EDELAN

Package leaflet: Information for the user

Edelan, 1 mg/g, cream
Mometasoni furoas
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Edelan is and what it is 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 Edelan is and what it is used for

Edelan contains the active substance mometasoni furoas, a potent corticosteroid.
When applied topically, the medicine exerts anti-inflammatory, antipruritic, and vasoconstrictive effects.
Indications
Edelan cream is indicated for topical application to alleviate inflammatory symptoms and itching in corticosteroid-responsive skin disorders, 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, shingles, chickenpox, common warts, plantar warts, molluscum contagiosum), parasitic or fungal skin infections (e.g. those caused by dermatophytes or yeasts),
• in post-vaccination reactions,
• in cutaneous tuberculosis,
• in syphilitic skin lesions,
• in anal or genital pruritus,
• in diaper dermatitis,
• on damaged or ulcerated skin.

Warnings and precautions
Before starting treatment with Edelan, discuss this with your doctor or pharmacist.
Avoid using Edelan:

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

If application to the face is necessary, treatment should not last longer than 5 days.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.
If irritation or allergic reactions occur after applying the medicine, discontinue use and contact a doctor immediately.
If an infection develops, the doctor will initiate appropriate antibacterial or antifungal treatment.
Since the medicine is absorbed through the skin, there is an increased risk of systemic adverse effects.
Use the smallest effective amount of medicine needed to control symptoms, especially in children. Prolonged corticosteroid treatment may impair children's growth and development.
In children, due to a higher body surface area to body weight ratio than in adults, there is a greater likelihood of systemic adverse effects, including hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome.
Do not use Edelan on skin covered by diapers, as diapers may act similarly to occlusive dressings and increase percutaneous absorption of the medicine.
Topically applied Edelan is not intended for ophthalmic use (including the area around the eyelids) due to the risk of developing open-angle glaucoma or subcapsular cataracts.
Patients with psoriasis should use Edelan with particular caution.
Using Edelan in psoriasis may lead to disease recurrence due to the development of tolerance, generalized pustular psoriasis, or systemic toxic effects associated with impaired skin integrity.
Like other corticosteroid-containing medicines, Edelan may alter the appearance of certain skin lesions, potentially making it difficult for the doctor to establish a correct diagnosis, and may also delay wound healing.

Edelan and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
There is no data on interactions with other medicines.

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

Pregnancy
During pregnancy, this medicine should only be used if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus. However, the medicine should not be used over large areas of the body or for prolonged periods.
Animal studies have shown that corticosteroids may harm the fetus.

Breastfeeding
Corticosteroids pass into breast milk. The doctor will decide whether to discontinue breastfeeding or to stop treatment with the medicine, taking into account the importance of treatment for the mother and the potential adverse effects of the medicine on the infant.

Driving and operating machinery
Edelan has no effect on the ability to drive or operate machinery.

3. How to use Edelan

This medicine should always be used as directed by a physician. If in doubt, consult your doctor or pharmacist.
This medicine is intended for topical use on the skin.
Adults:
Apply a thin layer of Edelan to the affected areas of skin once daily.
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 should be applied once daily, and only to a small area of skin.
The safety and efficacy of prolonged use beyond 3 weeks have not been established.
Duration of treatment:
Prolonged use, i.e. longer than 3 weeks, should be avoided.
Use on the face should not exceed 5 days.
Use of a higher than recommended dose of Edelan
Prolonged use or application over large areas of skin may lead to symptoms of overdose such as edema, hypertension, elevated blood glucose levels, glycosuria, reduced immunity, and Cushing's disease (symptoms including, among others: facial and trunk obesity, muscle weakness, growth retardation in children).
In cases of chronic intoxication, the physician will recommend gradually discontinuing the medicine or switching to weaker-acting corticosteroids.
Missed dose of Edelan
If a dose is missed at the usual time, wait until the next scheduled dose. Do not apply a double dose to make up for the missed dose.
Discontinuation of Edelan
Sudden discontinuation of treatment should be avoided. Abrupt withdrawal may result in intensified redness, burning, and stinging pain. This can be prevented by gradually reducing the dose and increasing the interval between applications. In such cases, consult your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Possible adverse effects:
Very rare (occur in fewer than 1 in 10,000 people):

• folliculitis,
• burning sensation, itching.

Frequency unknown (cannot be estimated from available data):

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

When the medicine is applied to large areas of skin or for prolonged periods, especially when occlusive dressings (impermeable) are used, the medicine may be absorbed into the body.
With topical use of other corticosteroids, the following have been observed:
dry skin, skin irritation, dermatitis, perioral dermatitis, skin maceration, sweating, and appearance of dilated small blood vessels (telangiectasia).
These effects may also occur after application of Edelan. This particularly applies to children, in whom growth and developmental disorders may additionally occur (see section 2 "Important information before using Edelan").
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
e-mail: [email protected]
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Edelan medicine

Keep this medicine out of the sight and reach of children.
No special storage instructions are required for this medicine.
Do not store in the refrigerator or freeze.
The 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 stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Edelan contains

• The active substance is mometasone furoate. Each g 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), aluminium octenylsuccinate starch, phosphoric acid diluted, white soft paraffin containing all-rac-α-tocopherol.

What Edelan looks like and contents of the pack
Edelan is a white or almost white, smooth, homogeneous cream in an aluminium tube coated with latex, with a cap made of HDPE, packed in a cardboard box.
The pack contains 15 g or 30 g of cream.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA SA
ul. Pelplińska 19, 83-200 Starogard Gdański, Poland

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

For further information, contact the local representative of the Marketing Authorisation Holder:
POLPHARMA Biuro Handlowe Sp. z o.o.
ul. Bobrowiecka 6
00-728 Warsaw
tel. 22 364 61 01