Elocom

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Elocom (Elocom)
1 mg/g (0.1%) ointment
Mometasoni furoas
Elocom and Elocom are the same brand names of the same medicine written in Polish and Bulgarian.
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 pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions 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 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 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 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 itching,
• in diaper dermatitis,
• on damaged skin or skin covered with ulcers.

Warnings and precautions
Before starting to use Elocom, discuss this with your doctor or pharmacist.
If symptoms 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 therapy should be discontinued until the infection has resolved.
Due to the increased risk of systemic side effects from 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.
Any adverse effects reported after 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 a greater likelihood of systemic adverse effects from 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 percutaneous 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 cataracts.
Patients with psoriasis should use this medicine with particular caution.
Use of the medicine in psoriasis may lead to disease recurrence 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, and may also delay healing.
Consult your doctor, even if the above warnings relate 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 might be pregnant, or is planning to have a child, 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 that allows them to pass into breast milk.
Use of Elocom in breastfeeding women is possible only if decided by a doctor after careful consideration of the risk of adverse effects in infants versus the benefit of treatment for the mother.
If the doctor determines that long-term therapy is 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 exactly as directed by the physician. In case of doubt, consult
your 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 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 or older, although the safety and efficacy of Elocom have not been established for treatment periods longer than 3 weeks.
There are insufficient data on the use of this medicine in children under 2 years of age.
The smallest 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.
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 medicinal product may cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been observed during the use of corticosteroids applied to the skin:

• Very rare (occurring in less than 1 patient out of 10,000): folliculitis, burning sensation, itching.
• Frequency unknown (cannot be estimated from the available data): infections, abscess, paresthesia, contact dermatitis, hypopigmentation, hypertrichosis, striae, acneiform changes, skin atrophy, pain at application site, application site reactions, blurred vision.

When the medicinal product is applied over a large area of skin for prolonged periods, and particularly when occlusive dressings are used, systemic absorption of the active substance may occur.
The following adverse reactions have been observed with topical corticosteroids:
dry skin, skin irritation, dermatitis, perioral dermatitis, maceration, hyperhidrosis, 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 a 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 181 C; 02-222 Warsaw, phone: (+48 22) 49 21 301, fax: (+48 22) 49 21 309, website: http://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder or parallel importer.
Reporting adverse reactions enables further information on the safety of this medicinal product to be collected.

5. How to store Elocom

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Keep the product for up to 4 weeks 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 carton. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly 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 (E 477), white wax, and white soft paraffin. This medicine contains 20 mg of propylene glycol stearate (E 477) in each gram of ointment, equivalent to 300 mg of propylene glycol stearate per unit (15 g tube) or 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 15 g or 30 g of ointment, placed in a cardboard box.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Bulgaria, country of export:
N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands
Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium
Parallel importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Poland
Repackaged in:
CEFEA Sp. z o.o. Sp. k.
ul. Forteczna 35-37
87-100 Toruń
Synoptis Industrial Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Shiraz Productions Sp. z o.o.
ul. Działkowa 56
02-234 Warsaw
Marketing Authorisation number in Bulgaria, country of export: 9700329
Parallel import authorisation number: 100/25