Humex Miel Orange Sans Sucre, Édulcorée À L’isomalt Et À L’aspartam (Benzydamine Hydrochloride)

Humex Miel Orange Sans Sucre is indicated for the symptomatic relief of several common oral conditions.

• Sore throat caused by minor irritation or viral infection.
• Inflammation of the oral mucosa (stomatitis).
• Pain associated with minor mouth ulcers.
• Discomfort from post‑operative dental procedures.
• Temporary relief of throat irritation due to dry air or smoking.

• Benzydamine hydrochloride exerts its anti‑inflammatory, analgesic and local anesthetic actions by inhibiting the synthesis and release of pro‑inflammatory cytokines such as interleukin‑1β and tumor necrosis factor‑α, and by stabilising cell membranes of peripheral nerve endings. The compound also reduces the activity of cyclo‑oxygenase enzymes, limiting prostaglandin formation, which together significantly diminish pain signalling and swelling in the oral mucosa locally.

Benzydamine hydrochloride may cause local or systemic adverse reactions, most of which are mild, transient, and resolve without medical intervention.

Common

• Transient burning or tingling sensation in the mouth or throat.
• Mild nausea or upset stomach.
• Unpleasant taste or after‑taste.
• Temporary increase in salivation.
• Dry mouth sensation after use.
• Mild headache.

Serious

• Allergic reactions such as rash, pruritus or angio‑edema.
• Severe mouth or throat swelling that interferes with breathing.
• Persistent dizziness or faintness.
• Unexplained fever or chills.
• Rare cases of hepatic enzyme elevation.
• Severe hypersensitivity with bronchospasm.
• Acute oral mucosal ulceration in rare hypersensitive individuals.

When using Humex Miel Orange Sans Sucre, certain precautions should be observed to minimise risk and ensure appropriate use.

• Do not use if you have a known allergy to benzydamine or any excipients in the product.
• Avoid prolonged use; limit treatment to the duration recommended on the label.
• Keep the product out of reach of children; accidental ingestion may cause irritation.
• Consult a healthcare professional before use if you have chronic oral conditions or recent oral surgery.
• Discontinue use and seek medical advice if signs of an allergic reaction appear.
• Pregnant or breastfeeding individuals should discuss use with a clinician, as safety data are limited.

Benzydamine hydrochloride can interact with certain medicines or substances; awareness of these interactions helps prevent reduced efficacy or increased adverse effects.

Avoid

• Concurrent use with other topical oral anesthetics, which may amplify local numbness.
• Simultaneous intake of strong CYP450 inhibitors, although benzydamine is minimally metabolised, caution is advised.

Use with caution

• Use cautiously with systemic NSAIDs, as additive gastrointestinal irritation may occur.
• Caution when combined with anticoagulants, because of potential increased bleeding risk from mucosal irritation.
• Alcohol consumption may enhance the burning sensation in the mouth.