Hascofungin

Package Leaflet: Information for the Patient

HASCOFUNGIN
10 mg/ml, solution for cutaneous application
Ciclopirox olamine
You should carefully read the contents of this 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 your 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 ask your pharmacist.
If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

1. What is Hascofungin solution for cutaneous application and what is it used for
2. Important information before using Hascofungin solution for cutaneous application
3. How to use Hascofungin solution for cutaneous application
4. Possible side effects
5. How to store Hascofungin solution for cutaneous application
6. Contents of the pack and other information

1. What is Hascofungin solution for cutaneous application and what is it used for

The active substance of Hascofungin solution for cutaneous application (ciclopirox olamine) has antifungal effects, destroying the cells of pathogenic fungi and yeast that cause skin diseases, as well as anti-inflammatory and anti-itching effects.
The following are sensitive to the effects of ciclopirox olamine: pathogenic fungi and yeast, as well as some bacteria (Gram-positive and Gram-negative).

Indications for Use

Local treatment of all forms of skin fungal infections:

• skin candidiasis (yeast infection that usually occurs between the toes, under the breasts, and in skin folds);
• fungal infections of the feet, lower legs, and groin;
• tinea versicolor (colorful fungus);
• subacute eczema caused by fungi and yeast.

2. Important Information Before Using Hascofungin Solution for Cutaneous Application

Do not use Hascofungin solution for cutaneous application

• If you are allergic to ciclopirox olamine or any other component of this medicine (see section 6).

Precautions before using Hascofungin solution for cutaneous application
You should be cautious when using this medicine in children, as their skin is more sensitive.
You should avoid contact with the eyes.
In the case of recurring fungal skin infections, you should consult a doctor to determine the cause of the recurrence and implement appropriate treatment.

Concomitant Medications

No interactions with other medications have been found.

Pregnancy and Breastfeeding

Before using the medicine, you should consult a doctor or pharmacist.
There is insufficient data on the use of Hascofungin during pregnancy and breastfeeding. Therefore, during pregnancy and breastfeeding, the medicine should only be used when the benefit to the mother outweighs the potential risk to the child.

Driving and Operating Machines

The medicine does not affect the ability to drive vehicles and operate machines.

Children and Adolescents

There is no data on the use of this medicine in children.

HascoFungin Solution for Cutaneous Application and Other Medications

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

No interactions with other medications have been found.

Pregnancy and Breastfeeding

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

Driving and Operating Machines

The medicine does not affect the ability to drive vehicles and operate machines.

3. How to Use HascoFungin Solution for Cutaneous Application

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you have any doubts, you should consult a doctor or pharmacist.
The medicine is intended for cutaneous use only.
Usually, the medicine is applied to the affected areas of the skin and surrounding areas 2 times a day (morning and evening).
Treatment should be continued until the disappearance of the disease changes, usually from 2 to 4 weeks, and in the case of foot fungus for a month or longer. If the changes do not disappear, you should contact a doctor.
The packaging should be removed by twisting the cap. Then, press the button firmly and, directing the stream towards the affected area of the skin, evenly distribute the medicine. During the first use, you should press the pump button several times to vent and obtain proper spraying.
Using a higher dose of HascoFungin solution for cutaneous application than recommended
There is no data on overdose.
If you use a higher dose of the medicine than recommended, you should immediately consult a doctor or pharmacist.

Missing a Dose of HascoFungin Solution for Cutaneous Application

You should use the medicine as soon as possible.
If you have any further doubts about using this medicine, you should consult a doctor or pharmacist.

4. Possible Side Effects

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

Common (may affect up to 1 in 10 people)

• skin irritation at the application site
• itching

Uncommon (may affect up to 1 in 100 people)

• rash
• skin redness

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

• allergic reactions

Very Rare (may affect up to 1 in 10,000 people)

• angioedema

Reporting Side Effects

If you experience any side effects, you should report them to your doctor or pharmacist or directly to the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.

5. How to Store Hascofungin Solution for Cutaneous Application

Store at a temperature below 25°C. Store in the original, closed packaging to protect from light.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of Hascofungin Solution for Cutaneous Application

What Hascofungin solution for cutaneous application contains and what the packaging contains

• The active substance of the medicine is ciclopirox olamine. 1 ml of the solution contains 10 mg of ciclopirox olamine.
• The other ingredients (excipients) are: isopropyl alcohol, macrogol 400, purified water.

What Hascofungin solution for cutaneous application looks like and what the packaging contains
Hascofungin solution for cutaneous application is a clear solution with a characteristic odor.
One packaging of the medicine contains 30 ml.
Responsible entity and manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A. 51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine information
tel. +48 22 722 00 22
e-mail: [email protected]
Date of the last update of the leaflet: