Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Elocom, 1 mg/g, ointment
Mometasone furoate
Please read carefully the entire leaflet 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 another person, 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 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, and vasoconstrictive effects.
Elocom ointment is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive skin diseases, 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 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 signs of irritation or allergic reaction occur after applying the medicine, contact your doctor immediately.
If an infection develops, your doctor should initiate appropriate antibacterial or antifungal treatment. If there is no rapid positive response to treatment, corticosteroid therapy 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 facial skin and skin folds, especially in children. If application to the face is necessary, treatment should not exceed 5 days.
All adverse effects reported with systemic corticosteroids, including suppression of adrenal cortex function, may also occur with topical corticosteroids, particularly in infants and children.
In children, due to the higher body surface area to body weight ratio compared to adults, there is an increased risk of systemic corticosteroid side effects, 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 transdermal 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 the very rare risk of developing glaucoma or subcapsular cataracts.
Patients with psoriasis should use this medicine with particular caution.
Treatment with Elocom in psoriasis may lead to disease recurrence due to the 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 may make accurate diagnosis by a physician more difficult, and may also delay wound healing.
Consult your doctor, even if the above warnings relate to conditions that occurred in the past.
If the patient experiences blurred vision or other visual disturbances, contact a 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 the patient plans to take.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
The safety of using Elocom during pregnancy has not been established.
Elocom may 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 an extent that allows passage into breast milk.
Use of Elocom in breastfeeding women is possible only if decided by a doctor after careful consideration of the risk of adverse effects in infants versus the benefit of treatment for the mother.
If the doctor considers long-term therapy necessary, 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 the ointment.
The ointment is recommended for the treatment of dry, scaly, and cracked lesions.
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 or 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 this medicine in children under 2 years of age.
The lowest effective dose that controls disease symptoms should be used.
Long-term treatment with corticosteroids may impair growth and development in children.

Use of a higher than recommended dose of Elocom
There have been no reported cases of overdose.
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 administer appropriate symptomatic and supportive treatment. Acute corticosteroid overdose symptoms are usually reversible. In cases of chronic toxicity, the physician 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 (affects less than 1 patient in 10,000): folliculitis, burning sensation, pruritus.
Frequency unknown (frequency cannot be estimated from the 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 reactions have been observed during local application of corticosteroids:
dry skin, skin irritation, dermatitis, perioral dermatitis, maceration, sweating, 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 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions enables better assessment of the medicine's safety profile.

5. How to store Elocom

Keep the medicine out of sight and reach of children.
Store below 25°C in the original packaging.
Keep the container tightly closed.
Use within 4 weeks after first opening the container.
Do not use containers that are damaged or show 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. These measures help protect the environment.

6. Contents of the pack 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, polyglyceryl-6 stearate, white wax, and petroleum jelly. This medicine contains 20 mg of polyglyceryl-6 stearate in each gram of ointment, equivalent to 300 mg of polyglyceryl-6 stearate per unit (15 g tube).

What Elocom looks like and contents of the pack
Elocom is an ointment.
Packaging
An aluminium tube containing 15 g of ointment, placed in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Romania, country of export:
ORGANON BIOSCIENCES S.R.L.
Strada Av. Popișteanu, Nr. 54A, Expo Business Park, Clădirea 2
Birou 306 și Birou 307, Etaj 3, Sectorul 1, Bucharest, Romania
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
Marketing Authorisation number in Romania, country of export: 11024/2018/01
Parallel import licence number: 276/15