Brodacid

Package Leaflet: Information for the Patient

BRODACID

Lactic Acid + Salicylic Acid
(50.4 mg + 100 mg)/g
liquid for the skin
This medicine should always be used exactly as described in the package leaflet or as directed by your doctor or pharmacist, or nurse.

• You should keep this leaflet, you may need to read it again.
• If you need advice or further information, you should speak to your pharmacist.
• If you get any side effects, talk to your doctor or pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse, you should contact your doctor.

Table of Contents of the Leaflet:

• 1. What is BRODACID and what is it used for
• 2. Important information before using BRODACID
• 3. How to use BRODACID
• 4. Possible side effects
• 5. Storing BRODACID
• 6. Other information

1. WHAT IS BRODACID AND WHAT IS IT USED FOR

BRODACID is a liquid for the skin, containing the active substances salicylic acid and lactic acid. Salicylic acid acts keratolytically, softening and loosening the thickened skin, making it easier to remove.
Lactic acid is a cauterizing agent that destroys the thickened skin layer.
The excipient of the medicine - dimethyl sulfoxide increases the penetration of the active ingredients into the tissue.

Indications

Treatment of common warts, periungual warts, plantar warts, and mosaic warts.

2. IMPORTANT INFORMATION BEFORE USING BRODACID: WHEN NOT TO USE

Do not use BRODACID

• if you are allergic to the active substances - lactic acid or salicylic acid, or any of the other ingredients of this medicine (listed in section 6),
• for the treatment of flat warts and lesions located in the eye area, on mucous membranes, and on the face,
• on hairy and non-hairy moles,
• on infected or inflamed skin,
• during pregnancy and breastfeeding,
• in children under 2 years of age.

Warnings and Precautions

Before starting to use BRODACID, you should discuss it with your doctor, pharmacist, or nurse.
The medicine is intended for external use only.
You should stop the treatment if skin irritation occurs.
You should protect your eyes, respiratory tract, and mucous membranes from the medicine and its vapors. In case of accidental contact of the medicine with your eyes or mucous membranes, you should rinse them immediately with a large amount of water.
The medicine should be applied only to the warts.
You should not use the medicine on healthy, unchanged skin, or on damaged skin, as salicylic acid can be absorbed through the skin and cause systemic side effects. If the medicine accidentally gets on the surrounding healthy skin, you should rinse it with water immediately.
In case of accidental ingestion of the medicine, you should contact your doctor immediately.

Use in Children

Do not use in children under 2 years of age.
In children from 2 to 12 years of age, it can be used only under the supervision of a doctor.

BRODACID and Other Medicines

You should tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about the medicines you plan to take.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before using this medicine.
Due to the lack of studies on the use of the medicine in pregnant and breastfeeding women, the medicine cannot be used during pregnancy and breastfeeding.

Driving and Using Machines

BRODACID has no influence on the ability to drive and use machines.

3. HOW TO USE BRODACID

This medicine should always be used exactly as described in the package leaflet or as directed by your doctor, pharmacist, or nurse. If you are unsure, you should ask your doctor, pharmacist, or nurse.
Apply the medicine to the clean and dry surface of the wart using the applicator. After unscrewing the cap and removing the applicator, wait for a moment until the excess liquid flows back into the bottle, and then apply the medicine only to the surface of the wart, making sure that the liquid does not get on the healthy skin, mucous membranes, or eyes.
After applying the medicine to the wart, wait for a moment until the liquid dries in the form of a white film.
Use twice a day on clean and dry skin. Apply only to the surface of the wart, depending on the treatment result, for several days, up to a maximum of 6-8 weeks.
Store the bottle tightly closed, and screw the cap back on after each use.
Protect from evaporation.

Use in Children

Do not use in children under 2 years of age.
In children from 2 to 12 years of age, it can be used only under the supervision of a doctor.

Using More Than the Recommended Dose of BRODACID

There is no data on overdose of the medicine when used according to the indications and recommended use.

Missing a Dose of BRODACID

You should not use a double dose to make up for a missed dose.

Stopping the Use of BRODACID

If you have any further questions about the use of the medicine, you should ask your doctor, pharmacist, or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, BRODACID can cause side effects, although not everybody gets them.
Around the surrounding skin, burning and erosion may occur, leaving temporary discoloration.
In case of extensive redness in the surrounding skin or other side effects, you should stop using the medicine and contact your doctor.
If any of the side effects get worse or if you notice any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.

Reporting Side Effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. 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, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail:
ndl@urpl.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 BRODACID

Keep out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the label.
Store below 25°C.
The medicine is flammable.
Due to the flammability of the product, store away from fire and heat sources.
Medicines should not be disposed of via wastewater or household waste. You should 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 BRODACID contains

The active substances of BRODACID are lactic acid and salicylic acid.
1 g of liquid for the skin contains 50.4 mg of lactic acid, in the form of a 90% solution of lactic acid, and 100 mg of salicylic acid.
The medicine also contains the excipients:

• nitrocellulose (2:1) + ethyl acetate, dimethyl sulfoxide.

What BRODACID looks like and contents of the pack

The medicine is a liquid for the skin.
Packaging:
A colorless glass bottle containing 8 g of liquid for the skin with a polyethylene applicator and cap, placed in a cardboard box.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
GRUPA INCO S.A.
ul. Wspólna 25
00-519 Warsaw
Manufacturer:
Wydział Produkcji Leków
ul. Ks. Kurowskiego 93
05-080 Izabelin Os. Hornówek
To obtain more detailed information, you should contact the representative of the Marketing Authorization Holder:
Wydział Produkcji Leków
05-080 Izabelin
tel. 22 722 89 01
fax. 22 722 89 00

Date of Approval of the Leaflet: