Package leaflet: Information for the user

Elocom, 1 mg/g, skin solution
Mometasoni furoas
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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 skin solution contains the active substance mometasoni furoas. Mometasoni furoas is a synthetic corticosteroid which, when applied topically, exerts anti-inflammatory, antipruritic, and vasoconstrictive actions.
Elocom skin solution is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp, 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 bacterial (e.g. impetigo, pyoderma), viral (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 your doctor or pharmacist.
If irritation or allergic reactions occur after applying the medicine, contact your doctor immediately.
If infections occur, your doctor will initiate appropriate antibacterial or antifungal treatment. If there is no rapid positive response to treatment, corticosteroid therapy should be discontinued until the infection resolves.
Due to the increased risk of systemic corticosteroid side effects, avoid using Elocom over large skin areas, under occlusive dressings, for prolonged periods, or on facial skin and skin folds, especially in children. If application to the face is necessary, treatment should not exceed 5 days.
All 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 corticosteroid adverse effects, 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 transdermal absorption of mometasone furoate.
Use the smallest effective dose that controls symptoms, especially in children. Prolonged corticosteroid treatment may impair growth and development in children.
Topically administered Elocom is not intended for ophthalmic use (including the area around the eyelids), due to a very rare risk of developing glaucoma or subcapsular cataract.
Patients with psoriasis should use this medicine with particular caution.
Use of Elocom in psoriasis may lead to relapse due to development of tolerance, generalized pustular psoriasis, or systemic toxic effects associated with 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 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 your 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 might be pregnant, or is planning to become pregnant, she should consult her 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 fetus. However, the medicine should not be applied over large body surface areas or for prolonged periods. Animal studies have shown that corticosteroids may harm the fetus.

Breastfeeding
It is unknown 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 the doctor after carefully weighing the risks of adverse effects in the infant against the benefits of treatment for the mother.
If the doctor determines that prolonged therapy is necessary, breastfeeding should be discontinued.

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

Elocom solution contains propylene glycol (E1520)
Propylene glycol may cause skin irritation.

3. How to use Elocom

This medicine should always be used as directed by a physician. If in doubt, consult a doctor or pharmacist.
This medicine is intended for topical application to the skin.
Usually, several drops of the solution should be applied once daily to the affected areas of the scalp. Gently and thoroughly massage until the solution disappears.
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 periods longer than 3 weeks.
There is insufficient data on the use of this medicine in children under 2 years of age.
The lowest effective dose that controls disease symptoms should be used.
Long-term treatment with corticosteroids may interfere with children's growth and development.

Use of more than the recommended dose of Elocom
There have been no reported cases of overdose.
Prolonged topical use of corticosteroids may suppress the hypothalamic-pituitary-adrenal (HPA) axis and consequently lead to adrenal insufficiency.
In case of overdose, the physician will administer appropriate symptomatic and supportive treatment. Acute symptoms of corticosteroid overdose are usually reversible. In cases of chronic toxicity, the physician will recommend gradual withdrawal of the medicine.
If the medicine is ingested, contact a doctor immediately.

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 (occurring in less than 1 patient in 10,000): 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, reactions at application site, blurred vision.

When the medicine was applied over a large skin surface area for prolonged periods, especially when using occlusive dressings, systemic absorption of the drug occurred.
The following adverse reactions have been observed during local application of corticosteroids:
dry skin, skin irritation, dermatitis, perioral dermatitis, skin maceration, hyperhidrosis, and appearance of dilated small blood vessels (telangiectasia).

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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 4921301, Fax: +48 22 4921309,
Website: https://smz.ezdrowie.gov.pl .
Adverse reactions can also be reported directly to the marketing authorization holder.
Reporting adverse reactions helps to 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.
Do not use containers that are damaged or show signs of having been opened.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the specified month.

6. Contents of the package and other information

What Elocom contains

The active substance is mometasone furoate.
The other ingredients are: isopropyl alcohol, propylene glycol (E1520), hypromellose, disodium dihydrogen phosphate dihydrate, phosphoric acid, purified water. This medicine contains 300 mg of propylene glycol (E1520) in each millilitre of the solution, equivalent to 6 g of propylene glycol per unit (20 ml bottle) or 9 g of propylene glycol per unit (30 ml bottle).

What Elocom looks like and contents of the pack
Elocom is a cutaneous solution.
Packaging
A polyethylene bottle containing 20 ml or 30 ml of solution, placed in a cardboard carton.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Organon Polska Sp. z o.o.
Marszałkowska Street 126/134
00-008 Warsaw
Tel.: + 48 22 306 57 64
[email protected]
Manufacturer
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium