Amol
Poland
Table of Contents
Package leaflet: Information for the patient
Amol
Complex product,
Oral liquid, topical liquid
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 according to the
instructions given by the doctor or pharmacist.
- Keep this leaflet, so that you can 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 side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement or if you feel worse, contact your doctor.
Leaflet contents
- What Amol is and what it is used for
- Important information before using Amol
- How to use Amol
- Possible side effects
- How to store Amol
- Contents of the pack and other information
1. What Amol is and what it is used for
Amol is a solution of menthol and a mixture of essential oils in ethanol.
The active substances in 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 results from the action of individual active substances.
The medicine is intended for traditional use in the indications listed, and its efficacy is based solely on long-term use and experience.
Amol has traditionally been used for the following indications:
externally:
- to relieve general malaise, e.g. during colds, headaches, and muscle pain;
- to reduce discomfort following insect bites; internally:
- for digestive complaints (dyspeptic symptoms), such as bloating and indigestion.
2. Important information before using Amol
When not to use Amol
- if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
- in bronchial asthma and other respiratory tract diseases associated with marked airway hyperreactivity.
- in children under 12 years of age, due to lack of sufficient data on the use of Amol in this age group.
Internally:
- in biliary tract obstruction (e.g. in gallstones), inflammation of the gallbladder;
- in patients with chronic liver disease;
- in patients with alcohol dependence.
Externally:
- on damaged skin, e.g. in burns, rashes, and open wounds;
- in skin diseases associated with rash;
- on mucous membranes and around the eyes.
Warnings and precautions
Protect the eyes from contact with the medicine. If Amol gets into the eyes, rinse thoroughly with water.
If symptoms persist, consult a doctor.
In case of breathing difficulties (e.g. bronchospasm), seek medical advice immediately; in case of skin reactions, consult a doctor.
After applying the Amol solution, hands should be washed thoroughly.
Do not use the medicine under occlusive dressings or as compresses, as this may impair air access to the skin.
May cause stinging on damaged skin.
If further information is needed, consult a doctor or pharmacist before use.
Children and adolescents
Do not use in children under 12 years of age.
Patients with impaired liver or biliary tract function
In patients with gallstones, Amol may be taken orally only after consultation with a doctor.
Amol and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
The alcohol contained in this medicine may alter the effects of other medicines.
Pregnancy, breastfeeding and fertility
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.
There are no clinical data on the use of Amol during pregnancy and breastfeeding.
Due to lack of safety data, the use of Amol is not recommended during pregnancy and breastfeeding.
Driving and operating machinery
Due to its ethanol content, Amol may affect the central nervous system.
Therefore, driving and operating machinery are not recommended after oral administration of the medicine.
Amol contains ethanol.
Amol contains 67% ethanol (alcohol). With the recommended dosage, each oral dose of 10–15 drops introduces up to 0.46 g of ethanol into the body, equivalent to 8–11 ml of beer (5% v/v) and 3–5 ml of wine (12% v/v). Harmful for individuals with alcohol-related disorders.
Consider this when using in pregnant or breastfeeding women, children, and individuals in high-risk groups, 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 information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose and method of administration
Do not use this medicine under occlusive dressings or as compresses, as these may impair air access.
Adults and adolescents over 12 years of age:
Externally for massage to relieve general discomfort (e.g. in colds, headaches, muscle pain)
Rub a small amount of the undiluted medicine onto the skin several times daily.
Externally to relieve discomfort from insect bites
Wipe the affected area with a swab soaked in the undiluted medicine.
Orally for digestive (dyspeptic) discomfort
Take 10 to 15 drops of the medicine with liquid or sugar, as needed when symptoms occur, up to 3 times daily.
If symptoms worsen or do not improve, consult a doctor.
Use of a higher than recommended dose of Amol
If larger quantities of the medicine are accidentally ingested, symptoms typical of alcohol overdose may occur. In case of overdose, consult a doctor or pharmacist immediately.
Missed use of Amol
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 everyone experiences them.
The frequency of the possible adverse reactions listed below is defined as follows:
very rare (occur in less than 1 in 10,000 people);
Gastrointestinal disorders:
- stomach irritation
Skin and subcutaneous tissue disorders:
- skin and mucous membrane irritation, contact dermatitis, hypersensitivity reactions
Respiratory, thoracic and mediastinal disorders:
- cough (dry), bronchospasm
Frequency unknown (cannot be estimated from available data)
General disorders and administration site conditions:
- burning sensation at the application site.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed
in this leaflet, treatment with the medicine should be discontinued and a doctor, pharmacist, or
nurse should be informed.
Adverse reactions may be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may 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 Amol
Keep this medicine out of sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the package and other information
What Amol contains
- The active substances in Amol are: 1 g of Amol contains Mentholum (menthol) 17.23 mg; Citronellae aetheroleum (citronella essential oil) 1.00 mg; Caryophylli floris aetheroleum (clove essential oil) 1.00 mg; Cinnamomi zeylanici corticis aetheroleum (cinnamon bark essential oil) 2.40 mg; Limonis aetheroleum (lemon essential oil) 5.70 mg; Menthae piperitae aetheroleum (peppermint essential oil) 2.40 mg; Lavandulae aetheroleum (lavender essential oil) 2.40 mg.
- Other ingredients (excipients) are: ethanol 96% (v/v), water.
What Amol looks like and contents of the pack
Amol is a clear, colourless liquid which may vary in colour from yellowish to greenish-yellow. The colour of the product results from the presence of naturally derived ingredients. Supplied in colourless glass bottles with a dropper and a cap made of polyethylene or polypropylene, packed in a cardboard box.
Bottle sizes: 100 ml, 150 ml, 250 ml.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Orifarm Healthcare A/S
Energivej 15
5260 Odense S
Denmark
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orifarm Healthcare Sp. z o.o.
ul. Przyokopowa 31
01-208 Warszawa
Poland
[email protected]
Manufacturer
Orifarm Manufacturing Poland Sp. z o.o.
ul. Księstwa Łowickiego 12
99-420 Łyszkowice
Poland