Drug for oral cavity conditions
Indications
Septolete is indicated in adults and children over 6 years of age for the anti-inflammatory, analgesic and antiseptic treatment of irritation of the throat, mouth and gums, gingivitis, pharyngitis and laryngitis.
Composition
Active ingredients
Each lozenge contains 3 mg of benzydamine hydrochloride and 1 mg of cetylpyridinium chloride. Excipient with known effect: • Isomalt (E953): 2471.285 mg/lozenge. For the full list of excipients, see section 6.1.
Excipients
Eucalyptus oil Levomenthol Citric acid, anhydrous (E330) Sucralose (E955) Isomalt (E953) Brilliant blue FCF (E133)
Directions for use and Dosage
Adults: The recommended dose is 3–4 lozenges per day. The lozenge should be slowly dissolved in the mouth every 3–6 hours.
Elderly patients: The recommended dose is the same as for adults.
Children over 12 years of age: The recommended dose is 3–4 lozenges per day. The lozenge should be slowly dissolved in the mouth every 3–6 hours.
Children 6 to 12 years of age: The recommended dose is 3 lozenges per day. The lozenge should be slowly dissolved in the mouth every 3–6 hours. Septolete can be used in this age group only on medical advice.
Children under 6 years of age: Septolete is contraindicated in children under 6 years of age. For optimal effect, it is recommended not to use the product immediately before or after brushing your teeth. Do not exceed the recommended dose. Septolete can be used in children under 6 years of age. Septolete can be used for up to 7 days.
Method of administration The lozenge should be slowly dissolved in the mouth every 3–6 hours.
Warnings
Septolete should not be used for more than 7 days. If no appreciable results are seen after 3 days, a doctor should be consulted. Use of topical preparations, especially if prolonged, may give rise to sensitization phenomena, in which case treatment should be discontinued and appropriate therapy instituted. Septolete should not be used together with anionic compounds, such as those found in toothpastes, for example, therefore it is recommended not to use the product immediately before or after brushing your teeth. Septolete contains isomalt (E953). Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Interactions
Septolete should not be used simultaneously with other antiseptics. The lozenges should not be taken with milk because milk reduces the antimicrobial efficacy of cetylpyridinium chloride.
Pregnancy and breastfeeding
Pregnancy There are no or limited amounts of data from the use of benzydamine hydrochloride and cetylpyridinium chloride in pregnant women. Septolete is not recommended during pregnancy.
Breastfeeding It is not known whether benzydamine hydrochloride/metabolites are excreted in human milk. A risk to the newborn cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from Septolete therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Format
16 tablets
Product Code:FRCM117929
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