Undofen max

Package leaflet: Information for the user

UNDOFEN MAX 10 mg/g, cream
Terbinafini hydrochloridum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after several days, or if you feel worse, contact your doctor.

Table of contents

1. What Undofen Max is and what it is 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. Contents of the pack and other information

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

Undofen Max is an antifungal medicine for topical use. The medicine contains the active substance
terbinafini hydrochloridum, which has antifungal activity against various species of fungi causing
skin diseases in humans. Undofen Max has fungicidal activity against dermatophytes, moulds, and some
dimorphic fungi. Against yeasts, depending on the species, it acts either fungicidally or fungistatically
(inhibits fungal growth).
Indications for use of Undofen Max:
■ fungal skin infections:

• athlete's foot (tinea pedis),
• fungal infection of skin folds,
• tinea of smooth skin. ■ pityriasis versicolor.

Athlete's foot – occurs on one or both feet, most commonly between the toes. It may also appear on
the plantar surface of the foot (sole). Fungal lesions between the toes are characterized by maceration,
desquamation, and may also be vesicular. Acute exacerbations with numerous small blisters and
vesicles typically occur during hot weather. Itching, pain, inflammation, and vesicle formation may be
mild or severe. In long-standing cases of athlete's foot, nail infection may develop (onychomycosis on
the surface or beneath the nail plate). Nails become thickened, dull, and subungual accumulation of
keratinous material occurs. Nail plate delamination follows, and the nail may be destroyed. If nail
changes as described above occur, medical advice should be sought, as Undofen Max is not effective
in treating fungal nail infections.
Fungal infection of skin folds – may appear in skin areas that are folded and moist, such as:

• in the groin;

• on the inner surface of the thighs (lesions may be bilateral, but often more pronounced on one side; they may spread to the buttocks or upwards towards the abdomen);

• under the breasts;

• in the armpits. Fungal lesions in these areas cause redness, itching, and desquamation of the epidermis.

Tinea of smooth skin – may occur anywhere on the body, but is most commonly seen on the
non-hairy skin of the head, neck, face, and arms. Characteristic features are annular lesions with a
pink to red color. The lesions are covered with papules and scales, spread peripherally, and tend to
clear centrally.
Pityriasis versicolor – appears on the skin as scaly, plaque-like lesions. These changes may become
more evident only during summer, as the affected areas do not tan when exposed to sunlight, thus
appearing as hypopigmented spots of varying sizes. Pityriasis versicolor mainly occurs on the trunk,
neck, and arms, especially during hot weather and increased sweating.
If there is no improvement after several days, or if you feel worse, consult your 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 treatment with Undofen Max, consult your doctor or pharmacist.
Undofen Max is for external use only. Eyes should be protected from contact with the medicine. If the medicine gets into the eyes, rinse thoroughly with clean, warm water.
Children and adolescents
Undofen Max should not be used in children.
Undofen Max and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
No interactions between Undofen Max and other medicines are known.
Undofen Max with food and drink
Undofen Max can be used regardless of meals.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Undofen Max should not be used during pregnancy unless, in the opinion of the doctor, it is absolutely necessary.
Undofen Max should not be used during breastfeeding.
Infants and young children should not have access to the skin of a woman being treated with this medicine during breastfeeding.
Driving and operating machinery
Undofen Max has no effect on the ability to drive or operate machinery.
Undofen Max contains cetyl stearyl alcohol
This medicine may cause local skin reactions (e.g. contact dermatitis).
Undofen Max contains benzyl alcohol
The medicine contains 10 mg of benzyl alcohol in each g 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 this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This is a topical medicine for skin application.
Adults
Undofen Max cream may be applied once or twice daily. Before applying the cream, thoroughly clean and dry the skin area to be treated. Then, apply a thin layer of cream to the affected skin areas and surrounding regions, and gently rub in. If lesions are located in skin folds (under the breasts, between fingers, between buttocks, in the groin area), a gauze dressing may additionally be applied, especially at night.
Duration of treatment
Athlete's foot, skin fold infections, smooth skin – 7 days.
Pityriasis versicolor – 14 days.
Clinical improvement is usually observed within a few days. Inconsistent use or premature discontinuation of treatment may result in disease recurrence.
Use in children and adolescents
Undofen Max should not be used in children, as the safety and efficacy of the medicine have not been studied in this age group.
Use in elderly patients
No dosage adjustment is necessary in elderly patients.
Use of a higher than recommended dose
If a higher than recommended dose is used, contact a doctor.
Missed dose of Undofen Max
If a dose is missed, apply the medicine as soon as possible, then continue treatment according to the prescribed schedule. Do not use a double dose to make up for the missed dose.
Discontinuation of Undofen Max
Undofen Max should be used as directed. If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
At the application site, symptoms such as itching, skin peeling, pain at the application site,
irritation at the application site, skin discoloration, skin burning sensation, redness of the skin,
crusting, etc. may occur. However, these symptoms should not be confused with hypersensitivity reactions,
including rash, which require discontinuation of treatment.
Common adverse reactions (may occur in 1 out of 10 people)
Skin peeling, itching.
Uncommon adverse reactions (may occur in 1 out of 100 people)
Skin changes, crusting, skin disorders, skin discoloration, redness, burning sensation, pain,
pain at the application site, irritation at the application site.
Rare adverse reactions (may occur in 1 out of 1000 people)
Dry skin, contact dermatitis, rash, worsening of disease symptoms at the application site.
If Undofen Max comes into contact with the eyes, eye irritation may occur.
Reporting of adverse reactions
If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet,
you should 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.
By reporting adverse reactions, more information on the safety of the medicine can be collected.

5. How to store Undofen Max

Keep this medicine out of sight and reach of children.
Store below 25°C. Do not freeze.
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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package 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, cetostearyl alcohol, synthetic paraffin, sorbitan monostearate, polysorbate 60, benzyl alcohol, sodium hydroxide, purified water.

What Undofen Max looks like and contents of the pack
Undofen Max is a white, homogeneous cream.
The medicine is packed in a tube containing 15 g of cream, placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Perrigo Poland Sp. z o.o.
ul. Domaniewska 48
02-672 Warsaw
Tel.: +48 (22) 852 55 51
{Perrigo logo}
Manufacturer:
Medgenix Benelux NV
Vliegveld 21
8560 Wevelgem
Belgium