Pentalgin® (Pentalgin)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbsptablets, film-coated.
Composition:Composition per one tablet.
Active substances: paracetamol - 325 mg, naproxen - 100 mg, caffeine anhydrous - 50 mg, drotaverina hydrochloride - 40 mg, phenylramine maleate - 10 mg.
Excipients:
Core: cellulose microcrystalline, potato starch, croscarmellose sodium, giprolose (hydroxypropylcellulose (clocel EF)), citric acid monohydrate, butylhydroxytoluene (E 321), magnesium stearate, talc, dye quinoline yellow (E 104), indigo carmine (E 132).
Sheath: hypromellose (hydroxypropylmethylcellulose), povidone (polyvinylpyrrolidone medium molecular weight medical), polysorbate-80 (tween-80), titanium dioxide, talc, dye quinoline yellow, indigo carmine (E 132).
Description:tablets, film-coated from light green to green, biconvex in the form of capsules with bevelled edges, with a risk on one side and embossing PENTALGIN on the other. On the cut, the tablet is light green with white patches.
Pharmacotherapeutic group:Analgesic agent (analgesic non-narcotic agent + non-steroidal anti-inflammatory drug + psychostimulant + antispasmodic + H1-histamine receptor blocker).
ATX: & nbsp
  • Paracetamol
    • Pharmacodynamics:The combined preparation has analgesic, anti-inflammatory, antispasmodic, antipyretic effect.
    Paracetamol - non-narcotic analgesic, has an antipyretic and analgesic effect due to blockade of cyclooxygenase in the central nervous system and exposure to pain centers and thermoregulation.
    Naproxen - non-steroidal anti-inflammatory drug, has an anti-inflammatory, analgesic and antipyretic effect associated with a non-selective inhibition of cyclooxygenase activity regulating the synthesis of prostaglandins.
    Caffeine - causes an expansion of blood vessels of skeletal muscles, heart, kidneys; increases mental and physical performance, helps to eliminate fatigue and drowsiness; increases the permeability of histohematological barriers and increases the bioavailability of non-narcotic analgesics, thereby contributing to the enhancement of the therapeutic effect. Has a tonic effect on the vessels of the brain.
    Drotaverine - has a myotropic antispasmodic effect caused by inhibition of phosphodiesterase IV,It acts on smooth muscles in the gastrointestinal tract, bile ducts, genitourinary and vascular systems.
    Pheniramine - blocker of H1-histamine receptors. Has spasmolytic and mild sedative effect, reduces the effects of exudation, and also enhances the analgesic effect of paracetamol and naproxen.
    Indications:Pain syndrome of different genesis, including pains in the joints, muscles, radiculitis, menstrual pains, neuralgia, dental and headaches (including headache caused by spasm of the brain vessels).
    Pain syndrome associated with spasm of smooth muscles, including chronic cholecystitis, cholelithiasis, postcholecystectomy syndrome, renal colic.
    Post-traumatic and postoperative pain syndrome, including those accompanied by inflammation.
    Catarrhal diseases accompanied by febrile syndrome (as symptomatic therapy).
    Contraindications:Hypersensitivity to the drug components, erosive-ulcerative lesions of the gastrointestinal tract (in the phase of exacerbation), gastrointestinal bleeding,complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, including history, severe hepatic and / or renal failure, oppression of bone marrow hematopoiesis, condition after aorto-coronary shunting; severe organic diseases of the cardiovascular system (including acute myocardial infarction), paroxysmal tachycardia, frequent ventricular extrasystole, severe arterial hypertension, hyperkalemia, children under 18 years of age, pregnancy and lactation.
    Carefully:cerebrovascular diseases, diabetes mellitus, peripheral arterial diseases, gastrointestinal ulcer lesions in the history, renal and hepatic insufficiency of mild or moderate severity, viral hepatitis, alcoholic liver damage, benign hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor syndrome), epilepsy and propensity to convulsive attacks, deficiency of glucose-6-phosphate dehydrogenase, elderly age.
    If you have any of the listed diseases / conditions, always consult a doctor before taking the drug.
    Dosing and Administration:Inside.
    The drug is taken 1 tablet 1-3 times a day. The maximum daily dose is 4 tablets.
    Duration of treatment no more than 3 days as an antipyretic agent and no more than 5 days - as an anesthetic. Continuation of treatment with the drug is possible only after consulting a doctor.
    Do not exceed the indicated dose!
    Side effects:Allergic reactions: skin rash, itching, urticaria, angioedema;
    From the hematopoiesis: Thrombocytopenia, leukopenia, agranulocytosis, anemia, methemoglobinemia;
    From the nervous system: stimulation, anxiety, increased reflexes, tremor, headache, sleep disturbances, dizziness, decreased concentration of attention;
    From the cardiovascular system: palpitations, arrhythmias, increased blood pressure;
    From the digestive system: erosive and ulcerative lesions of the gastrointestinal tract, nausea, vomiting, epigastric discomfort, abdominal pain, constipation, impaired liver function;
    From the urinary system: impaired renal function;
    From the sense organs: hearing loss, tinnitus, increased intraocular pressure in patients with closed-angle glaucoma;
    Other: dermatitis, tachypnea (rapid breathing).
    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.
    Overdose:Symptoms: pallor of the skin, anorexia (lack of appetite), abdominal pain, nausea, vomiting, gastrointestinal bleeding, agitation, motor anxiety, confusion, tachycardia, arrhythmia, hyperthermia (fever), frequent urination, headache, tremor or muscle twitching; epileptic seizures, increased activity of "hepatic" transaminases, hepatonecrosis, increased prothrombin time. Symptoms of liver dysfunction may appear 12-48 hours after an overdose. In severe overdose, hepatic failure develops with progressive encephalopathy, coma, death; acute renal failure with tubular necrosis; arrhythmia,pancreatitis. If you suspect an overdose, seek medical help immediately.
    Treatment: gastric lavage followed by administration of activated charcoal. Specific antidote for paracetamol poisoning is acetylcysteine. The introduction of acetylcysteine ​​is important for 8 hours. With gastrointestinal bleeding it is necessary to administer antacids and rinse the stomach with an ice-cold 0.9% solution of sodium chloride; maintenance of ventilation and oxygenation; with epileptic seizures - intravenous diazepam; maintaining the balance of liquid and salts.
    Interaction:It is necessary to avoid simultaneous reception of the drug with barbiturates, tricyclic antidepressants, rifampicin and alcohol-containing beverages (the risk of hepatotoxic effect increases).
    Paracetamol increases the effect of anticoagulants of indirect action and reduces the effectiveness of uricosuric drugs.
    Long-term use of barbiturates reduces the effectiveness of paracetamol. Simultaneous use of paracetamol with ethanol increases the risk of acute pancreatitis.
    Inhibitors of microsomal oxidation (incl. cimetidine) reduce the risk of hepatotoxic effects of paracetamol.
    Diflunisal increases the plasma concentration of paracetamol by 50%, which increases the risk of hepatotoxicity.
    Naproxen can cause a decrease in the diuretic effect of furosemide, an increase in the effect of indirect anticoagulants, increases the toxicity of sulfonamides and methotrexate, reduces the excretion of lithium and increases its concentration in the blood plasma.
    With the joint use of caffeine and barbiturates, primidone, anticonvulsants (hydantoin derivatives, especially phenytoin) it is possible to increase metabolism and increase caffeine clearance; with the simultaneous administration of caffeine and cimetidine, oral contraceptives, disulfiram, ciprofloxacin, norfloxacin - a decrease in the metabolism of caffeine in the liver (slowing its elimination and increasing blood concentrations). Simultaneous use of caffeine-containing beverages and other agents that stimulate the central nervous system can lead to excessive stimulation of the central nervous system.
    With simultaneous application drotaverine can weaken the antiparkinsonian effect of levodopa.
    With the simultaneous use of phenylamines with tranquilizers, hypnotics, monoamine oxidase inhibitors, alcohol, an increase in the inhibitory effect on the central nervous system is possible.
    Special instructions:The simultaneous use of the drug with other agents containing paracetamol and / or other non-steroidal anti-inflammatory drugs, as well as with agents to relieve the symptoms of colds, flu and nasal congestion.
    When using the drug for more than 5-7 days, it is necessary to monitor the peripheral blood and the functional state of the liver.
    Paracetamol distorts the results of laboratory studies of glucose and uric acid in the blood plasma.
    If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test. It should be borne in mind that naproxen increases bleeding time.
    The effect of caffeine on the central nervous system depends on the type of nervous system and can be manifested as excitation or inhibition of higher nervous activity.
    During the treatment period, alcohol-containing drinks should not be consumed.
    Effect on the ability to drive transp. cf. and fur:In some cases, the concentration of attention and speed of psychomotor reactions may be reduced, therefore, during the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:Film-coated tablets.
    Packaging:By 2, 4, 6, 10 or 12 tablets in a contour cell packaging made of a polyvinylchloride film and aluminum foil
    lacquered.
    1 or 2 contour packs with instructions for use in a pack of cardboard.
    Storage conditions:Store at a temperature not exceeding 25 ° C.
    Keep out of the reach of children.
    Shelf life:2 years. Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-005571/10
    Date of registration:17.06.2010 / 26.05.2015
    Manufacturer: & nbsp
    Information update date: & nbsp2016-01-29
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