Melis-tonic
Poland
Table of Contents
MELIS-TONIC, oral liquid
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.
- Keep this leaflet for future reference.
- If you have any questions, consult your doctor or pharmacist. If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement or if the patient feels worse, consult a doctor.
Table of contents of the leaflet:
- What MELIS-TONIC is and what it is used for
- Important information before taking MELIS-TONIC
- How to take MELIS-TONIC
- Possible side effects
- How to store MELIS-TONIC
- Contents of the pack and other information
1. What MELIS-TONIC is and what it is used for
MELIS-TONIC is a herbal medicinal product obtained by macerating the following plant materials: lemon balm leaf, hawthorn flower, chamomile flower head, licorice root, and caraway fruit in a mixture of ethanol and water, followed by the addition of honey. The product is traditionally used as an adjunctive treatment in states of excessive nervous tension. The effectiveness of this product in the indicated conditions is based solely on long-term use and experience.
If there is no improvement or if the patient feels worse, consult a doctor.
2. Information before using MELIS-TONIC.
When not to use MELIS-TONIC.
If the patient is allergic to the active substance, chamomile or other plants from the Asteraceae family (formerly known as Compositae), caraway or other plants from the Apiaceae family (such as dill, anise, celery, coriander, and parsley), lemon balm or birch, or to any of the other ingredients of this medicine.
Warnings and precautions.
Before starting to use MELIS-TONIC, consult your doctor or pharmacist.
This product contains 30–35% (V/V) ethanol (alcohol). A single dose (5 ml) contains approximately 1.4 g of ethanol, equivalent to 35 ml of beer or 15 ml of wine. This amount is harmful for individuals with alcohol dependence.
The alcohol content should be taken into account in pregnant or breastfeeding women and in high-risk groups such as patients with liver disease or epilepsy.
The use of this medicine is not recommended in patients with liver disease, biliary tract inflammation, achlorhydria, gallstones, or other biliary disorders due to the presence of caraway fruit.
Due to the presence of liquorice root, exposure to sunlight and intense UV radiation should be avoided during treatment, as UV radiation may convert furocoumarins into carcinogenic forms.
Children.
This product must not be used in children under 12 years of age.
MELIS-TONIC and other medicines.
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient intends to take.
Pregnancy, breastfeeding and fertility.
Due to lack of data, the use of this medicine is not recommended during pregnancy and breastfeeding. There is no information available regarding its effect on fertility.
Driving and operating machinery.
Each single dose (5 ml) contains approximately 1.4 g of ethanol, equivalent to 35 ml of beer or 15 ml of wine. This medicine may affect the ability to drive or operate machinery.
3. How to use MELIS-TONIC.
This medicine should always be used exactly as described in the patient information leaflet or as directed by a physician or pharmacist. If in doubt, consult a physician or pharmacist.
Dosage.
The traditional dosage regimen is as follows:
Elderly patients, adults and adolescents over 12 years of age: approximately 5 ml of product (1 teaspoon) three times daily. Dilute the medicine in ¼ glass of water.
Administration method:
Oral administration.
Use in children.
Do not use in children under 12 years of age.
Accidental overdose of MELIS-TONIC.
Cases of overdose have not been reported.
Possible occurrence of photosensitivity reactions.
Missed dose of MELIS-TONIC.
If a dose of MELIS-TONIC is missed, do not take a double dose to make up for the missed dose.
Discontinuation of MELIS-TONIC.
If you have any further doubts regarding the use of this medicine, consult your physician or pharmacist.
4. Possible adverse reactions.
Like all medicines, MELIS-TONIC may cause adverse reactions, although not everyone will experience them.
In very rare cases, hypersensitivity reactions to chamomile (e.g. contact allergy) may occur. In individuals allergic to plants from the Asteraceae family (formerly known as Compositae), cross-reactivity may occur, for example with mugwort (Artemisia vulgaris). When taken internally, very rare cases of severe allergic reactions (anaphylactic shock, asthma, facial swelling, urticaria) have been reported.
Reporting of adverse reactions.
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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: [email protected].
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.
5. How to store MELIS-TONIC.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
Store in tightly closed containers, at a temperature not exceeding 25°C.
6. Contents of the package and other information.
What the medicinal product MELIS-TONIC contains.
100 ml contains:
Active substance:
Extractum fluidum ex (liquid extract composed) (1:5) – 82 g:
Melissae folium (leaves of lemon balm) – 6.56 g,
Crataegi folium cum flore (hawthorn flowering tops) – 5.74 g,
Matricariae flos (chamomile flower heads) – 1.64 g,
Angelicae radix (angelica root) – 1.64 g,
Carvi fructus (caraway fruit) – 0.82 g,
Extraction solvent: ethanol 40% (V/V)
Excipient:
Honey – 20.5 g
The medicinal product contains 30–35% (V/V) ethanol.
What MELIS-TONIC looks like and contents of the pack.
MELIS-TONIC is an oral liquid, honey-brown in colour, with a herbal-honey odour.
Pack: Bottle containing 100 ml of liquid.
Marketing Authorisation Holder and Manufacturer.
Krakowskie Zakłady Zielarskie „Herbapol” w Krakowie Sp. z o.o.
ul. Chałupnika 14, 31-464 Kraków, Poland
tel. 12 411 69 11, fax 12 411 58 37
e-mail: [email protected]
Marketing Authorisation number: R/0474.
Date of text approval: