Package leaflet: Information for the patient

Pirolam, 10 mg/ml, solution for skin application
Ciclopirox olamine
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 the doctor or pharmacist.
Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, consult your doctor.

Contents of the leaflet

What Pirolam is and what it is used for
Important information before using Pirolam
How to use Pirolam
Possible side effects
How to store Pirolam
Contents of the pack and other information

1. What Pirolam is and what it is used for

Pirolam is an antifungal medicine intended for topical application to the skin.
The active substance in Pirolam (ciclopirox olamine) acts against fungi present on the skin,
known as dermatophytes, yeast-like fungi, moulds, and mixed fungal infections.
It also has anti-inflammatory and antibacterial effects against certain bacteria (Gram-positive
and Gram-negative).
The medicine penetrates the skin through the epidermis, hair follicles, and sebaceous glands.
Pirolam is used for the treatment of:

fungal infections of smooth skin,
fungal infections of hairy skin,
fungal infections of the feet (athlete's foot),
fungal infections of the lower legs.

Fungal infection of smooth skin – may occur anywhere on the body, but is most commonly found on the non-hairy skin of the head, neck, face, and arms. Characteristic features are ring-shaped lesions ranging in colour from pink to red. These lesions are covered with papules and scales, spread peripherally, and tend to clear centrally.
Fungal infection of hairy skin – occurs on hairy skin in the form of large, round lesions characterized by skin scaling and broken hairs, or as grey-yellow crusts embedded in the skin.
Fungal infection of the feet – affects one or both feet, most commonly between the toes. It may also appear on the sole of the foot. Fungal lesions between the toes are characterized by maceration (softening and peeling). These changes may also present as vesicular eruptions. Acute flare-ups with numerous small blisters and larger blisters typically occur during hot weather. Itching, pain, inflammation, and blistering may be mild or severe. In cases of long-standing fungal infection of the feet, medical advice should be sought, as nail infection (onychomycosis) may develop. In case of nail infection, Pirolam Nail Lacquer is recommended.
Fungal infection of the lower legs – symptoms include papules around hair follicles and broken hairs at skin level.
If in doubt about the cause of the infection, consult a doctor before using this medicine.

2. Important information before using Pirolam

When not to use Pirolam

if the patient is allergic to ciclopirox olamine or to 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 treatment with Pirolam, discuss it with your doctor or pharmacist.
If an allergic reaction occurs, discontinue treatment and contact your doctor immediately.
Before starting treatment with Pirolam, consult a doctor:

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

This medicine is intended for topical use only.
Do not scratch itchy, infected areas.
Avoid contact with the eyes.
Do not inhale the medicine.
Avoid wearing clothing and footwear that do not allow moisture and heat to escape.
After washing or bathing, thoroughly dry the affected areas.
Clothing, towels, and sponges that come into contact with affected skin should be changed daily
and washed at 90°C (the use of disposable towels is recommended).
Do not use acidic soaps, as they promote the growth of certain 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 the patient is currently using,
has recently used, or plans to use.
There are no data available on possible interactions between ciclopirox olamine and other
medicines.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have
a child, she should consult her doctor or pharmacist before using this medicine.
Do not use during pregnancy or breastfeeding unless the doctor decides it is absolutely
necessary.
There are no data on the effect of Pirolam on fertility.
Driving and operating machinery
Pirolam has no influence on the ability to drive or operate machinery.

3. How to use Pirolam

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Use in adults and children over 6 years of age:

This medicine is for topical application to the skin.
Pirolam is usually applied twice daily to the affected skin area, gently rubbing in or leaving it to dry.
Spray the medicine from a distance of approximately 10 cm.
Treatment should continue until symptoms have resolved.
The optimal treatment duration is 3 weeks.
To prevent recurrence of the disease, it is recommended to continue treatment for an additional 10 days after the disappearance of clinical lesions.

If symptoms do not improve after 4 weeks of treatment, consult a doctor.
To use the medicine correctly, follow these steps:

Clean and dry the skin area to be treated;
Remove the protective cap;
Spray a small amount of the liquid onto the affected skin areas and surrounding regions, ensuring complete coverage;
Replace the protective cap;
After each application, wash your hands. The bottle should be held in an upright position during spraying.

Do not use dressings or plasters.
Use of a higher than recommended dose of Pirolam
There is no data available on overdose with topical medicines containing ciclopirox olamine.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Common (affecting less than 1 in 10 patients):

swelling.

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

allergic contact dermatitis.

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

burning sensation, skin irritation, erythema, itching.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, 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
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 Pirolam

Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Do not store in the refrigerator or freeze.
Store in the original packaging.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Period of use after first opening of the bottle: 3 months.
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 package and other information

What Pirolam contains

The active substance is ciclopirox olamine. Each ml of topical solution contains 10 mg of ciclopirox olamine.
The other ingredients are: myristyl isopropylate, absolute ethanol F.

What Pirolam looks like and contents of the pack
The carton contains a brown glass bottle with a spray pump, holding 30 ml of topical solution.
Marketing Authorisation Holder
POLPHARMA S.A. Pharmaceutical Works
Pelplińska Street 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
POLPHARMA S.A. Pharmaceutical Works
Medana Branch in Sieradz
Władysława Łokietka Street 10, 98-200 Sieradz