Edelan

Package leaflet: Information for the user

Edelan, 1 mg/g, ointment
Mometasoni furoas
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• 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. It may harm them 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.

Contents of the leaflet

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 locally, this medicine exerts anti-inflammatory, antipruritic, and vasoconstrictive effects.
Indications
Edelan ointment is indicated for topical use on the skin to relieve inflammatory and pruritic manifestations 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, herpes zoster, varicella, common warts, genital warts, molluscum contagiosum), parasitic or fungal skin infections (e.g. 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 ointment, consult your doctor or pharmacist.
Avoid using Edelan ointment:

• 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 exceed 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 growth and development in children.
In children, due to a higher skin surface area to body mass ratio compared to adults, there is a greater likelihood of systemic adverse effects, including hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome.
Do not apply the medicine to skin covered by diapers, as diapers may act like occlusive dressings and increase percutaneous absorption of the medicine.
Topically applied Edelan is not intended for ophthalmic use (including the eyelid area) due to the risk of glaucoma or subcapsular cataract.
Patients with psoriasis should use Edelan with particular caution.
Use of the medicine in psoriasis may lead to disease relapse due to development of tolerance, generalized pustular psoriasis, or systemic toxic effects related to impaired skin integrity.
Edelan, like other corticosteroid-containing medicines, may alter the appearance of certain skin lesions, making it difficult for the physician to establish a correct diagnosis, and may also delay wound healing.

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

Pregnancy and breastfeeding

If the patient is pregnant or 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 be used only if, in the opinion of the physician, the benefit to the mother outweighs the potential risk to the fetus. However, the medicine should not be applied 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 physician will decide whether to discontinue breastfeeding or to stop the treatment, taking into account the importance of the treatment for the mother and the potential adverse effects of the medicine on the infant.

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

Edelan contains butylated hydroxytoluene (E 321)
This medicine may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Edelan

This medicine should always be used exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
This medicine is intended for topical use on the skin.
Adults:
Apply a thin layer of Edelan ointment to the affected areas of skin once daily.
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:
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, but only to a small
area of skin.
The safety and efficacy of this medicine have not been established for use longer than 3 weeks.
Duration of use:
Prolonged use of the medicine should be avoided, i.e., longer than 3 weeks.
Use on the face should not exceed 5 days.
Use of a higher than recommended dose of Edelan
Prolonged use of the medicine or application over a large area of skin may lead to symptoms of
overdose such as edema, hypertension, elevated blood glucose levels, glycosuria, reduced immunity,
and Cushing's syndrome (symptoms including, among others, facial and truncal obesity, muscle
weakness, and growth retardation in children).
In cases of chronic intoxication, the physician will recommend gradual discontinuation of the
medicine or switching to a weaker corticosteroid.
Missed dose of Edelan
If a dose of Edelan 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 of the medicine may
cause intense 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 doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

Possible side effects:

Very rare (occur in fewer than 1 in 10,000 patients):

• folliculitis,
• burning sensation, itching.

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

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

When applied over a large area of skin or for prolonged periods, and especially when occlusive dressings 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, maceration (softening and breaking down of skin), sweating, and appearance of dilated small blood vessels (telangiectasia). These effects may also occur with Edelan. This is particularly relevant for children, in whom growth and developmental disorders may additionally occur (see section 2, "Important information before using Edelan").

Reporting of side effects

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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

Adverse reactions can also be reported to the marketing authorization holder.

Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Edelan medicine

Keep the medicine out of sight and reach of children.
Store below 30°C.
Do not freeze.
Period of use after first opening of 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 in use. 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.
• Other ingredients are: hexylene glycol, purified water, white wax, propylene glycol monostearate monopalmitate, phosphoric acid 10%, white soft paraffin, butylhydroxytoluene (E 321).

What Edelan looks like and contents of the pack
Edelan is a semi-transparent, white, soft, homogeneous ointment in an aluminium tube with a latex cap, enclosed in a cardboard box.
The pack contains 15 g or 30 g of ointment.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
POLPHARMA S.A. Pharmaceutical Works
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01
Importer/Manufacturer
Glenmark Pharmaceuticals s.r.o.,
Fibichova 143,
566 17 Vysoké Mýto, Czech Republic