Askofen of L of the tab. No. 10

Translation of the instruction Mose

ASKOFEN of L of the tablet

Instruction

On medical use of medicine

Askofen of l

Ingredients:

Active ingredients: 1 tablet contains acetylsalicylic acid 200 mg, paracetamol of 200 mg; caffeine of 40 mg;

excipients: citric acid, monohydrate; potato starch; calcium stearate.

Dosage form.

Tablet.

Main physical and chemical properties: integral correct round cylinders, upper and lower surfaces of which flat, edges of surfaces mown, with a notch for division on the one hand, white color. On a surface of tablets the marbling is allowed.

Pharmacotherapeutic group.

Analgetiki's

. other analgetik and antipyretics. acetylsalicylic acid, combinations without psikholeptik.

ATX N02B A51 Code.

Pharmacological properties.

Pharmacodynamics.

Drug has analgeziruyushchy, febrifugal and anti-inflammatory effect. The components which are a part of medicament enhance effects of each other.

Antipyretic effect of acetylsalicylic acid is implemented by

through the central nervous system by oppression of synthesis of PGF _{2 prostaglandins} in a hypothalamus in response to influence of endogenous pyrogens. The analgetic effect has both peripheral, and central origin: peripheral effect — oppression of synthesis of prostaglandins of the inflamed fabrics; the central effect — influence on the centers of a hypothalamus. Acetylsalicylic acid also reduces aggregation of thrombocytes.

Paracetamol renders to

analgeziruyushchy, febrifugal and very weak anti-inflammatory action that is connected with its influence on the center of thermal control in a hypothalamus and mild ability to inhibit synthesis of prostaglandins in peripheral fabrics.

Kofein excites the central nervous system. Also strengthens positive conditioned reflexes, stimulates physical activity, weakens effect of somnolent and narcotic substances, strengthens effect of analgetics and febrifuges.

Pharmacokinetics.

it was not investigated by p.

Clinical characteristics.

Indication.

Therapy of a weak or moderate pain syndrome: at head or a toothache, neuralgia, myalgia, an arthralgia, primary dysmenorrhea. as febrifuge in the diseases which are followed by fever.

Contraindication.

Hypersensitivity to medicine components, hypersensitivity to other derivatives of xanthines (theophylline, theobromine), other salicylates;

• bronchial asthma, a small tortoiseshell or rhinitis caused by use of salicylates or other non-steroidal anti-inflammatory medicaments (NPVS) in the anamnesis;
• congenital hyperbilirubinemia, profound renal or liver failure, congenital insufficiency glyukozo-6-fosfatdegidrogenazy, Gilbert's syndrome;
• a disease of blood, hemorrhagic diathesis, hemophilia, a prothrombinopenia, a leukopenia, anemia, the increased tendency to bleedings, thrombosis, thrombophlebitis, hemorrhagic diseases;
• acute gastrointestinal ulcers; gastrointestinal bleeding; surgical interventions which are followed by plentiful bleeding;
• a serious cardiovascular illness, including disturbances of a rhythm, a Bouveret's disease, the profound atherosclerosis, a severe form of coronary heart disease, the profound heart failure, an acute myocardial infarction, the profound arterial hypertension, portal hypertensia, tendency to an angiospasm;
• a condition of overexcitement, sleep disorder, advanced age, glaucoma, alcoholism, hyperthyroidism, acute pancreatitis, prostatauxe, severe forms of diabetes.

Use along with monoamine oxidase inhibitors (MAO) and also within 2 weeks after the termination of their use. The combination with a methotrexate in a dose of 15 mg a week or is more.

Simultaneous use with tricyclic antidepressants or β-blockers.

Interaction with other medicines and other types of interactions.

Contraindicated combinations.

Methotrexate — at the combined use with salicylates in a dose of 15 mg/week and more raises hematologic toxicity of a methotrexate owing to decrease in renal clearance of a methotrexate by anti-inflammatory agents and its replacement from communication with plasma proteins therefore such combination is contraindicated.

MAO Inhibitors — at the combined use with caffeine perhaps dangerous increase in arterial blood pressure therefore such combination is contraindicated.

Combination which need to be applied with care.

Paracetamol. Anticonvulsant medicines (including Phenytoinum, barbiturates, carbamazepine), antidepressants and other stimulators of microsomal oxidation — these medicines increase products of the hydroxylated active metabolites influencing function of a liver, predetermining a possibility of development of heavy intoxications at small overdoses of medicine.

At simultaneous use with hepatotoxic means the toxic influence of medicines on a liver increases. Simultaneous use of high doses of paracetamol with an isoniazid increases risk of development of a hepatotoxic syndrome.

Speed of absorption of paracetamol can increase at simultaneous use with Metoclopramidum and domperidony and decrease at use with holestiraminy. Paracetamol reduces efficiency of diuretics. Derivatives of coumarin (warfarin) at prolonged use of paracetamol increase risk of developing bleedings. Not to apply along with alcohol.

under the influence of paracetamol the elimination half-life of chloramphenicol increases by 5 times.

Kofein. Cimetidinum, hormonal contraceptives, an isoniazid strengthen effect of caffeine. Caffeine reduces effect of opioid analgetik, anxiolytics, hypnotic medicaments and sedatives, is an antagonist of the anesthetics and other medicaments oppressing the central nervous system (CNS), the competitive antagonist of the medicaments oppressing central nervous system, the competitive antagonist of medicaments of adenosine, adenosine triphosphate (ATP). At simultaneous use of caffeine with ergotamine the absorption of ergotamine from a digestive tract improves, with thyritropic means — the thyroid effect increases. Caffeine reduces concentration of lithium in blood. Caffeine increases effect (improves bioavailability) analgetikov-antipyretics, exponentiates effects of derivatives of xanthine, α- and β-adrenomimetik, psychogogic means.

Acetylsalicylic acid. Simultaneous use with uricosuric means, such as benzobromaron, probenetsid, reduces effect of removal of uric acid (thanks to the competition of removal of uric acid renal tubules). At simultaneous use with digoxin the concentration of the last in blood plasma increases owing to decrease in renal excretion. APF inhibitors in a combination with high doses of acetylsalicylic acid cause decrease in filtration in balls as a result of inhibition of vazodilatatorny prostaglandins and decrease in hypotensive effect.

Selective serotonin reuptake inhibitors: the risk of bleeding from upper parts of a digestive tract because of a possibility of synergy effect increases. At simultaneous use with valproic acid acetylsalicylic acid forces out it from communication with blood plasma proteins, increasing toxicity.

Medicine strengthens action of the means reducing fibrillation and aggregation of thrombocytes, side effect of corticosteroids, sulphonylurea, a methotrexate.

combination needs to avoid

with barbiturates, anticonvulsants, salicylates, rifampicin, alcohol.

Feature of use.

Before use of medicine should consult with the doctor.

not to use medicament with other means containing paracetamol, acetylsalicylic acid.

not to exceed the specified medicament doses. For short-term use.

to use Drug with care in gastrointestinal ulcers in the anamnesis, including in a chronic or recurrent peptic ulcer or gastrointestinal bleedings in the anamnesis; simultaneous use of anticoagulants.

to Patients with renal failures and a liver needs to consult with the doctor concerning a possibility of use of drug.

Sick with functional unsufficiency of hepatic and kidneys a medicament dose needs to reduce or increase an interval between receptions. At disturbance of functions of kidneys and a liver the interval between receptions has to be not less than 8 hours.

As acetylsalicylic acid, as well as all non-selective non-steroidal anti-inflammatory drugs, causes irritation of a mucous membrane of a digestive tract, medicine needs to be accepted only after a meal, washing down with water, alkaline mineral waters, Natrii hydrocarbonas solution (it is the best of all — milk).

At prolonged use of medicament needs to check presence of blood in Calais for identification of ulcerogenic action and to do blood tests (influence on aggregation of thrombocytes, some anticoagulating activity). medicine it is desirable for p to appoint

At a hyperthermia only in case of inefficiency of other analgetikov-antipyretics as there is a risk of development of a syndrome of Ray. If use of medicament is resulted by vomiting, then it is necessary to suspect Ray's syndrome.

to Consider

that at patients with alcoholic damage of a liver the risk of hepatotoxic action of paracetamol increases. Drug can affect results of laboratory researches on content in blood of glucose and uric acid.

Disease of a liver increase risk of damage of a liver paracetamol. The danger of overdose is higher at patients with netsirrozny alcoholic diseases of a liver.

At patients with heavy infections, such as sepsis which are followed by decrease in level of glutathione at intake of paracetamol the risk of developing of a metabolic acidosis increases. Symptoms of a metabolic acidosis is the deep, speeded-up or complicated breath, nausea, vomiting, loss of appetite. It is necessary to see immediately a doctor in case of these symptoms.

At surgeries (including dental) use of the medicaments containing acetylsalicylic acid increases the probability of emergence/strengthening of bleeding that it is caused by oppression of aggregation of thrombocytes after use of acetylsalicylic acid for some time. In 5–7 days prior to surgical intervention it is necessary to cancel medicine use (for reduction of risk of the increased bleeding).

Patient has to warn the doctor about administration of medicament of Askofen-L in advance.

At patients with allergic complications, including with bronchial asthma, allergic rhinitis, a small tortoiseshell, a skin itching, hypostasis of a mucous membrane and a pollinosis of a nose and also at their combination to persistent infections of airways and at patients with hypersensitivity to non-steroidal anti-inflammatory medicaments the development of a bronchospasm or attack of bronchial asthma is possible

therefore use of NPVS of this category of patients is contraindicated.

Acetylsalicylic acid which is a part of medicine even in small doses can reduce removal of uric acid from an organism that can become the reason of a bad attack of gout at sensitive patients.

As acetylsalicylic acid causes irritation mucous, not to use medicament to children because of risk of development of a syndrome of Ray. At patients with bronchial asthma, allergic diseases, hypersensitivity to NPVS the development of allergic reaction or exacerbation of a basic disease is possible.

during medicament treatment is not recommended to take excessive amount of the drinks containing caffeine (for example coffee, tea). It can cause a sleep disorder, a tremor, feeling of tension, irritability, unpleasant feeling behind a breast because of heartbeat.

during treatment not to take alcoholic beverages (increase in risk of gastrointestinal bleeding).

to Patients needs to consult with the doctor if they accept analgetik every day in arthritises of an easy form if they apply the warfarin or similar medicines having anticoagulating effect and also at use of the medicament Askofen-L before reception of an ibuprofen as anesthetic.

should not be applied at hypersensitivity to analgetichesky, anti-inflammatory, antirheumatic drugs. With care to apply together with anticoagulants and also the patient with blood circulation disturbances (for example, pathology of vessels of a kidney, stagnant heart failure, a hypovolemia, extensive operations, sepsis or severe bleedings) as acetylsalicylic acid also increases risk of a renal failure and acute renal failure. The ibuprofen can reduce inhibitory influence of acetylsalicylic acid on aggregation of thrombocytes.

Medicine can affect results of laboratory researches concerning the content in blood of glucose and uric acid.

does not recommend to apply

Askofen-L without consultation of the doctor more than 5 days as analgesic and more than 3 days as febrifuge.

If symptoms do not disappear, to see a doctor.

If the headache becomes a constant, it is necessary to see a doctor. it is contraindicated to p to appoint

patient with bronchial asthma, at the increased bleeding. With extra care to use medicament at simultaneous therapy by anticoagulants (coumarin and heparin), in abnormal liver functions and diseases of kidneys and also at simultaneous performing anti-inflammatory therapy.

Use during pregnancy or feeding by a breast.

Medicine not to apply

during pregnancy or feeding by a breast.

Acetylsalicylic acid has teratogenic influence; its use during pregnancy in the I trimester leads to splitting of the upper sky, in the III trimester — to slowing down of patrimonial activity (inhibition of synthesis of prostaglandins), closing of an arterial channel at a fruit that causes a hyperplasia of pulmonary vessels and hypertensia in vessels of a small circle of blood circulation, disturbance of functions of kidneys with possible subsequent development of a renal failure with oligogidroamniozy, extension of a bleeding time, antiagregantny effect which can arise even after use of very low doses.

Kofein increases risk of a spontaneous abortion.

Medicine gets into breast milk that increases risk of developing of bleedings at children owing to dysfunction of thrombocytes.

Ability to influence speed of response at control of motor transport or other mechanisms.

As emergence of side reactions from nervous system (dizziness, hyperexcitability, disturbance of orientation and attention) is possible

, at use of medicament of askofen-l it is necessary to avoid driving and work requiring special attention and speed of psychomotor reactions.

Route of administration and doses.

Medicine is intended to

for intake.

Adult: on 1 tablet 2–3 times a day after a meal. The maximum daily dose of medicine makes 6 tablets (in 3 receptions).

Duration of a course of treatment depends on the course and severity of a disease and should not exceed 5 days at use as anesthetic and 3 days — as febrifuge.

not to accept

together with other medicines containing paracetamol.

Children.

not to use Drug to children because of risk of development of a syndrome to Reja (a hyper pyrexia, a metabolic acidosis, disturbances from nervous system and mentality, vomiting, abnormal liver functions) at a hyperthermia against the background of viral diseases.

Overdose.

paracetamol overdose Symptoms.

Damage of a liver is possible

at adults who accepted 10 g and more paracetamol, and at the children who took the medicament in a dose more than 150 mg/kg. At patients with risk factors (long-term treatment by carbamazepine, phenobarbital, Phenytoinum, Primidonum, rifampicin, a St. John's wort or other medicines which induce liver enzymes), the regular use of excessive amounts of ethanol; the glutationovy cachexia (digestive disturbances, a mucoviscidosis, HIV infection, hunger, a cachexia)) can lead use of 5 g or more paracetamol to damage of a liver.

Damage of a liver can be shown by

in 12–48 hours after reception of excess doses of drug. In the first 24 hours there can be following symptoms: pallor, nausea, vomiting, anorexia, abdominal pain. In a serious poisoning the liver failure can progress to encephalopathy, a hypoglycemia, a coma and a lethal outcome. The acute renal failure with acute necrosis of tubules can be shown by severe lumbar pain, a hamaturia, a proteinuria and to develop even in the absence of severe damage of kidneys. There can be disturbances of metabolism of glucose and a metabolic acidosis. Also cardiac arrhythmia and pancreatitis was noted. At prolonged use of medicament in high doses from bodies of a hemopoiesis the aplastic anemia, thrombocytopenia, a pancytopenia, an agranulocytosis, a neutropenia, a leukopenia can develop. At reception of high doses from central nervous system — dizziness, psychomotor initiation and disturbance of orientation; from an urinary system — nephrotoxicity (renal colic, interstitial nephrite, capillary necrosis).

emergency medical service is necessary for

At overdose. The patient should be taken immediately to hospital even if there are no early symptoms of overdose. Symptoms can be limited to nausea and vomiting or can not reflect weights of overdose or risk of defeat of bodies. It is necessary to consider expediency of treatment by activated carbon if the overdose of paracetamol was accepted within 1 hour. Concentration of paracetamol should be measured in blood plasma in 4 hours or later after reception (earlier concentration are not reliable). Treatment by N-Acetylcysteinum can be performed within 24 hours after intake of paracetamol, but the maximum protective effect occurs at its use within 8 hours after reception. The efficiency of antidote sharply decreases after this time. If necessary the patient intravenously should enter N-Acetylcysteinum in doses to the existing recommendations. In the absence of vomiting it is possible to apply methionine orally as the corresponding alternative in the remote areas out of hospital.

needs to take also all-supporting measures.

Symptoms of overdose of acetylsalicylic acid.

Overdose of salicylates is possible

because of chronic intoxication which resulted from long therapy (use more than 100 mg/kg/days can cause more than 2 days toxic effects) and also because of acute intoxication which poses threat for life (overdose) and which reasons can be an accidental use (children) or unexpected overdose.

Chronic poisoning with salicylates can have the hidden character as its signs are not specific. The moderate chronic intoxication caused by salicylates or a salitsilizm, meets, as a rule, only after repeated receptions of high doses. Main symptoms: balance disturbance, dizziness, a ring in ears, deafness, the strengthened sweating, nausea and vomiting, a headache, confusion of consciousness. The specified symptoms can be controlled a dose decline. The ring in ears can be noted at concentration of salicylates in blood plasma over 150-300 mkg/ml. More serious side reactions meet at concentration of salicylates in blood plasma more than 300 mkg/ml.

significant change of acid-base balance which can differ depending on age and weight of intoxication testifies To acute intoxication. Weight of a state cannot be defined only on the basis of concentration of salicylates in blood plasma.

Absorption of acetylsalicylic acid can slow down in connection with a delay of gastric release, forming of concrements in a stomach.

Treatment: intoxication caused by overdose of acetylsalicylic acid is defined by severity, clinical symptoms and is treated by standard methods which apply in poisoning. All measures have to be allocated for acceleration of removal of medicine and recovery of electrolytic and acid-base balance. Apply activated carbon, the forced alkaline diuresis. Depending on a condition of acid-base equilibrium and electrolytic balance carry out infusional administration of solutions of electrolytes. In a serious poisoning the hemodialysis is shown. At prolonged use of high doses the aplastic anemia, thrombocytopenia, a pancytopenia, an agranulocytosis, a neutropenia, a leukopenia are possible. At reception of high doses the emergence of disturbances from the central nervous system (dizziness, psychomotor initiation, disturbance of orientation and attention, insomnia, a tremor, nervousness, concern) is possible, from an urinary system — nephrotoxicity (renal colic, interstitial nephrite, papillary necrosis). In case of overdose the raised potovydeleniye, psychomotor excitement or oppression of central nervous system, drowsiness, consciousness disturbance, disturbance of a warm rhythm, tachycardia, premature ventricular contraction, a tremor, hyperreflexia, spasms can be observed.

caffeine overdose Symptoms.

High doses of caffeine can cause pain in epigastric area, vomiting, a diuresis, rapid breathing, premature ventricular contraction, tachycardia or cardiac arrhythmia, influence on the central nervous system (dizziness, insomnia, nervousness, nervous excitement, a syndrome of the increased neuroreflex irritability, a headache, irritability, the heat of passion, uneasiness, concern, a tremor, spasms). Clinically significant symptoms of overdose of caffeine are connected also with damage of a liver paracetamol.

Treatment. At overdose the emergency medical service is necessary even if symptoms of overdose are absent. Prescribing of methionine orally or Acetylcysteinum can intravenously give positive effect within 48 hours after overdose. It is necessary to take also general supporting measures, symptomatic therapy, including use of antagonists of β-adrenoceptors who can eliminate cardiotoxic effects. Specific antidote is absent.

Side reactions.

by

At askofen-l medicine use for certain patients the side reactions characteristic of acetylsalicylic acid, paracetamol or caffeine can be observed.

from organs of sight: a disorder of vision that can demonstrate overdose.

from organs of hearing and a vestibular mechanism: a ring in ears, sonitus, orientation disturbance.

from a respiratory system: rhinitis, congestion of a nose, a bronchospasm at the patients sensitive to acetylsalicylic acid and to other NPVS.

from a cardiovascular system: tachycardia, heart consciousness, arterial hypertension, arrhythmia.

from the system of blood and lymphatic system: anemia, a sulfatgemoglobinemiya and a methemoglobinemia (cyanosis, short wind, pain in heart), hemolytic anemia, bruises or bleedings, at prolonged use in high doses — aplastic anemia, a pancytopenia, a neutropenia, thrombocytopenia, an agranulocytosis. Because of antiagregantny action on thrombocytes acetylsalicylic acid increases risk of developing bleedings. Such bleedings as intraoperative hemorrhages, hematomas, bleedings from bodies of an urinogenital system, nasal bleedings, odontorrhagias, gastrointestinal bleedings and brain hemorrhages (especially at patients with uncontrollable arterial hypertension were observed and/or at simultaneous use of anti-hemostatics) which in isolated cases threatened life.

from nervous system: headache, nervousness, concern, dizziness, tremor, paresthesias, hyperexcitability, irritability, sleep disorder, insomnia, general weakness, irritability.

from mentality: sensation of fear, concern, alarm.

from a digestive tract: dispeptic disorders, including nausea, vomiting, discomfort and pain in epigastriums, heartburn, abdominal pain; inflammation of a digestive tract, erosive cankers of a digestive tract which can become in isolated cases the cause of gastrointestinal bleedings and perforation with the corresponding laboratory and clinical manifestations; ulcers on a mucous membrane of an oral cavity.

from the immune system: reactions of hypersensitivity, including an anaphylaxis, an acute anaphylaxis.

At patients with individual hypersensitivity to salicylates the development of allergic reactions of skin, including such symptoms as a dermahemia, feeling of heat, rash, a small tortoiseshell, hypostasis, an itching, a Quincke's disease, rhinitis, congestion of a nose is possible

. At patients with bronchial asthma the increase in frequency of emergence of a bronchospasm is possible; allergic reactions from insignificant to moderate degree which can affect skin, airways, a digestive tract, a cardiovascular system and to be shown in the form of rash, small tortoiseshells, hypostasis, an itching.

from an endocrine system: a hypoglycemia, up to a hypoglycemic coma.

from an urinary system: nephrotoxicity (renal colic, interstitial nephrite, papillary necrosis).

from a gepatobiliarny system: an abnormal liver function, increase in activity of liver enzymes, as a rule without development of jaundice, gepatonekroz (dose-dependent effect), a tranzitorny liver failure with increase in level of transaminases of a liver.

from skin and hypodermic cellulose: a skin itching, rashes on skin and mucous membranes (usually generalizirovanny rashes, erythematic, a small tortoiseshell), a Quincke's disease, a multiformny exudative erythema (including Stephens-Johnson's syndrome), a toxic epidermal necrolysis (Lyell's disease).

General disorders: general weakness.

Other: bleedings can lead to an acute and chronic posthemorrhagic/iron deficiency anemia (owing to the so-called latent microbleeding) with the corresponding laboratory manifestations and clinical symptoms, such as asthenia, pallor of an integument, hypoperfusion, not cardiogenic fluid lungs.

Expiration date.

3 years.

Storage conditions.

to Store

in original packing at a temperature not above 25 °C.

to Store

out of children's reach.

Packing.

On 6 tablets in blisters;

on 10 tablets in blisters.

Category of release.

Without prescription.

Producer.

PJSC lubnyfarm.

Location of the producer and address of the place of implementation of its activity.

Ukraine, 37500, Poltava Region, of a lubna, st. of a barvinkov, 16.