Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Elocom (Elocom)
1 mg/g (0.1%) ointment
Mometasoni furoas
Elocom and Elocom are the same brand names of the same medicinal product written in Polish and Bulgarian.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet to be able to 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 pass it on to others. The medicine may harm another person, even if their symptoms are identical.
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

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 dermatoses 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, shingles and 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 tuberculosis of the skin;
in syphilitic skin lesions;
in anal or genital pruritus;
in diaper dermatitis;
on damaged or ulcerated skin.

Warnings and precautions
Before starting treatment with Elocom, consult a doctor or pharmacist.
If symptoms of irritation or allergy 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 in skin folds, especially in children. If application to the face is necessary, treatment should not exceed 5 days.
All adverse effects reported after 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 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 the medicine on skin covered by diapers, as diapers may act similarly to occlusive dressings and increase transdermal 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.
Patients with psoriasis should use the medicine with particular caution.
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. 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, which could make diagnosis more difficult for the physician, and may also delay wound healing.
Consult a 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 the doctor or pharmacist about all medicines currently used or recently used, 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 baby, 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 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 such an extent that they can pass into breast milk.
Use of Elocom in breastfeeding women is possible only if a doctor decides so after carefully weighing the risk of adverse effects in infants against the benefit of treatment for the mother.
If the doctor considers long-term 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 the physician. If in doubt, consult a 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 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 smallest effective dose that controls disease symptoms should be used.
Prolonged corticosteroid treatment 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, 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 intoxication, the physician will recommend gradual discontinuation of the medicine.

Missed dose of Elocom
Do not apply a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following adverse reactions have been observed during the use of corticosteroids applied to the skin:

Very rare (affects less than 1 in 10,000 patients): folliculitis, burning sensation, itching.
Frequency not known (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.

When the medicine is used over a large area of skin for prolonged periods, and particularly when occlusive dressings are used, systemic absorption of the corticosteroid may occur.
The following side effects have been observed with topical corticosteroids: dry skin, skin irritation, dermatitis, perioral dermatitis, maceration (softening of the skin), sweating, and appearance of dilated small blood vessels (telangiectasia).

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department for Monitoring Adverse Drug Reactions, 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 side effects helps provide more information on the safety of this medicine.

5. How to store Elocom

Keep the medicine out of sight and reach of children.
Store below 25°C.
Keep the container tightly closed.
Discard the product after 1 month of first opening the container.
Do not use if the packaging is damaged or shows signs of prior opening.
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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the package and other information

What Elocom contains

The active substance is mometasone furoate. 1 gram of ointment contains 1 mg of mometasone furoate.
The other ingredients are: hexylene glycol, purified water, phosphoric acid, propylene glycol stearate, white wax, white soft paraffin. This medicine contains 20 mg of propylene glycol stearate in each gram of ointment, which corresponds to 300 mg of propylene glycol stearate per unit (15 g tube) or 600 mg of propylene glycol stearate per unit (30 g tube).

What Elocom looks like and contents of the pack
Elocom is an ointment.
Packaging
Aluminium tube with cap made of LDPE or laminate tube with head made of HDPE and cap made of PP,
containing 15 g or 30 g of ointment, placed in a cardboard box.
For more detailed information, please contact the responsible entity or the parallel importer.
Responsible entity in Bulgaria, 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Bulgaria, country of export, marketing authorization number: 9700329
Parallel import authorization number: 429/15