Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Elocom
1 mg/g, cream
Mometasone furoate
Please read the entire 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 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 someone else, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist or nurse. 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 cream contains the active substance mometasone furoate. Mometasone furoate is a synthetic corticosteroid with potent activity; when applied topically, it exerts anti-inflammatory, antipruritic (anti-itch), 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 skin or skin covered with ulcers.

Warnings and precautions
Before starting treatment with Elocom, consult a doctor or pharmacist.
If irritation or allergic reactions occur after applying the medicine, contact a doctor immediately.
If infections develop, the doctor will initiate appropriate antibacterial or antifungal treatment. If there is no rapid and 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 skin folds, especially in children. If application to the face is necessary, treatment should not exceed 5 days.
Adverse effects associated 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 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 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 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 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 tolerance development, 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, marked 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, potentially making diagnosis more difficult, and may also delay wound healing.
Consult a doctor, even if the above warnings refer to conditions experienced 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 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 may be used during pregnancy only if, in the doctor's opinion, 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 unknown 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 a doctor after carefully weighing the risk of adverse effects in infants against the benefit of treatment for the mother.
If prolonged therapy is deemed necessary by the doctor, 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 cream.
If the effect of the medicine seems too strong or too weak, consult a doctor.

Use in children
Elocom should be used with caution in children aged 2 years or older, although the safety and efficacy of Elocom have not been studied 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 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 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 adverse reactions

Like any medicine, 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 out of 10,000): folliculitis, burning sensation, itching.
Frequency not known (cannot be estimated based on 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 drug may occur.
The following adverse reactions have been observed with local application of 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 adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions 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 adverse reactions enables better assessment of the medicine's safety profile.

5. How to store Elocom medicine

Keep the medicine out of the sight and reach of children.
Store below 25°C in the original packaging.
Use within 4 weeks after first opening the container.
Do not use the medicine 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 month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the pack and other information

What Elocom contains

The active substance is mometasone furoate. 1 gram of cream contains 1 mg of mometasone furoate.
The other ingredients are: hexylene glycol, purified water, phosphoric acid, hydrogenated soya lecithin, aluminium starch octenylsuccinate, titanium dioxide, white wax, white petrolatum.

What Elocom looks like and contents of the pack
Elocom is a cream.
Pack: Aluminium tube containing 15 g of cream, placed in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, country of export:
ORGANON BIOSCIENCES S.R.L.
Strada Av. Popișteanu, Nr. 54A, Expo Business Park, Clădirea 2
Birou 306 și Birou 307, Etaj 3, Sectorul 1, Bucharest, Romania
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
Marketing authorisation number in Romania, country of export: 11023/2018/01
Parallel import authorisation number: 560/15