Undofen max spray
Poland
Table of Contents
Patient Information Leaflet
UNDOFEN MAX SPRAY, 10 mg/g, cutaneous aerosol, solution
Terbinafini hydrochloridum
Please read all of this leaflet carefully before using the medicine, as it contains important information for you.
You must always use this medicine exactly as described in this patient leaflet or as advised by your doctor or pharmacist.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or further information, please contact your doctor or pharmacist.
- If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement after several days of treatment, or if you feel worse, contact your doctor.
Table of Contents
- What UNDOFEN MAX SPRAY is and what it is used for
- Important information before using UNDOFEN MAX SPRAY
- How to use UNDOFEN MAX SPRAY
- Possible side effects
- How to store UNDOFEN MAX SPRAY
- Contents of the pack and other information
1. What UNDOFEN MAX SPRAY is and what it is used for
UNDOFEN MAX SPRAY is an antifungal medicine for topical use on the skin. The active substance is terbinafine hydrochloride, which has antifungal activity against various species of fungi causing skin infections in humans. UNDOFEN MAX SPRAY exerts a fungicidal effect against dermatophytes, moulds, and some dimorphic fungi.
Indications for UNDOFEN MAX SPRAY:
■ Fungal skin infections:
- Athlete's foot (tinea pedis)
- Fungal infection of skin folds (tinea cruris)
- Fungal infection of smooth skin (tinea corporis)
■ Pityriasis versicolor
Athlete's foot – occurs on one or both feet, most commonly between the toes. It may also affect the plantar arch (sole) of the foot. Fungal lesions between the toes are characterized by maceration and desquamation, and may also present as vesicular eruptions. Acute flare-ups with numerous small blisters often occur during hot weather. Itching, pain, inflammation, and blistering may be mild or severe. In long-standing cases of athlete's foot, nail infection (onychomycosis) may develop. Nails become thickened, dull, and subungual hyperkeratosis accumulates beneath the free edge of the nail. Onycholysis and nail destruction may follow. If nail changes as described above occur, medical advice should be sought, as UNDOFEN MAX SPRAY 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:
- Groin area
- Inner 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
- Armpits
Fungal lesions in these areas cause redness, itching, and epidermal scaling.
Fungal infection of smooth skin (tinea corporis) – may occur anywhere on the body, but is most commonly seen on the non-hairy skin of the head, neck, face, and arms. Characteristic lesions are ring-shaped, pink to red in color, covered with papules and scales. They spread peripherally and tend to clear centrally.
Pityriasis versicolor – appears on the skin as scaly, plaque-like lesions. These lesions may become more visible in summer, as the affected areas do not tan upon sun exposure and appear as hypopigmented or hyperpigmented spots of varying sizes. Pityriasis versicolor mainly affects the trunk, neck, and arms, particularly during hot weather and increased sweating.
If there is no improvement after several days of treatment, or if you feel worse, consult your doctor.
2. Important information before using the medicine UNDOFEN MAX SPRAY
When not to use UNDOFEN MAX SPRAY:
- 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 SPRAY, discuss this with your doctor or pharmacist.
UNDOFEN MAX SPRAY is intended for external use only. Use with caution on areas sensitive to alcohol, as they may be irritated by the alcohol contained in the product. Do not apply to the skin of the face.
Protect the eyes from contact with the medicine. In case of contact with the eyes, rinse thoroughly with running water.
In case of accidental inhalation, if any disturbing symptoms occur, contact a doctor.
Keep UNDOFEN MAX SPRAY out of the sight and reach of children.
Children and adolescents
Do not use UNDOFEN MAX SPRAY in children.
UNDOFEN MAX SPRAY and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No interactions between UNDOFEN MAX SPRAY and other medicines are known.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Do not use UNDOFEN MAX SPRAY during pregnancy unless absolutely necessary in the opinion of a doctor.
Do not use UNDOFEN MAX SPRAY during breastfeeding.
Infants and young children should not have access to the skin of a mother treated with this medicine.
Driving and operating machinery
UNDOFEN MAX SPRAY has no effect on the ability to drive or operate machinery.
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 this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is intended for external use on the skin only.
To use the medicine correctly:
■ clean and dry the area of skin to which it will be applied;
■ remove the protective cap;
■ before first use, press the pump several times (approximately 3 times) until the liquid appears;
■ the medicine can be used both in upright and inverted positions;
■ spray a small amount of liquid onto the affected skin areas and the surrounding region, covering them completely;
■ replace the protective cap;
■ after each application, wash your hands.
Adults
Treatment duration:
Athlete's foot, skin fold and smooth skin fungal infections – once daily for 7 days.
Pityriasis versicolor – twice daily for 7 days.
Clinical improvement is usually observed within a few days. Inadequate treatment or premature discontinuation may result in recurrence of the infection.
If no improvement is observed within a few days of starting treatment, consult a doctor.
What to do during treatment with UNDOFEN MAX SPRAY
To enhance the therapeutic effect, the affected skin should be:
■ kept clean by regular washing;
■ gently dried, without rubbing;
■ not scratched.
Prevention of fungal skin infections includes using your own towel and personal clothing, as well as frequent washing.
Use of UNDOFEN MAX SPRAY in elderly patients
Dosage adjustment is not required in elderly patients.
Use in children and adolescents
UNDOFEN MAX SPRAY should not be used in children.
Use of more than the recommended dose of UNDOFEN MAX SPRAY
If more than the recommended dose is used, contact a doctor.
Missed dose of UNDOFEN MAX SPRAY
Continue treatment as scheduled.
Do not use a double dose to make up for a missed dose.
4. Possible adverse reactions
Like all medicines, this product may cause adverse reactions, although not everyone experiences them.
At the site of application, symptoms such as itching, skin peeling, pain at the application site, irritation at the application site, skin discoloration, burning sensation, skin redness, scab formation, 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, scabs, skin disorders, skin discoloration, redness, burning, 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 SPRAY comes into contact with the eyes, eye irritation may occur.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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, phone: +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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store the medicine
Keep the medicine out of sight and reach of children.
Store below 25°C, do not freeze. Keep 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the packaging and other information
What UNDOFEN MAX SPRAY contains
- The active substance is terbinafine hydrochloride. 1 g of cutaneous aerosol solution contains 10 mg of terbinafine hydrochloride.
- Other components are: cetostearyl macrogol ether, propylene glycol, ethanol 96%, purified water.
What UNDOFEN MAX SPRAY looks like and contents of the pack
The medicinal product pack is a bottle containing 30 ml of solution, closed with a spray pump and a protective cap.
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
{logo Perrigo}
Manufacturer:
Richard Bittner GmbH,
Ossiacherstraße 7,
9560 Feldkirchen in Kärnten
Austria