Algocalmin, 500 mg, 20 tablets, Zentiva
Composition:
One tablet contains metamizole sodium salt monohydrate 500 mg as metamizole sodium salt monohydrate DC 538.80 mg and excipients: sugar, corn starch, magnesium stearate.
Pharmacotherapeutic group:
Analgesics and antipyretics, pyrazolone derivatives.
Therapeutic indications:
Severe acute post-injury or postoperative pain; colic; tumor pain; other severe acute or chronic pain, when other therapeutic means are not indicated.
Fighting fever when it is refractory to another treatment.
Contraindications:
Hypersensitivity to metamizole or to any of the excipients of the product, hypersensitivity to pyrazole derivatives, intolerance to non-steroidal anti-inflammatory drugs (NSAIDs), haematopoietic bone marrow disease, history of agranulocytosis, glucose-6-phosphate dehydrogenase deficiency, subunit 3, hepatic porphyria less than 5 kg (for the active substance).
Severe heart failure.
Precautions:
Metamizole may cause anaphylactic allergies, such as agranulocytosis or shock.
Because agranulocytosis occurs unexpectedly and is independent of the dose and duration of treatment, in the event of fever and / or angina and / or mouth ulcers, immediate discontinuation of treatment and urgent hemogram should be performed. Continued administration increases the risk of death.
In case of long-term treatment, regular medical supervision is required (blood count should be monitored).
Adverse reactions can be minimized by administering the lowest effective dose for the shortest period necessary to control symptoms.
Interactions: The
combination of metamizole with other drugs known as myelotoxics is not recommended.
Pyrazolone derivatives may interact with captopril, lithium, methotrexate and triamterene. Metamizole may alter the efficacy of antihypertensives and diuretics (except furosemide).
Because metamizole may decrease the plasma concentration of cyclosporine, it should be monitored when both drugs are used concomitantly.
Special warnings:
Before starting treatment, a careful history of any allergic conditions is required, as well as a history of allergy to pyrazole derivatives or salicylates.
In patients with an increased risk of anaphylactic shock, the product should be administered only if absolutely necessary, after careful evaluation of the potential risk / therapeutic benefit ratio and under strict medical monitoring.
For the following diseases the risk of anaphylactic shock is higher:
- allergic asthma, allergic rhinitis;
- urticaria;
- intolerance to ethyl alcohol (after ingestion of small amounts appear: sneezing, tearing, pronounced facial hyperemia; intolerance to ethyl alcohol may show the existence of asthma in NSAIDs);
- patients with intolerance to dyes (eg tartrazine) and preservatives (eg benzoate).
In patients with a history of hypertension and/or mild to moderate congestive heart failure, caution (discussion with physician or pharmacist) is required prior to initiating treatment, as reports have shown that NSAID treatment is associated with fluid retention and edema.
Medications such as Algocalmin 500 mg may be associated with a slightly increased risk of heart attack ('myocardial infarction') or stroke. Risks of any kind are more likely at high doses and with long-term treatment. Do not exceed the recommended dose and duration of 3 days for treatment.
If you have a history of heart problems, a stroke, or consider that you may be at risk for these conditions (for example, if you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should discuss treatment with your doctor or pharmacist.
The existing data are insufficient to exclude such a risk in the case of metamizole administered/administered in a daily dose of 0.5-5 g.
Because it contains sugar, if your doctor warns you that you have an intolerance to some categories of carbohydrates, please ask before taking this medicine.
Pregnancy and lactation
Preclinical studies in animals with high doses of metamizole have shown teratogenic effects. In the fetus there is a risk of hematological damage. Metamizole administration around birth may cause premature closure of the arterial canal. Due to the data presented, the administration of metamizole is contraindicated in the first and last trimester of pregnancy; in the second trimester it can be used only if absolutely necessary.
Drug metabolites are excreted in human milk; due to the myelotoxic risk, breast-feeding is discontinued within 48 hours after administration.
Ability to drive or use machines When
administered at the recommended doses, metamizole has no effect on the ability to drive or use machines.
Posology and method of administration:
Adults and children over 15 years of age
500-1000 mg of metamizole sodium salt monohydrate (1-2 tablets of Algocalmin 500 mg) is administered orally once. If necessary, it can be repeated up to 4 times a day. The 24-hour dose should not exceed 5 g metamizole sodium salt monohydrate (approximately 70 mg metamizole sodium salt monohydrate / kg).
Patients with renal or hepatic impairment
Because elimination of metamizole is delayed in patients with renal or hepatic impairment, high doses should not be administered. In case of short-term administration there is no need to reduce the dose. In terms of long-term administration, there is not enough experience.
Elderly
In elderly or impaired patients, both renal and hepatic function may be considered. It is necessary to administer the minimum effective doses.
Children under 15 years of
age Metamizole should not be given to children under 15 years of age (tablets and age-appropriate dosages) are recommended.
Side effects:
Adverse reactions reported in association with NSAID treatment were edema, hypertension, and heart failure.
Medications such as Algocalmin 500 mg may be associated with a slightly increased risk of heart attack ('myocardial infarction') or stroke.
Anaphylactic and anaphylactoid reactions
Metamizole can rarely cause severe anaphylactic or anaphylactoid reactions. They can appear immediately after oral administration, but also a few hours after administration (usually they appear in the first hour after administration). Anaphylactic reactions are manifested by acute dyspnea, even apnea by bronchospasm and laryngeal edema, hypotension leading to collapse, urticaria, etc. The evolution can be rapidly lethal if the appropriate treatment is not administered in a timely manner: inject adrenaline immediately, preferably slowly intravenously (0.1-0.25 mg adrenaline diluted in 10 ml compatible infusion solution) in 5-15 min; hydrocortisone hemisuccinate 250-500 mg is also introduced intravenously, slowly or by infusion.
Anaphylactoid reactions consist of apnea (bronchial spasm and laryngeal edema) and / or collapse. Asthma attacks In
asthma
patients with NSAIDs, asthma attacks have been observed.
Skin and mucous membranes
Hives, maculopapular eruptions and isolated cases of Lyell's syndrome or Stevens-Johnson syndrome may occur.
Hematological changes
Leukopenia can rarely occur and very rarely agranulocytosis or thrombocytopenia. The main manifestations in case of agranulocytosis are fever, ulcer-necrotic angina and hemorrhages. The hemogram shows the almost total disappearance of the polymorphonuclear cells, and in the bone marrow there is a blockage of maturation in the promyelocytes. The appearance of these manifestations requires the immediate cessation of treatment with metamizole sodium salt monohydrate.
Renal system
Very rarely, acute renal failure or interstitial nephritis may occur, sometimes accompanied by a nephrotic syndrome with proteinuria.
Overdoses:
In case of acute overdose were reported: nausea, abdominal pain, impaired renal function and - rarely - symptoms in the CNS (dizziness, drowsiness, coma, convulsions), low blood pressure to shock and arrhythmias (tachycardia).
After administration of very high doses, the elimination of a non-toxic metabolite (rubazonic acid) may cause the urine to turn red.
If the administration of metamizole is recent, the usual measures to reduce absorption (gastric lavage, respectively administration of activated charcoal) can be tried. The major metabolite (4-N-methylaminoantipyrine) can be removed by hemodialysis, hemofiltration, hemoperfusion or plasma filtration.
Both the treatment of intoxication and the prevention of complications require hospitalization in an intensive care unit.
Storage:
Do not use after the expiry date which is stated on the pack.
Store below 25 ° C in the original package.
Keep out of the reach and sight of children.
Packaging:
Box of 2 PVC / Al blisters of 10 tablets.
One tablet contains metamizole sodium salt monohydrate 500 mg as metamizole sodium salt monohydrate DC 538.80 mg and excipients: sugar, corn starch, magnesium stearate.
Pharmacotherapeutic group:
Analgesics and antipyretics, pyrazolone derivatives.
Therapeutic indications:
Severe acute post-injury or postoperative pain; colic; tumor pain; other severe acute or chronic pain, when other therapeutic means are not indicated.
Fighting fever when it is refractory to another treatment.
Contraindications:
Hypersensitivity to metamizole or to any of the excipients of the product, hypersensitivity to pyrazole derivatives, intolerance to non-steroidal anti-inflammatory drugs (NSAIDs), haematopoietic bone marrow disease, history of agranulocytosis, glucose-6-phosphate dehydrogenase deficiency, subunit 3, hepatic porphyria less than 5 kg (for the active substance).
Severe heart failure.
Precautions:
Metamizole may cause anaphylactic allergies, such as agranulocytosis or shock.
Because agranulocytosis occurs unexpectedly and is independent of the dose and duration of treatment, in the event of fever and / or angina and / or mouth ulcers, immediate discontinuation of treatment and urgent hemogram should be performed. Continued administration increases the risk of death.
In case of long-term treatment, regular medical supervision is required (blood count should be monitored).
Adverse reactions can be minimized by administering the lowest effective dose for the shortest period necessary to control symptoms.
Interactions: The
combination of metamizole with other drugs known as myelotoxics is not recommended.
Pyrazolone derivatives may interact with captopril, lithium, methotrexate and triamterene. Metamizole may alter the efficacy of antihypertensives and diuretics (except furosemide).
Because metamizole may decrease the plasma concentration of cyclosporine, it should be monitored when both drugs are used concomitantly.
Special warnings:
Before starting treatment, a careful history of any allergic conditions is required, as well as a history of allergy to pyrazole derivatives or salicylates.
In patients with an increased risk of anaphylactic shock, the product should be administered only if absolutely necessary, after careful evaluation of the potential risk / therapeutic benefit ratio and under strict medical monitoring.
For the following diseases the risk of anaphylactic shock is higher:
- allergic asthma, allergic rhinitis;
- urticaria;
- intolerance to ethyl alcohol (after ingestion of small amounts appear: sneezing, tearing, pronounced facial hyperemia; intolerance to ethyl alcohol may show the existence of asthma in NSAIDs);
- patients with intolerance to dyes (eg tartrazine) and preservatives (eg benzoate).
In patients with a history of hypertension and/or mild to moderate congestive heart failure, caution (discussion with physician or pharmacist) is required prior to initiating treatment, as reports have shown that NSAID treatment is associated with fluid retention and edema.
Medications such as Algocalmin 500 mg may be associated with a slightly increased risk of heart attack ('myocardial infarction') or stroke. Risks of any kind are more likely at high doses and with long-term treatment. Do not exceed the recommended dose and duration of 3 days for treatment.
If you have a history of heart problems, a stroke, or consider that you may be at risk for these conditions (for example, if you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should discuss treatment with your doctor or pharmacist.
The existing data are insufficient to exclude such a risk in the case of metamizole administered/administered in a daily dose of 0.5-5 g.
Because it contains sugar, if your doctor warns you that you have an intolerance to some categories of carbohydrates, please ask before taking this medicine.
Pregnancy and lactation
Preclinical studies in animals with high doses of metamizole have shown teratogenic effects. In the fetus there is a risk of hematological damage. Metamizole administration around birth may cause premature closure of the arterial canal. Due to the data presented, the administration of metamizole is contraindicated in the first and last trimester of pregnancy; in the second trimester it can be used only if absolutely necessary.
Drug metabolites are excreted in human milk; due to the myelotoxic risk, breast-feeding is discontinued within 48 hours after administration.
Ability to drive or use machines When
administered at the recommended doses, metamizole has no effect on the ability to drive or use machines.
Posology and method of administration:
Adults and children over 15 years of age
500-1000 mg of metamizole sodium salt monohydrate (1-2 tablets of Algocalmin 500 mg) is administered orally once. If necessary, it can be repeated up to 4 times a day. The 24-hour dose should not exceed 5 g metamizole sodium salt monohydrate (approximately 70 mg metamizole sodium salt monohydrate / kg).
Patients with renal or hepatic impairment
Because elimination of metamizole is delayed in patients with renal or hepatic impairment, high doses should not be administered. In case of short-term administration there is no need to reduce the dose. In terms of long-term administration, there is not enough experience.
Elderly
In elderly or impaired patients, both renal and hepatic function may be considered. It is necessary to administer the minimum effective doses.
Children under 15 years of
age Metamizole should not be given to children under 15 years of age (tablets and age-appropriate dosages) are recommended.
Side effects:
Adverse reactions reported in association with NSAID treatment were edema, hypertension, and heart failure.
Medications such as Algocalmin 500 mg may be associated with a slightly increased risk of heart attack ('myocardial infarction') or stroke.
Anaphylactic and anaphylactoid reactions
Metamizole can rarely cause severe anaphylactic or anaphylactoid reactions. They can appear immediately after oral administration, but also a few hours after administration (usually they appear in the first hour after administration). Anaphylactic reactions are manifested by acute dyspnea, even apnea by bronchospasm and laryngeal edema, hypotension leading to collapse, urticaria, etc. The evolution can be rapidly lethal if the appropriate treatment is not administered in a timely manner: inject adrenaline immediately, preferably slowly intravenously (0.1-0.25 mg adrenaline diluted in 10 ml compatible infusion solution) in 5-15 min; hydrocortisone hemisuccinate 250-500 mg is also introduced intravenously, slowly or by infusion.
Anaphylactoid reactions consist of apnea (bronchial spasm and laryngeal edema) and / or collapse. Asthma attacks In
asthma
patients with NSAIDs, asthma attacks have been observed.
Skin and mucous membranes
Hives, maculopapular eruptions and isolated cases of Lyell's syndrome or Stevens-Johnson syndrome may occur.
Hematological changes
Leukopenia can rarely occur and very rarely agranulocytosis or thrombocytopenia. The main manifestations in case of agranulocytosis are fever, ulcer-necrotic angina and hemorrhages. The hemogram shows the almost total disappearance of the polymorphonuclear cells, and in the bone marrow there is a blockage of maturation in the promyelocytes. The appearance of these manifestations requires the immediate cessation of treatment with metamizole sodium salt monohydrate.
Renal system
Very rarely, acute renal failure or interstitial nephritis may occur, sometimes accompanied by a nephrotic syndrome with proteinuria.
Overdoses:
In case of acute overdose were reported: nausea, abdominal pain, impaired renal function and - rarely - symptoms in the CNS (dizziness, drowsiness, coma, convulsions), low blood pressure to shock and arrhythmias (tachycardia).
After administration of very high doses, the elimination of a non-toxic metabolite (rubazonic acid) may cause the urine to turn red.
If the administration of metamizole is recent, the usual measures to reduce absorption (gastric lavage, respectively administration of activated charcoal) can be tried. The major metabolite (4-N-methylaminoantipyrine) can be removed by hemodialysis, hemofiltration, hemoperfusion or plasma filtration.
Both the treatment of intoxication and the prevention of complications require hospitalization in an intensive care unit.
Storage:
Do not use after the expiry date which is stated on the pack.
Store below 25 ° C in the original package.
Keep out of the reach and sight of children.
Packaging:
Box of 2 PVC / Al blisters of 10 tablets.