Next, pills 400 mg+200 mg 20 pcs.

Composition

Active ingredients: ibuprofen-400 mg, paracetamol-200 mg.

Auxiliary substances:

core: calcium hydrophosphate-80.0 mg, microcrystalline cellulose-64.5 mg, croscarmellose sodium-24.3 mg, hyprolose (hydroxypropylcellulose) – 19.3 mg, talc-12.1 mg, magnesium stearate-7.3 mg, colloidal silicon dioxide (aerosil) – 2.5 mg;

shell:

OPADRY 20 AND 250004 RED (OPADRY 20 AND 250004 RED) [hypromellose (hydroxypropyl methylcellulose) – 13,1 mg hyprolose (hydroxypropyl cellulose) and 8.1 mg, talc – 6,4 mg, titanium dioxide – 2,5 mg, dye crimson [Ponceau 4R] (E 124) 0.9 mg, dye sunset yellow (E 110) – 0.5 mg] – 31,5 mg, OPADRY II 85F19250 TRANSPARENT (OPADRY II CLEAR 85F19250) [macrogol (polyethylene glycol) – 0.3 mg, polyvinyl alcohol – 1.0 mg, Polysorbate 80,0.1 mg, talc – 0.6 mg] – 2,0 mg.

Pharmacological properties

Pharmacotherapeutic group:

analgesic tool combo

(NSAID + non-narcotic analgesic agent)

ATX code: M 01 AE 51

Pharmacological properties

Pharmacodynamics

Combined drug, has analgesic, anti-inflammatory and antipyretic effects.

Paracetamol is a non-narcotic analgesic, has an antipyretic and analgesic effect due to the blockade of cyclooxygenase in the central nervous system and the effect on the pain centers and thermoregulation.

Ibuprofen is a nonsteroidal anti-inflammatory drug that has analgesic, anti-inflammatory and antipyretic effects associated with non-selective suppression of cyclooxygenase activity, which regulates prostaglandin synthesis.

The components of the drug affect both the central and peripheral mechanisms of pain syndrome formation. The directed, complementary action of the two components has a rapid therapeutic effect and a pronounced analgesic effect.

Pharmacokinetics

Paracetamol

Absorption is high, the maximum concentration (cmax) is 5-20 mcg / ml, the time to reach the maximum concentration (tmax) is 0.5-2 hours; plasma protein binding is 15%. Penetrates the blood-brain barrier.

It is metabolized in the liver by glucuronidation, sulfation and hydroxylation, with the formation of both active and inactive metabolites. An isoenzyme of the cytochrome P450 CYP2 E1 system participates in the metabolism of paracetamol.

The elimination half-life (T_1/2) is 1-4 hours. Mainly excreted by the kidneys in the form of metabolites-glucuronides and sulfates,3% – unchanged.

Ibuprofen

It is well absorbed from the gastrointestinal tract. The time to reach the maximum concentration (tmax) when taken on an empty stomach is 45 minutes, when taken after meals – 1.5 – 2.5 hours. The relationship with plasma proteins is 90%. The concentration of the drug in synovial fluid exceeds the content in plasma.

It undergoes presystemic and post-systemic metabolism in the liver. The cytochrome P450 isoenzyme CYP2C9 is involved in the metabolism of ibuprofen.

It has a two-phase elimination kinetics, T_1/2 is 2-2.5 h. It is excreted by the kidneys (no more than 1% unchanged) and to a lesser extent – with bile.

Indications

: Headache (including migraine);

– toothache;

– algomenorrhea (painful menstruation);

– ophthalmology;

– myalgia;

pain in back;

joint pain, pain syndrome with inflammatory and degenerative diseases of the musculoskeletal system;

pain from bruises, sprains, dislocations, fractures;

post – traumatic and postoperative pain;

– fevers (including the flu and colds).

The drug is used as a means of symptomatic treatment of febrile conditions, headache, muscle pain in acute respiratory diseases and influenza. 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

If it is necessary to use the drug in the first and second trimester of pregnancy, caution should be exercised – use is possible only as prescribed by a doctor in cases where the potential benefit outweighs the possible risk. The use of the drug in the third trimester of pregnancy is contraindicated.

During breastfeeding, if necessary, the use of the drug should stop breastfeeding.

Contraindications

– Hypersensitivity to the components of the drug, including other nonsteroidal anti-inflammatory drugs (NSAIDs);

– erosive and ulcerative diseases of the gastrointestinal tract (in acute phase), gastro-intestinal bleeding;

a progressive kidney disease;

– severe renal impairment (creatine clearance (CC) of less than 30 ml/min);

– severe hepatic impairment or active liver disease;

– disorders of blood clotting (hemophilia, prolonged bleeding time, a tendency to bleeding, hemorrhagic diathesis);

– cerebrovascular or other bleeding;

– complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, including in the anamnesis;

– chronic heart failure (functional class III-IV NYHA classification);

– status after conducting coronary artery bypass grafting;

– confirmed hyperkalemia;

– deficiency of glucose-6-phosphate dehydrogenase;

– pregnancy (III trimester);

– the period of breastfeeding;

– children’s age till 18 years.

With caution in

Chronic heart failure, viral hepatitis, alcoholic liver disease, hepatic and/or renal failure moderate and mild, benign hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor), liver cirrhosis with portal hypertension, nephrotic syndrome; diabetes mellitus, peripheral artery disease, peptic ulcer of stomach and duodenum (in the anamnesis); gastritis, enteritis, colitis, bronchial asthma, bronchospasm; elderly; pregnancy (I and II trimesters – the application is possible only on prescription in cases when the potential benefit outweighs the potential risk).

Side effects

Side effects are listed with an indication of the frequency of occurrence according to the WHO classification: very common (with a frequency of more than 1/10), common (with a frequency of at least 1/100, but less than 1/10), infrequent (with a frequency of at least 1/1000, but less than 1/100), rare (with a frequency of at least 1/10000, but less than 1/1000), very rare (with a frequency of less than 1/10000, including isolated reports), the frequency is unknown (cannot be determined from available data).

From the nervous system: infrequently-headache, dizziness, sleep disorders, anxiety, hallucinations, confusion, rarely-aseptic meningitis, very rarely-depression.

From the cardiovascular system: often-peripheral edema, very rarely – tachycardia, increased blood pressure, heart failure.

From the respiratory system: very rarely – shortness of breath, bronchospasm.

From the gastrointestinal tract: often-abdominal pain, nausea, vomiting, heartburn, decreased appetite, diarrhea, flatulence, erosive and ulcerative lesions of the gastrointestinal tract; infrequently-constipation, ulceration of the gum mucosa, aphthous stomatitis, pancreatitis, gastrointestinal bleeding.

Sensory organs: very rare-hearing disorders, ringing or tinnitus, visual disturbances, blurred vision or diplopia, frequency unknown-dry and irritated eyes.

From the urinary system: very rarely – acute renal failure, nephrotic syndrome, cystitis; frequency unknown-polyuria.

Allergic reactions: infrequently-skin rash, pruritus, allergic rhinitis, angioedema; very rarely-erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome).

Hematopoietic disorders: very rare – anemia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis, leukopenia, eosinophilia.

From the skin and subcutaneous tissues: often-hyperhidrosis.

With prolonged use in large doses – hepatotoxic and nephrotoxic effects (hepatitis, interstitial nephritis and papillary necrosis); hemolytic anemia, aplastic anemia, methemoglobinemia, pancytopenia.

If you experience side effects, you should consult a doctor.

Interaction

Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, which causes the possibility of severe intoxication in overdose.

Microsomal oxidation inhibitors (including cimetidine) reduce the risk of hepatotoxic effects.

Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.

Cyclosporine and gold preparations increase the nephrotoxicity of the drug.

The combination of ibuprofen with ethanol, glucocorticosteroids increases the risk of erosive and ulcerative lesions of the gastrointestinal tract.

Concomitant use of paracetamol with ethanol increases the risk of acute pancreatitis.

Paracetamol and ibuprofen enhance the effect of indirect anticoagulants and reduce the effectiveness of uricosuric drugs.

Long-term use of barbiturates reduces the effectiveness of paracetamol.

Diflunisal increases the plasma concentration of paracetamol by 50%, which increases the risk of hepatotoxicity.

Ibuprofen reduces the hypotensive activity of vasodilators, natriuretic and diuretic-furosemide and hydrochlorothiazide.

Antacids and colestyramine reduce the absorption of ibuprofen.

Caffeine increases the analgesic effect of ibuprofen.

Ibuprofen enhances the effect of oral hypoglycemic agents and insulin.

Ibuprofen increases the concentration of digoxin, lithium and methotrexate in the blood.

When administered concomitantly with acetylsalicylic acid, ibuprofen reduces its anti-inflammatory and antiplatelet effects.

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

How to take, course of administration and dosage

Inside, after eating. 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.

Overdose

Symptoms: abdominal pain, nausea, vomiting, agitation or lethargy, drowsiness, confusion, tachycardia, arrhythmia, acute renal failure, metabolic acidosis, frequent urination, hyperthermia, headache, tremor or muscle twitching; increased activity of “liver” transaminases, increased prothrombin time. If an overdose is suspected, seek immediate medical attention.

Treatment: gastric lavage, followed by the appointment of activated charcoal; alkaline drinking, forced diuresis, symptomatic therapy, administration of donors of sulfhydryl groups (acetylcysteine) and precursors of glutathione synthesis (methionine).

Special instructions

Concomitant use of the drug with other medicinal products containing paracetamol and/or non-steroidal anti-inflammatory drugs should be avoided.

When used concomitantly with indirect anticoagulants, monitoring of hemostatic parameters is necessary.

When using the drug for more than 5-7 days, peripheral blood parameters and the functional state of the liver should be monitored.

Paracetamol distorts the results of laboratory tests of glucose and uric acid in blood plasma.

If symptoms of NSAID-induced gastropathy (nausea, vomiting, abdominal pain, heartburn, decreased appetite, flatulence, epigastric discomfort) appear, careful monitoring is indicated, including esophagogastroduodenoscopy, a blood test to determine hemoglobin and hematocrit, and a fecal occult blood test.

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.

During the treatment period, it is not recommended to take alcoholic beverages.

Influence on the ability to drive vehicles and mechanisms

While taking the drug, patients should refrain from all activities that require increased attention, rapid mental and motor reactions.

Form of production

Tablets

Storage conditions

 In a dark place, at a temperature not exceeding 25 °C.

Shelf life

2 years

Active ingredient

: Ibuprofen, Paracetamol

Dosage form

Tablets

Purpose

Children over 12 years of age, Pregnant women in the first and second trimester as prescribed by a doctor, For adults

Indications

Tendon Inflammation, Lumbago, Sprains and Sprains, Arthritis, Osteochondrosis, Flu, Neuritis, Colds, Migraines, Bursitis, Myositis, Sciatica, Osteoarthritis

Weight

Weight: 30 gr.