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 this leaflet carefully 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 other people, 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 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 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 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 (e.g. impetigo, pyoderma), viral (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 treatment with Elocom, discuss it with your doctor or pharmacist.

If signs of irritation or hypersensitivity occur after application, contact your doctor immediately.
If infections develop, 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 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 treatment on the face is necessary, it should not exceed 5 days.
Systemic adverse effects reported with systemic corticosteroid therapy, 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 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 necessary 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 glaucoma or subcapsular cataract.
Particular caution should be exercised by patients with psoriasis.
Use of the medicine in psoriasis may lead to relapse 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 ("rebound effect") may occur. In such cases, contact your doctor.
Elocom, like other corticosteroid-containing medicines, may alter the appearance of certain skin lesions, which may complicate diagnosis by a physician, and may also delay wound healing.
Consult your doctor, even if the above warnings relate to conditions experienced in the past.
If blurred vision or other visual disturbances occur, contact your doctor.

Elocom and other medicines
No data available.
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before using this medicine.

Pregnancy
The safety of 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 the 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 sufficient to pass into breast milk.
Use of Elocom in breastfeeding women is possible only if decided by the 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 influence on 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 ointment is recommended for the treatment of dry, scaling, and cracked lesions.
If the effect of the medicine seems too strong or too weak, consult a doctor.

Use in children
Elocom should be used cautiously 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 lowest effective dose of the medicine 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, 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 use 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 will experience them.
The following side effects have been observed during the use of corticosteroids on the skin:

Very rare (affects less than 1 in 10,000 patients): folliculitis, burning sensation, itching.
Frequency not known (frequency cannot be determined from available data): infections, furuncle, paresthesia, contact dermatitis, hypopigmentation, hypertrichosis, striae, acneiform eruptions, skin atrophy, pain at application site, application site reactions, blurred vision.
With prolonged use of corticosteroids over large areas of skin, particularly when occlusive dressings are used, systemic absorption into the general circulation may occur.

The following side effects have been observed with local use of corticosteroids:
dry skin, skin irritation, dermatitis, perioral dermatitis, maceration, miliaria, 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 or pharmacist.
Side effects can be reported directly to the Department of Monitoring of 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 side effects 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 below 25°C.
Usable for 1 month 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 in use. This will 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, propylene glycol stearate, white wax, white petrolatum.

This medicine contains 20 mg of propylene glycol stearate in each gram of ointment, which
corresponds to 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
An aluminium tube containing 30 g of ointment, placed in a cardboard carton.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Bulgaria, the country of export:
Merck Sharp & Dohme Bulgaria EOOD
55 Nikola Vaptzarov blvd. EXPO 2000
1407 Sofia
Bulgaria
Manufacturer:
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 at:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in Bulgaria, the country of export: 9700329
Parallel Import Licence Number: 335/17