Ivoxel

Package leaflet: Information for the patient

Ivoxel
1 mg/g, cream
Mometasoni furoas
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Ivoxel is and what it is 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 pack and other information

1. WHAT IVOXEL IS AND WHAT IT IS USED FOR

Ivoxel contains as its active substance mometasoni furoas, which belongs to a group of medicines called
corticosteroids (or steroids) for topical use.
Topical corticosteroids are classified according to their potency into 4 groups: mild,
moderate, potent, and very potent. Ivoxel is classified as a "potent corticosteroid".
In adults, adolescents, and children aged 2 years and older, Ivoxel is used to reduce symptoms caused by certain inflammatory skin diseases, such as psoriasis (excluding extensive plaque psoriasis) and atopic dermatitis.
Ivoxel will not cure the disease, but it should help relieve 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 any of the other ingredients of this medicine listed in section 6,
• in other skin disorders, because Ivoxel may worsen these conditions, particularly:
• rosacea (a skin disease of the face),
• acne vulgaris,
• perioral dermatitis,
• itching around the anus and genital area,
• diaper rash,
• bacterial infections such as impetigo, viral infections such as herpes simplex, shingles and chickenpox, fungal infections such as athlete's foot (red, itchy, scaly skin of the feet) or yeast infection (vaginal infection which may cause discharge and itching),
• bacterial infections such as tuberculosis (lung disease) or syphilis (sexually transmitted disease),
• if the patient has recently experienced a reaction after vaccination (e.g. against influenza),
• on the eyelids.

Warnings and precautions
Before starting to use Ivoxel, discuss this with your doctor or pharmacist.

• Do not use Ivoxel on the eyelids.
• Avoid contact of the cream with the eyes. If the medicine gets into the eyes, rinse thoroughly with clean water. If eye irritation persists, contact your doctor.
• Do not apply the cream to broken or damaged skin or mucous membranes.
• Do not use Ivoxel on the face without strict medical supervision.
• If irritation or allergic reaction occurs after applying Ivoxel, inform your doctor immediately.
• Use of this medicine in psoriasis treatment may lead to worsening of symptoms (e.g. development of pustular psoriasis). The doctor should regularly monitor disease progression, as treatment with this medicine in psoriasis requires close medical supervision.
• If the patient experiences blurred vision or other visual disturbances, contact a doctor.

Children (under 2 years of age):
Ivoxel must not be used in children under 2 years of age.
Ivoxel and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as other products or dietary supplements such as vitamins.
Consult your doctor before using any medicine.

• Do not use latex-containing products (e.g. condoms, vaginal diaphragm) during application of Ivoxel around the genital area or anus, as the safety (effectiveness) of these products may be reduced.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

• If a doctor prescribes the cream during pregnancy or breastfeeding, the patient should avoid using large doses and should use the medicine for the shortest possible duration.
• Do not apply Ivoxel to the skin of the breasts during breastfeeding.

Ivoxel contains cetostearyl alcohol emulsifying, cetyl alcohol, and butylated hydroxytoluene.
Cetostearyl alcohol emulsifying and cetyl alcohol may cause local skin reactions (e.g. contact dermatitis). Butylated hydroxytoluene may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. HOW TO USE THE MEDICINAL PRODUCT IVOXEL

This medicinal product should always be used according to the doctor's instructions. If in doubt, consult your doctor or pharmacist. The doctor should regularly review the treatment with this medicinal product.

Adults, including elderly patients, adolescents, and children aged 2 years and older:

• Apply a thin layer of cream gently to the affected skin area once daily.
• Use only a small amount of cream. A quantity of cream applied to the tip of an adult finger (from the tip of the index finger to the first joint) is sufficient to cover an area of skin twice the size of an adult hand. Never use more cream or apply it more frequently than instructed by your doctor or pharmacist.

Adults, including elderly patients:

• Do not apply the cream to large areas of the body (more than 20% of body surface area) or for prolonged periods (e.g., daily for more than three weeks).
• Unless otherwise directed by your doctor, do not cover the treated area with a bandage or dressing. Doing so may increase absorption of the medicinal product and intensify potential adverse effects.

Children (aged 2 years and older):

• Do not use the cream in children over 2 years of age on any part of the body without strict medical supervision.
• Do not apply the cream to an area exceeding 10% of the child's body surface area.
• Do not apply in skin folds or under occlusive dressings.
• Do not use for longer than 3 weeks.

Method of administration
Ivoxel is intended for use on the skin (topical application).
This medicinal product is for external use only.

Use of more than the recommended dose of Ivoxel

• If the cream is accidentally swallowed, it is unlikely to cause adverse effects. However, if concerned, contact your doctor or pharmacist.
• If the cream is used more frequently than recommended or over large areas of skin, it may affect the function of certain hormones. In children, this may lead to disturbances in growth and development.
• If the cream has been used contrary to the doctor's dosing instructions, too frequently and/or for prolonged periods, inform your doctor or pharmacist.

Missed dose of Ivoxel

• Apply the cream as soon as possible, then continue treatment as previously directed.
• Do not apply a double dose or use the cream twice in one day to make up for a missed dose.

Stopping treatment with Ivoxel

• After prolonged use, do not stop using the cream abruptly, as this may be harmful.
• Treatment should be discontinued gradually, in accordance with your doctor's instructions.

If you have any further questions about the use of this medicinal product, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Ivoxel can cause adverse reactions, although not everyone experiences them.
If there is no improvement after using the medicine as recommended by the doctor, or if symptoms worsen,
you should contact your doctor.
Adverse reactions in children and adults associated with topical use of
corticosteroids include the following:
Common: may occur in up to 1 in 10 people:
Mild to moderate burning sensation at the application site, tingling/pricking sensation,
itching, bacterial infections, sensory disturbances (paraesthesia), skin boils (furunculosis),
skin thinning (skin atrophy).
Uncommon: may occur in up to 1 in 100 people:
Irregular skin changes (striae), skin irritation, excessive hair growth (hypertrichosis),
skin pigmentation changes, perioral dermatitis, skin softening and whitening (skin maceration),
allergic contact dermatitis, pustular lesions on the facial skin (rosacea-like dermatitis),
inflammatory conditions (including acneiform reactions), purplish or dark bluish skin discoloration (subcutaneous haemorrhages),
sweating, dryness, sensitization, folliculitis, and secondary infections.
Very rare: may occur in up to 1 in 10,000 people:
Dilated blood vessels in the skin or "spider veins"
Frequency unknown: frequency cannot be estimated from the available data:
Blurred vision.
When large doses are used, large skin areas are treated, treatment is prolonged, or when the medicine is used under occlusive dressings, the risk of adverse reactions increases.
Corticosteroids may interfere with normal steroid production in the body. This is more likely with long-term use of high doses.
Especially in children treated with corticosteroid ointments or creams, the medicine may be absorbed through the skin, leading to disturbances known as Cushing's syndrome, with multiple symptoms such as "moon face" and muscle weakness. Children undergoing prolonged treatment may grow more slowly than their peers. To avoid this, the doctor will prescribe the lowest dose of corticosteroid that adequately controls disease symptoms.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 IVOXEL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the tube
following the words: "Expiry date". The expiry date refers to the last day of the stated month.
Do not store above 25°C.
The shelf life of the medicinal product after first opening of the container (tube): 6 months.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Ivoxel contains

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

What Ivoxel looks like and contents of the pack
Ivoxel is a white cream.
Ivoxel is supplied in laminated tubes made of PE/Aluminium with a polipropylene cap, packed in a cardboard box.
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 Authorisation Holder and Manufacturer
Almirall Hermal GmbH
Scholtzstrasse 3
21465 Reinbek
Germany
(Logo of the Marketing Authorisation Holder)
For further information, contact the local representative of the Marketing Authorisation 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 authorised for use in the Member States of the European
Economic Area under the following names: