ELOKOM 1 mg/g CREAM

2. What you need to know before you start using Elocom

Do notuse 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 condition 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 had a reaction after vaccination, or if you have tuberculosis or syphilis (a sexually transmitted disease).
• if the skin is wounded or has ulcers.
• if you are allergic to peanuts or soy because it contains hydrogenated soy phosphatidylcholine.

Warnings and precautions

Talk to your doctor or pharmacist before you start using Elocom.

• The cream should not be used in the eyes.
• The cream should not be used in children under 2 years of age.
• If an allergic reaction occurs when using Elocom, treatment should be discontinued and your 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, with extensive or prolonged treatments.

• The cream should not be applied with occlusive dressings or on skin folds.
• The cream should not be used for prolonged periods or on large areas of the body.
• The cream 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 cream should not be used for more than 3 weeks. Children are more susceptible to having side effects due to increased absorption of the corticosteroid 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 with other medicines are known for Elocom.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

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

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

It is not known whether topical corticosteroids can be absorbed in sufficient amounts to produce detectable quantities 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 or use machines.

3. How to use Elocom

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is:

Apply a thin layer of cream to the affected area once a day.

This medicine is for topical use.

The cream 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.

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 told you, for a longer 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, stating the medicine and the amount taken.

If you forget to use Elocom

If you forget to apply Elocom at the right time, do so as soon as you remember and then continue with your treatment as before. Do not apply double the amount, or apply the cream twice on the same day to make up for a forgotten application.

If you stop using Elocom

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

If you have any further questions on 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:

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

Side effects with frequency not known:

• Infections
• Skin inflammation (furuncle)
• Abnormal skin sensation, such as numbness, tingling, pricking, or burning of the skin (paresthesia)
• Allergic skin reaction (contact dermatitis)
• Changes in skin color (hypopigmentation)
• Increased hair growth
• Stretch marks on the skin
• Acne-like skin reaction (acneiform dermatitis)
• Skin thinning (atrophy)
• Papules (small bumps on the skin)
• Pustules (small bumps on the skin filled 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, allergic skin reaction (dermatitis), inflammation of the skin 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, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: 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.

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 is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 cream contains 1 mg of mometasone furoate.

• The other ingredients (excipients) are white petrolatum, white beeswax, hydrogenated soy phosphatidylcholine, hexylene glycol, titanium dioxide (E-171), aluminum starch octenylsuccinate, purified water, and concentrated phosphoric acid (pH adjustment).

Appearance of the product and pack contents

Elocom is a white to off-white cream.

It is available in tubes containing 30 g and 50 g of cream.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 last revision of this leaflet:11/2019

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/