Ibuclin, pills 400 mg +325 mg 10 pcs.

Composition

Each film-coated tablet contains:Active ingredients:ibuprofen 400 mg and paracetamol 325 mg. Auxiliary substances:microcrystalline cellulose 120 mg, corn starch 76 mg, glycerol 3 mg, sodium carboxymethyl starch (type A) 7 mg, colloidal silicon dioxide 5 mg, talc 8 mg, magnesium stearate 6 mg. Shell:hypromellose 6 CPS to 11.32 mg, dye sunset yellow (E 110) lacquer aluminum 1,78 mg, macrogol-6000 2.2 mg, talc 4,06 mg, titanium dioxide 0.16 mg, Polysorbate-80 0,16 mg, sorbic acid 0.16 mg, Dimethicone 0,16 mg.

Pharmacological action

Pharmacodynamically the drug, which is due to its constituent components. 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 ibuprofenabsorption is high, rapidly and almost completely absorbed from the gastrointestinal tract. The time to reach the maximum concentration (TCmax) after oral administration is about 1-2 hours. The relationship with plasma proteins is more than 90%. The half-life (T1 / 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. paracetamolabsorption 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 value of Cmax is 5-20 micrograms / ml, TCmax is 0.5-2 hours. 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-n-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. T1 / 2 – 2-3 hours. In patients with cirrhosis of the liver, T1 / 2 slightly increases. In elderly patients, drug clearance decreases and T1 increases/2. 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 therapy of infectious and inflammatory diseases (colds, flu), accompanied by high fever, chills, headache, pain in muscles and joints, sore throat and
• myalgia;
• neuralgia;
• pain in back;
• pain in the joints, pain syndrome with inflammatory and degenerative diseases of the musculoskeletal system;
• pain from bruises, sprains, dislocations, fractures;
• post-traumatic and postoperative pain;
• toothache;
• algomenorrhea (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 use of Ibuclin® is possible only 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 components of Ibuclin®have not been established. Before using Ibuclin®, if you are pregnant or believe 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.
• Lesions of 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-it is possible to 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

Disorders of the gastrointestinal tract: gastropathy – nausea, vomiting, heartburn, anorexia, epigastric discomfort or pain, diarrhea, flatulence; rarely-erosive and ulcerative lesions, bleeding; impaired liver function, hepatitis, pancreatitis; irritation or dryness in the oral cavity, pain in the mouth, ulceration of the gum mucosa, 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 systemanemia (including hemolytic and aplastic), thrombocytopenia, thrombocytopenic purpura, agranulocytosis, leukopenia, pancytopenia.Respiratory and mediastinal disorders Shortness of breath, bronchospasm, and bronchial asthma. Renal and urinary tract disorders Allergic nephritis, acute renal failure, nephrotic syndrome, edema, polyuria, cystitis, hematuria, proteinuria, nephritic syndrome, papillary necrosis, interstitial nephritis. Allergic reactionscutaneous rash, pruritus, urticaria, angioedema, bronchospasm, dyspnea, 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. Prochieinceneration of 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

• When taken concomitantly with acetylsalicylic acid, ibuprofen reduces its anti-inflammatory and antiplatelet effects (it is possible to increase the frequency of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent after starting ibuprofen).

• Ibuprofen increases the effect of direct (heparin) and indirect (coumarin and indandione derivatives) anticoagulants, thrombolytic agents (alteplase, anistreplase, streptokinase, urokinase), antiplatelet agents — colchicine-increases the risk of hemorrhagic complications.

• Increases the hypoglycemic effect of insulin and oral hypoglycemic drugs.

• Reduces the effects of antihypertensive drugs and diuretics (by inhibiting the synthesis of renal PG).

• Increases the concentration of digoxin, lithium and methotrexate in the blood.

• Caffeine enhances the analgesic effect of ibuprofen.

• Cyclosporine and gold preparations increase nephrotoxicity.

• Cefamandol, cefoperazone, cefotetan, valproic acid, and plicamycin increase the incidence of hypoprothrombinemia.

• Antacids and colestyramine reduce the absorption of the drug.

• Myelotoxic drugs contribute to the manifestation of hematotoxicity of the drug.

How to take, course of administration 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 (diarrhoea, nausea, vomiting, anorexia, epigastric pain), increased blood pressure PV, bleeding after 12-48 hours, lethargy, drowsiness, depression, headache, tinnitus, impaired consciousness, cardiac arrhythmias, decreased blood pressure Blood pressure, manifestations of hepatotoxicity and nephrotoxicity, seizures, 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; administration of activated charcoal, administration of SH-group donors and glutathione synthesis precursor-methionine-8-9 hours after overdose and N-acetylcysteine orally or intravenously after 12 hours, antacids; hemodialysis; symptomatic therapy. The need for additional therapeutic measures (further administration of methionine, intravenous administration of N-acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after taking it.

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

Form of production

Ibuclin tablets, orange-coated, capsule-shaped, with a risk on one side; for individual tablets, marbling of color is allowed.

Storage conditions

At a temperature not exceeding 25 °C. Keep out of reach of children!

Shelf life

5 years

Active ingredient

: Ibuprofen, Paracetamol

Dosage form

Tablets

Indications

Joint pain, Acute respiratory viral infections, Myalgia, Fever, Neuralgia, Painful Menstruation, Bruises, Headache, Toothache

Weight

Weight: 20 g.