Softa-man

Leaflet attached to the packaging: patient information

Softa-Man

[ Ethanol (96 per cent) + Propanol]
(47.90 g + 18 g)/100 ml, solution for the skin
This medicinal product should always be used exactly as described in the patient information leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, you may need to read it again.
• If you need advice or more information, you should speak to a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. 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 Softa-Man and what is it used for
• 2. Important information before using Softa-Man
• 3. How to use Softa-Man
• 4. Possible side effects
• 5. How to store Softa-Man
• 6. Contents of the pack and other information

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

Softa-Man is a solution for the skin, containing the active substances ethanol and propanol, which have bactericidal effects on Gram-positive and Gram-negative bacteria (including mycobacteria) and antiviral and antifungal effects. It does not act on spores.

Indications for use:

Disinfection of the skin of the hands and surgical disinfection of the skin of the hands.

2. Important information before using Softa-Man

When not to use Softa-Man:

• if you are allergic to ethanol or propanol, or any of the other ingredients of this medicinal product (listed in section 6),
• orally,
• on wounded or dry skin.

Warnings and precautions

Before starting to use the medicinal product, you should discuss it with your doctor or pharmacist.
The medicinal product is intended for use on the skin of the hands only.
Do not use the medicinal product on wounded or diseased skin.
Avoid contact with the eyes and mucous membranes. In case of accidental contact with the eyes or mucous membranes, rinse them with a large amount of water.
In case of use of the medicinal product not in accordance with the indications and method of use, the alcohols contained in the medicinal product may cause irritation or be absorbed through the skin, especially damaged skin, and cause systemic effects.
Due to the ethanol content, the medicinal product may cause a burning sensation on damaged skin.
The medicinal product is flammable. Keep it away from fire, do not smoke near it.
You should consult a doctor, even if the above warnings concern situations that have occurred in the past.

Pregnancy, breast-feeding, fertility:

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicinal product.

Driving and using machines:

No data available.

Other medicines and Softa-Man

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
No data available on the use with other medicines.

Softa-Man contains a fragrance composition

Substances that are part of the fragrance composition may cause allergic reactions.
Additional information - see section 6.

3. How to use Softa-Man

This medicinal product should always be used exactly as described in the patient information leaflet or as directed by your doctor, pharmacist or nurse. If you are unsure, you should speak to your doctor, pharmacist or nurse.
The medicinal product is intended for use on the skin only.
Do not dilute the medicinal product.
Disinfection of the skin of the hands:
Rub 3 ml of undiluted Softa-Man solution into your hands for 30 seconds until the skin is dry.
Surgical disinfection of the skin of the hands:
Rub 2 x 5 ml of undiluted Softa-Man solution into your hands and forearms for 2 minutes. The skin must be moistened with the solution for 2 minutes.
Prophylaxis of viral hepatitis B (VHB):
Rub 5 ml of undiluted Softa-Man solution into your hands for 5 minutes. The skin must be moistened with the solution for 5 minutes.
If you feel that the effect of the medicinal product is too strong or too weak, you should speak to your doctor.

In case of use of a larger dose of Softa-Man than recommended

No data available on overdose when used according to the indications and method of use.

In case of accidental ingestion of Softa-Man

In case of accidental ingestion of the medicinal product, you should immediately contact a doctor, as poisoning may occur.

4. Possible side effects

Like all medicines, Softa-Man can cause side effects, although not everybody gets them.
Frequency not known - 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 skin dryness, especially in winter.

Reporting of side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or nurse. 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of the medicinal product.

5. How to store Softa-Man

The medicinal product should be kept out of the sight and reach of children.
Store in a temperature below 25°C.
Shelf-life after first opening of the packaging – 12 months.
The medicinal product is flammable.
Store the packaging tightly closed.
Do not use the medicinal product after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
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 pack and other information

What Softa-Man contains

• The active substances of Softa-Man are ethanol and propanol. 100 ml of the medicinal product contains 47.90 g of ethanol 96% and 18 g of propanol.
• The other ingredients are: diisopropyl adipate, macrogol-6-glycerol caprylocaprate (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

Softa-Man is a solution for the skin
Bottles containing 100 ml, 500 ml or 1000 ml of solution for the skin
Canister containing 5 l of solution for the skin.

Marketing authorisation holder:

B.Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen
Germany
To obtain more detailed information, you should contact the representative of the marketing authorisation holder:
ADDRESS
Aesculap Chifa Sp. z o.o.
ul. Tysiąclecia 14
64-300 Nowy Tomyśl
phone: (061) 44 20 100
fax: (061) 44 23 936
Date of last revision of the leaflet:

• 20.04.2021