Edelan

Package Leaflet: Information for the User

Edelan, 1 mg/g, Cream

Mometasone Furoate

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Package Leaflet Contents

• 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. Package contents and other information

1. What is Edelan and what is it used for

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

Indications

Edelan cream 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 medication (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., common herpes, shingles, and chickenpox, common warts, molluscum contagiosum), parasitic and fungal skin infections (e.g., caused by dermatophytes or yeast),
• in post-vaccination reactions,
• in cutaneous tuberculosis,
• on syphilitic skin lesions,
• in anal and genital itching,
• in diaper dermatitis,
• on damaged and ulcerated skin.

Warnings and precautions

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

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

If it is necessary to apply the medication to the face, treatment should not last more than 5 days.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
If irritation or allergic symptoms occur after using the medication, it should be discontinued and the doctor contacted immediately.
In case of infection, the doctor will prescribe appropriate antibacterial or antifungal treatment.
Since the medication is absorbed through the skin, there is an increased risk of systemic side effects.
The smallest effective amount of medication should be used, allowing for the relief of disease symptoms, especially in children. Prolonged treatment with corticosteroids may disrupt 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 medication should not be used on skin covered with a diaper, as it may act like a dressing and increase the percutaneous absorption of the medication.
Edelan 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 medication in psoriasis may cause the disease to flare up due to the development of tolerance, the occurrence of generalized pustular psoriasis, and general toxic effects related to skin barrier disruption.
Edelan, like other medications 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 medications

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medication.
Pregnancy
The medication may be used during pregnancy only if the doctor believes that the benefits to the mother outweigh the potential risks to the fetus. However, the medication 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 medication, considering the importance of treatment for the mother and the potential side effects of the medication on the child.

Driving and using machines

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

3. How to use Edelan

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

Adults:

A thin layer of Edelan should be applied to the affected areas of the skin once a day.

Children and adolescents:

Use in children under 2 years of age:
Edelan 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 skin.
The safety and efficacy of the medication have not been studied for periods longer than 3 weeks.

Duration of use:

Prolonged use of the medication, i.e., longer than 3 weeks, should be avoided.
Use on the face should not last longer than 5 days.

Using more than the recommended dose of Edelan

After prolonged use of the medication or use on large areas of skin, symptoms of overdose may occur, such as edema, hypertension, hyperglycemia, glucosuria, decreased immunity, or Cushing's syndrome (symptoms include, among others: moon face and central obesity, muscle weakness, growth retardation in children).
In case of chronic poisoning, the doctor will gradually discontinue the medication 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 Edelan treatment

Stopping treatment abruptly should be avoided. After sudden discontinuation of the medication, 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 medication, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

Possible side effects:

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

• folliculitis,
• burning sensation, itching.

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

• infections, furuncles,
• paresthesia,
• contact dermatitis, hypopigmentation,
• hypertrichosis,
• striae, acne-like changes, skin atrophy,
• pain at the application site, application site reactions,
• blurred vision.

When using the medication on large areas of skin or for extended periods, especially under occlusive dressings, the medication is absorbed into the body.
During topical use of other corticosteroids, the following have been observed:
dry skin, skin irritation, dermatitis, perioral dermatitis, skin maceration, and the occurrence of dilated small blood vessels (telangiectasia).
These symptoms may also occur after using Edelan. This is especially true for 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 package leaflet, the patient should inform their doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
e-mail: ndl@urpl.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 medication.

5. How to store Edelan

The medication should be stored out of sight and reach of children.
There are no special precautions for storing the medication.
Do not store in the refrigerator or freeze.
Shelf life after first opening the tube: 12 weeks.
Do not use this medication after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
The inscription on the packaging after the abbreviation EXP means the expiration date, and after the abbreviation Lot means the batch number.
Medications should not be disposed of in the sewage system or household waste containers. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package contents and other information

What Edelan contains

• The active substance of Edelan is mometasone furoate. Each gram of cream contains 1 mg of mometasone furoate.
• The other ingredients are: hexylene glycol, purified water, white wax, hydrogenated soybean lecithin, titanium dioxide (E 171), aluminum starch octenylsuccinate, phosphoric acid diluted, white petrolatum containing all-rac-α-tocopherol.

What Edelan looks like and what the package contains

Edelan is a white or almost white, smooth, uniform cream in an aluminum tube with a latex cap, packaged in a cardboard box.
The package contains 15 g or 30 g of cream.
Not all pack sizes may be marketed.

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański, Poland

Importer/Manufacturer

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

For more information, please contact the local representative of the marketing authorization holder:

POLPHARMA Biuro Handlowe Sp. z o.o.
Bobrowiecka 6
00-728 Warsaw
phone: 22 364 61 01
Date of last revision of the package leaflet:March 2023