Amol

Leaflet attached to the packaging: patient information

Amol

combined product,
oral liquid, skin liquid

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 according to the doctor's or pharmacist's instructions.

• 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 Amol and what is it used for
• 2. Important information before using Amol
• 3. How to use Amol
• 4. Possible side effects
• 5. How to store Amol
• 6. Contents of the packaging and other information

1. What is Amol and what is it used for

Amol is a solution of menthol and a mixture of essential oils in ethanol.
The active substances of Amol are: peppermint oil, whose main component is menthol;
lavender oil; citronella oil; cinnamon oil; clove oil; lemon oil;
menthol.
The effect of the medicine is due to the action of individual active substances.

The medicine is intended for traditional use in the indications listed and its effectiveness is based solely on a long period of use and experience.

Amol is traditionally used for the following indications:
externally:

• to improve poor well-being, e.g. in the course of a cold, headaches, muscle pains;
• to reduce discomfort after insect bites; internally:
• for digestive disorders (dyspeptic) e.g. bloating and indigestion.

2. Important information before using Amol

When not to use Amol

• in bronchial asthma and other respiratory diseases accompanied by severe hypersensitivity of the respiratory tract.
• in children under 12 years of age, due to the lack of sufficient studies on the use of Amol in this age group.

Internally:

• in the case of bile duct obstruction (e.g. in the course of cholelithiasis), cholecystitis;
• in people with chronic liver diseases;
• in people addicted to alcohol.

Externally:

• on damaged skin, e.g. with burns, rashes and open wounds;
• in skin diseases with rash;
• on mucous membranes and in the eye area.

Warnings and precautions

Eyes should be protected from contact with the medicine. If the medicine gets into the eyes, they should be rinsed with plenty of water. If the symptoms do not disappear, consult a doctor.
In case of breathing difficulties (e.g. bronchospasm), a doctor should be called immediately, and in case of skin changes, consult a doctor.
After rubbing the solution, hands should be washed carefully.
The medicine should not be used under a dressing that restricts air access or in the form of compresses.
It may cause burning of damaged skin.
If additional information is needed before using the medicine, consult a doctor or pharmacist.

Children and adolescents

Do not use in children under 12 years of age.

Patients with liver and bile duct disorders

In people with cholelithiasis, Amol may be used orally only after consulting a doctor.

Amol and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Alcohol in this medicine may change the effect of other medicines.

Pregnancy, breastfeeding, and fertility

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.
There are no clinical data on the use of the medicine during pregnancy and breastfeeding.
Due to the lack of data on safety, it is not recommended to use Amol during pregnancy and breastfeeding.

Driving and using machines

Due to the ethanol content, Amol may affect the central nervous system.
Therefore, it is not recommended to drive vehicles and operate machines after oral use of the medicine.

Amol contains ethanol.

Amol contains 67% ethanol (alcohol). When using the recommended dosage, after each oral administration of the medicine in the amount of 10-15 drops, 0.46 g of ethanol will be introduced into the body, which is equivalent to 8-11 ml of beer (5% v / v) and 3-5 ml of wine (12% v / v). Harmful to people with alcohol disease.
This should be taken into account when used in pregnant or breastfeeding women, children, and people at high risk, such as patients with liver disease or epilepsy.

3. How to use Amol

This medicine should always be used exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions. If in doubt, consult a doctor or pharmacist.
Recommended dose and method of administration
The medicine should not be used under a dressing that restricts air access or in the form of compresses.
Adults and adolescents over 12 years of age:

Externally for rubbing to improve poor well-being (e.g. in the course of a cold, headaches, muscle pains)

Rub a small amount of the medicine in its pure form several times a day.

Externally to reduce discomfort after insect bites

Rub the bite site with a swab soaked in the medicine in its pure form.

Orally for digestive disorders (dyspeptic)

Take 10 to 15 drops of the medicine with a liquid or sugar, as needed, when symptoms occur, up to 3 times a day.
If symptoms worsen or do not improve, consult a doctor.

Using a higher dose of Amol than recommended

In case of accidental ingestion of larger amounts of the medicine, symptoms typical of alcohol overdose occur. If a higher dose of the medicine than recommended is taken, consult a doctor or pharmacist.

Missing a dose of Amol

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is as follows:
very rare (occurs in less than 1 in 10,000 people);
Gastrointestinal disorders:

• gastric irritation

Skin and subcutaneous tissue disorders:

• skin and mucous membrane irritation, contact dermatitis, hypersensitivity reactions

Respiratory, thoracic, and mediastinal disorders:

• dry cough, bronchospasm

Frequency not known (cannot be estimated from the available data)
General disorders and administration site conditions:

• blisters at the injection site.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, discontinue use of the medicine and inform your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will allow for more information to be collected on the safety of the medicine.

5. How to store Amol

Keep the medicine out of sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
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. Contents of the packaging and other information

What Amol contains

• The active substances of Amol are: 1 g of Amol contains Mentholum (menthol) 17.23 mg; Citronellae aetheroleum (citronella oil) 1.00 mg; Caryophylli floris aetheroleum (clove oil) 1.00 mg; Cinnamomi zeylanici corticis aetheroleum (cinnamon oil) 2.40 mg; Limonis aetheroleum (lemon oil) 5.70 mg; Menthae piperitae aetheroleum (peppermint oil) 2.40 mg; Lavandulae aetheroleum (lavender oil) 2.40 mg.
• The other ingredients (excipients) are: ethanol 96% (v/v), water.

What Amol looks like and what the pack contains

Amol is a clear, colorless liquid that may turn yellowish-green. The color of the medicine is due to the presence of natural ingredients. A glass bottle with a dropper and a polyethylene or polypropylene cap in a cardboard box.
Bottles of 100 ml, 150 ml, 250 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder

Orifarm Healthcare A/S
Energivej 15
5260 Odense S
Denmark
To obtain more detailed information about this medicine, please contact the representative of the marketing authorization holder:
Orifarm Healthcare Sp. z o.o.
Przyokopowa Street 31
01-208 Warsaw
Poland
[email protected]

Manufacturer

Orifarm Manufacturing Poland Sp. z o.o.
Księstwa Łowickiego Street 12
99-420 Łyszkowice
Poland
Date of last revision of the leaflet:07/2023