Elocom 1 mg/g cutaneous solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Elocom 1 mg/g cutaneous solution
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, ask 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of this leaflet
- What Elocom is and what it is used for
- What you need to know before using Elocom
- How to use Elocom
- Possible adverse 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 disorders of the scalp, such as psoriasis.
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 your skin is injured or has ulcers.
Warnings and precautions
Talk to your doctor or pharmacist before using Elocom.
- The solution must not be used in the eyes.
- The solution must not be used in children under 2 years of age.
- If you experience any allergic reaction while using Elocom, 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 until the infection is under control.
- Adverse effects associated with corticosteroids, including adrenal gland suppression, may also occur with topical use due to systemic absorption of the active ingredient, especially in children, or when used over large areas of skin or for prolonged periods.
- Do not apply the solution under occlusive dressings or in skin folds.
- The solution must not be used for prolonged treatments or over large areas of the body.
- The solution 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 solution must not be used for longer 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
Tell 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, 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 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 administration of corticosteroids results in sufficient systemic absorption to produce detectable levels 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
Elocom is not known to affect the ability to drive or operate machinery.
Elocom contains propylene glycol
This medicine contains 300 mg of propylene glycol (E-1520) in each milliliter of solution, equivalent to 18 g per unit (60 ml bottle).
Propylene glycol may cause skin irritation. This medicine contains propylene glycol; do not use on open wounds or large damaged skin areas (such as burns) without first consulting your doctor or pharmacist.
3. How to use Elocom
Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose is:
Apply a few drops of the cutaneous solution to the affected area once daily.
This medicine is for cutaneous use only.
The solution should be applied with a gentle massage, covering the affected area. Do not cover or bandage the area unless 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 the treatment as before. Do not apply a double amount, nor apply the solution twice on the same day to make up for a missed dose.
If you stop using Elocom
Do not stop treatment abruptly. As with all highly active corticosteroids, 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 at 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
- 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), skin maceration, 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 or 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
No special storage conditions are required.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Period of validity after first opening: 3 months.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. If you are in any doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the container and other information
Composition of Elocom
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The active substance is mometasone furoate. Each gram of cutaneous solution contains 1 mg of mometasone furoate.
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The other components (excipients) are isopropyl alcohol, hydroxypropylcellulose (E-463), monobasic sodium phosphate, propylene glycol (E-1520), purified water, and phosphoric acid (pH adjustment).
Appearance of the product and contents of the container
Elocom 1 mg/g cutaneous solution is a solution ranging from whitish to colourless.
It is presented in 60 ml containers of cutaneous solution made of low-density polyethylene, with a low-density polyethylene dropper and a high-density polyethylene cap.
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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/