Herbion na kashel mokri

Leaflet attached to the packaging: patient information

Herbion for wet cough, 7 mg/ ml, syrup

Hederae helicis folii extractum siccum

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 as directed by a doctor or pharmacist.

• 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 side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor. Table of contents of the leaflet:
• 1. What is Herbion for wet cough and what is it used for
• 2. Important information before using Herbion for wet cough
• 3. How to use Herbion for wet cough
• 4. Possible side effects
• 5. How to store Herbion for wet cough
• 6. Package contents and other information

1. What is Herbion for wet cough and what is it used for

Herbion for wet cough contains dry extract of ivy leaves.
Herbion for wet cough is a herbal medicinal product used as an expectorant in the case of productive (wet) cough.

2. Important information before using Herbion for wet cough

When not to use Herbion for wet cough

Warnings and precautions

Before starting to use the medicine, discuss it with a doctor or pharmacist.

• In case of difficulty breathing, fever, or the appearance of purulent sputum (containing pus), contact a doctor or pharmacist.
• If symptoms do not improve after 7 days of using the medicine, consult a doctor.
• Do not take this product with other cough-suppressing medicines (antitussives, such as codeine or dextromethorphan) without consulting a doctor.
• Particular caution is recommended in patients with stomach problems (gastritis, stomach ulcers). Children

In children aged 2 to 4 years with prolonged or recurrent cough, consult a doctor before starting treatment.

Herbion for wet cough and other medicines

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

Herbion for wet cough with food and drink

The medicine can be taken independently of meals.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a baby, they should consult a doctor or pharmacist before using this medicine.
Due to insufficient data on the use of dry ivy leaf extract in pregnant and breastfeeding women, Herbion for wet cough is not recommended during pregnancy and breastfeeding.

Driving and using machines

No studies have been conducted on the effect on the ability to drive and use machines.
No effect of Herbion for wet cough on the ability to drive and use machines has been reported.

Herbion for wet cough contains sorbitol (E420), sodium benzoate (E 211), ethanol, and sodium (from sodium benzoate)

A single dose of the medicine for adults (5 ml) contains 1750 mg of sorbitol, 10 mg of sodium benzoate, and 0.5 mg of ethanol (a component of the flavoring substance Lemon balm Flavour).
Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, hereditary fructose intolerance, in which the patient's body does not break down fructose, the patient should consult a doctor before taking the medicine or giving it to their child.
Tell your doctor before taking this medicine if your child should not consume sweet foods or drinks for longer than recommended due to nausea, vomiting, or unpleasant side effects, such as bloating, stomach cramps, or diarrhea.
Sorbitol (≥ 140 mg/kg/day) may cause gastrointestinal discomfort and may have a mild laxative effect.
This medicine contains 0.5 mg of alcohol (ethanol) per 5 ml of syrup (1 measuring spoon). The amount of alcohol in the maximum dose of 15 ml of this medicine is equivalent to less than 0.0375 ml of beer or 0.015 ml of wine.
The small amount of alcohol in this medicine will not have noticeable effects.
This medicine contains less than 1 mmol (23 mg) of sodium per 5 ml, which means the medicine is considered "sodium-free".

3. How to use Herbion for wet cough

This medicine should always be used exactly as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults, elderly, and adolescents over 12 years of age: the recommended dose is 5 to 7.5 ml of syrup twice a day.

Use in children

Children aged 6 to 11 years:the recommended dose is 5 ml of syrup twice a day.
Children aged 2 to 5 years: the recommended dose is 2.5 ml of syrup twice a day.
Use in children under 2 years of ageis contraindicated.
The syrup should be taken in the morning and early afternoon. The medicine can be taken independently of meals.
When using Herbion for wet cough, it is recommended to drink plenty of water or other warm, non-caffeinated beverages.
If symptoms persist for more than 7 days while using the medicine, consult a doctor or pharmacist.

Taking a higher dose of Herbion for wet cough than recommended

Do not take doses higher than recommended. Taking a dose higher than recommended (more than double the daily dose) may cause nausea, vomiting, diarrhea, and excitement. Treatment is symptomatic.

Missing a dose of Herbion for wet cough

Do not take a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of possible side effects is listed below.
Frequency not known (frequency cannot be estimated from the available data)

• nausea, vomiting, diarrhea
• allergic reactions manifesting as hives, rash, and difficulty breathing (dyspnea)
• severe allergic reaction (anaphylactic reaction), which may manifest as swelling of the lips, tongue, face, and/or throat, difficulty breathing or swallowing (chest tightness or wheezing)

In case of an allergic reaction, stop taking the medicine and consult a doctor. In case of a severe allergic reaction, seek immediate medical attention.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. 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.: +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 help to gather more information on the safety of this medicine.

5. How to store Herbion for wet cough

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
The syrup should be used within 3 months of opening the bottle.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Herbion for wet cough contains

• The active substance is dry extract of ivy leaves. 1 ml of syrup contains 7 mg of dry extract of ivy leaves (Hedera helix L., folium) (5-7.5:1). Extractant: Ethanol 30% (m/m).
• The other ingredients are: liquid sorbitol (non-crystallizing) (E420), glycerol (E422), sodium benzoate (E211), citric acid monohydrate (E330), flavoring substance Lemon balm Flavour: also contains ethanol, purified water. See section 2 "Herbion for wet cough contains sorbitol (E420), sodium benzoate (E 211), ethanol, and sodium (from sodium benzoate)".

What Herbion for wet cough looks like and what the package contains

Yellow-brown syrup with a specific smell and taste, possibly with a small sediment.
The syrup is available in a package containing 150 ml of syrup in a bottle with a measuring spoon.

Marketing authorization holder and manufacturer:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
This medicine is authorized in the Member States of the European Economic Area under the following names:
To obtain more detailed information on this medicine, consult the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5

02-235 Warsaw
Tel. 22 57 37 500
Date of last revision of the leaflet:15.01.2021