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Solunovar Compuesto

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Indications:

Painful & inflammatory mouth & throat conditions including tonsillitis, sore throat, radiation mucositis, aphthous ulcer, post-orosurgical & post-periodontal procedures.

Contraindications:

Patients with known hypersensitivity to benzydamine HCl or to any of the components of the vehicle.

Adverse reactions:

Benzydamine hydrochloride Anti-Inflammatory Lozenges/Solution is generally well tolerated and adverse effects are minor. Local Adverse Reactions: The most commonly reported reaction is oral numbness (2.6%). Occasional burning or stinging sensation may occur and has been reported in 1.4% of treated cases. Other local adverse effects were less common and included dryness or thirst (0.2%), tingling (0.2%), warm feeling in mouth and altered sense of taste (<0.1%). Systemic Adverse Reactions: These were very uncommon and never of a serious nature. They consisted mainly of nausea, vomiting, retching, gastrointestinal disorders (0.4%), dizziness (0.1%), headache and drowsiness (<0.1%).

Interactions:

There are no known drug interactions with benzydamine.

Warnings:

If a sore throat is either caused or complicated by a bacterial infection, appropriate antibacterial therapy should be considered in addition to the use of Benzydamine hydrochloride Anti-Inflammatory Lozenges/Solution. Use with caution in patients with hepatic or renal impairment (see Dosage & Administration). Benzydamine hydrochloride Anti-Inflammatory Lozenges: It should not be chewed. They should be slowly dissolved in the mouth. Benzydamine hydrochloride Solution: It is indicated for use as a rinse or gargle. It should not be swallowed but rather should be expectorated after each use. Benzydamine hydrochloride Solution should generally be used undiluted but if burning or stinging occur, it may be diluted with water. Use in pregnancy: Benzydamine hydrochloride Anti-Inflammatory Lozenges/Solution has been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate and may be lacking, but available data show no evidence of an increased occurrence of fetal damage. Use in children: Because of the lack of sufficient clinical experience, Benzydamine hydrochloride Anti-Inflammatory Lozenges/Solution is not recommended in children <6 years.

Form:

SOLUTION FOR INJECTION

Dosage and Administration

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