SEPTOLETE 16PAST3+1MG LIM FIOR

SEPTOLETE AROMA LIMONE AND FIORIES OF SAMBUCO 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): 2448,3 mg/pastilla; - Hydroxyanisol butilato (E320): 0,0004 mg/sheep; - Benzoate sodium (E211): up to 0,00075 mg/pastil. For the full list of excipients, see paragraph 6.1.

Excellent

Peppermint oil, Levomentol, Sucralose (E955), Citric Acid (E330), Isomalto (E953), Lemon Aroma (Hydroxyanisol Butilate containment (E320)), Elderflower Aroma, Curcumina (E100) (Bnzoate Sodium Containant (E211), Chloroine Fill Complexes (E14).

Therapeutic indications

Septolete lemon aroma and elder flowers 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

Posology. 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 elder flowers can be used in this age group only on medical advice. Children under 6 years: Septolete lemon aroma and elder flowers is contraindicated in children under 6 years old. 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 elder flowers 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 elder flowers 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 aroma and elder flowers 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 elder flowers contains isomalto (E953). Patients with rare hereditary problems of fructose intolerance should not take this medicine. Septolete lemon aroma and elder flowers contains butylated hydroxyanisol (E320). It could cause local skin reactions (e.g. contact dermatitis), or irritation of the eyes and mucosa of the membranes. Septolete lemon aroma and elder flowers contains benzoate sodium (E211). Slightly irritating to the skin, eyes and mucous membranes. Septolete lemon aroma and elder flowers contains up to 0,00075 mg of sodium benzoate (E211) in each pill. It can cause local irritation.

Interactions

Septolete lemon aroma and elder flowers 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-reazioni-avverse.

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 elder flowers 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 the therapy with Septolete lemon aroma and elder flowers taking into consideration the benefit of breastfeeding for the child and the benefit of the therapy for the woman.

Source: Farmadati