Next - instructions for use, dose, side effects, contraindications

core: calcium hydrophosphate (Fujikalin) - 80.0 mg, microcrystalline cellulose - 64.5 mg, croscarmellose sodium - 24.3 mg, giprolose (hydroxypropylcellulose (Klutsel EF)) - 19.3 mg, talcum - 12.1 mg, magnesium stearate - 7.3 mg, silicon dioxide colloid (aerosil) - 2.5 mg;

shell: DIARREL 20A250004 RED (OPADRY 20A250004 RED) [hypromellose (hydroxypropylmethylcellulose) - 13.1 mg, giprolose (hydroxypropylcellulose) - 8.1Crimson [Ponso 4R] (E 124) - 0.9 mg, dye sunset yellow (E 110) - 0.5 mg] - 31.5 mg, OUDRIDE II 85F19250 TRANSPARENT (OPADRY II 85F19250 CLEAR) macrogol (polyethylene glycol) - 0.3 mg, polyvinyl alcohol - 1.0 mg, polysorbate 80-0,1 mg, talc 0.6 mg] 2.0 mg.

Description:

Oval biconvex tablets, covered with a film coating of red color, with

Riska, in the cross section, the core is white or almost white.

Pharmacotherapeutic group:Analgesic combined (NSAID + analgesic non-narcotic)

ATX: & nbsp

M.01.A.E.51 Ibuprofen in combination with other drugs

Pharmacodynamics:

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

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

Ibuprofen - non-steroidal anti-inflammatory drug, renders Analgesic, anti-inflammatory and antipyretic effects associated with nonselective suppression of cyclooxygenase activity regulating synthesis prostaglandins.

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

Pharmacokinetics:

Paracetamol

Absorption - high, maximum concentration (C_max) is 5-20 μg / ml, time to reach the maximum concentration (T_sst) - 0.5-2 hours; communication with plasma proteins -15%. Penetrates through the blood-brain barrier. Metabolised in the liver, with the formation of both active and inactive metabolites. The half-life (T1 / 2) is 1-4 hours. It is 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) at reception on an empty stomach - 45 minutes, at reception after meal - 1.5-2.5 ч. Communication with fibers of plasma - 90%. The concentration of the drug in the synovial fluid exceeds the content in the plasma. It is subjected to the systemic and post-systemic metabolism in the liver. It has a two-phase kinetics of excretion, T1 / 2 is 2-2.5 hours. It is excreted by the kidneys (unchanged not more than 1%) and to a lesser extent - with bile.

Indications:

- headache (including migraine);

- toothache;

- algodismenorea (painful menstruation);

- neuralgia;

- myalgia;

- back pain;

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

- pain with bruises, sprains, dislocations, fractures;

- post-traumatic and postoperative pain syndrome;

- febrile conditions (including with influenza and colds).

Contraindications:

- hypersensitivity to the components of the drug;

- erosive and ulcerative diseases of the gastrointestinal tract (in the phase of exacerbation), gastrointestinal bleeding;

- severe hepatic and / or renal insufficiency;

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

- complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, incl. in the anamnesis;

- condition after aortocoronary bypass surgery;

- confirmed hyperkalemia;

- deficiency of glucose-6-phosphate dehydrogenase;

- pregnancy (III trimester);

- Children under 12 years old.

Carefully:Chronic heart failure; viral hepatitis, alcoholic liver damage, hepatic and / or renal insufficiency of mild and moderate severity, benign hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor syndrome), liver cirrhosis with portal hypertension, nephrotic syndrome; diabetes, peripheral arterial disease, gastric and duodenal ulcer (in history); gastritis, enteritis, colitis; bronchial asthma, bronchospasm; elderly age; Pregnancy (I and II trimesters - application is possible only according to the doctor's prescription in cases when the potential benefit exceeds the possible risk), lactation period (if breastfeeding is necessary, stop breastfeeding).

Pregnancy and lactation:

If it is necessary to use the drug in the first and second trimester of pregnancy, care should be taken - the application is possible only according to the doctor's prescription in those cases where the potential benefit exceeds the possible risk. The use of the drug in the third trimester of pregnancy is contraindicated.

If breastfeeding is necessary, breast-feeding should be discontinued.

Dosing and Administration:

Inside, after eating.

Adults: 1 tablet 3 times a day. The maximum daily dose is 3 tablets. Children over 12 years of age (body weight over 40 kg): 1 tablet 2 times a day. Duration of treatment no more than 3 days as an antipyretic agent and no more than 5 days - as an anesthetic. Continuation of treatment with the drug is possible only after consulting a doctor.

Side effects:

From the nervous system: headache, dizziness, sleep disorders, anxiety, depression.

From the cardiovascular system: tachycardia, increased blood pressure pressure, heart failure.

On the part of the respiratory system: dyspnea, bronchospasm.

On the part of the gastrointestinal tract: abdominal pain, nausea, vomiting, heartburn, decreased appetite, diarrhea or constipation, flatulence, ulceration of the gingival mucosa, aphthous stomatitis, pancreatitis.

Organs of senses: hearing impairment, ringing or tinnitus, visual impairment, blurred vision or diplopia, dryness and irritation of the eyes.

From the urinary system: acute renal failure, nephrotic syndrome, polyuria, cystitis.

Allergic reactions: skin rash, skin itch, allergic rhinitis, angioedema, multi-form exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome). On the part of the organs of hematopoiesis: anemia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis, leukopenia, eosinophilia.

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

Overdose:

Symptoms: abdominal pain, nausea, vomiting, agitation or inhibition, drowsiness, confusion, tachycardia, arrhythmia, acute renal insufficiency, metabolic acidosis, frequent urination, hyperthermia, headache, tremor, or muscle twitching; an increase in the activity of "hepatic" transaminases, an increase in prothrombin time. If you suspect an overdose, seek medical help immediately.

Treatment: washing the stomach, followed by the appointment of activated charcoal; alkaline drink, forced diuresis, symptomatic therapy.

Interaction:

Inductors of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, which makes it possible to develop severe intoxication during an overdose.

Inhibitors of microsomal oxidation (incl. cimetidine) reduce the risk of hepatotoxic effects.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

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

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

Paracetamol and ibuprofen increase the effect of anticoagulants of indirect action 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 colestramine reduce the absorption of ibuprofen.

Ibuprofen enhances the effect of oral hypoglycemic agents and insulin. Ibuprofen increases the concentration in the blood of digoxin, lithium and methotrexate.

With concomitant administration with acetylsalicylic acid ibuprofen reduces its anti-inflammatory and antiaggregant effect.

Cefamandol, cefaperazone, cefotetan, valproic acid, plikamycin increase the frequency of hypoprothrombinemia.

Special instructions:

The simultaneous use of the drug with other drugs containing paracetamol and / or non-steroidal anti-inflammatory agents.

When using the drug for more than 5-7 days, it is necessary to monitor the peripheral blood and the functional state of the liver.

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

When symptoms of NSAID-gastropathy appear, careful monitoring is performed, including esophagogastroduodenoscopy, a blood test with determination of hemoglobin and hematocrit, and analysis of feces for latent blood.

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

Against the background of taking the drug patients should refrain from all activities that require increased attention, rapid mental and motor reaction.

During the period of treatment, it is not recommended to take alcohol-containing drinks.

Effect on the ability to drive transp. cf. and fur:Against the background of taking the drug patients should refrain from all activities that require increased attention, rapid mental and motor reaction.

Form release / dosage:Tablets, film-coated 400 mg + 200 mg. For 2, 6, 10 or 12 tablets in a planar cell package. 1 or 2 contourcell packs with instructions for use in a pack of cardboard.

Storage conditions:At a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:2 of the year. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-001389

Date of registration:20.12.2011

The owner of the registration certificate:PHARMSTANDART-FORESTRY, OJSC PHARMSTANDART-FORESTRY, OJSC Russia

Manufacturer: & nbsp

PHARMSTANDART-TOMSKHIMFARM, OJSC Russia

Representation: & nbspPHARMSTANDART JSC PHARMSTANDART JSC Russia

Information update date: & nbsp30.06.2014

Illustrated instructions

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