden withdrawal may result in rebound phenomena such as intense redness, burning, and stinging pain. In such cases, contact your doctor.
Like other corticosteroid-containing medicines, Elocom may alter the appearance of certain skin lesions, potentially complicating diagnosis, and may delay wound healing.
Consult your doctor, even if the above warnings relate to conditions experienced in the past.
If you experience blurred vision or other visual disturbances, contact your doctor.

Elocom and other medicines
No data available.
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your 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, avoid using the medicine over large areas of the body and for prolonged periods. Animal studies have shown that corticosteroids may harm the fetus.

Breastfeeding
It is not known whether topically applied corticosteroids are absorbed through the skin to an extent that allows passage into breast milk.
Use of Elocom in breastfeeding women is possible only if decided by a doctor 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 using machines
Elocom does not affect the ability to drive or operate machinery.

3. How to use Elocom

This medicine should always be used exactly as directed by the doctor. If in doubt, consult
your doctor or pharmacist.
Affected skin areas are usually treated once daily with a thin layer of ointment.
The ointment 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 safety and efficacy have not been established for treatment periods longer than 3 weeks.
There are insufficient data on the use of Elocom 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 doctor will initiate appropriate symptomatic and supportive treatment.
Acute corticosteroid overdose symptoms are usually reversible. In cases of chronic toxicity, the doctor 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects 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 estimated from available data): infections, furuncle, paresthesia, contact dermatitis, hypopigmentation, hypertrichosis, striae, acneiform eruptions, skin atrophy, pain at application site, application site reactions, blurred vision.

When the medicine is applied over a large area of skin for prolonged periods, and particularly when occlusive dressings are used, systemic absorption into the general circulation may occur.
The following adverse effects have been observed during local application of corticosteroids:
dry skin, skin irritation, dermatitis, perioral dermatitis, maceration, miliaria, and appearance of dilated small blood vessels (telangiectasia).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects enables better assessment of the medicine's safety profile.

5. How to store Elocom

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Use within 1 month after first opening the container.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must 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 packaging and other information

What Elocom contains:

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

What Elocom looks like and contents of the pack
Elocom is an ointment.
Pack size
Aluminium tube containing 30 g of ointment, placed in a cardboard carton.
For further information, please contact the responsible party 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Spanish Marketing Authorisation Number (country of export): 797977.7
Parallel Import Licence Number: 267/15