Polopiryna Throat (8.75 mg) orange-flavored hard lozenges x 16

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

Taking the medicinal product in the smallest effective dose for the shortest possible period necessary to relieve symptoms reduces the risk of adverse reactions (see "Gastrointestinal disorders" and "Effects on the cardiovascular system and cerebral vessels" below). The elderly. The elderly are more likely to experience adverse reactions after NSAID administration, particularly gastrointestinal bleeding or perforation, which can lead to death. Respiratory disorders. Bronchospasm may occur in patients with bronchial asthma or allergic diseases, or with a history of bronchial asthma or allergic diseases. Caution should be exercised when using flurbiprofen in these patients. Other NSAIDs. Avoid concomitant use of flurbiprofen with other NSAIDs, including selective cyclooxygenase-2 inhibitors. Systemic Lupus Erythematosus (SLE) and mixed connective tissue disease. Patients with systemic lupus erythematosus and mixed connective tissue disease may have an increased risk of developing aseptic meningitis. However, this effect usually does not occur during short-term, limited use of products such as flurbiprofen lozenges. 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 using diuretics, and the elderly, but this effect usually does not occur during short-term, limited use of products such as flurbiprofen lozenges. Monitor renal function in patients with renal impairment, as NSAIDs can cause deterioration of renal function. Caution should be exercised in patients with mild to moderate hepatic impairment. Effects on the cardiovascular system and cerebral vasculature. In patients with a history of hypertension and/or heart failure, caution (consultation with a physician or pharmacist) is advised before starting treatment, 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 periods of time) may be associated with a small increase in the risk of arterial blockages (e.g., heart attack or stroke). There are insufficient data to exclude such a risk for flurbiprofen when used at a daily dose not exceeding 5 lozenges. Effects on the nervous system. Headache induced by analgesics: In case of prolonged or inconsistent use of analgesics, headaches may occur, which should not be treated with increased doses of the drug product. In such cases, treatment with NSAIDs should be discontinued, and the patient should seek medical attention. Gastrointestinal disorders. NSAIDs should be used with caution in 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, have been described after the use of all NSAIDs at any time of treatment, with or without accompanying warning symptoms and with or without a history of severe gastrointestinal adverse 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; however, this risk is usually not present during short-term, limited use of products such as flurbiprofen lozenges. Patients with a history of gastrointestinal toxicity, especially elderly patients, should report any worrisome abdominal symptoms (especially gastrointestinal bleeding) to their physician. Caution should be advised in patients receiving concomitant medications that may increase the risk of gastrointestinal ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet drugs such as acetylsalicylic acid. If gastrointestinal bleeding or ulceration occurs, flurbiprofen should be discontinued. Skin reactions. Very rarely, severe, sometimes fatal, skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been described after NSAID use. Flurbiprofen should be discontinued after the first symptoms, such as skin rash, mucosal damage or other hypersensitivity symptoms. Infections. The patient should consult a physician immediately if symptoms of bacterial infection appear or worsen during the use of flurbiprofen, since isolated cases of exacerbation of inflammatory diseases caused by infection (e.g. necrotizing fasciitis) have been described in connection with systemic use of NSAIDs. Consider whether it is advisable to start an antibiotic. If symptoms worsen or if new symptoms appear, reassess treatment. Masking symptoms of coexisting infections. Epidemiological studies show that systemically acting nonsteroidal anti-inflammatory drugs (NSAIDs) can mask symptoms of infection, which can lead to delayed initiation of appropriate treatment and thus worsening of the infection. This situation has been observed in cases of bacterial extramedullary pneumonia and bacterial complications of chickenpox. When administering Polopyrin Throat during the presence of fever or pain associated with infection, it is recommended to control the course of the infection. The position of the lozenge in the mouth should be changed until it dissolves. If irritation of the oral cavity occurs, flurbiprofen should be discontinued. Information on excipients. The product contains isomalt and maltitol. The product should not be used in patients with rare hereditary fructose intolerance. The product may have a slight laxative effect. Caloric value of 2.3 kcal/g maltitol and isomalt. The product contains the azo dyes cochineal red (E 124) and orange yellow (E 110). The product may cause allergic reactions.