Undofen Max Sprai

Leaflet attached to the packaging: information for the user

UNDOFEN MAX SPRAY, 10 mg/g, skin spray, solution

Terbinafine hydrochloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a doctor or pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after a few days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is UNDOFEN MAX SPRAY and what is it used for

UNDOFEN MAX SPRAY is an antifungal medicine for use on the skin. The medicine contains the active substance terbinafine hydrochloride, which has an antifungal effect on various species of fungi that cause skin diseases in humans. UNDOFEN MAX SPRAY has a fungicidal effect on dermatophytes, molds, and some dimorphic fungi.

Indications for use of UNDOFEN MAX SPRAY:

■Fungal skin infections:

• fungal infection of the feet,
• fungal infection of skin folds,
• fungal infection of smooth skin. ■Pityriasis versicolor.

Fungal infection of the feet -occurs on one or both feet, most often between the toes. It also appears on the plantar surface of the foot (sole). The fungal changes between the toes are characterized by maceration, peeling, and may also have a vesicular character. Sudden exacerbations with the appearance of numerous vesicles and blisters usually occur during heatwaves. Itching, pain, inflammation, and the appearance of vesicles may be mild or severe. In the case of long-standing fungal infection of the feet, there may be an infection of the nails (fungal infection on the surface or under the nail plate). The nails become thickened, dull, and there is an accumulation of horny masses under the free edge. The nail plate becomes layered, and the nail may be destroyed. If the above-mentioned changes occur in the nails, you should consult a doctor, as UNDOFEN MAX SPRAY is not effective in fungal nail infections.

Fungal infection of skin folds -may appear in areas of the skin that are folded and moist, i.e.:

• in the groin;
• on the inner surface of the thighs (bilateral changes, but also often more severe on one side; these changes may spread to the buttocks or up the abdomen);
• under the breasts;
• in the armpits. The fungal changes that appear in these areas cause redness, itching, and peeling of the skin.

Fungal infection of smooth skin -may occur on the entire body, most often found on non-hairy skin of the head, neck, face, and arms. Characteristic are ring-shaped foci of pink to red color. They are covered with granules and scales, spread peripherally, and tend to regress in the central part.

Pityriasis versicolor -occurs on the skin in the form of peeling, patchy foci. These changes may appear only in the summer, as the fungal lesions do not tan under the influence of sunbathing, they appear as spots of different sizes. Pityriasis versicolor usually appears on the torso, neck, arms, especially during heatwaves, with increased sweating of the skin.

If after a few days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before using UNDOFEN MAX SPRAY

When not to use UNDOFEN MAX SPRAY:

Warnings and precautions

Before starting to use UNDOFEN MAX SPRAY, you should discuss it with your doctor or pharmacist.

UNDOFEN MAX SPRAY is intended for use on the skin only. It should be used with caution in areas sensitive to the effects of alcohol, as they may be irritated by the alcohol contained in the product. The medicine should not be used on the face.

You should protect your eyes from contact with the medicine. If the medicine comes into contact with the eyes, they should be rinsed thoroughly with running water.

In case of accidental inhalation of the medicine, if any worrying symptoms occur, you should contact your doctor.

UNDOFEN MAX SPRAY should be kept out of the sight and reach of children.

Children and adolescents

UNDOFEN MAX SPRAY should not be used in children.

UNDOFEN MAX SPRAY and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking, or have recently taken, and any medicines you plan to take.

No interactions of UNDOFEN MAX SPRAY with other medicines are known.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.

UNDOFEN MAX SPRAY should not be used during pregnancy, unless your doctor considers it absolutely necessary.

UNDOFEN MAX SPRAY should not be used during breastfeeding.

Infants and young children should not have access to the skin of the mother being treated with this medicine.

Driving and using machines

UNDOFEN MAX SPRAY has no effect on the ability to drive and use machines.

UNDOFEN MAX SPRAY contains propylene glycol

The medicine contains 5 g of propylene glycol in 100 g of solution.

Propylene glycol may cause skin irritation.

UNDOFEN MAX SPRAY contains ethanol

This medicine contains 23.5 g of alcohol (ethanol) in 100 g of solution.

The medicine may cause a burning sensation on damaged skin.

3. How to use UNDOFEN MAX SPRAY

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

The medicine is intended for use on the skin only.

To use the medicine properly, you should:

■ clean and dry the skin surface to which it will be applied;

■ remove the protective cap;

■ before the first use, press the pump several times (about 3 times) until the liquid appears;

■ the medicine can be used in both upright and inverted positions;

■ spray a small amount of liquid onto the diseased areas of the skin and around them, so as to cover them completely;

■ put the protective cap back on;

■ after each use of the medicine, wash your hands.

Adults

Treatment duration:

Fungal infection of the feet, skin folds, smooth skin - 1 time a day for 7 days.

Pityriasis versicolor - 2 times a day for 7 days.

Clinical improvement is usually achieved after a few days. Using the medicine inconsistently with the recommendations or stopping treatment too early may lead to a relapse of the disease.

If after a few days of starting treatment, there is no improvement, you should consult a doctor.

How to proceed during the use of UNDOFEN MAX SPRAY

To increase the therapeutic effect, you should keep the diseased skin:

■ clean through regular washing.

■ gently pat dry, do not rub.

■ avoid scratching.

The basis for the prevention of fungal skin diseases is the use of your own towel, personal clothes, and frequent washing.

Using UNDOFEN MAX SPRAY in elderly patients

In elderly patients, there is no need to change the dosage.

Using UNDOFEN MAX SPRAY in children and adolescents

UNDOFEN MAX SPRAY should not be used in children.

Using a higher dose of UNDOFEN MAX SPRAY than recommended

In case of using a higher dose of the medicine than recommended, you should contact your doctor.

Missing a dose of UNDOFEN MAX SPRAY

You should continue using the medicine.

You should not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

At the site of application, symptoms such as itching, peeling of the skin, pain at the site of application, irritation at the site of application, change in skin color, burning sensation of the skin, redness of the skin, formation of scabs, etc. may occur. However, these symptoms should not be confused with hypersensitivity reactions, including rash, which require discontinuation of treatment.

Common side effects (may affect up to 1 in 10 people)

Peeling of the skin, itching.

Uncommon side effects (may affect up to 1 in 100 people)

Skin changes, scabs, skin disorders, change in skin color, redness, burning, pain, pain at the site of application, irritation at the site of application.

Rare side effects (may affect up to 1 in 1000 people)

Dryness of the skin, contact dermatitis, rash, exacerbation of disease symptoms at the site of application.

In case of contact of UNDOFEN MAX SPRAY with the eyes, eye irritation may occur.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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

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 UNDOFEN MAX SPRAY

The medicine should be stored in a place out of sight and reach of children.

Store in a temperature below 25°C, do not freeze. Store in the original packaging.

Do not use this medicine after the expiry date stated on the carton after: Expiry date. The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. You should ask your 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 UNDOFEN MAX SPRAY contains

• The active substance of the medicine is terbinafine hydrochloride. 1 g of skin spray solution contains 10 mg of terbinafine hydrochloride
• The other ingredients are: macrogol ether cetostearyl, propylene glycol, ethanol 96%, purified water.

What UNDOFEN MAX SPRAY looks like and contents of the packaging

The packaging of the medicine is a bottle containing 30 ml of the medicine, closed with a spray pump and a protective cap.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Perrigo Poland Sp. z o.o.

ul. Domaniewska 48

02-672 Warsaw

tel.: +48 (22) 852 55 51

{logo Perrigo}

Manufacturer:

Richard Bittner AG,

Ossiacherstraße 7,

A-9560 Feldkirchen

Austria

Date of last revision of the leaflet: August 2024