Mucoplant na kashel blushh forte

Package Leaflet: Information for the Patient

Mucoplant for Cough Ivy Forte, 33 mg/dose, Syrup in a Sachet

Hederae helicis folii extractum siccum

Read the package leaflet carefully before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in the package leaflet for the patient or as advised 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 possible side effects not listed in the 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 Mucoplant for Cough Ivy Forte and what is it used for
• 2. Important information before using Mucoplant for Cough Ivy Forte
• 3. How to use Mucoplant for Cough Ivy Forte
• 4. Possible side effects
• 5. How to store Mucoplant for Cough Ivy Forte
• 6. Contents of the pack and other information

1. What is Mucoplant for Cough Ivy Forte and what is it used for

Mucoplant for Cough Ivy Forte contains dry extract of ivy leaves.
Mucoplant for Cough Ivy Forte is a herbal medicinal product used as an expectorant in the case of productive (wet) cough in adults, adolescents, and children from 6 years of age.
If there is no improvement after 7 days or the patient feels worse, they should consult their doctor.

2. Important information before using Mucoplant for Cough Ivy Forte

When not to use Mucoplant for Cough Ivy Forte:

• if the patient is allergic to ivy leaves, other plants of the Araliaceae family, or any of the other ingredients of this medicine (listed in section 6).
• 6).
• in children under 2 years of age due to the risk of exacerbation of respiratory symptoms due to the use of expectorant medicines.

Warnings and precautions

Before starting to use Mucoplant for Cough Ivy Forte, the patient should discuss it with their doctor or pharmacist.

• If breathing difficulties, fever, or purulent sputum occur, the patient should consult their doctor or pharmacist.
• If the patient has stomach problems (gastritis, stomach ulcer), the medicine should be used with caution.

Children

This medicine should not be given to children under 2 years of age due to the risk of exacerbation of respiratory symptoms (see "When not to use Mucoplant for Cough Ivy Forte").
Mucoplant for Cough Ivy Forte packaged in sachets is not suitable for use in children under 6 years of age, as the amount of active substance in the sachet is not appropriate for this age group. For children under 6 years of age, a different strength and formulation of the medicine is available (Mucoplant for Cough Ivy).

Mucoplant for Cough Ivy Forte and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No interaction studies have been conducted.

Using Mucoplant for Cough Ivy Forte with food and drink

Mucoplant for Cough Ivy Forte 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 using this medicine.
Mucoplant for Cough Ivy Forte 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 the ability to drive and use machines.

Mucoplant for Cough Ivy Forte contains maltitol, liquid (containing sorbitol).

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
This medicine contains up to 137 mg of sorbitol in each sachet.
Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, hereditary fructose intolerance, in which the patient's body does not break down fructose, they should consult their doctor before taking the medicine or giving it to their child.

3. How to use Mucoplant for Cough Ivy Forte

This medicine should always be used exactly as described in this patient leaflet or as advised by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The recommended dose is:

• Adolescents over 12 years of age, adults, and the elderly:One 5 ml sachet three times a day.
• Children from 6 to 11 years of age:One 5 ml sachet twice a day.

Children under 6 years of age:

Mucoplant for Cough Ivy Forte should not be used in children under 6 years of age (see "Warnings and precautions") and should not be used in children under 2 years of age (see "When not to use Mucoplant for Cough Ivy Forte").
Patients with kidney or liver impairment:
Due to the lack of data, it is not possible to determine the recommended dose.
Mucoplant for Cough Ivy Forte is taken undiluted, independently of meals.
Before use, the sachet should be lightly squeezed.
During the use of Mucoplant for Cough Ivy Forte, the patient should drink plenty of water or other warm, non-caffeinated beverages throughout the day.
If symptoms persist for more than a week despite using the medicine, the patient should consult their doctor or pharmacist.

Using a higher dose of Mucoplant for Cough Ivy Forte than recommended

A higher dose than recommended should not be taken. Taking doses higher than recommended (more than three times the single dose) may cause nausea, vomiting, diarrhea, and excitement. The patient should consult their doctor, who will decide on the necessary treatment.
One case of a 4-year-old child who experienced aggressive behavior and diarrhea after accidentally taking an ivy extract equivalent to 1.8 g of plant material (corresponding to 45 ml or 9 sachets of Mucoplant for Cough Ivy Forte syrup) has been reported.

Missing a dose of Mucoplant for Cough Ivy Forte

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

If the patient has any further questions on the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Mucoplant for Cough Ivy Forte 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 such as hives, skin rash, breathing difficulties (dyspnea), and anaphylactic reaction has been reported. The frequency is not known.
If an allergic reaction occurs, the patient should stop using the medicine and contact their doctor immediately.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should consult their doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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 Cough Ivy Forte

The medicine should be stored out of the sight and reach of children.
Mucoplant for Cough Ivy Forte should not be used after the expiry date stated on the carton and sachet after "EXP:". The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Mucoplant for Cough Ivy Forte contains

• The active substance is dry extract of ivy leaves. One 5 ml sachet contains 33 mg of dry extract of ivy leaves Hederae helicis foliiextractum siccum(DER 4-8:1). Extraction solvent: ethanol 30% (m/m).
• The other ingredients are: potassium sorbate (E 202), hydroxyethylcellulose, blackcurrant flavor SD (652281), liquid maltitol (contains sorbitol), citric acid, purified water.

What Mucoplant for Cough Ivy Forte looks like and contents of the pack

Mucoplant for Cough Ivy Forte is a brown-yellow to dark brown, slightly cloudy syrup with a characteristic odor (blackcurrant).
Mucoplant for Cough Ivy Forte is available in 5 ml sachets.
Cartons containing 15 x 5 ml, 21 sachets x 5 ml, and 30 sachets x 5 ml are available. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Dr. Theiss Naturwaren GmbH
Michelinstrasse 10
66424 Homburg, Saarland
Germany
drug-safety@naturwaren-theiss.de

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:September 2023