Structure

Active ingredients: metamizole sodium monohydrate, pitofenona hydrochloride, fenpiveriniya bromide.

1 tablet contains metamizole sodium of monohydrate 500 mg, a pitofenona of a hydrochloride of 5.25 mg, a fenpiveriniya of bromide of 0.1 mg;

Excipients: microcrystalline cellulose, starch wheat, lactoses monohydrate, K-25 povidone, talc, magnesium stearate, Natrii hydrocarbonas, silicon dioxide colloidal waterless.

Dosage form

Tablet.

Main physical and chemical properties: round flat tablets with a facet and dividing risky, with a diameter of 13 mm, from white till almost white color, flavourless.

Pharmacotherapeutic group

Antispasmodics in a combination from analgetika. Synthetic anticholinergics in a combination from analgetika. Pitofenon and analgetik.

ATX A03D A02 Code.

Pharmacological properties

Pharmacodynamics.

"Spazmil-M of ^® " combines analgesic, spasmolytic (papaverinopodobny), cholinolytic (atropinopodobny) and some anti-inflammatory activity.

Metamizol has the expressed analgesic and febrifugal effect in combination with less expressed anti-inflammatory and spasmolytic activity. Its effects are result of oppression of synthesis of prostaglandins and endogenous algogen, increases in an excitation threshold in a thalamus and carrying out painful ekstero- and interoceptive impulses in the central nervous system, also metamizol influences a hypothalamus and formation of endogenous pyrogens.

Fenpiveriny has moderate ganglioblokiruyushchy and cholinolytic effect, reduces a tone and motility of smooth muscles of a stomach, intestines, biliary and urinary tract.

Pitofenon has papaverinopodobny effect on vascular and extravasated smooth muscles with the expressed spasmolytic character.

Pharmacokinetics.

fast and full resorption is characteristic

metamizol. In 30 minutes after intake in blood serum quantities which are 5% of the maximum serumal concentration are found. Partially contacts proteins of blood plasma. In an organism is exposed to intensive biotransformation. At the same time its main metabolites pharmacological are active. It Eliminirutsya with urine in the form of metabolites. Only 3% of quantity which is distinguished are represented by not changed metamizol. Degree of biotransformation is influenced also by genetically caused acetylation type. Separate components get into breast milk.

Symptomatic treatment is weak

Indication

also a moderate pain syndrome at spasms of unstriated muscles of internals:

• renal colic and inflammatory diseases of urinary tract which proceed with pain and dizuriyny disorders;
• spasms of a stomach and intestines, hepatic colic, dyskinesia of biliary tract;
• primary and secondary dysmenorrhea.

Contraindication

Hypersensitivity to metamizol, to pyrazyl ketone derivatives (including at patients at whom the Agranulocytosis after the previous use of such substances developed) or to other non-steroidal anti-inflammatory medicaments (NPVS) and/or to any component of medicine.

Dysfunction of marrow (for example, after treatment by cytostatics) or diseases of a hemopoietic system (Agranulocytosis, a leukopenia, aplastic anemia).

Disease of blood (anemia of various etiology, cytostatic or infectious neutropenia).

Heavy abnormal liver functions.

Heavy renal failures.

Atony bilious or bladder.

Deficit glyukozo-6-fosfatdegidrogenazy.

Tachyarrhythmia.

Sharp porphyria of a liver.

Closed-angle glaucoma.

Benign hyperplasia and a prostatauxe with a tendency to an ischuria.

Gastrointestinal impassability and megacolon.

Hypotonic states (including kollaptoidny states) and hemodynamic instability.

Suspicion of sharp surgical pathology.

Bronchial asthma.

Interaction with other medicines and other types of interactions

Combination "Spazmil-M of ^® " with other medicines requires special attention because of the content of metamizol which is the inductor of enzymes.

should not appoint

along with drugimipirazolonovy analgetika. Combined use skhloramfenikoly, tsitostatikamiya drugimimiyelotoksichesky preparatamiusilivat myelotoxic action. Metamizol raises plasma a koncentratsiikhlorokhin, reduces plasma concentration and effektykumarinovy an antikoagulyantovitsiklosporina. The danger of hypersensitivity reaction and undesirable reactions at concomitant use SNPVS amplifies.

Metamizol strengthens sedative a deystviyeetanol, simultaneous application by skhlorpromazinomilidrugy derivatives fenotiazina-can lead to development of the expressed hypothermia. It is not necessary to apply srentgenokontrastny substances, colloidal krovezamenitelyamiipenitsilliny. Metamizol increases aktivnostperoralny hypoglycemic medicines, sulfanamide medicines, indirect anticoagulants, glucocorticosteroids, Phenytoinum, ibuprofenaiindometatsinaputy their replacement from communication with protein. The sarcolysine, mercazolil (Thiamazolum), medicines suppressing activity of marrow including medicines zolotauvelichivat gematotoksichnost probability, including development of a leukopenia.

Allopyrinolum, tranquilizers, tempidon, tricyclic antidepressants, neuroleptics, peroral kontratseptivypovyshat toxicity "Spazmil-M of ^® " as a result of violation of his metabolism in a liver. Neuroleptics, sedative preparatyitrankvilizatoryusilivat the anesthetizing effect of metamizol. Barbiturates, phenylbutazone, glyutetimididrugy inductors of microsomal enzymes pechenimonut to reduce effect of metamizol. Metamizol reduces plasma a koncentratsiitsiklosporin And, and its simultaneous application can be risky in case of transplantation of fabrics. "Spazmil-M of ^® " can combine cm cholinolytics, hinidinomikodeiny as with them he shows synergism.

About a class proizvodnykhpirazolonaizvestno that they can interact skaptoprily, lithium, metotreksatomitriamtereny and also to change effektivnostyantigipertenzivny preparatovidiuretik. As far as these properties are significant at metamizol, it is unknown.

Feature of application

Before an initiation of treatment medicine should consult to the doctor. It is not necessary to use medicament longer than an established period without consultation with the doctor.

should not exceed the recommended medicine doses.

not to use medicine for removal of an acute pain in a stomach (before clarification of the reason).

should use Drug with care at a renal failure and/or a liver of moderate severity, at stomach diseases (achalasia, a gastroesophageal reflux, a stenosis of peloric department of a stomach), inflammatory bowel diseases (including nonspecific ulcer colitis and Crohn's disease), at tendency to arterial hypotension and orthostatic reactions, at chronic bronchitis and a bronchospasm, in the presence of a hyper thyroidism, at violations of a rhythm of warm activity (at a tachyarrhythmia – see. the section "Contraindications"), coronary heart disease (especially at a sharp myocardial infarction), chronic stagnant heart failure, at hypersensitivity to non-narcotic analgetika or at other manifestations of an allergy (allergic rhinitis), at simultaneous use of cytostatic medicines (only under control of the doctor), to patients of advanced age (can lead to increase in frequency of side reactions, especially from digestive system).

At use of medicine "Spazmil-M of ^® " longer than the recommended 3-day term needs to check and control a condition of peripheral blood (leukocytic formula) and function of a liver.

"Spazmil-M of ^® " contains medicinal substance metamizol. Metamizol can cause the Agranulocytosis and thrombocytopenia. Development of an agranulocytosis does not depend on a dose and it cannot be provided, it can come after the first reception or after repeated application. Typical symptoms of an agranulocytosis are fever, a sore throat, painful swallowing, inflammation of a mucous membrane of a mouth, nose, throat, anorectal and genital zones. At sudden deterioration in the general state and emergence of symptoms of an agranulocytosis the treatment by metamizol should be stopped and made the general blood test.

As metamizol possesses

anti-inflammatory and the anesthetizing properties, it can mask symptoms of an infection, symptoms of non-communicable diseases and complications with a pain syndrome which can complicate their diagnostics.

does not recommend to apply

"Spazmil-M of ^® " along with other medicines containing metamizole sodium.

Drug can affect a psychophysical condition of patients at a concomitant use with the alcohol and medicines oppressing the central nervous system.

Starch wheat as a part of a tablet may contain only traces of gluten and it is considered safe for persons with a Gee's disease (gluten enteropathy). Patients with an allergy to wheat (not Gee's disease) should not accept this medicine.

lactose is a part of medicine. Patients with rare hereditary forms of intolerance of a galactose, deficiency of Lappa lactases or malabsorption of glucose galactose cannot accept this medicine.

It is medicine contains 34 mg of sodium on a dose. It should be considered if the patient adheres to a diet with control of amount of sodium.

Metabolites of metamizole sodium can change

color of urine to red that has no clinical value.

If symptoms of a disease do not begin to disappear or, on the contrary, the state of health will worsen, or there will be undesirable phenomena, it is necessary to suspend use of medicine and to see behind consultation a doctor of rather further application.

Use during pregnancy or feeding by a breast

Use during pregnancy or feeding by a breast contraindicated.

Ability to influence speed of response at control of motor transport or other mechanisms.

With care to take the medicament to the drivers and persons working with difficult mechanisms. At prolonged use of medicine its cholinolytic effect can lead to dizziness or disturbance of accommodation.

Route of administration and doses

to take the Drug inside, washing down with a small amount of liquid after meal.

Adults and children are more senior than 15 years.

For adults and children 15 years are more senior than

– on 1-2 tablet a day. The maximum daily dose – 2 tablets.

Patients are more senior than 65 years.

Usually dose adjustment is not required to

. For patients with age abnormal liver functions and kidneys it is necessary to reduce a dose as increase in time of semi-removal of metabolites of metamizol is possible.

Patients with a renal failure.

Metamizol is removed by

with urine in the form of metabolites. For patients with a slight or moderate renal failure it is recommended to apply ½ doses to adults.

Patients with an abnormal liver function.

At such patients the elimination half-life of active metabolites of metamizol can be more long. It is necessary to avoid application of high doses to patients with an abnormal liver function. At short-term application there is no need of reduction of a dose. There is no sufficient experience of more long application for patients with a renal failure or a liver.

Duration of application "Spazmil-M of ^® " – no more than 3 days.

Children.

to Children aged up to 15 years the use of medicine is contraindicated to

.

by

Overdose

At accidental reception of a large number of tablets the nausea, vomiting, a lowering of arterial pressure, confusion of consciousness, an abnormal liver function and kidneys, a toksiko-allergic syndrome, spasms, a hypothermia with bulbar paresis, breath violation, paralysis of airways, collapse or a coma can be observed. There are an Agranulocytosis, aplastic and hemorrhagic anemias, hemorrhagic diathesis less often.

Treatment: gastric lavage, use of activated carbon, the accelerated diuresis, artificial ventilation of the lungs, antishock and symptomatic treatment. There is no specific antidote.

Side reactions

Listed below side reactions are caused generally by metamizol which is a part of medicine.

from the immune system: the fixed medicinal dieback, makulopapulezny rash, anaphylactic or anaphylactoid reactions, an asthmatic attack (at patients with analgetichesky asthma), Stephens-Johnson or Layell's syndrome, circulator shock.

easier reactions are shown by typical reactions from skin and a mucous membrane (for example, an itch, burning, reddening, urticaria, hypostases), dispnoe, there can seldom be complaints from digestive tract. Such easier reactions can pass into more severe forms with generalized urticaria, a heavy Quincke's disease (including laryngeal), a heavy bronchospasm, violations of a warm rhythm, lowering of arterial pressure (sometimes with the previous increase in arterial blood pressure).

from digestive tract: dryness in a mouth, nausea, vomiting, an abdominal pain and discomfort, a lock, exacerbation of gastritis and peptic ulcer of a stomach, in rare instances ultseration and bleeding, hepatitis.

from heart: palpitation, tachycardia, cyanosis.

from vessels: arterial hypotension.

from blood and lymphatic system: a leukopenia, the Agranulocytosis, thrombocytopenia, anemia, including hemolytic and aplastic, a granulocytopenia.

Risk of appearance of an agranulocytosis cannot be expected. The agranulocytosis can develop also at patients who applied metamizol in the past without emergence of side reactions.

from nervous system: dizziness.

from organs of sight: disorders of vision, accommodation violation.

from an urinary system: a proteinuria, an oliguria, an anury, a polyuria, interstitial nephrite, coloring of urine in red color, an ischuria, a sharp renal failure.

Others: sweating reduction.

in case of any side reactions use of medicine should stop and see immediately a doctor behind consultation.

Expiration date

3 years.

Storage conditions

to Store

out of children's reach. To store in original packing (in the dry, protected from light place) at a temperature not above 25 °C.

Packing

On 10 tablets in the blister from film PVC / aluminum foil. 2 blisters in a cardboard pack.

Category of a holiday

Without recipe.