Hedelix

( measuring spoon with graduations )

Package leaflet: Information for the patient

Hedelix, 40 mg/5 ml, syrup
(Hederae helicis folii extractum spissum)
Thick extract of ivy leaves
Please read carefully the entire leaflet before taking the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed
by the physician 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 side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days of treatment, or if symptoms worsen, consult your doctor.

Table of contents

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

1. What Hedelix is and what it is used for

Hedelix is a syrup containing as its active substance a thick extract of common ivy leaves
(Hederae helicis folii extractum spissum).
This is a herbal medicinal product used as an expectorant in productive (so-called "wet") cough.
If there is no improvement after 7 days, or if the patient feels worse, medical advice should be sought.

2. Important information before taking Hedelix

When not to take Hedelix:

• if the patient is allergic to ivy leaf extract or to plants of the Araliaceae family, or to any of the other ingredients of this medicine (listed in section 6).
• Do not use in children under 2 years of age, as respiratory symptoms may worsen in this age group (exacerbation of disease symptoms).

Warnings and precautions
Consult a doctor or pharmacist before using this medicine.
Do not take Hedelix in cases of argininosuccinic acid synthetase deficiency (a metabolic disorder in the urea cycle).
Persistent or recurrent cough in children aged 2 to 4 years should be diagnosed before using this medicine.
If shortness of breath, fever or purulent sputum occurs, consult a doctor or pharmacist.
Concomitant use with opioid antitussive agents such as codeine or dextromethorphan is not recommended without medical supervision.
Caution is advised in patients with gastric irritation or gastric ulcer.
Due to the presence of plant extract, Hedelix syrup may form a sediment in the bottle. The sediment may cause cloudiness of the solution, and the taste may undergo slight changes.

Other medicines and Hedelix
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
No interactions with other medicines have been reported.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The safety of use during pregnancy and lactation has not been established. Due to insufficient data, use during pregnancy and lactation is not recommended.

Driving and operating machinery
No influence.

Hedelix contains sorbitol
The medicine contains 1.75 g of sorbitol per 5 ml (equivalent to 0.44 g of fructose) and amounts to approximately 0.15 carbohydrate units.
Sorbitol is a source of fructose. If intolerance to certain sugars has previously been diagnosed in the patient (or their child), or if hereditary fructose intolerance—a rare genetic disorder in which the patient's body cannot break down fructose—has been diagnosed, the patient should consult a doctor before taking the medicine or giving it to a child.

3. How to take Hedelix

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
To ensure accurate dosing, use the dosing spoon provided with the packaging.
Recommended dose:
Adolescents, adults and elderly patients:
5 ml three times daily.
Children aged 6–11 years:
2.5 ml four times daily.
Children aged 2–5 years:
2.5 ml three times daily.
Children under 2 years of age:
Do not use in children under 2 years of age (see section 2. Important information before taking Hedelix).
Hedelix should be taken undiluted. It is recommended to drink a generous amount of fluid afterwards, preferably a glass of water.
Duration of treatment
Hedelix may be used without medical supervision for up to 7 days.
If symptoms persist beyond one week during treatment, consult your doctor or pharmacist.
If you feel that the effect of Hedelix is too strong or too weak, consult your doctor or pharmacist.
Taking more Hedelix than recommended
Taking one or two extra single doses is unlikely to cause any symptoms.
Taking a significantly larger amount may cause nausea, vomiting, diarrhoea and agitation.
In such a case, contact your doctor.
If you forget to take Hedelix
Do not take a double dose to make up for a forgotten dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following classification is used to define the frequency of adverse reactions:
very common (≥ 1/10);
common (≥ 1/100 to <1/10);
uncommon (≥ 1/1,000 to <1/100);
rare (≥ 1/10,000 to <1/1,000);
very rare (<1/10,000);
frequency not known (cannot be estimated from the available data).

Immune system disorders:
Frequency not known: allergic reactions (urticaria, skin rash, dyspnoea).

Gastrointestinal disorders:
Frequency not known: gastrointestinal disturbances (nausea, vomiting, diarrhoea).

If any adverse reactions occur other than those listed above, please consult your doctor or pharmacist.

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:
Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw, Poland
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 Hedelix medicine
Keep the medicine out of the sight and reach of children.
Store below 25°C.
Do not use the medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of the stated month.
Shelf life after first opening: 6 months.

6. Contents of the package and other information

What the medicine Hedelix contains

• The active substance in the medicine is a dry extract of common ivy leaves (Hederae helicis folii extractum spissum). 100 ml of syrup contains 0.8 g of dry extract from Hedera helix L., folium (common ivy leaf) (2.2 - 2.9:1); extraction solvent: ethanol 96% (V/V); propylene glycol; water (45:2:53) m/m/m.
  Other ingredients: macrogolglycerol hydroxystearate, aniseed oil, hydroxyethylcellulose, sorbitol (70% solution) (E 420), propylene glycol, glycerol, purified water.

The medicine does not contain ethanol (alcohol).
What Hedelix looks like and contents of the pack
Hedelix is a clear, yellowish-brown solution.
Hedelix is available in packages of: 100 ml and 200 ml.
A dosing syringe is included in the package.
Marketing Authorisation Holder:
Dr. Theiss Naturwaren GmbH
Michelinstrasse 10
66424 Homburg
Germany
Manufacturer:
Krewel Meuselbach GmbH
Krewelstrasse 2
D-53783 Eitorf
Germany
(Dosing syringe)

Package leaflet: information for the patient

Hedelix, 40 mg/5 ml, syrup
(Hederae helicis folii extractum spissum)
Dry extract of ivy leaves
Please read carefully all the information in this leaflet before taking the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a 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 effects, including any possible adverse effects 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.

Leaflet contents

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

1. What Hedelix is and what it is used for

Hedelix is a syrup containing as the active substance a dry extract of common ivy leaves (Hederae helicis folii extractum spissum).
This is a herbal medicinal product used as an expectorant in productive (so-called "wet") cough.
If there is no improvement after 7 days, or if you feel worse, consult your doctor.

2. Important information before taking Hedelix

When not to take Hedelix:

• If you are allergic to the extract of ivy leaves or to plants of the Araliaceae family, or to any of the other ingredients of this medicine (listed in section 6). Do not use in children under 2 years of age, as respiratory symptoms may worsen in this age group (exacerbation of disease symptoms).

Warnings and precautions
Consult your doctor or pharmacist before using this medicine.
Do not take Hedelix in cases of argininosuccinic acid synthetase deficiency (a metabolic disorder in the urea cycle).
Persistent or recurrent cough in children aged 2 to 4 years should be diagnosed before treatment.
If shortness of breath, fever or purulent sputum occur, consult your doctor or pharmacist.
Concomitant use with opioid antitussive agents such as codeine or dextromethorphan is not recommended without medical supervision.
Caution is advised in patients with gastric irritation or gastric ulcer.
Due to the presence of herbal extract, Hedelix syrup may form a sediment in the bottle. The sediment may cause cloudiness of the solution, and the taste may undergo slight changes.
Other medicines and Hedelix
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
No interactions with other medicines have been reported.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
The safety of use during pregnancy and lactation has not been established. Due to insufficient data, use during pregnancy and lactation is not recommended.
Driving and operating machinery
No effect.
Hedelix contains sorbitol
The medicine contains 1.75 g of sorbitol (equivalent to 0.44 g of fructose) in 5 ml, corresponding to approximately 0.15 carbohydrate units.
Sorbitol is a source of fructose. If fructose intolerance has previously been diagnosed in you (or your child), or if hereditary fructose intolerance—a rare genetic disorder in which the body cannot break down fructose—has been diagnosed, consult your doctor before taking this medicine or giving it to your child.

3. How to take Hedelix

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
To ensure accurate dosing, use the dosing syringe provided with the package.

Recommended dose:

• Adolescents, adults and elderly patients:*
  5 ml three times daily.
• Children aged 6–11 years:*
  2.5 ml four times daily.
• Children aged 2–5 years:*
  2.5 ml three times daily.
• Children under 2 years of age:*
  Do not use in children under 2 years of age (see section 2. Important information before taking Hedelix).

How to use the dosing syringe:
An accurate scale necessary for measuring the correct dose is printed on the dosing syringe.

2. Unscrew the bottle cap. Attach the dosing syringe to the open bottle. Gently insert the syringe into the bottle until it is securely fixed. The plunger should remain inside the syringe at this time.
3. Carefully turn the bottle upside down and draw the required amount of syrup by gently pulling the plunger to the appropriate mark on the scale.
4. Return the bottle to its original upright position and gently remove the syringe by twisting it slightly. Close the bottle after administering the dose.
5. The syrup can be administered directly by emptying the dosing syringe into the mouth against the cheek, or using a spoon.
6. After administration, wash each part of the syringe and dry it thoroughly.

Hedelix should be taken undiluted. It is recommended to drink a generous amount of fluid afterwards, preferably a glass of water.
Duration of treatment
Hedelix may be used without medical supervision for up to 7 days.
If symptoms persist beyond one week during treatment, consult your doctor or pharmacist.
If you feel the effect of Hedelix is too strong or too weak, consult your doctor or pharmacist.
Taking more Hedelix than recommended
Taking one or two extra single doses is unlikely to cause any symptoms.
Taking a significantly larger amount may cause nausea, vomiting, diarrhoea and agitation.
In such a case, consult your doctor.
If you miss a dose of Hedelix
Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody will experience them.
The following frequency classification is used to describe the occurrence of adverse reactions:
very common (≥ 1/10);
common (≥ 1/100 to < 1/10);
uncommon (≥ 1/1,000 to < 1/100);
rare (≥ 1/10,000 to < 1/1,000);
very rare (< 1/10,000);
frequency not known (cannot be estimated from available data).

Immune system disorders:
Frequency not known: allergic reactions (urticaria, skin rash, shortness of breath).

Gastrointestinal disorders:
Frequency not known: gastrointestinal disturbances (nausea, vomiting, diarrhoea).

If you experience any side effects not listed above, consult your doctor or pharmacist.
Reporting of side effects
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects can be reported directly to:
Department of Monitoring of Adverse Drug Reactions, 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Hedelix

Keep the medicine out of sight and reach of children.
Store below 25°C.
Do not use after the expiry date stated on the label and carton. The expiry date refers to the last day of the stated month.
Shelf life after first opening: 6 months.

6. Contents of the package and other information

What the medicine Hedelix contains

• The active substance is a dry extract of common ivy leaves (Hederae helicis folii extractum spissum). 100 ml of syrup contains 0.8 g of dry extract from Hedera helix L., folium (common ivy leaf) (2.2 - 2.9:1); extraction solvent: ethanol 96% (V/V); propylene glycol; water (45:2:53) m/m/m.

Other ingredients: macrogolglycerol hydroxystearate, aniseed oil, hydroxyethylcellulose, sorbitol (70% solution) (E 420), propylene glycol, glycerol, purified water.
The medicine does not contain ethanol (alcohol).
What Hedelix looks like and contents of the pack
Hedelix is a clear, yellowish-brown solution.
Hedelix is available in packages of: 100 ml and 200 ml.
A dosing syringe is included in the package.
Marketing Authorisation Holder:
Dr. Theiss Naturwaren GmbH
Michelinstrasse 10
66424 Homburg
Germany
Manufacturer:
Krewel Meuselbach GmbH
Krewelstrasse 2
D-53783 Eitorf
Germany