Package leaflet: Information for the patient

Pirolam, 10 mg/g, gel
Ciclopirox olaminum
Please read the entire leaflet carefully before using the medicine, as 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 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 adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, contact your doctor.

Table of contents

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
called dermatophytes, yeast-like fungi, molds, 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:

Treatment of tinea of smooth skin,
Treatment of tinea of hairy skin,
Treatment of tinea pedis (athlete's foot),
Treatment of tinea of the lower legs.

Tinea of smooth skin – may occur anywhere on the body, most commonly seen on the non-hairy skin of the head, neck, face, and arms. Characteristic features are annular lesions with pink to red discoloration. They are covered with papules and scales, spread peripherally, and tend to clear centrally.
Tinea of hairy skin – occurs on hairy skin in the form of large, round lesions characterized by skin desquamation and broken hairs, or as gray-yellow crusts embedded in the skin.
Tinea pedis – occurs on one or both feet, most frequently between the toes. It may also appear on the sole of the foot (plantar surface). Fungal changes between the toes are characterized by maceration (softening and peeling). These lesions may also present as vesicular eruptions. Acute exacerbations with numerous vesicles and blisters typically occur during hot weather. Itching, pain, inflammation, and vesicle formation may be mild or severe. In cases of persistent tinea pedis, medical consultation is essential, as nail infection may develop. In cases of onychomycosis, Pirolam Nail Lacquer is recommended.
Tinea 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 physician before using the 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 or areas around the eye,
in infants and children under 6 years of age.

Warnings and precautions
Before starting to use Pirolam, discuss this with your doctor or pharmacist.
If an allergic reaction occurs, treatment must be stopped and you should 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, or immune system disorders (e.g. HIV infection, transplant patients, patients simultaneously treated 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.
Itching, infected areas should not be scratched.
Take care to protect the eyes from contact with the medicine.
Avoid wearing clothes and footwear that do not allow moisture and heat to escape.
After washing or bathing, affected areas should be thoroughly dried.
Clothing in contact with affected skin, towels and sponges 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 interactions between ciclopirox olamine and other
medicines.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant,
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 effect on the ability to drive or operate machinery.
Pirolam gel contains ethanol, methyl parahydroxybenzoate (E 218),
propyl parahydroxybenzoate and propylene glycol (E 1520).
Ethanol
This medicine contains 160 mg of alcohol (ethanol) in each gram of gel.
It may cause a burning sensation on damaged skin.
Methyl parahydroxybenzoate and propyl parahydroxybenzoate
This medicine may cause allergic reactions (delayed-type reactions are possible).
Propylene glycol
The medicine contains 110 mg of propylene glycol in each gram of gel.
Propylene glycol may cause skin irritation.

3. How to use Pirolam

This medicine should always be used exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Use in adults and children over 6 years of age:

Apply the medicine topically to the skin.
Pirolam is usually applied twice daily to the affected skin area, gently rubbing in or leaving it to dry.
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 0.-10 days after the disappearance of clinical lesions.

If symptoms do not improve after 4 weeks of treatment, consult your doctor.
Do not use dressings or plasters.
Use of a higher than recommended dose of Pirolam
There is no data available on overdose with topical ciclopirox olamine-containing medicinal products.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience 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 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
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.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Pirolam

Keep the medicine out of the sight and reach of children.
Do not store at temperatures 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.
Shelf-life after first opening the tube: 3 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Pirolam contains

The active substance is ciclopirox olamine. Each gram of gel contains 10 mg of ciclopirox olamine.
The other ingredients are: propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, ethanol 96%, glycerol, carbomer, tromethamine, purified water.

What Pirolam looks like and contents of the pack
An aluminium tube closed with a plastic cap, containing 20 g of gel, placed in a cardboard box.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
Tel. +48 22 364 61 01
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
Władysława Łokietka Street 10, 98-200 Sieradz