Herbion na kashel mokri

Leaflet attached to the packaging: patient information

Herbion for wet cough, hard tablets

Hederae helicis folii extractum siccum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• 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 there is no improvement after 7 days 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 taking Herbion for wet cough
• 3. How to take 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 a dry extract of ivy leaves.
Herbion for wet cough is a herbal medicinal product used in adults, adolescents, and children over 6 years of age as an expectorant in the case of productive cough (wet cough).

2. Important information before taking Herbion for wet cough

When not to take Herbion for wet cough

• if the patient is allergic to ivy leaf extract, to other plants of the Araliaceaefamily (the 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.

Warnings and precautions

Before taking Herbion for wet cough, the patient should discuss it with their doctor or pharmacist.

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

Children

Do not use hard tablets of Herbion for wet cough in children under 2 years of age. It is not recommended to use hard tablets of Herbion for wet cough in children from 2 to 5 years of age, as there is no possibility of adjusting the dose for this form of the medicine. In this age group, it is recommended to use the medicine in the form of a syrup.

Herbion for wet cough and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
No interaction has been found between the dry extract of ivy leaves and other medicines.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking 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 effects of this medicine on the ability to drive and use machines.

Herbion for wet cough contains isomalt (E 953) and butylhydroxyanisole (E 320)

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
Butylhydroxyanisole (E 320) may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation.

3. How to take Herbion for wet cough

This medicine should always be taken as directed by the doctor or pharmacist. If there are any doubts, the patient should consult their doctor or pharmacist.
Adults, elderly patients, and adolescents over 12 years of age: the recommended dose is 1 hard tablet three times a day.

Use in children

Children from 6 to 11 years of age:the recommended dose is 1 hard tablet twice a day.
The tablet should be dissolved in the mouth. The patient should not take the tablets directly before or during meals.
When taking 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 taking the medicine, the patient should contact their 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 there are any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
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, the patient should stop taking the medicine and consult their doctor. In case of a severe allergic reaction, they should seek immediate medical attention.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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 gather more information on the safety of this medicine.

5. How to store Herbion for wet cough

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 after: EXP.
The expiry date refers to the last day of the specified month.
Do not store above 25°C.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Herbion for wet cough contains

• The active substance of the medicine is a dry extract of ivy leaves. One hard tablet contains 35 mg of extract (in the form of a dry extract) from Hedera helixL., folium (ivy leaf) (5-7.5:1) Extraction solvent: Ethanol 30% (m/m).
• The other ingredients are isomalt (E 953), citric acid (E330), natural caramel flavor (propylene glycol (E1520)), natural citrus flavor (butylhydroxyanisole (E 320)), sucralose (E 955), peppermint essential oil. See section 2 "Herbion for wet cough contains isomalt (E 953) and butylhydroxyanisole (E 320)".
• The excipient used in the extract: simethicone.

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

A round tablet with a flat edge and a rough surface, brown in color. Possible presence of yellow to brown specks, lighter spots, air bubbles, and small surface irregularities. Tablet diameter: 18.0 mm - 19.0 mm, thickness: 7.0 mm - 8.0 mm.
Hard tablets are available in cardboard boxes containing 8, 16, 24, 32, and 40 hard tablets in blisters.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia