Herbion for dry cough

Package leaflet: Information for the user

Herbion na kaszel mokry, 7 mg/ml, syrup
Hederae helicis folii extractum siccum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient information leaflet or as directed 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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Contents of the leaflet:

1. What Herbion na kaszel mokry is and what it is used for
2. Important information before taking Herbion na kaszel mokry
3. How to take Herbion na kaszel mokry
4. Possible side effects
5. How to store Herbion na kaszel mokry
6. Contents of the pack and other information

1. What Herbion na kaszel mokry is and what it is used for

Herbion na kaszel mokry contains dry extract of ivy leaves (Hedera helix).
Herbion na kaszel mokry is a herbal medicinal product used as an expectorant in productive (wet) cough.

2. Important information before using Herbion na kaszel mokry

When not to use Herbion na kaszel mokry

• if the patient is allergic to ivy leaf extract, to other plants from the Araliaceae family (a botanical family to which ivy belongs), or to any of the other ingredients of this medicine (listed in section 6). Do not use in children under 2 years of age due to the risk of worsening respiratory symptoms associated with cough medicines that work by thinning mucus in the airways.

Warnings and precautions
Before starting treatment, discuss this with your doctor or pharmacist.

• If breathing difficulties, fever, or purulent sputum (containing pus) occur, contact your doctor or pharmacist.
• If symptoms do not improve after 7 days of treatment, consult your doctor.
• Do not take this product together with other cough suppressants (antitussive medicines such as codeine or dextromethorphan) without medical advice.
• Special caution is advised in patients with stomach problems (gastritis, gastric ulcers).

Children
In children aged 2 to 4 years with chronic or recurring cough, consult a doctor before starting treatment.

Herbion na kaszel mokry and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take. No interaction of this medicine with other drugs has been observed.

Herbion na kaszel mokry with food and drink
This medicine may be taken regardless of meals.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your 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 na kaszel mokry is not recommended during pregnancy and breastfeeding.

Driving and operating machinery
No studies have been conducted on the effect of this medicine on the ability to drive or operate machinery.
No effects of Herbion na kaszel mokry on the ability to drive or operate machinery have been reported.

Herbion na kaszel mokry contains sorbitol (E420), sodium benzoate (E211), ethanol, and sodium (from sodium benzoate)
A single adult dose (5 ml) contains 1750 mg of sorbitol, 10 mg of sodium benzoate, and 0.5 mg of ethanol (from the flavoring ingredient Lemon balm Flavour).

Sorbitol is a source of fructose. If intolerance to certain sugars has previously been diagnosed in the patient (or their child), or if hereditary fructose intolerance—a rare genetic disorder in which the body cannot break down fructose—has been diagnosed, the patient should consult a doctor before taking the medicine or giving it to a child.

Inform your doctor before taking this medicine if your child should not consume sweetened foods or drinks due to nausea, vomiting, or adverse 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) in 5 ml of syrup (one 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 cause noticeable effects.

This medicine contains less than 1 mmol (23 mg) of sodium per 5 ml, meaning the medicine is considered "sodium-free".

3. How to use Herbion na kaszel mokry

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
Adults, elderly and adolescents aged 12 years and older: the recommended dose is
5 to 7.5 ml of syrup twice daily.
Use in children
Children aged 6 to 11 years: the recommended dose is 5 ml of syrup twice daily.
Children aged 2 to 5 years: the recommended dose is 2.5 ml of syrup twice daily.
Use in children under 2 years of age is contraindicated.
The syrup should be taken in the morning and early afternoon. This medicine may be taken
independently of meals.
When using Herbion na kaszel mokry, it is recommended to drink large amounts of water or other
warm, non-caffeinated beverages.
If symptoms persist for longer than 7 days during treatment, consult a physician or pharmacist.
Taking more than the recommended dose of Herbion na kaszel mokry
Do not take more than the recommended dose. Taking a higher than recommended dose (more than
double the daily dose) may cause nausea, vomiting, diarrhoea and states of excitation. Treatment
is symptomatic.
Missed dose of Herbion na kaszel mokry
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The frequency of possible adverse reactions is listed below.
Frequency unknown (frequency cannot be estimated from the available data)

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

If an allergic reaction occurs, discontinue use of the medicine and consult a doctor.
In the case of a severe allergic reaction, seek immediate medical advice.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. 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, website: https://smz.ezdrowie.gov.pl. Adverse reactions can also be reported to the marketing authorization holder. By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Herbion na kaszel mokry

Keep this 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 stated month.
No special precautions for storage of the medicine are required.
The syrup should be used within 3 months after opening the bottle.
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 packaging and other information

What Herbion na kaszel mokry 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). Extraction solvent: Ethanol 30% (m/m).
• Other ingredients are: liquid sorbitol (non-crystallizing) (E420), glycerol (E422), sodium benzoate (E211), citric acid monohydrate (E330), lemon balm flavouring: also contains ethanol, purified water. See section 2 "Herbion na kaszel mokry contains sorbitol (E420), sodium benzoate (E211), ethanol and sodium (from sodium benzoate)".

What Herbion na kaszel mokry looks like and contents of the pack
Yellow-brown syrup with a characteristic odour and taste, possibly with a slight sediment. The syrup is available in a pack containing 150 ml of syrup in a bottle with a measuring spoon.

Marketing Authorisation Holder and Manufacturer:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This medicine is authorized for sale in the European Economic Area under the following names:

For more detailed information about this medicinal product, please contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Phone: 22 57 37 500