Spasmalgon DUO 20 tablets — Made in Bulgaria — Free Delivery

Pharmacological properties

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

Metamizole sodium has a pronounced analgesic and antipyretic effect in combination with a less pronounced anti-inflammatory and antispasmodic activity. Its effects are a consequence of inhibition of the synthesis of prostaglandins and endogenous allogens, an increase in the threshold of excitability in the thalamus and the conduction of painful extero- and interoceptive impulses in the central nervous system; it also affects the hypothalamus and the formation of endogenous pyrogens.

Fenpiverinium has a moderate ganglion-blocking and parasympathetic effect, reduces the tone and motility of smooth muscles of the stomach, intestines, biliary and urinary tract.

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

Pharmacokinetics. Rapid and complete resorption is characteristic of metamizole. 30 minutes after ingestion, the amount of the preparation is determined in the blood plasma, which is 50% Cmax. Partially binds to blood proteins. In the human body, it undergoes intensive biotransformation. Moreover, its main metabolites are pharmacologically active. Eliminated in the urine as metabolites. Only 3% of the amount that is released is unchanged metamizole. The degree of biotransformation is also influenced by the genetically determined type of acetylation. There are very few data in the available medical literature on the processes of resorption and distribution of pitofenone and fenpiverinium. It is known that resorption occurs in the upper gastrointestinal tract and is incomplete. Chemical compounds undergo significant ionization and have a weak liposolubility, which determines a weak level of penetration through the BBB. The profile of their concentration in blood plasma is biphasic.

Pitofenone and fenpiverinium are metabolized in the liver, mainly by oxidation, while about 90% of the substance in the form of metabolites is excreted in the urine and about 10% in the feces as an unchanged compound. There is evidence that their T½ from blood plasma is 10 hours. Individual components are excreted in breast milk.

Indications

Symptomatic treatment for mild and moderate pain syndrome with spasms of smooth muscles of internal organs:

• renal colic and inflammatory diseases of the urinary tract, occurring with pain and dysuric disorders;
• cramps of the stomach and intestines, hepatic colic, biliary dyskinesia;
• spastic dysmenorrhea.

Application

Spasmalgon tablets are taken orally after meals with water. the recommended daily dose for adults and children over the age of 15 is 1-2 tablets, the maximum daily dose is 2 tablets.

The duration of Spasmalgon`s use is no more than 3 days.

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

Contraindications

Hypersensitivity to metamizole, pyrazolone derivatives and / or any component of the preparation substance; gastrointestinal obstruction and megacolon; atony of the gall or bladder; severe impairment of kidney and liver function; changes in the composition of peripheral blood (agranulocytosis, leukopenia); blood diseases (anemia of any etiology, cytostatic or infectious neutropenia); deficiency of glucose-6-phosphate dehydrogenase; liver porphyria; angle-closure glaucoma; suspicion of acute surgical pathology; ba; collaptoid states; tachyarrhythmia; hypertrophy of the prostate with a tendency to urinary retention; the period of pregnancy or lactation.

Side effects

Adverse reactions when using the preparation spasmalgon are most often temporary and disappear after stopping treatment.

From the immune system: urticaria, skin rashes, itching, conjunctivitis; rarely - bronchospasm, angioedema, anaphylactic shock, toxic epidermal necrolysis and Stevens-Johnson syndrome.

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

From the side of the cardiovascular system: palpitation, lowering blood pressure, tachycardia, cardiac arrhythmias.

From the nervous system: dizziness, blurred vision.

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

From the urinary system: oliguria, anuria, proteinuria, urine staining red, development of acute renal failure and interstitial nephritis.

With prolonged use in high doses, a decrease in renal function is possible (especially in people with a history of kidney disease), in some cases, papillary necrosis.

Others: hepatitis, decreased sweating.

Special instructions

The preparation is used with caution when:

• impaired renal and / or liver function;
• diseases of the stomach (achalasia, gastroesophageal reflux, stenosis of the pyloric stomach);
• tendency to arterial hypotension and orthostatic reactions;
• chronic bronchitis and bronchospasm (the preparation increases the viscosity of bronchial secretions);
• the presence of hyperthyroidism;
• cardiac arrhythmias, ischemic heart disease (especially in acute myocardial infarction), chronic congestive heart failure;
• availability of data on hypersensitivity to NSAIDs and / or non-narcotic analgesics or other manifestations of allergy (allergic rhinitis).

With prolonged use of Spasmalgon, it is necessary to check the state of the peripheral blood and liver function.

Perhaps the appearance or increase in the severity of the existing headache after prolonged analgesic treatment (3 months) with the use of analgesics every other day or more.

Headache caused by overuse of analgesics should not be controlled by increasing the dose. In such cases, analgesic treatment should be discontinued after consulting a doctor.

The preparation can affect the psychophysical state of patients when used simultaneously with alcohol and preparations that suppress the central nervous system.

It is not recommended to use other preparations, which include metamizole, simultaneously with Spasmalgon.

Given the content of wheat starch in the composition of the preparation, patients with gluten enteropathy should not use it.

Given the lactose content, this preparation 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 lactation. Do not use.

The ability to influence the reaction rate when driving or working with other mechanisms. During the use of the preparation Spasmalgon, care should be taken when driving vehicles or working with other mechanisms, since due to the presence of an anticholinergic effect, prolonged use of Spasmalgon can lead to dizziness and impaired accommodation.

Interactions

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

Overdose

Symptoms: in case of an overdose, symptoms of metamizole intoxication prevail in combination with anticholinergic effects; dysfunction of the liver, kidneys, paralysis of the respiratory tract. most often there is a toxic-allergic syndrome, symptoms of damage to the functions of hematopoiesis, gastrointestinal disorders, in severe cases - symptoms of brain damage.

Treatment. If an overdose is suspected, it is necessary to immediately stop using the preparation and take measures for its rapid elimination from the body (induce vomiting, make gastric lavage, increase urine output). Symptomatic remedies are used. There is no specific antidote.

Storage conditions

In a dry, dark place at a temperature not exceeding 25 ° C.