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  • Bronchenolo® Throat 0.25% Spray 15ml -35%

Bronchenolo® Throat 0.25% Spray 15ml

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Bronchenolo® Throat 0.25% Spray - Anti-inflammatory

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.

Composition

BRONCHENOL THROAT 0.25% Mouthwash 100 ml of solution contain

Active ingredient: Flurbiprofen 0.25 g BRONCHENOL THROAT 0.25% Spray for oral mucosa 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 polyoxyethylenate 2.00 g dye blue patent V (E131) 0.0006 g.

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.

Dosage

Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms.
The recommended dose is 2 sprays 3 times a day addressed directly to the affected area.

Warnings and Precautions

At the recommended doses, any swallowing of BRONCHENOL THROAT 0.25% Spray for oral mucosa does not cause any harm to the patient as these doses are far lower than those of the single systemic dosage of the product. 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 BRONCHENOL THROAT 0.25% Spray for oral mucosa, especially if prolonged, can give rise to sensitization phenomena or local irritation; in such cases it is necessary to stop 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 (possibly delayed). Patent V blue dye (E131) can cause allergic reactions. Hydrogenated castor oil – 40 polyoxyethylene can cause localized skin reactions. Both the mouthwash and the spray contain a small amount of ethyl alcohol, less than 100 mg per dose.

Interactions

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

Side effects

The following undesirable effects have been reported, particularly after administration of formulations for systemic use: Blood and lymphatic system disorders Thrombocytopenia, aplastic anemia and agranulocytosis Immune system disorders Anaphylaxis, angioedema, allergic reaction. Psychiatric disorders Depression Nervous system disorders Dizziness, cerebrovascular accidents, visual disturbances, optic neuritis, migraine, paraesthesia, depression, confusion, hallucination, dizziness, malaise, fatigue and somnolence. Acoustic and labyrinth disorders Tinnitus Cardiovascular disorders Edema, hypertension and heart failure Clinical studies and epidemiological data suggest that the intake of some NSAIDs (especially at high doses and in case of long-term treatment) may be associated with an increased risk arterial thrombotic events (e.g. myocardial infarction or stroke). Respiratory, thoracic and mediastinal disorders Respiratory tract reactivity (asthma, bronchospasm and dyspnoea) Gastrointestinal disorders The most commonly observed adverse events are gastrointestinal in nature. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, gastrointestinal haemorrhage and exacerbation of colitis and Crohn's disease have been reported following administration of flurbiprofen (see Contraindications section). Gastritis, peptic ulcer, perforation and ulcer haemorrhage were observed less frequently. Local irritation can occur with suppositories. Cases of pancreatitis have been reported very rarely. Skin and subcutaneous tissue disorders Skin disorders including rash, pruritus, urticaria, purpura, angioedema and very rarely bullous dermatosis (including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Erythema multiforme). 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%). Renal and urinary tract disorders Nephrotoxicity in various forms, including interstitial nephritis and nephrotic syndrome. As with other NSAIDs, rare cases of renal failure have been reported.

Pregnancy and breastfeeding

Pregnancy

Inhibition of prostaglandin synthesis can 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 oligohydroamnios; • 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.

Format

15ml spray.

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