Eztom

Package Leaflet: Information for the User

Eztom, 1 mg/g, Cream

Mometasone Furoate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

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

1. What is Eztom and what is it used for

Eztom belongs to a group of medicines called topical corticosteroids.
The medicine contains a corticosteroid with a "strong" effect. It is used on the skin to reduce redness and itching caused by certain skin diseases.
In adults and children aged 2 to 18 years, Eztom is used on the skin to reduce redness and itching caused by certain skin diseases such as psoriasis and eczema.
Psoriasis is a skin disease characterized by itchy, scaly, pink skin lesions on the elbows, knees, scalp, and other parts of the body. Eczema is a condition caused by the skin's reaction to external factors, such as detergents, which cause redness and itching.

2. Important information before using Eztom

When not to use Eztom:

• if you are allergic (hypersensitive) to mometasone furoate or any of the other ingredients of Eztom (listed in section 6).
• on other skin lesions, as this medicine may worsen their symptoms:
• rosacea (skin disease of the face)
• acne
• skin atrophy (thinning of the skin)
• perioral dermatitis
• pruritus ani et genitalis
• diaper dermatitis
• herpes simplex
• chickenpox
• shingles
• warts
• skin ulcers
• damaged skin and
• other skin infections.

If you are unsure, ask your doctor or pharmacist.

Warnings and precautions

Before starting treatment with Eztom, discuss it with your doctor or pharmacist.

• If this medicine is used to treat psoriasis, as it may worsen the symptoms of the disease (e.g., pustular psoriasis may occur). The doctor should regularly assess the progress of treatment, as this medicine should be used under close medical supervision.
• If, after using Eztom, skin irritation or an allergic reaction occurs, stop using the medicine and contact your doctor.

If your condition worsens during treatment, contact the doctor who prescribed the medicine – it may be an allergic reaction, infection, or other treatment may be necessary. If the disease recurs soon after stopping treatment, within 2 weeks, do not restart using the cream without consulting a doctor, unless the doctor has previously recommended it. If the disease has resolved and during its recurrence, redness spreads beyond the initial treatment area and the patient experiences burning, consult a doctor before resuming treatment.
If you experience blurred vision or other vision disturbances, contact your doctor.

Children and adolescents

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

Eztom and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, especially if you are taking medicines containing cobicistat, ritonavir (used to treat HIV infection), or itraconazole (used to treat fungal infections).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

3. How to use Eztom

Always use Eztom exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.
Usually, in adults and children over 2 years of age, a thin layer of Eztom should be gently rubbed into the affected skin once a day.

• Use only a small amount of medicine.
• A single application of cream (the amount of cream applied from the tip of the adult's index finger to the first crease) is sufficient to cover a skin area equal to the surface of two adult hands. Never use more than the recommended amount or more frequently than recommended by your doctor or pharmacist.

your doctor or pharmacist.

Special warnings:

• Do not use on the face for more than 5 days.
• Do not use the cream on the skin of children, on any part of the body, for more than 5 days.
• Do not use the cream on the skin under a diaper, as this may increase the absorption of the medicine and increase the risk of side effects.
• Before applying the cream under a bandage or dressing, consult your doctor. Do not apply the cream under a bandage or dressing on the face in children.
• Do not use the cream on large areas of the body or for a long period (e.g., daily for several weeks or months).
• Do not use the cream on the skin around the eyes, including the eyelids.

Use in children
Eztom should not be used in children under 2 years of age.

Using more than the recommended dose of Eztom

If you (or someone else) accidentally swallow a dose of cream, no side effects should occur. However, if you are unsure, contact your doctor.
If you use the cream more frequently than recommended by your doctor or on a larger skin area, it may disrupt the body's hormonal balance. In children, it may cause growth and development disorders.
If you have not used the cream as recommended by your doctor and have used it too frequently and/or for longer than indicated, inform your doctor or pharmacist.

Missing a dose of Eztom

If you miss a dose, use it as soon as you remember, then continue as recommended.

Stopping treatment with Eztom

If you have used Eztom for a long time and it seems that the symptoms of the disease have disappeared, do not stop using the cream suddenly. If you stop using the cream suddenly, the skin may become red and burning or stinging may occur. To avoid this, contact your doctor, who will recommend gradually reducing the frequency of application until treatment is completely stopped.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Eztom can cause side effects, although not everybody gets them.
In a small number of patients, the following side effects may occur after using Eztom:

• allergic skin reactions
• bacterial infections and secondary skin infections
• acne
• folliculitis (inflammation and/or infection of the hair follicles)
• skin atrophy (thinning of the skin)
• red spots on the skin with pustules
• skin depigmentation
• burning
• stinging
• itching
• tingling
• excessive hair growth
• skin thinning and stretch marks
• blurred vision
• steroid withdrawal symptoms: In case of uninterrupted use for a longer period, after stopping treatment, some or all of the following withdrawal symptoms may occur: redness of the skin, which may spread beyond the initially treated area, burning or stinging sensation, increased itching, skin peeling, weeping open sores.

Other side effects that may occur after topical use of corticosteroids include dryness of the skin, skin irritation, dermatitis, perioral dermatitis, and minor blood vessel dilation.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. 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
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Eztom

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the tube after EXP. and on the carton after: Expiry date (EXP). The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine. Do not store in a refrigerator or freeze.
Once opened, the tube with unused cream should be discarded after 12 weeks.
Medicines should 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 pack and other information

What Eztom contains

• The active substance is mometasone furoate. Each gram of Eztom contains 1 mg of mometasone furoate.
• The other ingredients are: hexylene glycol, purified water, white wax, hydrogenated soybean lecithin, titanium dioxide (E171), aluminum starch octenyl succinate, phosphoric acid, white petrolatum, all-rac-alpha-tocopherol.

What Eztom looks like and contents of the pack

Eztom is a white or almost white, homogeneous cream.
Eztom is available in aluminum tubes (coated with latex), with an HDPE screw cap, containing 15 g or 30 g of cream.
Not all pack sizes may be marketed.

Marketing authorization holder

Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

Manufacturer

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

For further information about this medicine, please contact the local representative of the marketing authorization holder:

Glenmark Pharmaceuticals Sp. z o. o.
ul. Dziekońskiego 3
00-728 Warsaw
Email: poland.receptionist@glenmarkpharma.com

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany (RMS):
Mometasonfuroat Glenmark 1mg/g Creme
Denmark:
Mometasonfuroat Glenmark 1mg/g Creme
Spain:
Mometasona Viso Farmacéutica 1 mg/g crema
Norway:
Mometason Glenmark 0,1 % Krem
Poland:
Eztom
Sweden:
Mometason Glenmark 1 mg/g kräm
Italy:
Mometasone Sandoz GmbH 1 mg/g crema
Date of last revision of the leaflet:June 2025