Mucoplant for cough ivy

Package leaflet: information for the patient

Mucoplant na kaszel bluszcz, 1.54 mg/ml, syrup
Dry extract of ivy leaves
Hederae helicis folii extractum siccum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if symptoms worsen, consult your doctor.

Contents of the leaflet:

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

1. What Mucoplant na kaszel bluszcz is and what it is used for

Mucoplant na kaszel bluszcz syrup contains dry extract of ivy leaves (Hederae helicis folii extractum siccum).
Mucoplant na kaszel bluszcz is a herbal medicinal product used as an expectorant in productive (wet) cough in adults, adolescents, and children above 2 years of age.
If there is no improvement after 7 days, or if symptoms worsen, consult your doctor.

2. Important information before using Mucoplant na kaszel bluszcz

When not to use Mucoplant na kaszel bluszcz:

• if the patient is allergic to the active substance, including plants from the Araliaceae family – Araliaceae, or to any of the excipients (listed in section 6).
• in children under 2 years of age due to the risk of worsening respiratory symptoms as a result of using secretolytic (expectorant) drugs.

Warnings and precautions
Before starting treatment with Mucoplant na kaszel bluszcz, consult a doctor or pharmacist.
Persistent or recurrent cough in children aged 2 to 4 years should be diagnosed by a doctor before initiating treatment.
If breathing difficulties, fever, or purulent sputum occur, consult a doctor or pharmacist.
If symptoms do not improve within 7 days of starting treatment, consult a doctor.
Concurrent use of this medicine with other cough-suppressant drugs (opioid antitussives such as codeine or dextromethorphan) is not recommended without medical consultation.
Caution is advised in patients with stomach problems (gastritis, peptic ulcer).
In case of renal or hepatic impairment, consult a doctor or pharmacist before taking Mucoplant na kaszel bluszcz.
Recommended dosages in these patients have not been established.

Mucoplant na kaszel bluszcz and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
No influence on the action of other drugs has been reported. Interaction studies have not been conducted.

Use of Mucoplant na kaszel bluszcz with food, drink, and alcohol
Mucoplant na kaszel bluszcz can be taken independently of meals.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Mucoplant na kaszel bluszcz is not recommended during pregnancy and breastfeeding due to insufficient data on the use of dry ivy leaf extract in pregnant women and breastfeeding mothers.

Driving and operating machinery
No studies have been conducted on the effect on the ability to drive or operate machinery.
There is no evidence that Mucoplant na kaszel bluszcz affects the ability to drive or operate machinery.

Mucoplant na kaszel bluszcz contains maltitol
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.
Advice for diabetics: 10 ml contains 4 g of maltitol, equivalent to 0.3 carbohydrate exchange units. The energy value is 2.3 kcal/g of maltitol.
Maltitol may have a mild laxative effect.

3. How to use Mucoplant na kaszel bluszcz

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
Recommended dosage:
Adults and adolescents over 12 years of age: 15 ml, 3 times daily.
Children from 6 to 11 years of age: 15 ml, 2 times daily.
Children from 2 to 5 years of age: 10 ml, 2 times daily.
Children under 2 years of age:
Use is contraindicated.
For correct dosing, use the measuring device provided.
Patients with renal impairment or hepatic function disorders: Due to lack of data,
recommended dosage cannot be established. (See also "Warnings and precautions").
Mucoplant na kaszel bluszcz should be taken undiluted and independently of meals.
During treatment with Mucoplant na kaszel bluszcz, drink plenty of water or other warm,
non-caffeinated beverages throughout the day.
If symptoms persist for longer than one week during use of this product, consult a
physician or pharmacist.
If the effect of Mucoplant na kaszel bluszcz seems too strong or too weak, consult a
physician or pharmacist.
Use of a higher than recommended dose of Mucoplant na kaszel bluszcz
Do not take more than the recommended dose. Taking doses higher than recommended
(more than three times the single dose) may cause nausea, vomiting, diarrhoea,
and agitation. If a higher than recommended dose has been taken and adverse
effects occur, seek medical advice.
One case has been reported in a 4-year-old child who developed aggression and
diarrhoea after accidental ingestion of ivy extract equivalent to 1.8 g of herbal
substance (corresponding to 195 ml of Mucoplant na kaszel bluszcz syrup).
Missed dose of Mucoplant na kaszel bluszcz
Do not take a double dose to make up for a missed dose.
If you have any further questions concerning the use of this medicine, consult a
physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everybody will experience them.
Gastrointestinal reactions (nausea, vomiting, diarrhoea) have been reported. Frequency is unknown (cannot be estimated from the available data).
Allergic reactions have been reported, manifesting as urticaria, skin rash, breathing difficulties (dyspnoea), and anaphylactic reaction. Frequency is unknown (cannot be estimated from the available data).
If an allergic reaction occurs, discontinue use of the medicine immediately and contact your doctor without delay.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult 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
ul. 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 Authorisation Holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Mucoplant na kaszel bluszcz

Keep this medicine out of the sight and reach of children.
Do not use Mucoplant na kaszel bluszcz after the expiry date "EXP:" stated on the carton. The expiry date refers to the last day of the specified month.
Do not store above 25°C.
Expiry after first opening: 6 weeks.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Mucoplant ivy cough contains

• The active substance is dry extract of ivy leaves (Hederae helicis folii extractum siccum). One ml of syrup contains 1.54 mg of dry extract from ivy leaves Hedera helix L. (folium) (DER 4-8:1). Extraction solvent: ethanol 30% (m/m).
• Other ingredients are: potassium sorbate, hydroxyethylcellulose, blackcurrant flavour SD (652281), maltitol liquid (E 965), citric acid, purified water.

What Mucoplant ivy cough looks like and contents of the pack
Mucoplant ivy cough is a brownish-yellow, slightly cloudy syrup with a characteristic smell (blackcurrant).
Mucoplant ivy cough is available in packaging containing a measuring cup and 100 ml, 200 ml, 250 ml of syrup in a brown glass bottle.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Dr. Theiss Naturwaren GmbH
Michelinstrasse 10
66424 Homburg-Saar
Germany
This medicinal product is authorised for marketing in the Member States of the European
Economic Area under the following names: