Pirolam

Package Leaflet: Information for the Patient

Pirolam, 10 mg/ml, Skin Solution

Ciclopirox Olamine

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 directed by a doctor or pharmacist.
• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet

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

1. What is Pirolam and what is it used for

The active substance of Pirolam is ciclopirox olamine. Pirolam is an antifungal medicine for topical use on the skin.
This medicine works on fungi on the skin called dermatophytes, yeast-like fungi, molds, and mixed fungal infections. It also has anti-inflammatory effects, which are particularly important when the fungal infection is accompanied by inflammation.
The medicine penetrates the skin through the epidermis, hair follicles, and sebaceous glands.

Pirolam is used for:

• treatment of smooth skin fungal infections,
• treatment of hairy skin fungal infections,
• treatment of foot fungal infections,
• treatment of lower leg fungal infections.

Smooth skin fungal infection – can occur on the entire body, most commonly found on 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 outward and tend to clear in the central part.
Hairy skin fungal infection – occurs on hairy skin in the form of large, round lesions, which are characterized by skin peeling and broken hairs or in the form of grayish-yellow scabs embedded in the skin.
Foot fungal infection – occurs on one or both feet, most commonly between the toes. It also appears on the sole of the foot (heel). Fungal changes between the toes are characterized by maceration (peeling). These changes can also have a vesicular character. Sudden exacerbations with the eruption of numerous vesicles and blisters usually occur during heatwaves. Itching, pain, inflammation, and vesicle eruption can be mild or severe. In the case of long-lasting foot fungal infection, it is necessary to consult a doctor, as nail infection may occur. In the case of nail fungal infection, the use of Pirolam Lacquer is recommended.
Lower leg fungal infection – symptoms are nodules in the area of hair follicles, and the hairs are broken at the skin surface.
In case of doubts about the cause of the infection before using the medicine, consult a doctor.

2. Important information before using Pirolam

When not to use Pirolam

• if the patient is allergic to ciclopirox olamine or any of the other ingredients of this medicine (listed in section 6),
• if the patient has a fungal infection of the eye, eye area, or vagina,
• in infants and children under 6 years of age.

Warnings and precautions

Before starting to use Pirolam, discuss it with your doctor or pharmacist.
If an allergic reaction occurs, stop the treatment and contact your doctor immediately.
Before starting to use Pirolam, you must consult your doctor:

• if the patient has diabetes, circulatory disorders in the hands and feet, immune system disorders (e.g., HIV infection, patients after transplantation, patients treated with corticosteroids, patients with recurrent or long-lasting herpes or eczema);
• if the patient has skin diseases, such as psoriasis or other chronic skin diseases.

The medicine is intended for use only on the skin.
Do not scratch itching, infected areas.
Protect your eyes from contact with the medicine.
Do not inhale the medicine.
Avoid wearing clothes and shoes that do not allow moisture and heat to escape.
After washing and bathing, dry the affected areas thoroughly.
Clothing that comes into contact with the affected skin, towels, and sponges should be changed daily and washed at 90°C (it is recommended to use disposable towels).
Do not use acidic soaps, as they promote the growth of some fungi.

Children

Do not use in infants and children under 6 years of age.

Pirolam and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
There are no data on the interaction between ciclopirox olamine and other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
Do not use during pregnancy and breastfeeding, unless your doctor decides it is absolutely necessary.
There are no data on the effect of Pirolam on fertility.

Driving and using machines

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

3. How to use Pirolam

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
Use in adults and children over 6 years of age:

• The medicine is applied topically to the skin.
• Pirolam is usually used 2 times a day on the affected skin, gently rubbing or leaving to dry.
• Spray the medicine from a distance of about 10 cm.
• Treatment should be continued until the symptoms of the disease disappear.
• The optimal treatment time is 3 weeks.
• To prevent the recurrence of the disease, it is recommended to continue treatment for 10 days after the symptoms have disappeared.

If the symptoms do not disappear after 4 weeks of treatment, contact your doctor.
To use the medicine properly, you should:

• clean and dry the skin surface to be applied;
• remove the protective cap;
• spray a small amount of liquid on the affected areas of the skin and around them, so that they are completely covered;
• put the protective cap back on;
• wash your hands after each use of the medicine. When spraying the medicine, hold the bottle upright.

Do not use dressings and bandages.

Using more than the recommended dose of Pirolam

There are no data on the overdose of medicines containing ciclopirox olamine used topically.

4. Possible side effects

Like all medicines, Pirolam can cause side effects, although not everybody gets them.
Common(occurring in less than 1 in 10 patients):

• swelling.

Rare(occurring in less than 1 in 1,000 patients):

• allergic contact dermatitis.

Frequency not known(frequency cannot be estimated from the available data):

• burning, skin irritation, redness, itching.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell 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
Phone: +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 Pirolam

Keep the medicine out of sight and reach of children.
Do not store above 25°C. Do not store in the refrigerator or freeze.
Store in the original package.
Do not use this medicine after the expiry date stated on the package .The expiry date refers to the last day of the specified month.
Shelf life after first opening the bottle: 3 months.
Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Pirolam contains

• The active substance is ciclopirox olamine. Each ml of skin solution contains 10 mg of ciclopirox olamine.
• The other ingredients are: isopropyl myristate, absolute ethanol F.

What Pirolam looks like and contents of the package

The carton contains a brown glass bottle with a spray pump, containing 30 ml of skin solution.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz

Date of last revision of the leaflet: