Europe — EMA
Hedussin
Learn about Hedussin, an oral ivy leaf dry extract (Der 4‑8:1) with 30% ethanol, its uses, safety profile, precautions, and interactions.
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What is Dry Extract Of Hederae Folium (Der 4-8:1), Extracting Agent: Ethanol 30 % (M/M)?
Hedussin is a herbal product that contains a dry extract of Hederae folium (ivy leaf) standardized at a 4‑8:1 ratio and prepared with 30 % ethanol (m/m) as the extracting agent. The preparation is supplied in oral dosage form, with strength and specific formulation details not disclosed, and is marketed within the European Union. It is a botanical extract not assigned an ATC code or defined therapeutic class.
What is Dry Extract Of Hederae Folium (Der 4-8:1), Extracting Agent: Ethanol 30 % (M/M) used for?
Hedussin is primarily marketed as a herbal extract of ivy leaf; at present, no specific medical indications have been formally approved, and its use is generally aligned with traditional applications of Hederae folium.
- Traditional use as a respiratory herbal supplement. - Inclusion in phytotherapeutic formulations for expectorant purposes. - Potential role in supporting mucosal health of the upper airway. - Used as a component in over‑the‑counter herbal cough mixtures. - Investigated in some studies for anti‑inflammatory activity of leaf constituents. - Employed in topical preparations for soothing minor skin irritation.
What are the side effects of Dry Extract Of Hederae Folium (Der 4-8:1), Extracting Agent: Ethanol 30 % (M/M)?
The safety profile of Hedussin reflects that of typical ivy leaf extracts; most reported effects are mild and reversible, while rare serious reactions have been documented.
Common: - Mild gastrointestinal discomfort such as nausea or stomach upset. - Transient headache. - Skin redness or mild rash at the site of contact. - Dizziness or light‑headedness. - Dry mouth. - Taste disturbance.
Serious: - Severe allergic reaction (anaphylaxis). - Persistent vomiting or diarrhea. - Significant bronchospasm in sensitive individuals. - Hepatic enzyme elevation (rare). - Acute liver injury. - Cardiovascular effects such as hypotension.
What precautions apply to Dry Extract Of Hederae Folium (Der 4-8:1), Extracting Agent: Ethanol 30 % (M/M)?
When considering Hedussin, several precautionary measures should be observed to minimize risk, especially for individuals with pre‑existing conditions or those taking other medications.
- Avoid use in persons with known hypersensitivity to ivy or related plants. - Exercise caution in patients with asthma or chronic obstructive pulmonary disease. - Do not use during pregnancy or lactation unless advised by a healthcare professional. - Monitor liver function in patients with existing hepatic disease. - Keep out of reach of children. - Discontinue use and seek medical attention if signs of an allergic reaction appear.
What does Dry Extract Of Hederae Folium (Der 4-8:1), Extracting Agent: Ethanol 30 % (M/M) interact with?
Herbal extracts can interact with conventional medicines; the following potential interactions have been reported for ivy leaf constituents.
Avoid: - Concurrent use with potent bronchodilators may increase risk of bronchospasm. - Combination with anticoagulant or antiplatelet agents could enhance bleeding tendency.
Use with caution: - May affect metabolism of drugs processed by CYP450 enzymes; monitor levels of such medications. - May potentiate the effects of other cough suppressants; adjust dosing accordingly. - Co‑administration with diuretics may increase electrolyte disturbances.
Frequently asked questions
What is the active ingredient in Hedussin?+
How is Hedussin administered?+
Is Hedussin approved for any specific medical condition?+
Can Hedussin be used during pregnancy?+
What are the most common side effects of Hedussin?+
Are there any serious adverse reactions associated with Hedussin?+
Should I avoid Hedussin if I have asthma?+
Does Hedussin interact with blood thinners?+
Can Hedussin affect liver function?+
Is Hedussin suitable for children?+
What should I do if I experience an allergic reaction to Hedussin?+
Where is Hedussin marketed?+
Product details
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