Analgin 500MG N10 Tablets (Rus)

ANALGIN, 500 mg tablets

ANALGIN composition

Active ingredient: 1 tablet contains 500 mg metamizole sodium.

Indications for use

Severe acute or chronic pain syndromes, pain occurring during injuries and after operations, colic, oncological diseases, and situations where other therapeutic measures for pain relief are contraindicated. High fever that does not respond to other treatment methods.

Contraindications

- Hypersensitivity to metamizole sodium and other pyrazolone derivatives, as well as to pyrazolidines, for example phenylbutazone (including patients who have experienced agranulocytosis as a result of using these medicinal products), or to any other component contained in the product; - analgesic bronchial asthma or intolerance to analgesics (urticaria – angioedema type), i.e., patients suffering from the presence of other forms of bronchospasm or anaphylactoid reactions (e.g., urticaria, rhinitis, angioedema) in response to the use of non-steroidal anti-inflammatory drugs such as salicylates, paracetamol, or diclofenac, ibuprofen, indometacin, or naproxen; − impaired bone marrow function (e.g., after cytostatic treatment) or diseases occurring in the blood-forming organs; − inherited deficiency of the glucose-6-phosphate dehydrogenase enzyme (risk of hemolysis); − acute intermittent hepatic porphyria (risk of developing porphyria attacks); − pregnancy (first and third trimesters) and lactation; − children under 15 years of age.

Use during pregnancy and lactation

Metamizole sodium crosses the placenta barrier. Considering that there is insufficient information about the use of the medicinal product during pregnancy, metamizole sodium must not be used in the first trimester of pregnancy; in the second trimester, the use of metamizole sodium is possible only if the expected benefit to the mother outweighs the potential risk to the fetus. Despite the fact that metamizole sodium weakly inhibits prostaglandin synthesis, it is not possible to exclude the possibility of premature closure of the arterial duct (ductus arteriosus) and also perinatal complications associated with impaired platelet aggregation in the mother or newborn. Therefore, the use of metamizole sodium in the third trimester of pregnancy is contraindicated.

Metamizole sodium metabolites pass into breast milk; therefore, when using the product and also for 48 hours after taking the last dose, breastfeeding must be discontinued.

Effect on the ability to drive vehicles and operate other potentially dangerous machinery

The effect of the medicinal product on attention concentration and the speed of psychomotor reactions within the recommended dosage range has not been established. When using higher doses of the product, it is recommended to take precautions when driving a vehicle and when engaging in potentially dangerous activities that require high concentration of attention and rapid psychomotor reactions.

How to use ANALGIN and dosage

The dosage depends on the intensity of pain or fever, as well as on individual sensitivity to the effects of analgesics. Tablets should be taken whole with a sufficient amount of liquid. Initially, the lowest effective dose should be used. The maximum effect of the medicinal product develops, as a rule, 30–60 minutes after oral administration.

For adults and adolescents over 15 years of age (body weight > 53 kg), the single dose is 500–1000 mg (1–2 tablets). If sufficient effect is not achieved, the single dose may be used up to 4 times per day. The maximum daily dose is 4000 mg (8 tablets). The product must not be used as an analgesic for more than 5 days or as an antipyretic for more than 3 days.

In elderly patients: taking into account the reduced excretion of metamizole sodium metabolites, a dose reduction is required. Severe general condition and impaired creatinine clearance: in patients with severe general condition and when creatinine clearance is impaired, the dose should be reduced, taking into account the reduced excretion of metamizole sodium metabolites. Renal or hepatic impairment: in patients suffering from impaired renal or hepatic function, repeated use of high doses should be avoided, taking into account the reduced excretion rate of the medicinal product. No dose reduction is required when used for a short period.

There is no information regarding long-term use experience.