Pentalgin tablets, No. 12

• Pain syndrome of various origins, incl. for pain in joints, muscles, radiculitis, menstrual pain, neuralgia, toothache and headache (including headache caused by spasm of cerebral vessels);

• pain syndrome associated with smooth muscle spasm, incl. with chronic cholecystitis, cholelithiasis, postcholecystectomy syndrome, renal colic;

• post-traumatic and postoperative pain syndrome, incl. accompanied by inflammation;

• colds accompanied by febrile syndrome (as symptomatic therapy).

Inside.

The drug is taken in 1 table. 1-3 times a day. The maximum daily dose is 4 tablets. The duration of treatment is 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.

Film-coated tablets

1 tab.

active substances:

paracetamol 325 mg

naproxen 100 mg

caffeine anhydrous 50 mg

drotaverine hydrochloride 40 mg

pheniramine maleate 10 mg

excipients: MCC - 128 mg; potato starch - 55.38 mg; croscarmellose sodium - 32 mg; hyprolose (hydroxypropyl cellulose) - 32.52 mg; citric acid monohydrate - 3 mg; butylhydrokentoluene (E321) - 0.3 mg; magnesium stearate - 7.2 mg; talc - 16.12 mg; quinoline yellow dye (E 104) - 0.4608 mg; indigo carmine (E132) - 0.0192 mg film shell: hypromellose (hydroxypropyl methylcellulose) - 12.17 mg; povidone (PVP medium molecular weight medical, povidone K25) - 3.87 mg; polysorbate 80 (tween 80) - 1.1 mg; titanium dioxide - 3.43 mg; talc - 4.218 mg; quinoline yellow dye (E104) - 0.2 mg; indigo carmine (E132) - 0.0127 mg or Opadry 13A210001 shell green (Opadry 13A210001 Green): (hypromellose - 12.17 mg, povidone - 3.87 mg, polysorbate 80 - 1.1 mg, titanium dioxide - 3.43 mg , talc - 4.218 mg, quinoline yellow - 0.2 mg,FD&C blue # 2 / indigo carmine - 0.0127 mg) - 25,0007 mg.

• Hypersensitivity to the components of the drug, erosive and ulcerative lesions of the gastrointestinal tract (in the exacerbation phase);

• gastrointestinal bleeding, complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including history);

• severe hepatic and / or renal impairment;

• oppression of bone marrow hematopoiesis;

• condition after coronary artery bypass grafting;

• severe organic diseases of the CVS (including acute myocardial infarction);

• paroxysmal tachycardia;

• frequent ventricular premature beats;

• severe arterial hypertension;

• hyperkalemia;

• pregnancy;

• lactation period;

• children under 18 years of age.

With care: cerebrovascular disease; diabetes; peripheral arterial disease; history of ulcerative lesions of the gastrointestinal tract; renal and hepatic impairment of mild to moderate severity; viral hepatitis; alcoholic liver damage; benign hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndrome); epilepsy and tendency to seizures; deficiency of glucose-6-phosphate dehydrogenase; elderly age.

If the patient has one of the listed diseases / conditions, it is imperative to consult a doctor before taking the drug.

pharmachologic effect

The combined drug has an analgesic, anti-inflammatory, antispasmodic, antipyretic effect.

Paracetamol is an analgesic-antipyretic, has antipyretic and analgesic effects due to the blockade of COX in the central nervous system and the effect on the centers of pain and thermoregulation.

Naproxen is an NSAID that has anti-inflammatory, analgesic and antipyretic effects associated with non-selective suppression of the activity of COX, which regulates the synthesis of prostaglandins.

Caffeine is a psychostimulant that causes dilation of blood vessels in skeletal muscles, heart, kidneys; increases mental and physical performance, helps to eliminate fatigue and drowsiness; increases the permeability of histohematogenous barriers and increases the bioavailability of non-narcotic analgesics, thereby enhancing the therapeutic effect. Has a tonic effect on the vessels of the brain.

Drotaverine - has a myotropic antispasmodic effect due to inhibition of PDE 4, acts on the smooth muscles of the gastrointestinal tract, biliary tract, genitourinary system, blood vessels.

Pheniramine is a histamine H1 receptor blocker. It has an antispasmodic and mild sedative effect, reduces exudation phenomena, and also enhances the analgesic effect of paracetamol and naproxen.

Side effect

Allergic reactions: skin rash, itching, urticaria, angioedema.

From the hematopoietic system: thrombocytopenia, leukopenia, agranulocytosis, anemia, methemoglobinemia.

From the side of the central nervous system: agitation, anxiety, increased reflexes, tremors, headache, sleep disturbances, dizziness, decreased concentration.

From the side of 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, liver dysfunction.

From the urinary system: impaired renal function.

From the senses: hearing loss, tinnitus, increased intraocular pressure in patients with angle-closure glaucoma.

Others: dermatitis, tachypnea (increased breathing rate).

If any of the side effects indicated in the instructions are aggravated, or the patient notes any other side effects not indicated in the instructions, he should inform the doctor about it.

Application during pregnancy and lactation

The drug is contraindicated for use during pregnancy.

If necessary, the use of the drug during lactation should stop breastfeeding.

Application for violations of liver function

Use is contraindicated in severe hepatic impairment.

Application for impaired renal function

Use is contraindicated in severe renal failure.

Application in children

Contraindication: children and adolescents up to 18 years of age.

Use in elderly patients

The drug should be used with caution in elderly patients.

special instructions

Avoid the simultaneous use of the drug PentalginЃ with other drugs containing paracetamol and / or NSAIDs, as well as with drugs to relieve the symptoms of colds, flu and nasal congestion.

When using the drug PentalginЃ for more than 5-7 days, the peripheral blood parameters and the functional state of the liver should be monitored.

Paracetamol distorts the results of laboratory tests of the content of glucose and uric acid in the blood plasma.

If it is necessary to determine the 17-ketosteroids, PentalginЃ should be canceled 48 hours before the study. 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 the nervous system and can manifest itself as arousal and inhibition of higher nervous activity.

During the period of treatment, you should not consume alcoholic beverages.

Influence on the ability to drive vehicles and mechanisms

During the period of treatment, the patient should be careful when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Overdose

Symptoms: pallor of the skin, anorexia (lack of appetite), abdominal pain, nausea, vomiting, gastrointestinal bleeding, agitation, restlessness, confusion, tachycardia, arrhythmia, hyperthermia (fever), frequent urination, headache, tremors 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, you should immediately seek medical help.

Treatment: gastric lavage followed by intake of activated charcoal. Acetylcysteine ??is a specific antidote for paracetamol poisoning. The introduction of acetylcysteine ??is relevant within 8 hours after taking paracetamol. In case of gastrointestinal bleeding, it is necessary to administer antacids and gastric lavage with ice-cold 0.9% sodium chloride solution; maintenance of ventilation and oxygenation; for epileptic seizures - intravenous administration of diazepam; maintaining the balance of fluids and salts.

Drug interactions

With the simultaneous administration of the drug PentalginЃ with barbiturates, tricyclic antidepressants, rifampicin, ethanol, the risk of hepatotoxic action increases (these combinations should be avoided).

Paracetamol enhances the effect of indirect anticoagulants and reduces the effectiveness of uricosuric drugs.

Long-term use of barbiturates reduces the effectiveness of paracetamol.

With the simultaneous use of paracetamol with ethanol, the risk of acute pancreatitis increases.

Inhibitors of microsomal oxidation (including cimetidine) reduce the risk of hepatotoxic effects of paracetamol.

With simultaneous use with diflunisal, the plasma concentration of paracetamol increases by 50%, which increases the risk of developing 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 combined use of caffeine and barbiturates, primidone, anticonvulsants (hydantoin derivatives, especially phenytoin), it is possible to increase metabolism and increase the clearance of caffeine; while taking caffeine and cimetidine, oral contraceptives, disulfiram, ciprofloxacin, norfloxacin - a decrease in the metabolism of caffeine in the liver (slowing down its excretion and increasing its concentration in the blood).

The simultaneous use of caffeinated beverages and other drugs that stimulate the central nervous system can lead to overstimulation of the central nervous system.

With the simultaneous use of drotaverine can weaken the antiparkinsonian effect of levodopa.

With the simultaneous use of pheniramine with tranquilizers, hypnotics, MAO inhibitors, ethanol, an increase in the inhibitory effect on the central nervous system is possible.