Package leaflet: Information for the patient

Bialcol Med 1 mg/ml cutaneous solution

benzethonium chloride
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

Keep this leaflet. You may need to read it again.
If you would like more information or advice, consult your pharmacist.
If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

What Bialcol Med is and what it is used for
What you need to know before using Bialcol Med
How to use Bialcol Med
Possible side effects
How to store Bialcol Med
Contents of the pack and other information

1. What Bialcol Med is and what it is used for

Bialcol Med contains the active substance benzalkonium chloride, a substance used as a skin disinfectant.
Bialcol Med is used to help prevent infections and to disinfect the skin in case of abrasions and
wounds.
Consult your doctor if you do not feel better or if you feel worse (for example, if the wound is swollen, painful, if
you have a fever, or if a skin reaction occurs) after 3 days.

2. What you need to know before using Bialcol Med

Do not use Bialcol Med

if you are allergic to benzalkonium chloride, to other disinfectants containing quaternary ammonium compounds, or to any of the other ingredients of this medicine (listed in section 6)
if you have a deep wound
inside the ear
to disinfect mucous membranes
in body cavities or to clean the intestine
to disinfect soft contact lenses

Warnings and precautions
Talk to your doctor or pharmacist before using Bialcol Med.
Take special care:

do not swallow Bialcol Med; it is for external use only
do not use Bialcol Med in body cavities or for enemas
avoid contact with eyes, ears (auditory canal), mucous membranes of mouth and nose, and deep wounds. In case of accidental contact, rinse the affected area thoroughly with plenty of water
do not use Bialcol Med on the breast if you are breastfeeding. Newborns must not come into contact with skin treated with Bialcol Med
if symptoms persist or your condition worsens—for example, if the wound becomes swollen, painful, or you develop a fever—or if you experience a skin reaction, stop using Bialcol Med and contact your doctor immediately
do not use Bialcol Med frequently or for more than 3 days without first consulting your doctor. Prolonged and repeated use of this medicine may cause allergic skin reactions, even severe ones, which may be accompanied by swelling of the skin or mucous membranes
ingestion or inhalation of certain disinfectants, such as Bialcol Med, may have serious, even fatal, consequences. In case of accidental ingestion of Bialcol Med, contact your doctor immediately.

Children
Newborns must not come into contact with skin treated with Bialcol Med.
Other medicines and Bialcol Med
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those not requiring a prescription.
Do not use Bialcol Med together with other disinfectants or skin detergents.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Bialcol Med may be used during pregnancy in small amounts (on small wounds).
Breastfeeding
Bialcol Med may be used during breastfeeding in small amounts (on small wounds). Be careful not to apply Bialcol Med to the breast if you are breastfeeding, as newborns must not come into contact with treated skin.
Driving and using machines
Bialcol Med does not affect the ability to drive or operate machinery.

3. How to use Bialcol Med

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

After cleaning the affected area with warm water and gently drying by lightly patting with a soft cloth, apply a small amount of Bialcol Med to the area to be treated.
Apply Bialcol Med topical solution directly to the skin or using a sterile gauze or cotton.
Take care to prevent the liquid from accumulating in skin folds.
Repeat the application 4–5 times a day or as needed.

Do not use this medicine for more than 3 days and do not exceed the recommended doses.
If symptoms persist or the condition worsens—for example, if the wound becomes swollen, painful, or if you develop fever—or if a skin reaction occurs, stop using Bialcol Med and contact your doctor immediately.

If you use more Bialcol Med than you should
In case of accidental ingestion or overdose, contact your doctor immediately or go to the nearest hospital.
Under normal conditions of use, symptoms of overdose have not been reported. However, if ingested, Bialcol Med may cause damage to the esophagus with symptoms such as nausea and vomiting.
Following ingestion of large quantities of substances similar to Bialcol Med, the following symptoms have been reported: difficulty breathing, bluish discoloration of the skin and mucous membranes, asphyxia due to paralysis of the respiratory muscles, depression of the Central Nervous System, low blood pressure, and coma.
Your doctor will treat accidental overdose of Bialcol Med according to your condition.

If you forget to use Bialcol Med
Do not take a double dose to make up for the missed dose.

If you stop using Bialcol Med
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare side effects (may affect up to 1 in 1,000 people)

skin irritation

Very rare side effects (may affect up to 1 in 10,000 people)

allergic reactions, anaphylactic reactions
skin reactions, including urticaria
swelling of the skin or mucous membranes

Following the instructions in this leaflet reduces the risk of side effects.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bialcol Med

Keep the bottle tightly closed. This medicine does not require any special storage temperature.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.
It is important to always keep the medicine information available; therefore, keep the packaging box.

6. Package contents and other information

What Bialcol Med contains

The active substance is benzethonium chloride. 100 ml of cutaneous solution contain 100 mg of benzethonium chloride.
The other ingredients are isopropyl alcohol, acetone, ethyl acetate, glacial acetic acid, pine essential oil, diethylene glycol monoethyl ether, ethoxylated octylphenol, sodium hydroxide, purified water.

Description of the appearance of Bialcol Med and contents of the pack
Each pack contains one 300 ml bottle of Bialcol Med 1 mg/ml cutaneous solution.
Marketing Authorization Holder
Vemedia Manufacturing B.V.
Verrijn Stuartweg 60
1112 AX Diemen (The Netherlands)
Manufacturer
Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe, 1
Cortemaggiore (PC)