Flurbiprofen epipharma Oral Mucosa Spray 15ml 0.25%

Flurbiprofen -based spray.

Therapeutic indications

Flurbiprofene Colluttorio Eg is used in the symptomatic treatment of irritative-inflammatory states also associated with pain in the oropharyngeal cavity (eg gingivitis, stomatitis, pharyngitis), also as a consequence of conservative or extractive dental therapy.

Dosage and Posology

The drug should be taken according to the following doses and methods: the recommended dose is 2 sprays 3 times a day addressed directly to the affected part.

Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms.

Overdose

Symptoms of overdose may include nausea, vomiting and gastrointestinal irritation.

Treatment should include gastric lavage and, if necessary, correction of the serum electrolyte picture. There is no specific antidote for flurbiprofen.

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

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: 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. ulcer perforation and bleeding.
• 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 disorders: Nephrotoxicity in various forms, including interstitial nephritis and nephrotic syndrome. As with other NSAIDs, rare cases of renal failure have been reported.

The topical use of the product, especially if prolonged, can give rise to sensitization or local irritation phenomena. The dissolution in the oral cavity of the product in the form of tablets may be accompanied by sensations of heat or tingling in the oropharynx. In such cases, treatment must be interrupted and appropriate therapy instituted if necessary

Pregnancy and breastfeeding

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 increased 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 that 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

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.

Special warnings

At the recommended doses, when using the product in its various pharmaceutical forms, any swallowing does not cause any harm to the patient, as the dose of flurbiprofen is much lower than that commonly used in systemic treatments. The use of the product, especially if prolonged, can give rise to sensitization phenomena or local irritation; in such cases it is necessary to interrupt the treatment and consult the doctor to establish, if necessary, a suitable therapy. 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. Cases of bronchospasm have been reported with flurbiprofen in patients with a history of bronchial asthma.

Flurbiprofen should be administered with caution to patients with a history of peptic ulcer and other gastrointestinal diseases as these conditions may be exacerbated. The risk of gastrointestinal bleeding, ulcer or perforation is higher with increasing flurbiprofen dosage in patients with a history of ulcer, particularly if complicated with haemorrhage and perforation and in the elderly. These patients should start treatment with the lowest available dose. Gastrointestinal bleeding, ulcer or perforation have been reported with all NSAIDs at any time during treatment. These adverse events can be fatal and can occur with or without warning symptoms or with a previous history of serious gastrointestinal events. Patients with a history of gastrointestinal disease, particularly if elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) in the initial stages of treatment. Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal haemorrhage and perforation, which can be fatal. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms.

Flurbiprofen Mouthwash Eg contain para-hydroxy-benzoates which can cause delayed allergic reactions, such as contact dermatitis; more rarely they can cause immediate reactions, with hives and bronchospasm.

The Oromucosal Spray and Spray contain para-hydroxybenzoates which can cause allergic reactions (including delayed ones). Patent V blue dye (E131) can cause allergic reactions. Polyoxyethylenated 40-hydrogenated castor oil can cause localized skin reactions. Both the Spray and the Spray contain a small amount of ethyl alcohol, less than 100 mg per dose.

Expiration and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Shelf life after first opening the bottle is 9 weeks.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

100 ml of Flurbiprofene Mouthwash Eg Spray contain:

Active principle

Flurbiprofen 0.25 g

Excipients

Glycerol (98%), ethanol, non-crystallizable liquid sorbitol, hydrogenated castor oil-40 polyoxyethylenate, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint flavor, patent blue V (E131), anhydrous citric acid, sodium hydroxide, purified water.