Пенталгин®

General characteristics. Structure:

Active agents: paracetamol - 325 mg, Naproxenum - 100 mg, caffeine anhydrous - 50 mg, Drotaverinum a hydrochloride - 40 mg, pheniramine a maleate - 10 mg.
Excipients:
Kernel: cellulose microcrystallic, potato starch, croscarmellose sodium, a hypro rod (hydroxypropyl cellulose (klutset EF)), citric acid monohydrate, butyl hydroxytoluene (Е 321), magnesium stearate, talc, dye quinolinic yellow (Е 104), indigo carmine (Е 132).
Cover: gipromelloz (gidroksipropilmetiltsellyuloz), povidone (polyvinylpirrolidone middlemolecular medical), polysorbate-80 (twin-80), titanium dioxide, talc, dye quinolinic yellow, indigo carmine (Е 132).

Description: tablets, film coated from light green till green color, biconvex in the form of the capsule with slanted edges, with risky on one party and PENTALGIN stamping on another. On a cut a tablet of light green color with white impregnations.

Pharmacological properties:

The combined drug, renders analgeziruyushchy, antiinflammatory, spasmolytic, febrifugal action.

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.

Naproxenum - non-steroidal anti-inflammatory drug, has the antiinflammatory, analgeziruyushchy and febrifugal effect connected with non-selective suppression of activity of the cyclooxygenase regulating synthesis of prostaglandins.

Caffeine - causes expansion of blood vessels of skeletal muscles, hearts, kidneys; increases intellectual and physical effeciency, promotes elimination of exhaustion and drowsiness; increases permeability of gistogematichesky barriers and increases bioavailability of non-narcotic analgesics, promoting thereby strengthening of therapeutic effect. Has tonic effect on brain vessels.

Drotaverinum - has the myotropic spasmolytic effect caused by phosphodiesterase IV inhibition, affects unstriated muscles in digestive tract, biliary tract, urinogenital and vascular systems.

Pheniramine - _H1 blocker - histamine receptors. Has spasmolytic and easy sedative effect, reduces the exudation phenomena, and also strengthens analgetic effect of paracetamol and Naproxenum.

Indications to use:

• Pain syndrome of various genesis, including at joint pains, muscles, radiculitis, menstrual pains, neuralgia, tooth and head pains (including at the headache caused by a brain vasospasm).
• The pain syndrome connected with a spasm of smooth muscles including at chronic cholecystitis, cholelithiasis, a postcholecystectomy syndrome, renal colic.
• The posttraumatic and postoperative pain syndrome including which is followed by an inflammation.
• The catarrhal diseases which are followed by a feverish syndrome (as symptomatic therapy).

Route of administration and doses:

Inside.
Drug is accepted on 1 tablet by 1-3 times a day. The maximum daily dose - 4 tablets.
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.

Not to exceed the specified dose!

Features of use:

It is necessary to avoid simultaneous use of drug with other means containing paracetamol and/or other non-steroidal anti-inflammatory drugs and also with means for relief of symptoms of "cold", flu and a congestion of a nose.

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.

In need of definition of 17 ketosteroids drug should be cancelled for 48 h prior to a research. It is necessary to consider that Naproxenum increases a bleeding time.

Influence of caffeine on the central nervous system depends on type of a nervous system and can be shown both by excitement, and braking of higher nervous activity.

During treatment it is not necessary to take alcohol-containing drinks.

Decrease in concentration of attention and speed of psychomotor reactions therefore during treatment it is necessary to be careful during the driving of motor transport and occupation other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions is in some cases possible.

Side effects:

• Allergic reactions: skin rash, itch, small tortoiseshell, Quincke's disease;
• From bodies of a hemopoiesis: thrombocytopenia, leukopenia, agranulocytosis, anemia, methemoglobinemia;
• From a nervous system: excitement, uneasiness, strengthening of reflexes, tremor, headache, sleep disorders, dizziness, decrease in concentration of attention;
• From cardiovascular system: heartbeat, arrhythmias, increase in arterial pressure;
• From the alimentary system: digestive tract erosive cankers, nausea, vomiting, discomfort in epigastriums, abdominal pains, a lock, an abnormal liver function;
• From an urinary system: renal failure;
• From sense bodys: decrease in hearing, a sonitus, increase in intraocular pressure at patients with closed-angle glaucoma;
• Others: dermatitis, tachypnea (breath increase).

If any of the side effects specified in the instruction are aggravated, or you noticed any other side effects which are not specified in the instruction, report about it to the doctor.

Interaction with other medicines:

It is necessary to avoid a concomitant use of drug with barbiturates, tricyclic antidepressants, rifampicin and alkogolsoderzhashchy drinks (the risk of a hepatotoxic action increases).

Paracetamol strengthens effect of anticoagulants of indirect action and reduces efficiency of uricosuric drugs.

Long use of barbiturates reduces efficiency of paracetamol.

Simultaneous use of paracetamol with ethanol increases risk of developing of acute pancreatitis.

Inhibitors of a microsomal oxidation (including Cimetidinum) reduce risk of a hepatotoxic action of paracetamol.

Diflunisal increases plasma concentration of paracetamol for 50% that increases risk of development of a hepatotoxic.

Naproxenum can cause reduction of diuretic effect of furosemide, strengthening of effect of indirect anticoagulants, increases toxicity of streptocides and a methotrexate, reduces removal of lithium and increases its concentration in a blood plasma.

At combined use of caffeine and barbiturates, Primidonum, anticonvulsants (hydantoin derivatives, especially Phenytoinum) strengthening of metabolism and increase in clearance of caffeine is possible; at a concomitant use of caffeine and Cimetidinum, peroral contraceptive means, Disulfiramum, ciprofloxacin, norfloxacin - decrease in metabolism of caffeine in a liver (delay of its removal and increase in concentration in blood).

The simultaneous use of the kofeinsoderzhashchy drinks and other means stimulating the central nervous system can lead to excessive stimulation of the central nervous system.

At simultaneous use Drotaverinum can weaken protivoparkinsonichesky effect of a levodopa.

At simultaneous use of pheniramine with tranquilizers, hypnagogues, monoamine oxidase inhibitors, alcohol strengthening of the oppressing influence on the central nervous system is possible.

Contraindications:

Hypersensitivity to drug components, digestive tract erosive cankers (in an aggravation phase), gastrointestinal bleeding, 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 heavy liver and/or renal failure, oppression of a marrowy hemopoiesis, a state after performing aortocoronary shunting; a serious organic illness of cardiovascular system (including an acute myocardial infarction), a Bouveret's disease, frequent ventricular premature ventricular contraction, heavy arterial hypertension, a hyperpotassemia, children's age up to 18 years, pregnancy and the period of a lactation.

With care - cerebrovascular diseases, a diabetes mellitus, diseases of peripheral arteries, digestive tract cankers in the anamnesis, a renal and liver failure easy or moderate severity, a viral hepatitis, alcoholic damage of a liver, high-quality hyperbilirubinemias (Gilbert's syndrome, the Cudgel Johnson and the Rotor), epilepsy and tendency to convulsive attacks, deficit glyukozo-6-fosfatdegidrogenazy, advanced age.

If at you one of the listed diseases/states, before administration of drug surely consult with the doctor.

Overdose:

Symptoms: pallor of integuments, anorexia (lack of appetite), an abdominal pain, nausea, vomiting, gastrointestinal bleeding, excitement, motive concern, confusion of consciousness, tachycardia, arrhythmia, a hyperthermia (fervescence), the speeded-up urination, a headache, a tremor or muscular twitchings; epileptic seizures, increase in activity of "hepatic" transaminases, гепатонекроз, increase in a prothrombin time. Symptoms of an abnormal liver function can appear in 12-48 h after overdose. At heavy overdose the liver failure with the progressing encephalopathy, a coma, death develops; an acute renal failure with a tubular necrosis; arrhythmia, pancreatitis. At suspicion on overdose it is necessary to ask for medical assistance immediately.
Treatment: a gastric lavage with the subsequent reception of absorbent carbon. A specific antidote at poisoning with paracetamol is Acetylcysteinum. Introduction of Acetylcysteinum is urgent during 8 h. At gastrointestinal bleeding introduction of antiacid means and a gastric lavage of ice 0,9% sodium chloride solution is necessary; maintenance of ventilation of the lungs and oxygenation; at epileptic seizures - intravenous administration of diazepam; maintenance of balance of liquid and salts.

Storage conditions:

In the dry, protected from light place at a temperature not higher than 25 ° C.
To store in the place, unavailable to children.

Period of validity - 2 years. Not to use after the period of validity specified on packaging.

Issue conditions:

Without recipe

Packaging:

Tablets, film coated.
On 2, 10 or 12 tablets in a blister strip packaging from a film of the polyvinyl chloride and printing aluminum foil varnished.
1 or 2 blister strip packagings together with the application instruction in a pack from a cardboard.