Elocom

Patient Information Leaflet

Warning! Keep this leaflet – the packaging information is 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 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 share it with others. This medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Elocom is and what it is used for
2. Important information before using Elocom
3. How to use Elocom
4. Possible side effects
5. How to store Elocom
6. 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 skin diseases, 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, 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 covered with ulcers.

Warnings and precautions
Before starting to use Elocom, discuss it with your doctor or pharmacist.
If signs of irritation or allergy 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 and positive response to treatment, corticosteroid use should be discontinued until the infection has resolved.
Due to the increased risk of systemic side 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 with systemic corticosteroids, 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 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 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 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 (so-called "rebound effect") may occur. In such cases, contact your doctor.
Elocom, like other corticosteroid-containing medicines, may alter the appearance of certain skin lesions, making it difficult for the doctor to establish a correct diagnosis, 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 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 may be pregnant, or is planning to have a baby, 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 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 applied corticosteroids are absorbed through the skin to an extent sufficient to pass into the breast milk of nursing mothers.
Use of Elocom in breastfeeding women is possible only if decided by a doctor after carefully weighing the risk of adverse effects in the infant 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 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 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 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.
Long-term 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 doctor will administer appropriate symptomatic and supportive treatment. Acute corticosteroid overdose symptoms are usually reversible. In cases of chronic toxicity, the doctor 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects have been observed during the use of corticosteroids on the skin:

• Very rare (affects less than 1 patient in 10,000): folliculitis, burning sensation, itching.
• Frequency not known (cannot be estimated from available data): infections, furuncle, paresthesia, contact dermatitis, hypopigmentation, hypertrichosis, striae, acne-like changes, skin atrophy, pain at application site, application site reactions, blurred vision.

When applied over a large area of skin for prolonged periods, especially when using occlusive dressings (sealed coverings), absorption of the drug into the systemic circulation has occurred.
During local application of corticosteroids, the following adverse effects have been observed:
dry skin, skin irritation, dermatitis, perioral dermatitis, maceration of the skin, sweating, and appearance of dilated small blood vessels (telangiectasia).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects allows further information on the safety of the medicine to be collected.

5. How to store Elocom

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 carton. 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 helps protect the environment.

6. Contents of the package and other information

What Elocom contains

• The active substance is 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, corresponding to 300 mg of propylene glycol stearate per unit (15 g tube).

What Elocom looks like and contents of the pack
Elocom is an ointment.
Pack:
An aluminium tube containing 15 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 Romania, the country of export:
ORGANON BIOSCIENCES S.R.L.
Strada Av. Popişteanu, Nr. 54A, Expo Business Park, Clădirea 2
Birou 306 şi Birou 307, Etaj 3, Sectorul 1
Bucharest
Romania
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 Romania, the country of export: 11024/2018/01
Parallel Import Licence Number: 240/19