Elosone

Patient Information Leaflet

Elosone, 1 mg/g, ointment
(Mometasone furoate)
Please read all of this leaflet carefully before 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Elosone ointment is and what it is used for
2. Important information before using Elosone ointment
3. How to use Elosone ointment
4. Possible side effects
5. How to store Elosone ointment
6. Contents of the pack and other information

1. What Elosone ointment is and what it is used for

Elosone ointment contains the active substance mometasone furoate, a synthetic glucocorticosteroid with potent activity. When applied topically, it exerts anti-inflammatory, antipruritic, and vasoconstrictive effects.
Indications
Elosone ointment is indicated for the short-term topical treatment of inflammatory skin diseases associated with itching that respond to glucocorticosteroid therapy, such as psoriasis and atopic dermatitis.

2. Important information before using Elosone cream

When not to use Elosone cream

• if the patient is allergic to mometasone furoate, other medicines in the corticosteroid group, or any of the other ingredients of this medicine (listed in section 6);

• in children under 2 years of age;

• in acne vulgaris and rosacea;

• in atrophic skin lesions;

• in perioral dermatitis;

• in cases of itching (pruritus) around the anus or genital area;

• in diaper dermatitis (redness and rash localized in the area covered by a diaper);

• in bacterial infections (e.g. impetigo, pyoderma), viral infections (e.g. herpes simplex, cutaneous warts, genital warts – warts localized around the anus and genital organs, molluscum contagiosum – a disease characterized by skin lesions appearing as firm, waxy-white nodules), and parasitic or fungal infections
  (e.g. those caused by fungi known as yeasts or dermatophytes);

• in varicella-zoster virus infection (chickenpox or shingles);

• in tuberculosis;

• in syphilis;

• if the patient has experienced a post-vaccination reaction (an adverse reaction occurring after vaccination, manifested for example by rash or skin redness);

• on wounds or ulcerated skin.

Warnings and precautions
Before starting treatment with Elosone cream, consult a doctor or pharmacist.
If skin irritation or allergic reaction occurs during treatment with Elosone cream, discontinue use and contact a doctor.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.
If the patient notices changes in the appearance of the skin treated with Elosone cream, inform the doctor immediately. These may be signs of bacterial or fungal infection. If an infection is present, the doctor will initiate appropriate treatment. If no positive response to treatment occurs within a short time, the doctor may decide to discontinue use of Elosone cream.
Although Elosone cream is applied topically, mometasone furoate may be absorbed into the body, potentially leading to hormonal disturbances, such as reversible suppression of the hypothalamic-pituitary-adrenal (HPA) axis (the system regulating adrenal hormone secretion, including glucocorticoids) after treatment ends, or Cushing's syndrome (a constellation of symptoms including obesity, "moon face", facial redness, striae, weakness, reduced immunity, increased blood pressure, associated with elevated blood levels of glucocorticoids), increased blood glucose levels, or glucosuria.
When Elosone cream is used over large areas of skin or under occlusive dressings, the doctor will periodically monitor the patient's condition.
Patients treated with Elosone cream over large areas of damaged skin, skin folds, or under occlusive dressings (e.g. plastic film) have an increased risk of adverse effects. Elosone cream should not be used under occlusive dressings on the face or in children.
If application to the face is necessary, treatment should not last longer than 5 days.
Prolonged use of Elosone cream should be avoided in all patients, regardless of age.
Abrupt discontinuation of Elosone cream should be avoided. After long-term therapy with Elosone cream, a "rebound" effect may occur, characterized by inflammatory skin reactions with intense redness, burning, and stinging pain. To avoid this, consult a doctor, who may decide to gradually reduce the dose or frequency of application until treatment is completed.
Elosone cream should be used with particular caution in patients with psoriasis, as it may cause recurrence or worsening of symptoms (e.g. generalized pustular psoriasis) or other adverse effects. When used in psoriasis, the patient's condition should be closely monitored by a doctor.
Elosone cream may alter the appearance of certain skin lesions, which could make it difficult for the doctor to establish an accurate diagnosis. The medicine may also delay wound healing.
Elosone cream must not be applied to the eyes or eyelids.
Care should be taken to avoid contact with the eyes during application.

Children and adolescents
Elosone cream must not be used in children under 2 years of age due to insufficient data on safety and efficacy in this age group.
If treatment is necessary in children over 2 years of age, particular caution should be exercised and the doctor's instructions strictly followed.
Children have an increased risk of systemic adverse effects, including disturbances in hormonal regulation (see section 4).

Elosone cream and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
There are no data available on interactions with other medicines.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Elosone cream may be used during pregnancy only if the doctor decides it is absolutely necessary. The medicine should not be applied over large body surface areas or for prolonged periods.

Breastfeeding
Elosone cream must not be used during breastfeeding unless the doctor considers it absolutely necessary. If treatment requires higher doses or prolonged use, breastfeeding should be discontinued.

Fertility
There are no data available on the effect on fertility.

Driving and operating machinery
There are no available data on the effect of Elosone cream on the ability to drive or operate machinery.

Elosone cream contains cetostearyl alcohol
The medicine may cause local skin reactions (e.g. contact dermatitis).

Elosone cream contains propylene glycol
The medicine contains 100 mg of propylene glycol in 1 g of cream. Propylene glycol may cause skin irritation.

3. How to use Elosone ointment

This medicine should always be used as directed by the physician. In case of doubts, consult a
physician or pharmacist.
Do not extend the recommended duration of treatment.
Adults:
Apply a small amount of the medicine to the affected areas of skin once daily. Do not use the medicine
under occlusive dressings (sealed plasters). Treatment should not be continued continuously for more
than 2 weeks. Do not use on the facial skin for longer than 5 days.
Use in children:
Do not use in children under 2 years of age.
In children aged 2 years and older, apply the medicine only to a small area of skin once daily, for a
maximum of 5 days. The medicine should be used with great caution in children; do not apply to the
face.
If you feel the medicine's effect is too strong or too weak, consult your doctor.
Use of more than the recommended dose of Elosone ointment
In case of application of a higher than recommended dose or accidental ingestion, contact a physician
immediately.
Prolonged use of the medicine may disturb the body's hormonal balance. If symptoms of overdose
occur, the physician will initiate appropriate treatment, if necessary.
Missed dose of Elosone ointment
Do not use a double dose to make up for a missed dose.
Apply the missed dose as soon as possible, then continue with the usual dosing schedule.
Discontinuation of Elosone ointment
Do not abruptly stop using Elosone ointment after prolonged use. Otherwise, symptoms may recur in
an intensified form. Discontinuation of treatment should be gradual and carried out slowly, according
to the physician's instructions (see section 2 "Warnings and precautions").
If you have any further questions regarding the use of this medicine, consult your physician or
pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
The following adverse reactions have been observed during the use of medicines containing mometasone:
Very rare (may occur in not more than 1 out of 10,000 people):

• folliculitis
• burning sensation, itching (pruritus).

Frequency unknown (frequency cannot be estimated from the available data):

• contact dermatitis
• hypopigmentation
• hypertrichosis
• striae
• acneiform eruptions
• skin atrophy
• infections, boils
• paresthesia (tingling, numbness)
• pain at application site, reactions at application site
• blurred vision.

In addition, with topical use of glucocorticosteroids, the following adverse reactions have been rarely observed: dry skin, skin irritation, perioral dermatitis, maceration (softening of the skin), miliaria (sweat retention), and telangiectasias (dilation of blood vessels beneath the skin).
Children and adolescents
Due to a higher skin surface area to body weight ratio, children and adolescents may be more susceptible than adults to suppression of the hypothalamic-pituitary-adrenal (HPA) axis function and development of Cushing's syndrome (see section 2 - Warnings and precautions).
Chronic therapy with glucocorticosteroids, including Elosone, may impair growth and development in children.
Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, phone +48 22 49 21 301, fax +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Elosone ointment

Store below 25°C. Do not freeze.
Keep the medicine in a place invisible and inaccessible to children.
Check the expiry date stated on the packaging before use.
Do not use this medicine after the expiry date indicated on the packaging.
Medicines must not be disposed of via the sewage system or household waste bins. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What the medicine Elosone ointment contains
The active substance is mometasone furoate.
1 gram of ointment contains 1 mg of mometasone furoate.
The other ingredients are: propylene glycol, cetostearyl alcohol, sterol alcohols from lanolin, glycerol monostearate, liquid paraffin, citric acid monohydrate, white vaseline.

What Elosone ointment looks like and contents of the pack
Elosone ointment is a white or almost white, translucent, greasy ointment.
The medicine is available in an aluminium tube containing 15 g or 30 g of ointment, placed in a cardboard box.

Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer
Przedsiębiorstwo Farmaceutyczne Jelfa SA
58-500 Jelenia Góra, ul. Wincentego Pola 21