GNH USA

Europe — EMA

Hadorta

Hadorta is an OTC oral expectorant containing dry ivy leaf extract (Der 4‑8:1) for cough relief and mucus clearance in respiratory infections.

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)?

Hadorta is an over‑the‑counter oral product that contains a dry extract of Hederae Folium (ivy leaf) standardized to a 4‑8:1 ratio and prepared with 30 % ethanol as the extracting agent. The preparation is marketed in the European Union and is classified as an expectorant for use in respiratory tract disorders such as cough and bronchitis.

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

Hadorta is indicated for the symptomatic relief of cough and mucus retention associated with acute respiratory infections and chronic bronchial conditions. It may be used as part of a broader supportive care plan for respiratory health.

- Relief of productive cough caused by acute upper respiratory tract infections. - Adjunct therapy for bronchitis to facilitate mucus clearance. - Supportive treatment for chronic obstructive pulmonary disease (COPD) when a productive cough is present. - Use in seasonal allergies when cough is a predominant symptom. - May be combined with non‑pharmacologic measures such as hydration and chest physiotherapy.

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

Side effects of Hadorta are generally mild and related to its pharmacologic activity on bronchial secretions. Serious adverse events are rare but should be recognized.

Common: - Mild gastrointestinal discomfort or nausea. - Transient headache. - Slight increase in salivation. - Mild skin irritation at the oral mucosa. - Dizziness, especially when standing quickly.

Serious: - Allergic reactions such as rash, itching, or swelling. - Severe bronchospasm in sensitive individuals. - Persistent vomiting or diarrhea. - Signs of hepatic dysfunction (rare).

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

Precautions for Hadorta focus on patient selection, underlying conditions, and appropriate use. Patients should follow label instructions and consult healthcare professionals when needed.

- Not recommended for individuals with known hypersensitivity to ivy leaf or ethanol. - Use caution in patients with asthma or a history of bronchospasm. - Pregnant or breastfeeding women should seek medical advice before use. - Avoid prolonged use without medical supervision. - Keep out of reach of children; accidental ingestion may cause gastrointestinal upset. - Do not exceed the recommended daily dose.

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

Hadorta may interact with other medications that affect the respiratory system or liver metabolism. Awareness of potential interactions helps minimize risks.

Avoid: - Concurrent use with other strong expectorants or mucolytics without professional guidance. - Combination with monoamine oxidase inhibitors (MAOIs) due to possible additive effects on bronchial tone.

Use with caution: - Antihistamines that may cause dry mouth, potentially reducing expectorant effectiveness. - Hepatically metabolized drugs such as certain statins, as ethanol content could influence metabolism. - Herbal supplements containing similar expectorant compounds. - Medications that lower the seizure threshold, though evidence is limited.

Frequently asked questions

What is the active ingredient in Hadorta?+
Hadorta contains a dry extract of Hederae Folium (ivy leaf) standardized to a 4‑8:1 ratio, extracted with 30 % ethanol.
How does Hadorta help with a cough?+
The ivy leaf extract stimulates bronchial secretions, making mucus less viscous and easier to expectorate, which can reduce coughing.
Is Hadorta available without a prescription?+
Yes, Hadorta is classified as an over‑the‑counter (OTC) product in the European Union.
Can I take Hadorta if I am pregnant?+
Pregnant or breastfeeding individuals should consult a healthcare professional before using Hadorta, as safety data are limited.
What are common side effects of Hadorta?+
Common side effects may include mild gastrointestinal discomfort, headache, increased salivation, skin irritation in the mouth, and occasional dizziness.
Are there any serious adverse reactions to watch for?+
Serious reactions are rare but can include allergic rash, swelling, severe bronchospasm, persistent vomiting, or signs of liver dysfunction.
Should I avoid using Hadorta with other cough medicines?+
Avoid combining Hadorta with other strong expectorants or mucolytics unless advised by a healthcare provider.
Can children use Hadorta?+
Hadorta should be kept out of reach of children, and use in pediatric patients should follow the dosing instructions on the label or a physician’s recommendation.
How long can I use Hadorta safely?+
Prolonged use without medical supervision is not recommended; typically, it is used for the duration of an acute cough episode.
Does Hadorta contain alcohol?+
Yes, the extract is prepared with 30 % ethanol, which contributes to the final product composition.
What should I do if I miss a dose of Hadorta?+
If a dose is missed, take it as soon as you remember unless it is close to the time of the next scheduled dose; do not double the dose.
Is Hadorta effective for dry coughs?+
Hadorta is primarily indicated for productive (wet) coughs where mucus clearance is needed; it may be less effective for dry coughs.
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
Zaklady Farmaceutyczne Polpharma S.A.
Origin
EU

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