PROMANUM PURE

Package leaflet: Information for the user

Promanum pure
(78.1 g + 10.0 g)/100 g, skin solution
( Ethanolum + Alcohol isopropylicus )
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• This medicine should always be used according to the instructions in this patient information leaflet or as directed by a doctor, pharmacist, or nurse.
• Keep this leaflet so that you can read it again if necessary.
• Consult your pharmacist if you need advice or further information.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. If there is no improvement or if the patient feels worse, contact a doctor.

Contents of the leaflet:

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

1. What Promanum pure is and what it is used for

The medicine contains the active substances – ethanol (ethyl alcohol) and isopropyl alcohol, which act
bactericidally against Gram-positive and Gram-negative bacteria (including mycobacteria) and have antiviral (including against HBV, HIV) and fungicidal effects. It is not effective against spores.
Indications:
Hand skin disinfection and surgical hand disinfection.

2. Important information before using Promanum pure

When not to use Promanum pure:

• in case of hypersensitivity to ethyl alcohol or isopropyl alcohol, or to any of the excipients of the medicinal product;
• orally;
• on injured or dry skin.

Warnings and precautions
The medicinal product is intended for topical use on hands only.
Avoid contact with eyes and mucous membranes. In case of accidental contact with eyes or
mucous membranes, rinse thoroughly with plenty of water.
If the product is used in a manner not consistent with the indications and instructions for use, the alcohols contained in
the formulation may cause irritation or be absorbed through the skin, especially damaged skin, leading to
systemic effects.
The product is highly flammable. Keep away from fire; do not smoke near it.
Pregnancy, breastfeeding, and effects on fertility
Consult a physician before using the product.
Although Promanum pure is applied topically to intact skin and skin absorption of alcohol is minimal, caution is advised when using the product for skin disinfection during
pregnancy and breastfeeding.
Driving and operating machinery:
Promanum pure has no influence on the ability to drive motor vehicles or operate mechanical equipment in motion.
Other medicines and Promanum pure
No data available.

3. How to use Promanum pure

Do not dilute the product.
Hand skin disinfection:
Rub 3 ml of undiluted solution into hands for 30 seconds until the skin dries.
Surgical disinfection of hand skin:
Rub 2 times 3 ml of undiluted solution into hands and forearms for 90 seconds. The skin must remain
moist throughout the application.
If you feel the effect of the product is too strong or too weak, consult a doctor.
In case of using more than the recommended dose of Promanum pure
There are no data regarding overdose when the product is used according to the indications and method of
application.
In case of accidental ingestion of Promanum pure
In case of accidental ingestion, seek immediate medical advice from a doctor, as poisoning may occur.

4. Possible adverse reactions

Like any medicinal product, this medicine can cause adverse reactions.
Hypersensitivity reactions in the skin may occur, such as contact allergy. Local skin irritation, such as itching and redness, has been reported, particularly with frequent use. Symptoms of dry skin may occur, especially during winter.
In some individuals, other adverse reactions may occur during treatment with this medicine. If any adverse effects not listed in this leaflet occur, inform your doctor.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or nurse. 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
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Promanum pure
Keep the medicine out of the reach and sight of children.
Store below 25°C.
The medicine is flammable.
The container should be kept tightly closed.
Do not use the medicine after the expiry date stated on the packaging.

6. Contents of the pack and other information

The active substances in the medicinal product are: ethyl alcohol 96% and isopropyl alcohol.
100 g of the skin application solution contains:

• active substances: 78.1 g of ethyl alcohol 96% and 10.0 g of isopropyl alcohol;
• excipients: sorbitol, povidone, myristyl isopropylate, cetearyl ethylhexanoate, butanone, purified water.

What Promanum pure looks like and contents of the pack
The medicinal product is a clear, colourless solution.
Available pack sizes:
Bottles of 100 ml, 500 ml and 1000 ml, and canister of 5000 ml.
Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun Strasse 1
D-34212 Melsungen, Germany
19.04.2023