Do not use Spitaderm^®:

If you are hypersensitive to the active substances or to any of the excipients. The medicine must not be used to disinfect mucous membranes or wounds. Do not apply to the eye area.

Warnings and precautions

Flammable; do not spray near flame; Flash point (according to DIN 51755): 20°C; observe application times and safety precautions; wait for the medicinal product to dry before switching on electrical equipment; use cautiously on alcohol-sensitive surfaces. An enzymatic test for glucose determination can only be performed at least 1 minute after application. Chemical burns have been reported as a result of topical use of chlorhexidine gluconate in newborns and infants. Premature babies are at particular risk owing to the immaturity of their epidermal barrier. Therefore, Spitaderm should only be used in newborns and infants if there are no alternative medicines and the expected therapeutic benefits outweigh the risks. Any surplus liquid should be removed immediately.

Pregnancy, breastfeeding and fertility

Pregnancy

There are no results of controlled clinical trials on the use of the medicine in pregnant women. No animal studies have been performed. Use caution when using the medicine during pregnancy.

Breastfeeding period

No clinical data are available.

Driving and operating machinery

The effect of Spitaderm^® on your ability to drive or operate machinery is not known.

Important information about some of the ingredients of Spitaderm^®

Possible allergic skin irritation caused by chlorhexidine.

Always take this medicine as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

How to use:

For external use only.

Surgical hand disinfection:

Rub at least 5 ml of the medicine into hands and forearms for 90 seconds. Repeat the procedure. Hands should remain moist during disinfection.

Hygienic hand disinfection:

Rub 3 ml of medicine for 30 seconds.

Skin disinfection before injections:

Apply the medicine to the skin for 15 seconds.

Skin disinfection before punctures, surgery:

Apply the medicine to the skin for 60 seconds.

If you use more Spitaderm^® than you should

In case of accidental ingestion:

mouth rinsing, medical consultation.

In case of accidental contact with the eyes:

immediately flush eyes with clean water for a minimum of 10 minutes, seek medical advice. If you have any questions about the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Most frequently, short-term redness of the skin appears, which does not pose any threat and passes by itself. Urticaria and allergic reactions, including anaphylactic shock, were rare (from greater than 1/10,000 to less than 1/1,000). Skin irritation and contact dermatitis were common (from greater than 1/100 to less than 1/10). Chemical burns in newborns and infants (frequency unknown). Concomitant use of agents containing anionic surfactants may result in the deactivation of chlorhexidine.

Reporting of side effects

If you experience any side effects, including any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse. Side effects may be reported directly to the Department for Monitoring Adverse Actions of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocides [Departament Monitorowania Niepożądanych Działań Produktów Leczniczych Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych], Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl

Side effects may also be reported to the marketing authorisation holder. Reporting side effects helps us gather more information on the safety of the medicine.

Store the medicine below 25°C. Shelf life after first opening: 6 months. Keep out of sight and out of reach of children.

Do not use after the expiry date.

Applies to packaging above 1,000 ml: if the packaging is to be filled with the medicine, this should take place under sterile conditions (sterile workplace). Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

What Spitaderm^® contains

100 g solution contains:

Active substance:
70 g isopropanol,
0.5 g chlorhexidine digluconate,
1.5 g 30% hydrogen peroxide solution.

Other ingredients are: macrogol 6 glycerol caprylocaprate, fragrance 70/0676, purified water.

What Spitaderm^® looks like and contents of the package

• Spitaderm^® is a clear, slightly yellow, transparent solution with a characteristic isopropyl alcohol smell.
• pH value: 6.5–7.5.
• Packaging: 500 ml bottles or 5,000 ml canister.

Opinion on the use of the medicine No 35/94 issued by the Neonatology Clinic of the Institute of Mother and Child in Warsaw.

Marketing authorisation No 13042.
This leaflet was last updated: 2018/07/20

Available packaging

In case of side effects, please contact us.

LPC: +48  691 190 098

Deputy LPC:  +48 508 238 861