SEPTOLETE 16PAST 3MG+1MG EUCALYPTUS

SEPTOLETE AROMA EUCALIPTO 3 MG/1MG PASTIGLIE

active ingredients

Each pill contains 3 mg of benzidamine hydrochloride and 1 mg of cetilpiridinium chloride. Excipient with known effects: - Isomalto (E953): 2471,285 mg/pastilla. For the full list of excipients, see paragraph 6.1.

Excellent

Eucalyptus Oil Levomentol Citric Acid (E330) Sucralose (E955) Isomalto (E953) Bright Blue FCF (E133)

Therapeutic indications

Septolete eucalyptus aroma is indicated in adults, teenagers and children over 6 years of age for anti-inflammatory, analgesic and antiseptic treatment in 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 because the pharmaceutical form is not suitable for this age group.

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 aroma eucalyptus can be used in this age group only on medical advice. Children under 6 years: Septolete aroma eucalyptus is contraindicated in children under 6 years of age. For an optimal effect, it is recommended not to use the product immediately before or after washing the teeth. Do not exceed the recommended doses. Septolete aroma eucalyptus 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 any special storage temperature.

Warnings

Septolete aroma eucalyptus should not be used for more than 7 days. If you do not notice appreciable results after 3 days, you should consult your doctor. The use especially if prolonged preparations by topical means can give rise to awareness-raising phenomena, in which case it is necessary to suspend treatment and to establish suitable therapy. Septolete eucalyptus 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. Septolete aroma eucalyptus contains isomalto (E953). Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Interactions

Septolete aroma eucalyptus 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			Urgent Mucosa Oral Mucosa Anesthesia
Respiratory, chest and mediastinic pathologies	Broncospasmo
Gastrointestinal diseases		Irritation of the oral mucosa Feeling of burning in the mouth
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 are no limited amounts of data on the use of benzidamine hydrochloride and cetilpiridinium chloride in pregnant women. Septolete aroma eucalyptus 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/ refrain from therapy with Septolete eucalyptus aroma while taking into consideration the benefit of breastfeeding for the child and the benefit of the therapy for the woman.

Source: Farmadati