PACKAGE LEAFLET

MEDICINAL PRODUCT NAME: USTIOSAN
ATC CODE: D08AH03 oxichinolina
AIC CODE: 021247
PACKAGE CODE: 085
USTIOSAN “cream” tube 30g
Please read this leaflet carefully because it contains important information for you.
This medicine is available without medical prescription. However, you must use it carefully to
achieve the best results.
Keep this leaflet, you may need to read it again.
If you need further information or advice, consult your pharmacist.
If your symptoms worsen or do not improve after a short period of treatment, you should
contact your doctor.
In this leaflet:

What USTIOSAN is and what it is used for
Before using USTIOSAN
How to use USTIOSAN
Possible side effects
How to store USTIOSAN
Further information

1. WHAT USTIOSAN IS AND WHAT IT IS USED FOR

Pharmacotherapeutic category
USTIOSAN is a topical anesthetic and antiseptic.
Therapeutic indications

Skin lesions such as superficial wounds, abrasions, insect bites.
Minor burns, sunburns.
Skin irritations caused by various chemical-physical agents.

2. BEFORE USING USTIOSAN

Do not use USTIOSAN in the following cases:
Hypersensitivity to the components or to other substances closely related from a chemical point of view.

Pregnancy and breastfeeding
Use only when clearly necessary and under direct medical supervision.

Pediatric and elderly use
In children and elderly patients, use only when clearly necessary and under direct medical supervision.

Special warnings and precautions for use
The use, especially if prolonged, of topical products may lead to sensitization reactions. If this occurs, discontinue treatment and consult a physician to initiate, if necessary, an appropriate therapy. Use only on limited areas of skin and for short periods of time. Avoid applying the medication near the ocular conjunctiva.

Interaction with other medicinal products, foods and other forms of interaction
Generally, the concurrent use of antiseptics at the same site should be avoided. Consult your doctor or pharmacist if you are using other medicinal products, including those without a prescription.

Effects on the ability to drive and use machinery
None.

3. HOW TO USE USTIOSAN

How much and how to use
Cream for external use. Apply an even layer of 1–2 cm of cream to the affected area; if necessary, cover with a protective dressing using sterile gauze and adhesive tape.
Caution: Do not exceed the recommended doses without medical advice.
When and for how long:
Repeat application 1–2 times daily.
Caution: Use only for short-term treatment.
If no noticeable improvement occurs after a short period of treatment, consult a doctor, as well as if irritation occurs or redness, swelling, or pain persists. Consult your doctor if the condition recurs or if you have noticed any recent changes in its characteristics. Speak to your doctor or pharmacist for any doubts regarding the use of this medicine.
If you use too much USTIOSAN
Accidental ingestion of significant amounts of the product may cause symptoms such as diarrhea, dizziness, and cyanosis. The antidote used in such cases is methylene blue, which must be administered at an emergency facility.
In such cases, contact your doctor immediately or go to the nearest hospital.
What to do if you forget to use USTIOSAN
None. Do not use a double dose to make up for the missed application.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, USTIOSAN may cause adverse reactions; following the instructions contained in the package leaflet reduces the risk of adverse reactions. Inform your doctor or pharmacist if you experience any adverse reactions not described in the package leaflet.

5. HOW TO STORE USTIOSAN

Do not use the medicine after the expiry date stated on the container.
This medicine does not require any special storage conditions.
Keep the medicine out of the reach and sight of children.

6. OTHER INFORMATION

Composition: 100 g contain:
Active substances:
Procaine hydrochloride 500 mg equivalent to 433 mg of Procaine
Lidocaine hydrochloride 500 mg equivalent to 406 mg of Lidocaine
8-Hydroxyquinoline sulfate 270 mg equivalent to 193 mg of 8-hydroxyquinoline
Excipients:
Polyglycolized fatty acids (PEG-8 C12-18 alkyl ester), Glyceryl stearate, Hydrogenated lanolin, Avocado oil, Glycerin, Butylated hydroxyanisole, Distilled water of Hamamelis virginiana.
Pharmaceutical form and content
"cream" tube of 30 g
Marketing Authorization Holder
Kelémata S.r.l. C.so Re Umberto n.20 – 10128 Turin A.I.C. 021247085
Manufacturer and final controller
Kelémata S.r.l., Martellago (VE) plant, via Castellana, 120