Undofen Max

Package Leaflet: Information for the User

UNDOFEN MAX 10 mg/g, cream

Terbinafine hydrochloride

Read the package leaflet carefully before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in the package leaflet for the patient or as advised by
the doctor or pharmacist.

• The package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after a few days or the patient feels worse, they should contact their doctor.

Package Leaflet Contents

• 1. What is Undofen Max and what is it used for
• 2. Important information before using Undofen Max
• 3. How to use Undofen Max
• 4. Possible side effects
• 5. How to store Undofen Max
• 6. Package contents and other information

1. What is Undofen Max and what is it used for

Undofen Max is an antifungal medicine for use on the skin. The active substance is terbinafine hydrochloride, which has an antifungal effect on various species of fungi that cause skin diseases in humans. Undofen Max has a fungicidal effect on dermatophytes, molds, and some dimorphic fungi. On yeasts, depending on the species, it has a fungicidal or fungistatic effect (inhibiting fungal growth).
Indications for use of Undofen Max:
■fungal skin infections:

• athlete's foot,
• fungal infections of skin folds,
• fungal infections of smooth skin. ■pityriasis versicolor.

Athlete's foot -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 numerous vesicles and blisters usually occur during heatwaves. Itching, pain, inflammation, and vesicles may be mild or severe. In the case of long-standing athlete's foot, nail infection (fungal infection on the surface or under the nail plate) may occur. The nails become thickened, dull, and there is an accumulation of keratinous masses under the free edge of the nail. The nail plate becomes stratified, and the nail may be destroyed. If the above-mentioned changes occur in the nails, a doctor should be consulted, as Undofen Max is not effective in treating nail fungus.
Fungal infections of skin folds -may occur 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 often more severe on one side; these changes may spread to the buttocks or up the abdomen);

on the skin under the breasts;

• in the armpits. The fungal changes that occur in these areas cause redness, itching, and peeling of the skin.

Fungal infections of smooth skin -may occur on the entire body, most often on the non-hairy skin of the head, neck, face, and arms. Characteristic are ring-shaped lesions with a pink to red color. They are covered with crusts and scales, spread peripherally, and tend to clear in the central part.
Pityriasis versicolor -occurs on the skin in the form of peeling, patchy lesions. These changes may only be visible in the summer, as the fungal lesions do not tan under the influence of sun exposure, and appear as spots of various sizes. Pityriasis versicolor usually occurs on the torso, neck, arms, especially during heatwaves, with increased sweating of the skin.
If there is no improvement after a few days or the patient feels worse, they should contact their doctor.

2. Important information before using Undofen Max

When not to use Undofen Max:

• if the patient is allergic to terbinafine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Undofen Max, the doctor or pharmacist should be consulted.
Undofen Max is intended for use on the skin only. The eyes should be protected from contact with the medicine. If the medicine gets into the eyes, they should be rinsed with clean, warm water.

Children and adolescents

Undofen Max should not be used in children.

Undofen Max and other medicines

The doctor or pharmacist should be informed about all medicines currently being taken or recently taken, as well as any medicines that the patient plans to take.
No interactions between Undofen Max and other medicines are known.

Undofen Max with food and drink

Undofen Max can be used independently of meals.

Pregnancy, breastfeeding, and fertility

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.
Undofen Max should not be used during pregnancy, unless the doctor considers it absolutely necessary.
Undofen Max should not be used during breastfeeding.
Infants and young children should not have access to the skin of a breastfeeding woman treated with this medicine.

Driving and using machines

Undofen Max has no effect on the ability to drive and use machines.

Undofen Max contains cetyl alcohol

The medicine may cause a local skin reaction (e.g., contact dermatitis).

Undofen Max contains benzyl alcohol

The medicine contains 10 mg of benzyl alcohol in each gram of cream.
Benzyl alcohol may cause allergic reactions or mild local irritation.

3. How to use Undofen Max

This medicine should always be used exactly as described in the package leaflet for the patient or as advised by
the doctor or pharmacist. If there are any doubts, the doctor or pharmacist should be consulted.
The medicine is for use on the skin.
Adults
Undofen Max cream can be used once or twice a day. Before applying the cream, the skin surface should be thoroughly cleaned and dried. Then, a thin layer of cream should be applied to the affected areas of the skin and around them, and gently rubbed in. If the changes are in skin folds (under the breast, between the toes, between the buttocks, in the groin), a gauze dressing can be applied, especially at night.
Treatment duration
Athlete's foot, fungal infections of skin folds, smooth skin - 7 days.
Pityriasis versicolor - 14 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.

Use in children and adolescents

Undofen Max should not be used in children, as the safety and efficacy of the medicine in this age group have not been studied.

Use in elderly patients

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

Using more than the recommended dose of Undofen Max

In case of using more than the recommended dose of the medicine, the doctor should be contacted.

Missing a dose of Undofen Max

In case of missing a dose, it should be used as soon as possible, and then the medicine should be used according to the dosing schedule. A double dose should not be used to make up for the missed dose.

Stopping use of Undofen Max

Undofen Max should be used as recommended. If there are any further doubts about using this medicine, the doctor or pharmacist should be consulted.

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, skin discoloration, 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 treatment to be discontinued.

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, skin discoloration, redness, burning sensation, pain, pain at the site of application, irritation at the site of application.

Rare side effects (may affect up to 1 in 1,000 people)

Dryness of the skin, contact dermatitis, rash, exacerbation of disease symptoms at the site of application.
In case of contact between Undofen Max and the eyes, eye irritation may occur.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the package leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Undofen Max

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C, do not freeze.
The medicine should not be used 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. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Package contents and other information

What Undofen Max contains

• The active substance is terbinafine hydrochloride. 1 g of cream contains 10 mg of terbinafine hydrochloride.
• The other ingredients are: isopropyl myristate, cetyl alcohol, synthetic oleic acid, sorbitan stearate, polysorbate 60, benzyl alcohol, sodium hydroxide, purified water.

What Undofen Max looks like and what the package contains

Undofen Max is a white cream with a uniform consistency.
The package contains a tube with 15 g of cream, placed in a cardboard box.

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:

Medgenix Benelux NV
Vliegveld 21
8560 Wevelgem
Belgium

Date of last revision of the package leaflet: August 2024