IVOXEL 1 mg /G Cream

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Ivoxel
3. 1 mg/g, cream
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. WHAT IS IVOXEL AND WHAT IS IT USED FOR
5. IMPORTANT INFORMATION BEFORE USING IVOXEL
   1. When not to use Ivoxel
   2. Warnings and precautions
   3. Children (under 2 years of age):
   4. Ivoxel and other medicines
   5. Pregnancy and breastfeeding
   6. Ivoxel contains cetostearyl alcohol, cetyl alcohol, and butylhydroxytoluene.
6. HOW TO USE IVOXEL
   1. Adults, including elderly patients, adolescents, and children over 2 years of age:
   2. Adults, including elderly patients:
   3. Children (over 2 years of age):
   4. Using more than the recommended dose of Ivoxel
   5. Missing a dose of Ivoxel
   6. Stopping the use of Ivoxel
7. POSSIBLE SIDE EFFECTS
   1. Side effects in children and adults associated with topical corticosteroids include reactions occurring:
   2. Common: may affect up to 1 in 10 people:
   3. Uncommon: may affect up to 1 in 100 people:
   4. Rare: may affect up to 1 in 10,000 people:
   5. Frequency not known: frequency cannot be estimated from the available data:
   6. Reporting side effects
8. HOW TO STORE IVOXEL
9. CONTENTS OF THE PACKAGING AND OTHER INFORMATION
   1. What Ivoxel contains
   2. What Ivoxel looks like and contents of the packaging
   3. Marketing authorization holder and manufacturer
   4. The medicinal product has been authorized in the Member States of the European Economic Area under the following names:

Leaflet accompanying the packaging: patient information

Ivoxel

1 mg/g, cream

Mometasone furoate

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. WHAT IS IVOXEL AND WHAT IS IT USED FOR

Ivoxel contains mometasone furoate as the active substance, which belongs to the group of topical corticosteroids (or steroids).
Topical corticosteroids can be divided into 4 groups according to their potency: mild, moderate, potent, and very potent. Ivoxel is classified as a "potent corticosteroid".
In adults, adolescents, and children over 2 years of age, Ivoxel is used to reduce the symptoms of certain inflammatory skin diseases, such as psoriasis (excluding extensive plaque psoriasis) and atopic dermatitis.
Ivoxel will not cure the disease, but it should help to alleviate its symptoms.

2. IMPORTANT INFORMATION BEFORE USING IVOXEL

When not to use Ivoxel

• if the patient or child is allergic to mometasone furoate or any other corticosteroid or anyof the other ingredients of this medicine, listed in section 6,
• in other skin disorders, as Ivoxel may exacerbate these disorders, in particular:
• rosacea (skin disease of the face),
• acne vulgaris,
• perioral dermatitis,
• pruritus in the anal and genital area,
• diaper rash,
• bacterial infections, such as impetigo, viral infections, such as herpes, shingles, and chickenpox, fungal infections, such as athlete's foot (red, itchy, flaky skin on the feet) or yeast infections (vaginal infection that can cause discharge and itching),

in bacterial infections, such as tuberculosis (lung disease) or syphilis (sexually transmitted disease),

• if the patient has recently had a vaccination reaction (e.g., against influenza),
• on the eyelids.

Warnings and precautions

Before starting to use Ivoxel, the patient should discuss it with their doctor or pharmacist.

• Ivoxel should not be used on the eyelids.
• Contact of the cream with the eyes should be avoided. If the medicine comes into contact with the eyes, they should be rinsed thoroughly with clean water. If eye irritation persists, the patient should consult their doctor.
• The cream should not be used on damaged skin and mucous membranes.
• Ivoxel should not be used on the face without close medical supervision.
• If irritation or an allergic reaction occurs after using Ivoxel, the patient should tell their doctor immediately.
• Using Ivoxel in the treatment of psoriasis may worsen the symptoms of the disease (e.g., the development of pustular psoriasis). The doctor should assess the progress of the disease at regular intervals, as the use of this medicine in psoriasis requires close medical supervision.
• If the patient experiences blurred vision or other vision disturbances, they should consult their doctor.

Children (under 2 years of age):

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

Ivoxel and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, or which they plan to use, including those that are available without a prescription and other products or dietary supplements, such as vitamins.
Before using any medicine, the patient should consult their doctor.

• Do notuse products containing latex (e.g., condoms, diaphragms) while using Ivoxel in the genital or anal area, as the safety (efficacy) of these products may be reduced.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before using this medicine.

• If the doctor prescribes the cream to a pregnant or breastfeeding woman, she should avoid using large amounts of the medicine and use it for the shortest possible period.
• Do notuse Ivoxel on the breast skin during breastfeeding.

Ivoxel contains cetostearyl alcohol, cetyl alcohol, and butylhydroxytoluene.

Cetostearyl alcohol and cetyl alcohol may cause local skin reactions (e.g., contact dermatitis). Butylhydroxytoluene may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.

3. HOW TO USE IVOXEL

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. The doctor should assess the use of the medicine at regular intervals.

Adults, including elderly patients, adolescents, and children over 2 years of age:

• Once a day, a thin layer of cream should be gently applied to the affected skin area.
• A small amount of cream should be used. The amount of cream that fits on the tip of the finger (between the end of the adult's index finger and its first joint) is enough to cover an area of skin twice the size of an adult's hand. Never use more cream or apply it more often than the doctor or pharmacist has recommended.

Adults, including elderly patients:

• The cream should not be used on large areas of the body (more than 20% of the body surface) or for prolonged periods (e.g., daily for more than three weeks).
• Unless the doctor has recommended otherwise, the treated area should not be covered with a bandage or dressing. This could increase the absorption of the medicine and enhance the possible side effects.

Children (over 2 years of age):

• Do notuse the cream in children over 2 years of age on any part of the body without close medical supervision.
• Do notuse the cream on a skin surface exceeding 10% of the child's body surface.
• Do notuse the cream in skin folds or under a tight dressing.
• Do notuse the cream for more than 3 weeks.

Method of administration
Ivoxel is intended for topical use (application to the skin).
This medicine is for external use only.

Using more than the recommended dose of Ivoxel

• In case of accidental ingestion of the cream, the medicine is unlikely to cause any side effects. However, if concerned, the patient should consult their doctor or pharmacist.
• If the cream is used more frequently than recommended or on large areas of the body, the medicine may affect the function of certain hormones. In children, this may lead to growth and development disorders.
• If the cream has been used not in accordance with the doctor's recommendations regarding dosage, too frequently, and/or for a prolonged period, the patient should tell their doctor or pharmacist.

Missing a dose of Ivoxel

• The cream should be applied as soon as possible, then the patient should continue using it as before.
• Do notuse a double dose of the cream or apply the cream twice in one day to make up for a missed dose.

Stopping the use of Ivoxel

• In case of prolonged use, the patient should not stop using the cream abruptly, as this may be harmful.
• Treatment should be discontinued gradually, as directed by the doctor.

In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Ivoxel can cause side effects, although not everybody gets them.
If there is no improvement after using the medicine as directed by the doctor or if the symptoms worsen, the patient should consult their doctor.

Side effects in children and adults associated with topical corticosteroids include reactions occurring:

Common: may affect up to 1 in 10 people:

Mild to moderate burning sensation at the application site, tingling/stinging, itching, bacterial infections, sensory disturbances (paresthesia), folliculitis (inflammation of the hair follicles), skin thinning (atrophy).

Uncommon: may affect up to 1 in 100 people:

Irregular skin changes (striae), skin irritation, excessive hair growth (hypertrichosis), skin discoloration, perioral dermatitis, skin softening and whitening (maceration), allergic contact dermatitis, pus-filled bumps on the face (acne-like rash), inflammatory conditions (including acne-like reactions), purple or dark blue skin discoloration (subcutaneous hemorrhages), sweat rash, dryness, hypersensitivity, folliculitis, and secondary infections.

Rare: may affect up to 1 in 10,000 people:

Widening of blood vessels on the skin or "spider veins"

Frequency not known: frequency cannot be estimated from the available data:

Blurred vision.
When using large amounts, treating large skin areas, prolonged treatment, or using under dressings, there is an increased risk of side effects.
Corticosteroids may disrupt the normal production of steroids in the body. This is more likely to occur with prolonged use of large amounts of the medicine.
Especially in children treated with corticosteroids in ointments or creams, there may be absorption of the medicine through the skin and the occurrence of disorders called Cushing's syndrome with many symptoms, such as a "moon face" and weakness. Children treated for a long time may grow more slowly than their peers. To avoid this, the doctor will prescribe the smallest dose of steroid that controls the symptoms of the disease.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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, more information can be collected on the safety of the medicine.

5. HOW TO STORE IVOXEL

The medicine should be kept out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube after the words "Expiry date". The expiry date refers to the last day of the month.
Do not store above 25°C.
Shelf life of the medicinal product after first opening the packaging (tube): 6 months.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACKAGING AND OTHER INFORMATION

What Ivoxel contains

• The active substance of Ivoxel is mometasone furoate. One gram of cream contains 1 mg of mometasone furoate.
• Other ingredients: purified water, white petrolatum containing butylhydroxytoluene (E 321), liquid paraffin, 2-methylpentane-2,4-diol, cetostearyl alcohol (type A), containing disodium/potassium phosphate to adjust the pH, macrogol cetostearyl ether, cetyl alcohol, glycerol, citric acid, sodium citrate, xanthan gum.

What Ivoxel looks like and contents of the packaging

Ivoxel is a white cream.
The packaging of Ivoxel consists of laminated PE/Aluminum tubes with a polypropylene screw cap, in a cardboard box.
Available pack sizes: 10 g, 15 g, 20 g, 25 g, 30 g, 35 g, 50 g, 60 g, 70 g, 90 g, or 100 g of cream.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Almirall Hermal GmbH
Scholtzstrasse 3
21465 Reinbek
Germany
(Logo of the marketing authorization holder)
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:
Almirall Sp. z o. o.
ul. Pileckiego 63
02-781 Warsaw
phone: 22 330 02 57
fax: 22 313 01 57

The medicinal product has been authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: 05/2024