Pyralgina

Pyralgina belongs to non-opioid analgesics from the group of pyrazolone derivatives with analgesic and antipyretic properties. It also relaxes smooth muscles.

Intended Use

Pyralgina is indicated for the treatment of:

• severe pain of various origins and fever, when the use of other measures is contraindicated or ineffective.

Active substance: Metamizolum natricum

Composition of Pyralgina

1 tablet contains	500 mg of metamizole sodium monohydrate
	The other ingredients are: potato starch, gelatin, magnesium stearate.

Dosage of Pyralgina

Always use this medicine exactly as described in the package leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults

The dosage depends on the intensity of pain or fever and the individual sensitivity of the patient to metamizole. Always use the lowest effective dose.
In occasional pain and fever – from 500 mg to 1000 mg (1 to 2 tablets) at a time. The maximum single oral dose is 1 g (2 tablets), the maximum daily dose is 3 g (6 tablets).

The tablets are taken with a sufficient amount of fluid (e.g. a glass of water). The drug should be taken during or immediately after meals.

Do not use the drug for more than 3-5 days without consulting a doctor or consult a doctor immediately if, despite taking the drug, the symptoms worsen.

Elderly patients, patients in poor general condition and reduced creatinine clearance (indicative of impaired renal function)
In elderly patients, patients in poor general condition and reduced creatinine clearance, the dose should be reduced due to slow metabolism of the drug.

Patients with hepatic and renal impairment

Patients with hepatic impairment should avoid repeated high doses as excretion of the drug and its metabolites is slowed down in these conditions. Short-term use of the drug does not require dose reduction. There are no data on the long-term use of metamizole in patients with severe hepatic and renal disorders.

Children and adolescents

Pyralgina is not intended for use in children and adolescents.

Contraindications

When should Pyralgina not be used?

• if you are allergic to metamizole, other pyrazolone and pyrazolidine derivatives (e.g. propyphenazone, phenazone or phenylbutazone) or any of the other ingredients of this medicine;
• if the patient has analgesic asthma syndrome or known intolerance to analgesics manifested by urticaria, angioedema (swelling of the tongue, face, lips and / or throat), i.e. patients who react with bronchospasm or other anaphylactoid reaction to salicylates, paracetamol or other non-opioid painkillers, including non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac, ibuprofen, indomethacin or naproxen;
• if you have problems with the bone marrow function (e.g. after taking medicines that suppress the body’s resistance) or changes in blood counts such as a decrease in the total number of white blood cells (leucopenia) or a certain type of white blood cell – granulocytes (agranulocytosis), or anemia;
• if you suffer from acute renal or hepatic failure, acute hepatic porphyria;
• if you have congenital glucose-6-phosphate dehydrogenase deficiency (a rare hereditary disease);
• if you are taking a medicine from the group of pyrazolone and pyrazolidine derivatives (e.g. phenylbutazone, propyphenazone);
• if you are pregnant or breast-feeding.

Notes for use

Pyralgina contains sodium

This medicinal product contains 1.5 mmol (34.5 mg) sodium per tablet. To be taken into consideration by patients with reduced kidney function and patients on a controlled sodium diet.

Contents

White to off-white, oblong, biconvex tablets. 6 tablets

Storage method

15°C-25°C

Manufacturer

POLPHARMA

Warnings

This is medicine. For safety, use it according to the leaflet attached to the package. Do not exceed the maximum dose of the drug. If in doubt, consult your doctor or pharmacist.

Talk to your doctor or pharmacist before taking Pyralgina:

• if you have systolic blood pressure less than 100 mmHg or heart disease and circulatory disorders (e.g. myocardial infarction, coronary artery disease or multiple trauma), cerebral vasoconstriction, reduced circulating blood volume, and in dehydrated patients, as the drug may cause lowering blood pressure;
• if you have a high fever;
• if you suffer from kidney and/or liver failure;
• if you suffer from gastric and duodenal ulcers;
• when the patient has bronchial asthma, in particular if it is accompanied by polypoid rhinosinusitis;
• when the patient has allergic diseases, including atopic, chronic urticaria;
• if you are intolerant to certain dyes (e.g. tartrazine) or preservatives (e.g. benzoates);
• in patients with alcohol intolerance manifested by sneezing, watery eyes and severe reddening of the face in reaction to even small amounts of alcohol; this may indicate previously undiagnosed analgesic asthma.

Due to the threat to life, the drug should be discontinued immediately and medical help should be called in the event of symptoms of an allergic (anaphylactic) reaction, e.g.:

• swelling of the face, lips, tongue and/or throat which may cause difficulty in swallowing or breathing;
• severe bronchospasm,
• skin and mucosal changes, such as itching, burning, redness, hives;
• shock (decrease in blood pressure, weakness, fainting).

Patients who show a hypersensitivity or other immunological reaction to metamizole are also at risk of a similar reaction to other pyrazolones and pyrazolidines and other non-opioid analgesics.

Anaphylactic shock may occur in allergic patients. Therefore, special caution is recommended when using the drug in patients with asthma or atopy (e.g. atopic dermatitis or mucositis, hay fever, allergic asthma).

In patients at increased risk of hypersensitivity-like reactions, metamizole should only be administered after careful risk-benefit consideration. If necessary, it should be administered under close medical supervision, with the possibility of providing assistance in an emergency.

The drug should be discontinued immediately and consult a doctor if the following symptoms occur:

• agranulocytosis, e.g. increased body temperature with chills, sore throat, difficulty swallowing and ulcers in the mouth, nose, throat, genitals and rectum.

The use of the drug in high doses or for a long time increases the risk of agranulocytosis, therefore the drug should not be used for more than 7 days.
If long-term use of the drug is necessary, the doctor will absolutely recommend blood tests, as metamizole can cause damage to the bone marrow.
Patients who develop agranulocytosis in response to treatment with metamizole are at particular risk of developing a similar reaction to other pyrazolones and pyrazolidine.

• thrombocytopenia, e.g. petechiae on the skin and mucous membranes, hematomas, recurrent bleeding from the gums, nose, digestive tract;
• pancytopenia (significant decrease in the number of all blood cells: red and white blood cells and platelets), e.g. general malaise, fever, signs of infection, hematoma, bleeding, paleness;
• severe allergic disease – Stevens-Johnson syndrome: blisters and sores on the skin, mouth, eyes and genitals, fever and joint pain
• or severe, violent allergic disease – toxic epidermal necrolysis: giant blisters bursting, extensive erosions on the skin, peeling of large patches of skin and fever. In the event of such symptoms, metamizole must never be used again. The skin should be carefully monitored for the presence of the above. symptoms, especially in the first weeks of treatment.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Interactions with other drugs

Tell your doctor about all the medicines you are taking, have recently taken or might take.
The use of Pyralgina is contraindicated:

• with drugs from the group of pyrazolone and pyrazolidine derivatives (phenylbutazone, propyphenazone).

Tell your doctor if you are using:

• coumarin anticoagulants;
• oral diabetes medications;
• phenytoin (anti-epileptic medicine);
• sulfonamides (antibacterial drugs);
• cyclosporin (a drug that lowers the body’s resistance used, among others, to prevent rejection of transplants);
• barbiturates (e.g. phenobarbital – a drug used, among others, in epilepsy);
• monoamine oxidase inhibitors (e.g. selegiline, moclobemide – drugs used, among others, in depression);
• chlorpromazine (a drug used, among others, in the treatment of schizophrenia);
• lithium (an antidepressant);
• – medicines to lower blood pressure (e.g. captopril);
• – diuretics (e.g. triamterene);
• – methotrexate (a medicine used to treat cancer).

Side effects of Pyralgina

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Due to the threat to life, the drug should be discontinued immediately and medical help should be sought in the event of severe allergic (anaphylactic) reactions:

• rare swelling of the face, lips, tongue and/or throat which may cause difficulty in swallowing or breathing;
• very rare severe bronchospasm;
• skin and mucosal changes, such as itching, burning, redness, hives;
• anaphylactic shock (life-threatening decrease in blood pressure, weakness, fainting) – frequency unknown.

Stop taking the medicine immediately and see your doctor if you experience the following very rare serious side effects:

• Stevens-Johnson syndrome (corrosive blisters on the mucous membranes of the mouth, conjunctiva, genitals);
• Lyell’s syndrome (toxic epidermal necrolysis, erythematous and bullous changes in the skin and mucous membranes, leading to large areas of epidermis peeling off and large areas of skin being exposed);
• pancytopenia (significant decrease in the number of all blood cells: red and white blood cells and platelets, manifested by general malaise, fever, signs of infection, hematomas, bleeding, pale skin);
• agranulocytosis (complete or almost complete loss of granulocytes in the blood) manifested by:
  • high fever, chills;
  • sore throat, difficulty swallowing and inflammation of the mucous membranes of the mouth, nose, throat, genitals and rectum;
  • elevated ESR;
  • hemoglobin, erythrocytes and platelets are not always normal, although most often they are normal;
  • slightly enlarged lymph nodes and spleen, although they are most often unchanged.

Single reports indicate that the risk of agranulocytosis may increase when metamizole is taken for more than one week.

Other side effects:
Consult your doctor if you experience any of the following side effects:

Uncommon (less than 1 in 100 patients):

• drug rash (transient rash of various types: papular, macular, pustular, erythematous);
• excessive decrease in blood pressure.

Rarely (affects less than 1 in 1,000 patients):

• maculopapular skin changes;
• leucopenia (decrease in the number of white cells in the blood).

Very rare (affects less than 1 in 10,000 patients):

• analgesic asthma (see “Do not take Pyralgina” in section 2), asthma attacks;
• thrombocytopenia (hematomas, bleeding);
• sudden deterioration of kidney function, including proteinuria, oliguria or anuria;
• acute kidney failure;
• interstitial nephritis.

Not known (frequency cannot be estimated from the available data):

• nausea, vomiting, abdominal pain, stomach irritation, diarrhea, dry mouth;
• liver damage;
• headaches and dizziness;
• hemolytic anemia, aplastic anemia, bone marrow damage, sometimes fatal. In patients with glucose-6-phosphate dehydrogenase deficiency, the drug causes haemolysis of blood cells;
• red color of urine (after using very high doses of metamizole).