Aromatol

Package Leaflet: Information for the Patient

AROMATOL

Concentrate for solution for mouthwash and throat, oral solution, for skin use and for steam inhalation.

Read the package 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 package leaflet for the patient or as directed by a doctor, pharmacist, or nurse.

• 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, pharmacist, or nurse. 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 Aromatol and what is it used for
• 2. Important information before using Aromatol
• 3. How to use Aromatol
• 4. Possible side effects
• 5. How to store Aromatol
• 6. Package contents and other information

1. What is Aromatol and what is it used for

The medicine is intended for traditional use in the indicated applications, and its effectiveness is based solely on a long period of use and experience.
The medicine is an alcoholic mixture of menthol and essential oils: lemon oil from common lemon ( Citrus limon), cinnamon oil from Ceylon cinnamon bark ( Cinnamomum zeylanicum), peppermint oil from field mint ( Mentha arvensis), lavender oil from medicinal lavender ( Lavandula officinalis), citronella oil from citronella grass ( Cymbopogon nardus), and clove oil from clove tree ( Caryophylus aromaticus). Menthol has choleretic and spasmolytic effects.
The medicine can be administered orally, used for throat rinsing, applied externally to the skin, or used in the form of steam inhalation.
Aromatol is used traditionally:

• externally - to improve poor well-being, e.g., in the case of a cold (for rubbing, inhalation, or throat rinsing), in headaches, muscle pains, after insect bites;
• internally - in digestive disorders (dyspeptic disorders), e.g., bloating, indigestion.

2. Important information before using Aromatol

When not to use Aromatol:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6),
• in bronchial asthma and other respiratory diseases accompanied by strong hypersensitivity of the respiratory tract,
• in children under 12 years of age, due to the content of ethanol and incomplete data on safety and efficacy,
• do not use orally in the case of bile duct obstruction (e.g., in the course of cholelithiasis), gallbladder inflammation, in people with severe liver damage or alcohol dependence,
• do not apply to damaged skin, e.g., in burns, rashes, and open wounds, in skin diseases with rash, on mucous membranes, and in the eye area.

Warnings and precautions

Before starting to use Aromatol, discuss it with your doctor, pharmacist, or nurse.
Aromatol contains ethanol; frequent external use may cause skin irritation and dryness.
Protect your eyes from contact with the medicine. If Aromatol gets into your eyes, rinse them thoroughly with water and consult a doctor.
In case of hypersensitivity symptoms: breathing difficulties (e.g., bronchospasm), consult a doctor immediately, and in case of skin changes, consult a doctor.
After rubbing with the medicine or its solution, wash your hands carefully.
The medicine contains 63.0 - 72.0% (V/V) ethanol. One milliliter of the medicine contains approximately 0.57 g of ethanol, 10 drops contain ethanol in an amount equivalent to approximately 2.2 ml of wine with a 12% (V/V) alcohol content or approximately 5.3 ml of beer with a 5% (V/V) alcohol content, which should be taken into account when using it in children and people with liver diseases or epilepsy. The medicine should not be used in people with alcoholism.

Children

Do not use in children under 12 years of age.

Aromatol and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Alcohol in the medicine may enhance or weaken the effect of other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Due to the lack of full assessment of safety and the content of ethanol, the use of the medicine is not recommended in pregnant and breastfeeding women.

Driving and using machines

Using the medicine may impair your ability to drive and use machines.

3. How to use Aromatol

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor, pharmacist, or nurse.
In case of doubts, consult a doctor, pharmacist, or nurse.
Administer orally, use for throat rinsing, apply externally to the skin, or use in the form of steam inhalation. The medicine is intended for adults and adolescents over 12 years of age.
Oral administration
In digestive disorders (dyspeptic disorders), e.g., indigestion, bloating: 1 to 3 times a day, take 10 to 15 drops of Aromatol mixed with water.
Application to the skin
For rubbing: 1 to 3 times a day, rub Aromatol until the skin surface is dry;
to reduce discomfort after insect bites: wipe the bite site with a swab soaked in Aromatol.
For throat rinsing
Dilute about 5 ml (1 teaspoon) of Aromatol in about 250 ml (a glass) of warm water, rinse the throat and mouth 1 to 3 times a day.
Use in the form of inhalation (in case of a cold)
Dilute about 5 ml (1 teaspoon) of Aromatol in about 250 ml (a glass) of hot water and inhale the resulting vapors for a few minutes. Repeat the inhalation up to 3 times a day.

Using a higher dose of Aromatol than recommended

In case of taking a significantly higher dose of the medicine than recommended, consult a doctor or pharmacist.

Missing a dose of Aromatol

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

4. Possible side effects

Like all medicines, Aromatol can cause side effects, although not everybody gets them.
Sometimes, in sensitive individuals, contact with essential oils may cause skin allergic reactions, and sometimes also respiratory system disorders (e.g., cough, bronchospasm).

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, inform your doctor, 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Aromatol

Keep the medicine out of the sight and reach of children.
Store in a temperature not exceeding 25°C. At temperatures below 15°C, opalescence of the solution may occur. This process is reversible at room temperature and does not affect the quality of the final product.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Aromatol contains

• The active substances of the medicine are (per 100 g): Levomentholum(levomenthol) 1.72 g, Limonis aetheroleum(lemon oil) 0.57 g, Cinnamomi zeylanici corticis aetheroleum(cinnamon oil) 0.24 g, Menthae arvensis aetheroleum partim mentholi privum(peppermint oil with reduced menthol content) 0.24 g, Lavandulae aetheroleum(lavender oil) 0.24 g, Citronellae aetheroleum(citronella oil) 0.1 g, Caryophylli floris aetheroleum(clove oil) 0.1 g.
• The other ingredients (excipients) are: ethanol 96%, purified water.

What Aromatol looks like and what the package contains

Aromatol is a colorless, clear liquid.
One package contains 100 ml, 150 ml, or 250 ml of the medicine.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Information about the medicine

tel. +48 (22) 742 00 22
e-mail: informacjaoleku@hasco-lek.pl

Date of the last update of the leaflet: