Elocom

Package Leaflet: Information for the User

Elocom, 1 mg/g, Ointment

Mometasone Furoate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Elocom and what is it 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 is Elocom and what is it used for

Elocom ointment contains the active substance mometasone furoate. Mometasone furoate is a synthetic corticosteroid with strong effects; when used locally, it has anti-inflammatory, anti-itching, and vasoconstrictive effects. Elocom ointment is indicated for the relief of inflammatory and itching symptoms in corticosteroid-responsive skin diseases, such as psoriasis and atopic dermatitis.

2. Important information before using Elocom

When not to use Elocom:

• in acne vulgaris,
• in rosacea,
• in skin atrophy,
• in perioral dermatitis,
• in bacterial infections (e.g., impetigo, pyoderma), viral infections (e.g., herpes simplex, chickenpox, and shingles, common warts, plantar warts, molluscum contagiosum), parasitic and fungal skin infections (e.g., caused by dermatophytes or yeasts),
• in post-vaccination reactions,
• in skin tuberculosis,
• on syphilitic skin lesions,
• in anal and genital itching,
• in diaper dermatitis,
• on damaged and ulcerated skin.

Warnings and precautions

Before starting to use Elocom, discuss it with your doctor or pharmacist. If you experience any irritation or allergic symptoms after using the medicine, contact your doctor immediately. In case of infections, the doctor will prescribe appropriate antibacterial or antifungal treatment. If there is no rapid and positive response to treatment, corticosteroid use should be discontinued until the infection is controlled. Due to the increased risk of systemic side effects of corticosteroids, Elocom should be avoided on large areas of the body, under dressings, for prolonged periods, and on the face and skin folds, as well as in children. If it is necessary to apply the medicine to the face, treatment should not last more than 5 days. As with other potent topical corticosteroids, sudden discontinuation of treatment may lead to severe redness, burning, and stinging (so-called "rebound effect"). In such cases, contact your doctor. Elocom, like other medicines containing corticosteroids, may change the appearance of some skin lesions, making it difficult for the doctor to diagnose, and may also delay healing. You should consult your doctor, even if the above warnings refer to situations that have occurred in the past. If you experience blurred vision or other vision disturbances, contact your doctor.

Elocom and other medicines

No data available. Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

The safety of Elocom during pregnancy has not been established. During pregnancy, Elocom should only be used if the doctor considers that the benefits to the mother outweigh the potential risks to the mother and fetus. However, the medicine should not be used on 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 into the bloodstream in amounts sufficient to pass into breast milk. The use of Elocom by breastfeeding women is only possible if the doctor decides, after careful consideration of the risk of side effects in children, that the benefits of treatment for the mother outweigh the risks. If the doctor considers long-term therapy necessary, breastfeeding should be discontinued.

Driving and using machines

Elocom does not affect the ability to drive or use machines.

3. How to use Elocom

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Affected areas of the skin are usually smeared with a thin layer of ointment once a day. The use of ointment is recommended for the treatment of dry, scaly, and cracked skin lesions. If you feel that the effect of the medicine is too strong or too weak, contact your doctor.

Use in children

Elocom should be used with caution in children over 2 years of age, although the safety and efficacy of Elocom have not been investigated for periods longer than 3 weeks. There are insufficient data on the use of the medicine in children under 2 years of age. The smallest effective dose of the medicine should be used, allowing for the relief of symptoms. Long-term treatment with corticosteroids may affect the growth and development of children.

Using more than the recommended dose of Elocom

No cases of overdose have been reported. Prolonged local use of corticosteroids may lead to suppression of the hypothalamic-pituitary-adrenal axis and subsequent adrenal insufficiency. In case of overdose, the doctor will provide appropriate symptomatic and supportive treatment. Acute symptoms of corticosteroid overdose are usually reversible. In the case of chronic poisoning, the doctor will recommend gradual withdrawal of the medicine.

Missing a dose of Elocom

Do not use a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, Elocom can cause side effects, although not everybody gets them. The following side effects have been observed during the use of topical corticosteroids:

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

After using the medicine on large areas of the skin for a long time, especially under occlusive dressings, systemic absorption of the medicine has been observed. The following side effects have been observed during the local use of corticosteroids: dry skin, skin irritation, dermatitis, perioral dermatitis, skin maceration, folliculitis, and telangiectasia.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help 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. Store below 25°C. Shelf life after first opening: 4 weeks. Do not use damaged or opened packages. Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month stated.

6. Contents of the pack 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 (E477), white wax, white petrolatum. This medicine contains 20 mg of propylene glycol stearate (E477) per gram of ointment, which corresponds 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. The pack contains an aluminum tube with 15 g or 30 g of ointment, placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Organon Polska Sp. z o.o.
ul. Marszałkowska 126/134
00-008 Warsaw
Tel.: +48 22 105 50 01
[email protected]

Manufacturer

Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

Date of last revision of the leaflet: 11/2022