Некст

General characteristics. Structure:

Active agents: ibuprofen of 400 mg, paracetamol of 200 mg.

Excipients: kernel: calcium hydrophosphate (Fudzhikalin) - 80,0 mg, cellulose microcrystallic - 39,0 mg, croscarmellose sodium - 24,3 mg, a hypro rod (hydroxypropyl cellulose (Klutsel EF)) - 44,8 mg, talc - 12,1 mg, magnesium stearate - 7,3 mg, silicon dioxide colloid (aerosil) - 2,5 mg.

Cover: OPADRAY 20A250004 RED (OPADRY 20A250004 RED) [a gipromelloza (hydroxy - a propilmetiltsellyuloza) - 13,1 mg, a hypro rod (hydroxypropyl cellulose) - 8,1 mg, talc - 6,4 mg, titanium dioxide - 2,5 mg, dye crimson [Ponso 4R] (E124) - 0,9 mg, dye a sunset yellow (E110) - 0,5 mg] - 31,5 mg, OPADRAY II 85F19250 TRANSPARENT (OPADRY II 85F19250 CLEAR) [a macrogoal (polyethyleneglycol) - 1,3 mg, polyvinyl alcohol - 4,4 mg, polysorbate of 80 - 0,3 mg, talc - 2,5 mg] - 8,5 mg.

Pharmacological properties:

Pharmacodynamics. The combined drug, has analgetic, antiinflammatory and febrifugal effect.

Paracetamol - non-narcotic analgesic, has the febrifugal and anesthetizing effect caused by blockade of cyclooxygenase in the central nervous system and impact on the centers of pain and thermal control.

The ibuprofen - non-steroidal anti-inflammatory drug, has the analgeziruyushchy, antiinflammatory and febrifugal effect connected with non-selective suppression of activity of the cyclooxygenase regulating synthesis of prostaglandins.
Components of drug influence both on central, and on peripheral mechanisms of formation of a pain syndrome. The bystry therapeutic effect and the expressed analgeziruyushchy action has the directed, complementary effect of two components.

Pharmacokinetics.
Paracetamol
Absorption - high, maximum concentration (Cmax) makes 5-20 mkg/ml, time of achievement of the maximum concentration (Tcmax) – 0,5-2 h; communication with proteins of plasma - 15%. Gets through a blood-brain barrier.
It is metabolized in a liver, with formation of both active, and inactive metabolites.
Elimination half-life (T1/2) - 1-4 hours. It is preferential removed by kidneys in the form of metabolites - glucuronides and sulfates, 3% - in not changed look.

Ibuprofen.
It is well absorbed from digestive tract. Time of achievement of the maximum concentration (Tcmax) at reception on an empty stomach - 45 min., at reception after food – 1,5-2,5 h. Communication with proteins of plasma - 90%. Concentration of drug in synovial fluid exceeds the content in plasma.
Is exposed to presistemny and post-system metabolism in a liver. Has two-phase kinetics of removal, T1/2 is equal to 2-2,5 h. It is removed by kidneys (in not changed look no more than 1%) and to a lesser extent - with bile.

Indications to use:

- headache (including migraine);
- dentagra;
- альгодисменорея (painful periods);
- neuralgia;
- mialgiya;
- dorsodynias;
- joint pains, a pain syndrome at inflammatory and degenerative diseases of a musculoskeletal system;
- pains at bruises, stretchings, dislocations, fractures;
- posttraumatic and postoperative pain syndrome;
- feverish states (including at flu and catarrhal diseases).

Route of administration and doses:

Inside, after food.
Adult: on 1 tablet 3 times a day. The maximum daily dose - 3 tablets.
To children 12 years are more senior (body weight more than 40 kg): on 1 tablet 2 times a day.
Duration of treatment is no more than 3 days as an antipyretic and no more than 5 days - as anesthetic. Treatment continuation by drug perhaps only after consultation with the doctor.

Features of use:

It is necessary to avoid simultaneous use of drug with other medicines containing paracetamol and/or non-steroidal anti-inflammatory drugs.

At drug use more than 5-7 days it is necessary to control indicators of peripheral blood and a functional condition of a liver.

Paracetamol distorts results of laboratory researches of content of glucose and uric acid in a blood plasma.

At emergence of symptoms of the NPVP-gastropathy the careful control including carrying out an ezofagogastroduodenoskopiya, blood test with definition of hemoglobin and a hematocrit, the analysis a calla on the occult blood is shown.

In need of definition of 17 ketosteroids drug should be cancelled in 48 hours prior to a research.

Against the background of administration of drug patients should abstain from all types of activity requiring special attention, bystry mental and motor reaction.

During treatment reception of alkogolsoderzhashchy drinks is not recommended.

Side effects:

From a nervous system: headache, dizziness, sleep disorders, uneasiness, depression.
From cardiovascular system: tachycardia, increase in arterial pressure, heart failure.
From respiratory system: asthma, bronchospasm.
From digestive tract: abdominal pains, nausea, vomiting, heartburn, loss of appetite, diarrhea or lock, meteorism, ulceration of a mucous membrane of gums, aphthous stomatitis, pancreatitis.
Sense bodys: hearing disorder, ring or sonitus, vision disorders, illegibility of sight or diplopia, dryness and irritation of eyes.
From an urinary system: acute renal failure, nephrotic syndrome, polyuria, cystitis.
Allergic reactions: skin rash, skin itch, allergic rhinitis, Quincke's disease, mnogoformny exudative erythema (including Stephens-Johnson's syndrome), toxic epidermal necrolysis (Lyell's disease).
From bodies of a hemopoiesis: anemia, thrombocytopenia, Werlhof's disease, agranulocytosis, leukopenia, eosinophilia.
At prolonged use in high doses - hepatotoxic and nephrotoxic (hepatitis, intersticial nephrite and a papillary necrosis) action; hemolitic anemia, aplastic anemia, methemoglobinemia, pancytopenia.

Interaction with other medicines:

Inductors of a microsomal oxidation in a liver (Phenytoinum, ethanol, barbiturates, флумецинол, rifampicin, phenylbutazone, tricyclic antidepressants) increase products of hydroxylated active metabolites that causes a possibility of development heavy an intoksika
Inhibitors of a microsomal oxidation (including Cimetidinum) reduce risk of a hepatotoxic action.
Myelotoxic medicines strengthen manifestations of a gematotoksichnost of drug.
The ibuprofen combination to ethanol, glucocorticosteroids increases risk of an erosive canker of digestive tract.
Simultaneous use of paracetamol with ethanol increases risk of developing of acute pancreatitis.
Paracetamol and ibuprofen strengthen effect of anticoagulants of indirect action and reduce efficiency of uricosuric drugs.
Long use of barbiturates reduces efficiency of paracetamol.
Diflunisal increases plasma concentration of paracetamol for 50% that increases risk of development of a hepatotoxic.
The ibuprofen reduces hypotensive activity of vazodilatator, natriuretic and diuretic - furosemide and a hydrochlorothiazide.
Antacids and Colestyraminum reduce absorption of an ibuprofen.
The ibuprofen strengthens effect of peroral hypoglycemic means and insulin.
The ibuprofen increases concentration in blood of digoxin, drugs of lithium and a methotrexate.
At co-administration with acetylsalicylic acid the ibuprofen reduces its antiinflammatory and antiagregantny action.
Tsefamandol, цефаперазон, цефотетан, valproic acid, пликамицин increase the frequency of development of a prothrombinopenia.

Contraindications:

- hypersensitivity to drug components;
- erosive and ulcer diseases of bodies of digestive tract (in an aggravation phase), gastrointestinal bleeding;
- heavy liver and/or renal failure;
- disturbances of coagulability of blood (hemophilia, lengthening of a bleeding time, tendency to bleedings, hemorrhagic diathesis);
- a full or incomplete combination of bronchial asthma, the nose recuring a polypose and okolonosovy bosoms and intolerance of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, including in the anamnesis;
- a state after performing aortocoronary shunting;
- the confirmed hyperpotassemia;
- deficit glyukozo-6-fosfatdegidrogenazy;
- pregnancy (III trimester);
- children's age up to 12 years.

With care
Chronic heart failure; a viral hepatitis, alcoholic damage of a liver, a liver and/or renal failure of average and easy severity, high-quality hyperbilirubinemias (Gilbert's syndrome, the Cudgel Johnson and the Rotor), cirrhosis with portal hypertensia, a nephrotic syndrome; a diabetes mellitus, diseases of peripheral arteries, a peptic ulcer of a stomach and duodenum (in the anamnesis); gastritis, enteritis, colitis; bronchial asthma, bronchospasm; advanced age; pregnancy (I and II trimesters - use is possible only on doctor's orders when the potential advantage exceeds possible risk), the lactation period (in need of use of drug during breastfeeding it is necessary to stop feeding by a breast).

Use at pregnancy and a lactation
In need of use of drug in I and II trimesters of pregnancy it is necessary to be careful - use is possible only on doctor's orders when the potential advantage exceeds possible risk. Use of drug in the III trimester of pregnancy is contraindicated.

During breastfeeding in need of use of drug it is necessary to stop feeding by a breast.

Overdose:

Symptoms: an abdominal pain, nausea, vomiting, excitement or block, drowsiness, confusion of consciousness, tachycardia, arrhythmia, an acute renal failure, a metabolic acidosis, the speeded-up urination, a hyperthermia, a headache, a tremor or muscular twitchings; increase in activity of "hepatic" transaminases, increase in a prothrombin time. At suspicion on overdose it is necessary to ask for medical assistance immediately.

Treatment: a gastric lavage, with the subsequent purpose of absorbent carbon; alkaline drink, artificial diuresis, symptomatic therapy.

Storage conditions:

At a temperature not above 25 °C.
To store in the place, unavailable to children.

Issue conditions:

Without recipe

Packaging:

Tablets, film coated, 400 mg + 200 mg.
On 2, 6, 10 or 12 tablets in a blister strip packaging.
1 or 2 blister strip packagings with the application instruction in a pack from a cardboard.