Flamidez

General characteristics. Structure:

Active ingredient: 500 mg of paracetamol, 50 mgdiklofenak of potassium, 15 mg of a serratiopeptidaza of equivalent fermental activity of 30 000 PIECES in the form of granules.

Excipients: the tselyulloza is microcrystallic; starch corn; povidone (K-30); lactose, monohydrate;  gipromelloza; polyethyleneglycols (PEG 6000) ; titanium dioxide (Е 171); talc; polisorbat (80); tartrazine (Е 102); опадрай white 58901.

Excipients of granules of a serratiopeptidaza: sodium of a kroskarmelloz, magnesium stearate, silicon dioxide of koloidniya anhydrous, cellulose microcrystallic.

Complex analgetic, antipyretic, antiinflammatory, fibrinolitic and antiedematous drug.

Pharmacological properties:

Pharmacodynamics. Flamidez contains potassium diclofenac, a serratiopeptidaza and paracetamol which potentiate and supplement action of each other.
Diclofenac of potassium and paracetamol nonsteroid antiinflammatory substances with the expressed analgetic activity. Diclofenac of potassium and paracetamol not selectively inhibit cyclooxygenase, breaking products of prostaglandins and prostacyclins. Diclofenac has the antiinflammatory, anesthetizing and febrifugal activity. Paracetamol has preferential analgetic and antipyretic effect while antiinflammatory effect of paracetamol is insignificant (owing to a substance inactivation cellular peroxidases). Besides, diclofenac of potassium reduces emission of lizosomalny enzymes and synthesis of proteoglycan in cartilaginous tissue oppresses.

Serratiopeptidaza – the proteolytic enzyme received from a nonpathogenic colibacillus of Serratia E 15. Serratiopeptidaza has the expressed fibrinolitic, antiedematous and antiinflammatory activity, and also has some analgetic effect due to oppression of release of painful amines. Serratiopeptidaza due to hydrolysis of a histamine, bradikinin and serotonin reduces dilatation of capillaries, normalizes permeability of a vascular wall, and also due to oppression of activity of inhibitors of plasmin increases fibrinolitic effect of plasmin.

Active components of drug Flamidez are well absorbed at oral administration. The peak of plasma concentration of diclofenac of potassium is noted 1-2 hours later after reception, paracetamol – 10-60 minutes after reception, and a serratiopeptidaza – 30-120 minutes after reception. Paracetamol and diclofenac of potassium are metabolized in a liver.

Pharmacokinetics. Paracetamol after intake quickly and almost is completely soaked up from a digestive tract, the maximum concentration in a blood plasma is reached in 10-60 min. Linkng with proteins of plasma represents about 10%. Metabolism happens in a liver preferential in pharmacological inactive metabolites ‒ a glucuronide (60-80%) and paracetamol sulfate (20-30%). Less than 4% are metabolized by oxidation with formation of cysteine and merkaptopurovy acid (with P450 cytochrome participation). The elimination half-life makes about 2-2,5 hours. It is removed with urine, generally in the form of metabolites. In an invariable look about 5% are removed. Metabolism of paracetamol at a liver failure does not change.

Potassium diclofenac after reception inside is quickly soaked up, the food can slow down absorption speed, without influencing its completeness. The maximum concentration in plasma is reached in 1-2 hours. Bioavailability ‒ 50%; intensively gives in to presistemny   elimination. Communication with proteins of a blood plasma ‒ is more than 99%. Well gets into fabrics and synovial fluid where its concentration grows more slowly, in 4 hours reaches values above, than in a blood plasma. About 35% are removed in the form of metabolites with a stake; about 65% are metabolized in a liver and removed by kidneys in the form of inactive derivatives (in an invariable look less than 1% are removed). Elimination half-life ‒ about 2 hours, synovial fluid ‒ 3-6 hours; at observance of the recommended interval between receptions does not kumulirut.

Serratiopeptidaza gets through a stomach wall in an invariable look and is absorbed in intestines. In insignificant quantity is defined in urine.

Indications to use:

Flamidez is intended for therapy of patients with the musculoskeletal system diseases (preferential joints) which are followed by the expressed pain syndrome. Including Flamidez appoint to the patients suffering from a pseudorheumatism, an osteoarthritis, and also postoperative and posttraumatic pain.

Flamidez appoint to patients with a mialgiya and an ostealgia which is followed by fervescence, and also in gynecologic practice for therapy of the patients having inflammatory diseases with a pain syndrome.

Flamidez can be appointed to the patients having sinusitis and other diseases of ENT organs with the expressed inflammatory process and a pain syndrome.

Drug Flamidez is used in complex therapy of cystitis, epididymite, alveolar abscess.

Drug can be appointed as analgetic means after tooth excretion.

Route of administration and doses:

Flamidez is intended for intake. Tablets, coated, Flamidez it is necessary to accept entirely, washing down with a large amount of drinking water. Flamidez is recommended to accept drug after meal. Flamidez determines duration of therapy and a dose of drug the doctor.

Purpose of 1 tablet twice or three times a day is, as a rule, recommended to adults.
Purpose of 1 tablet one or two of time a day is, as a rule, recommended to teenagers.
At long therapy it is necessary to reduce a dose of drug to 2 tablets a day for adults and 1 tablet a day for teenagers.

The maximum recommended daily dose of drug Flamidez for adults makes 3 tablets.

Drug should be accepted during the minimum period before elimination of symptoms of a disease. In case of need appoint a repeated course of therapy

Features of use:

Drug use Flamidez during pregnancy is forbidden. Before therapy at women of reproductive age it is necessary to exclude pregnancy.

If it is impossible to avoid administration of drug Flamidez in the period of a lactation it is necessary to resolve an issue of breastfeeding interruption as active components of drug get into breast milk.

Flamidez can slow down psychomotor reactions therefore it is necessary to refrain from control of vehicles or work with difficult mechanisms during drug use.

To take drug the patient with bronchial asthma, seasonal allergic rhinitis, a rhinedema, chronic obstructive diseases of lungs with caution or persistent infections of the airways (which are especially tied with allergic symptoms similar to rhinitises) in which is more often than others there are reactions similar to an exacerbation of asthma, a Quincke's edema or a small tortoiseshell. In this regard special measures of restraint are recommended to such patients. Flamidez patients need to take with caution with symptoms which demonstrate disturbance from a digestive tract or in the anamnesis of which there is stomach ulcer or intestines, bleeding or perforation; inflammatory diseases of intestines, such as disease Krone or nonspecific ulcer colitis. At use of this drug gastrointestinal bleeding, an ulcer or perforation can be lethal and can arise throughout treatment, with/without precautionary symptoms or the serious gastrointestinal phenomena in the anamnesis at any time.

With care patients who receive the accompanying drugs which can increase risk of an ulcer or bleeding, such as system corticosteroids, anticoagulants, antitrombotichesky means or the selection inhibitors of the return hobby of serotonin should apply Flamidez.

Patients with abnormal liver functions at Flamidez's use need careful medical supervision as their state can worsen. Level of one and more hepatic enzymes can raise. If abnormal liver functions remain or worsen if clinical signs or symptoms can be connected with the progressing diseases of a liver or if other manifestations are observed (for example an eosinophilia, a rash), uses of drug should be stopped. The course of diseases, such as hepatitises, can pass without prodromal symptoms.

Flamidez is not recommended for treatment of postoperative pain and during operation of aortocoronary shunting.

Flamidez patients should take with caution with a renal failure (including a functional renal failure against the background of a hypovolemia, a nephrotic syndrome, a vovlchankovy nephropathy and dekompensirovanny cirrhosis), arterial hypertension in the anamnesis, the patient of advanced age, the patient who receive the accompanying therapy by diuretics or drugs which significantly influence renal function, and for patients with essential decrease in extracellular volume of liquid for any reason, for example to or after serious surgical intervention as it was reported about a delay of liquid and hypostasis. In such cases as measures of restraint monitoring of renal function is recommended. The therapy termination usually predetermines return to a state which preceded treatment.

It is necessary to estimate carefully a ratio risk advantage before appointment to Flamidez to patients with clinically confirmed coronary heart disease, cerebrovascular disorders, obliterating diseases of peripheral arteries or considerable risk factors (for example hypertensia, a hyperglycemia, a diabetes mellitus, smoking).

Through risk of emergence of trombotichesky cardiovascular and cerebrovascular complications; a gastrointestinal ulcer, bleeding or perforation it is necessary to apply the smallest effective doses of drug during the shortest time.

Use of drug should be stopped at the first emergence of rash on skin, damages of mucous membranes or any other signs of hypersensitivity.

Flamidez thanks to the pharmakodinamicheskiy properties can mask signs and symptoms of an infection.

Side effects:

At reception of therapeutic doses of drug Flamidez undesirable effects developed seldom. However it is impossible to exclude development of such side effects during therapy by drug Flamidez:

From gepatobiliarny system and digestive tract: a gastropathy, disturbances of a chair, a loss of appetite, vomiting, nausea, a meteorism, liver depression of function, increase in level of liver enzymes in plasma. Besides, in isolated cases development of hepatitis and erosive cankers of mucous membranes of digestive tract is possible.

From peripheral and central nervous system: tremor of extremities, spasms, dizziness, disturbances of a sleep pattern and wakefulness, hyperexcitability, irritability, fatigue.

From heart, vessels and system of a hemopoiesis: change of arterial pressure, thrombocytopenia, anemia, leukopenia.

Allergic reactions: eczema, Stephens-Johnson's syndrome, erythrosis, bronchospasm, acute anaphylaxis, Quincke's edema, photosensitization.

Others: intersticial nephrite, eosinophilic pneumonia.

Interaction with other medicines:

The combined use of drug Flamidez with other drugs containing non-steroidal anti-inflammatory drugs is forbidden.

Flamidez at the combined use exponentiates effect of indirect anticoagulants and increases risk of development of damages of a liver at simultaneous use with potentially hepatotoxic drugs.

Strengthening of absorption of paracetamol at the combined use with Metoclopramidum and decrease in absorption at the combined use with holestiraminy is noted.

Barbiturates at simultaneous use can reduce antipyretic effect of paracetamol.

Alcohol increases risk of development of a hepatotoxic action of paracetamol.

Increase in plasma concentration of lithium, peroral antidiabetic means, drugs of a hinolonovy row and digoxin at the combined use with drug Flamidez is possible.

Increase in toxicity of a methotrexate, glucocorticosteroids and cyclosporine at the combined use with potassium diclofenac is noted.

The risk of development of a hyperpotassemia at simultaneous use of drug increases Flamidez and kaliysberegayushchy diuretics.

Acetylsalicylic acid at the combined use reduces plasma concentration of diclofenac of potassium.

Strengthening of pharmacological action of coagulants at the combined use with serratiopeptidazy is noted.

Contraindications:

Flamidez do not appoint to patients with individual hypersensitivity to components of drug and other non-narcotic analgesics (including development of an "aspirinovy" triad in the anamnesis).

Tablets, coated, Flamidez patients should not accept with disturbance of absorption of a glyukozo-galactose, a galactosemia and insufficiency of lactase.

Flamidez is not intended for therapy of patients with disturbances of a hemopoiesis of the obscure etiology, cankers of mucous membranes of a duodenum and stomach, and also inflammatory diseases of intestines in an aggravation stage.

Flamidez do not apply in pediatric practice to treatment of children 14 years are younger.
It is necessary to be careful, appointing drug Flamidez to the patients suffering from decrease in functions of a liver and kidneys, dyspepsia after operative measures, a porphyria, bronchial asthma and congestive heart failure and also patients with digestive tract diseases in the anamnesis.

Flamidez patients of advanced age should appoint with care.
It is necessary to avoid driving of the car and control of potentially unsafe mechanisms during therapy by drug Flamidez.

Overdose:

At use of the overestimated drug doses Flamidez at patients development of pallor of integuments, abdominal pains, vomitings, disturbances of functions of a liver and kidneys, and also a headache and dizziness was noted. At drug use Flamidez in the dose, by 10 times exceeding recommended paracetamol overdose development which is followed by hepatotoxic effects, including gepatonekrozy and hepatic encephalopathy up to a coma is possible.

There is no specific antidote. At overdose carrying out a gastric lavage and purpose of enterosorbentny means is shown. Besides, at drug overdose Flamidez purpose of symptomatic means is shown.

At overdose of paracetamol introduction of a specific antidote is shown (methionine orally or Acetylcysteinum intravenously). Drug overdose treatment Flamidez has to take place in hospital conditions at continuous monitoring of function of a liver and kidneys.

Storage conditions:

To store in original packaging in the place, dry, unavailable to children, at a temperature not above 25 degrees Celsius.

Issue conditions:

According to the recipe

Packaging:

On 10 tablets in the blister from aluminum foil. On 1 or 10 blisters in cardboard packaging.