Pirolam

Package Leaflet: Information for the Patient

Pirolam, 10 mg/g, Skin Suspension

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 further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If you do not improve or 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. Contents of the pack 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 properties, which is 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 foci of pink to red color. They are covered with crusts and scales, spread peripherally, and tend to regress in the central part.
Hairy skin fungal infection - occurs on hairy skin, in the form of large, round foci, 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, the use of Pirolam Lacquer is recommended.
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, consult a doctor.

2. Important information before using Pirolam

When not to use Pirolam

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, consult your doctor:

The medicine is intended for use on the skin only.
Do not scratch itching, infected areas.
The medicine is not intended for the treatment of vaginal fungal infections.
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, 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 might take.
There is 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, 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 is no data on the effect of Pirolam on fertility.

Driving and using machines

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

Pirolam, skin suspension, contains cetostearyl alcohol, benzyl alcohol, and propylene glycol (E1520)

The medicine may cause local skin reaction (e.g., contact dermatitis).
Pirolam contains 9 mg of benzyl alcohol in each gram of suspension. Benzyl alcohol may cause allergic reactions or 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 the package leaflet for the patient or as directed by a doctor or pharmacist. If you are unsure, 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 used 2 times a day on 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 symptoms have disappeared.

If the symptoms do not disappear after 4 weeks of treatment, consult your doctor.
Do not use dressings and patches.

Using more than the recommended dose of Pirolam

There is 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 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 specified month.
Shelf life after first opening the tube: 3 months.
Medicines should 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 pack and other information

What Pirolam contains

• The active substance is ciclopirox olamine. Each gram of skin suspension contains 10 mg of ciclopirox olamine.
• The other ingredients are: propylene glycol, benzyl alcohol, liquid paraffin, cetostearyl alcohol, lactic acid, macrogol cetostearyl ether, purified water.

What Pirolam looks like and contents of the pack

Immediate packaging: aluminum tube closed with a plastic cap, containing 20 g of skin suspension.
Outer packaging: 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: