Spasmalgon tablets 50 pcs

Pharmacological properties

Pharmacodynamics. Spasmalgon is a combined drug with analgesic, antispasmodic (papaverine-like), cholinolytic (atropine-like) and some anti-inflammatory effects.

Metamizole sodium has a pronounced analgesic and antipyretic effect in combination with less pronounced anti-inflammatory and antispasmodic activity. Its effects are a consequence of inhibiting the synthesis of prostaglandins and endogenous allogens, raising the threshold of excitability in the thalamus and conducting external pain and interoceptive impulses in the CNS; it also affects the hypothalamus and the formation of endogenous pyrogens.

Fenpiverinium exhibits a greater ganglioblocking and parasympathetic effect, reduces the tone and motility of the smooth muscles of the stomach, intestines, biliary and urinary tracts.

Pitofenone has a papaverine-like effect on the smooth muscles of blood vessels and internal organs with a pronounced antispasmodic effect.

Pharmacokinetics. Metamizole is characterized by rapid and complete resorption. 30 minutes after administration, the amount of the drug increases in the middle of the blood plasma, which is 50% of C max. It partially binds to blood proteins. It undergoes intense biotransformation in the human body. At the same time, its main metabolites are pharmacologically active. Eliminates with urine in the form of metabolites. Only 3% of the excreted content is unchanged metamizol. The degree of biotransformation is affected by the genetically determined type of acetylation. There is very little data in the available medical literature about the processes of resorption and distribution of pitophenone and fenpiverine. It is known that resorption occurs in the upper parts of the gastrointestinal tract and is incomplete. Chemical compounds subjected to significant ionization have weak liporosolubility, which reduces the weak level of penetration through the blood-brain barrier. The profile of their concentration in the blood plasma is biphasic in nature.

Pitofenone and fenpiverine are metabolized in the liver, mainly by oxidation, while about 90% of substances in the form of metabolites are excreted with urine and about 10% – with feces in the form of an unchanged compound. There are data that their T ½ from blood plasma is 10 years. Some components are excreted in breast milk.

Indication

Symptomatic treatment for weak and more pronounced pain syndrome with spasms of smooth muscles of internal organs:

kidney disease and inflammatory diseases of the urinary tract, which are accompanied by pain and dysuric disorders;
spasms of the stomach and intestines, morbid quantity, dyskinesia of the biliary tract;
spastic dysmenorrhea.

Application

Spasmalgon tablets are taken in the middle after a meal, washed down with water. the recommended daily dose for adults and children aged 15 and over is 1-2 tablets, the maximum daily dose is 2 tablets.

Duration of use of Spazmalgon – no more than 3 days.

Children. Spazmalgon is not prescribed for children under 15 years of age.

Contraindication

Hypersensitivity to metamizole, pyrazolone derivatives and/or any component of the medicinal product; gastrointestinal obstruction and megacolon; atony of the gallbladder or bladder; severe kidney function disorders and diseases; change in the composition of peripheral blood (agranulocytosis, leukopenia); blood diseases (anemia of any etiology, cytostatic or infectious neutropenia); deficiency of glucose-6-phosphate dehydrogenase; porphyria of the liver; closed-angle glaucoma; suspicion of acute surgical pathology; ba; colaptoid state; tachyarrhythmia; hypertrophy of the prostate gland with a tendency to retention of urine; which or breastfeeding.

Side effects

Adverse reactions when using Spasmalgon are most often temporary and disappear after stopping treatment.

From the side of the immune system: urticaria, skin rashes, itching, conjunctivitis; bad – bronchospasm, angioneurotic inflammation, anaphylactic shock, toxic epidermal necrolysis and Stevens-Johnson syndrome.

From the side of the digestive system: discomfort, dry mouth, constipation, exacerbation of gastritis, stomach and duodenal ulcers.

From the side of the cardiovascular system: increased heartbeat, decrease in blood pressure, tachycardia, heart rhythm disorders.

From the side of the nervous system: dizziness, visual disturbances.

From the hematopoietic system: granulocytopenia, anemia, agranulocytosis, thrombocytopenia, leukopenia.

On the part of the urinary system: oliguria, anuria, proteinuria, red color of urine, development of acute renal failure and interstitial nephritis.

With long-term repetition in high doses, a decrease in kidney function is possible (especially in people with a history of kidney disease), in some cases – papillary necrosis.

Others: hepatitis, decreased sweating.

Special instructions

The drug is used with caution in:

• impaired kidney and/or liver function;
• diseases of the stomach (achalasia, gastroesophageal reflux, stenosis of the pyloric part of the stomach);
• tendency to hypotension and orthostatic reactions;
• chronic bronchitis and bronchospasm (the drug increases the viscosity of bronchial secretion);
  presence of hyperthyroidism;
• heart rhythm disorders, ischemic heart disease (especially with acute myocardial infarction), chronic congestive heart failure;
• the presence of data on hypersensitivity to non-steroidal anti-inflammatory drugs and / or non-narcotic analgesics or other manifestations of allergy (allergic rhinitis).

With long-term use of Spazmalgon, it is necessary to check the condition of peripheral blood and liver function.

The appearance or increase in severity of an existing headache is possible after long-term analgesic treatment (3 months) with the use of analgesics every other day or more often.

Headache caused by excessive use of analgesics should not be treated by increasing their dose. In such cases, analgesic treatment should be stopped after consulting a doctor.

The drug can affect the psychophysical condition of patients when used simultaneously with alcohol and drugs that depress the central nervous system.

It is not recommended to use other medicinal products, which include metamizole, at the same time as Spasmalgon.

Due to the content of wheat starch in the medicinal product, it should not be used by patients with gluten enteropathy.

Due to the lactose content, this drug should not be used in patients with rare congenital forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.

Metamizole sodium metabolites can change the color of urine to red, which has no clinical significance.

Use during pregnancy and breastfeeding. Do not apply.

The ability to influence the speed of reaction when driving a motor vehicle or working with other mechanisms. When using Spazmalgon, you should be careful when driving a vehicle or working with other mechanisms, because due to the presence of a cholinolytic effect, long-term use of Spazmalgon can lead to dizziness and impaired accommodation.

Interactions

Metamizole increases the concentration in the blood plasma of chloroquine, reduces the concentration in the blood plasma and reduces the severity of the effects of coumarin anticoagulants and cyclosporine. increases the hematotoxic effect of myelotoxic drugs, chloramphenicol. antipsychotics, sedatives and tranquilizers enhance the analgesic effect of metamizole. Tempidone and tricyclic antidepressants, contraceptives, allopurinol disrupt the metabolism of metamizole and increase its toxicity. barbiturates, phenylbutazone and other inducers of microsomal liver enzymes can reduce the effect of metamizol. simultaneous use of the drug with other analgesics and NSAIDs increases the risk of developing toxic effects. metamizole reduces the concentration of cyclosporin and in the blood plasma, its simultaneous use can be risky in the case of existing tissue transplantation. combining spasmalgon and other drugs requires special care due to the content of metamizole, which is an enzyme inducer.

Overdose

Symptoms: in case of an overdose, the symptoms of metamizole intoxication prevail in combination with cholinolytic effects; dysfunction of the liver, kidneys, paralysis of the respiratory tract. toxic-allergic syndrome, symptoms of damage to hematopoietic functions, gastrointestinal disorders, in severe cases – symptoms of brain damage are most often observed.

Treatment. If an overdose is suspected, it is necessary to immediately stop using the drug and take measures to quickly remove it from the body (induce vomiting, wash the stomach, increase urine output). Symptomatic drugs are used. There is no specific antidote.

Storage conditions

In a dry place protected from light at a temperature not higher than 25 °C.

Information about the drug for healthcare professionals.