Fluractive 0.25% Flurbiprofen Oral Mucosa Spray 15 ml

Oral mucosal spray based on Flurbiprofen .

Therapeutic indications

Fluractive 0.25% Flurbiprofen Spray 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 and Posology

Administer 2 sprays 3 times a day addressed directly to the affected area.

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

- Disorders of the immune system

• Anaphylaxis, angioedema, allergic reaction.

- Psychiatric disorders

• Depression

- Nervous system disorders

• Dizziness, cerebrovascular accidents, visual disturbances, optic neuritis, migraine, paraesthesia, depression, confusion, hallucination, vertigo, malaise, fatigue and somnolence.

- Acoustic and labyrinth disturbances

• 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 the case of long-term treatment) may be associated with an increased risk of 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.
• Gastritis, peptic ulcer, perforation and ulcer haemorrhage were observed less frequently.
• 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%).

- Kidney 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

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 oligo-hydroamnios;

the mother and the newborn, at the end of pregnancy, to:

• Possible prolongation of 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, any swallowing of Fluractive 0.25% Mouthwash and Fluractive 0.25% Spray for oral mucosa does not cause any harm to the patient as these doses are well below 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 Fluractive 0.25% Mouthwash and Fluractive 0.25% Spray for oral mucosa, especially if prolonged, can give rise to sensitization or local irritation phenomena; 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.

Mouthwash and oral mucosal 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 mouthwash and the spray contain a small amount of ethyl alcohol, less than 100 mg per dose.

Expiry and Retention

The expiry date indicated refers to the product in intact and correctly stored packaging. Shelf life after first opening the bottle is 21 weeks.

Warning : do not use Fluractive Spray after the expiry date stated on the package

Composition

100 ml of Fluractive 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.