Expiration date: 12/2026
Composition: Each tablet contains active substances: Metamizole sodium monohydrate, 527 mg in terms of metamizol sodium 500 mg, 5 pitofenone hydrochloride, 25 mg in terms of pitofenon 5 mg and fenpiverinia bromide 0, 1 mg.
Excipients: gelatin 4 mg, wheat starch 38.65 mg lactose monohydrate to 5 mg. magnesium stearate 4 mg. of sodium bicarbonate 5 mg talc 6 mg microcrystalline cellulose 25 mg.
Description: Round, valium pill white with a faint yellowish tint with a break-line on one side.
Pharmacotherapeutic group: Analiziruyutsya tool combo (non-narcotic analgesic remedy + antispasmodic).
Code ATX: [N02BB52].
Pharmacological action
Pharmacodynamics Metamizole sodium, derived pirazolona possesses analgesic, antipyretic and weak anti-inflammatory effects, the mechanism of which is associated with inhibition of prostaglandin synthesis. Pitofenon - miotropony worth has a direct effect on the smooth muscles of the internal organs and causes its relaxation. Fenpiverinia bromide - m-holinoblokator has an additional spasmolytic effect on smooth muscles. The pharmacokinetics of Metamizole sodium: well and rapidly absorbed from the gastro-kishechnogo tract (GIT). In the bowel wall hydrolyses education active metabolite • not changed Metamizole sodium in the blood is absent (only after the on/in the introduction of a small concentration found in plasma). The connection of the active metabolite to plasma proteins: 50-60 %. Metabolized in liver, excreted by the kidneys. At therapeutic doses passes into breast milk. Pitofenon rapidly absorbed from gastrointestinal tract, maximal concentration in plasma is reached within 30 - 60 min, rapidly distributed to organs and tissues and quickly excreted in the urine. The half-life is 1.8 hours. Fenpiverinia bromide is also rapidly absorbed from the gastrointestinal tract and reaches maximum concentration in plasma within 1 hour. Display memory 32, 4 - 40, 4% unchanged, in the bile excreted 2, 5 - 5, 3% substance.
Indications: mild to moderate pain syndrome spasm of smooth muscles of internal organs renal colic, spasm of the ureter and bladder biliary colic, intestinal colic, biliary dyskinesia in hyperkinetic type, postcholecystectomical syndrome, chronic colitis, algomenorrhea. For short-term therapy: arthralgia, myalgia, neuralgia, sciatica. As a subsidiary of the medicine: diseases of organs of small pelvis, pain after surgical interventions and diagnostic procedures.
Contraindications: Hypersensitivity to any of drug and/ or excipients (including to pyrazolone derivative), oppression of bone marrow hematopoiesis, severe hepatic and/or renal failure, the deficit glukozo-6-fosfatdegidrogenaza deficit lactea. lactose intolerance, glucose-galactose malabsorption. tachyarrhythmias, severe angina, angle-closure glaucoma, prostatic hyperplasia (with clinical manifestations), intestinal obstruction, megacolon, collapse, pregnancy, lactation, children up to age 8 years. With caution and under the supervision of a physician should use the drug in disorders of the liver or kidneys, with tendency to hypotension, bronchospasm, hypersensitivity to NSAIDs, a full or partial combination of asthma, nasal polyposis and intolerances acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs.
Method of application and dose: Inside, after meal. with water. The reception frequency: 2-3 times/day. Adults and adolescents over 15 years: 1-2 tablets 2-3 times a day. The maximum daily dose - 6 tablets. Children dose set depending on age: aged 8 to 11 years the recommended dose is 1/2 tablet, maximum daily dose of 4 tablets, 12 to 14 years-1 tablet, maximum daily dose 6 tablets.
Duration of treatment: not more than 5 days. Increase in daily dose or duration of treatment only under medical supervision.
Side effects: Frequency: very often (more 10%), often (1-10%), uncommon and tranquilizers increase the analgesic (0, 1-1 %), rarely (0, 01-0, 1%), very rare (less than 0, 01%). the effect of Spazioblog. From the digestive system: very rarely - in case of simultaneous use with blockers of Hi-a burning sensation in the epigastric region, dry mouth. histamine receptors, derivatives butirofenona From the heart-vascular system: rarely - phenothiazine, amantadine and quinidine may reduce blood pressure (BP), tachycardia. the increase in m-anticholinergic action of drugs.
With the hematopoietic system: rarely IN simultaneous use with ethanol is possible (usually with a long reception) - thrombocytopenia, mutual enhancement effects. leukopenia, and pellet ositos (may manifest the following symptoms: unmotivated rise in temperature, chills, sore throat, difficulty swallowing, stomatitis, as well as the development of the phenomena of vaginitis or proctitis). From Savigliano system: rarely (usually with prolonged use or when administered at high doses) - impaired renal function, oliguria, anuria, proteinuria, interstitial nephritis, urine staining in red color, difficulty urinating. Allergic reactions: rare - urticaria (including the conjunctiva and mucous membranes of the nasopharynx), very rarely - angioneurotic edema, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome) bronchospastic syndrome, anaphylactic shock. Other: dizziness: rarely-decreased sweating, paresis of accommodation: in rare cases - headache.
Overdose: Symptoms: Vomiting, decreased blood pressure, drowsiness, confusion, nausea, epigastric pain, disorders of the liver and kidneys, cramps.
Treatment: gastric lavage, reception activated carbon, symptomatic therapy.
Interaction with other medicinal products: Simultaneous use of Spazioblog polyenzyme with other analgesics can lead to mutual reinforcement effects.
With simultaneous use of tricyclic antidepressants, oral contraceptives, allopurinol violate the metabolism of metamizol sodium 8 of the liver and increase its toxicity.
While the use of barbiturates, phenyl-Boutheon and other inducers of microsomal liver enzymes weaken the effect of metamizol sodium. X-ray contrast agents, colloidal blood substitutes and penicillin should not be used during cookie preparations containing metamizol sodium. While the use of cyclosporine decreases the concentration of the latter in the blood. Metamizole, displacing connection with the plasma protein oral hypoglycemic drugs, indirect anticoagulants, corticosteroids and indomethacin. can increase the severity of their actions. Special instructions
Metabolite of metamizol sodium can cause red staining of urine, which has no clinical significance and disappear after discontinuation of the drug.
If you suspect a agranulocytosis, or in the presence of thrombocytopenia should stop taking the drug. During long-term (more than weeks) use of the drug needed to be monitored picture peripheral blood and functional state of the liver.
Cannot be used for the relief of acute abdominal pain (to determine cause).
Patients with atopic bronchial asthma and hay fever have an increased risk of allergic reactions. During the period of use of the drug should avoid drinking alcohol. Effects on ability to drive vehicles and mechanisms
In the period of the drug is not recommended to drive vehicles and doing other potentially hazardous activities that require speed of psychomotor reactions.
Form release: 2 Tablets or 10 tablets per blister. 1 blister of 2 tablets. 2 and/ or 10 blisters of 10 tablets with leaflet in a carton pack.
Storage: protected from light place at temperature not above 25 , C. Keep out of reach of children.
Shelf life: 3 years. Do not use after the expiry date printed on the package.
