ELOKOM 1 mg/g OINTMENT

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:
• 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, 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 vaccination, or if you have tuberculosis or syphilis (a 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 ointment should not be used in the eyes.
• The ointment 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 corticoids, 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 ointment should not be applied with occlusive dressings, nor in skin folds.
• The ointment should not be used for prolonged treatments or on large areas of the body.
• The ointment 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 aged 2 years or older. The ointment should not be used for more than 3 weeks. Children are more susceptible to having side effects due to greater absorption of the corticoid by their body. Elocom should not be used in children under 2 years of age.

Using Elocom with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

No interactions of Elocom with other medicines 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 medicine.

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 if 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 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 the instructions for administration of this medicine exactly 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 to the affected area once a day.

This medicine is for topical use.

The ointment should be applied with a gentle massage to the affected area. Do not cover or bandage the area unless your doctor has told you to do so.

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, 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 indicated time, do so as soon as possible and then continue with the treatment as before. Do not apply double the amount, nor apply the ointment twice on the same day to make up for a missed application.

If you stop using Elocom

Do not stop treatment abruptly. As with all highly active 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects can 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 the available data)

The following side effects have been observed with Elocom:

Very rare side effects:

• Follicular inflammation (folliculitis)
• Burning
• Itching

Side effects with frequency not known:

• 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 pigmentation (hypopigmentation)
• Increased hair growth
• Stretch marks on the skin
• Acne-like skin reaction (acneiform dermatitis)
• Skin thinning (atrophy)
• 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 of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) website: https://www.notificaram.es. By reporting side 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 of 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 is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If in doubt, consult your pharmacist about how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Elocom

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

• The other ingredients (excipients) are hexylene glycol, white beeswax, propylene glycol stearate, white petrolatum, purified water, and phosphoric acid (pH adjuster).

Appearance of the 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 Health, 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 last revision of this leaflet:05/2020.

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