CORYFIN THROAT PAIN * SPRAY 15ML

CORYFIN THROAT PAIN * SPRAY 15ML

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).CORYFIN THROAT PAIN 2.5 mg / ml mouthwash DosageThe recommended dose is two or three rinses or gargles a day with 10ml of mouthwash.Method of administrationFor oropharyngeal use. Rinse or keep in mouth while gargling for up to 1 minute. Do not swallow. The mouthwash can be diluted in water.CORYFIN THROAT PAIN 2.5 mg / ml spray for oral mucosa DosageThe recommended dose is 2 sprays 3 times a day addressed directly to the affected area.Method of administrationFor oropharyngeal use. Direct the dispenser and spray on the affected part.Pediatric populationDo not administer to children under 12 years of age (see section 4.3).Elderly people: the clinical data currently available are limited; therefore, no recommendation on a posology can be made. Elderly people have an increased risk of serious consequences in case of adverse reactions (see section 4.4).Patients with hepatic insufficiency: No dose reduction is required in patients with mild to moderate hepatic impairment. Flurbiprofen is contraindicated in patients with severe hepatic impairment (see section 4.3).Patients with renal insufficiency: No dose reduction is required in patients with mild to moderate renal impairment. Flurbiprofen is contraindicated in patients with severe hepatic impairment (see section 4.3).

Contraindications

• Do not use the medicine in children under 12 years of age. • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • CORYFIN THROAT PAIN is contraindicated in patients with known hypersensitivity (asthma, urticaria, allergy, rhinitis, angioedema, bronchospasm) 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, severe hepatic insufficiency and renal insufficiency (see section 4.4). • Third trimester of pregnancy.

Side effects

Hypersensitivity reactions to NSAIDs have been reported and these may consist of: (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactivity, e.g. asthma, aggravated asthma, bronchospasm, dyspnoea, (c) various skin disorders, including for example skin rashes of various types, pruritus, urticaria, purpura, angioedema and, more rarely, exfoliative and bullous dermatosis (including epidermal necrolysis and erythema multiforme). The most commonly observed adverse events are gastrointestinal in nature. Local use of the drug, especially if prolonged, can give rise to sensitization or local irritation. They have been reported, particularly after administration of formulationsfor systemic use, the following side effects. They refer to those detected with the use of flurbiprofen used in the short term and at doses compatible with the classification of self-medication. When treating chronic conditions and over long periods of time, additional side effects may occur. Undesirable effects associated with the use of flurbiprofen are categorized below by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥1 / 100, Blood and lymphatic system disorders Not known: anemia, thrombocytopenia, aplastic anemia and agranulocytosis.Disorders of the immune systemRare: anaphylactic reactions. Not known: angioedema, hypersensitivity.Psychiatric disordersUncommon: insomnia. Not known: depression, hallucination.Nervous system disordersCommon: dizziness, headache, paraesthesia. Uncommon: somnolence. Not known: cerebrovascular accidents, optic neuritis, migraine, confusion, vertigo.Eye disordersNot known: visual disturbances.Ear and labyrinth disordersNot known: tinnitus.Cardiovascular DisordersNot known: heart failure, edema.Vascular disorders:Not known: hypertension.Respiratory, thoracic and mediastinal disordersCommon: throat irritation. Uncommon: asthma, bronchospasm and dyspnoea, oropharyngeal blistering, oropharyngeal hypoesthesia.Gastrointestinal disordersCommon: diarrhea, mouth ulcers, nausea, oral pain, oral paraesthesia, oropharyngeal pain, oral discomfort (hot or burning sensation, tingling of the mouth). Uncommon: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, gloxidinia, dysgeusia, oral dysesthesia, vomiting. Very rare: pancreatitis. Not known: melaena, haematemesis, gastrointestinal haemorrhage, colitis, exacerbation of Crohn's disease, gastritis, peptic ulcer, perforation and ulcer haemorrhage.Skin and subcutaneous tissue disordersUncommon: rash, pruritus. Not known: urticaria, purpura, bullous dermatitis (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme).Renal and urinary disordersNot known: nephrotoxicity in various forms, including interstitial nephritis and nephrotic syndrome. As with other NSAIDs, rare cases of renal failure have been reported.General disorders and administration site conditionsUncommon: pyrexia, pain. Not known: discomfort, fatigue, malaise, local irritation (which can occur with suppositories).Hepatobiliary disordersNot known: hepatitis.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: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

At the recommended doses, the possible swallowing ofCORYFIN THROAT PAIN 2.5 mg / ml mouthwashAndCORYFIN THROAT PAIN 2.5 mg / ml spray for oral mucosait does not cause any harm to the patient as these doses are well below those of the single posology of the product for the systemic route.Elderly people:Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal haemorrhage and perforation, which can be fatal.Respiratory pathologiesCases of bronchospasm have been reported with flurbiprofen in patients with a history of bronchial asthma or allergies. Flurbiprofen should be used with caution in these patients.Other NSAIDsIt is advisable not to combine the medicinal product with other NSAIDs (see section 4.5).Systemic lupus erythematosus (SLE) and mixed connective tissue diseasePatients with systemic lupus erythematosus and mixed connective tissue disease may have an increased risk of aseptic meningitis (see section 4.8), however this effect is not usually seen with products intended for limited and short-term use such as flurbiprofen.Cardiac, hepatic and renal impairmentThe medicine should be used with caution in patients with heart, kidney or liver failure. NSAIDs have been reported to cause various forms of nephrotoxicity, including interstitial nephritis, nephrotic syndrome and renal failure. Administration of an NSAID can cause a dose-dependent reduction in prostaglandin formation and precipitate renal failure. Patients at the highest risk of developing this reaction are those with impaired renal function, cardiac impairment, hepatic dysfunction, those on diuretic therapy and the elderly; however, this effect is not usually observed with products intended for limited and short-term use such as flurbiprofen.Cardiovascular and cerebrovascular effectsCaution is required before starting treatment in patients with a history of hypertension and / or heart failure (discuss with your doctor or pharmacist), as fluid retention, hypertension and edema have been reported in association with NSAID treatment. Clinical studies and epidemiological data suggest that the use of some NSAIDs, especially at high doses and for long-term treatments, may be associated with a modest increased risk of arterial thrombotic events such as, for example, myocardial infarction or stroke. There are insufficient data to exclude such a risk for flurbiprofen. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with flurbiprofen after careful consideration. Similar considerations should be made before initiating long-term treatment in patients with risk factors for cardiovascular disease (eg, hypertension, hyperlipidaemia, diabetes mellitus, smoking).Effects on the central nervous systemAnalgesic-induced headache. Headache may occur in case of prolonged or unregulated use of analgesics, which should not be treated by increasing the dose of the medicine.Gastrointestinal EffectsFlurbiprofen 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 reactions can be fatal and can occur with or without warning symptoms or with a previous history of severe gastrointestinal reactions. 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. 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). Caution should be advised in patients receiving concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking flurbiprofen, treatment should be stopped.Dermatological effectsThe use ofCORYFIN THROAT PAIN, especially if prolonged, it 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. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Flurbiprofen should be discontinued at the first appearance of rash, mucosal lesions or any other signs of hypersensitivity.InfectionsAs isolated cases of infection-related exacerbation of inflammation (e.g. development of necrotizing fasciitis) have been reported in temporal association with systemic use of NSAID class medicinal products, it is recommended that patients seek immediate medical attention if signs of a bacterial infection appearing or worsening during flurbiprofen therapy. A possible indication should be considered at the start of antibiotic therapy. If mouth irritation develops, treatment should be discontinued. 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. Do not use for treatments lasting more than 7 days. After short periods of treatment (3 days) with no appreciable results, consult your doctor, as the cause may be a different pathological condition. Excipients:CORYFIN THROAT PAIN 2.5 mg / ml mouthwashAndCORYFIN THROAT PAIN 2.5 mg / ml spray for oral mucosathey contain: • macrogolglycerol hydroxystearate (hydrogenated polyhydroxide castor oil). It can cause localized reactions and gastric disturbances; • methyl para-hydroxybenzoate and propyl para-hydroxybenzoate. They can cause allergic reactions (even delayed), such as contact dermatitis; more rarely they can cause immediate reactions, with hives and bronchospasm.

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, flurbiprofen should not be administered except in strictly necessary cases. 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 oligohydramnios; 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.Feeding timeFlurbiprofen is excreted in breast milk; however, the amount excreted is only a small fraction of the maternal dose and is unlikely to have adverse effects on the breastfed infant. Administration of flurbiprofen is not recommended in nursing mothers.FertilityThere is evidence indicating that cyclooxygenase / prostaglandin synthesis inhibitors may cause impairment of female fertility by an effect on ovulation. This is reversible upon discontinuation of treatment.

Expiry and retention

This medicinal product does not require any special storage conditions. For storage conditions after first opening see section 6.3.

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 medications. Flurbiprofen should be avoided in combination with: - Aspirin: unless taking aspirin at low doses (not exceeding 100 mg / day or local prophylactic doses for cardiovascular protection) has been recommended by the doctor; as with other NSAID-containing medicinal products, concomitant administration of flurbiprofen and aspirin is generally not recommended due to the potential for increased undesirable effects (see section 4.4). - Cox-2 inhibitors and other NSAIDs: Concomitant use of other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to potential additive effects and an increased risk of adverse reactions (see section 4.4). Flurbiprofen should be used with caution in combination with: - Anticoagulants: NSAIDs may potentiate the effects of anticoagulants such as warfarin (see section 4.4) - Antiplatelet agents: increased risk of gastrointestinal bleeding - Selective serotonin reuptake inhibitors (SSRIs) : increased risk of gastrointestinal bleeding - Antihypertensives (diuretics, ACE inhibitors and angiotensin II antagonists): NSAIDs may reduce the effect of diuretics. Other antihypertensive drugs may potentiate nephrotoxicity caused by cyclooxygenase inhibition, especially in patients with impaired renal function (these patients must be adequately hydrated) - Alcohol: may increase the risk of adverse reactions, especially of bleeding in the gastrointestinal tract - Cardiac glycosides: NSAIDs can exacerbate heart failure, reduce GRV (glomerular filtration rate) and increase plasma levels of glycosides - Ciclosporin: increased risk of nephrotoxicity - Corticosteroids: increased risk of gastrointestinal ulcer or bleeding with NSAIDs (see section 4.4) - Lithium: there is evidence for a possible increase in plasma levels of lithium - Methotrexate: there may be an increase in plasma levels of methotrexate - Mifepristone: NSAIDs should not be used for 8-12 days after administration of mifepristone, as NSAIDs can reduce the effect of mifepristone - Quinolone antibiotics: Animal data indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures - Tacrolimus: possible increased risk of nephrotoxicity when NSAIDs are co-administered with tacrolimus - Zidovudine: increased risk of haematological toxicity when NSAIDs are given with zidovudine.

Overdose

Considering the reduced content of active ingredient and its local use, it is unlikely that overdose situations will occur.SymptomsSymptoms of overdose may include nausea, vomiting and gastrointestinal irritation, epigastric pain, or more rarely diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more severe cases of NSAID intoxication, central nervous system toxicity is observed, manifesting as drowsiness, occasionally excitability, blurred vision, and disorientation or coma. Occasionally patients develop seizures. In the event of severe NSAID intoxication, metabolic acidosis may occur and the prothrombin time / INR may be prolonged, possibly due to interference with the action of circulating coagulation factors. Acute renal failure and liver damage can occur. An exacerbation of asthma is possible in asthmatics.TreatmentTreatment should be symptomatic and supportive and should include maintaining a patent airway and monitoring cardiac function and vital signs until stabilization. Oral administration of activated charcoal and, if necessary, correction of serum electrolytes should be considered if the patient presents within one hour of ingesting a potentially toxic amount. Seizures should be treated with intravenous diazepam or lorazepam if they are frequent or prolonged. Administer bronchodilators for asthma. There is no specific antidote for flurbiprofen.

Active principles

CORYFIN THROAT PAIN 2.5 mg / ml mouthwash1 ml of solution contains: flurbiprofen 2.5 mgCORYFIN THROAT PAIN 2.5 mg / ml spray for oral mucosa1 ml of solution contains: flurbiprofen 2.5 mgExcipients with known effects: methyl para-hydroxybenzoate, propyl para-hydroxybenzoate, macrogolglycerol hydroxystearate. For the full list of excipients, see section 6.1

Excipients

CORYFIN THROAT PAIN 2.5 mg / ml mouthwashAndCORYFIN THROAT PAIN 2.5 mg / ml spray for oral mucosa: glycerol (98 per cent), ethanol 96 per cent, non-crystallizable liquid sorbitol,macrogolglycerol hydroxystearate, sodium saccharin,methyl para-hydroxybenzoate,propyl para-hydroxybenzoate, mint flavor, patent V blue dye (E131), anhydrous citric acid, sodium hydroxide, purified water.