Paracytolgin pills 400mg +325mg, 10pcs

Composition

One film-coated tablet contains: Active ingredients: Ibuprofen 400,00 mgParacetamol 325,00 Mgcontributive substances of the core: Microcrystalline cellulose M 102 76.00 mg Corn starch 65.25 mgGlycerol (glycerol) 3.00 Mgcarboxymethyl starch sodium (sodium starch glycolate (type A), primogel) 14.25 mgSilicon dioxide colloidal 38.00 MGTALK 19.00 MGM Magnesium stearate 9.50 mg Shell composition: Hypromellose 12.90 mgMacrogol-4000 3.20 Mgtitan dioxide 2.30 Mgpropylene Glycol 1.60 mg

Pharmacological action

Pharmacotherapy group

Analgesic agent, combined (NSAID + non-narcotic analgesic agent).

ATX code:

M 01 AE 51

Pharmacological properties

Pharmacodynamics

A combined drug, the action of which is due to the components included in its composition.

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory, and antipyretic effects. Inhibiting cyclooxygenase (COX) 1 and 2, it disrupts the metabolism of arachidonic acid, reduces the amount of prostaglandins (mediators of pain, inflammation and hyperthermic reaction), both in the focus of inflammation and in healthy tissues, suppresses the exudative and proliferative phases of inflammation.

Paracetamol-selectively blocks COX, mainly in the central nervous system, has little effect on water-salt metabolism and the mucous membrane of the gastrointestinal tract (GIT). It has analgesic and antipyretic effects. In inflamed tissues, peroxidases neutralize the effect of paracetamol on COX 1 and 2, which explains the low anti-inflammatory effect.

The effectiveness of the combination is higher than that of individual components. Relieves arthralgia at rest and during movement, reduces morning stiffness and swelling of the joints, helps to increase the volume of movement.

Pharmacokinetics

of Ibuprofen

Absorption – high, quickly and almost completely absorbed from the gastrointestinal tract. The time to reach the maximum concentration (TCmax) after oral use is about 1-2 hours. The relationship with plasma proteins is more than 90%. The half-life (T 1/2) is about 2 hours. It slowly penetrates the joint cavity, accumulates in the synovial fluid, creating higher concentrations in it than in the blood plasma. After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into the active S-form. It is metabolized. More than 90% is excreted by the kidneys (no more than 1% unchanged) and to a lesser extent with bile in the form of metabolites and their conjugates.

Paracetamol

Absorption is high, plasma protein binding is less than 10% and increases slightly with overdose. The sulfate and glucuronide metabolites do not bind to plasma proteins even in relatively high concentrations. The Cmax value is 0.5-2 h. TCmax is 5-20 mcg / ml.

It is fairly evenly distributed in the body’s liquid media. Penetrates the blood-brain barrier.

About 90-95% of paracetamol is metabolized in the liver to form inactive conjugates with glucuronic acid (60%), taurine (35%) and cysteine (3%), as well as small amounts of hydroxylated and deacetylated metabolites. A small portion of the drug is hydroxylated by microsomal enzymes to form the highly active N-acetyl-p-benzoquinonimine, which binds to the sulfhydryl groups of glutathione. When glutathione reserves in the liver are depleted (in case of overdose), the enzyme systems of hepatocytes can be blocked, leading to the development of their necrosis.

T 1/2 – 2-3 hours. In patients with cirrhosis of the liver, T 1/2 slightly increases. In elderly patients, drug clearance decreases and T 1/2 increases. It is excreted by the kidneys mainly in the form of glucuronide and sulfate conjugates (less than 5% – unchanged). Less than 1% of the taken dose of paracetamol passes into breast milk. In children, the ability to form conjugates with glucuronic acid is lower than in adults.

Indications

Symptomatic treatment of infectious and inflammatory diseases (cold, flu), accompanied by fever, chills, headache, muscle and joint pain, sore throat:

• myalgia:
• neuralgia;
• back pain;
• joint pain, pain syndrome in inflammatory and degenerative diseases of the musculoskeletal system;
• pain in bruises, sprains, dislocations, fractures;
• post-traumatic and postoperative pain syndrome;
• toothache;
• algodismenorrhea (painful menstruation).

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, and does not affect the progression of the disease.

Use during pregnancy and lactation

In the first and second trimester of pregnancy, the drug can only be used as prescribed by a doctor in cases where the potential benefit exceeds the possible risk to the mother and the potential risk to the fetus. The use of the drug in the third trimester of pregnancy is contraindicated.

If it is necessary to use the drug during breastfeeding, breast-feeding should be discontinued.

In experimental studies, the embryotoxic, teratogenic and mutagenic effects of the drug components were not established.

Before using the drug, if you are pregnant or think that you might be pregnant, or are planning to become pregnant, you should consult your doctor.

Contraindications

Increased individual sensitivity to the components of the drug (including other NSAIDs).

Erosive and ulcerative diseases of the gastrointestinal tract (including peptic ulcer of the stomach and duodenum, Crohn’s disease, ulcerative colitis) active or history of ulcerative bleeding (two or more confirmed episodes of peptic ulcer disease or ulcerative bleeding).

Cerebrovascular or other bleeding.

Hemophilia or other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis, intracranial hemorrhage.

Severe renal insufficiency (creatinine clearance < 30 ml / min).

Complete or incomplete combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis, and intolerance to acetylsalicylic acid or other NSAIDs (including in the anamnesis).

Severe heart failure (Class IV according to the classification of the New York Heart Association NYHA).

Decompensated heart failure.

Damage to the optic nerve.

Genetic absence of glucose-6-phosphate dehydrogenase.

Diseases of the blood system.

The period after coronary artery bypass grafting.

Progressive kidney diseases.

Severe liver failure or active liver disease.

Confirmed hyperkalemia.

Pregnancy (third trimester).

Children under 18 years of age.

With caution

Coronary heart disease, chronic heart failure, peripheral arterial diseases, arterial hypertension, blood diseases of unknown etiology (leukopenia and anemia), cerebrovascular diseases, dyslipidemia/hyperlipidemia.

A history of a single episode of gastric and duodenal ulcer or ulcerative bleeding of the gastrointestinal tract, the presence of Helicobacter pylori infection, gastritis, enteritis, colitis, ulcerative colitis in the anamnesis.

Viral hepatitis, moderate and mild hepatic insufficiency, benign hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndrome), cirrhosis of the liver with portal hypertension.

Renal failure, including dehydration (creatinine clearance less than 30-60 ml / min), nephrotic syndrome.

Bronchial asthma or allergic diseases in the acute stage or in the anamnesis may develop bronchospasm.

Systemic lupus erythematosus or mixed connective tissue disease (Sharp’s syndrome) – increased risk of aseptic meningitis.

Chickenpox, severe somatic diseases, diabetes mellitus.

Concomitant use of other NSAIDs, oral glucocorticosteroids (including prednisone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline).

Old age, smoking, alcoholism.

Pregnancy I-II trimester, breast-feeding period.

Side effects

To determine the frequency of side effects of the drug, the following classification is used: very often (≥1/10), often (≥1/100 and <1/10), infrequently (≥1/1000 and <1/100), rarely (≥1/10 000 and

Violations of the gastrointestinal tract

of NSAID-gastropathy – nausea, vomiting, heartburn, anorexia, discomfort or pain in the epigastrium, diarrhea, flatulence, rarely – erosive and ulcerative lesions, bleeding; impaired liver function, hepatitis, pancreatitis, irritation or dryness of the mouth, pain in the mouth, ulceration of the mucous membrane of the gums, aphthous stomatitis, constipation. Peptic ulcer, melena, bloody vomiting, in some cases fatal, especially in elderly patients, gastritis, exacerbation of colitis and Crohn’s disease, increased activity of “liver” transaminases, jaundice.

Disorders of the nervous system and sensory organs

Headache, dizziness, insomnia, anxiety, nervousness, irritability, agitation, drowsiness, depression, confusion, hallucinations; rarely-aseptic meningitis (more often in patients with autoimmune diseases); hearing loss, tinnitus, visual disturbances, toxic damage to the optic nerve, blurred vision or double vision, scotoma, amblyopia.

Disorders of the cardiovascular system

Heart failure, peripheral edema, with prolonged use, the risk of thrombotic complications (for example, myocardial infarction), increased blood pressure, tachycardia is increased.

Disorders of the blood and lymphatic system

Anemia (including hemolytic and aplastic), thrombocytopenia, thrombocytopenic purpura, agranulocytosis, leukopenia, pancytopenia.

Respiratory and mediastinal disorders

Shortness of breath, bronchospasm, and bronchial asthma.

Kidney and urinary tract disorders

Allergic nephritis, acute renal failure, nephrotic syndrome, edema, polyuria, cystitis, hematuria, proteinuria, nephritic syndrome, papillary necrosis, interstitial nephritis.

Allergic reactions

Skin rash, pruritus, urticaria, angioedema, bronchospasm, dyspnoea, allergic rhinitis, dry and irritated eyes, conjunctival and eyelid edema, eosinophilia, fever, anaphylactic shock, erythema multiforme (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome).

Laboratory parameters

Decrease in serum glucose concentration, decrease in hematocrit and hemoglobin, increase in bleeding time, increase in serum creatinine concentration.

Other services

Increased sweating.

With prolonged use in high doses: ulceration of the gastrointestinal mucosa, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual impairment (color vision disorder, scotoma, amblyopia).

If you experience any of the side effects listed in the instructions, or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

With the simultaneous use of the drug Paracytolgin with drugs, various interaction effects may develop:

• antiemetics: reduction of speed of absorption of paracetamol, while the use of metoclopramide or domperidone;
• anticoagulants: long-term use of products containing paracetamol may increase effect of anticoagulants, in particular, warfarin and increase the risk of bleeding;
• antacids, cholestyramine: reduces absorption of paracetamol
• with simultaneous use of ibuprofen reduces inflammatory and antiplatelet effect of acetylsalicylic acid (may increase in the incidence of acute coronary insufficiency in patients receiving antiplatelet as a means of small doses of acetylsalicylic acid after the use of ibuprofen);
• other NSAIDs, particularly selective COX-2 inhibitors: should avoid the simultaneous use of two or more drugs from the NSAID group because of a possible increase in the risk of side effects;
• ibuprofen enhances the effect of direct (heparin) and indirect (coumarin derivatives and indandione) anticoagulants, thrombolytic agents (alteplase, anistreplase, streptokinase, urokinase), antiplatelet agents, colchicine increases the risk of hemorrhagic complications;
• insulin and oral hypoglycemic drugs: increased hypoglycemic action;
• antihypertensives (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs can reduce the efficacy of these groups. In some patients with impaired renal function (for example, in patients with dehydration or in elderly patients with impaired renal function), the simultaneous use of ACE inhibitors or angiotensin II antagonists and cyclooxygenase inhibitors may lead to deterioration of renal function, including the development of acute renal failure (usually reversible). These interactions should be considered in patients taking coxibs concomitantly with ACE inhibitors or angiotensin II antagonists. In this regard, the combined use of the above drugs should be prescribed with caution, especially in the elderly. Patients should be prevented from becoming dehydrated, and renal function monitoring should be considered after starting this combination treatment and periodically thereafter. Diuretics and ACE inhibitors may enhance the nephrotoxicity of NSAIDs;
• corticosteroids: increased risk of gastrointestinal ulcers and gastrointestinal bleeding;
• ethanol, corticotropin: increased risk of erosive and ulcerative lesions of the gastrointestinal tract;
• antiplatelet agents and selective inhibitors of serotonin reuptake: increased risk of gastrointestinal bleeding;
• cardiac glycosides: co-use of NSAIDs and cardiac glycosides may exacerbate cardiac failure, reduce glomerular filtration rate and increase the concentration of cardiac glycosides in plasma,
• lithium drugs, methotrexate: there are data on the probability of increasing the concentration of lithium in blood plasma on the background of NSAIDs;
• cyclosporine: increased risk of nephrotoxicity with concomitant use of NSAIDs and cyclosporine;
• gold drugs: increased risk of nephrotoxicity with concomitant use of NSAIDs and gold preparations;
• the mifepristone: NSAIDs should begin no earlier than 8-12 days after mifepristone as NSAIDs can reduce the efficacy of mifepristone;
• tacrolimus: when concomitant use of NSAIDs and tacrolimus may increase the risk of nephrotoxicity;
• zidovudine: simultaneous use of NSAIDs and zidovudine may result in the increase gematotoksichnosti. There is evidence of an increased risk of hemarthrosis and hematomas in HIV-positive patients with hemophilia who received co-treatment with zidovudine and ibuprofen;
• quinolone antibiotics: patients receiving joint treatment with NSAIDs and antibiotics hinolonovogo series, may increase the risk of seizures;
• of cefamandol, cefoperazone, cefotetan, valproic acid, plicamycin: an increase in the frequency of gipoprotrombinemii;
• myelotoxic drugs increase the manifestation gematotoksichnosti product;
• caffeine increases the analgesic effect;
• drugs that block tubular secretion: a decreased excretion and increased plasma concentrations of ibuprofen;
• inductors of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants): increase the production of hydroxylated active metabolites, increasing the risk of development of severe intoxication;
• inhibitors of microsomal oxidation: reduction of risk of hepatotoxicity;
• uricosuric drugs: decrease the effectiveness of drugs.

If you are using the above or other medications (including over-the-counter medications), please consult your doctor before using Paracytolgin.

How to take, course of use and dosage

Inside (before or 2-3 hours after a meal), without chewing, with a sufficient amount of water. Take 1 tablet 3 times a day. The maximum daily dose is 3 tablets.

The duration of treatment is no more than 3 days as an antipyretic and no more than 5 days as an analgesic. Continuation of treatment with the drug is possible only after consultation with a doctor.

If there is no improvement after treatment, or if the symptoms worsen or new symptoms appear, you should consult your doctor. Use the drug only according to the indications, the method of use and in the doses indicated in the instructions.

Overdose

Symptoms: gastrointestinal disorders (diarrhea, nausea, vomiting, anorexia, epigastric pain), increased prothrombin time, bleeding after 12-48 hours, lethargy, drowsiness, depression, headache, tinnitus, impaired consciousness, heart rhythm disorders, decreased blood pressure, manifestations of hepatotoxicity and nephrotoxicity, convulsions, possible development of hepatonecrosis. If an overdose is suspected, seek immediate medical attention.

Treatment: gastric lavage during the first 4 hours; alkaline drinking, forced diuresis; activated charcoal inside, use of SH-group donors and precursors of glutathione-methionine synthesis 8-9 hours after overdose and N-acetylcysteine inside or intravenously-after 12 hours antacids; hemodialysis; symptomatic therapy.

The need for additional therapeutic measures (further use of methionine, intravenous use of N-acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after taking it.

Description

Tablets are oval in shape, biconvex, covered with a film-coated white or almost white color. Roughness of the tablet surface is allowed. On a cross-section – the core is white or almost white in color.

Special instructions

It is recommended to take the drug in the shortest possible course and in the minimum effective dose necessary to eliminate symptoms.

In patients with acute bronchial asthma or allergic diseases, as well as in patients with a history of bronchial asthma/allergic disease, the drug may provoke bronchospasm.

The use of the drug in patients with systemic lupus erythematosus or mixed connective tissue disease is associated with an increased risk of aseptic meningitis.

Patients with hypertension, including a history of hypertension and/or chronic heart failure, should consult a doctor before using the drug, as the drug can cause fluid retention, increased blood pressure and edema.Patients with uncontrolled hypertension, NYHA class II-III congestive heart failure, coronary artery disease, peripheral artery disease, and/or cerebrovascular disease should only be prescribed ibuprofen after careful benefit-risk assessment, and high doses of ibuprofen (≥2400 mg/day) should be avoided.

The use of NSAIDs in patients with chickenpox may be associated with an increased risk of developing severe purulent complications of infectious and inflammatory diseases of the skin and subcutaneous fat (for example, necrotizing fasciitis). In this regard, it is recommended to avoid using the drug for chickenpox.

Information for women planning pregnancy: the drug suppresses COX and prostaglandin synthesis, affects ovulation, disrupting female reproductive function (reversible after discontinuation of the drug).

Concomitant use of the drug with other medicinal products containing paracetamol and/or non-steroidal anti-inflammatory drugs should be avoided. When using the drug for more than 5-7 days as prescribed by a doctor, peripheral blood parameters and liver function should be monitored.

With the simultaneous use of indirect anticoagulants, it is necessary to monitor the parameters of the blood coagulation system.

In order to avoid possible damaging effects on the liver, alcohol should not be consumed during the period of taking the drug.

The drug may distort the results of laboratory tests in the quantitative determination of glucose, uric acid in blood serum,17-ketosteroids (it is necessary to cancel the drug 48 hours before the study).

Influence on the ability to drive vehicles and mechanisms

During treatment, the patient should refrain from engaging in potentially dangerous activities that require increased attention and speed of psychomotor reactions.

Form of production

Film-coated tablets,400 mg + 325 mg.

10,20 tablets in polymer cans made of polyethylene or polypropylene with a screw-on or tensioned lid made of low-pressure polyethylene and high-pressure polyethylene. In the absence of a cork sealer, the free space in the jar is filled with medical hygroscopic cotton wool or a shock absorber.

5,10,20 tablets in a contour cell package made of polyvinyl chloride film and aluminum foil printed varnished.

1 jar or 1,2,4 contour cell packages with instructions for use are placed in a pack of cardboard.

Storage conditions

At a temperature not exceeding 25 °C. Do not use after the expiration date.

Shelf

life is 2 years. Keep out of reach of children.

Active ingredient

: Ibuprofen, Paracetamol

Dosage form

Tablets