Sonol

Package Leaflet: Information for the Patient

SONOL

(21 mg + 21 mg + 2 mg)/1 ml, liquid for the skin
(Levomenthol+ Salicylic Acid+ Thymol)

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Sonol and what is it used for
• 2. Important information before using Sonol
• 3. How to use Sonol
• 4. Possible side effects
• 5. How to store Sonol
• 6. Package contents and other information

1. What is Sonol and what is it used for

Sonol is a liquid medicine used externally as an auxiliary agent in the treatment of infectious skin diseases.

2. Important information before using Sonol

When not to use Sonol:

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

Warnings and precautions

Before starting to use Sonol, discuss it with a doctor or pharmacist.
In case of hypersensitivity to any of the ingredients of the medicine (persistent skin redness), discontinue use and consult a doctor.

Children

Since salicylic acid is easily absorbed through the skin, it should not be used on large areas of skin for a long time, especially in children.

Sonol and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
Do not use with other medicines containing scaling ingredients, such as resorcinol, sulfur, as skin irritation may occur.

Pregnancy, breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
Do not use during pregnancy and breastfeeding without consulting a doctor.

Driving and using machines

Sonol has no effect on the ability to drive and use machines.
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 doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Dosage
Adolescents over 12 years and adults
Itchy areas and rashes on the lips should be applied thinly and evenly, initially 4-5 times a day, and when improvement occurs, 2-3 times a day.

Use in children

Do not use in children under 12 years of age.

Using more than the recommended dose of Sonol

One case of salicylic acid intoxication has been reported in a patient with large psoriatic lesions.
Salicylic acid is easily absorbed through the skin and, when overdosed, causes symptoms of salicylate poisoning, including dizziness, ringing in the ears, vomiting, headaches, and impaired consciousness. After high doses, severe poisoning may occur with symptoms of respiratory center paralysis, fever, weakness, and ketonuria. It may also lead to damage to the central nervous system, respiratory system, and circulation. Children are particularly susceptible to its effects.

Missing a dose of Sonol

Do not use a double dose to make up for a missed dose.

Stopping the use of Sonol

In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Sonol can cause side effects, although not everybody gets them.
The side effects of Sonol are presented according to the classification of organs and systems according to MedDRA and frequency of occurrence: frequency not known (cannot be determined based on available data).
Frequency not known (frequency cannot be determined based on available data):

• skin irritation.

Reporting side effects
If any side effects occur, including any side effects not listed in the leaflet, inform your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 . Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Sonol

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: "expiry date". The expiry date refers to the last day of the specified month.
Store in a dry place, at a temperature below 25 °C, protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Sonol contains

The active substances of Sonol are levomenthol, salicylic acid, and thymol.
1 ml of the medicine contains 21 mg of levomenthol, 21 mg of salicylic acid, and 2 mg of thymol.
The other ingredient is the excipient propylene glycol.

What Sonol looks like and what the package contains

Sonol is a liquid for application to the skin. It is packaged in a bottle (HDPE) with a roll-on closure and a cap (PP) and a ball (LDPE, PP). Available in 8 g packages.

Marketing authorization holder and manufacturer

Elanda Pharma Sp. z o. o.
ul. Sportowa 9, 97-340 Rozprza

Date of the last update of the leaflet