ELOCOM

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Elocom
1 mg/g, cream
Mometasoni furoas
Please read the entire leaflet carefully before using the 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 pass it on to others. The medicine may harm others, even if their symptoms are similar.
• If the patient experiences any adverse effects, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents

1. What Elocom is and what it is used for
2. Important information before using Elocom
3. How to use Elocom
4. Possible side effects
5. How to store Elocom
6. Contents of the pack and other information

1. What Elocom is and what it is used for

Elocom cream contains the active substance mometasoni furoas. Mometasoni furoas is a synthetic corticosteroid with potent anti-inflammatory action; 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, 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 or ulcerated skin.

Warnings and precautions
Before starting to use 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 should 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 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 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 a greater likelihood 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 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 open-angle glaucoma or subcapsular cataracts.
Patients with psoriasis should use the medicine with particular caution.
Using the medicine 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 erythema, 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, making it difficult for a doctor to establish an accurate diagnosis, and may also delay wound 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 currently or recently taken, as well as any medicines planned for future use.

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 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 applied 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 carefully weighing the risk of adverse effects in infants against the benefit of treatment for the mother. If the doctor considers prolonged therapy necessary, breastfeeding should be discontinued.

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

3. How to use Elocom

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Affected skin areas are usually treated once daily with a thin layer of cream.
If you feel that 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 is 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.
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 doctor will administer appropriate symptomatic and supportive treatment. Acute corticosteroid overdose symptoms are usually reversible. In cases of chronic intoxication, 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 effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
The following adverse effects have been observed during the use of corticosteroids on the skin:

• Very rare (occurring in less than 1 patient out of 10,000): folliculitis, burning sensation, pruritus.
• Frequency not known (cannot be estimated from available data): infections, furuncle, paresthesia, contact dermatitis, hypopigmentation, hypertrichosis, striae, acne-like changes, skin atrophy, pain at application site, application site reactions, blurred vision.

Application of the medicine over large areas of skin for prolonged periods, especially under occlusive dressings, may result in systemic absorption of the drug.
The following adverse effects have been observed with topical use of corticosteroids: dry skin, skin irritation, dermatitis, perioral dermatitis, skin maceration, hyperhidrosis, 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 a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 helps provide more information on the safety of the medicine.

5. How to store Elocom

Keep this medicine out of the sight and reach of children.
Store below 25°C in the original packaging.
Usable period after first opening the container – 4 weeks.
Do not use the product 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 package 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, phosphoric acid, hydrogenated soybean lecithin, aluminium starch octenylsuccinate, titanium dioxide, white wax, white petrolatum.

What Elocom looks like and contents of the pack
Elocom is an opaque, smooth, homogeneous, white cream.
Pack: An aluminium tube containing 15 g of cream, placed in a cardboard box.
For further information, please contact the responsible entity or the parallel importer.

Responsible entity in Romania, country of export:
ORGANON BIOSCIENCES S.R.L.
Strada Av. Popişteanu, Nr. 54A, Expo Business Park, Clădirea 2
Birou 306 şi Birou 307, Etaj 3, Sectorul 1
Bucharest
Romania

Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorization number in Romania, country of export: 11023/2018/01
Parallel import authorization number: 225/20