Elosone

Package Leaflet: Information for the Patient

Elosone, 1 mg/g, Ointment

(Mometasone Furoate)

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Table of Contents of the Leaflet:

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

Elosone ointment contains the active substance mometasone furoate, a synthetic glucocorticosteroid with strong action. The medicine used locally shows anti-inflammatory, anti-itching, and vasoconstrictive effects.

Indications

Elosone ointment is used for short-term local treatment of inflammatory skin diseases with itching, responding to glucocorticosteroid therapy, such as psoriasis and atopic dermatitis.

2. Important information before using Elosone ointment

When not to use Elosone ointment

• if you are allergic to mometasone furoate, other corticosteroid medicines, or any of the other ingredients of this medicine (listed in section 6);
• in children under 2 years of age;
• in common and rosacea acne,
• in atrophic skin changes;
• in perioral dermatitis;
• in the case of itching (pruritus) in the anal or genital area;
• in the case of diaper dermatitis (redness and rash localized in the area of the diaper);
• in bacterial (e.g., ringworm, purulent skin inflammation), viral (e.g., common herpes, skin warts, condyloma acuminata - warts localized in the anal and genital areas, molluscum contagiosum - a disease characterized by the occurrence of skin changes in the form of hard, wax-like nodules) and parasitic and fungal infections (e.g., caused by yeast or dermatophytes);

in the case of chickenpox herpes zoster infection;

• in the case of tuberculosis;
• in the case of syphilis;
• if you have had a post-vaccination reaction (an abnormal reaction of the body occurring after vaccination, e.g., skin rash or redness);
• on wounds and ulcerated skin.

Warnings and precautions

Before starting to use Elosone ointment, discuss it with your doctor or pharmacist. If skin irritation or allergy occurs during the use of Elosone ointment, discontinue the use of the medicine and contact your doctor. If you experience blurred vision or other vision disturbances, contact your doctor. If you notice any changes in the appearance of the skin to which Elosone ointment is applied, tell your doctor immediately. These may be symptoms of a bacterial or fungal infection. In the event of an infection, your doctor will prescribe appropriate treatment. If there is no positive response to treatment in a short time, your doctor may decide to discontinue the use of Elosone ointment. Although Elosone is applied to the skin, mometasone furoate may be absorbed into the body, leading to hormonal disorders, e.g., reversible suppression of the hypothalamic-pituitary-adrenal axis (a system regulating the secretion of adrenal hormones, including glucocorticosteroids) after the end of treatment or the occurrence of Cushing's syndrome (a set of symptoms such as obesity, moon face, facial redness, stretch marks, weakness, decreased immunity, increased blood pressure, related to increased levels of glucocorticosteroids in the blood), increased glucose levels in the blood or glucose excretion in the urine. When using Elosone ointment on large areas of skin or under a dressing, your doctor will periodically monitor your condition. In patients who use Elosone ointment on large areas of damaged skin, skin folds, or under an occlusive dressing (e.g., foil), there is a greater risk of side effects. Elosone ointment should not be used under a dressing on the face and in children. If it is necessary to apply the medicine to the face, treatment should not last longer than 5 days. You should avoid long-term use of Elosone ointment in all patients, regardless of age. You should avoid sudden discontinuation of Elosone ointment. After stopping long-term therapy with Elosone, a rebound effect may occur, manifested by a state of skin inflammation with intensified redness, burning, and stabbing pain. To avoid this, consult your doctor, who may decide to gradually reduce the dose or frequency of application of the medicine until the end of treatment. Elosone ointment should be used with special caution in patients with psoriasis, among other things, because it may cause a relapse or worsening of the disease symptoms (generalized pustular psoriasis may occur) or other side effects. When using the medicine in psoriasis, your doctor will closely monitor your condition. Elosone ointment may change the appearance of some disease changes, making it difficult for your doctor to make a proper diagnosis. The medicine may also delay healing. Elosone ointment should not be used in the eyes and on the eyelids. You should be careful not to get the medicine in your eyes during use.

Children and adolescents

Elosone ointment should not be used in children under 2 years of age due to the lack of sufficient data on the safety and efficacy of the medicine in this age group. When using the medicine in children over 2 years of age, special caution should be exercised and the doctor's instructions should be followed closely. Children are at greater risk of systemic side effects, including hormonal disorders (see section 4).

Elosone ointment and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take. There are no data on interactions with other medicines.

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. Pregnancy Elosone ointment can be used during pregnancy only if your doctor decides that it is absolutely necessary. Do not use the medicine on large areas of the body and for a longer period. Breastfeeding You should not use Elosone ointment during breastfeeding unless your doctor decides that it is absolutely necessary. If it is necessary to use the medicine in larger doses or for a longer period, you should stop breastfeeding. Fertility There are no data on fertility.

Driving and using machines

There are no available data on the effect of using Elosone ointment on the ability to drive and use machines.

Elosone ointment contains cetostearyl alcohol

The medicine may cause local skin reactions (e.g., contact dermatitis).

Elosone ointment contains propylene glycol

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

3. How to use Elosone ointment

This medicine should always be used as directed by your doctor. If you are unsure, ask your doctor or pharmacist. Do not extend the prescribed treatment period. Adults: Apply a small amount of the medicine to the affected areas of the skin once a day. Do not use the medicine under an occlusive dressing (occlusive dressing). Treatment should not be continued without interruption for more than 2 weeks. On the skin of the face, do not use for more than 5 days. Use in children: Do not use in children under 2 years of age. In children over 2 years of age, use the medicine only on a small area of skin once a day, for a maximum of 5 days. In children, the medicine should be used with great caution and not applied to the skin of the face. If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Using a higher dose of Elosone ointment than recommended

If you have used a higher dose of the medicine than recommended or accidentally swallowed it, contact your doctor immediately. Long-term use of the medicine may disrupt the body's hormonal balance. In the event of overdose symptoms, your doctor will provide appropriate treatment if necessary.

Missing a dose of Elosone ointment

Do not use a double dose to make up for a missed dose. Use the missed dose as soon as possible, and then continue with the usual dosing schedule.

Stopping the use of Elosone ointment

After long-term use, do not suddenly stop using Elosone ointment. Otherwise, symptoms may occur in an intensified form. The end of treatment should be gradual and carried out according to your doctor's instructions (see section 2 "Warnings and precautions"). 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. During the use of mometasone-containing medicines, the following side effects have been observed:

Very rare (may affect up to 1 in 10,000 people):

• folliculitis
• burning sensation, itching (pruritus).

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

• contact dermatitis
• skin depigmentation
• hypertrichosis
• stretch marks
• acne-like changes
• skin atrophy
• infections, furuncles
• paresthesia (tingling, numbness)
• pain at the application site, reactions at the application site
• blurred vision.

Additionally, during the local use of glucocorticosteroids, the following side effects have been rarely observed: dry skin, skin irritation, perioral dermatitis, maceration (skin softening), sweat spots, and telangiectasias (dilation of blood vessels under the skin).

Children and adolescents

Due to the larger skin surface area to body mass ratio, children and adolescents may show greater susceptibility to suppression of the hypothalamic-pituitary-adrenal axis and the occurrence of Cushing's syndrome (see section 2 - Warnings and precautions). Chronic glucocorticosteroid therapy, including Elosone, may disrupt the growth and development of children.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel. +48 22 49 21 301, fax +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Elosone ointment

Store in a temperature below 25°C. Do not freeze. The medicine should be stored out of the sight and reach of children. Before using, check the expiry date stated on the packaging. Do not use this medicine after the expiry date stated on the packaging. 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 other information

What 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, lanolin alcohols, glycerol monostearate, liquid paraffin, citric acid monohydrate, white petrolatum.

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 aluminum tube containing 15 g or 30 g of ointment, placed in a cardboard box.

Marketing authorization 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 Date of last revision of the leaflet: