Composition, form of production and packaging
? Tablets .
metamizole sodium 500 mg
Pitophenone (in the form of hydrochloride) 5 mg
fenpiverinia bromide 100 Ојg
10 pieces. - blisters (2) - packs of cardboard.
10 pieces. - blisters (10) - packs of cardboard.
10 pieces. - blisters (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
Megamizol sodium, a derivative of pyrazolone, has an analgesic, antipyretic and weak anti-inflammatory effect, the mechanism of which is associated with inhibition of prostaglandin synthesis due to nonselective inhibition of cyclooxygenase.
Pitophenone - myotropic antispasmodic - has a direct effect on the smooth muscles of the internal organs, causing it to relax.
Fenpiverinia bromide - m-holinoblokator has an additional spasmolytic effect on smooth muscles.
Metamizole sodium is well and quickly absorbed from the digestive tract. In the intestinal wall it hydrolyzes with the formation of an active metabolite - there is no unchanged metamizole of sodium in the blood (only after intravenous administration its insignificant concretration is detected in the plasma). The association of the active metabolite with plasma proteins is 50-60%. Metabolized in the liver, excreted by the kidneys. In therapeutic concentrations penetrates into breast milk.
Pitophenone is rapidly absorbed from the digestive tract; C max in plasma is achieved within 30-60 min; quickly distributed in organs and tissues and quickly removed with urine. T 1/2 is 1.8 hours.
Fenpiverinia bromide is rapidly absorbed from the digestive tract and reaches a maximum concentration in the blood plasma for 1 hour. It is excreted by the kidneys 32.4-40.4% unchanged, intestine 2.5-5.3%.
Weak or moderately expressed pain syndrome with spasms of smooth muscles of internal organs:
- biliary colic;
- spasms of smooth muscles of the gastrointestinal tract;
- biliary dyskinesia of hyperkinetic type;
Inside, not liquid, squeezed a small amount of liquid.
Adults and adolescents older than 15 years - 1-2 tablets 2-3 times a day; the maximum daily dose should not exceed 6 tablets. Children 13-15 years: 1 tablet 2-3 per day. Children 8-12 years: 1/2 tablet 2-3 times a day.
The course of treatment should not exceed 5 days.
Allergic reactions: skin rash, itching, urticaria (including conjunctiva and mucous membranes of the nasopharynx), angioedema; malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), bronchospasm, anaphylactic shock.
From the side of the central nervous system: headache, dizziness.
From the side of the organ of vision: indistinctness of visual perception, paresis of accommodation.
From the digestive system: dry mouth, heartburn, constipation.
From the side of the urinary system: renal dysfunction, oliguria, anuria, proteinuria, interstitial nephritis, urine staining red (due to metamizol sodium metabolites), difficulty urinating.
From the cardiovascular system: lowering blood pressure, tachycardia, cyanosis.
On the part of the organs of hematopoiesis: thrombocytopenia, leukopenia, agranulocytosis (unmotivated rise in body temperature, chills, sore throat, painful swallowing, stomatitis, as well as the development of phenomena of vaginitis or proctitis) can manifest themselves following symptoms.
- Severe violations of the liver and / or kidney function;
Decompensation of chronic heart failure;
- severe angina pectoris;
- deficiency of glucose-6-phosphate dehydrogenase;
- an angle-closure glaucoma;
- hyperplasia of the prostate (with clinical manifestations);
- oppression of bone marrow hematopoiesis (including granulocytopenia);
- intestinal obstruction;
- hypersensitivity to the drug components (as well as to other pyrazolone derivatives).
renal and / or hepatic insufficiency of mild and moderate degree;
- propensity to arterial hypotension, bronchospasm;
- Hypersensitivity to NSAIDs or non-narcotic analgesics (including an indication in the history of a complete or incomplete combination of bronchial asthma, nasal polyposis and intolerance to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs.).
PREGNANCY AND LACTATION
The use of the drug during pregnancy and during breast-feeding is contraindicated.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution in renal failure of mild to moderate.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution in liver failure, mild to moderate.
APPLICATION FOR CHILDREN
Assign to children from 8 years.
During the treatment with the drug is not recommended to take ethanol.
Against the background of Plenolgin's intake (due to the sodium metamizole contained in it), it is possible to develop agranulocytosis, in connection with which, when an unmotivated rise in temperature, chills, sore throats, difficulty swallowing, stomatitis, phenomena of vaginitis or proctitis, and when thrombocytopenia is detected immediate cancellation of the drug.
Admission of the drug in patients with atopic bronchial asthma and pollinosis increases the risk of allergic reactions.
It is inadmissible (until finding out the causes of the onset of pain syndrome) use of the drug for the purpose of relief of acute pain in the abdomen.
Care should be taken during vehicle administration for drivers of vehicles and for persons involved in potentially hazardous activities that require an increased concentration of attention and speed of the psychomotor reaction.
Cases of overdose are possible if the dosing regime is not observed.
Symptoms: dryness.vo mouth, nausea, vomiting, abdominal pain, lowering blood pressure, impaired sweating, drowsiness, paresis of accommodation, confusion, impaired liver and kidney function, convulsions.
Treatment: gastric lavage, reception of activated charcoal, symptomatic therapy.
Radiocontrast agents, colloidal blood substitutes and penicillin should not be used during treatment with drugs containing metamizole sodium. With the simultaneous use of metamizole sodium with cyclosporine, the concentration of the latter in the blood decreases.
Metamizole sodium, displacing from the connection with plasma proteins, oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids and indomethacin, increases their effect.
Phenylbutazone, barbiturates and other inducers of microsomal liver enzymes with simultaneous use reduce the effectiveness of metamizole sodium.
Simultaneous use with non-narcotic analgesics, tricyclic antidepressants, hormonal contraceptives and allopurinol may lead to an increase in the toxicity of metamizole sodium.
Sedative and anxiolytic drugs (tranquilizers) increase the analgesic effect of metamizole sodium.
Thiamazole and cytostatics increase the risk of developing leukopenia when using drugs containing metamizole sodium.
The effect of metamizole sodium is enhanced by codeine, H 2 -gistamine receptor blockers and propranolol (slows metabolism).
Myelotoxic drugs increase the manifestation of hematotoxicity of metamizole sodium.
Derivatives of butyrophenone, phenothiazine, tricyclic antidepressants, H 1 -gistamine receptor blockers, amantadine and chiidine enhance the m-cholinoblocking effect of fenpiperinium bromide.
With the simultaneous use of fenpiverinia bromide and phenothiazine derivatives (eg, chlorpromazine), development of severe hyperthermia can be observed.
Metamizole sodium enhances the effect of ethanol.
TERMS OF RELEASE FROM PHARMACY
TERMS AND CONDITIONS OF STORAGE
In dry, dark place at a temperature of no higher than 25 В° C. Keep out of the reach of children. Shelf life - 5 years.