Mometaxon

Patient Information Leaflet

MOMETAXON, 1 mg/g, ointment
Mometasoni furoas
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Mometaxon is and what it is 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 Mometaxon is and what it is used for

Mometaxon is an ointment for topical use on the skin. This medicine contains the active substance
mometasoni furoas, which is a potent corticosteroid intended for local application. When applied to the skin, Mometaxon exerts anti-inflammatory, antipruritic, and vasoconstrictive effects.
Indications
Mometaxon is used in the treatment of inflammatory and itchy skin conditions that respond to topical glucocorticosteroid therapy, such as psoriasis, atopic dermatitis, and irritant or allergic contact dermatitis.

2. Important information before using Mometaxon

When not to use Mometaxon:

• if the patient is allergic to mometasone furoate, other corticosteroids, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has other skin problems, as this medicine may worsen their course; this includes especially:
• rosacea (a skin condition affecting the face),
• acne vulgaris,
• skin atrophy (thinning of the skin),
• perioral dermatitis (inflammation around the mouth),
• itching in the anal or genital area,
• diaper dermatitis,
• bacterial infections such as impetigo, or purulent skin infections,
• tuberculous or syphilitic skin lesions (syphilis – a sexually transmitted disease),

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• viral infections such as herpes simplex, shingles (herpes zoster), or chickenpox,
• warts,
• fungal skin infections such as athlete's foot (symptoms include redness, itching, peeling of the skin of the feet), yeast infections, parasitic infections, or other skin infections,
• skin ulceration or skin damage,
• reactions following vaccination.

Warnings and precautions
Before starting treatment with Mometaxon, discuss this with your doctor or pharmacist.
If skin irritation or hypersensitivity reaction occurs during treatment, discontinue use of the medicine immediately and consult your doctor.
If an infection occurs, your doctor will initiate appropriate antibacterial or antifungal treatment.
The medicine may penetrate through the skin into the body, causing systemic adverse effects of corticosteroids, such as disturbances in the hypothalamic-pituitary-adrenal axis function, Cushing's syndrome, high blood sugar levels (hyperglycemia), and glucose in the urine (glucosuria).
Do not use the medicine on large areas of the body (more than 20% of body surface area) or for prolonged periods (e.g. longer than 3 weeks).
In children aged 2 years and older, the medicine should not be applied to more than 10% of body surface area.
Unless otherwise directed by a physician, do not cover the treated area with a bandage or dressing, as this increases absorption of the medicine and may intensify adverse effects.
In children or on the face, do not cover treated skin areas with dressings (bandages, plasters, or diapers).
If Mometaxon is used on the facial skin, treatment should not last longer than 5 days.
Using Mometaxon in the treatment of psoriasis may exacerbate symptoms of the disease (e.g. development of pustular psoriasis). The doctor will regularly monitor treatment progress, as use of this medicine requires strict supervision.
Do not apply the medicine to the eyelids or around the eye area. Take care to avoid getting the medicine into the eyes.
As with other topically applied medicines containing potent corticosteroids, abrupt discontinuation of treatment should be avoided. Abrupt withdrawal may result in a "rebound effect," characterized by inflammatory skin conditions, increased redness, burning, and stinging pain. In such cases, contact your doctor.
The medicine may alter the appearance of certain skin lesions, which may make it difficult for the doctor to establish a correct diagnosis; it may also delay wound healing.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.

Children
Due to insufficient data, Mometaxon should not be used in children under 2 years of age.
In children aged 2 years and older, the medicine should be used with caution. Chronic treatment with corticosteroids may interfere with children's growth and development.
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Mometaxon with other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.

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 this medicine to a pregnant or breastfeeding woman, she should avoid using large doses and should use the medicine for the shortest possible duration.

Pregnancy
Mometaxon may be used during pregnancy only under strict medical supervision.
As with all corticosteroids, it should be remembered that in pregnant women the medicine may cross the placenta and interfere with fetal growth.

Breastfeeding
Mometaxon may be used during breastfeeding only under strict medical supervision.
If a doctor determines that treatment with higher doses or for a prolonged period is absolutely necessary, breastfeeding should be discontinued.
Do not apply the medicine to the breast area, especially around the nipples.

Driving and operating machinery
Mometaxon has no effect or negligible effect on the ability to drive vehicles or operate machinery.

Mometaxon contains propylene glycol monostearate palmitate
The medicine contains 20 mg of propylene glycol monostearate palmitate in each gram of ointment.
Propylene glycol monostearate palmitate may cause skin irritation.

3. How to use Mometaxon

This medicine should always be used as directed by the physician. If in doubt, consult your
doctor or pharmacist.
Mometaxon is intended for topical use on the skin.
Recommended dose:
Mometaxon should be applied once daily.
Method of application:
A thin layer of Mometaxon should be applied to the affected area of skin.
This medicine is recommended for the treatment of lesions associated with dry, flaky, and cracked skin.
Do not apply to the skin around the eyes or on the eyelids.
Duration of use:
Avoid prolonged use of Mometaxon (longer than 3 weeks) or application over a large
surface area (more than 20% of body surface area).
Use on the face should not exceed 5 days.
If you feel that the effect of Mometaxon is too strong or too weak, consult your
doctor or pharmacist.
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Use in children and adolescents
Children under 2 years of age
Due to insufficient data, Mometaxon should not be used in children under 2 years of age.
Children aged 2 years and older
There are insufficient clinical data on the safety of long-term use (beyond 3 weeks) of mometasone-containing medicines in children.
In children, Mometaxon should be used for the shortest possible duration and at the lowest effective dose required to control symptoms.
In children aged 2 years and older, treatment duration should not exceed 3 weeks, and when applied to facial skin, not exceed 5 days. Mometaxon should only be used on small areas of skin (less than 10% of body surface area) in children.
Use of a higher than recommended dose of Mometaxon
If the patient (or another person) accidentally swallows the medicine, this is unlikely to cause any adverse effects.
However, if in doubt, consult a doctor or pharmacist.
If the medicine is used more frequently than recommended or over large areas of the body, it may affect the function of certain hormones; in children, this may lead to disturbances in growth and development.
If the patient has not used the medicine as directed, has used it too frequently and/or for too long, this should be reported to the doctor or pharmacist.
Prolonged topical use of corticosteroids may lead to suppression of the hypothalamic-pituitary-adrenal (HPA) axis and, consequently, adrenal insufficiency.
Missed dose of Mometaxon
If the patient forgets to apply the medicine at the usual time, the medicine should be applied as soon as the omission is remembered, then treatment should continue as directed.
Do not apply a double amount of medicine or apply it twice within one day to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Below is a list of adverse effects observed in children and adults after topical application of corticosteroids (may occur at the site of application):

Uncommon (may affect fewer than 1 in 100 people):

• dry skin,
• dermatitis,
• perioral inflammation (inflammation around the mouth),
• maceration (softening and whitening of the skin),
• miliaria (sweat rash),
• blurred vision.

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Very rare (may affect fewer than 1 in 10,000 people):

• folliculitis,
• burning sensation,
• pruritus (itching).

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

• skin allergic reactions,
• pain and reactions at the application site,
• skin infection, boils,
• prominent red lines under the skin (so-called "spider veins" – telangiectasia),
• acneiform dermatitis (acne-like skin inflammation),
• tingling or pricking sensation,
• striae (stretch marks),
• skin atrophy (thinning of the skin),
• changes in skin pigmentation,
• hypertrichosis (excessive hair growth).

Using higher doses, over large skin areas, for prolonged periods, or under occlusive dressings increases the absorption of the medicine and raises the risk of systemic and local corticosteroid adverse effects.
Corticosteroids may interfere with the normal production of steroids in the body. This is more likely when high doses of the medicine are used for long periods.
Particularly in children treated with corticosteroid ointments or creams, absorption through the skin may occur, potentially leading to disorders known as Cushing's syndrome, with multiple symptoms including a "moon-shaped" face and muscle weakness. Children treated for prolonged periods may grow more slowly than their peers. To avoid this, the doctor will prescribe the lowest effective dose.
In children receiving topical corticosteroids, cases of intracranial hypertension have been reported, with symptoms possibly including bulging fontanelle, headache, and bilateral optic disc swelling.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: 22 49 21 301, fax: 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Mometaxon

Do not store at temperatures above 25°C. Do not store in the refrigerator. Do not freeze.
Shelf life after first opening the tube: 3 years, but not beyond the expiry date stated on the
packaging.
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Keep the medicine out of the 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Mometaxon contains

• The active substance is mometasone furoate. 1 g of the ointment contains 1 mg of mometasone furoate.
• Other ingredients (excipients) are: hexylene glycol, white wax, propylene glycol monopalmityl stearate, white soft paraffin, concentrated phosphoric acid, purified water.

What Mometaxon looks like and contents of the pack
Mometaxon is a white to slightly yellow ointment.
Packaging:
An aluminium tube with an epoxy-phenolic lacquered inner seal, fitted with a polyethylene (HDPE) cap with a piercing device, placed in a cardboard box.
One package contains 15 g of ointment.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information on the medicinal product
tel.: 22 742 00 22
e-mail: [email protected]
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