Pentalgin pills, 24pcs

Composition

Active ingredients:  

paracetamol – 325.0 mg,

naproxen-100.0 mg,

caffeine anhydrous-50.0 mg,

drotaverine hydrochloride-40.0 mg,

phenyramine maleate-10.0 mg.

Excipients: cellulose microcrystalline – 128,0000 mg, potato starch – 55,3800 mg, croscarmellose sodium – 32,0000 mg hyprolose (hydroxypropyl cellulose) – 32.5200 mg, citric acid monohydrate – 3,0000 mg butylhydroxytoluene (N 321) – 0,3000 mg, magnesium stearate – 7,2000 mg, talc – 16.1200 mg, dye quinoline yellow (E 104) – 0,4608 mg, Indigo Carmine (E 132)-0,0192 mg

Shell: hypromellose (hydroxypropyl – methylcellulose) – 12,1700 mg, povidone(polyvinylpyrrolidone middle medical, povidone 25) -3.8700 mg, Polysorbate-80 (tween-80) – 1.1000 mg, titanium dioxide – 3.4300 mg, talc – 4,2180 mg, dye quinoline yellow (E 104) – of 0.2000 mg, Indigo Carmine (E 132)-0,0127 mg,

or

Shell OPALRAY 13 A 210001 Green (OPADRY 13 A 210001 GREEN) – 25.0007 mg[hypromellose-12.1700 mg, povidone-3.8700 mg, polysorbate-80-1.1000 mg, titanium dioxide-3.4300 mg, talc-4.2180 mg, quinoline yellow-0.2000 mg. FD & C blue #2/ indigo carmine-0.0127 mg].

Pharmacological action

Pharmacotherapeutic group: analgesic agent (non-narcotic analgesic agent+ non-steroidal anti-inflammatory drug + psychostimulant agent + antispasmodic agent+_H1-histamine receptor blocker).

ATX code: N02 BE 71

Pharmacological properties

Combined drug, has analgesic, anti-inflammatory, antispasmodic, antipyretic effect.

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

Naproxen is a non-steroidal anti-inflammatory drug that has anti-inflammatory, analgesic and antipyretic effects associated with non-selective suppression of cyclooxygenase activity, which regulates prostaglandin synthesis.

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

Drotaverin-has a myotropic antispasmodic effect due to inhibition of phosphodiesterase IV, acts on smooth muscles in the gastrointestinal tract, biliary tract, genitourinary and vascular systems.

Phenyramine is a blocker of H1-histamine receptors. It has antispasmodic and mild sedative effects, reduces the effects of exudation, and also enhances the analgesic effect of paracetamol and naproxen.

Indications

• Pain syndrome of various origins, including pain in joints, muscles, sciatica, menstrual pain, neuralgia, tooth and headache (including headache caused by spasm of the brain vessels).

• Pain syndrome associated with smooth muscle spasm, including chronic cholecystitis, cholelithiasis, postcholecystectomy syndrome, and renal colic.

• Post-traumatic and postoperative pain syndrome, including those accompanied by inflammation.

• Colds accompanied by febrile syndrome (as a symptomatic therapy).

Use during pregnancy and lactation

The drug is contraindicated for use during pregnancy. If it is necessary to use the drug during lactation, stop breastfeeding.

Contraindications

Hypersensitivity to the components of the drug, erosive and ulcerative lesions of the gastrointestinal tract(in the acute phase), gastrointestinal bleeding, complete or incomplete combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, including in the anamnesis, severe hepatic and/or renal failure, suppression of bone marrow function. hematopoiesis, condition after aorto-coronary bypass surgery; 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.

Use caution for cerebrovascular diseases, diabetes mellitus, peripheral arterial diseases, a history of gastrointestinal ulcers, mild or moderate renal and hepatic insufficiency, viral hepatitis, alcoholic liver damage, benign hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndrome), epilepsy and a tendency to convulsive seizures, glucose-6-phosphate dehydrogenase deficiency, elderly people age.

If you have one of these diseases/If you have any serious medical conditions, be sure to consult your doctor before taking the drug.

Side effects

Allergic reactions: skin rash, pruritus, urticaria, angioedema;

Hematopoietic disorders: thrombocytopenia, leukopenia, agranulocytosis, anemia, methemoglobinemia;

Nervous system disorders: agitation, anxiety, increased reflexes, tremor, headache, sleep disorders, dizziness, decreased concentration.

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;

Sensory disorders: hearing loss, tinnitus, increased intraocular pressure in patients with angle-closure glaucoma;

Other: dermatitis, tachypnea (rapid breathing).

If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Concomitant use of the drug with barbiturates, tricyclic antidepressants, rifampicin and alcoholic beverages should be avoided (the risk of hepatotoxic effects increases).

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

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

Concomitant use of paracetamol with ethanol increases the risk of acute pancreatitis.

Microsomal oxidation inhibitors (including 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 blood plasma.

With the combined use of caffeine and barbiturates, primidone, anticonvulsants (hydantoin derivatives, especially phenytoin), it is possible to increase the metabolism and increase the clearance of caffeine; with the simultaneous use of caffeine and cimetidine, oral contraceptives, disulfiram, ciprofloxacin, norfloxacin-a decrease in the metabolism of caffeine in the liver (slowing its excretion and increasing concentration in the blood).

Concomitant consumption of caffeinated beverages and other central nervous system stimulants can lead to over-stimulation of the central nervous system.

When used concomitantly, drotaverine may weaken the antiparkinsonian effect of levodopa.

With the simultaneous use of phenyramine with tranquilizers, sleeping pills, monoamine oxidase inhibitors, alcohol, it is possible to increase the depressing effect on the central nervous system.

How to take, course of use and dosage

Inside.

The drug is taken 1 tablet 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 and no more than 5 days as an analgesic. Continuation of treatment with the drug is possible only after consultation with a doctor.

Do not exceed the specified dose!

Overdose

Symptoms: pallor of the skin, anorexia (lack of appetite), abdominal pain, nausea, vomiting, gastrointestinal bleeding, agitation, motor restlessness, confusion, tachycardia, arrhythmia, hyperthermia (increased body temperature), frequent urination, headache, tremor or muscle twitching; epileptic seizures, increased activity of “hepatic” transaminases, hepatonecrosis, increased prothrombin time time limit.

Symptoms of impaired liver function may appear 12-48 hours after an overdose. Severe overdose leads to liver failure with progressive encephalopathy, coma, death; acute renal failure with tubular necrosis; arrhythmia, pancreatitis. If an overdose is suspected, seek immediate medical attention.

Treatment: gastric lavage followed by use of activated charcoal. A specific antidote for paracetamol poisoning is acetylcysteine. The introduction of acetylcysteine is relevant for 8 hours.

In case of gastrointestinal bleeding, it is necessary to administer antacids and gastric lavage with an icy 0.9% sodium chloride solution; maintain ventilation and oxygenation; in case of epileptic seizures, intravenous use of diazepam; maintain fluid and salt balance.

Special instructions

Concomitant use of the drug with other drugs containing paracetamol and/or other non-steroidal anti-inflammatory drugs, as well as with means to relieve the symptoms of “colds”, flu and nasal congestion, should be avoided.

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

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

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. Keep in mind that naproxen increases the bleeding time.

The effect of caffeine on the central nervous system depends on the type of nervous system and can be manifested by both excitation and inhibition of higher nervous activity.

Alcohol-containing beverages should not be consumed during the treatment period.

Influence on the ability to drive vehicles and mechanisms

During the treatment period, care should be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reaction.

Form of production

Tablets

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Paracetamol, Naproxen, Caffeine, Drotaverine, Phenyramine

Dosage form

Tablets

Purpose

For adults

Indications

Migraine, Myositis, Osteoarthritis and Arthritis, Sciatica, Cholecystitis, Cholelithiasis, Rheumatoid Arthritis