Package leaflet: Information for the user

Eztom, 1 mg/g, cream
Mometasoni furoas
Please read the entire 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, 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 reactions, including any adverse reactions not listed in this leaflet, inform 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.
The medicine contains a glucocorticosteroid with "potent activity". This medicine is applied to 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 conditions known as psoriasis and dermatitis.
Psoriasis is a skin disease characterized by itchy, scaly, pink skin lesions appearing on elbows, knees, the scalp, and other parts of the body. Dermatitis is a condition caused by the skin's reaction to external factors, such as detergents, which lead to redness and itching.

2. Important information before using Eztom

When not to use Eztom:

if the patient is allergic (hypersensitive) to mometasone furoate, any of the other ingredients of Eztom (listed in section 6), or to similar medicines.
for other skin diseases, as this medicine may worsen their symptoms:
rosacea (a skin condition affecting the face)
acne vulgaris
skin atrophy (thinning of the skin)
perioral dermatitis
itching around the anus and genital organs
diaper dermatitis
herpes simplex
chickenpox
shingles
warts
skin ulcers
damaged skin and
other skin infections.

If in doubt, consult a doctor or pharmacist.
Warnings and precautions
Before starting to use Eztom, discuss it with your doctor or pharmacist.

If this medicine is used to treat psoriasis, as it may cause worsening of symptoms (e.g. pustular psoriasis may occur). The doctor should regularly monitor treatment progress, as this medicine must be used under strict medical supervision.
If skin irritation or allergic reaction occurs after applying Eztom, discontinue use immediately and contact your doctor.

If the patient's condition worsens during treatment, contact the doctor who prescribed the medicine – this may be an allergic reaction, infection, or another treatment may be required. If the disease recurs shortly after stopping treatment, within 2 weeks do not restart using the cream without consulting a doctor, unless previously advised otherwise by the doctor. If the condition has resolved, but upon recurrence redness spreads beyond the initial treatment area and the patient experiences burning, medical advice should be sought before resuming treatment.
If the patient experiences blurred vision or other visual disturbances, contact a 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 the patient is currently taking or has recently taken, 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, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

3. How to use Eztom

Eztom should always be used exactly as directed by the doctor. In case of doubt, consult a
doctor or pharmacist.
In adults and children over 2 years of age, a thin layer of Eztom should usually be gently
rubbed into the affected skin once daily.

Only a small amount of the medicine should be used.
A single fingertip unit (the amount of cream squeezed from the tip of the index finger up to the first crease under the fingertip) is sufficient to cover an area of skin equal to the surface of two adult palms. The amount used should never exceed the recommended dose or be applied more frequently than prescribed by the
doctor or pharmacist.

Special warnings:

Do not use on the facial skin for longer than 5 days.
Do not use the cream on children’s skin on any part of the body for longer than 5 days.
Do not use the cream under a diaper on a child, as this may increase absorption of the medicine and raise the risk of adverse effects.
Consult a doctor before applying the cream under a bandage or dressing. Do not apply the cream under a bandage or dressing used on the facial skin of children.
Do not use the cream on large areas of skin or for prolonged periods (e.g. daily for several weeks or months).
Do not apply the cream to the skin around the eyes, including the eyelids.

Use in children
Eztom must not be used in children under 2 years of age.
Use of more than the recommended dose of Eztom
If a patient (or someone in the patient’s family) accidentally swallows some of the cream,
no adverse effects are expected. However, if in doubt, consult a doctor.
If the cream is used more frequently than prescribed or applied to a larger area of skin, 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 cream as directed and has used it too frequently and/or for
longer than indicated, inform the doctor or pharmacist.
Missed dose of Eztom
If a dose is missed, apply the cream as soon as the patient remembers, then continue as
directed.
Stopping treatment with Eztom
If the patient has used Eztom for a prolonged period and the symptoms of the disease appear
to have disappeared, do not stop using the cream suddenly. Sudden discontinuation may
cause the skin to become red, itchy, and burning. To avoid this, consult the doctor, who will
recommend gradually reducing the frequency of application until treatment is completely
discontinued.
If there are any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
The following adverse reactions may occur in a small number of patients after using the medicine 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 fragility and stretch marks
blurred vision
steroid withdrawal symptoms: After prolonged continuous use, upon discontinuation of treatment, some or all of the following withdrawal symptoms may occur: skin redness, which may extend beyond the initially treated area, burning or stinging sensation, intense itching, skin peeling, oozing open sores.

Other adverse reactions that may occur following topical application of glucocorticosteroids include: dry skin, skin irritation, dermatitis, perioral dermatitis, and minor dilation of blood vessels.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization 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 the sight and reach of children.
Do not use this medicine after the expiry date stated on the tube after "EXP"
and on the cardboard box after: Expiry date (EXP). The expiry date refers to the last day
of the stated month.
No special storage conditions are required. Do not store in the refrigerator or freeze.
An opened tube containing unused cream should be discarded after 12 weeks.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Eztom contains

The active substance is mometasoni furoas. Each gram of Eztom contains 1 mg of mometasoni furoas.
The other ingredients are: hexylene glycol, purified water, white wax, hydrogenated soybean lecithin, titanium dioxide (E171), aluminium octenylsuccinate starch, concentrated phosphoric acid, white soft paraffin.

What Eztom looks like and contents of the pack
Eztom is a white or almost white, homogeneous cream.
Eztom is available in aluminium tubes (latex-lined), with a cap made of HDPE, containing 15 g or 30 g of cream.
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
Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Glenmark Pharmaceuticals Sp. z o.o.
ul. Dziekonińskiego 3
00-728 Warsaw
Email: [email protected]
This medicinal product is authorised in 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