Elocom
Poland
Table of Contents
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language!
Elocom,
1 mg/g, cream
Mometasoni furoas
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 the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Table of contents of the leaflet
- What Elocom is and what it is used for
- Important information before using Elocom
- How to use Elocom
- Possible side effects
- How to store Elocom
- Contents of the pack and other information
1. What Elocom is and what it is used for
Elocom cream contains the active substance mometasoni furoas. Mometasoni furoas is a synthetic corticosteroid with potent activity; when applied topically, it exerts anti-inflammatory, antipruritic, and vasoconstrictive effects.
Elocom cream is indicated for the relief of inflammatory and pruritic manifestations in 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 (e.g. impetigo, pyoderma), viral (e.g. herpes simplex, herpes zoster, 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 or ulcerated skin.
Warnings and precautions
Before starting treatment with Elocom, consult a doctor or pharmacist.
If signs of irritation or allergy occur after applying the medicine, contact a doctor immediately.
If infections occur, the doctor should 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 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 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 Elocom 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 sufficient to control 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 area around the eyelids) due to the very rare risk of developing open-angle glaucoma or subcapsular cataract.
Particular caution is required in patients with psoriasis.
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. Sudden withdrawal may result in intense redness, burning, and stinging pain (so-called "rebound effect"). In such cases, consult a doctor.
Like other corticosteroid-containing medicines, Elocom may alter the appearance of certain skin lesions, potentially making diagnosis more difficult, and may also delay healing.
Consult a doctor even if the above warnings refer to conditions previously experienced.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.
Elocom and other medicines
No data available.
Inform the 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 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 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 has no influence 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 a doctor or pharmacist.
Affected areas of skin are usually treated once daily with a thin layer of cream.
If you feel the medicine's effect 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 periods longer than 3 weeks.
There is insufficient data on the use of Elocom in children under 2 years of age.
The lowest effective dose of the medicine that controls disease symptoms should be used.
Prolonged corticosteroid treatment may impair growth and development in children.
Use of a higher than recommended dose of Elocom
Cases of overdose have not been reported so far.
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 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 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 not everyone will experience them.
The following adverse reactions have been observed during the use of corticosteroids on the skin:
- Very rare (affects less than 1 in 10,000 patients): folliculitis, burning sensation, pruritus.
- Frequency not known (cannot be estimated from 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 is applied over a large skin surface for prolonged periods, especially when occlusive dressings are used, systemic absorption of the drug may occur.
During local application of corticosteroids, the following adverse reactions have been observed:
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 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 allows collection of further information on the safety of the medicine.
5. How to store Elocom
Keep the medicine out of sight and reach of children.
Do not store above 25°C.
Keep the container tightly closed.
Do not use after the expiry date stated on the container. The expiry date refers to the last day of the specified month.
Do not use this medicine after the expiry date printed on the packaging.
Do not use containers that are damaged or show signs of tampering.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.
6. Contents of the packaging and other information
What Elocom contains
- The active substance is mometasone furoate.
- The other ingredients are: hexylene glycol, purified water, concentrated phosphoric acid, hydrogenated soybean phosphatidylcholine, starch aluminum octenylsuccinate, titanium dioxide, white wax, white petrolatum.
What Elocom looks like and contents of the pack
Elocom is a cream.
Packaging of the medicine
An aluminium tube internally coated with epoxy resin, with a polyethylene cap, containing 30 g of cream, placed in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Spain, the country of export:
Organon Salud, S.L.
Paseo de la Castellana, 77
28046 Madrid
Spain
Manufacturer:
Schering-Plough Labo N.V.
Industriepark, 30
B-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
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Spanish marketing authorisation number (country of export): 797894.7
Parallel import licence number: 255/22