FLUIBRON THROAT * SPRAY 15ML

FLUIBRON THROAT * SPRAY 15ML

Therapeutic indications

Symptomatic treatment of irritative-inflammatory states also associated with oropharyngeal pain (eg gingivitis, stomatitis, pharyngitis), also as a consequence of conservative or extractive dental therapy.

Dosage and method of use

Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.4).Mouthwash:the recommended dose is two or three rinses or gargles a day with 10 ml of mouthwash. It can be diluted in water.Oral mucosal spray: the recommended dose is 2 sprays 3 times a day addressed directly to the affected area.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Flurbiprofen is contraindicated in patients with known hypersensitivity (asthma, urticaria or allergic type) to flurbiprofen or to any of the excipients, and to aspirin or other NSAIDs. Flurbiprofen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation related to previous NSAID treatment. Flurbiprofen should not be taken by patients with active or anamnestic ulcerative colitis, Crohn's disease, recurrent peptic ulcer or gastrointestinal bleeding (defined as two or more distinct episodes of proven ulceration or bleeding). Flurbiprofen is contraindicated in patients with severe heart failure. Third trimester of pregnancy

Side effects

Clinical studies and epidemiological data suggest that the intake of some NSAIDs (especially at high doses and in the case of long-term treatment) may be associated with an increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). During clinical trials with flurbiprofen patches, the most commonly reported adverse reactions were local skin reactions (including redness, rash, itching, rash, numbness and tingling); however the incidence was low (4.6%). The undesirable effects listed in the table, reported in particular after administration of formulations for systemic use, are categorized by system organ class and frequency, defined using the following convention: Very common (≥1 / 10); common (≥1 / 100 y

Reporting of suspected adverse reactions:

Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

At the recommended doses, the possible swallowing of FLUIBRON THROAT 0.25% Mouthwash and FLUIBRON THROAT 0.25% Spray for oral mucosa does not cause any harm to the patient as these doses are much lower than those of the single dosage of the product by route. systemic. During the first and second trimester of pregnancy, flurbiprofen should not be administered except in strictly necessary cases. Administration of flurbiprofen is not recommended in nursing mothers. The use of FLUIBRON THROAT 0.25% Mouthwash and FLUIBRON THROAT 0.25% Spray for oral mucosa, especially if prolonged, can give rise to sensitization or local irritation; in such cases it is necessary to interrupt the treatment and consult the doctor to establish, if necessary, a suitable therapy. Do not use for prolonged treatments. After short periods of treatment without appreciable results, consult your doctor.Important information about some of the ingredients:mouthwash and oral mucosal spray contain para-hydroxybenzoates which can cause allergic reactions (even delayed). Patent V blue dye (E131) can cause allergic reactions. Polyoxyethylenated 40-hydrogenated castor oil can cause localized skin reactions. Both the mouthwash and the spray contain a small amount of ethyl alcohol, less than 100 mg per dose.

Pregnancy and breastfeeding

Pregnancy: Inhibition of prostaglandin synthesis may adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, flurbiprofen should not be administered except in strictly necessary cases. If flurbiprofen is used by a woman attempting to conceive or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: • Cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); • Renal dysfunction, which can progress to renal failure with oligo-hydroamnios; • the mother and the newborn, at the end of pregnancy, to: • Possible prolongation of the bleeding time, an antiplatelet effect which can occur even at very low doses; • Inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently flurbiprofen is contraindicated during the third trimester of pregnancy.Feeding time:Flurbiprofen is excreted in breast milk; however the amount excreted is only a small fraction of the maternal dose. Administration of flurbiprofen is not recommended in nursing mothers.

Expiration and retention

None

Interactions with other drugs

At the recommended doses, no interactions with other medicinal or other drugs have been reported. However, inform your doctor if you are taking other medications.

Overdose

SymptomsSymptoms of overdose may include nausea, vomiting and gastrointestinal irritation.TreatmentTreatment should include gastric lavage and, if necessary, correction of the serum electrolyte picture. There is no specific antidote for flurbiprofen.

Active principles

FLUIBRON THROAT 0.25% Mouthwash. 100 ml of solution contain: Active ingredient: Flurbiprofen 0.25 g. FLUIBRON THROAT 0.25% Oral mucosal spray. 100 ml of solution contain: Active ingredient: Flurbiprofen 0.25 g. Excipients: ethanol: 8.64 g; methyl p-hydroxybenzoate: 0.10 g; propyl p-hydroxybenzoate: 0.02 g; hydrogenated castor oil-40 polyoxyethylene: 2.00 g; patent blue dye V (E131): 0.0006 g. For the full list of excipients, see section 6.1.

Excipients

FLUIBRON THROAT 0.25% Mouthwash and FLUIBRON THROAT 0.25% Spray for oral mucosa: Glycerol (98%), ethanol, non-crystallizable liquid sorbitol, hydrogenated castor oil-40 polyoxyethylene, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, flavor mint, patent blue V (E131), anhydrous citric acid, sodium hydroxide, purified water.