Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language!
Elocom,
1 mg/g (0.1%) ointment
Mometasoni furoas
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 give it to others. The medicine may harm another person, even if their symptoms are the same.
If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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 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 skin diseases responsive to corticosteroid therapy, 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 skin or skin with ulcers.

Warnings and precautions
Before starting treatment with Elocom, discuss it with your doctor or pharmacist.
If irritation or allergic symptoms occur after applying the medicine, contact your doctor immediately.
If infections occur, the doctor will initiate appropriate antibacterial or antifungal treatment. If there is no rapid 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 body surface areas, 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 associated with systemic corticosteroid therapy, including suppression of adrenal cortex function, may also occur with topical corticosteroid use, 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 that controls disease 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 required when using the medicine in patients with psoriasis.
Use of the medicine in psoriasis may lead to disease recurrence due to 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. Sudden withdrawal may result in intense redness, burning, and stinging pain (so-called "rebound effect"). In such cases, contact your doctor.
Like other corticosteroid-containing medicines, Elocom may alter the appearance of certain skin lesions, potentially making accurate diagnosis more difficult for the physician, and may also delay wound 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 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 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 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 body surface areas 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 prolonged therapy necessary, breastfeeding should be discontinued.

Driving and operating machinery
Elocom does not affect the ability to drive or operate machinery.

3. How to use Elocom

This medicine should always be used as directed by a physician. If in doubt, consult a doctor or pharmacist.
Affected skin areas are usually treated once daily with a thin layer of ointment.
The oint游戏副本

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 in 10,000): folliculitis, burning sensation, itching.
Frequency not known (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 is applied over a large skin surface for prolonged periods, and particularly when occlusive dressings are used, systemic absorption of the drug may occur.
The following adverse reactions have been observed with topical 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 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 enables better assessment of the medicine's safety and helps collect additional information on its safe use.

5. How to store Elocom

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Usable period after first opening of the container - 1 month.
Do not use containers that are damaged or show 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 stated month.

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, phosphoric acid, propylene glycol stearate, white soft paraffin, white wax, purified water.

What Elocom looks like and contents of the pack
Elocom is an ointment.
Pack contents:
An aluminium tube containing 30 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 Bulgaria, the country of export:
N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands
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
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation Number in Bulgaria, the country of export: 9700329
Parallel Import Licence Number: 262/19