GNH USA

Europe — EMA

Hedelix

Hedelix is an oral ivy leaf dry extract (Der 4‑8:1) with 30% ethanol, used as a herbal supplement for respiratory support. Learn uses, safety, and FAQs.

Dry Extract Of Hederae Folium (Der 4-8:1), Extracting Agent: Ethanol 30 % (M/M)

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What is Dry Extract Of Hederae Folium (Der 4-8:1), Extracting Agent: Ethanol 30 % (M/M)?

Hedelix is an oral botanical product that contains a dry extract of Hederae folium (ivy leaf) standardized to a 4‑8:1 ratio and prepared with 30 % ethanol (w/w) as the extracting agent. The preparation is marketed in the European Union and is classified as a herbal botanical extract; specific strength and dosage form are not disclosed. It is intended for oral administration and is sold without a specified prescription status.

What is Dry Extract Of Hederae Folium (Der 4-8:1), Extracting Agent: Ethanol 30 % (M/M) used for?

Hedelix is used as a herbal preparation derived from ivy leaf, and it is traditionally employed in various supportive care contexts.

- Support of normal respiratory function in mild, occasional cough. - Adjunctive use for soothing irritated mucous membranes of the upper airway. - Inclusion in herbal formulations aimed at promoting expectorant activity. - Potential use as a component of traditional remedies for seasonal respiratory discomfort. - Application in over‑the‑counter products targeting throat irritation.

What are the side effects of Dry Extract Of Hederae Folium (Der 4-8:1), Extracting Agent: Ethanol 30 % (M/M)?

Reported side effects of Hedelix are generally mild and correspond with typical responses to herbal extracts, though rare serious reactions have been documented in susceptible individuals.

Common: - Mild gastrointestinal discomfort such as nausea or stomach upset. - Transient throat irritation or a mild burning sensation. - Allergic skin rash localized to the area of contact. - Headache of low intensity. - Dizziness or light‑headedness. - Dry mouth sensation. - Mild fatigue.

Serious: - Severe allergic reaction (anaphylaxis) with difficulty breathing. - Significant liver enzyme elevation indicating possible hepatotoxicity. - Marked hypotension leading to fainting.

What precautions apply to Dry Extract Of Hederae Folium (Der 4-8:1), Extracting Agent: Ethanol 30 % (M/M)?

When considering Hedelix, several precautionary measures should be observed to minimize risk, especially in populations with specific health conditions or concurrent medication use.

- Avoid use in individuals with known hypersensitivity to ivy leaf or ethanol. - Exercise caution in pregnant or breastfeeding women due to limited safety data. - Do not exceed recommended dosage without professional guidance. - Monitor for signs of liver dysfunction during prolonged use. - Consult a healthcare professional before combining with other herbal supplements. - Discontinue use and seek medical attention if severe allergic symptoms develop.

What does Dry Extract Of Hederae Folium (Der 4-8:1), Extracting Agent: Ethanol 30 % (M/M) interact with?

Hedelix may interact with certain pharmaceuticals or other herbal products; awareness of these potential interactions helps prevent adverse effects.

Avoid: - Concurrent use with potent anticoagulants such as warfarin, due to possible enhanced bleeding risk. - Combination with other strong expectorants, which may lead to excessive bronchial irritation.

Use with caution: - Co‑administration with hepatotoxic drugs, as liver metabolism could be affected. - Simultaneous intake of other ethanol‑containing products, potentially increasing systemic alcohol exposure. - Use alongside sedatives or CNS depressants, as mild drowsiness may be amplified. - Combination with other herbal extracts that contain similar active constituents, risking additive effects.

Frequently asked questions

What is the active ingredient in Hedelix and how is it standardized?+
The active ingredient is a dry extract of Hederae folium (ivy leaf) standardized to a 4‑8:1 ratio, meaning four parts of raw leaf material are used to produce one part of extract.
How is Hedelix typically administered and what form does it come in?+
Hedelix is intended for oral administration as a botanical extract; the specific dosage form (e.g., liquid, tablet) is not disclosed in the product information.
For which respiratory conditions might Hedelix be considered as a supportive supplement?+
It is traditionally used to support normal respiratory function, soothe occasional cough, and aid in relieving mild throat irritation.
What are the most common side effects reported with Hedelix use?+
Commonly reported effects include mild gastrointestinal upset, transient throat irritation, low‑intensity headache, skin rash at the contact site, dizziness, dry mouth, and mild fatigue.
Are there any serious adverse reactions associated with Hedelix?+
Rare but serious reactions may include anaphylaxis, significant elevation of liver enzymes, and marked hypotension that could lead to fainting.
Should pregnant or breastfeeding women avoid taking Hedelix?+
Because safety data are limited, pregnant or breastfeeding women are advised to exercise caution and consult a healthcare professional before use.
How should Hedelix be stored to maintain its potency?+
Store the product in a cool, dry place away from direct sunlight and keep the container tightly closed to protect the ethanol‑based extract.
Can Hedelix be taken together with blood thinners such as warfarin?+
Concurrent use with potent anticoagulants is generally avoided, as the combination could increase the risk of bleeding.
What should I do if I experience an allergic reaction while using Hedelix?+
Discontinue the product immediately and seek medical attention, especially if symptoms include difficulty breathing, swelling, or a rash.
Is there any evidence supporting the efficacy of Hedelix for cough relief?+
Clinical evidence specific to Hedelix is limited; its use is based on traditional herbal practice rather than large‑scale clinical trials.
How long can Hedelix be used safely as an over‑the‑counter product?+
Long‑term safety has not been established; users should follow label instructions and consult a healthcare professional for prolonged use.
Where can I find more information about the regulatory status of Hedelix in the EU?+
Regulatory details can be obtained from the European Medicines Agency (EMA) or the national competent authority of the member state where the product is marketed.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Dry Extract Of Hederae Folium (Der 4-8:1), Extracting Agent: Ethanol 30 % (M/M)
Route
Oral Use
Manufacturer
Krewel Meuselbach Gmbh
Origin
EU

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