The instruction for medical use of Tsinepar Ekstra Torgovoye medicine a name Tsinepar Ekstra the International unlicensed name Is not present the Dosage form of the Tablet Structure One Tablet contains active agents: acetaminophen (paracetamol) of 500 mg, caffeine of 65 mg. Excipients: starch corn, K-30 povidone, microcrystalline cellulose, talc purified of magnesium stearate, silicon dioxide colloidal anhydrous, sodium of a kroskarmelloz, methylparahydroxybenzoate, propilparagidroksibenzoat, sodium glikolit starch, starch corn (for paste). OpisanieTabletki white color of round shape with risky on one party Pharmacotherapeutic group Analgetics. Other analgetics-antipyretics. Anilides. Paracetamol in a combination with other drugs (excepting psikholeptik) the ATX N02BE51 Code the Pharmacological Pharmacokinetics Acetaminophen properties – is quickly and almost completely soaked up (96%) from digestive tract. The maximum concentration in blood about 6 mkg/ml, time of achievement of the maximum concentration of 10-60 min. Communication with proteins less than 10%. Acetaminophen is metabolized in a liver, its most part enters conjugation tests with glucuronic acid and sulfates with formation of inactive metabolites and is removed with urine in the form of sulphatic and glucuronic conjugates. Period of semi-elimination of 1.68 h. Caffeine – is quickly soaked up at oral administration, the maximum concentration in blood plasma is reached within one hour, elimination half-life makes about 3.5 hours. 65-80% of the accepted caffeine are removed with urine in the form of 1-methyl-uric acid and 1 methylxanthine. A pharmacodynamics Acetaminophen – analgetic-antipyretic. Renders the anesthetizing and febrifugal effect by suppression of synthesis of prostaglandins in a hypothalamus. Has weak anti-inflammatory activity. Drug possesses anesthetics and febrifugal properties. Does not cause irritation mucous a stomach and intestines. Does not influence water salt metabolism as does not influence synthesis of prostaglandins in peripheral fabrics. Caffeine belongs to group of alkaloids (methylxanthines). Possesses psychogogic and analeptical action. In a combination with analgetics, in particular, with paracetamol, enhances its analgesic effect due to improvement of bioavailability and stimulation of the central nervous system (CNS). Indications Symptomatic treatment: a headache, migraine, a toothache, neuralgia, pain after odontectomy, a joint pain and muscles, a back pain, a sore throat in a tonsillitis, painful periods and the increased temperature the Route of administration and doses Adults and children are more senior than 12 years: 1-2 tablets up to 3 times a day, preferably after a meal. An interval between receptions – not less than 4 hours. The maximum single dose - 1 tablet, the maximum daily dose – 4 tablets. Treatment duration on average 3-5 days. Drug is not recommended to apply more than five days as anesthetic and more than three days as febrifugal without appointment and observation of the doctor. In the absence of sufficient therapeutic effect and also emergence of new symptoms to see a doctor. Side effects Paracetamol Very seldom (& lt, 1/10.000) - allergic reactions (skin rash, a Quincke's edema, Stephens-Jones's syndrome, an anaphylaxis) - a bronchospasm at patients with hypersensitivity to acetylsalicylic acid or other NPVP - disturbances of a system of blood (anemia, thrombocytopenia, a methemoglobinemia) - renal colic, a nonspecific bacteriuria, interstitial nephrite, papillary necrosis - hepatotoxic action - pains in epigastriums, nausea - dizziness, backfilling disturbance, hyperexcitability At emergence of unusual symptoms it is necessary to see a doctor. Contraindications hypersensitivity the profound abnormal liver functions or kidneys genetic absence blood disease dehydrogenase glyukozo-6-phosphate considerable arterial hypertension, the expressed phenomena of atherosclerosis, a serious cardiovascular illness pregnancy and the period of breastfeeding with care should be applied to acetaminophen, caffeine or other ingredients of drug at Gilbert's syndrome (constitutional hyperbilirubinemia) sleep disorder glaucoma diabetes children's age up to 12 years Medicinal interactions At reception drug for a long time strengthens effect of indirect anticoagulants (warfarin and other coumarins) that increases risk of bleedings. Inductors of microsomal oxidation of a liver (barbiturates, Phenytoinum, ethanol, rifampicin, phenylbutazone, tricyclic antidepressants) increase risk of hepatotoxic action at overdoses. Inhibitors of microsomal oxidation (Cimetidinum) reduce risk of hepatotoxic action. Under the influence of acetaminophen time of removal of chloramphenicol increases by 5 times. The activity of a zidovudine at intake of acetaminophen can decrease. Acetaminophen slows down removal of antibiotics from an organism. Tetracycline increases risk of developing anemia, methemoglobinemia at acetaminophen use. Caffeine accelerates ergotamine absorption. The concomitant use of paracetamol and alcoholic beverages increases risk of development of hepatotoxic effects and acute pancreatitis. Metoclopramidum and domperidon is increased, and Colestyraminum reduces paracetamol absorption speed. Drug can reduce efficiency of uricosuric drugs. At smokers the removal of drug is increased. The special instructions Drug are appointed with care to the elderly, weakened patients, patients with an abnormal liver function and kidneys. It is not necessary to accept along with other paratsetamolsoderzhashchy drugs, with alcoholic beverages. During administration of drug the excess consumption of tea and coffee as it can lead to excitement, a sleep disorder, tachycardia, cardiac arrhythmia is not recommended. The persons abusing alcohol before administration of drug need to consult to the doctor. In case of exceeding the recommended dose, paracetamol can have toxic effect on a liver. At prolonged use in high doses the probability of an abnormal liver function and kidneys (renal colic, a nonspecific bacteriuria, interstitial nephrite, papillary necrosis) increases and control of a picture of blood is necessary. The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms during administration of drug should be careful at control of vehicles and work as potentially dangerous mechanisms. Overdose Acetaminophen Symptoms: nausea, vomiting, stomach aches, pallor of integuments, anorexia. In 1-2 days, signs of damage of a liver are defined. In hard cases the liver failure and coma develops. Pre-medical help: the victim should make gastric lavage both to appoint adsorbents (activated carbon) and to see a doctor. Treatment: to stop administration of drug and to see immediately a doctor. Gastric lavage and reception of enterosorbents (activated carbon, Polyphepanum) is recommended. Use of Acetylcysteinum or methionine is possible. Caffeine Symptoms: pain in epigastriums, vomiting, the raised diuresis, tachycardia or cardiac arrhythmia, stimulation of the central nervous system (insomnia, concern, excitement, nervousness, a tremor, convulsions). Treatment: There is no specific antidote, but maintenance therapy (use of antagonists of beta adrenoceptors) can facilitate cardiotoxic effect. A form of release and packing On 10 tablets in blister strip packaging from a film of polyvinylchloride and aluminum foil. On 10 blister strip packagings together with the instruction for use on state and Russian place in a cardboard box. To Store storage conditions at a temperature not above +25ºC to Store out of children's reach! 4 years not to use a period of storage after expiry date. Prescription status Without prescription of Distribyyutor Kyyuramaks Ltd, England Marion Biotek Pvt.Ltd. Producer B-49, Sector-67, Noiade, India Owner of the registration certificate Marion Biotek Pvt.Ltd., India the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of Spektramaks LLP, Republic of Kazakhstan, Almaty, Seyfullin Ave. 458-460/95, office 312.
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