Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Elocom, 1 mg/g (0.1%) cream
Mometasone furoate
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including those 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
What you need to know 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 activity; when applied topically, it exerts anti-inflammatory, antipruritic, 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, 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, consult a doctor or pharmacist.
If irritation or allergic symptoms occur after applying the medicine, contact a 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 use 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 skin folds, especially in children. If application to the face is necessary, treatment should not exceed 5 days.
Adverse effects reported with systemic corticosteroid use, 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 use Elocom on skin covered by diapers, as diapers may act similarly to occlusive dressings and increase percutaneous 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 developing open-angle glaucoma or subcapsular cataract.
Particular caution is advised in patients with psoriasis.
Use of Elocom in psoriasis may lead to disease recurrence due to development of tolerance, generalized pustular psoriasis, or systemic toxic effects related to 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 (so-called "rebound effect") may occur. In such cases, contact a doctor.
Like other corticosteroid-containing medicines, Elocom may alter the appearance of certain skin lesions, potentially making accurate diagnosis more difficult, and may also delay healing.
Consult a 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 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 or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a 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 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 to such an extent that they can pass 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 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 the effect of the medicine seems too strong or too weak, consult a 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 Elocom in children under 2 years of age.
The lowest effective dose that controls disease symptoms should be used.
Prolonged 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 on the skin:

Very rare (occur in less than 1 patient in 10,000): folliculitis, burning sensation, itching.
Frequency unknown (frequency cannot be estimated from the available data): infections, abscess, paresthesia, contact dermatitis, hypopigmentation, hypertrichosis, striae, acne-like changes, skin atrophy, pain at application site, application site reactions, blurred vision. Systemic absorption has occurred when the medicine was applied over a large skin surface area for prolonged periods, particularly when occlusive dressings were used.

The following adverse reactions have been observed during local application of corticosteroids:
dry skin, skin irritation, dermatitis, perioral dermatitis, maceration of the skin, 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 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Elocom

Keep this medicine out of sight and reach of children.
Store at room temperature (between 15°C and 25°C).
Do not use packages 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.
Expiry date after first opening the container – 4 weeks.
Medicines must not be disposed of in wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. 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 cream contains 1 mg of mometasone furoate.
Other components: hexylene glycol, purified water, concentrated phosphoric acid, hydrogenated soy lecithin, starch aluminium octenylsuccinate, titanium dioxide (E 171), white wax, white petrolatum.

What Elocom looks like and contents of the pack
Elocom is a cream.

Packaging
A tube containing 20 g of cream, placed in a cardboard box.
For further information, please contact the responsible party or the parallel importer.

Responsible entity in Belgium, country of export:
Organon Belgium
Rue du Commerce 31
B-1000 Brussels, Belgium

Manufacturer:
NV Schering-Plough Labo
Industriepark 30
B-2220 Heist-op-den-Berg, Belgium

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing authorization number in Belgium, country of export: BE163292
Parallel import authorization number: 362/22