Trombopol 30s 150 mg film-coated tablets solution / intestinal.

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Sku: b4a2b4b7f29a
Ingredient: Acetylsalicylic Acid
The instruction for medical use




of Trombopol Torgovoye medicine a name
Trombopol

Mezhdunarodnoye the unlicensed name
Acetylsalicylic acid

the Dosage form
of the Tablet, covered with a kishechnorastvorimy cover, 75 mg and 150 mg

Structure
One tablet, contains
active agent – acetylsalicylic acid of 75 mg or 150 mg,
excipients: corn starch, cellulose powdery, sodium of starch glikolit,
structure of a cover: hydroksipropilmetiltsellyuloza, copolymer of methacrylic acid, triethyl citrate, titan dioxide, talc, sodium lauryl sulfate, varnish of koshenilovy red E-124, silicon dioxide colloidal, sodium bicarbonate.

The description
of the Tablet, covered with a kishechnorastvorimy cover, pink color, round with a biconvex surface.

Pharmacotherapeutic group Inhibitors of aggregation of thrombocytes.
The code of automatic telephone exchange B01AC06

the Pharmacological

Pharmacokinetics Acetylsalicylic Acid properties quickly and substantially gets into the majority of fabrics and biological liquids of an organism. About 33% of drug contact proteins. The maximum concentration in plasma is observed in 6 hours and makes, on average, 12.7 mkg/ml for tablets of 150 mg and 6.72 mkg/ml for tablets of 75 mg. Existence of food in digestive tract slows down drug absorption. Acetylsalicylic acid is partially metabolized during absorption.
Salicylates conjugate, mainly, with glycine with formation of salitsilurovy acid, and with glucuronic acid with formation of a salitsilfenol and the salitsilatsil-glyukuronat, only their small part is hydroxylated with formation of gentisic acid, 2.3-dihydroxybenzoic and 2,3,5-trigidroksibenzoyny acid.
Elimination half-life (T ½) of acetylsalicylic acid makes 15-20 minutes of plasma.
1% of orally accepted dose of acetylsalicylic acid is removed with urine in the form of not hydrolyzed acetylsalicylic acid, the rest is removed in the form of salicylates and their metabolites.
80-100% of a single dose of drug are removed with urine within 24-72 hour.
The pharmacodynamics
Trombopol - antitrombichesky means, inhibitor of aggregation of thrombocytes, contains acetylsalicylic acid which suppresses aggregation of thrombocytes, has the febrifugal, anesthetizing and anti-inflammatory action.
The mechanism of suppression of aggregation by acetylsalicylic acid consists in suppression of activity of cyclooxygenase in thrombocytes which transforms arachidonic acid to cyclic peroxides, being predecessors of prostaglandins and thromboxanes. The pharmaceutical form of the drug Trombopol is the tablets covered with a kishechnorastvorimy cover which are not dissolved in a stomach therefore irritant action of acetylsalicylic acid decreases by a mucous obochka of a stomach. Dissolution of a tablet and discharge of active agent happens in more alkaline environment of a duodenum.

Indications
Suppression of aggregation of thrombocytes
- in prevention of coronary heart disease, including, a myocardial infarction,
at absence or presence of a circulatory unefficiency
- in prevention of other diseases which are characterized by formation
of blood clots in blood vessels

the Route of administration
of the Tablet swallow, without chewing - entirely, washing down with a small amount of water.
1 - 2 tablets of 75 mg or 1 tablet of 150 mg a day in time or after a meal.
About duration of a course of treatment the doctor solves.


Side effects
- heartburn, lack of appetite, feeling of completeness in epigastriß area,
nausea, vomiting, diarrhea, an abdominal pain
- a headache, dizziness
- urticaria, angonevrotichesky hypostasis, a spasm of bronchial tubes, rhinitis,
dacryagogue, collapse, a Quincke's edema, an acute anaphylaxis
- injury of a mucous membrane of a stomach, exacerbation
of a peptic ulcer of a stomach and duodenum, bleeding
- increase in a liver, superactivity of aminotransferases of serum,
alkaline phosphatase, increase in concentration of bilirubin, reduction
of concentration of thromboxane
- noise and a ring in ears
- disorders of vision
- an albuminuria, existence in urine of leukocytes and erythrocytes, a nephropathy with
necrosis of renal nipples
- rash, bleeding from mucous membranes and also toxic
kollikvatsionny necrosis of epidermis
- a leukopenia, thrombocytopenia, aplastic anemia, an agranulocytosis,
an eosinopenia, a purpura,

the Contraindication IDCS
- hypersensitivity to drug or an allergy to other
non-steroidal anti-inflammatory drugs
- a peptic ulcer of a stomach and a peptic ulcer of a duodenum,
in an aggravation phase
- gastrointestinal bleeding
- hemophilia, an angiohemophilia, a teleangiectasia, thrombocytopenia
- bronchial asthma
- a heavy liver and renal failure
- the I-III trimester of pregnancy
- viral diseases (especially flu and chicken pox) at children
are aged younger than 15 years

Medicinal interactions
Due to the atsetilyation of proteins acetylsalicylic acid can change their communication with other medicines, e.g., acetylized albumine shows bigger affinity with phenylbutazone.
Trombopol uslivat action:
- heparin and oral antithrombotic drugs
- thrombolytic drugs, such as streptokinase, an alteplaza
- oral anti-diabetic drugs (chlorpropamide)
- a methotrexate
- valproic acid
- fibrinolytic means
- corticosteroids
- digoxin, barbiturates and compounds of lithium
Trombopol can weaken action:
- Spirolactonum (the natriuretichesky effect of Spirolactonum and absorption of its active metabolite – a kanrenon)
- the drugs strengthening discharge with urine of uric acid (phenylbutazone, a probenetsid, Sulfinpyrazonum is slightly weakened). Sulfinpyrazonum reduces discharge of acetylsalicylic acid through kidneys.
Simultaneous use of acetylsalicylic acid and inhibitors of a karboangidraza (acetazoleamide) can increase concentration of inhibitors of a karboangidraza in serum as a result of kompetetsionny suppression of their discharge through renal tubules (symptoms of side effect, for example such as metabolic acidosis can amplify). Inhibitors of a karboangidraza can increase toxicity of salicylates also.

Special instructions
as a result of use of drug the peptic ulcer can develop and appear gastrointestinal bleeding.
As acetylsalicylic acid and its metabolites are removed with urine, the risk of strengthening of side effects at patients with disturbance of functions of kidneys and chronic kidney disease increases.
Drug should be used with care at patients with a prothrombinopenia in the anamnesis, a lack of vitamin K, thrombocytopenia, heavy injury of kidneys and taking the antithrombotic drugs.
It is necessary to stop intake of acetylsalicylic acid in 5-7 days prior to the planned surgery in connection with disorder of fibrillation and the increased risk of bleedings.
It is careful to accept in a case: plentiful menstrual bleeding, use of intrauterine kontartseptiv, urate diarez, hypertension, heart failure, lack of glyukozo-6-phosphate-dehydrogenase.
At treatment, acetylsalicylic acid forbids to take alcohol as it increases risk of strengthening of side effects from digestive tract.
At patients 65 years acetylsalicylic acid are more senior it is necessary to apply in smaller doses (75 mg) and with big time intervals.
Pregnancy and lactation
during the II trimester of pregnancy acetylsalicylic acid can be applied only when, according to the doctor, the potential advantage for mother exceeds risk for a fruit.
It is not necessary to appoint drug during breastfeeding.
Features of influence of medicine on ability to control of vehicles and to service of moving mechanisms
Considering side effects of medicine it is necessary to be careful when driving or potentially dangerous mezanizm.

Overdose
Symptoms - strengthening of side effects.
Treatment: it is necessary to carry out gastric lavage and to cause vomiting, plentiful drink, to accept activated carbon, at treatment of acidosis it is necessary to enter sodium bicarbonate intravenously. In cases of lengthening of a prothrombin time it is necessary to apply vitamin K. Dialysis effectively brings acetylsalicylic acid out of an organism and helps with restoration of acid-base and water and electrolytic exchange.

The form of release and packing
the Drug Trombopol is packed on 10 tablets into blister strip packaging from a film of polyvinylchloride and aluminum foil. On 3 or 6 blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.


To Store storage conditions in the dry, protected from light place at a temperature not above 25 °C.
To store out of children's reach!

A period of storage
2 years
not to use drug after expiry date

Prescription status
Without prescription

the Producer
the Pharmaceutical plant "POLFARMA"
S.A. St. of Pelplinsk 19, 83-200 Starogard Gdanski, Poland


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