Pyralgina 500 mg x 12 tablets

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

Storage: Store at ambient temperature

Metamisole Sodium

Zakłady Farmaceutyczne Polpharma S.A.

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

The use of metamizol is associated with a rare but life-threatening risk of agranulocytosis or shock. Agranulocytosis and thrombocytopenia. High-dose or long-term use of the drug product increases the risk of agranulocytosis. Advise the patient to discontinue the product immediately and contact a physician if symptoms of agranulocytosis occur, such as increased body temperature combined with sore throat and mouth ulcers or thrombocytopenia. A blood test is necessary. Treatment should be discontinued immediately, even before laboratory results are obtained. Patients who have developed agranulocytosis in response to treatment with metamizol are at particular risk of developing a similar reaction to the use of other pyrazolones and pyrazolidine. If it is necessary to administer metamizol to a patient for a long period of time, it is imperative to have regular follow-up blood tests, as metamizol can cause bone marrow damage. Pancytopenia: If pancytopenia occurs, treatment should be discontinued immediately and a full blood test should be performed until the situation normalizes. The patient should be advised to see a doctor immediately if signs and symptoms that indicate blood dyscrasia (e.g., general malaise, infection, persistent fever, hematuria, bleeding, pallor) occur during treatment. Anaphylactic and anaphylactoid reactions. Patients should be advised to stop the product immediately and call for medical help if they experience symptoms of anaphylactic or anaphylactoid reaction, such as shortness of breath, swelling of the tongue, angioedema, rash or hives, as there is a risk to life. Patients showing an anaphylactic or other immune reaction to metamizole are also at risk of a similar reaction to other pyrazolones and pyrazolidines. Patients showing an anaphylactoid reaction to metamizol are also at particular risk for a similar reaction to non-opioid analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs). The risk of severe anaphylactoid reactions after taking a product containing metamizol is significantly increased in patients: with analgesic asthma syndrome or intolerance to analgesics manifested by urticaria, angioedema, especially if accompanied by polypoid rhinosinusitis; with bronchial asthma, especially with concomitant sinusitis and nasal polyps, with chronic urticaria, with intolerance to certain dyes (e.g. tartrazine) or preservatives (e.g., benzoates), with intolerance to alcohol manifested by sneezing, watery eyes and severe facial redness in response to even small amounts of alcohol, may indicate previously unrecognized analgesic asthma. Anaphylactic shock can occur in allergic patients. Therefore, special caution is recommended when using metamizol in patients with asthma or atopy. Patients with an increased risk of anaphylactoid reactions should be given metamizole only after careful consideration of the benefit/risk ratio. If necessary, it should be administered under close medical supervision, with provision for emergency care. Severe skin reactions. Severe cutaneous adverse reactions (SCAR, or severe cutaneous reactions) have been reported during treatment with metamizole. severe cutaneous adverse reactions), including Stevens Johnson syndrome (SJS, a severe allergic disease manifested by blisters and erosions on the skin, mouth, eyes and genitals, fever and joint pain), toxic necrotizing epidermal separation (TEN, Lyell's disease, a severe violent allergic disease manifested by bursting giant subepidermal blisters, extensive erosions on the skin, desquamation of large patches of epidermis, and fever) and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), which can be life-threatening or fatal. The patient should be informed of the subject and physical symptoms and closely monitored for skin reactions. If physical and subjective symptoms indicative of these reactions appear, treatment with metamizole should be discontinued immediately and never reintroduced. Reactions proceeding with a significant drop in blood pressure. Metamizol can cause hypotensive reactions. These reactions may be dose-dependent. They are more likely to occur with parenteral administration of the drug product, especially when the intravenous form is injected too quickly. The risk of a drop in blood pressure is increased in patients with systolic blood pressure less than 100 mm Hg or with heart failure and circulatory disorders (e.g., myocardial infarction or multi-organ trauma), also in patients with reduced circulating blood volume and dehydrated patients with high fever. Therefore, for these patients, the need for the product should be considered, and close monitoring should be conducted if used. Preventive measures (e.g., compensating for circulatory disorders) may be necessary to reduce the risk of hypotensive reactions. In patients in whom it is necessary to avoid lowering blood pressure, such as those with severe coronary artery disease or significant intracerebral vasoconstriction, metamizole may be used only under close control of hemodynamic parameters. Use the drug product with caution in patients with renal insufficiency, hepatic insufficiency, in gastric and duodenal ulcer disease after weighing the benefit-risk ratio. Drug-induced liver damage. Cases of acute hepatitis have been reported in patients treated with metamizole, occurring mainly with hepatocellular damage and appearing a few days to a few months after the start of treatment. Subject and physical symptoms include increased serum liver enzymes, including jaundice, often in the context of hypersensitivity reactions to other drugs (e.g., skin rash, blood cell dyscrasias, fever and eosinophilia) or with concomitant features of autoimmune hepatitis. In most patients, symptoms resolved after discontinuation of metamizole treatment, but in isolated cases progression to acute liver failure with the need for transplantation of this organ was noted. The mechanism of liver damage due to metamizol use is not clearly defined, but data suggest an immune-allergic mechanism. Patients should be advised to contact their doctor if they develop symptoms indicative of liver damage. In such a patient, treatment with metamizole should be discontinued and liver function tests should be performed. If a patient has suffered liver damage while taking metamizole, metamizole treatment should not be restarted unless other causes of liver damage have been identified. The drug product contains 34.5 mg of sodium per tablet, which corresponds to 1.7% of the WHO recommended maximum 2 g daily sodium intake in adults.