Mucoplant na kashel blushh

Leaflet attached to the packaging: patient information

Mucoplant for ivy cough, 1.54 mg/ml, syrup

Dry extract of ivy leaves
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 advised by
the doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 7 days, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Mucoplant for ivy cough and what is it used for
• 2. Important information before taking Mucoplant for ivy cough
• 3. How to take Mucoplant for ivy cough
• 4. Possible side effects
• 5. How to store Mucoplant for ivy cough
• 6. Package contents and other information

1. What is Mucoplant for ivy cough and what is it used for

Mucoplant for ivy cough syrup contains dry extract of ivy leaves (Hederae helicis folii
extractum siccum).
Mucoplant for ivy cough is a herbal medicinal product used as an expectorant in the case of productive (wet) cough in adults, adolescents, and children over 2 years old.
If there is no improvement or the patient feels worse after 7 days, they should consult their doctor.

2. Important information before taking Mucoplant for ivy cough

When not to take Mucoplant for ivy cough:

• -if the patient is allergic to the active substance, including plants of the Araliaceae family, or any of the excipients (listed in section 6).
• -in children under 2 years of age due to the risk of exacerbating respiratory symptoms due to the use of secretolytic (expectorant) medications.

Warnings and precautions

Before taking Mucoplant for ivy cough, the patient should discuss it with their doctor or pharmacist.
Persistent or recurrent cough in children aged 2 to 4 years requires a diagnosis by a doctor before treatment.
If there are difficulties breathing, fever, or purulent sputum, the patient should consult their doctor or pharmacist.
If symptoms do not improve within 7 days of taking the medicine, the patient should consult their doctor.
It is not recommended to take this medicine with other cough-suppressing medicines (opioid cough suppressants, such as codeine or dextromethorphan) without consulting a doctor.
Care should be taken in patients with stomach problems (gastritis, stomach ulcers).
In case of kidney or liver failure, the patient should talk to their doctor or pharmacist before taking Mucoplant for ivy cough.
No data are available on the recommended doses for these patients.

Mucoplant for ivy cough and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
No interactions have been reported. No interaction studies have been performed.

Taking Mucoplant for ivy cough with food, drink, and alcohol

Mucoplant for ivy cough can be taken independently of meals.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Mucoplant for ivy cough 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 using machines

No studies have been conducted on the effects on driving and using machines.
There is no evidence that Mucoplant for ivy cough affects driving and using machines.

Mucoplant for ivy cough contains maltitol

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
Guidelines for diabetics: 10 ml contains 4 g of maltitol, equivalent to 0.3 bread units. The energy value is 2.3 kcal/g of maltitol.
Maltitol may have a mild laxative effect.

3. How to take Mucoplant for ivy cough

This medicine should always be taken exactly as advised by the doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The recommended dose is:
Adults and adolescents over 12 years:15 ml, 3 times a day.
Children aged 6 to 11 years:15 ml, 2 times a day.
Children aged 2 to 5 years:10 ml, 2 times a day.

Children under 2 years:

Use is contraindicated.
To ensure correct dosing, the enclosed measuring cup should be used.
Patients with kidney or liver impairment: Due to lack of data, it is not possible to determine the recommended dose. (See also "warnings and precautions").
Mucoplant for ivy cough should be taken undiluted and independently of meals.
During the day, while taking Mucoplant for ivy cough, the patient should drink plenty of water or other warm, non-caffeinated beverages.
If symptoms persist for more than a week while taking this product, the patient should consult their doctor or pharmacist.
If the effect of Mucoplant for ivy cough seems too strong or too weak, the patient should talk to their doctor or pharmacist.

Taking a higher dose of Mucoplant for ivy cough than recommended

No higher doses than recommended should be taken. Taking higher doses than recommended (more than three times the single dose) may cause nausea, vomiting, diarrhea, and excitement. If a higher dose than recommended is taken and side effects occur, medical advice should be sought.
One case has been reported of a 4-year-old child who experienced aggression and diarrhea after accidentally taking an extract of ivy equivalent to 1.8 g of herbal substance (corresponding to 195 ml of Mucoplant for ivy cough syrup).

Missing a dose of Mucoplant for ivy cough

A double dose should not be taken to make up for a missed dose.

In case of 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.
Gastrointestinal reactions (nausea, vomiting, diarrhea) have been reported. The frequency is not known (cannot be estimated from the available data).
An allergic reaction with symptoms of hives, skin rash, difficulty breathing (dyspnea), and anaphylactic reaction has been reported. The frequency is not known (cannot be estimated from the available data).
If an allergic reaction occurs, the patient should stop taking the medicine and consult their doctor immediately.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the patient should consult 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. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Mucoplant for ivy cough

The medicine should be stored out of sight and reach of children.
Mucoplant for ivy cough should not be taken after the expiry date "EXP:" stated on the carton. The expiry date refers to the last day of the month.
The medicine should not be stored above 25°C.
Shelf life after first opening: 6 weeks.
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 Mucoplant for ivy cough contains

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

What Mucoplant for ivy cough looks like and what the pack contains

Mucoplant for ivy cough is a brownish-yellow, slightly cloudy syrup with a characteristic odor (blackcurrant).
Mucoplant for ivy cough is available in packs 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 authorization holder and manufacturer

Dr. Theiss Naturwaren GmbH
Michelinstrasse 10
66424 Homburg-Saar
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: