Cofalginum of the tab. No. 10

Translation of the instruction Mose

COFALGINUM of the tablet

Instruction

On medical use of medicine

Ingredients:

Active ingredients:

1 tablet contains metamizol of sodium salt (in recalculation for 100% dry matter) — 300 mg, caffeine-sodium benzoate (with 40% content of caffeine) (in recalculation for 100% dry matter) — 50 mg;

excipients: microcrystalline cellulose, povidone, magnesium stearate.

Dosage form.

Tablet.

Main physical and chemical properties: tablets of round shape, white or yellow-white color, with slanted edges (with a facet) and risky.

Pharmacotherapeutic group.

Analgetiki's

and antipyretics. metamizole sodium, combinations without psikholeptik. atx n02b b52 code.

Pharmacological properties.

Pharmacodynamics.

Cofalginum — the combined medicine which effect is caused by properties of the components which are its part.

Metamizole sodium — analgetik-antipyretic, derivative pyrazyl ketone, renders analgesic, febrifugal and weak anti-inflammatory action which mechanism is connected with oppression of synthesis of prostaglandins generally in the central nervous system.

Kofein — derivative methylxanthine, stimulates the psychomotor centers of a brain, has analeptical effect, enhances effect of metamizole sodium, eliminates drowsiness and feeling of fatigue, increases physical and intellectual effeciency.

Pharmacokinetics.

by

it was not studied.

Clinical characteristics.

Indication.

Moderate pain syndrome, headache, neuralgia, arthritises, miozita, rheumatism; as febrifuge in fever of various origin.

Contraindication.

Hypersensitivity to any component of drug; hypersensitivity to derivatives of pyrazyl ketone, other derivative xanthines (theophylline, Euphyllinum, theobromine); arterial hypertension; glaucoma; hyperexcitability; sleep disorders; profound abnormal liver functions and kidneys; oppression of a hemopoiesis, blood disease: anemia of any etiology, cytostatic or infectious neutropenia, agranulocytosis, leukopenia; bronchial asthma; suspicion of acute surgical pathology; organic diseases of a cardiovascular system (including acute myocardial infarction, profound atherosclerosis); a prostatauxe with an ischuria; deficit glyukozo-6-fosfatdegidrogenazy; advanced age.

not to apply

together with inhibitors of a monoaminooxidase (MAO) and within 2 weeks after phase-out of MAO inhibitors.

Interaction with other medicines and other types of interactions.

Barbiturates, codeine, paracetamol, n2-blockers of histamine receptors, anaprilin: strengthening of their effects.

Sarcolysine, mercazolil, Thiamazolum, medicaments oppressing activity of marrow including gold drugs: increase in probability of a gematotoksichnost, including development of a leukopenia.

Ketokonazol, Disulfiramum, ciprofloxacin, norfloxacin, enoksatsin, pipemidinovy acid: delay of release of caffeine and increase in its concentration in blood is possible.

Oral antidiabetic means: increase in their hypoglycemic activity.

Alcohol: increase in its sedative action.

Cyclosporine: decrease in its concentration in blood plasma.

Ergotamine: caffeine can strengthen its action.

Fluvoksamin: increase in level of caffeine in blood plasma.

Meksiletin: decrease in removal of caffeine by 50%.

Nikotin: increase in clearance rate of caffeine.

Methoxalenum: reduction of removal of caffeine from an organism with possible strengthening of its effect and development of toxic action.

Clozapine: increase in concentration of clozapine in blood plasma.

Theophylline and other xanthines: decrease in clearance of these drugs, increase in risk of additive pharmakodinamichesky and toxic effects.

Lities: increase in removal of lithium with urine.

Other medicaments which effect can be changed in interaction with caffeine: idrotsilamid, fenilpropanolamin, Phenytoinum, pentobarbital, diazepam.

MAO Inhibitors, furasolidone, Procarbazinum and selegilin: perhaps dangerous increase in arterial blood pressure.

Analgetiki-antipiretiki: caffeine enhances their effect (improves bioavailability).

Psychogogic means, α- and β-adrenomimetik: potentiation of their effects.

Cimetidinum, hormonal contraceptives, isoniazid: strengthening of effect of caffeine.

Opiodny analgetik, anxiolytics, hypnotic medicaments and sedatives: caffeine reduces their effect.

Kofein is an antagonist of the anesthetics and other medicaments oppressing the central nervous system, the competitive antagonist of medicaments of adenosine, ATP.

Thyritropic means: increase in thyroid effect.

Drinks and medicines containing caffeine at combined use with medicament can lead

to excessive stimulation of the central nervous system. High doses of caffeine can cause a tremor and heartbeat. Patients should avoid excess consumption of coffee or tea.

Interaction which can be caused by presence of metamizole sodium

Chlorpromazinum or other derivatives of a fenotiazin: development of the expressed hypothermia is possible.

X-ray contrast substances, colloidal blood substitutes and penicillin: it is not necessary to apply during treatment by metamizole sodium.

Indirect anticoagulants, glucocorticosteroids and indometacin: metamizole sodium increases activity of these medicaments by replacement them from communication with protein.

Phenylbutazone, other gepatoinduktor: reduction of efficiency of metamizole sodium.

Tricyclic antidepressants, hormonal contraceptives and Allopyrinolum: strengthening of toxicity of metamizole sodium is possible.

Sedatives and tranquilizers (Sibazonum, Trioxazinum), valocordin: strengthening of the anesthetizing effect of metamizole sodium.

Non-narcotic analgetik, other non-steroidal anti-inflammatory medicaments (NPVS): their anesthetic and febrifugal action is exponentiated and the probability of additive undesirable side effects increases.

Methotrexate: metamizol in high doses can lead to increase in concentration of a methotrexate in blood plasma and to strengthening of its toxic effects (first of all on a digestive tract and the system of a hemopoiesis).

Sulfonilamidny oral hypoglycemic drugs: strengthening of their hypoglycemic action at use together with NPVS, including with metamizole sodium is possible.

Diuretics (furosemide): decrease in diuretic effect is possible.

Feature of use.

to

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

As metamizole sodium 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.

by

With care to appoint medicament to patients with a hyperthyroidism, epilepsy, persistent infection of airways, renal failures, with diseases of kidneys in the anamnesis (pyelonephritis, a glomerulonephritis), with inflammatory bowel diseases, including nonspecific ulcer colitis and Crohn's disease; with the profound arterial hypotension, cardiovascular insufficiency, at hypersensitivity to analgetika and NPVS, with allergic reactions (including. pollinosis) or with preliminary history of these diseases (the risk of allergic reactions increases), at simultaneous use of cytostatic medicines (only under control of the doctor), in alcoholism.

At prolonged use of medicament (more than 7 days) needs to control composition of peripheral blood (because of a metamizol miyelotoksichnost), function of kidneys and a liver.

At administration of medicament the coloring of urine in red color because of removal of a metabolite of metamizole sodium is possible

.

At use of medicament should avoid excessive consumption of the coffee, strong tea, other tonics, alcohol and medicines containing caffeine.

in case of prolonged use of medicament the development of mental dependence is possible

. The sharp termination of treatment leads to strengthening of braking of the central nervous system (drowsiness, a depression).

Caffeine can become the reason of false increase in uric acid in blood that is defined by the Bittner method.

Kofein can increase levels of 5-hydroxyindolacetic acid (5-HIAA), vanililmindalny acid (VMA) and catecholamines in urine that can result in false positive results of diagnostics of a pheochromocytoma and neuroblastoma.

With care use medicament to patients with a peptic ulcer of a digestive tract in the anamnesis.

Patients should warn in an initiation of treatment that at emergence of an unmotivated fever, fevers, a sore throat, the complicated swallowing, bleeding of gums, blanching of integuments, an asthenia, at development of a vaginitis or proctitis it is necessary to cancel medicament immediately. Also administration of medicament needs to be stopped in the first enanthesis and mucous. At emergence of these symptoms it is necessary to see a doctor immediately.

should not use medicament longer than an established period without consultation of the doctor!

Use during pregnancy or feeding by a breast.

Use of medicament during pregnancy is contraindicated to

.

In need of medicament use feeding by a breast should be stopped.

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

do not have

data on influence of medicament on speed of response at control of motor transport or other mechanisms, but it is necessary to consider the probability of developing of dizziness.

Route of administration and doses.

Cofalginum to appoint

to adults and children from 14 years on 1 tablet 2-3 times a day. not to chew, wash down a tablet with a small amount of water. the maximum daily dose — 3 tablets.

treatment Duration — not longer 3 days.

If symptoms of a disease do not disappear within 3 days, it is necessary to see a doctor of rather further administration of drug.

Children.

to Children up to 14 years medicament not to appoint

.

Overdose.

metamizole sodium Overdose: hypothermia, heart consciousness, tremor, profound lowering of arterial pressure, tachycardia, dysphagy, asthma, sonitus, nausea, vomiting, gastralgia/gastritis, weakness, drowsiness, nonsense, consciousness disturbances, convulsive syndrome; development of an acute agranulocytosis, a hemorrhagic syndrome, oliguria, anury, an acute renal or liver failure, paralysis of respiratory muscles is possible.

caffeine Overdose: a gastralgia, uneasiness, excitement, nervousness, dizziness, insomnia, irritability, the heat of passion, face reddening, psychomotor arousing, confusion of consciousness, a delirium, dehydration, tachycardia, arrhythmias, a hyperthermia, increase in frequency of urination, increase in respiration rate, a headache, the increased tactile or painful sensitivity, a tremor or muscular twitchings; nausea and vomiting, sometimes with blood impurity, pain in epigastric area; a ring in ears, convulsive attacks (at acute overdose — toniko-clonic spasms).

Treatment: gastric lavage, artificial diuresis, purpose of enterosorbents, support of ventilation of the lungs and oxygenation; in convulsive attacks — intravenously diazepam, phenobarbital or Phenytoinum; support of balance of liquid and salts. In hard cases the hemodialysis, hemoperfusion, peritoneal dialysis is possible. Symptomatic therapy is directed to maintenance of the vital functions.

Side reactions.

from the immune system: manifestations of reactions of hypersensitivity, including an enanthesis and mucous, conjunctivitis, an itching, urticaria, a Quincke's disease (Quincke's edema), a bronchospasm, an acute anaphylaxis, a syndrome of a stivensa-johnson, a Lyell's disease are possible.

from a digestive tract: nausea, vomiting, pain in epigastriums, exacerbation of a peptic ulcer.

from a cardiovascular system: feeling of compression in breasts, heart consciousness, tachycardia, arrhythmias, an increase/lowering of arterial pressure.

from nervous system: dizziness, uneasiness, hyperexcitability, tremor, concern, headache, sleep disorders, muscular twitchings, convulsive attacks, strengthening of reflexes, tachypnea; at sudden cancellation — strengthening of braking of the central nervous system with the advent of feeling of the increased fatigue, drowsiness, the muscular tension, a depression.

from an urinary system: usually at patients with a renal failure and/or at use of excess doses the tranzitorny oliguria, an anury, interstitial nephrite, a proteinuria, increase in clearance of creatinine, increase in excretion of sodium and calcium is observed. Coloring of urine in red color is possible.

from a gepatobiliarny system: hepatitis.

from the system of blood: at prolonged use the leukopenia, thrombocytopenia, hemolytic anemia, a granulocytopenia/agranulocytosis are possible.

Laboratory indicators: perhaps false increase in uric acid in blood that is defined by the Bittner method, a hypoglycemia/hyperglycemia, slight increase of 5-hydroxyindolacetic acid (5-HIAA), vanililmindalny acid (VMA) and catecholamines in urine.

Others: congestion of a nose, at prolonged use — the decrease in effect of caffeine connected with formation of new adenosine receptors, medicamentous dependence.

Expiration date.

2 years.

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 the blister, on 1 blister in a pack; on 10 tablets in the blister, on 2 blisters in a pack.

Category of release.

Without prescription.

Producer.

Public joint stock company "research and production center "borgashchovsky chemical and pharmaceutical plant".

LLC Agrofarm.

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

Ukraine, 03134, of cues, st. of the world, 17.

Ukraine, 08200, Kiev Region, Irpen, Centralnaya St., 113-A.