Europe — EMA
Humex Citron Sans Sucre, Édulcorée À L’isomalt Et À L’aspartam
Humex Citron Sans Sucre, Édulcorée À L’isomalt Et À L’aspartam contains benzydamine hydrochloride for oral sore throat relief – OTC, sugar‑free, EU product.
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What is Benzydamine Hydrochloride?
Humex Citron Sans Sucre, Édulcorée À L’isomalt Et À L’aspartam is an over‑the‑counter oral preparation that contains the non‑steroidal anti‑inflammatory drug benzydamine hydrochloride. It is marketed in the European Union as a sugar‑free formulation sweetened with isomalt and aspartame, intended for local application to the oropharynx to relieve discomfort in people with sore throat, pharyngitis, oral mucositis or mouth‑ulcer pain. The product is suitable for adults and contains no sugars.
What is Benzydamine Hydrochloride used for?
Humex Citron Sans Sucre, Édulcorée À L’isomalt Et À L’aspartam is indicated for relief of discomfort in the oral cavity caused by several common conditions. The product provides a local anti‑inflammatory and analgesic effect, helping to reduce pain and inflammation without systemic absorption.
- Sore throat associated with viral or mild bacterial infections. - Pharyngitis causing irritation and pain in the throat. - Oral mucositis related to chemotherapy, radiotherapy, or trauma. - Painful mouth ulcers or aphthous lesions. - Post‑operative throat discomfort after minor ENT procedures.
What are the side effects of Benzydamine Hydrochloride?
Adverse reactions to benzydamine hydrochloride are generally mild and limited to the area of application, but rare serious events have been reported.
Common: - A brief burning or stinging feeling that resolves within minutes after use. - Slight alteration of taste, often described as metallic or sweet, which disappears after a short period. - Localized itching or mild irritation of the oral mucosa without ulceration. - Sensation of dry mouth that typically subsides with continued use.
Serious: - Development of allergic contact dermatitis presenting as redness, swelling, or rash in the mouth. - Angio‑edema affecting the lips, tongue, or surrounding tissues, potentially compromising airway. - Rare systemic hypersensitivity such as anaphylactic reaction requiring immediate medical attention.
What precautions apply to Benzydamine Hydrochloride?
When using Humex Citron Sans Sucre, it is important to follow safety guidelines to minimize risks and ensure appropriate use.
- Do not use if you have a known hypersensitivity to benzydamine or any excipients. - Avoid swallowing large amounts; the product is intended for topical use only. - Keep out of reach of children; accidental ingestion may cause gastrointestinal irritation. - Discontinue use and seek medical advice if symptoms persist longer than 7 days. - Use with caution in patients with severe liver or kidney impairment, as metabolism may be altered. - Pregnant or breastfeeding women should consult a healthcare professional before use due to limited safety data.
What does Benzydamine Hydrochloride interact with?
Benzydamine hydrochloride may interact with other substances applied to the oral cavity or systemic medications that affect coagulation or immune response.
Avoid: - Concurrent use of other topical oral anesthetics or anti‑inflammatory sprays, which may increase local irritation. - Alcohol‑based mouthwashes, as they can enhance mucosal absorption and irritation. - Systemic non‑steroidal anti‑inflammatory drugs (NSAIDs) when combined with high‑dose benzydamine, potentially increasing bleeding risk.
Use with caution: - Anticoagulant therapy (e.g., warfarin) because local inflammation reduction may mask bleeding signs. - Immunosuppressive agents, as altered mucosal immunity could affect healing.
Frequently asked questions
What is the active ingredient in Humex Citron Sans Sucre, Édulcorée À L’isomalt Et À L’aspartam?+
Is Humex Citron Sans Sucre suitable for children?+
How does benzydamine hydrochloride relieve sore throat pain?+
Can I swallow the product after spraying it in my mouth?+
Is the product sugar‑free?+
What should I do if I experience a burning sensation after use?+
Are there any known drug interactions with benzydamine?+
Is it safe to use this product while pregnant?+
How long can I use the spray for a sore throat?+
Can I use Humex Citron Sans Sucre together with a regular mouthwash?+
What are the signs of a serious allergic reaction to benzydamine?+
Product details
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