Leaflet:information for the user

Elocom 1mg/g solutioncutaneous

Furoate of mometasone

Read this 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 yourdoctororpharmacist.

-This medicine has been prescribedonlyfor you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section4.

1.What is Elocom and what is it used for

2.What you need to know before using Elocom

3.How to use Elocom

4.Possible side effects

5.Storage of Elocom

6.Contents of the pack and additional information

Elocom isa nonsteroidal anti-inflammatory drug, belonging to the group of medications known as corticosteroids (or steroids), for topical administration.

Elocom is indicated for the relief of manifestations such as inflammation and itching, caused by certain inflammatory disorders of the scalp, such as psoriasis.

Do not use Elocom:

• if you are allergic to furoate mometasone, other corticosteroids, or any of the other components of this medication (listed in section 6).
• if you have other skin conditions, especially:
• 1. rosacea (a skin disease that affects the face)
  2. acne
  3. skin thinning (atrophy)
  4. inflammation around the mouth (perioral dermatitis)
  5. itching in the perianal and genital areas
  6. diaper rash.
• if you have a bacterial infection (such as impetigo or pyoderma, a skin disease that produces pus), viral (such as herpes simplex, herpes zoster, varicella, warts, condyloma acuminatum, and molluscum contagiosum), parasitic, and/or fungal (such as candida or dermatophytes), unless the causes of the infection are also being treated.
• if you have a reaction after receiving a vaccine, or if you have tuberculosis or syphilis (a sexually transmitted disease).
• if the skin is injured or has ulcers.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Elocom.

• Do not use the solution in the eyes.
• Do not use the solution in children under 2 years old.
• If an allergic reaction occurs while using Elocom, discontinue treatment and consult your doctor.
• If a skin infection occurs, your doctor will prescribe the appropriate treatment for fungal or bacterial infections.If you do not respond to that treatment, your doctor will discontinue Elocom treatment until the infection is controlled.
• The adverse effects described with the use of corticosteroids, including adrenal gland alteration, can also occur with topical use of the active ingredient, especially in children, in treatments of large areas or prolonged duration.
• Do not apply the solution with occlusive dressings, or in skin folds.
• Do not use the solution in prolonged or extensive body treatments.
• Do not apply the solution to the face for more than 5 days.
• If you are being treated for psoriasis, a strict medical supervision is recommended.
• Elocom should 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 2 years of age or older.Do not use the solution for more than 3 weeks.Children are more susceptible to adverse effects due to a higher absorption of the corticosteroid by their body.Elocom should not be used for children under 2 years old.

Use of Elocom with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

No interactions of Elocom with other medications are known.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The safety of Elocom use in pregnant women or during lactation has not been established.Avoid treatment in extensive body areas or prolonged duration.

Like other topical corticosteroids, Elocom should be used in pregnant women only if the potential benefit justifies the potential risk to the fetus or mother.

No information is available on whether topical administration of corticosteroids can produce detectable amounts in breast milk.Elocom should be used during lactation only after careful consideration of the risk-benefit ratio.If high doses or long-term treatment is indicated, breastfeeding should be discontinued.

Driving and operating machinery

No information is available on whether Elocom affects the ability to drive and operate machinery.

Elocom contains propylene glycol

This medication contains 300 mg of propylene glycol (E-1520) in each milliliter of solution equivalent to 18 g per unit (bottle of 60 ml).

Propylene glycol may cause skin irritation.This medication 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.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Apply a few drops of topical solution to the affected area once a day.

This medication is for topical 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 should not be used in children under 2 years old.

If you use more Elocom than you should

If you use Elocom more frequently than prescribed by your doctor, for a prolonged period, or on large areas of the body, it may affect some of your hormones. In children, it may affect their growth and development. for a prolonged period or on 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service at (91) 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Elocom

If you forgot to apply Elocom at the scheduled time, do it as soon as possible and continue with the treatment as before. Do not apply double the amount, nor apply the solution twice on the same day to compensate for the missed application.

If you interrupt the treatment with Elocom

Do not stop treatment abruptly. Like all highly active steroids, treatment should be discontinued gradually.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Side effects may occur at certain frequencies, which are defined below:

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)

Unknown frequency (the frequency cannot be estimated from available data)

The following side effects have been observed with Elocom:

Very rare side effects:

• Folliculitis (inflammation of hair follicles)
• Burning sensation
• Itching

Side effects of unknown frequency:

• Infections
• Skin inflammation (carbuncle)
• Abnormal skin sensation, such as numbness, tingling, prickling, or burning in the skin (paresthesia)
• Contact dermatitis (skin allergic reaction)
• Changes in skin color (hypopigmentation)
• Excessive hair growth
• Striae in the skin
• Dermatitis acneiformis (skin reaction similar to acne)
• Atrophy of the skin
• Pustules (boils)
• Blistering with pus
• Pain and reactions at the application site
• Blurred vision

Rarely, the following side effects have been reported with the use of topical corticosteroids:Dryness or cracking of the skin, skin irritation, contact dermatitis, specific skin inflammation around the upper lip and chin (perioral dermatitis), skin maceration, red rash on the skin with blisters (miliaria), and skin lesions due to dilation of small blood vessels (telangiectasia).

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

No requires special conditions for conservation.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe packagingafter CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Elocom

• The active ingredient isfuroate of mometasone. Each gram of topical solution contains 1mg of furoate of mometasone.

• The other components (excipients) areisopropyl alcohol, hydroxypropylcellulose (E‑463), sodium monobasic phosphate, propylene glycol (E-1520), purified water, and phosphoric acid (pH adjustment).

Appearance of the product and content of the container

Elocom 1 mg/g topical solution is a solution ofwhite to colorless.

It is presented in 60 ml bottles of topical solution.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Responsible for manufacturing:

Organon Heist bv

Industriepark30

2220Heist-op-den-Berg

Belgium

Last review date of thisleaflet:05/2020.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/