Patient Information Leaflet

Pirolam, 10 mg/g, topical suspension
Ciclopirox olaminum
Please read this 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 doctor or pharmacist.
Keep this leaflet for future reference.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, contact your doctor.

Table of contents

What is Pirolam and what is it 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 is Pirolam and what is it 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,
Athlete’s foot (tinea pedis),
Tinea cruris (fungal infection of the groin area).

Fungal infection 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 include ring-shaped lesions with pink to red discoloration. 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.
Athlete’s foot – occurs on one or both feet, most frequently between the toes. It may also affect the sole of the foot (plantar surface). Fungal lesions between the toes are characterized by maceration (skin softening and peeling). These changes may also have a vesicular appearance. Acute flare-ups with numerous vesicles and blisters typically occur during hot weather. Itching, pain, inflammation, and vesicle formation may range from mild to severe. In cases of persistent athlete’s foot, medical consultation is essential, as nail infection (onychomycosis) may develop. For fungal nail infections, Pirolam Nail Lacquer is recommended.
Tinea cruris (fungal infection of the groin) – symptoms include papules around hair follicles and broken hairs at the skin surface.
If you are uncertain about the cause of the infection, consult your 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 or surrounding areas,
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, discontinue treatment immediately and contact your doctor.
Before starting treatment with Pirolam, you must consult a doctor:

if the patient has diabetes, circulatory disorders in the hands and feet, or immune system disorders (e.g. HIV infection, transplant patients, patients receiving 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 or infected areas.
Pirolam is not intended for the treatment of vaginal fungal infections.
Avoid contact of the medicine with the eyes.
Avoid wearing clothing and footwear that do not allow moisture and heat to escape.
After washing and bathing, thoroughly dry the affected areas.
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
Inform your doctor or pharmacist about all medicines you are currently using,
have recently used, or plan 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 influence on the ability to drive or operate machinery.
Pirolam, cutaneous suspension, contains cetostearyl alcohol, benzyl alcohol, and propylene glycol (E 1520)
The medicine may cause local skin reactions (e.g. contact dermatitis).
Pirolam contains 9 mg of benzyl alcohol in each gram of suspension. Benzyl alcohol
may cause allergic reactions. Pirolam may cause mild local irritation.
Pirolam contains 50 mg of propylene glycol in each gram of suspension.

3. How to use Pirolam

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.
Use in adults and children over 6 years of age:

The medicine is applied topically to the skin.
Pirolam is usually applied twice daily to the affected skin area, gently rubbed in or left 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 days after the disappearance of clinical signs.

If symptoms do not improve after 4 weeks of treatment, consult a doctor.
Do not use dressings or patches.
Use of a higher than recommended dose of Pirolam
There is no data available regarding 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 reactions occur, including any adverse reactions not listed
in this leaflet, inform a 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.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

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.
Period of use after first opening of 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 topical suspension contains 10 mg of ciclopirox olamine.
The other ingredients are: propylene glycol, benzyl alcohol, liquid paraffin, cetostearyl alcohol, lactic acid, cetostearyl macrogol ether, purified water.

What Pirolam looks like and contents of the pack
Immediate packaging: an aluminium tube closed with a plastic cap, containing 20 g of topical suspension.
Outer packaging: a cardboard box.
Marketing Authorisation Holder
POLPHARMA S.A. Pharmaceutical Works
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
POLPHARMA S.A. Pharmaceutical Works
Medana Branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz