Herbion for wet cough

Package leaflet: Information for the user

Herbion for productive cough, hard tablets
Hederae helicis folii extractum siccum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Table of contents of the leaflet:

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

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

Herbion for productive cough contains dry extract of ivy leaves.
Herbion for productive cough is a herbal medicinal product used in adults, adolescents and children aged 6 years and older 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 family Araliaceae (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 starting to use Herbion na kaszel mokry, discuss this with a doctor or
pharmacist.

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

Children
Do not use Herbion na kaszel mokry hard pastilles in children under 2 years of age. Use of Herbion na kaszel mokry hard pastilles is not recommended in children aged 2 to 5 years, as dosage adjustment is not possible with this dosage form. In this age group, use of the syrup formulation is recommended.
Herbion na kaszel mokry and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to take.
No interaction of dry ivy leaf extract with other medicines has been reported.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she 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 na kaszel mokry is not recommended during pregnancy and breastfeeding.
Driving and operating machinery
No studies on the effect on the ability to drive vehicles and operate machinery have been conducted.
Herbion na kaszel mokry contains isomalt (E 953) and butylated hydroxyanisole (E 320)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Butylated hydroxyanisole (E 320) may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

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 patients, and adolescents aged 12 years and older: the recommended dose is 1
hard pastille three times daily.
Use in children
Children aged 6 to 11 years: the recommended dose is 1 hard pastille twice daily.
The pastille should be dissolved in the mouth. Do not take pastilles immediately before or during
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.
Overdose of Herbion na kaszel mokry
Do not take more than the recommended dose. Ingestion of a dose higher than recommended (more than
the double 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 your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
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 present as swelling of the lips, tongue, face and/or throat, difficulty 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 reactions occur, including any adverse reactions 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, phone: +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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Herbion na kaszel mokry

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following: EXP.
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Store in the original packaging to protect from moisture.
Medicines must 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. Contents of the package and other information

What Herbion na kaszel mokry contains

• The active substance is dry extract of ivy leaves. Each hard tablet contains 35 mg of extract (in the form of dry extract) from Hedera helix L., folium (ivy leaf) (5-7.5:1). Extraction solvent: Ethanol 30% (m/m).
• Other ingredients are isomalt (E 953), citric acid (E330), natural caramel flavour (propylene glycol (E1520)), natural citrus flavour (butylated hydroxyanisole (E 320)), sucralose (E 955), peppermint essential oil. See section 2 "Herbion na kaszel mokry contains isomalt (E 953) and butylated hydroxyanisole (E 320)".
• Excipient used in the extract: simethicone.

What Herbion na kaszel mokry looks like and contents of the pack
Round, bevelled-edge tablet with a rough surface, light brown to brown in colour. Possible presence of yellow to brownish particles, lighter spots, air bubbles, and minor 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 blister packs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For further information, contact the representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
Tel. 22 57 37 500