Hedecton

Leaflet attached to the packaging: patient information

Hedecton, 700 mg/100 ml, syrup

Hederae helicis folii extractum siccum

You should carefully read the contents of the leaflet before using 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 directed by a doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Hedecton and what is it used for

Hedecton is a plant-based medicine used as an expectorant in cases of cough with expectoration in adults, adolescents, and children aged 2-11 years.

2. Important information before taking Hedecton

When not to take Hedecton

• if the patient is allergic to common ivy, plants of the Araliaceae family, or any of the other ingredients of this medicine (listed in section 6.)
• This medicine should not be given to children under 2 years of age, as respiratory symptoms may worsen in this patient group (symptoms of the disease may intensify).

Warnings and precautions

Before taking Hedecton, you should discuss it with your doctor or pharmacist. If shortness of breath, fever, or purulent expectoration occurs, you should consult your doctor or pharmacist. You should be cautious in case of stomach problems, such as gastritis or gastric ulcer disease.

Children

If a child aged 2 to 4 years has a persistent or recurrent cough, they should tell their doctor. The doctor will decide if this medicine is suitable for the child.

Hedecton and other medicines

You should tell your doctor or pharmacist about all medicines being taken and/or used by the patient currently or recently, as well as any medicines the patient plans to take and/or use. There are no known interactions between Hedecton and other medicines. No interaction studies have been conducted.

Taking Hedecton with food, drink, and alcohol

No special precautions are necessary.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. The safety of use during pregnancy and breastfeeding has not been established. Due to the lack of sufficient data, use during pregnancy and breastfeeding is not recommended. There are no data on fertility.

Driving and using machines

No special precautions are necessary. No studies have been conducted on the effect of the medicine on driving and using machines.

Hedecton contains maltitol

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicinal product.

3. How to take Hedecton

This medicine should always be taken as described in this information leaflet or as directed by a doctor or pharmacist. If you have any doubts, you should consult a doctor or pharmacist.

Recommended dose: [Dosage recommendation using a measuring spoon]

Adolescents, adults, and the elderly:

1 measuring spoon containing 5 ml of syrup three times a day (which corresponds to 105 mg of dry extract of common ivy leaves per day).

Children aged 6-11 years:

1 measuring spoon containing 5 ml of syrup twice a day (which corresponds to 70 mg of dry extract of common ivy leaves per day).

Children aged 2-5 years:

½ measuring spoon containing 2.5 ml of syrup twice a day (which corresponds to 35 mg of dry extract of common ivy leaves per day).

Children under 2 years:

This medicine should not be given to children under 2 years of age (see section 2. "Important information before taking Hedecton").

Patients with renal or hepatic impairment

No special recommendations for use in patients with renal or hepatic impairment due to the lack of sufficient data.
[Dosage recommendation using a dosing syringe]

Adolescents, adults, and the elderly:

5 ml of syrup three times a day (which corresponds to 105 mg of dry extract of common ivy leaves per day).

Children aged 6-11 years:

5 ml of syrup twice a day (which corresponds to 70 mg of dry extract of common ivy leaves per day).

Children aged 2-5 years:

2.5 ml of syrup twice a day (which corresponds to 35 mg of dry extract of common ivy leaves per day).

Children under 2 years:

This medicine should not be given to children under 2 years of age (see section 2. "Important information before taking Hedecton").

Patients with renal or hepatic impairment

No special recommendations for use in patients with renal or hepatic impairment due to the lack of sufficient data.
A measuring spoon/dosing syringe has been included with this medicinal product to ensure accurate dosing.

Method of administration

Oral administration. Before use, gently shake the bottle.
How to use the dosing syringe:
To ensure accurate dosing, a measuring scale has been printed on the syringe.

• 1. Connect the dosing syringe to the open bottle. Gently press the syringe into the neck of the bottle to secure it. At this point, the plunger should be in the syringe.
• 2. Carefully turn the bottle upside down and gently draw the liquid into the syringe by moving the plunger to the selected dose mark.
• 3. Turn the bottle back over and remove the syringe with a gentle twisting motion. After drawing the medicine, close the bottle.
• 4. The syrup can be taken directly by emptying the contents of the syringe into the mouth in the direction of the cheek or using a spoon.
• 5. After taking the medicine, the syringe parts should be washed and dried.

Duration of treatment

If symptoms persist for longer than a week during treatment with this medicine, you should consult your doctor or pharmacist.

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Taking more than the recommended dose of Hedecton

If a patient accidentally takes one or two more doses of the medicine than they should, it is unlikely that any harmful effects will occur. However, if a large amount of the product is taken, nausea, vomiting, diarrhea, and excitement may occur. In such a case, you should contact your doctor.
A case of a 4-year-old child has been reported, in which after accidental ingestion of another ivy leaf extract in an amount corresponding to 1.8 g of plant substance and approximately 43 ml of syrup, aggressive behavior and diarrhea occurred.

Missing a dose of Hedecton

You should not take a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects:

Frequency not known: cannot be estimated from the available data

• gastrointestinal reactions (nausea, vomiting, diarrhea)

Frequency not known: cannot be estimated from the available data

• allergic reactions, e.g., hives, skin rash, shortness of breath (difficulty breathing, anaphylactic reactions)

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hedecton

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after "EXP":
The expiry date refers to the last day of the month stated.

Storage conditions:

No special storage precautions for the medicinal product are necessary.

Information on the storage period after first opening the packaging:

After first opening the packaging - 6 months.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Hedecton contains

The active substance is: dry extract of common ivy leaves (Hederae helicis folii extractum siccum)
100 ml of syrup contains 0.7 g of extract (in the form of dry extract) from Hedera helix L., folium (common ivy leaf) (4-8:1); extraction solvent: ethanol 30% (m/m).
The other ingredients are:
Liquid maltitol, potassium sorbate, xanthan gum, anhydrous citric acid, cherry flavor, raspberry flavor, purified water.

What Hedecton looks like and what the packaging contains

Hedecton is a clear or opaque, yellowish-brown solution with a fruity odor.
A precipitate or cloudiness of the solution may occur, which can be eliminated by shaking the bottle.
Hedecton is available in 100 ml packaging.
A dosing device is included with the packaging.

Marketing authorization holder and manufacturer

Krewel Meuselbach GmbH
Krewelstrasse 2
53783 Eitorf
Germany
Phone: +49 2243/ 87-0
Fax: +49 2243/ 87-175
email: [email protected]

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

Croatia
Hedecton syrup
Czech Republic
Hedecton
Germany
Efeu Hustensaft
Poland
Hedecton
Slovakia
Hedecton syrup

Date of last revision of the leaflet:

Further information

During the production of the dry extract, alcohol is almost completely removed.