Europe — EMA
Hedelix S.A.
Hedelix S.A. is an EU‑manufactured oral herbal extract of Hedera helix leaf, used for mild respiratory support and cough relief.
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What is Extract Of Hedera Helix Folium (2.2 – 2.9 : 1), Extracting Agent: Ethanol 50% (V / V), Propylene Gly?
Hedelix S.A. is an oral herbal preparation containing a standardized extract of Hedera helix leaf (2.2–2.9 : 1) obtained with 50 % ethanol and propylene glycol as the extracting agents. The product is manufactured in the European Union and is marketed without a specified dosage form or strength. It is classified as a plant‑derived supplement and is typically used under the guidance of a health professional.
What is Extract Of Hedera Helix Folium (2.2 – 2.9 : 1), Extracting Agent: Ethanol 50% (V / V), Propylene Gly used for?
Hedelix S.A. is generally considered for supportive care of mild respiratory conditions where a plant‑based extract may be appropriate.
- May be used as an adjunct for occasional cough associated with throat irritation. - Occasionally included in formulations aimed at supporting normal bronchial function. - Sometimes employed in herbal regimens for seasonal upper‑respiratory discomfort. - May be part of complementary approaches for soothing mucosal membranes during minor cold symptoms.
What are the side effects of Extract Of Hedera Helix Folium (2.2 – 2.9 : 1), Extracting Agent: Ethanol 50% (V / V), Propylene Gly?
Side‑effect profiles for Hedera helix leaf extract are based on limited clinical observations and reported case series.
Common: - Mild gastrointestinal discomfort such as nausea or stomach upset. - Transient throat irritation or a slight burning sensation. - Light‑headedness or occasional dizziness. - Minor skin redness if applied topically (off‑label).
Serious: - Allergic reactions ranging from urticaria to anaphylaxis. - Significant bronchospasm in individuals with known asthma sensitivity. - Hepatic enzyme elevation in rare cases. - Severe gastrointestinal bleeding (very rare).
What precautions apply to Extract Of Hedera Helix Folium (2.2 – 2.9 : 1), Extracting Agent: Ethanol 50% (V / V), Propylene Gly?
When considering Hedelix S.A., several precautionary points should be reviewed.
- Verify absence of known allergy to ivy (Hedera helix) before use. - Use cautiously in individuals with a history of asthma or bronchial hyper‑reactivity. - Pregnant or breastfeeding persons should consult a health professional prior to intake. - Patients with liver disease should discuss potential risks with a clinician. - Keep out of reach of children; accidental ingestion may cause adverse effects. - Do not exceed recommended amounts in any herbal regimen.
What does Extract Of Hedera Helix Folium (2.2 – 2.9 : 1), Extracting Agent: Ethanol 50% (V / V), Propylene Gly interact with?
Potential interactions with other substances have been noted in case reports and pharmacovigilance data.
Avoid: - Concurrent use with strong bronchodilators or cough suppressants without medical advice. - Combining with other ivy‑containing products, which may increase exposure.
Use with caution: - Herbal preparations that affect liver metabolism (e.g., St. John's wort). - Antihistamines, as additive sedation may occur. - Medications that lower blood pressure, due to possible additive hypotensive effect. - Dietary supplements containing high levels of flavonoids or alkaloids.