Hedecton
Poland
Table of Contents
Patient Information Leaflet
Hedecton, 700 mg/100 ml, syrup
Hederae helicis folii extractum siccum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as described in this patient leaflet or as your doctor or pharmacist has instructed.
- Keep this leaflet for future reference.
- If you have any questions, consult your pharmacist.
- If you experience any adverse reactions, including any 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, consult your doctor.
Table of contents
- What Hedecton is and what it is used for
- Important information before taking Hedecton
- How to take Hedecton
- Possible side effects
- How to store Hedecton
- Contents of the pack and other information
1. What Hedecton is and what it is used for
Hedecton is a herbal medicine used as an expectorant in productive cough 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 leaves, to plants from the aralia family ( Araliaceae ), or to 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 (disease symptoms may intensify).
Warnings and precautions
Before starting to take Hedecton, discuss it with your doctor or pharmacist.
If shortness of breath (difficulty breathing), fever, or coughing up pus-containing mucus occurs, consult your doctor or pharmacist.
Exercise caution if you have stomach problems, such as gastric mucosa inflammation or peptic ulcer disease.
Children
If a child aged between 2 and 4 years has a persistent or recurring cough, inform the doctor. The doctor will decide whether this medicine is suitable for the child.
Hedecton and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking and/or using, or has recently taken and/or used, as well as any medicines the patient plans to take and/or use.
No interactions between Hedecton and other medicines are known.
Studies on interactions have not 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, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The safety of use during pregnancy and breastfeeding has not been established. Due to insufficient data, use during pregnancy and breastfeeding is not recommended. There are no data available regarding fertility.
Driving and operating machinery
No special precautions are required. Studies on the effect of the medicine on the ability to drive and operate machinery have not been conducted.
Hedecton contains maltitol
If the patient has been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicinal product.
3. How to take Hedecton
This medicine should always be taken exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dosage:
[Dosage recommendation using a measuring spoon]
Adolescents, adults and elderly:
1 measuring spoon containing 5 ml of syrup three times daily (corresponding to 105 mg of dry extract of Hedera helix leaves per day).
Children aged 6–11 years:
1 measuring spoon containing 5 ml of syrup twice daily (corresponding to 70 mg of dry extract of Hedera helix leaves per day).
Children aged 2–5 years:
½ measuring spoon containing 2.5 ml of syrup twice daily (corresponding to 35 mg of dry extract of Hedera helix leaves per day).
Children under 2 years of age:
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
There are no special dosage recommendations for patients with renal or hepatic impairment due to insufficient data.
[Dosage recommendation using an oral dosing syringe]
Adolescents, adults and elderly:
5 ml of syrup three times daily (corresponding to 105 mg of dry extract of Hedera helix leaves per day).
Children aged 6–11 years:
5 ml of syrup twice daily (corresponding to 70 mg of dry extract of Hedera helix leaves per day).
Children aged 2–5 years:
2.5 ml of syrup twice daily (corresponding to 35 mg of dry extract of Hedera helix leaves per day).
Children under 2 years of age:
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
There are no special dosage recommendations for patients with renal or hepatic impairment due to insufficient data.
To ensure accurate dosing, this medicinal product is supplied with a measuring spoon/oral dosing syringe.
Method of administration
For oral use. Gently shake before use.
How to use the dosing syringe:
To ensure accurate dosing, the syringe is marked with a graduated scale.
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- Attach the dosing syringe to the open bottle. Gently press the syringe onto the neck of the bottle to secure it properly. At this point, the plunger should be inside the syringe.
- Carefully invert the bottle and slowly draw the liquid into the syringe by pulling the plunger to the desired dose mark.
- Turn the bottle upright and remove the syringe with a gentle twisting motion. After withdrawing the medicine, close the bottle.
- The syrup may be administered directly by emptying the syringe contents into the mouth against the cheek, or via a spoon.
- After administration, disassemble the syringe and wash all parts thoroughly. Dry completely.
Duration of treatment
If symptoms persist for more than one week during treatment with this medicine, consult your doctor or pharmacist.
Taking more Hedecton than recommended
If a patient accidentally takes one or two doses more than prescribed, harmful effects are unlikely. However, if a significantly larger amount is taken, symptoms such as nausea, vomiting, diarrhoea, and agitation may occur. In such a case, contact a doctor immediately.
One case has been reported in a 4-year-old child who accidentally ingested another Hedera helix leaf extract equivalent to 1.8 g of plant material and approximately 43 ml of syrup, resulting in aggressive behaviour and diarrhoea.
If you forget to take Hedecton
Do not take a double dose to make up for a missed dose.
If you have any further questions about 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 everybody will get them.
Possible adverse reactions:
Frequency unknown: cannot be estimated from the available data
- Gastrointestinal reactions (nausea, vomiting, diarrhoea)
Frequency unknown: cannot be estimated from the available data
- Allergic reactions, e.g. urticaria, skin rash, dyspnoea (difficulty in breathing, anaphylactic reactions)
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in
this leaflet, inform 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, 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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Hedecton
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label following “EXP”:
The expiry date refers to the last day of the specified month.
Storage conditions:
No special requirements for storage of this medicinal product.
Information regarding storage period after first opening of the container:
After first opening of the container – 6 months.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
6. Contents of the pack and other information
What Hedecton contains
The active substance is: dry extract of 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).
Other ingredients are:
Maltitol liquid, potassium sorbate, xanthan gum, anhydrous citric acid, cherry flavor, raspberry flavor, purified water.
What Hedecton looks like and contents of the pack
Hedecton is a transparent or opaque, yellowish-brown solution with a fruity odour.
Coagulation or cloudiness of the solution may occur, which can be eliminated by shaking the bottle.
Hedecton is available in 100 ml packs.
An oral dosing device is provided in the pack.
Marketing Authorisation Holder and Manufacturer
Dr. Theiss Naturwaren GmbH
Michelinstrasse 10
66424 Homburg
Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Croatia Hedecton sirup
Czech Republic Hedecton
Germany Efeu Hustensaft
Poland Hedecton
Slovakia Hedecton sirup
Further information
During the production process of the dry extract, alcohol is almost completely removed.