Elocom

Patient Information Leaflet

Warning! Keep this leaflet – the packaging label is in a foreign language!
Elocom
1 mg/g, ointment
Mometasone furoate
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with 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, pharmacist, or nurse. 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 package 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 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, herpes zoster and 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, discuss it with your doctor or pharmacist.
If signs of irritation or allergy occur after applying the medicine, contact your doctor immediately.
If infections develop, your 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 in skin folds, especially in children. If application to the face is necessary, treatment should not exceed 5 days.
Adverse effects associated 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 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 apply the medicine to 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 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.
Like other corticosteroid-containing medicines, Elocom may alter the appearance of certain skin lesions, which may make it difficult for the doctor to establish a correct diagnosis. It 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 with other medicines
No data available.
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.

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 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 an extent that allows them 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 has no effect on 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 your
doctor or pharmacist.
Affected skin areas are usually treated once daily with a thin layer of the ointment.
The ointment is recommended for the treatment of dry, scaly, and cracked lesions.
If you feel the effect of the medicine 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 safety and efficacy have not been established for use longer than 3 weeks.
There is insufficient data on the use of Elocom in children under 2 years of age.
The lowest effective dose that controls symptoms should be used.
Prolonged corticosteroid treatment may impair growth and development in children.

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 apply appropriate symptomatic and supportive treatment.
Acute corticosteroid overdose symptoms are usually reversible. In cases of chronic intoxication, the physician will recommend gradual withdrawal 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 all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
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, pruritus.
• Frequency not known (cannot be estimated from the available data): infections, abscess, paresthesia, contact dermatitis, hypopigmentation, hypertrichosis, striae, acneiform eruptions, skin atrophy, pain at application site, application site reactions, blurred vision.

When the medicine is applied over a large skin surface area for prolonged periods, especially 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, hyperhidrosis, and 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 also be reported directly to the Department of 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 adverse reactions helps provide more information on the safety of this medicine.

5. How to store Elocom

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Keep the container tightly closed.
Do not use if the packaging is damaged or shows signs of tampering.
Do not use this medicine after the expiry date stated on the container. 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 required. This will help protect the environment.

6. Contents of the packaging 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, concentrated phosphoric acid, propylene glycol monostearate, white wax, and white petrolatum. This medicine contains 20 mg of propylene glycol monostearate in each gram of ointment, which corresponds to 600 mg of propylene glycol monostearate per unit (30 g tube).

What Elocom looks like and contents of the pack
Elocom is an ointment.
Packaging of the medicine
An aluminum tube containing 30 g of ointment, placed in a cardboard box.
For further information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Spain, the country of export:
Organon Salud, S.L.
Paseo de la Castellana, 77
28046 Madrid
Spain
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 Spain, the country of export: 797977.7
Parallel import licence number: 45/25