Patient Information Leaflet

Softa-Man
[ Ethanol (96 per centum) + Propanol ]
(47.90 g + 18 g)/100 ml, cutaneous solution
This medicine must always be used exactly as described in this patient information leaflet or as
directed by a physician or pharmacist.

Keep this leaflet for future reference.
If advice or further information is needed, consult a pharmacist.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a physician or pharmacist. See section 4.
If symptoms persist or worsen, consult a physician.

Table of Contents:

What Softa-Man is and what it is used for
Important information before using Softa-Man
How to use Softa-Man
Possible side effects
How to store Softa-Man
Contents of the pack and other information

1. What Softa-Man is and what it is used for

Softa-Man is a cutaneous solution containing the active substances ethanol and propanol, which exert a bactericidal effect against Gram-positive and Gram-negative bacteria (including mycobacteria), as well as antiviral and fungicidal activity. It is not effective against spores.
Indications:
Hand disinfection and surgical hand disinfection.

2. Information before using Softa-Man

When not to use Softa-Man:

if the patient is allergic to ethanol or propanol, or to any of the other ingredients of this medicine (listed in section 6),
orally,
on injured or dry skin.

Warnings and precautions
Before starting to use this medicine, discuss it with a doctor or pharmacist.
This medicine is intended for topical use on hands only.
Do not apply the medicine on injured or diseased skin.
Avoid contact of the medicine with eyes and mucous membranes. In case of accidental contact with eyes
or mucous membranes, rinse thoroughly with large amounts of water.
If the medicine is used in a manner not consistent with the instructions for use, the alcohols contained
in the medicine may cause irritation or be absorbed through the skin, especially damaged skin,
and cause systemic effects.
Due to its ethanol content, the medicine may cause stinging on damaged skin.
The medicine is flammable. Keep away from fire; do not smoke nearby.
Consult a doctor, even if the above warnings refer to conditions that occurred in the past.
Pregnancy, breastfeeding, and fertility:
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery:
No data available.
Other medicines and Softa-Man
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
No data on interactions with other medicines.
Softa-Man contains a fragrance composition
Substances contained in the fragrance composition may cause allergic reactions.
Additional information – see section 6.

3. How to use Softa-Man

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
This medicine is intended for topical use on the skin only.
Do not dilute the medicine.

Hand skin disinfection:
Rub 3 ml of undiluted Softa-Man into hands for 30 seconds until the skin is dry.

Surgical disinfection of hands and forearms:
Rub 5 ml of undiluted Softa-Man twice into hands and forearms for 2 minutes.
The skin must remain wet with the medicine for 2 minutes.

Prophylaxis of hepatitis B virus (HBV):
Rub 5 ml of undiluted Softa-Man into hands in portions for 5 minutes.
The skin must remain wet with the medicine for 5 minutes.

If you feel the effect of the medicine is too strong or too weak, consult your doctor.

In case of using more than the recommended dose of Softa-Man
There are no data regarding overdose when the medicine is used according to the indications and instructions for use.

In case of accidental ingestion of Softa-Man
If the medicine is accidentally swallowed, seek immediate medical advice from a doctor, as poisoning may occur.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Frequency unknown – cannot be estimated from the available data:
skin hypersensitivity reactions, e.g. contact allergy, local skin irritation, e.g.
itching, redness (especially with frequent use), symptoms of dry skin,
particularly in winter.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the 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 Softa-Man

Keep the medicine out of the reach and sight of children.
Store below 25°C.
Shelf life after first opening of the container – 12 months.
The medicine is flammable.
Keep the container tightly closed.
Do not use the 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 a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Softa-Man contains

The active substances are ethanol and propanol. 100 ml of the medicinal product contains 47.90 g of 96% ethanol and 18 g of propanol.
The other ingredients are: diisopropyl adipate, caprylocaproyl macrogol-6-glycerides (Softigen 767), dexpanthenol, bisabolol, fragrance composition [(Flair 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, benzyl alcohol, benzyl benzoate, benzyl salicylate, citral, citronellol, coumarin, d-limonene, eugenol, farnesol, geraniol, hexyl cinnamal, isoeugenol, linalool, oak moss], allantoin, purified water.

What Softa-Man looks like and contents of the pack
The medicinal product is a solution for skin application.
Bottles containing 100 ml, 500 ml or 1000 ml of solution for skin application.
Canister containing 5 l of solution for skin application.

Marketing Authorisation Holder:
B. Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen
Germany

For further information, please contact the local representative of the Marketing Authorisation Holder:
ADRES
Aesculap Chifa Sp. z o.o.
Tysiąclecia 14
64-300 Nowy Tomyśl
Poland
Tel. (061) 44 20 100
Fax (061) 44 23 936
20.04.2021