Septolete 3mg + 1mg KRKA 16 Tablets

Septolete 3mg + 1mg KRKA

Analgesic, anti-inflammatory, antiseptic

Active principles

Each tablet contains 3 mg of benzydamine hydrochloride and 1 mg of cetylpyridinium chloride. Excipient with known effects : • Isomalt (E953): 2471.285 mg / tablet. 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)

Therapeutic indications

Septolete is indicated in adults and children over 6 years of age for the anti-inflammatory, analgesic and antiseptic treatment in irritation of the throat, mouth and gums, gingivitis, pharyngitis and laryngitis.

Contraindications / Undesirable Effects

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Children under 6 years of age as the pharmaceutical form is not suitable for this age group.

Dosage

Posology Adults: The recommended dose is 3–4 tablets per day. The lozenge should be dissolved slowly in the mouth every 3–6 hours. Elderly patients: The recommended dose is the same as for adults. Pediatric population Children over 12 years of age: The recommended dose is 3–4 tablets per day. The lozenge should be dissolved slowly in the mouth every 3–6 hours. Children 6 to 12 years of age: The recommended dose is 3 tablets per day. The lozenge should be dissolved slowly in the mouth every 3–6 hours. Septolete can only be used in this age group 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 for up to 7 days. Method of administration The lozenge should be dissolved slowly in the mouth every 3–6 hours.

storage

Store in the original package to protect from light.

Warnings

Septolete should not be used for more than 7 days. If no appreciable results are seen after 3 days, the doctor should be consulted. The use, especially if prolonged, of topical preparations can give rise to sensitization phenomena, in which case it is necessary to suspend the treatment and institute suitable therapy. Septolete should not be used in conjunction with anionic compounds, such as those found for example in toothpastes, 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 as milk reduces the antimicrobial efficacy of cetylpyridinium chloride.

Side effects

• Very common (≤1 / 10) • Common (≤1 / 100, <1/10) • Uncommon (≤1 / 1,000, <1/100) • Rare (≤1 / 10,000, <1 / 1,000) • Very rare (<1 / 10,000), • Not known (frequency cannot be estimated from the available data) Tabulated list of adverse reactions

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili.

Overdose

Symptoms Toxic manifestations of benzydamine overdose consist of excitement, convulsions, sweating, ataxia, tremors and vomiting. Since there is no specific antidote, treatment of acute benzydamine intoxication is purely symptomatic. Signs and symptoms of intoxication following the ingestion of large quantities of cetylpyridinium chloride include nausea, vomiting, dyspnoea, cyanosis, asphyxia, resulting from paralysis of the respiratory muscles, CNS depression, hypotension and coma. In humans, the lethal dose is approximately 1–3 grams. Management Since there is no specific antidote, treatment of acute overdose is purely symptomatic.

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 newborns cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue / abstain from Septolete therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Format

Pack of 16 tablets.