Leaflet:information for the user

Elocom1mg/gcream

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 should not give it to others even if they have the same symptomsas 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 it is used for

2.What you need to know beforestarting touse Elocom

3.How to use Elocom

4.Possible side effects

5.Storage of Elocom

6. Contents of the pack and additional information

Elocomis an anti-inflammatory, which belongs to the group of medications known as corticosteroids (or steroids), for administration on the skin.

Elocom is indicated for the relief of manifestations such as inflammation and itching, caused by certain inflammatory skin disorders, including psoriasis (except extensive plaque psoriasis), atopic dermatitis, irritant dermatitis, and/or contact allergies.

No use Elocom:

• if you are allergic to furoate mometasone, other corticosteroids, or any of the other components of this medication (including those 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. perianal and genital itching
  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 cream on the eyes.
• Do not use the cream in children under 2 years.
• If an allergic reaction occurs when 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 this treatment does not respond, 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 cream with occlusive dressings, or in skin folds.
• Do not use the cream in prolonged or large-area treatments.
• Do not apply the cream 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 cream for more than 3 weeks. Children are more susceptible to adverse effects due to a higher absorption of the corticosteroid by their body.

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 if you 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 of large areas of the body or prolonged treatments.

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 have sufficient systemic absorption to 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 stearate

This medication contains 20 mg of propylene glycol stearate per gram of cream equivalent to 0.6 g per unit (30 g tube) or 1 g per unit (50 g tube).

Propylene glycol can 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 thin layer of ointment covering the affected area once a day.

This medication is for topical use.

The ointment 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.

If you use more Elocom than you should

If you use Elocom more frequently than your doctor has instructed, 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 forget to use Elocom

If you forget 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 ointment 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 very 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 (furuncle)
• 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 (skin thinning)
• Pustules (pimples with pus)
• Dermatitis in the application area
• 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 skin rash 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 pharmacistor 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.

Do not store at a temperature above 25°C. Use within one month after opening.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Elocom

• Theactive ingredient isfuroate of mometasone. Each gram of ointment contains 1mg of furoate of mometasone.

• The other components (excipients) arehexylene glycol, white beeswax, propylene glycol stearate, white vaseline, purified water, and phosphoric acid (pH adjustment).

Appearance of the product and contents of the packaging

Elocom is a whiteto off-whiteointment.

It is presented in tubes with 30 g and 50 g of ointment.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Organon Health, 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/