Spazmil-M

General characteristics. Structure:

Acting substances: Metamizol sodium of 500 mg; Pitofenona hydrochloride of 5,25 mg; Fenpiveriniya bromide of 0,1 mg.

Other ingredients: cellulose microcrystallic, starch wheat, lactose, K 25 povidone, talc, magnesium stearate, Natrii hydrocarbonas, silicon dioxide colloid anhydrous.

Pharmacological properties:

Spazmil-M is the combined drug with the expressed analgeziruyushchy and spasmolytic action. The combination of different medicinal substances promotes strengthening of the pharmacological action which is shown in pain relief, relaxation of unstriated muscles, decrease in the increased body temperature.
Pitofenon and фенпиверин belong to group of synthetic parasympatholytics with the expressed cholinolytic action in low doses. The spasmolytic effect is caused by direct myotropic and M-cholinolytic action on unstriated muscles of internals. Exert the expressed impact on gastroduodenal motility: reduce a tone, amplitude and frequency of the reductions which are under cholinergic control. Reduce a tone of unstriated muscles of a GIT, zhelche-and urinary tract and to a lesser extent — muscles of bronchial tubes. Suppress secretion gastric and sialadens, a pancreas, a stomach (it is preferential in relation to pepsin and mucin and somewhat — hydrochloric acid). Metamizol is an analgetic antipyretic of group of pyrazyl ketone with the expressed analgeziruyushchy activity, weaker antiinflammatory and spasmolytic action. Does not influence a convulsive threshold, breath and an uterine activity does not oppress. Does not result in medicinal dependence. The mechanism of antiinflammatory action is connected with oppression of synthesis of prostaglandins by inhibition of TsOG, stimulation of release of beta endorphines, decrease in level of endogenous pyrogen and influence on a hypothalamus.
Pitofenon and фенпиверин are characterized by an incomplete resorption, at the same time they are completely ionized. Possess a weak liporastvorimost. Do not get through GEB. Anti-secretory activity is shown in 1 h after oral administration of drug and about 3 p last. Are metabolized in a liver by oxidizing reactions, at the same time about 90% are removed with urine and about 10% — with a stake in not changed look. Concentration in a blood plasma decrease in the bi-phase way, and their T½ from a blood plasma is about 10 h. Metamizol is quickly and completely soaked up, in 30 min. after oral administration it is possible to reveal 50% of Cmax in blood serum. Partially contacts blood plasma proteins. In an organism is exposed to intensive biotransformation, and the main metabolites are pharmacological active. After peroral or in/in uses it is hydrolyzed in a GIT and a blood plasma to 4 methylaminoantipyrines (4-MAA) which demetilirutsya to 4 aminoantipyrines (4-AA) and is oxidized to 4 formylaminoantipyrines. 4-AA about 4 acetylaminoantipyrines by means of hepatic N-acetyltransferase are acetylated. Four main metabolites are removed with urine (65–70% of all applied metamizol dose). 10–20% 4-MAA are metabolized with the participation of a hepatic glyukuroniltransferaza. 30% of metamizol are allocated in not changed look.

Indications to use:

Pain syndrome at spasms of unstriated muscles of internals: intestines, stomach, gall bladder; renal colic; dyskinesia of biliary tract; spasms of ureters; bladder tenesmus; альгодисменорея. For reduction of expressiveness of pain at endoscopic and functional researches GITs and an urinogenital path; at posleoperatsiononny pain.

Route of administration and doses:

Drug is accepted inside, washing down with a small amount of liquid after meal.
Adults and children are aged more senior than 15 years: on 1–2 tablets 2–3 times a day, the maximum daily dose makes 6 tablets.
Children at the age of 12 years: on ½ tablets 2–3 times a day, the maximum daily dose — 2 tablets.
Children at the age of 13–15 years: on 1 tablet 2–3 times a day, the maximum daily dose — 3 tablets.
Duration of use of Spazmila-M — no more than 3 days.

Features of use:

Drug with care needs to be used at the following states: renal failure and/or liver, stomach disease (achalasia, gastroesophageal reflux, stenosis of peloric department zhedudka); prostate hyperplasia; tendency to hypotension and orthostatic reactions; chronic bronchitis and bronchospasm, hyper thyroidism; disturbance of a rhythm of cordial activity, an ischemic heart disease (especially at an acute myocardial infarction), chronic congestive heart failure; hypersensitivity to NPVP and/or non-narcotic analgesics or other displays of an allergy (allergic rhinitis, OH).
If Spazmil-M apply longer than the recommended 3-day term (> 1 week), control of a gemogramma and function of a liver is necessary.
Drug can affect a psychophysical condition of patients at a concomitant use with alcohol and medicines, the oppressing TsNS.
Wheat starch therefore drug should not be accepted the patient with a glyutotenovy enteropathy is a part of medicine.
Metabolites of metamizole sodium can cause coloring of urine in red color, however it has no clinical value.
Period of pregnancy and feeding by a breast. It is not recommended to use drug during pregnancy, especially in I and III trimesters, and also during feeding by a breast.
Children. To children aged up to 12 years drug use contraindicated due to the lack of clinical experience.
Ability to influence speed of response at control of vehicles or work with other mechanisms. With caution the drivers and persons working with difficult mechanisms should take drug. At prolonged use of drug its cholinolytic effect can lead to dizziness or disturbance of accommodation.

Side effects:

At administration of drug the following side effects can be noted.
Hypersensitivity reactions: itch, skin rash, urtikariya, small tortoiseshell; seldom — an acute anaphylaxis, a bronchospasm, a Quincke's disease; very seldom — a toxic epidermal necrolysis, Lyell's diseases and Stephens — Johnson.
From a GIT: discomfort, dryness in a mouth, a lock, an exacerbation of gastritis and a round ulcer of a stomach.
From cardiovascular system: decrease in the ABP, tachycardia, disturbance of a cordial rhythm.
From system of blood: leukopenia, agranulocytosis, thrombocytopenia.
From TsNS: dizziness, vision disorder.
From an urinary system: ischuria, development of OPN, intersticial nephrite.

Interaction with other medicines:

It is not necessary to appoint along with other pyrazolon analgetics. The combined use with chloramphenicol, cytostatics and other miyelotoksichny medicines strengthens myelotoxic effect of drug. Danger of hypersensitivity reaction and side reactions at a concomitant use with NPVP amplifies. Allopyrinolum, tranquilizers, neuroleptics, oral contraceptives increase toxicity of Spazmila-M as a result of disturbance of his metabolism in a liver. Spazmil-M it is possible to apply with M-cholinolytics, quinidine and codeine as in this combination he shows a synergism.

Contraindications:

Granulocytopenia; diseases of system of a hemopoiesis; the expressed abnormal liver functions and kidneys; atony bilious or bladder; deficit glyukozo-6-fosfatdegidrogenazy; tachyarrhythmias; acute porphyria; closed-angle glaucoma; benign hyperplasia of a prostate; gastrointestinal impassability; megacolon; kollaptoidny states; period of pregnancy and feeding by a breast; children aged up to 12 years; the increased sensitivity to drug components.

Overdose:

Symptoms: at accidental reception of a large number of tablets nausea, vomiting, decrease in the ABP, confusion of consciousness, an abnormal liver function and kidneys, spasms, a hypothermia with bulbar paresis, breath disturbance, a collapse or a coma are possible. There are an agranulocytosis, aplastic and hemorrhagic anemias, hemorrhagic diathesis less often.
Treatment: gastric lavage, use of absorbent carbon, artificial diuresis, IVL, antishock and symptomatic treatment.

Storage conditions:

In original packaging (in the dry, protected from light place) at a temperature not above 25 °C.

Issue conditions:

According to the recipe

Packaging:

Tab. blister, No. 20.