FENECOX THROAT * SPRAY 15ML 0.25%

FENECOX THROAT * SPRAY 15ML 0.25%

Therapeutic indications

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 method of use

Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.4).Mouthwash: The recommended dose is two or three rinses or gargles a day with 10ml of mouthwash. It can be diluted in water.Oral mucosal spray: The recommended dose is 2 sprays 3 times a day addressed directly to the affected area.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • 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 (see section 4.6).

Side effects

The following undesirable effects have been reported, particularly after administration of formulations for systemic use:Disorders of the blood and lymphatic systemThrombocytopenia, aplastic anemia and agranulocytosisDisorders of the immune systemAnaphylaxis, angioedema, allergic reaction.Psychiatric disordersDepressionNervous system disordersDizziness, cerebrovascular accidents, visual disturbances, optic neuritis, migraine, paraesthesia, depression, confusion, hallucination, vertigo, malaise, fatigue and somnolence.Ear and labyrinth disordersTinnitusCardiac pathologiesEdema, 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 of arterial thrombotic events (e.g. heart attack myocardium or stroke).Respiratory, thoracic and mediastinal disordersRespiratory tract reactivity (asthma, bronchospasm and dyspnoea)Gastrointestinal disordersThe 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 section 4.3 "Contraindications"). 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 disordersSkin 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 disordersNephrotoxicity 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 reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Special warnings

At the recommended doses, the possible swallowing of FENECOX 0.25% Mouthwash and FENECOX 0.25% Spray for oral mucosa does not cause any harm to the patient as these doses are much 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 (see section 4.6). Administration of flurbiprofen is not recommended in nursing mothers (see section 4.6). The use of FENECOX 0.25% Mouthwash and FENECOX 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 it is necessary to check the patient. In patients with renal, cardiac or hepatic insufficiency the product should be used with caution. It is advisable not to combine the product with other NSAIDs.Cases of bronchospasm with flurbiprofen have been reported in patients with a history of bronchial asthma. Gastrointestinal Effects 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 (see section 4.2).Important information about some of the ingredientsMouthwash 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.

Pregnancy and breastfeeding

PregnancyInhibition 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, the use of flurbiprofen is not recommended therefore it should be administered 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 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 timeFlurbiprofen 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 mothers who are breast-feeding.

Expiration and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

Caution should be exercised in patients treated with any of the medicines listed below, as interactions have been reported in some patients. However, inform your doctor if you are taking other medicines.Aspirin: As with other NSAID-containing medicines, concomitant administration of flurbiprofen and aspirin is generally not recommended due to the potential for increased side effects.Antiplatelet agents: increased risk of gastrointestinal bleeding.Selective Serotonin Reuptake Inhibitors (SSRIs): increased risk of gastrointestinal bleeding.Corticosteroids: increased risk of gastrointestinal ulcer or haemorrhage with NSAIDs.Cox-2 inhibitors and other NSAIDs: Concomitant use of other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to potential additive effects.

Overdose

SymptomsSymptoms of overdose may include nausea, vomiting and gastrointestinal irritation.TreatmentTreatment should include gastric lavage and, if necessary, correction of the serum electrolyte picture. There is no specific antidote for flurbiprofen.

Active principles

FENECOX 0.25% Mouthwash 100 ml of solution contain: Active ingredient: Flurbiprofen 0.25 g FENECOX 0.25% Spray for oral mucosa 100 ml of solution contain: Active ingredient: Flurbiprofen 0.25 g Excipients with known effects : 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 For the complete list of excipients, see section 6.1

Excipients

FENECOX 0.25% Mouthwash and FENECOX 0.25% Oromucosal spray Glycerol (98%), ethanol, non crystallizable liquid sorbitol, hydrogenated castor oil-40 polyoxyethylenate, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint flavor, blue patent V (E131), anhydrous citric acid, sodium hydroxide, purified water.