Elomoc 1 mg/g cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Elocom 1mg/g cream
Mometasone furoate
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Elocom is and what it is used for
- What you need to know before using Elocom
- How to use Elocom
- Possible side effects
5 Storage of Elocom
- Contents of the pack and other information
1. What Elocom is and what it is used for
Elocom is an anti-inflammatory medicine belonging to a group of medicines called corticosteroids (or steroids) for topical use.
Elocom is indicated for the relief of symptoms such as inflammation and itching caused by certain inflammatory skin disorders, such as psoriasis (except extensive plaque psoriasis), atopic dermatitis, irritant and/or allergic contact dermatitis.
2. What you need to know before using Elocom
Do not use Elocom:
- if you are allergic to mometasone furoate, to other corticosteroids, or to any of the other ingredients of this medicine (listed in section 6).
- if you have other skin conditions, especially:
- rosacea (a skin condition affecting the face)
- acne
- thinning of the skin (atrophy)
- inflammation around the mouth (perioral dermatitis)
- anal or genital itching
- diaper rash.
- if you have a bacterial infection (such as impetigo or pyoderma, a skin condition producing pus), viral (such as herpes simplex, herpes zoster, chickenpox, warts, genital warts, or molluscum contagiosum), parasitic, and/or fungal infections (such as candida or dermatophytes), unless the cause of the infection is also being treated.
- if you have a reaction following vaccination, or if you have tuberculosis or syphilis (a sexually transmitted infection).
- if your skin is injured or has ulcers.
- if you are allergic to peanuts or soy, because it contains hydrogenated soy phosphatidylcholine.
Warnings and precautions
Talk to your doctor or pharmacist before using Elocom.
-
The cream must not be used in the eyes.
-
The cream must not be used in children under 2 years of age.
-
If you develop any allergic reaction to Elocom, you must stop treatment and consult your doctor.
-
If a skin infection develops, your doctor will prescribe appropriate treatment for fungal or bacterial infections. If the infection does not respond to treatment, your doctor will discontinue Elocom treatment until the infection is under control.
-
Adverse effects associated with corticosteroid use, including adrenal gland suppression, may also occur with topical use due to systemic absorption of the active ingredient, especially in children, with treatment over large areas, or prolonged use.
-
The cream must not be applied under occlusive dressings or in skin folds.
-
The cream must not be used for prolonged periods or over large areas of the body.
-
The cream must not be applied to the face for more than 5 days.
-
If you are being treated for psoriasis, strict medical supervision is recommended.
-
Elocom must not come into contact with the eyes, mouth, or open wounds.
-
Contact your doctor if you experience blurred vision or other visual disturbances.
Children
Elocom should be used with caution in children aged 2 years and older. The cream must not be used for longer than 3 weeks. Children are more susceptible to adverse effects due to increased corticosteroid absorption through their skin. Elocom must not be used in children under 2 years of age.
Use of Elocom with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
No interactions with other medicines are known for Elocom.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
The safety of using Elocom in pregnant or breastfeeding women has not been established. Treatment over large areas of the body or prolonged treatment should be avoided.
Like other topical corticosteroids, Elocom should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus or mother.
It is not known whether topical administration of corticosteroids results in sufficient systemic absorption to produce detectable amounts in breast milk. Elocom should be used during breastfeeding only after careful consideration of the risk/benefit ratio. If long-term or high-dose treatment is required, breastfeeding should be discontinued.
Driving and using machines
It is not known that Elocom affects the ability to drive or operate machinery.
3. How to use Elocom
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose is:
Apply a thin layer of cream to cover the affected area once daily.
This medicine is for topical use only.
The cream should be applied gently with massage, covering the affected area. Do not cover or bandage the area unless instructed to do so by your doctor.
Use in children
Elocom must not be used in children under 2 years of age.
If you use more Elocom than you should
If you use Elocom more frequently than prescribed by your doctor, for prolonged periods, or over large areas of the body, it may affect some of your hormones. In children, it may affect growth and development.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number (91) 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Elocom
If you forget to apply Elocom at the scheduled time, do so as soon as possible and then continue with the treatment as before. Do not apply a double amount, nor apply the cream twice on the same day to make up for a missed application.
If you stop the treatment with Elocom
Do not stop the treatment abruptly. As with all highly potent steroids, treatment should be discontinued gradually.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects may occur with certain frequencies, defined as follows:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
Frequency not known (frequency cannot be estimated from the available data)
The following adverse effects have been observed with Elocom:
Very rare adverse effects:
- Inflammation of hair follicles (folliculitis)
- Burning sensation
- Itching
Adverse effects with frequency not known:
- Infections
- Skin inflammation (boil)
- Abnormal skin sensation, such as numbness, tingling, pricking, or burning of the skin (paraesthesia)
- Allergic skin reaction (contact dermatitis)
- Changes in skin colour (hypopigmentation)
- Increased hair growth
- Stretch marks on the skin (striae)
- Acne-like skin reaction (acneiform dermatitis)
- Thinning of the skin (atrophy)
- Small solid skin bumps (papules)
- Pus-filled blisters (pustules)
- Pain and reactions at the application site
- Blurred vision
Rarely, the following adverse effects have been reported with the use of topical corticosteroids: Dryness or cracking of the skin, skin irritation, allergic skin reaction (dermatitis), specific skin inflammation around the upper lip and chin (perioral dermatitis), maceration of the skin, red rash with blisters (miliaria), and skin lesions due to dilation of small blood vessels (telangiectasia).
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if these are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Elocom
Do not store above 25 ºC.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Elocom
-
The active substance is mometasone furoate. Each gram of cream contains 1 mg of mometasone furoate.
-
The other components (excipients) are white petrolatum, white beeswax, hydrogenated soybean phosphatidylcholine, hexylene glycol, titanium dioxide (E-171), aluminium octenylsuccinate starch, purified water, and concentrated phosphoric acid (pH adjustment).
Appearance of the product and contents of the pack
Elocom is a cream ranging in color from white to off-white.
It is available in tubes containing 30 g and 50 g of cream.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Organon Salud, S.L.
Paseo de la Castellana, 77
28046 Madrid
Spain
Tel.: 915911279
Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium
Date of the most recent revision of this summary: 11/2019
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/