Elocom

Patient Information Leaflet

Warning!
Keep this leaflet. The information on the immediate packaging is in a foreign language.
Elocom (Elocon)
1 mg/g (0.1%), cutaneous solution
Mometasone furoate
Elocom and Elocon are different trade names for the same medicinal product.
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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, 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 pack and other information

1. What Elocom is and what it is used for

Elocom cutaneous solution contains the active substance mometasone furoate. Mometasone furoate is a synthetic corticosteroid which, when applied topically, exerts anti-inflammatory, antipruritic, and vasoconstrictive effects.
Elocom cutaneous solution is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses involving 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 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 perianal or genital itching,
• in diaper dermatitis,
• on damaged skin or skin with ulcers.

Warnings and precautions
Before using Elocom, discuss it with your doctor or pharmacist.
If irritation or allergic reactions 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 skin, 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.
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 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 sufficient to control disease symptoms, especially in children. Prolonged corticosteroid treatment may interfere with growth and development in children.
Topically applied Elocom is not intended for ophthalmic use (including the eyelid area) due to a 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 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 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 a doctor.

Elocom and other medicines
No data available.
Inform your doctor or pharmacist about all medicines currently or recently taken, 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 plans 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 doctor's opinion, 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 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.

Elocom solution contains propylene glycol (E 1520)
Due to the presence of propylene glycol, the medicine may cause skin irritation.

3. How to use Elocom

This medicine should always be used exactly as your doctor has instructed. If in doubt, consult your doctor or pharmacist.
This medicine is for topical use on the skin.
Usually, apply once daily a few drops of the solution to the affected areas of the scalp. Gently and thoroughly massage until the solution disappears.
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 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.
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 with this medicine.
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 doctor will administer appropriate symptomatic and supportive treatment. Acute symptoms of corticosteroid overdose are usually reversible. In cases of chronic intoxication, the doctor will recommend gradual withdrawal of the medicine.
If the medicine is accidentally ingested, seek immediate medical advice.

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 everybody will experience them.
The following adverse reactions have been observed during the use of corticosteroids applied to the skin:

• Very rare (occur in less than 1 patient out of 10,000): folliculitis, burning sensation, pruritus.
• Frequency not known (frequency cannot be estimated from the available data): infections, furuncle, paresthesia, contact dermatitis, hypopigmentation, hypertrichosis, striae, acneiform eruptions, skin atrophy, pain at application site, application site reactions, blurred vision.

When the medicine was used over a large area of skin for prolonged periods, especially when occlusive dressings were used, 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, 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, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions enables continued monitoring of the safety of the medicine.

5. How to store Elocom

Keep the medicine out of the sight and reach of children.
Do not store above 25°C. Do not freeze. Store in the original packaging.
Do not use containers that are damaged or show 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 stated month.
Medicines must 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 package and other information

What Elocom contains

• The active substance is mometasone furoate. Each gram of solution contains 1 mg (0.1%) of mometasone furoate.
• The other ingredients are: isopropyl alcohol, propylene glycol (E 1520), hypromellose, disodium dihydrogen phosphate dihydrate, diluted phosphoric acid, purified water.
  This medicine contains 300 mg of propylene glycol (E1520) in each millilitre of liquid, corresponding to 6 g of propylene glycol per unit (20 ml bottle).

What Elocom looks like and contents of the pack

Elocom is a solution for the skin.
Packaging:
A polyethylene bottle containing 20 ml of solution, placed in a cardboard box.

For further information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Austria, country of export:
Organon Healthcare GmbH
Pestalozzistr. 31
80469 Munich, Germany

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
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Austrian marketing authorisation number (country of export): 1-19790
Parallel import authorisation number: 360/24