Melis-tonic

PATIENT INFORMATION LEAFLET: PATIENT INFORMATION

MELIS-TONIC, oral liquid

Read the contents of the leaflet carefully before using the medicine, as it contains

important information for the patient.

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any doubts, consult a doctor or pharmacist. If the patient experiences any side effects, including any possible side effects not listed in the leaflet, inform the doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, consult a doctor.

Table of contents of the leaflet:

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

1. What is MELIS-TONIC and what is it used for.

MELIS-TONIC is a herbal medicine obtained by macerating the following herbs: melissa leaf, hawthorn inflorescence, chamomile flower head, angelica root, and caraway fruit, with a mixture of ethanol and water, and then adding honey. The product is traditionally used as an auxiliary in states of excessive nervous tension. The effectiveness of the product in the indicated uses is based solely on long-term use and experience.
If there is no improvement or the patient feels worse, consult a doctor.

2. Important information before using MELIS-TONIC.

When not to use MELIS-TONIC.

If the patient is allergic to the active substance, chamomile, or other plants of the Asteraceae family (formerly Compositae), or to caraway or other plants of the Apiaceae family (such as parsley, anise, celery, coriander, and dill), or to angelica or birch, or to any of the other ingredients of this medicine.

Warnings and precautions.

Before starting to use MELIS-TONIC, discuss it with a doctor or pharmacist.
The product contains 30-35% (V/V) ethanol (alcohol). A single dose of the medicine (5 ml) contains approximately 1.4 g of ethanol, which is equivalent to 35 ml of beer or 15 ml of wine. This is a harmful dose for people with alcoholism.
The alcohol content should be taken into account in pregnant or breastfeeding women and high-risk groups, such as patients with liver disease or epilepsy.
The use of the medicine is not recommended in people with liver disease, bile duct inflammation, achlorhydria, gallstones, and other bile duct disorders due to the content of caraway fruit.
Due to the content of angelica root, during the use of the medicine, sunbathing and intense UV radiation should be avoided due to the possible transformation of furocoumarins into carcinogenic forms by UV radiation.

Children.

The product must not be used in children under 12 years of age.

MELIS-TONIC and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy, breastfeeding, and fertility

Due to the lack of data, the use of the medicine is not recommended during pregnancy and breastfeeding. There is no data on the effect on fertility.

Driving and using machines.

The preparation contains approximately 1.4 g of ethanol in a single dose (5 ml), which is equivalent to 35 ml of beer or 15 ml of wine. The preparation may affect the ability to drive vehicles and 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 doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
Dosage.
Traditionally, the following dosage regimen is used:
Adults, elderly, and adolescents over 12 years: approximately 5 ml of the product (1 teaspoon) 3 times a day. The medicine should be diluted in ¼ cup of water.
Method of administration:
Oral administration.

Use in children.

Do not use in children under 12 years of age.

Overdose of MELIS-TONIC.

Overdose cases are not known so far.
Possible occurrence of light-induced allergic reactions.

Missed dose of MELIS-TONIC.

In case of a missed dose, do not take a double dose to make up for the missed dose.

Stopping MELIS-TONIC.

In case of any further doubts related to the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects.

Like all medicines, MELIS-TONIC can cause side effects, although they may not occur in everyone.
In very rare cases, a hypersensitivity reaction to chamomile (e.g., contact allergy) may occur. In people allergic to plants of the Asteraceae family (formerly Compositae), e.g., wormwood, a cross-reaction may occur. With internal use, very rare cases of severe allergic reactions (anaphylactic shock, asthma, facial edema, urticaria) have been reported.
Reporting side effects.
If any side effects occur, including any side effects not listed in the leaflet, inform the doctor or 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: Al. Jerozolimskie 181C, 02-222 Warsaw, tel. 22 49-21-301, fax 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 MELIS-TONIC.

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
Store in closed containers, at a temperature not exceeding 25°C.

6. Contents of the pack and other information.

What MELIS-TONIC contains.

100 ml contains:
Active substance:
Extractum fluidumex(fluid extract) (1:5) – 82 g:
Melissae folium(melissa leaf) – 6.56 g,
Crataegi folium cum flore(hawthorn inflorescence) – 5.74 g,
Matricariae flos(chamomile flower head) – 1.64 g,
Angelicae radix(angelica root) – 1.64 g,
Carvi fructus(caraway fruit) – 0.82 g,
Ethanol 40% (V/V) extractant
Excipient:
Honey – 20.5 g
The medicine contains 30-35% (V/V) ethanol.

What MELIS-TONIC looks like and what the pack contains.

MELIS-TONIC is an oral liquid, brownish-yellow in color with a herbal-honey aroma.
Packaging: The bottle contains 100 ml of liquid.

Marketing authorization holder and manufacturer.

Krakowskie Zakłady Zielarskie „Herbapol” w Krakowie SA
ul. Chałupnika 14, 31-464 Kraków
tel. 12 411 69 11, fax 12 411 58 37
e-mail: herbapol@herbapol.krakow.pl
Marketing authorization number: R/0474.
Date of approval of the leaflet text: