Flurbiprofen zentiva Mouthwash 160ml 25mg/10ml

Therapeutic indications

FLURBIPROFENE ZENTIVA mouthwash is used in the 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

The recommended dose is two or three rinses or gargles a day with 10ml of mouthwash. It can be diluted in water or used pure.

Overdose

Considering the reduced content of active ingredient and its local use, it is unlikely that overdose situations will occur. Symptoms Symptoms of overdose may include nausea, vomiting and gastrointestinal irritation. Treatment In the event of this occurrence, appropriate treatments must be adopted; gastric lavage and, if necessary, correction of any imbalances of serum electrolytes are indicated. There are no specific antidotes to flurbiprofen.

Contraindications

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. - In patients who have a peptic ulcer or have had it in the past. - In the third trimester of pregnancy.

Side effects

The use of FLURBIPROFENE ZENTIVA Mouthwash, 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 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. Nervous system disorders Dizziness , cerebrovascular accidents, visual disturbances, optic neuritis, migraine, paraesthesia, depression, confusion, hallucination, dizziness, discomfort, fatigue and somnolence. Acoustic and labyrinth disorders Tinnitus. Respiratory, thoracic and mediastinal disorders Reactivity of the respiratory tract (asthma, bronchospasm and dyspnoea). Bronchospasm may occur in subjects with a history of asthma attacks related to the use of ASA (acetylsalicylic acid). 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. Gastritis, peptic ulcer, perforation and ulcer haemorrhage were observed less frequently. Skin and subcutaneous tissue disorders Skin disorders including rash, pruritus, urticaria, purpura and very rarely bullous dermatosis (including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Erythema multiforme). 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

During the first and second trimester of pregnancy, flurbiprofen should not be administered except in strictly necessary cases. Although no teratogenic effects have been demonstrated in preclinical studies in animals, the use of the product should, if possible, be avoided during pregnancy as the onset of labor may be delayed and its duration may be increased. In a limited number of studies, low concentrations of flurbiprofen have been observed in breast milk which are unlikely to cause adverse effects on the infant. However, administration of flurbiprofen is not recommended for nursing mothers.

Special warnings

At the recommended doses, the possible swallowing of FLURBIPROFENE ZENTIVA does not cause any harm to the patient, as these doses are well below those of the single dosage of the product systemically. The use of FLURBIPROFENE ZENTIVA Mouthwash throughout the day does not interfere with the waking state of the subject. The use of the product, especially if prolonged, can give rise to sensitization phenomena or local irritation. In such cases, treatment must be interrupted and appropriate therapy instituted if necessary. Do not use for prolonged treatments. After short periods of treatment without appreciable results, consult your doctor. In patients with renal, cardiac or hepatic insufficiency, the product should be used with caution. It is advisable not to associate the product with other NSAIDs. The product contains methyl parahydroxybenzoate and propyl parahydroxybenzoate as preservatives: they can cause allergic reactions sometimes of a delayed type, such as contact dermatitis; more rarely they can cause immediate reactions, with hives and bronchospasm. The product contains a small amount of ethyl alcohol less than 100 mg per dose. Patients with hereditary fructose intolerance problems should not take this product.

Expiry and Retention

This medicinal product does not require any special storage conditions.

Active principles

100 ml of mouthwash contain: Active ingredient: Flurbiprofen 250 mg. For the full list of excipients, see 6.1.

Excipients

Glycerol, ethanol 96%, non-crystallizable liquid sorbitol, hydrogenated castor oil – 40 polyoxyethylene, sodium hydroxide, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint flavor, patent blue V (E131), anhydrous citric acid, purified water.