Polopiryna Throat spray 0.25% x 15 ml

Directions for use: use w/ doctor's instructions.
Refer to the package insert for detailed directions for use.

Storage: Store at ambient temperature

Flurbiprofen

Zakłady Farmaceutyczne Polpharma S.A.

Zakłady Farmaceutyczne Polpharma S.A.,
19 Pelplińska street,
83-200 Starogard Gdański,
PL

Side effects can be minimized by using the lowest effective dose for the shortest period necessary to control symptoms. Infections. In connection with the systemic use of NSAIDs, isolated cases of exacerbation of inflammatory diseases caused by infection (e.g. necrotizing fasciitis) have been described. The patient should immediately consult a doctor if symptoms of bacterial infection appear or worsen during the use of flurbiprofen spray. Consider whether it is advisable to start an antibiotic. In the case of purulent bacterial pharyngitis/ tonsillitis, the patient should consult a doctor, as treatment should be reevaluated. If symptoms worsen, or if new symptoms appear, treatment should be reevaluated. If oral irritation occurs, flurbiprofen should be discontinued. Masking symptoms of coexisting infections. Epidemiological studies show that systemically acting nonsteroidal anti-inflammatory drugs (NSAIDs) can mask the symptoms of infection, which can lead to delayed initiation of appropriate treatment, thereby exacerbating the infection. This situation has been observed in cases of bacterial extramedullary pneumonia and bacterial complications of chickenpox. When POLOPIRINE THROAT SPRAY is administered during the presence of fever or pain associated with infection, it is recommended to control the course of the infection. Elderly patients. The elderly are more likely to experience adverse reactions after NSAID administration, particularly gastrointestinal bleeding or perforation, which can lead to death. Respiratory system. Bronchospasm may occur in people with asthma or a history of asthma or allergic disease. Therefore, caution should be exercised when using flurbiprofen spray in these patients. Other NSAIDs. Avoid concomitant use of flurbiprofen aerosol with NSAIDs, including selective cyclooxygenase-2 inhibitors. Systemic lupus erythematosus and mixed connective tissue disease. Patients with systemic lupus erythematosus and mixed connective tissue disease may have an increased risk of developing aseptic meningitis, but this effect usually does not occur during short-term, limited use of products such as flurbiprofen spray. Cardiovascular, renal and hepatic disorders. There are reports that NSAIDs have toxic effects on the kidneys, causing interstitial nephritis, nephrotic syndrome and renal failure. The use of NSAIDs can cause a dose-dependent decrease in prostaglandin production and accelerate the development of renal failure. Patients at highest risk of such complications are those with renal, cardiac, hepatic impairment, patients on diuretics and the elderly, but these effects usually do not occur during short-term, limited use of products such as flurbiprofen spray. Effects on the liver. Mild to moderate hepatic impairment. Effects on the cardiovascular system and cerebral vessels. Caution is required (discuss with your doctor or pharmacist) before starting treatment in patients with a history of hypertension and/or heart failure, as fluid retention, hypertension and edema have been described in association with NSAID treatment. Clinical studies and epidemiological data suggest that taking certain NSAIDs (especially at high doses and for long periods of time) may be associated with a small increase in the risk of arterial thrombosis (e.g., myocardial infarction or stroke). There are insufficient data to exclude such a risk for flurbiprofen when used at a daily dose not exceeding 5 doses of 8.75 mg (3 aerosol sprays per dose). Effects on the nervous system. Poanalgetic headache: in case of prolonged or inconsistent use of analgesics, headaches may occur, which should not be treated with increased doses of the drug product. Gastrointestinal tract. NSAIDs should be administered with caution to patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), as these conditions may be exacerbated. Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been described after the use of all NSAIDs, at any time during treatment, with or without a history of warning symptoms or serious gastrointestinal events. The risk of gastrointestinal bleeding, ulceration or perforation increases with higher doses of NSAIDs, in patients with a history of ulceration, especially if complicated by hemorrhage or perforation, and in the elderly. This risk is usually not present during short-term, limited use of products such as flurbiprofen spray. Patients with a history of gastrointestinal toxicity, especially the elderly, are advised to report any worrisome abdominal symptoms (especially gastrointestinal bleeding) to their physician. Caution should be exercised in patients concurrently taking medications that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors, and antiplatelet drugs such as acetylsalicylic acid. If gastrointestinal bleeding or ulceration occurs, flurbiprofen should be discontinued. Hematologic reactions. Like other NSAIDs, flurbiprofen may inhibit platelet aggregation and prolong bleeding time. Flurbiprofen spray should be used with caution in patients at risk of abnormal bleeding. Skin reactions. Very rarely, serious, sometimes fatal, skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been described after NSAID use. Flurbiprofen spray should be discontinued after the first symptoms, such as skin rash, mucosal damage or other hypersensitivity symptoms. Excipients. This product contains 9.91 mg of cyclodextrins (9.58 mg of betadex and 0.33 mg of hydroxypropyl betadex) in each dose (3 sprays), equivalent to 19.15 mg/ml of cyclodextrins (18.50 mg/ml of betadex and 0.65 mg/ml of hydroxypropyl betadex).