Pirolam

Leaflet attached to the packaging: patient information

Pirolam, 10 mg/g, gel

Ciclopirox olamine

Please read the contents of the 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 a doctor or pharmacist.
• Please keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, please contact a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.
• If you do not improve or feel worse, please 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. Contents of the packaging 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 that occur on the skin, called dermatophytes, yeast-like fungi, molds, and mixed fungal infections. It also has anti-inflammatory properties, 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 often 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, spreading outward and showing a tendency to regress 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 often 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 spread of numerous vesicles and blisters usually occur during heatwaves. Itching, pain, inflammation, and vesicle spread 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, it is recommended to use Pirolam Lacquer.
Lower leg fungal infection – symptoms are nodules in the area of hair follicles, and hairs are broken at the skin surface.
In case of doubts about the cause of the infection before using the medicine, please 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 eye infection and surrounding areas,
• in infants and children under 6 years of age.

Warnings and precautions

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

• if the patient has diabetes, circulatory disorders in 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.
Avoid wearing clothes and shoes that do not allow moisture and heat to escape.
After washing and bathing, please 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

Please tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you 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, please consult your doctor or pharmacist 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

Pirolam does not affect the ability to drive or use machines.

Pirolam gel contains ethanol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), and propylene glycol (E1520)

Etanol

This medicine contains 160 mg of alcohol (ethanol) per gram of gel.
It may cause burning of damaged skin.

Methyl parahydroxybenzoate and propyl parahydroxybenzoate

The medicine may cause allergic reactions (possible late-type reactions).

Propylene glycol

The medicine contains 110 mg of propylene glycol per 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 leaflet or as directed by a doctor or pharmacist. If you are unsure, please consult 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 applied 2 times a day to the affected skin, gently rubbing or leaving to dry.
• Treatment should be continued until the symptoms of the disease disappear.
• The optimal treatment duration is 3 weeks.
• To prevent the recurrence of the disease, it is recommended to continue treatment for 10 days after the disappearance of the disease symptoms.

If the symptoms do not disappear after 4 weeks of treatment, please contact your doctor.
Do not use dressings and plasters.

Using a higher dose of Pirolam than recommended

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):

• edema.

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, please 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 packaging.
Do not use this medicine after the expiry date stated on the packaging .The expiry date refers to the last day of the month stated.
Shelf life after first opening the tube: 3 months.
Medicines should not be disposed of via wastewater or household waste. Please ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging 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 packaging

An aluminum tube closed with a plastic cap, containing 20 g of gel, placed in a cardboard box.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +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: