Package leaflet: Information for the user

DISINTYL 0.2% cutaneous solution

Benzalkonium chloride
Please read this leaflet carefully before 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 need more information or advice, consult your pharmacist.
If you experience any 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 you notice a worsening of symptoms after several days of treatment.

Contents of this leaflet:

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

1. What DISINTYL is and what it is used for

DISINTYL contains the active substance benzalkonium chloride, which belongs to a group of medicines called antiseptics and disinfectants that reduce or block the growth of bacteria.
DISINTYL is indicated for disinfecting the skin in cases of minor injuries (small superficial wounds, abrasions). This medicine is also indicated for disinfecting the external genital organs.
Consult your doctor if you do not feel better or if you feel worse after a few days of treatment.

2. What you need to know before using DISINTYL

Do not use DISINTYL

if you are allergic to benzalkonium chloride or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using DISINTYL.
This medicine is for topical use on the skin only.
Do not apply DISINTYL to the eyes or into the inner ear (middle ear).
Furthermore, this medicine must not come into contact with the brain, the membranes covering the brain (meninges), or severely damaged skin.
Do not swallow or inhale DISINTYL, as serious, even fatal, consequences may occur.
After applying this medicine to the skin, avoid exposure to sunlight or sunlamps (artificial sources of ultraviolet radiation).
Do not use this medicine for prolonged treatments. If after a short period of treatment you do not notice any improvement, consult your doctor. If you use DISINTYL, especially for long periods, allergic reactions (sensitization phenomena) may occur. In such cases, discontinue treatment and inform your doctor, who will determine appropriate therapy.

Other medicines and DISINTYL
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
Do not use soaps (anionic detergents) together with DISINTYL, as the effect of this medicine is neutralized by soaps. During treatment with DISINTYL, avoid using other similar medicines (disinfectants or detergents).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, you may use this medicine only under medical supervision.

Driving and using machines
No effects on the ability to drive or operate machinery are known for this medicine.

Important information about certain excipients
Disintyl contains lemon essence, which in turn contains citral, d-limonene, and hydroxycitronellal.
Citral, d-limonene, and hydroxycitronellal may cause allergic reactions.

3. How to use DISINTYL

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
For skin disinfection, apply the solution undiluted directly to wounds or using a cotton ball.
For disinfection of external genitalia, dilute 1 tablespoon of the product in 1 litre of water. If necessary, you may repeat the procedure 2 or 3 times a day.
Do not exceed the recommended doses.

If you use more DISINTYL than you should
When used under the normal conditions indicated in this leaflet, this medicine does not pose risks of overdose-related harm.
Accidental ingestion of this medicine may cause nausea and vomiting. If large amounts of DISINTYL are ingested, symptoms such as difficulty breathing (dyspnea), bluish discoloration of the skin (cyanosis), sensation of suffocation (asphyxia) due to respiratory muscle paralysis, reduced brain activity (central nervous system depression), low blood pressure (hypotension), deep unconsciousness (coma), and death may occur.
The doctor will determine the appropriate treatment based on your symptoms. Do not induce vomiting or perform gastric lavage.
In case of accidental ingestion of an excessive dose of DISINTYL, contact your doctor immediately or go to the nearest hospital.

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 may cause side effects, although not everybody gets them.
Cases of intolerance may occur, with symptoms such as burning or skin irritation. These symptoms
usually do not require changes in treatment.
The product is toxic when applied to the ear and may damage the membrane lining the eye.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DISINTYL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp.”. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
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.

6. Package contents and other information

What DISINTYL contains

The active substance is benzalkonium chloride. 100 ml of solution contain 0.2 g of benzalkonium chloride.
The other components are: lemon flavour (containing: 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, citral, d-limonene, hydroxycitronellal), colour E 104, purified water.

Description of the appearance of DISINTYL and package contents
Pack containing a bottle of 50, 100, 200, 240 or 1000 ml. Drum containing 25 litres of solution.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zeta Farmaceutici S.p.A. Via Mentana, 38 - 36100 Vicenza
Manufacturer
Zeta Farmaceutici S.p.A. Via Galvani, 10 - 36066 Sandrigo (VI)