Spazmalgon tablets, No. 20

Weak or moderate pain syndrome with spasms of smooth muscles of internal organs - renal and hepatic colic, spastic pain along the intestines, algodismenorrhea.

It can be used for short-term symptomatic treatment for joint pain, neuralgia, sciatica, myalgia. As an adjuvant, it can be used to relieve pain after surgical and diagnostic interventions.

If necessary, the drug can be used to reduce elevated body temperature in case of colds and infectious and inflammatory diseases.

Adults and children over 15 years of age are taken orally (preferably after meals), usually 1-2 tablets 2-3 times a day. The daily dose should not exceed 6 tablets.

Duration of admission is no more than 5 days.

An increase in the daily dose of the drug or the duration of treatment is possible only on the recommendation and under the supervision of a physician.
Doses for children.

In children, the drug is used only as directed by a doctor.

Dose for children 6-11 years old - half a tablet, 12-14 years old - one tablet 2-3 times a day. Other dosing regimens are possible only after consulting a doctor.

Active ingredients: metamizole sodium - 500 mg, pitofenone hydrochloride - 5.0 mg, fenpiverinium bromide - 0.1 mg;
excipients: lactose monohydrate 10 mg, wheat starch 85.9 mg, talc (magnesium hydrosilicate) 6 mg, magnesium stearate 4 mg, gelatin 4 mg, sodium bicarbonate 5 mg.

• Hypersensitivity to pyrazolone derivatives (butadione, tribuzone), to other components of the drug.

• Suppression of bone marrow hematopoiesis,

• stable and unstable angina pectoris,

• chronic heart failure in the stage of decompensation,

• severe liver or kidney dysfunction,

• deficiency of glucose-6-phosphate dehydrogenase,

• tachyarrhythmias,

• angle-closure glaucoma,

• hyperplasia of the prostate with a tendency to urinary retention,

• intestinal obstruction and megalocon,

• granulocytopenia,

• pregnancy, lactation period,

• children under 6 years of age.

  With caution and under the supervision of a physician, the drug should be used in patients with mild and moderate severity of liver or kidney dysfunction, with a tendency to arterial hypotension (systolic pressure below 100 mm Hg), bronchospasm, as well as with increased individual sensitivity to non-steroidal anti-inflammatory drugs or non-narcotic analgesics.

Pharmacotherapeutic group:

Analgesic (non-narcotic analgesic + antispasmodic)

Pharmacological properties
The composition of the drug includes: non-narcotic analgesic metamizole sodium, myotropic antispasmodic agent pitofenone and m-anticholinergic agent fenpiverinium bromide.

Metamizole sodium is a pyrazolone derivative. It has analgesic, antipyretic and anti-inflammatory effects. Pitofenone, like papaverine, has a direct myotropic effect on the smooth muscles of the internal organs and causes its relaxation. Fenpiverinium bromide, due to its m-anticholinergic action, has an additional relaxing effect on smooth muscles.

The combination of the three components of the drug leads to pain relief, relaxation of smooth muscles, and a decrease in fever.

Use during pregnancy and during breastfeeding
Use during pregnancy and lactation is contraindicated.

Side effect
From the digestive system: burning sensation in the epigastric region, dry mouth.
From the nervous system: headache, dizziness, anticholinergic effects (decreased sweating, accommodation paresis, difficulty urinating).
From the side of the cardiovascular system: lowering blood pressure, tachycardia, cyanosis.
From the urinary system: impaired renal function, oliguria, anuria, proteinuria, interstitial nephritis, urine staining red.
From the side of hematopoiesis: with prolonged use - thrombocytopenia, leukopenia, agranulocytosis.
Allergic reactions: urticaria, bronchospastic syndrome, anaphylactic shock, Quincke's edema, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

Overdose
In case of an overdose of the drug, the following symptoms can be observed: vomiting, a feeling of dry mouth, decreased sweating, impaired accommodation, decreased blood pressure, drowsiness, confusion, impaired liver and kidney function, convulsions.
Treatment - gastric lavage, the appointment of activated carbon, symptomatic therapy.

Interaction with other medicinal products The
simultaneous use of Spazmalgon with other non-narcotic analgesics can lead to mutual enhancement of toxic effects. Sedatives and tranquilizers enhance the analgesic effect of metamizole sodium.

Tricyclic antidepressants, oral contraceptives, allopurinol disrupt the metabolism of metamizole sodium in the liver and increase its toxicity.

Barbiturates, phenylbutazone and other inducers of liver microsomal enzymes weaken the effect of sodium metamizole.

Radiopaque drugs, colloidal blood substitutes and penicillin should not be used during treatment with drugs containing metamizole sodium. Simultaneous use with cyclosporine reduces the concentration of the latter in the blood. Metamizole sodium, displacing oral hypoglycemic drugs, indirect anticoagulants, glucocorticoids and indomethacin from the connection with plasma proteins, can increase the severity of their action.

When used together with H1-histamine receptor blockers, butyrophenones, phenothiazines, tricyclic antidepressants, amantadine and quinidine, the m-anticholinergic action may be enhanced. Enhances the effects of ethanol.

Simultaneous use with chlorpromazine or other phenothiazine derivatives can lead to the development of severe hyperthermia. Thiamazole and cytostatics increase the risk of developing leukopenia.

The effect is enhanced by codeine, blockers of H1-histamine receptors and propranolol (slows down the inactivation of sodium metamizole).

If necessary, the simultaneous use of the above and other drugs, you should consult your doctor.

Special instructions
When using the drug, it is necessary to control the picture of peripheral blood (leukocyte count) and the functional state of the liver. If agranulocytosis is suspected or if thrombocytopenia is present, the drug should be discontinued.

During the period of drug treatment, alcohol should not be taken.

During treatment, it is not recommended to drive vehicles and engage in potentially hazardous activities that require quick physical and mental reactions.

The use of the drug in nursing mothers requires the termination of breastfeeding.