Aromatol

Package leaflet: Information for the patient

AROMATOL
concentrate for preparing a solution for mouth and throat rinsing, oral solution, for topical use and for preparing steam inhalations.
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 the patient leaflet or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, so that you may read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
• If there is no improvement or if you feel worse, consult your doctor.

Contents of the leaflet

1. What Aromatol is and what it is used for
2. Important information before using Aromatol
3. How to use Aromatol
4. Possible side effects
5. How to store Aromatol
6. Contents of the package and other information

1. What Aromatol is and what it is used for

This medicine is intended for traditional use in the indications listed, and its effectiveness is based solely on long-standing use and experience.
The medicine is an alcoholic mixture of menthol and essential oils: lemon oil from Citrus limon, cinnamon bark oil from Cinnamomum zeylanicum, field mint oil from Mentha arvensis, lavender oil from Lavandula officinalis, citronella oil from Cymbopogon nardus, and clove oil from Caryophylus aromaticus. Menthol exhibits cholagogue and spasmolytic effects.
Aromatol can be administered orally, used for gargling, applied topically to the skin, or used in the form of steam inhalation.
Traditionally, Aromatol is used:

• topically – to relieve general discomfort, e.g. during colds (for rubbing, inhalation or gargling), for headaches, muscle aches, and insect bites;
• internally – for gastrointestinal complaints (dyspeptic disorders), such as bloating and 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 tract diseases associated with marked respiratory hypersensitivity,
• in children under 12 years of age due to ethanol content and insufficient safety and efficacy data,
• do not administer orally in cases of biliary obstruction (e.g. gallstones), cholecystitis, in patients with severe liver damage or alcohol dependence,
• do not apply to damaged skin, e.g. in burns, rashes or open wounds, in skin diseases associated with rash, to mucous membranes or around the eyes.

Warnings and precautions
Before starting to use Aromatol, discuss it with your doctor, pharmacist or
nurse.
Aromatol contains ethanol; frequent topical use may cause skin irritation and dryness.
Protect eyes from contact with the medicine. If Aromatol gets into the eyes, rinse thoroughly with water and consult a doctor.
In case of hypersensitivity symptoms such as difficulty in breathing (e.g. bronchospasm), seek immediate medical attention; in case of skin reactions, consult a doctor.
After application of the medicine or its solution, hands should be washed thoroughly.
The medicine contains 63.0–72.0% (V/V) ethanol. One millilitre of the medicine contains approximately 0.57 g of ethanol; 10 drops contain ethanol equivalent to approximately 2.2 ml of wine containing 12% (V/V) alcohol or approximately 5.3 ml of beer containing 5% (V/V) alcohol. This should be taken into account when administering to children and patients with liver disorders or epilepsy. Do not use in patients with alcohol-related disease.
Children
Do not use in children under 12 years of age.
Aromatol and other medicines
Tell your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to use.
The alcohol contained in the medicine may enhance or reduce the effect of other medicines.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Due to lack of complete safety evaluation and the presence of ethanol, use of this medicine is not recommended in pregnant or breastfeeding women.
Driving and operating machinery
Use of this medicine may impair the ability to drive or operate machinery.

3. How to use Aromatol

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
Administer orally, use for gargling, apply externally to the skin, or use as steam inhalation. This medicine is intended for adults and adolescents over 12 years of age.

Oral administration
For gastrointestinal complaints (dyspeptic disorders), e.g. indigestion, bloating: take 10 to 15 drops of Aromatol 1 to 3 times daily, mixed with water.

Topical application to the skin
For rubbing: apply Aromatol 1 to 3 times daily by rubbing onto the skin until the surface becomes dry.
To relieve discomfort from insect bites: wipe the affected area with a swab soaked in Aromatol.

For gargling
Dilute approximately 5 ml (1 teaspoon) of Aromatol in about 250 ml (1 glass) of warm water and gargle with the solution 1 to 3 times daily.

Use as inhalation (in colds)
Dilute approximately 5 ml (1 teaspoon) of Aromatol in about 250 ml (1 glass) of hot water and inhale the resulting vapors for several minutes. Repeat inhalations up to 3 times daily.

Use of a higher than recommended dose of Aromatol
If a significantly higher than recommended dose has been taken, consult your doctor or pharmacist.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
In sensitive individuals, contact with essential oils may sometimes cause allergic skin reactions, and occasionally respiratory disorders (e.g. cough, bronchospasm).
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions of Medicinal Products, 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: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Aromatol

Keep the medicine out of the sight and reach of children.
Store at a temperature not exceeding 25°C. Opalescence of the solution may occur at temperatures below 15°C.
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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Aromatol contains

• The active substances in the medicine are (in 100 g): Levomentholum (levomenthol) 1.72 g, Limonis aetheroleum (lemon essential oil) 0.57 g, Cinnamomi zeylanici corticis aetheroleum (essential oil of cinnamon bark from Cinnamomum zeylanicum) 0.24 g, Menthae arvensis aetheroleum partim mentholi privum (corn mint essential oil, partially depleted of menthol) 0.24 g, Lavandulae aetheroleum (lavender essential oil) 0.24 g, Citronellae aetheroleum (citronella essential oil) 0.1 g, Caryophylli floris aetheroleum (clove flower essential oil) 0.1 g.
• Other components (excipients) are: ethanol 96%, purified water.

What Aromatol looks like and contents of the pack
Aromatol is a colourless, clear liquid.
Each pack contains 100 ml, 150 ml or 250 ml of the medicine.

Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Medicine information
tel. +48 (22) 742 00 22
e-mail: [email protected]