Mucoplant for cough ivy forte

Package leaflet: Information for the user

Mucoplant na kaszel bluszcz forte, 33 mg/dose, oral solution in sachet
Hederae helicis folii extractum siccum
Please read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
This medicine must always be taken exactly as described in this patient information 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 consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, you should contact your doctor.

Contents of the leaflet:

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

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

Mucoplant na kaszel bluszcz forte contains dry extract of ivy leaves.
Mucoplant na kaszel bluszcz forte is a herbal medicinal product used as an expectorant in productive (wet) cough in adults, adolescents and children aged 6 years and older.
If there is no improvement after 7 days, or if you feel worse, you should consult your doctor.

2. Important information before using Mucoplant na kaszel bluszcz forte

When not to use Mucoplant na kaszel bluszcz forte:

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

Warnings and precautions
Before starting treatment with Mucoplant na kaszel bluszcz forte, discuss this with your doctor or pharmacist.

• If breathing difficulties, fever, or purulent sputum occur, consult your doctor or pharmacist.
• If the patient has stomach problems (gastritis, peptic ulcer), this 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 worsening respiratory symptoms (see "When not to use Mucoplant na kaszel bluszcz forte").
Mucoplant na kaszel bluszcz forte packed in sachets is not suitable for use in children under 6 years of age, as the amount of active substance in a sachet is not appropriate for this age group. An alternative strength and dosage form (Mucoplant na kaszel bluszcz) is available for children under 6 years of age.

Mucoplant na kaszel bluszcz forte and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No studies on interactions have been conducted.

Taking Mucoplant na kaszel bluszcz forte with food and drink
Mucoplant na kaszel bluszcz forte may be taken independently of meals.

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

Driving and operating machinery
No studies have been conducted on the effect on the ability to drive vehicles or operate machinery.

Mucoplant na kaszel bluszcz forte contains maltitol, liquid (containing sorbitol).
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
This medicine contains up to 137 mg of sorbitol per sachet.
Sorbitol is a source of fructose. If the patient (adult or child) has previously been diagnosed with intolerance to certain sugars, or has been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot break down fructose, the patient should consult a doctor before taking the medicine or giving it to a child.

3. How to use Mucoplant na kaszel bluszcz forte

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

• Adolescents over 12 years of age, adults and elderly patients: One 5 ml sachet three times daily.
• Children aged 6 to 11 years: One 5 ml sachet twice daily.

Children under 6 years of age:
Mucoplant na kaszel bluszcz forte must not be used in children under 6 years of age (see section "Warnings and precautions") and must not be used in children under 2 years of age (see section "When not to use Mucoplant na kaszel bluszcz forte").
Patients with renal or hepatic impairment:
Due to lack of data, a recommended dose cannot be established.
Mucoplant na kaszel bluszcz forte should be taken undiluted, regardless of meals.
Before use, gently squeeze the sachet.
During treatment with Mucoplant na kaszel bluszcz forte, drink plenty of water or other warm, non-caffeinated beverages throughout the day.
If symptoms persist for more than one week despite treatment, consult your doctor or pharmacist.
Use of a higher than recommended dose of Mucoplant na kaszel bluszcz forte
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. Consult your doctor, who will decide on necessary treatment.
One case has been reported in a 4-year-old child who exhibited aggressive behaviour and diarrhoea after accidental ingestion of ivy extract equivalent to 1.8 g of herbal substance (corresponding to 45 ml or 9 sachets of Mucoplant na kaszel bluszcz forte syrup).
Missed dose of Mucoplant na kaszel bluszcz forte
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 doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Gastrointestinal reactions (nausea, vomiting, diarrhoea) have been reported. Frequency is not known
(cannot be estimated from available data).
Allergic reactions have been reported, manifesting as urticaria, skin rash, breathing difficulties (dyspnoea), and anaphylactic reaction. Frequency is not known.
If an allergic reaction occurs, treatment with the medicine should be discontinued and immediate contact made with a doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in the leaflet, consult a 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, Tel.: + 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. By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Mucoplant na kaszel bluszcz forte

Keep this medicine out of sight and reach of children.
Do not use Mucoplant na kaszel bluszcz forte after the expiry date stated on the carton and sachet following the abbreviation "EXP:". The expiry date refers to the last day of the stated month.
There are no special requirements for storage conditions of this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Mucoplant na kaszel bluszcz forte contains

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

What Mucoplant na kaszel bluszcz forte looks like and contents of the pack
Mucoplant na kaszel bluszcz forte is a yellowish-brown to dark brown, slightly turbid syrup with a characteristic odour (blackcurrant).

Mucoplant na kaszel bluszcz forte is available in sachets with a volume of 5 ml.
Pack sizes containing 15 x 5 ml, 21 x 5 ml and 30 x 5 ml sachets are available. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Dr. Theiss Naturwaren GmbH
Michelinstrasse 10
66424 Homburg, Saarland
Germany
[email protected]

This medicinal product is authorised in the European Economic Area member states under the following names: