Package leaflet: Information for the user

Kalium hypermanganicum Galena
100 mg, tablets
Potassium permanganate
Please read all of this leaflet carefully before you start 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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If your symptoms persist or worsen, consult your doctor.

Contents of the leaflet

What Kalium hypermanganicum Galena is and what it is used for
Important information before using Kalium hypermanganicum Galena
How to use Kalium hypermanganicum Galena
Possible side effects
How to store Kalium hypermanganicum Galena
Contents of the package and other information

1. What Kalium hypermanganicum Galena is and what it is used for

Kalium hypermanganicum Galena is a medicine in tablet form, containing the active substance potassium permanganate.
Kalium hypermanganicum Galena is used topically only in the form of a potassium permanganate solution prepared by dissolving the tablet in water.
The solution has antiseptic and astringent effects on the skin and mucous membranes.
Aqueous solutions of potassium permanganate are unstable and range in color from light pink to dark violet.

Indications for use
A 0.05% aqueous solution of potassium permanganate is used as an antiseptic for washing the skin, suppurating wounds, ulcers, and hands.
A 0.025% aqueous solution of potassium permanganate is used as an antiseptic for rinsing the mucous membranes of the throat and oral cavity.

2. Important information before using Kalium hypermanganicum Galena

When not to use Kalium hypermanganicum Galena

if the patient is allergic to potassium permanganate,
orally,
for eye irrigation.

Warnings and precautions
Aqueous solutions of the medicinal product should not be used in high concentrations or for prolonged periods, as they may cause irritation of the skin and mucous membranes.
The use of the medicinal product should be discontinued if signs of irritation occur.
The solution must not be swallowed during rinsing of the throat or oral mucosa.

Pregnancy and breastfeeding
Kalium hypermanganicum Galena should not be used during pregnancy and breastfeeding.

Driving and operating machinery
Kalium hypermanganicum Galena has no influence on the ability to drive or operate machinery.

3. How to use Kalium hypermanganicum Galena

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.
Kalium hypermanganicum Galena is intended for the preparation of a potassium permanganate solution for topical use.

Preparation of a 0.05% potassium permanganate solution for washing the skin, suppurating wounds,
ulcers, and also hands
Dissolve 1 tablet of the medicine in 200 ml (1 glass) of boiled water. The solution should be purple.

Preparation of a 0.025% potassium permanganate solution for rinsing the mucous membranes of the throat and oral cavity
Dissolve 1 tablet of the medicine in 400 ml (2 glasses) of boiled water. The solution should be pink.

Use freshly prepared solution. This solution should be used immediately after preparation. Do not swallow the solution.

Use of a higher than recommended dose of Kalium hypermanganicum Galena
Potassium permanganate solutions of high concentration are irritating to tissues. Application of potassium permanganate solution with concentration higher than therapeutic (including potassium permanganate in crystalline form or powder) to the skin or mucous membranes may cause skin burns and tissue necrosis.

If a tablet of Kalium hypermanganicum Galena or the solution (after dissolving the tablet in water) is ingested, swelling, nausea, vomiting, perforation of the oesophagus and stomach, liver and kidney damage, and cardiorespiratory failure may occur.

In case of overdose, seek immediate medical advice.

If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Repeated use of potassium permanganate solutions at the recommended concentrations may cause
severe irritation and brownish discoloration of the skin.
When using the Kalium hypermanganicum Galena solution on the oral mucous membranes,
an unpleasant taste in the mouth, discoloration of teeth and mucous membranes, nausea,
and vomiting may occur.
Inhalation of the Kalium hypermanganicum Galena solution vapors may lead to
swelling of the respiratory tract.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your 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
Phone: +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.
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Kalium hypermanganicum Galena

Keep in the original packaging.
The medicine should be stored out of sight and reach of children.
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 pack and other information

What Kalium hypermanganicum Galena contains

The active substance is potassium permanganate. Each tablet contains 100 mg of potassium permanganate.
Kalium hypermanganicum Galena does not contain any excipients.

What Kalium hypermanganicum Galena looks like and contents of the pack
Kalium hypermanganicum Galena is available as tablets. The tablet is violet-black, round, and flat on both sides.
Pack available:
30 tablets in a glass, amber-coloured bottle closed with a polyethylene stopper, placed in a cardboard box with a patient information leaflet.

Marketing Authorisation Holder and Manufacturer
Farmaceutyczna Spółdzielnia Pracy „GALENA”
ul. Dożynkowa 10
52-311 Wrocław
Poland
Tel. +48 71 710 62 01