BORASOL

Package leaflet: Information for the user

BORASOL 30 mg/g solution for skin application
Boric acid
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse, consult your doctor.

Contents of the leaflet

1. What Borasol is and what it is used for
2. Important information before using Borasol
3. How to use Borasol
4. Possible side effects
5. How to store Borasol
6. Contents of the pack and other information

1. What Borasol is and what it is used for

Borasol is a solution for topical application to the skin. Borasol contains the active substance boric acid, which has antifungal and antibacterial properties.
Indications
For disinfection in inflammatory skin conditions, rashes, burns, contusions, inflammatory soft tissue swellings, superficial damage to the epidermis or skin, and in inflammatory conditions of the external urogenital organs.

2. Important information before using Borasol

When not to use Borasol:

• if the patient is allergic to boric acid,
• orally,
• in the eyes,
• on extensive wounds and open cuts,
• on large areas of skin.

Warnings and precautions
Before starting to use Borasol, consult a doctor or pharmacist.
Prolonged treatment should be carried out only under medical supervision.
If skin irritation or redness occurs, discontinue use and seek advice from a doctor.

Children and adolescents
Do not use in infants and children under 11 years of age.

Borasol and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines you plan to take.
Do not use Borasol with medicines containing methenamine, tannin, carbonates, alkaline hydroxides, colloidal silver solutions, quaternary ammonium bases, or Peruvian balsam.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor before using this medicine.
There is a lack of data on the safety of using Borasol during pregnancy and breastfeeding.

Driving and operating machinery
No effects on the ability to drive or operate machinery have been observed.

3. How to use Borasol

This medicine should always be used exactly as described in this patient leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine is intended for topical application to the skin.
Unless otherwise advised by a doctor, the affected areas should usually be wiped with the medicine 2 to 3 times daily. Apply as compresses, dressings, or rinses. Use for a short period only.
If you feel that the effect of Borasol is too strong or too weak, consult a doctor.
Use of a higher than recommended dose of Borasol
If too much medicine is applied, wash it off the skin with water and contact a doctor.
Missed application of Borasol
If you miss an application of Borasol, continue treatment as usual according to the instructions.
If the medicine is accidentally swallowed, contact a doctor immediately.
If you have any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the medicine is applied to damaged skin, the following may occur: redness, rash, peeling of the stratum corneum, loss of appetite, vomiting, diarrhoea, convulsions, fever, collapse, kidney damage, oliguria, drowsiness, coma.
If the medicine is used long-term, symptoms of chronic boric acid poisoning may occur, such as gastrointestinal disturbances, dermatitis, menstrual disorders, anaemia, weakness, convulsions and alopecia.
If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform a doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C, 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 authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Borasol medicine

Keep the medicine out of the sight and reach of children.
Store below 25°C in the original, tightly closed packaging. Protect from light.
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.
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 package and other information

What Borasol contains

• The active substance is boric acid. 1 g of the skin solution contains 30 mg of boric acid.
• Other ingredient: purified water.

What Borasol looks like and contents of the pack
The medicine is a clear skin solution.
Available pack sizes
Bottles containing 50 g, 100 g, 190 g, 200 g, 250 g, 500 g, 1000 g and 5000 g of the medicine.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Poland
Poznańskie Zakłady Zielarskie "Herbapol" S.A.
ul. Towarowa 47-51, 61-896 Poznań
tel. +48 61 886 18 00, fax +48 61 853 60 58
Manufacturer
Poznańskie Zakłady Zielarskie "Herbapol" S.A.
Paterek, ul. Przemysłowa 3, 89-100 Nakło nad Notecią
tel. +48 52 386 73 10, fax +48 52 386 73 23