Structure

Active ingredients: metamizol sodium salt (analginum), pitofenona hydrochloride, fenpiveriniya bromide;

1 tablet contains

: metamizol sodium salt (analginum) — 500 mg, a pitofenona a hydrochloride — 5.0 mg, a fenpiveriniya bromide — 0.1 mg;

excipients: potato starch, calcium stearate.

Dosage form

Tablet.

Main physical and chemical properties: tablets of color, white or white with a yellowish shade, with a flat surface, risky and a facet.

Pharmacotherapeutic group

Antispasmodics in a combination with analgetics. synthetic anticholinergics in a combination with analgetics. pitofenon and analgetics. code atkh a03d a02.

Pharmacological properties

Pharmacodynamics.

Reonalgon ^® combines analgetic, spasmolytic (papaverinopodobny), cholinolytic (atropinopodobny) and some anti-inflammatory activity.

Metamizol has the expressed analgetic and febrifugal effect in a combination with less accurate 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 (CNS), also it influences a hypothalamus and formation of endogenous pyrogens.

Fenpiveriny has moderate ganglioblokiruyushchy and parasympathetic effect, reduces a tone and motility of smooth muscles of a stomach, intestines, bilious 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 min. after internal use in serum the quantities which are 5% of the maximum serumal concentration are found. Partially contacts proteins of plasma. In an organism gives in 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 represent not changed metamizol. Degree of biotransformation is influenced also by genetically caused acetylation type. Separate components are removed with 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 proceeding with pain and dysuric disorders;
• spasms of a stomach and intestines, hepatic colic, dyskinesia of bilious ways;
• spastic dysmenorrhea.

Contraindication

Hypersensitivity to metamizol, to pyrazyl ketone derivatives, to other non-steroidal anti-inflammatory medicaments (npvs), to any component of medicine. gastrointestinal impassability and megacolon; atony bilious or bladder; heavy renal failures and liver; change of composition of peripheral blood (Agranulocytosis, leukopenia, aplastic anemia); blood diseases (anemia of any etiology, cytostatic or infectious neutropenia); deficiency glyukozo-6-fosfatdegidrogenazy; liver porphyria; closed-angle glaucoma; suspicion of sharp surgical pathology; bronchial asthma; hypotonic states (including kollaptoidny states) and hemodynamic instability; tachyarrhythmia; a prostatauxe with a tendency to an ischuria.

Interaction with other medicines and other types of interactions

Metamizol increases plasma concentration of chloroquine, reduces plasma concentration and effects of coumarinic anticoagulants and cyclosporine.

is Raised by gematotoksichesky effect of myelotoxic medicines, chloramphenicol.

danger of hypersensitivity reaction and undesirable reactions at simultaneous application with NPVS Amplifies.

Metamizol strengthens sedative effect of ethanol, simultaneous application with Chlorpromazinum or other derivatives of a fenotiazin can lead to development of the expressed hypothermia. It is not necessary to apply with X-ray contrast substances, colloidal blood substitutes and penicillin. Metamizol increases activity of oral hypoglycemic medicines, sulfanamide medicines, indirect anticoagulants, glucocorticosteroids, Phenytoinum, an ibuprofen and indometacin by their replacement from communication with protein. The sarcolysine, mercazolil (Thiamazolum), medicines suppressing activity of marrow including gold medicines, increase gematotoksichnost probability, including development of a leukopenia.

Neuroleptics, sedative medicines and tranquilizers strengthen the anesthetizing effect of metamizol.

Tempidon and tricyclic antidepressants, oral contraceptives, Allopyrinolum break metabolism of metamizol and increase its toxicity.

Barbiturates, phenylbutazone, glyutetimid and other inductors of microsomal enzymes of a liver can reduce effect of metamizol.

Simultaneous use of the medicine Reonalgon ^® with other analgetics and non-steroidal anti-inflammatory medicaments increases risk of development of toxic effects.

Metamizol reduces plasma concentration of cyclosporine A, and its simultaneous application can be risky in case of the available transplantation of fabrics.

Combination of the medicine Reonalgon ^® and other medicines demands extra care, in view of the content of metamizol which is the inductor of enzymes.

Reonalgon ^® can be combined with M-cholinolytics, quinidine and codeine as with them he shows synergism.

knows that they can interact with captopril, lithium, a methotrexate and Triamterenum and also to change

About a class of derivatives of pyrazyl ketone efficiency of antihypertensive medicines and diuretics. As far as these properties are significant at metamizol, it is unknown.

Antagonists of H ₂ - histamine receptors, caffeine at simultaneous application enhance effect of metamizole sodium.

Feature of application

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

should not exceed the recommended medicine doses.

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

Drug with care is used:

• at a renal failure and/or a liver;
• at stomach diseases (achalasia, a gastroesophageal reflux, a stenosis of peloric department of a stomach);
• at 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 (Reonalgon ^® increases viscosity of a bronchial secret);
• in the presence of a hyperthyroidism;
• at violations of a rhythm of warm activity, coronary heart disease (especially at a sharp myocardial infarction), chronic stagnant heart failure;
• in the presence of data on hypersensitivity to non-steroidal anti-inflammatory drugs, non-narcotic analgesics or 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 the medicine Reonalgon ^® longer than the recommended 3-day term needs to check and control a condition of peripheral blood (leukocytic formula) and function of a liver.

emergence or strengthening of the available headache after long-term analgetic treatment (3 months) at use of analgetics every other day and more often Is possible

.

Headache caused by excessive use of analgetics should not treat, raising their dose. In such cases the analgetic treatment needs to be stopped after consultation with the doctor.

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

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

is not recommended to apply other medicines which part metamizol, along with the medicine Reonalgon ^{® is} .

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 administration of medicament and to see behind consultation a doctor of rather further application.

Use during pregnancy or feeding by a breast

is not applied during pregnancy or feeding by a breast.

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

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

Route of administration and doses

реональгон® apply

Tablet inside after a meal, washing down with water. the recommended daily doses for adults and children are more senior than 15 years — on 1–2 tablets a day; the maximum daily dose — 2 tablets.

Duration of use of the medicine Reonalgon ^® – no more than 3 days.

Patients are more senior than 65 years

Usually dose adjustment is not required. 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 prolonged by

. It is necessary to avoid application of high doses to patients with an abnormal liver function. At short-term application there is no need to reduce a dose. There is no sufficient experience of more prolonged use to patients with a renal failure or a liver.

Children

do not appoint

Reonalgon® to children up to 15 years.

by

Overdose

At overdose 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: at suspicion on overdose it is necessary to stop immediately use of medicine and to take measures to its fast removal from an organism: 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

side reactions Provided below 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 analgetic asthma), Stephens's syndrome — Johnson or a Lyell's disease, 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 reactions 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, violation 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, violation of a warm rhythm.

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: disorder 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

2 years.

not to apply

after the expiration date specified on packing.

Storage conditions

to Store

in original packing at a temperature not above 25 °C.

to Store

out of children's reach.

Packing

On 10 tablets in blisters.

On 10 tablets in the blister; on 1 or on 2 blisters in a pack from cardboard.

Category of a holiday

Without recipe.

Producer

Public joint stock company "chemical pharmaceutical plant "red star".

Location of the producer and address of the place of implementation of its activity

61010, Ukraine, Kharkiv, st. gordiyenkovsky, 1.