SEPTOLETE 16PAST 3+1MG LIM MY

SEPTOLETE AROME LIMONE AND MIELE 3 MG/1 MG PASTIGLIE

active ingredients

Each pill contains 3 mg of benzidamine hydrochloride and 1 mg of cetilpiridinium chloride. Excipient with known effects: - Isomalto (E953): 2452.8 mg/pastilla. - Benzoate sodium (E211): up to 0.0009 mg/pastiglia For the full list of excipients, see paragraph 6.1.

Excellent

Peppermint Oil Levomentolo Sucralosio (E955) Citric Acid (E330) Isomalto (E953) Lemon Aroma of Honey Curcumina (E100) (containing sodium benzoate (E211))

Therapeutic indications

Septolete lemon and honey aroma is indicated in adults, adolescents and children over 6 years of age for anti-inflammatory, analgesic and antiseptic treatment of throat, mouth and gum irritations, gums and pharyngitis.

Contraindications

Hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1. Children under the age of 6.

Population

Population Adults: the recommended dose is 3-4 tablets per day. The pastel must be dissolved slowly in the mouth every 3-6 hours. Senior Patients: the recommended dose is the same as adults. Pediatric population Teenagers over 12 years of age: the recommended dose is 3-4 tablets per day. The pastel must be dissolved slowly in the mouth every 3-6 hours. Children from 6 to 12 years old: the recommended dose is 3 tablets per day. The pastel must be dissolved slowly in the mouth every 3-6 hours. Septolete lemon aroma and honey can be used in this age group only on medical advice. Children under 6 years: Septolete aroma lemon and honey is contraindicated in children under 6 years of age. It is recommended not to use the product immediately before or after washing the teeth. Do not exceed the recommended doses. Septolete lemon aroma and honey can be used up to 7 days. Method of administration The pastel must be dissolved slowly in the mouth every 3-6 hours.

Conservation

Store in the original packaging to protect the medicine from light. This medicine does not require special temperature retention conditions.

Warnings

Septolete lemon aroma and honey should not be used for more than 7 days. If you do not notice appreciable results after 3 days, it is recommended to consult your doctor. The use of preparations for topical purposes, especially for a long period of time, can give rise to awareness-raising phenomena, in which case it is necessary to suspend treatment and consult the doctor to establish suitable therapy. Septolete lemon and honey aroma should not be used together with anionic compounds, such as those present for example in toothpastes, therefore it is recommended not to use the product immediately before or after washing the teeth. The use of benzidamine is not recommended in patients with hypersensitivity to salicylates (e.g. acetylsalicylic acid and salicylic acid) or other NSAIDs. Bronchospasm can worsen in patients suffering from or with a previous history of bronchial asthma. In these patients should be paid attention. Septolete lemon aroma and honey contains isomalto (E953). Patients with rare hereditary problems of fructose intolerance should not take this medicine. Septolete lemon and honey aroma contains up to 0,0009 mg benzoate sodium (E211) in each pastel. It can cause local irritation.

Interactions

Septolete lemon aroma and honey should not be used simultaneously with other antiseptics. Tablets should not be taken together with milk since milk reduces the antimicrobial effectiveness of chloride cetilpiridinium.

Effects

- Very common (≥ 1/10) - Common (≥ 1/100, Tabulated list of adverse reactions

	Rare	Very rare	Notable
Immune system disorders			Anaphylactic reactions Hypersensitivity reactions
Diseases of the nervous system			Hurricane mucosa
Respiratory, chest and mediastinic pathologies	Broncospasmo
Gastrointestinal diseases		Irritation of the oral mucosa Feeling of burning in the mouth	Anesthesia of oral mucosa
Pathologies of skin and subcutaneous tissue	Orticaria Photosensitivity

Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioniavverse.

Overdosing

Synonyms Toxic manifestations of benzidamine overdose consist of excitement, seizures, sweating, ataxia, tremors and vomiting. Since there is no specific antidote, the treatment of acute poisoning by benzidamine is purely symptomatic. Signs and symptoms of intoxication resulting from ingestion of significant amounts of cetilpiridinium chloride include nausea, vomiting, dispnea, cyanosis, asphyxiation, resulting in paralysis of respiratory muscles, SNC depression, hypotension and coma. In man the lethal dose is about 1-3 grams. Management Since there is no specific antidote, the treatment of acute overdose is purely symptomatic.

Pregnancy

There is or is limited data on the use of benzidamine hydrochloride and cetilpiridinium chloride in pregnant women. Septolete lemon aroma and honey is not recommended during pregnancy.

Breastfeeding

It is not known if benzidamine hydrochloride/metabolites are excreted in human milk. There is no risk for babies. It is necessary to decide whether to stop breastfeeding or to stop/abstain from the therapy with Septolete lemon aroma and honey taking into consideration the benefit of breastfeeding for the child and the benefit of the therapy for the woman.

Source: Farmadati