Eztom

Package Leaflet: Information for the User

Eztom, 1 mg/g, Ointment

Mometasone Furoate

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

• Keep this 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, please tell your doctor or pharmacist. See section 4.

Table of Contents of the 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. It contains a strong corticosteroid. This medicine is used on the skin to reduce redness and itching caused by certain skin conditions. 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 such as psoriasis and atopic dermatitis. Psoriasis is a skin condition characterized by itchy, scaly, pink patches on the elbows, knees, scalp, and other parts of the body. Atopic dermatitis is a condition caused by a reaction of the skin to external factors, such as detergents, causing redness and itching.

2. Important information before using Eztom

When not to use Eztom:

• if you are allergic to mometasone or any of the other ingredients of this medicine (listed in section 6).
• on other skin conditions, as the medicine may worsen symptoms, especially:
• rosacea (a skin condition of the face)
• acne
• skin thinning
• perioral dermatitis
• itching around the anus and genitals
• diaper rash
• bacterial infections, such as impetigo, tuberculosis (a lung disease), syphilis (a sexually transmitted disease), viral infections, such as chickenpox, shingles, herpes simplex
• fungal infections, such as athlete's foot
• parasitic infections
• if you have recently had a vaccination reaction
• herpes simplex
• shingles
• ulcerated skin
• damaged skin
• and other skin infections.

If in doubt, consult your doctor or pharmacist.

Warnings and precautions

If you experience skin irritation or an allergic reaction after using Eztom, stop using the medicine and contact your doctor. Eztom should not be used on the skin around the eyes or on the eyelids. If this medicine is used to treat psoriasis, it may worsen the condition (e.g., pustular psoriasis may occur). Your doctor should regularly assess the progress of the treatment, as it should be carried out under close supervision. If you experience blurred vision or other vision disturbances, contact your doctor. If your condition worsens while using the medicine, contact the doctor who prescribed it – it may be an allergic reaction, infection, or other treatment may be necessary. In case of recurrence of the disease soon after stopping treatment, within 2 weeks, do not restart using the ointment without consulting your doctor, unless the doctor has previously recommended it. If the disease has resolved and during its recurrence, redness extends beyond the initial treatment area and you experience burning, consult your doctor before resuming treatment.

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 and breastfeeding

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. However, if your doctor has prescribed the ointment for you while you are pregnant or breastfeeding, avoid using large amounts of the medicine and use it for a short period. During breastfeeding, do not use Eztom on the breast skin.

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 eye and mucous membrane irritation.

3. How to use Eztom

This medicine should always be used exactly as your doctor has told you. If you are not sure, ask 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 a day. If your doctor has prescribed the ointment, the amount taken with the fingertip (the amount of ointment applied from the tip of the finger to the first joint) is enough to cover a skin surface equal to the surface of two adult hands. Never use more medicine than your doctor or pharmacist has told you to. Your doctor should regularly check the progress of the treatment. In adults and children, Eztom should always be used according to the following instructions:

• Do not use the ointment on the face for more than 5 days.
• Before using the ointment under a bandage or dressing, consult your doctor. Do not apply the ointment under a bandage or dressing on the treated facial skin.
• Do not use large amounts of ointment on large skin areas for a long time (e.g., daily for several weeks or months).
• Do not use the ointment on the skin around the eyes, including the eyelids.

Adults

• Do not use the ointment for a long time (longer than 3 weeks) or on a large skin area (more than 20% of the body surface).

Children aged 2 years and older

• Do not use the ointment in children for more than 3 weeks.
• Do not use the ointment in children on the skin under the diaper, as this may increase the absorption of the active substance and increase the risk of side effects.
• Do not use a bandage or dressing on the treated skin in children.

Children under 2 years of age

• Do not use the ointment in children under 2 years of age.

Using more Eztom than you should

If you (or someone else) accidentally swallow a dose of the ointment, it is unlikely to cause any problems. However, if you have any concerns, contact your doctor or pharmacist. If you use the ointment more often than your doctor has told you to, or on a larger skin area, it may disrupt the hormonal balance of your body. In children, it may cause growth and development problems. If you have not used the ointment as you should, and have used it too frequently and/or for a longer period than recommended, tell your doctor.

Forgetting to use Eztom

If you forget to use the ointment at the right time, use it as soon as you remember, then continue using it at the usual time. Do not use a double dose or use the ointment twice a day to make up for the missed dose.

Stopping using Eztom

If you have used the medicine for a long time and it seems that the symptoms of the disease have disappeared, do not stop using the ointment suddenly. If you stop using the ointment, your skin may become red and you may experience stinging or burning. To avoid this, contact your doctor, who will advise you to gradually reduce the frequency of using the ointment until you stop the treatment completely. 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. If any side effect gets worse, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. After using Eztom, a small number of patients have experienced the following side effects:

• allergic skin reactions
• bacterial infections and secondary skin infections
• acne
• inflammation and/or infection of the hair follicles
• skin thinning
• red spots on the skin with pustules
• skin depigmentation
• burning
• stinging
• itching
• tingling
• excessive hair growth
• skin atrophy and stretch marks
• blurred vision
• steroid withdrawal symptoms: In case of continuous use for a long time, after stopping the 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, increased itching, skin peeling, weeping open sores.

Other side effects that may occur with topical corticosteroids include dry 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, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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. 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 Eztom after the expiry date which is stated on the carton after EXP. or on the tube after EXP. The expiry date refers to the last day of that month. Opened tubes with unused ointment should be discarded after 12 weeks. Do not store above 30°C. Do not store in the refrigerator or freeze. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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, phosphoric acid, propylene glycol monopalmitynostearate, white wax, white petrolatum, butylhydroxytoluene (E 321), purified water.

What Eztom looks like and contents of the pack

Eztom is a transparent, white, soft ointment. The ointment is packed in an aluminum tube with a polyethylene cap, placed in a cardboard box. Available pack sizes: Tubes of 15 g or 30 g of ointment. 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/Importer

Glenmark Pharmaceuticals s.r.o., Hvězdova 1716/2b, 140 78 Prague 4, 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: [email protected]

This medicine is authorized in the Member States of the European Economic Area 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

Date of last revision of the leaflet: