Elocom 1 mg/g ointment
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Elocom 1 mg/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 only for you; do not give it to others, even if they have the same symptoms as you, as it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are 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
- How to store 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 use on the skin.
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, other corticosteroids, or 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)
- perianal and genital itching
- diaper rash.
- if you have a bacterial infection (such as impetigo or pyodermitis, 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 disease).
- if the skin is injured or has ulcers.
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Elocom.
- Do not use the ointment in the eyes.
- Do not use the ointment in children under 2 years of age.
- If you experience any allergic reaction to the use of 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 treatment with Elocom until the infection is under control.
- Adverse effects associated with corticosteroid use, including adrenal gland suppression, may also occur with topical application due to systemic absorption of the active ingredient, especially in children, or when used over large areas of skin or for prolonged periods.
- The ointment must not be applied under occlusive dressings or in skin folds.
- The oint combust not be used for prolonged treatments or over large areas of the body.
- The ointment 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 ointment should not be used for more than 3 weeks. Children are more susceptible to adverse effects due to higher corticosteroid absorption through their skin. Elocom must not be used in children under 2 years of age.
Use of Elocom with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
No interactions between Elocom and other medicines are known.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, 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 breast-feeding women has not been established. Treatment over large areas of the body or for prolonged periods 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 application of corticosteroids results in sufficient systemic absorption to produce detectable amounts in breast milk. Elocom should be used during breast-feeding only after careful consideration of the risk/benefit balance. If long-term or high-dose treatment is required, breast-feeding should be discontinued.
Driving and using machines
It is not known that Elocom affects the ability to drive or operate machinery.
Elocom contains propylene glycol stearate
This medicine contains 20 mg of propylene glycol stearate per gram of ointment, equivalent to 0.6 g per unit (30 g tube) or 1 g per unit (50 g tube).
Propylene glycol may cause skin irritation. This medicine contains propylene glycol; do not use on open wounds or large areas of damaged skin (such as burns) without consulting your doctor or pharmacist first.
3. How to use Elocom
Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose is:
Apply a thin layer of ointment covering the affected area once daily.
This medicine is for topical use only.
The ointment should be applied with gentle massage, covering the affected area. Do not cover or bandage the area unless specifically instructed 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 their growth and development.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone (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 ointment twice on the same day in order to make up for a missed dose.
If you stop treatment with Elocom
Do not stop 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 experiences 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 adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 °C. Use within one month after opening.
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 refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Elocom
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The active substance is mometasone furoate. Each gram of ointment contains 1 mg of mometasone furoate.
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The other components (excipients) are hexylene glycol, white beeswax, propylene glycol stearate, white soft paraffin, purified water, and phosphoric acid (for pH adjustment).
Appearance of the medicinal product and contents of the pack
Elocom is a white to off-white ointment.
It is available in tubes containing 30 g and 50 g of ointment.
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 the package leaflet: 05/2020.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/