Kofitsil-plus - instructions for use, doses, side effects, contraindications

Tablets are white or white with a cream color shade, a flat-cylindrical shape with a facet and a risk. Marble is allowed on the surface of the tablets. The presence of the smell of acetic acid.

Pharmacotherapeutic group:Analgesic combined (NSAIDs + analgesic non-narcotic remedy + psychostimulant)

ATX: & nbsp

N.02.B.A.51 Acetylsalicylic acid in combination with other drugs, excluding psycholeptics

Pharmacodynamics:

Combined drug.

The drug has analgesic, antipyretic and psychostimulating effect.

Acetylsalicylic acid has antipyretic and anti-inflammatory effect, relieves pain, especially caused by the inflammatory process, and also moderately inhibits platelet aggregation and thrombosis, improves microcirculation in the inflammatory focus.

Caffeine increases the excitability of spinal cord reflex, excites the respiratory and vasomotor centers, dilates blood vessels in skeletal muscle, brain, heart, kidneys, reducing platelet aggregation; reduces drowsiness, a feeling of fatigue, increases mental and physical performance. In this combination caffeine in a small dose, practically does not have a stimulating effect on the central nervous system, but it increases the tone of the cerebral vessels and accelerates the blood flow.

Paracetamol has an analgesic, antipyretic and extremely weak anti-inflammatory effect, which is due to its influence on the thermoregulatory center in the hypothalamus and a weak ability to inhibit the synthesis of prostaglandins in peripheral tissues.

Indications:

Kofitsil-Plus is used in adults with pain syndrome of mild and moderate severity (of various origins): headache, migraine, toothache, neuralgia, myalgia, arthralgia,Algodismenorea (pain in menstruation).

In adults and children older than 15 years to reduce high fever, with "colds" and other infectious and inflammatory diseases.

Contraindications:

Children under 15 years, increased individual sensitivity to the drug, erosive and ulcerative lesions of the gastrointestinal tract (exacerbation), gastrointestinal bleeding, increased tendency to bleeding, the complete or partial combination of asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (including history), hemorrhagic diathesis (hemophilia, von Willebrand disease, teleangio ectasia, hypoprothrombinemia, thrombocytopenia, thrombocytopenic purpura), exfoliating aortic aneurysm, portal hypertension, deficiency of vitamin K, deficiency of glucose-6-phosphate dehydrogenase. severe arterial hypertension, severe course of ischemic heart disease, glaucoma, increased excitability, sleep disturbances; surgical interventions accompanied by bleeding.

Carefully:

Hyperuricemia, urate nephrolithiasis, gout, peptic ulcer and / or duodenal ulcer (in the anamnesis), severe heart failure, liver disease, elderly age.

Pregnancy and lactation:

The drug is contraindicated in pregnancy, at the time of treatment should stop breastfeeding.

Dosing and Administration:

The drug is used inside after eating. To reduce the irritant effect on the gastrointestinal tract, the drug should be taken with water, milk, alkaline mineral water.

1 tablet every 4 hours, with a pain syndrome - 1-2 tablets; the average daily dose is 3-4 tablets, the maximum daily dose is 8 tablets.

The drug should not be taken more than 5 days as an analgesic drug and more than 3 days - antipyretic (without appointment and supervision of a doctor).

Other doses and schedules are prescribed by the doctor.

The drug is not prescribed as an anesthetic for adolescents under 18 years old, as an antipyretic agent - for children under 15 years with acute respiratory diseases caused by viral infections because of the danger of developing Reye's syndrome (encephalopathy and acute fatty liver disease with acute development of liver failure).

Side effects:

Gastralgia, nausea, vomiting, hepatotoxicity, nephrotoxicity, erosive-ulcerative lesions of the gastrointestinal tract, allergic reactions (including Stevens-Johnson syndrome, Lyell), tachycardia, increased blood pressure, bronchospasm. Reye's syndrome in children (hyperpyrexia, metabolic acidosis, disorders of the nervous system and psyche, vomiting, liver dysfunction).

Dizziness, headache, blurred vision, tinnitus, decreased aggregation thrombocytes, hypocoagulation, hemorrhagic syndrome (epistaxis, bleeding gums, purpura, etc.), kidney damage with papillary necrosis; deafness.

Overdose:

Symptoms caused by acetylsalicylic acid: with light intoxication - nausea, vomiting, gastralgia, dizziness, ringing in the ears; severe intoxication - retardation, drowsiness, collapse, convulsions, bronchospasm, shortness of breath, anuria, bleeding.

Initially, the central hyperventilation leads to respiratory alkalosis (shortness of breath, dyspnea, cyanosis, perspiration). As the intoxication progressive paralysis and respiratory uncoupling of oxidative phosphorylation causes respiratory acidosis.

Symptoms caused by paracetamol: during the first 24 hours after administration - pallor of the skin, nausea, vomiting, anorexia, abdominal pain; disturbance of glucose metabolism, metabolic acidosis. Symptoms of liver dysfunction may appear 12-48 hours after an overdose. In severe intoxication - liver failure with progressive encephalopathy, coma, death; acute renal failure with tubular necrosis (including in the absence of severe liver damage); arrhythmia, pancreatitis.

Chronic overdose: symptoms due to acetylsalicylic acid: long-term use - dizziness, headache, visual impairment, tinnitus, decreased platelet aggregation, hypocoagulation, hemorrhagic syndrome (nosebleeds, bleeding gums, purpura and others), kidney damage with papillary necrosis, deafness.

Symptoms caused by paracetamol: with prolonged use in high doses, hepatotoxic and nephrotoxic effects are possible (renal colic, hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia).

Hepatotoxic effect in adults is manifested when taking 10 g or more.

Treatment: constant monitoring of changes in the parameters of the acid-base state (CBS) and electrolyte balance; depending on the state of metabolism - the introduction of sodium bicarbonate, sodium citrate or sodium lactate. Increased reserve alkalinity increases the excretion of acetylsalicylic acid due to the alkalinity of urine.

If there is liver damage, donators are injected SH-groups and the precursors of the synthesis of glutathione - methionine for 8-9 hours after an overdose and acetylcysteine - for 8 hours. The need for additional therapeutic measures (further introduction of methionine, intravenous injection of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Interaction:

Acetylsalicylic acid increases the toxicity of methotrexate, reducing its renal clearance,valproic acid; enhances the effects of non-steroidal anti-inflammatory drugs, narcotic analgesics, oral hypoglycemic drugs, heparin, indirect anticoagulants, thrombolytic and antiaggregants, sulfonamides (including co-trimoxazole), T3 (triiodothyronine); reduces the effect of uricosuric medicines (benzbromarone, sulfinpyrazone), antihypertensive drugs, diuretics (spironolactone, furosemide).

Glucocorticosteroid agents, ethanol and ethanol-containing drugs increase the damaging effect on the mucous membrane of the gastrointestinal tract, increase the risk of developing gastrointestinal bleeding.

Increases the concentration of digoxin, barbiturates, lithium salts in plasma.

Antacids containing magnesium ions and / or aluminum ions slow down and worsen the absorption of acetylsalicylic acid.

Myelotoxic drugs increase the manifestation of hematotoxicity of acetylsalicylic acid.

Paracetamol reduces the effectiveness of uricosuric medicines.The concomitant use of paracetamol in high doses increases the effect of anticoagulant drugs (a decrease in the synthesis of procoagulant factors in the liver).

Inductors of microsomal liver enzymes (phenytoin, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), ethanol and hepatotoxic drugs increase the production of hydroxylated active metabolites, which makes it possible to develop severe intoxication even with a slight overdose.

Long-term use of barbiturates reduces the effectiveness of paracetamol. Simultaneous reception of paracetamol and ethanol increases the risk of hepatotoxic effects.

Inhibitors of microsomal oxidation (including cimetidine) reduce the risk hepatotoxic action.

Prolonged sharing of paracetamol and other non-steroidal anti-inflammatory drugs increases the risk of developing "analgesic" nephropathy and renal papillary necrosis, the onset of the terminal stage of renal failure.

Simultaneous long-term administration of paracetamol in high doses and salicylates increases the risk of developing kidney or bladder cancer.

Diflunisal increases the plasma concentration of paracetamol by 50% - the risk of developing hepatotoxicity.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Under the influence of paracetamol, the half-life (T 1/2) of chloramphenicol increases fivefold. At repeated reception paracetamol can enhance the effect of anticoagulants (coumarin derivatives).

Caffeine is an adenosine antagonist (large doses of adenosine may be required).

With the joint use of caffeine and barbiturates, primidone, anticonvulsant drugs (hydantoin derivatives, especially phenytoin) it is possible to increase metabolism and increase caffeine clearance; cimetidine, oral contraceptive drugs, disulfiram, ciprofloxacin, norfloxacin - a decrease in the metabolism of caffeine in the liver (slowing its elimination and increasing blood concentrations).

Mexiletine - reduces caffeine withdrawal to 50%; nicotine - Increases the speed of caffeine removal.

Inhibitors of monoamine oxidase, furazolidone, procarbazine and selegiline - large doses of caffeine can cause the development of dangerous cardiac arrhythmias or severeincreasing blood pressure.

Caffeine reduces the absorption of calcium in the gastrointestinal tract.

Reduces the effect of narcotic and hypnotic drugs.

Increases the excretion of lithium drugs with urine.

Accelerates absorption and enhances the action of cardiac glycosides, increases their toxicity. Joint use of caffeine with beta-blockers can lead to mutual suppression of therapeutic effects; with adrenergic bronchodilator drugs - to additional stimulation of the central nervous system.

Special instructions:

With continued use of the drug, control of peripheral blood and the functional state of the liver is necessary.

Because the acetylsalicylic acid slows the clotting of the blood, the patient, if he is to undergo surgery, must warn the doctor in advance about taking the drug.

Acetylsalicylic acid in low doses reduces the excretion of uric acid. In patients with a corresponding predisposition, this can in some cases provoke a gout attack.

During treatment should be abandoned the use of ethanol (increased risk of gastrointestinal bleeding).

Effect on the ability to drive transp. cf. and fur:

When ingestion in high doses (up to 8 tablets per day) caffeine, which is part of the drug makes it difficult to concentrate, so you need to refrain from driving vehicles and practicing potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Pills.

Packaging:

By 6.10 tablets in a contour non-cellular package of paper with a polymer coating. For 10 tablets in a contour mesh package made of a polyvinylchloride film and aluminum foil or paper with a polymeric coating.

1,2,3,4,5 contour non-jammed packages or contour mesh packages together with the instruction for use are placed in a bundle.

Contour-free, cell-free packages or contoured cell packs with an equal number of instructions for use are placed in a polyethylene film bag or a cardboard box.

Storage conditions:

In dry, dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-001753

Date of registration:02.07.2012

The owner of the registration certificate:URALBIOFARM, OJSC URALBIOFARM, OJSC Russia

Manufacturer: & nbsp

URALBIOFARM, OJSC Russia

Information update date: & nbsp02.07.2012

Illustrated instructions

Instructions

Kofil®-plus (Coficil®-plus)