ELOKOM 1 mg/g CUTANEOUS SOLUTION

2. What you need to know before starting to use Elocom

Do notuse Elocom:

• if you are allergic to mometasone furoate, other corticosteroids, or any of the other components of this medication (listed in section 6).
• if you have other skin conditions, especially:
• 1. rosacea (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, which is a skin disease that produces pus), viral (such as herpes simplex, herpes zoster, chickenpox, 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 administration of a vaccine, or if you have tuberculosis or syphilis (sexually transmitted disease).
• if the skin is wounded or has ulcers.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Elocom.

• The solution should not be used in the eyes.
• The solution should not be used in children under 2 years of age.
• If an allergic reaction occurs when using Elocom, treatment should be discontinued and the doctor consulted.
• If a skin infection occurs, your doctor will prescribe the appropriate treatment for fungal or bacterial infections. If it does not respond to that treatment, your doctor will discontinue treatment with Elocom until the infection is controlled.
• The side effects described with the use of corticosteroids, including adrenal gland disorders, can also occur with topical use due to the absorption of the active ingredient into the body, especially in children, in treatments on large areas or for prolonged periods.
• The solution should not be applied with occlusive dressings or on skin folds.
• The solution should not be used for prolonged treatments or on large areas of the body.
• The solution should not be applied to the face for more than 5 days.
• If you are being treated for psoriasis, 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. The solution should not be used for more than 3 weeks. Children are more susceptible to having side effects due to greater absorption of the corticosteroid by their body. Elocom should not be used in children under 2 years of age.

Use of Elocom with other medications

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

No interactions of Elocom with other medications are known.

Pregnancy, breastfeeding, and fertility

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

The safety of using Elocom in pregnant or breastfeeding women has not been established. Treatment on large areas of the body or for prolonged periods should be avoided.

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.

It is not known whether topical corticosteroid administration can have 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 high-dose or long-term treatment is indicated, breastfeeding should be discontinued.

Driving and using machines

Elocom is not known to affect the ability to drive and use machines.

Elocom contains propylene glycol

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

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.

3. How to use Elocom

Follow your doctor's or pharmacist's instructions for administering this medication exactly. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

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

This medication is for cutaneous use.

The solution should be applied with a gentle massage, covering the affected area. Do not cover or bandage the area unless your doctor has indicated it.

Use in children

Elocom should 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 your doctor has indicated, 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 Toxicology Information Service, phone (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 indicated time, do so as soon as possible and then continue with the treatment as before. Do not apply double the amount or apply the solution twice on the same day to make up for a missed application.

If you stop treatment with Elocom

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Side effects may occur with 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)

Frequency not known (frequency cannot be estimated from available data)

The following side effects have been observed with Elocom:

Very rare side effects:

• Follicular inflammation (folliculitis)
• Burning
• Itching

Side effects with unknown frequency:

• Infections
• Skin inflammation (furuncle)
• Abnormal skin sensation, such as numbness, tingling, prickling, or burning of the skin (paresthesia)
• Allergic skin reaction (contact dermatitis)
• Changes in skin color (hypopigmentation)
• Increased hair growth
• Skin stretch marks
• Acne-like skin reaction (acneiform dermatitis)
• Skin thinning (atrophy)
• Bumps (papules)
• Pustules
• 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, allergic skin reaction (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 side effects:

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

5. Storage of Elocom

No special storage conditions are required.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Elocom composition

• The active ingredient is mometasone furoate. Each gram of cutaneous solution contains 1 mg of mometasone furoate.

• The other components (excipients) are isopropyl alcohol, hydroxypropyl cellulose (E-463), sodium phosphate monobasic, propylene glycol (E-1520), purified water, and phosphoric acid (pH adjustment).

Product appearance and package contents

Elocom 1 mg/g cutaneous solution is a white to colorless solution.

It is available in 60 ml bottles of cutaneous solution.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Organon Health, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Phone: 915911279

Manufacturer:

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

Date of last revision of this leaflet:05/2020.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/