Package leaflet: Information for the user

Eztom, 1 mg/g, ointment
Mometasone furoate
Please read the entire leaflet carefully before using this 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, please consult 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 effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents:

What Eztom is and what it is used for
Important information before using Eztom
How to use Eztom
Possible side effects
How to store Eztom
Contents of the pack and other information

1. What Eztom is and what it is used for

Eztom belongs to a group of medicines known as topical glucocorticosteroids.
This medicine contains a glucocorticosteroid with "potent activity". Eztom is applied to the skin to reduce
redness and itching caused by certain skin diseases.
In adults and children aged 2 years and older, Eztom is used on the skin to reduce redness and itching
caused by certain skin conditions known as psoriasis and atopic dermatitis.
Psoriasis is a skin disease characterized by itchy, scaly, pink patches on the elbows, knees, scalp, and other parts of the body. Atopic dermatitis is a skin condition caused by skin reactions to external factors, such as detergents, leading to redness and itching of the skin.

2. Important information before using Eztom

When not to use Eztom:

if the patient is allergic to mometasone or any of the other ingredients of this medicine (listed in section 6).
for other skin disorders, because the medicine may worsen symptoms, particularly:
rosacea (a skin disease affecting the face)
acne vulgaris
skin atrophy (thinning of the skin)
perioral dermatitis
pruritus ani and genital pruritus
diaper rash
bacterial infections, such as tinea, tuberculosis (lung disease), syphilis (sexually transmitted disease), viral infections such as chickenpox, shingles, varicella
fungal infections, such as athlete's foot (red, itchy, peeling skin on the feet)
parasitic infections
if the patient has recently experienced a reaction following vaccination
herpes simplex
shingles
ulcerated skin
damaged skin
and other skin infections.

If in doubt, consult a doctor or pharmacist.
Warnings and precautions
If skin irritation or hypersensitivity occurs after applying Eztom, discontinue use immediately and contact a doctor.
Eztom must not be used around the eyes and must not be applied to the eyelids.
If this medicine is used to treat psoriasis, it may exacerbate symptoms (e.g. pustular psoriasis may occur). The doctor should regularly monitor treatment progress, as therapy should be conducted under strict medical supervision.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.
If the patient's condition worsens during treatment, contact the prescribing doctor – this may be an allergic reaction, infection, or alternative treatment may be required. In case of recurrence of the disease shortly after discontinuation of treatment, do not restart the ointment within 2 weeks without consulting a doctor, unless previously advised otherwise by the doctor. If the disease has resolved, but upon recurrence the redness spreads beyond the initial treatment area and the patient experiences a burning sensation, medical advice should be sought before resuming treatment.
Eztom and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to take, especially if the patient is taking medicines containing cobicistat, ritonavir (used in the treatment of HIV infection), or itraconazole (used in the treatment of fungal infections).
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.
However, if a doctor has prescribed the ointment to a patient who is pregnant or breastfeeding, avoid using large amounts of the medicine and use it only for a short period. During breastfeeding, Eztom should not be applied to the skin of the breasts.
Eztom contains propylene glycol and butylhydroxytoluene (E 321)
Eztom contains propylene glycol, which may cause skin irritation, and also contains butylhydroxytoluene (E 321), which may cause local skin irritation (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Eztom

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
Eztom should not be used in children under 2 years of age.
Usually, in adults and children aged 2 years and older, a thin layer of Eztom should be gently rubbed into the affected skin once daily.
If the doctor has prescribed the ointment, the amount collected on the fingertip (the amount of ointment applied from the tip of the adult's index finger to the first crease under the fingertip) is sufficient to cover an area of skin equal to the surface of two adult palms. Never use more medicine than prescribed or apply it more frequently than directed by the doctor or pharmacist.
The physician should regularly assess the progress of treatment.
In adults and children, Eztom should always be used according to the following instructions:

Do not use the ointment on the facial skin for longer than 5 days.
Before applying the ointment under a bandage or dressing, consult your doctor. Do not apply the ointment under a bandage or dressing to treated facial skin.
Do not use large amounts of ointment on large areas of skin for prolonged periods (e.g., daily for several weeks or months).
Do not apply the ointment around the eyes, including on the eyelid skin.

Adults

Do not use the ointment for prolonged periods (longer than 3 weeks) or on large body surface areas (more than 20% of body surface).

Children aged 2 years and older

Do not use the ointment in children on any body part for longer than 3 weeks.
Do not use the ointment in children under the diaper area, as this may increase absorption of the active substance and increase the risk of adverse effects.
Do not apply a bandage or dressing to treated skin in children.

Children under 2 years of age

The ointment should not be used in children under 2 years of age.

Use of more than the recommended dose of Eztom
If the patient (or someone in the patient's family) accidentally swallows some of the ointment, no adverse effects are expected. However, in case of doubt, contact your doctor or pharmacist.
If the patient applies the ointment more frequently than prescribed or over a larger skin surface, it may disrupt the body's hormonal balance. In children, this may cause disturbances in growth and development.
If the patient has not used the ointment as directed and has applied it too frequently and/or for longer than indicated, inform the doctor.

Missed dose of Eztom
If a dose of the ointment is missed, apply it as soon as the patient remembers, then continue using the ointment at the correct time. Do not use a double dose or apply the ointment twice a day to make up for a missed dose.

Stopping Eztom treatment
If the patient has used the medicine for a prolonged period and symptoms appear to have disappeared, do not suddenly stop using the ointment.
If the patient stops using the ointment abruptly, the skin may become red and sensations of stinging or burning may occur. To avoid this, contact the doctor, who will advise gradually reducing the frequency of ointment application until treatment is completely discontinued.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
If any adverse reaction worsens, or if you experience any adverse reaction not listed in this leaflet,
you should inform your doctor or pharmacist.
The following adverse reactions have been reported in a small number of patients treated with Eztom:

allergic skin reactions
bacterial infections and secondary skin infections
acne
inflammation and/or infection of hair follicles
skin atrophy (thinning)
red spots on the skin with pustules
loss of skin pigment
burning sensation
stinging
itching
tingling
excessive hair growth
skin maceration and striae
blurred vision
steroid withdrawal symptoms: After prolonged continuous use, discontinuation of treatment may lead to some or all of the following withdrawal symptoms: skin redness which may spread beyond the initially treated area, burning or stinging sensation, intensified itching, skin peeling, oozing open lesions.

Other adverse reactions which may occur with topical glucocorticosteroids include
skin dryness, skin irritation, dermatitis, perioral dermatitis, and mild dilation of blood vessels.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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 Authorisation Holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Eztom

Keep this medicine out of sight and reach of children.
Do not use Eztom after the expiry date stated on the cardboard box after: Expiry (EXP) or on the tube following EXP. The expiry date refers to the last day of the stated month.
An opened tube with unused ointment should be discarded after 12 weeks.
Do not store above 30°C. Do not store in a refrigerator or freeze.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Eztom contains

The active substance is mometasoni furoas. Each gram of Eztom contains 1 mg of mometasone furoate.
The other ingredients are: hexylene glycol, concentrated phosphoric acid, polyglycol stearate monopalmitate, white wax, white petrolatum, butylhydroxytoluene (E 321), purified water.

What Eztom looks like and contents of the pack
Eztom is a white, soft, transparent ointment.
The ointment is packed in an aluminium tube with a polyethylene cap, placed in a cardboard box.
Pack sizes available:
Tubes containing 15 g or 30 g of ointment.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic
Manufacturer/Importer
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Glenmark Pharmaceuticals Sp. z o.o.
ul. Dziekońskiego 3
00-728 Warsaw
Email: [email protected]
This medicinal product is authorised in the European Economic Area countries under the following names:
Germany (RMS): Mometason Glenmark 1mg/g Salbe
Spain: Mometasona Viso Farmacéutica 1mg/g pomada
Netherlands: Mometasonfuroaat Glenmark 1 mg/g, zalf
Poland: Eztom
Portugal: Desdek 1mg/g Pomada
Sweden: Mometason Glenmark 1mg/g salva