Neo Borocillin throat pain 0.25% 15 ml mint flavor oral spray

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

NEO BOROCILLINA THROAT PAIN mouthwash / NEO BOROCILLINA THROAT PAIN spray for oral mucosa is used in the symptomatic treatment of irritative-inflammatory conditions also associated with pain in the oropharyngeal cavity (e.g. gingivitis, stomatitis, pharyngitis), also as a consequence of conservative or extractive dental therapy. NEO BOROCILLINA THROAT PAIN tablets are used in the symptomatic treatment of irritative-inflammatory states also associated with pain in the oropharyngeal cavity (e.g. gingivitis, stomatitis, pharyngitis).

ACTIVE INGREDIENTS

NEO BOROCILLINA THROAT PAIN 0.25% mouthwash and NEO BOROCILLINA THROAT PAIN 0.25% spray for oral mucosa (all presentations) 100 ml of solution contains: Active ingredient: Flurbiprofen 0.25 g. Excipients with known effects: ethanol 9.60 g; liquid sorbitol (non-crystallizable) 7.00 g; methyl-p-hydroxybenzoate 0.10 g; propyl-p-hydroxybenzoate 0.02 g; glycerol 10 g; sodium 6.8 mg. NEO BOROCILLINA THROAT PAIN 0.25% orange and honey flavor oral mucosa spray and NEO BOROCILLINA THROAT PAIN 0.25% lemon and honey flavor oral mucosa spray also contain the excipient with the known effect sunset yellow (E110): 100 ml of solution contains: sunset yellow (E110): 0.014 g (presentation 0.25% orange and honey flavor oral mucosa spray); 0.006 g (presentation 0.25% lemon and honey flavor oral mucosa spray) For the complete list of excipients, see paragraph 6.1 NEO BOROCILLINA THROAT PAIN 8.75 mg lozenges (all presentations) One tablet contains: Active ingredient: Flurbiprofen 8.75 mg. Excipients with known effects: glycerol 20 mg; isomalt 931.45 mg (orange and honey flavour); 936.45 mg (lemon and honey flavour); 913.25 mg (mint flavour). For the full list of excipients, see section 6.1

EXCIPIENTS

Mint flavored mouthwash and oral mucosa spray Glycerol, ethyl alcohol (ethanol 96%), sorbitol liquid (non-crystallizable), castor oil hydrogenated 40 polyoxyethylene, sodium hydroxide, saccharin sodium, methyl-p-hydroxybenzoate, propyl-p-hydroxybenzoate, tri-rectified mint essential oil, patent blue V (E 131), citric acid, purified water. Lemon and honey flavored oral mucosa spray Glycerol, ethyl alcohol (ethanol 96%), sorbitol liquid (non-crystallizable), castor oil hydrogenated 40 polyoxyethylene, sodium hydroxide, saccharin sodium, methyl -p-hydroxybenzoate, propyl-p-hydroxybenzoate, honey flavour, lemon flavour, mint flavour, sunset yellow (E110), citric acid, purified water. Orange and honey flavored oral mucosa spray Glycerol, ethyl alcohol (ethanol 96%), sorbitol liquid (non-crystallizable), castor oil hydrogenated 40 polyoxyethylene, sodium hydroxide, saccharin sodium, methyl -p-hydroxybenzoate, propyl-p-hydroxybenzoate, honey flavour, orange flavour, mint flavour, sunset yellow (E110), citric acid, purified water. Mint flavored sugar-free lozenges Glycerol dibeenate, acesulfame potassium, balsamic mint aroma, isomalt, copovidone. Sugar-free lemon and honey flavored lozenges Glycerol dibeenate, acesulfame potassium, lemon honey flavour, isomalt, copovidone. Orange and honey flavored sugar-free lozenges Glycerol dibeenate, acesulfame potassium, honey orange flavour, isomalt, copovidone.

CONTRAINDICATIONS AND SIDE EFFECTS

Flurbiprofen is contraindicated in patients with hypersensitivity (asthma, bronchospasm, urticaria or allergic type) towards flurbiprofen or to any of the excipients, and towards acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs). Third trimester of pregnancy. The administration of flurbiprofen is not recommended in breastfeeding mothers. Do not use in patients who have peptic ulcers or who have had them in the past. Do not give the tablets to children under the age of 12 years.

DOSAGE

Mouthwash The recommended dose is 2-3 rinses or gargles per day with 10 ml of mouthwash (using the appropriate measuring cup), diluted in half a glass of water or pure. Spray for oral mucosa The recommended dose is 2 sprays 3 times a day aimed directly at the affected part; each spray delivers 0.2 ml of solution, equivalent to 0.5 mg of active ingredient. Pads Adults and children over 12 years of age: 1 tablet to dissolve slowly in the mouth every 3-6 hours, as needed. Do not exceed the dose of 8 tablets in 24 hours. Do not administer to children under 12 years of age. For elderly people, no changes in dosage are necessary.

CONSERVATION

Mouthwash and oral mucosa spray: No particular storage conditions. Tablets: Store at temperatures not exceeding 25°C.

WARNINGS

At the recommended doses, when using the medicine in its various pharmaceutical forms, any swallowing does not, in itself, cause any harm to the patient, as these doses are widely lower than those commonly used in treatments with flurbiprofen systemically. In patients with renal, cardiac or hepatic insufficiency, the medicine NEO BOROCILLINA THROAT PAIN should be used with caution. It is recommended not to combine the medicine with NSAIDs. Use of the product, especially if prolonged, can give rise to local sensitization or irritation phenomena; in such cases it is necessary to interrupt the treatment and consult the doctor to institute, if necessary, a suitable therapy. Do not use for prolonged treatments. After a short period of treatment without appreciable results, consult your doctor. NEO BOROCILLINA THROAT PAIN mouthwash and NEO BOROCILLINA THROAT PAIN spray for oral mucosa (all presentations) contain: - 960 mg of ethanol per 10 ml of mouthwash. May cause burning sensation on damaged skin. - hydrogenated polyoxide castor oil which may cause localized skin reactions. - parahydroxy benzoates which can cause allergic reactions (even delayed). NEO BOROCILLINA THROAT PAIN 0.25% spray for oral mucosa orange and honey flavor and NEO BOROCILLINA THROAT PAIN 0.25% spray for oral mucosa lemon and honey flavor also contain the coloring sunset yellow (E110), which can cause allergic reactions.NEO BOROCILLINA THROAT PAIN 8.75 mg lozenges (all presentations) contains isomalt: patients suffering from rare hereditary problems of intolerance to fructose, you should not take this medicine.

INTERACTIONS

However, inform your doctor if you are taking other medicines. As demonstrated in some clinical studies, flurbiprofen may occasionally reduce the diuretic activity of furosemide. Furthermore, flurbiprofen may occasionally interfere with the action of anticoagulant drugs. However, no interaction of flurbiprofen with digoxin, tolbutamide and antacids has been demonstrated.

SIDE EFFECTS

The use of NEO BOROCILLINA THROAT PAIN, especially if prolonged, can give rise to sensitization or local irritation phenomena; in such cases it is necessary to interrupt the treatment and institute, if necessary, a suitable therapy. The following side effects have been reported, particularly after the administration of higher doses systemically: Pathologies of the blood and lymphatic system Thrombocytopenia, aplastic anemia and agranulocytosis. Immune system disorders Anaphylaxis, angioedema, allergic reaction. Nervous system disorders Dizziness, cerebrovascular accident, visual disturbances, optic neuritis, migraine, paraesthesia, depression, confusion, hallucination, vertigo, discomfort, fatigue and drowsiness. Ear and labyrinth disorders Tinnitus. Respiratory, thoracic and mediastinal disorders Reactivity of the respiratory tract (asthma, bronchospasm and dyspnea). Gastrointestinal disorders The most commonly observed adverse events are gastrointestinal in nature. The following have been reported after administration of flurbiprofen: nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, gastrointestinal haemorrhage and exacerbation of colitis and Crohn's disease. Less frequently, gastritis, peptic ulcer, perforation and ulcer bleeding have been observed. Pathologies of the skin and subcutaneous tissue Skin disorders including rash, pruritus, urticaria, purpura and very rarely bullous dermatoses (including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis and Erythema multiforme). Renal and urinary disorders Nephrotoxicity in various forms, including interstitial nephritis and nephrotic syndrome. As with other NSAIDs, rare cases of renal failure have been reported. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

OVERDOSE

With the use of NEO BOROCILLINA THROAT PAIN it is rare for overdose situations to occur. Symptoms Symptoms of overdose may include nausea, vomiting, and gastrointestinal irritation. Treatment Treatment should include gastric lavage and, if necessary, correction of the serum electrolyte picture. There is no specific antidote for flurbiprofen.

PREGNANCY AND BREASTFEEDING

During the first and second trimester of pregnancy, flurbiprofen should not be administered unless strictly necessary. The medicine administered during pregnancy can delay the onset of labor and increase its duration. The administration of flurbiprofen is not recommended in breastfeeding mothers.

EFFECTS ON DRIVING ABILITY

The medicine does not alter the ability to drive or use machines.