EDELAN 1 mg /G Ointment

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Edelan, 1 mg/g, Ointment
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Edelan and what is it used for
   1. Indications
4. Important information before using Edelan
   1. When not to use Edelan
   2. Warnings and precautions
   3. Edelan and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Edelan contains butylhydroxytoluene (E 321)
5. How to use Edelan
   1. Adults:
   2. Children and adolescents:
   3. Duration of use:
   4. Using more than the recommended dose of Edelan
   5. Missing a dose of Edelan
   6. Stopping use of Edelan
6. Possible side effects
   1. Possible side effects:
   2. Reporting side effects
7. How to store Edelan
8. Contents of the pack and other information
   1. What Edelan contains
   2. What Edelan looks like and contents of the pack
   3. Marketing authorization holder
   4. Importer/Manufacturer
   5. Date of last revision of the leaflet:

Package Leaflet: Information for the User

Edelan, 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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Edelan and what is it used for

Edelan contains the active substance mometasone furoate, a potent corticosteroid.
The medicine is used topically and has anti-inflammatory, anti-itching, and vasoconstrictive effects.

Indications

Edelan ointment is indicated for use on the skin to relieve inflammatory and itching symptoms in corticosteroid-responsive skin diseases, such as psoriasis and atopic dermatitis.

2. Important information before using Edelan

When not to use Edelan

• if the patient is allergic to mometasone furoate, other corticosteroids, or any of the other ingredients of this medicine (listed in section 6),
• in acne vulgaris,
• in rosacea,
• in skin atrophy,
• in perioral dermatitis,
• in bacterial infections (e.g., impetigo, pyoderma), viral infections (e.g., herpes simplex, chickenpox, and shingles, common warts, molluscum contagiosum), parasitic and fungal skin infections (e.g., caused by dermatophytes or yeasts),
• in post-vaccination reactions,
• in cutaneous tuberculosis,
• on syphilitic skin lesions,
• in anal and genital itching,
• in diaper rash,
• on damaged and ulcerated skin.

Warnings and precautions

Before starting treatment with Edelan ointment, the patient should discuss it with their doctor or pharmacist.
Edelan ointment should be avoided:

• on large areas of the body
• under occlusive dressings
• for prolonged periods
• on the face
• in skin folds
• in children.

If it is necessary to apply the medicine to the face, treatment should not last more than 5 days.
If the patient experiences blurred vision or other visual disturbances, they should contact their doctor.
If irritation or allergic reactions occur after using the medicine, it should be discontinued and the doctor contacted immediately.
If an infection occurs, the doctor will prescribe appropriate antibacterial or antifungal treatment.
Since the medicine is absorbed through the skin, there is an increased risk of systemic side effects.
The smallest effective amount of medicine should be used, allowing for relief of disease symptoms, especially in children. Long-term treatment with corticosteroids may affect growth and development in children.
In children, due to the larger ratio of body surface area to body mass compared to adults, there is a greater likelihood of systemic side effects, including disruption of the hypothalamic-pituitary-adrenal axis and Cushing's syndrome.
The medicine should not be used on skin covered with a diaper, as it may act like an occlusive dressing and increase the percutaneous absorption of the medicine.
Edelan used topically is not intended for ophthalmic use (including the eyelids) due to the risk of developing glaucoma or subcapsular cataract.
Patients with psoriasis should use Edelan with caution.
Using the medicine in psoriasis may cause the disease to flare up due to the development of tolerance, generalized pustular psoriasis, and general toxic effects related to skin barrier disruption.
Edelan, like other medicines containing corticosteroids, may change the appearance of some skin lesions, making it difficult for the doctor to diagnose, and may also delay wound healing.

Edelan and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
There are no data on interactions with other medicines.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
The medicine may be used during pregnancy only if the doctor considers that the benefit to the mother outweighs the potential risk to the fetus. However, the medicine should not be used on large areas of the body or for extended periods. Animal studies have shown that corticosteroids may harm the fetus.
Breastfeeding
Corticosteroids pass into breast milk. The doctor will decide whether to stop breastfeeding or discontinue the medicine, considering the importance of treatment for the mother and the potential side effects of the medicine on the baby.

Driving and using machines

Edelan ointment does not affect the ability to drive or use machines.

Edelan contains butylhydroxytoluene (E 321)

The medicine may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.

3. How to use Edelan

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The medicine is intended for use on the skin.

Adults:

A thin layer of Edelan ointment should be applied to the affected areas of the skin once a day.
The ointment is recommended for the treatment of dry, scaly, and cracked skin lesions.

Children and adolescents:

Use in children under 2 years of age:
The medicine should not be used in children under 2 years of age.
Use in children over 2 years of age:
In children over 2 years of age, Edelan is used once a day, only on a small area of the skin.
The safety and efficacy of the medicine have not been studied for periods longer than 3 weeks.

Duration of use:

Long-term use of the medicine should be avoided, i.e., for more than 3 weeks.
Use on the face should not last more than 5 days.

Using more than the recommended dose of Edelan

After prolonged use of the medicine or use on large areas of the skin, overdose symptoms may occur, such as edema, hypertension, hyperglycemia, glucosuria, decreased immunity, and Cushing's syndrome (symptoms including moon face and central obesity, muscle weakness, growth retardation in children).
In case of chronic poisoning, the doctor will gradually discontinue the medicine or prescribe a less potent corticosteroid.

Missing a dose of Edelan

If a dose is missed, the patient should wait until the next scheduled dose. A double dose should not be used to make up for the missed dose.

Stopping use of Edelan

Stopping treatment abruptly should be avoided. After sudden discontinuation of the medicine, severe redness, burning, and stinging may occur. This can be prevented by gradually reducing the dose and increasing the time between applications. In such cases, the patient should consult their doctor.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

Possible side effects:

Very rare (occurring in less than 1 in 10,000 patients):

• folliculitis,
• burning sensation, itching.

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

• infections, furuncles,
• paresthesia,
• contact dermatitis, hypopigmentation,
• hypertrichosis,
• striae, acneiform eruptions, skin atrophy,
• pain at the application site, application site reactions,
• blurred vision.

When using the medicine on large areas of the skin or for extended periods, especially under occlusive dressings, the medicine is absorbed into the body.
During topical use of other corticosteroids, the following have been observed:
dry skin, skin irritation, perioral dermatitis, maceration, and telangiectasias.
These symptoms may also occur after using Edelan, especially in children, who may also experience growth and development disorders (see section 2 "Important information before using Edelan").

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Edelan

The medicine should be kept out of the sight and reach of children.
Store in a temperature below 30°C.
Do not freeze.
Shelf life after first opening the tube: 12 weeks.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Edelan contains

• The active substance is mometasone furoate. 1 g of ointment contains 1 mg of mometasone furoate.
• The other ingredients are: hexylene glycol, purified water, white wax, propylene glycol monopalmitynostearate, phosphoric acid 10%, white petrolatum, butylhydroxytoluene (E 321).

What Edelan looks like and contents of the pack

Edelan is a semi-transparent, white, soft, uniform ointment in an aluminum tube with a latex cap, placed in a cardboard box.
The pack contains 15 g or 30 g of ointment.
Not all pack sizes may be marketed.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Importer/Manufacturer

Glenmark Pharmaceuticals s.r.o,
Fibichova 143,
566 17 Vysoké Mýto, Czech Republic

Date of last revision of the leaflet: