BENZIDAMINE TEVA * 20PASTL 3MG

BENZIDAMINE TEVA * 20PASTL 3MG

Therapeutic indications

Benzydamine Teva 3 mg lozenges are indicated for the local symptomatic treatment of acute sore throat in adults and children over 6 years of age.

Dosage and method of use

Dosage: Adults and children over 6 years: one tablet 3 times a day. Do not exceed 7 days of treatment. In case of persistent symptoms for more than 3 days or high fever, the clinical situation should be evaluated. Pediatric population: Due to the type of pharmaceutical form, Benzydamine Teva 3 mg tablets should not be given to children under 6 years of age. Children 6 to 11 years of age The product should be taken under the supervision of an adult.Method of administration:For oropharyngeal use. Slowly dissolve a lozenge in your mouth. Don't swallow. Don't chew.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Side effects

During the period of use, adverse reactions of the immune system and the gastrointestinal system were more frequently reported for the active substance of this medicinal product. Undesirable effects are listed using the following frequency scales: Very common (≥ 1/10), Common (≥ 1/100,

. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

Benzydamine Teva 3 mg lozenges should not be given to children under 6 years of age. The use of benzydamine is not recommended in patients with hypersensitivity to salicylates (e.g. acetylsalicylic acid and salicylic acid) or to other NSAIDs. Administer with caution in subjects who suffer or have suffered in the past from episodes of bronchial asthma, as bronchospasm phenomena may occur in this type of patients. In a limited number of patients, oropharyngeal ulcerations can be a sign of more serious pathologies. Therefore, in the event that symptoms worsen or do not improve or persist for more than three days, or if fever or other symptoms occur, the patient should contact their doctor.Excipients.Aspartame:Aspartame ingested orally is hydrolyzed in the gastrointestinal tract. Phenylalanine is the main product of its hydrolysis. It can be harmful to patients with phenylketonuria.Isomalt: Patients with rare hereditary problems of fructose intolerance should not take this medicine.Cochineal red dye: May cause allergic reactions.Sodium (component of quinoline yellow): This medicinal product contains less than 1 mmol (23 mg) sodium per tablet, ie essentially 'sodium-free'.

Pregnancy and breastfeeding

There are insufficient data from the use of benzydamine in pregnant and lactating women. Excretion into breast milk has not been studied. Animal studies are insufficient to detect effects on pregnancy and lactation (see section 5.3). The potential risk for humans is unknown. Benzydamine Teva 3 mg lozenges should not be used during pregnancy and breastfeeding.

Expiration and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

No interaction studies have been performed and no clinically relevant interactions with other medicinal products have been reported.

Overdose

No cases of overdose have been reported with the tablet formulation. However, symptoms of overdose in children such as excitation, convulsions, sweating, ataxia, tremor and vomiting have been reported very rarely after oral administration of benzydamine at a dosage approximately 100 times that of the tablets. In case of acute overdose, only symptomatic treatment can be performed; empty the stomach by inducing vomiting or by gastric lavage and keep the patient under observation by giving supportive treatment and maintaining adequate hydration.

Active principles

Each tablet contains 3 mg of benzydamine hydrochloride (equivalent to 2.68 mg of benzydamine).Excipients with known effects: Each tablet contains 2464.420 mg of isomalt (E-953), 3.409 mg of aspartame (E-951) and 0.013 mg of cochineal red dye (E-124). For the full list of excipients, see section 6.1.

Excipients

Isomalt (E-953), Citric Acid Monohydrate, Aspartame (E-951), Quinoline Yellow (E-104) (Contains Sodium), Honey Flavor, Orange Flavor, Peppermint Oil, Cochineal Red Color (E-124).