Package leaflet: Information for the patient

SONOL
(21 mg + 21 mg + 2 mg)/1 ml, cutaneous solution
(Levomentholum + Acidum salicylicum + Thymolum)
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a physician or pharmacist.

Keep this leaflet for future reference.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, consult your doctor.

Table of contents

What Sonol is and what it is used for
Important information before using Sonol
How to use Sonol
Possible side effects
How to store Sonol
Contents of the pack and other information

1. What Sonol is and what it is used for

Sonol is a medicine in the form of a solution for external use, used as an adjunctive treatment in infectious skin diseases.

2. Important information before using the medicine Sonol

When not to use the medicine Sonol:
If the patient is allergic (hypersensitive) to the active substances or any of the other
components of this medicine (listed in section 6);
If the patient has damaged skin;
If the patient has open wounds;
If the patient has extensive exfoliating skin lesions (e.g., in psoriasis);
In pregnant women without consulting a doctor;
In breastfeeding women without consulting a doctor;
Do not apply to mucous membranes;
Do not use in children under 12 years of age.

Warnings and precautions
Before starting treatment with Sonol, discuss it with your doctor or pharmacist.
If hypersensitivity to any of the components of the medicine occurs (persistent
skin redness), discontinue use and consult your doctor.

Children
Since salicylic acid is very easily absorbed through the skin, it should not be used over
large skin areas for prolonged periods, especially in children.

Sonol and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
Do not use together with other medicines containing exfoliating agents, such as resorcinol or sulfur, as skin irritation may occur.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Do not use during pregnancy or breastfeeding without consulting a doctor.

Driving and operating machinery
Sonol has no effect on the ability to drive or operate machinery.
Sonol contains propylene glycol, which may cause skin irritation.

3. How to use Sonol

This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult your doctor or pharmacist.
Dosage
Adolescents over 12 years of age and adults
Apply thinly and evenly to itchy areas and cold sores initially 4–5 times daily; when improvement occurs, reduce to 2–3 times daily.
Use in children
Do not use in children under 12 years of age.
Use of a higher than recommended dose of Sonol
One case of salicylic acid intoxication has been reported in a patient with extensive psoriatic lesions.
Salicylic acid is readily absorbed through the skin, and overdose may lead to salicylate poisoning, manifesting as dizziness, tinnitus, vomiting, headache, and disturbances in consciousness. After large doses, severe poisoning may occur, with symptoms including respiratory center paralysis, fever, weakness, and ketoacidosis. Damage to the central nervous system, respiratory system, and circulatory system may also occur. Children are especially susceptible to its effects.
Missed dose of Sonol
Do not use a double dose to make up for a missed dose.
Discontinuation of Sonol
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions to this medicine are listed according to MedDRA system organ class and frequency of occurrence: frequency unknown (cannot be estimated based on available data).
Frequency unknown (frequency cannot be estimated based on available data):

skin irritation.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: +48 22 49-21-301, fax: +48 22 49-21-309, e-mail: https://smz.ezdrowie.gov.pl . Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Sonol

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following: "expiry date". The expiry date refers to the last day of the stated month.
Store in dry places, at temperatures below 25 °C, and protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This practice helps protect the environment.

6. Contents of the package and other information

What Sonol contains
The active substances in Sonol are levomenthol, salicylic acid, and thymol.
1 ml of the medicinal product contains 21 mg of levomenthol, 21 mg of salicylic acid, and 2 mg of thymol.
Other ingredient: the excipient is propylene glycol.

What Sonol looks like and contents of the pack
Sonol is a liquid for topical application. It is packaged in a bottle (HDPE) with a roll-on closure and a screw cap (PP), as well as an applicator with a ball (LDPE, PP). Packs of 8 g are available.

Marketing authorisation holder and manufacturer
Elanda Pharma Sp. z o.o.
ul. Sportowa 9, 97-340 Rozprza