Mometaxon

Package Leaflet: Information for the Patient

MOMETAXON, 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.
• 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 those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Mometaxon and what is it used for

Mometaxon is an ointment for application to the skin. The medicine contains the active substance mometasone furoate, which is a corticosteroid with strong effects, intended for local use. Mometaxon applied to the skin has anti-inflammatory, anti-itching, and vasoconstrictive effects.

Indications

Mometaxon is used to treat all inflammatory and itching skin conditions that respond to local treatment with glucocorticosteroids, such as psoriasis, atopic dermatitis, and contact dermatitis due to irritation or allergy.

2. Important information before using Mometaxon

When not to use Mometaxon:

• rosacea (skin disease of the face),
• acne vulgaris,
• skin atrophy (thinning of the skin),
• perioral dermatitis,
• pruritus in the anal and genital areas,
• diaper dermatitis,
• bacterial infections, such as impetigo, purulent skin infections,
• tuberculous and syphilitic skin lesions (syphilis - a sexually transmitted disease),

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• viral infections, such as herpes, shingles, and chickenpox,
• warts,
• fungal skin infections, such as athlete's foot (symptoms include redness, itching, flaking skin on the feet), yeast infections, parasitic infections, or other skin infections,
• ulcers or skin damage,
• reactions to vaccination.

Warnings and precautions

Before starting treatment with Mometaxon, the patient should discuss it with their doctor or pharmacist.
If skin irritation or hypersensitivity reaction occurs during treatment, the patient should stop using the medicine immediately and consult their doctor.
If an infection occurs, the doctor will prescribe appropriate antibacterial or antifungal treatment.
The medicine may penetrate the skin and cause systemic side effects of corticosteroids, such as disorders of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, high blood sugar levels (hyperglycemia), and glucose in the urine (glycosuria).
The medicine should not be used on large areas of the body (more than 20% of the body surface) or for a long time (e.g., more than 3 weeks).
In children over 2 years of age, the medicine should be used on a maximum of 10% of the body surface.
Unless otherwise advised by the doctor, the treated area should not be covered with a bandage or dressing, as this increases the absorption of the medicine and enhances the side effects.
In children or on the face, the treated areas of the skin should not be covered with a dressing (bandage, plaster, or diaper).
If Mometaxon is used on the face, treatment should not last longer than 5 days.
Using Mometaxon in the treatment of psoriasis may cause worsening of the disease symptoms (e.g., occurrence of pustular psoriasis). The doctor will regularly monitor the progress of treatment, as the use of this medicine requires close supervision.
The medicine should not be applied to the eyelids or the area around the eyes. The patient should be careful not to get the medicine into their eyes.
As with other medicines used locally that contain potent corticosteroids, sudden discontinuation of treatment should be avoided. After sudden withdrawal of the medicine, a rebound effect may occur, manifested by skin inflammation, increased redness, burning, and stinging. In such cases, the patient should contact their doctor.
The medicine may change the appearance of some skin lesions, making it difficult for the doctor to diagnose them, and may also delay healing.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

Children

Due to the lack of sufficient data, Mometaxon should not be used in children under 2 years of age.
In children over 2 years of age, the medicine should be used with caution. Long-term treatment with corticosteroids may disrupt growth and development in children.
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Mometaxon and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
If the doctor prescribes the medicine to a pregnant or breastfeeding woman, she should avoid using large doses and use the medicine for as short a time as possible.

Pregnancy

During pregnancy, Mometaxon should only be used under strict medical supervision.
As with the use of all corticosteroids, it should be remembered that in pregnant women, the medicine may pass through the placenta and disrupt the growth of the unborn child.

Breastfeeding

During breastfeeding, Mometaxon should only be used under strict medical supervision.
If the doctor considers it necessary to use higher doses or treat for a longer period, the patient should stop breastfeeding.
The medicine should not be applied to the breast area.

Driving and using machines

The medicine has no influence or negligible influence on the ability to drive and use machines.

Mometaxon contains propylene glycol monostearate

The medicine contains 20 mg of propylene glycol monostearate per gram of ointment.
Propylene glycol monostearate may cause skin irritation.

3. How to use Mometaxon

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Mometaxon is intended for application to the skin.
Recommended dose:
Mometaxon should be used once a day.
Method of application:
A thin layer of Mometaxon should be applied to the affected skin area.
The medicine is recommended for the treatment of dry, flaky, and rough skin.
Do not use on the skin around the eyes or on the eyelids.
Duration of treatment:
Long-term use of Mometaxon (longer than 3 weeks) or on large areas of the body (more than 20% of the body surface) should be avoided.
Treatment on the face should not last longer than 5 days.
If the patient feels that the effect of Mometaxon is too strong or too weak, they should consult their doctor or pharmacist.
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Use in children and adolescents Children under 2 years of age

Due to the lack of sufficient data, Mometaxon should not be used in children under 2 years of age.
Children over 2 years of age
There are insufficient clinical data on the safety of using mometasone-containing medicines in children for more than 3 weeks.
In children, Mometaxon should be used for the shortest possible treatment period and the smallest possible dose that provides effective treatment.
In children over 2 years of age, the treatment duration is a maximum of 3 weeks, and when used on the face, 5 days. Mometaxon should be used in children only on small areas of the skin (less than 10% of the body surface).

Using a higher dose of Mometaxon than recommended

If the patient (or someone else) accidentally swallows the medicine, it should not cause any disorders. However, in case of doubts, the patient should consult their doctor or pharmacist.
If the medicine is used more frequently than recommended or on large areas of the body, it may affect the function of some hormones; in children, it may cause growth and development disorders.
If the patient has not used the medicine as directed, used it too frequently, and/or for a long time, they should inform their doctor or pharmacist.
Long-term local use of corticosteroids may lead to suppression of the hypothalamic-pituitary-adrenal axis and, consequently, to adrenal insufficiency.

Missing a dose of Mometaxon

If the patient forgets to apply the medicine at the usual time, they should use it as soon as they remember, and then continue treatment as directed.
The patient should not use a double dose of the medicine or apply it twice in one day to make up for the missed dose.
In case of any further doubts about using this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Mometaxon can cause side effects, although not everybody gets them.
The following side effects have been reported in children and adults after local use of corticosteroids (may occur at the site of application):
Uncommon(may occur in less than 1 in 100 people):

• dry skin,
• dermatitis,
• irritation and inflammation of the skin around the mouth,
• softening and whitening of the skin (maceration),
• sweating,
• blurred vision.

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Rare(may occur in less than 1 in 10,000 people):

• folliculitis,
• burning sensation,
• itching.

Side effects with unknown frequency(frequency cannot be estimated from the available data):

• skin allergic reactions,
• pain and reactions at the site of application,
• skin infections, furuncles,
• visible red lines under the skin (telangiectasias),
• acne-like dermatitis,
• tingling or prickling,
• stretch marks,
• skin atrophy (thinning of the skin),
• skin color changes,
• excessive hair growth.

Using higher doses, on large areas of the skin, for a long time, or under dressings, increases the absorption of the medicine and the risk of systemic and local side effects of corticosteroids.
Corticosteroids may disrupt the normal production of steroids in the body. This is more likely if large doses of the medicine are used for a long time.
In particular, in children treated with corticosteroids in ointments or creams, it is possible for the corticosteroid to be absorbed through the skin, which may cause disorders known as Cushing's syndrome with many symptoms, including 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 effective dose of the medicine.
In children treated with corticosteroids locally, increased intracranial pressure has been reported, with symptoms that may include bulging fontanelle, headache, and bilateral papilledema.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw,
phone: 22 49 21 301, fax: 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Mometaxon

Do not store above 25°C. Do not store in the refrigerator. Do not freeze.
Shelf life after first opening the tube: 3 years, but no longer than the expiry date stated on the packaging.
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The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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 pack and other information

What Mometaxon contains

• The active substance of the medicine is mometasone furoate. 1 g of ointment contains 1 mg of mometasone furoate.
• The other ingredients (excipients) are: hexylene glycol, white wax, propylene glycol monostearate, white petrolatum, phosphoric acid, purified water.

What Mometaxon looks like and contents of the pack

Mometaxon is a white to light yellow ointment.
Packaging of the medicine:
Aluminum tube with a sealing membrane, internally coated with epoxy-phenolic lacquer, with a polyethylene (HDPE) screw cap and a piercer, placed in a cardboard box.
One pack contains 15 g of ointment.

Marketing authorization holder and manufacturer

“HASCO-LEK” Pharmaceutical Company S.A.
51-131 Wrocław, Żmigrodzka 242 E Street
Medicine information
phone: 22 742 00 22
e-mail: [email protected]

Date of last revision of the leaflet:

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