PENTALGIN PILLS

Dosage form

Coated tablets

Composition

1 coated pill contains: Paracetamol 325 mg, Naproxen 100 mg, Caffeine 50 mg, Drotaverine hydrochloride 40 mg, Pheniramine maleate 10 mg

Excipients: Microcrystalline cellulose, potato starch, croscarmellose sodium, hyprolose (hydroxypropylcellulose (Klutsel EF)), citric acid monohydrate, butylhydroxytoluene (E321), Magnesium stearate, talc, dye, quinoline yellow, Iodine, Ia de Iera, Ia de Iera, Ia de Iere, Ia de Iera, Ia de Iera, Ia de Iera, Ia de Iera, Ia de Iera, Ia de Iera, Ia de Iera, Ia de Iera, Iryone, Iodine, Iodine, Iodine, Iodine, Iodine;

The composition of the film shell: Hypromellose (hydroxypropyl methylcellulose), povidone (medium molecular weight polyvinylpyrrolidone), polysorbate 80 (tween 80), titanium dioxide, talc, quinoline yellow dye (E104), indigo carmine (E132)

Packing

In a blister pack 4 tablets. In carton box 1 blister packaging.

Mechanism of action

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

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

NPVS, has anti-inflammatory, analgesic and antipyretic effects associated with non-selective suppression of the activity of COX, which regulates the synthesis of prostaglandins.

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

It has myotropic spasmolytic effect due to inhibition of PDE 4, acts on the smooth muscles of the gastrointestinal tract, biliary tract, genitourinary system, blood vessels.

Histamine H 1 receptor blocker. It has an antispasmodic and mild sedative effect, reduces the effects of exudation, and also enhances the analgesic effect of paracetamol and naproxen.

Indications and usage

- Pain syndrome of various genesis, including:
- Pain in the joints, muscles.
- Radiculitis.
- Algodismenorrhea.
- Neuralgia.
- Toothache.
- Headache (including due to spasm of cerebral vessels).

- Chronic cholecystitis.
- Gallstone disease.
- Postcholecystectomy syndrome.
- Renal colic.

Contraindications

- Erosive and ulcerative lesions of the digestive tract (in the acute phase).
- Gastrointestinal bleeding.
- A complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to Acetylsalicylic acid or other NSAIDs (including in history).
- Severe liver failure.
- Renal failure severe.
- Inhibition of bone marrow hematopoiesis.
- Condition after coronary artery bypass surgery.
- Severe organic diseases of the cardiovascular system (including acute myocardial infarction).
- Paroxysmal tachycardia.
- Frequent ventricular premature beats.
- Severe arterial hypertension.
- Hyperkalemia.
- Pregnancy.
- Lactation period (breastfeeding).
- Children's and teenage age up to 18 years.
- Hypersensitivity to the drug.

With caution should use the drug in patients with:

- Cerebrovascular diseases.
- Diabetes.
- Peripheral artery disease.
- Ulcerative lesions of the gastrointestinal tract in history.
- Renal and hepatic impairment mild or moderate severity.
- Viral hepatitis.
- Alcoholic damage to the liver.
- Benign hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes).
- Epilepsy.
- Tendency to convulsive seizures.
- Deficiency of glucose-6-phosphate dehydrogenase.
- Older age.

If any of the listed diseases and conditions are present, the patient should consult a doctor before using the drug.

Pregnancy and Breastfeeding

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Dosage and administration

The drug is administered orally 1 pill 1-3 times / day. Maximum daily dose - 4 tablets

The duration of treatment is no more than 3 days as an antipyretic and no more than 5 days as an anesthetic. Continuation of drug treatment is possible only after consulting a doctor.

Do not exceed the indicated dose of the drug.

Adverse reactions

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

From the hemopoietic system: Thrombocytopenia, leukopenia, agranulocytosis, anemia, methemoglobinemia.

From the side of the central nervous system: excitement, anxiety, increased reflexes, tremor, headache, sleep disturbances, dizziness, decreased concentration of attention.

Cardiovascular: Palpitations, arrhythmias, increased blood pressure.

On the part of the digestive system: Erosive and ulcerative lesions of the gastrointestinal tract, nausea, vomiting, epigastric discomfort, abdominal pain, constipation, and impaired liver function.

On the part of the urinary system: Impaired renal function.

On the part of the sense organs: Hearing loss, tinnitus, increased intraocular pressure in patients with angle-closure glaucoma.

Others: Dermatitis, tachypnea (rapid breathing).

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

Special notes

Use for violations of the liver: Contraindicated use in severe liver failure.

Application for violations of renal function: Contraindicated use for severe renal failure.

Impact on the ability to drive motor vehicles and control mechanisms: In some cases, the concentration of attention and speed of psychomotor reactions may decrease, therefore, during the treatment period, the patient must be careful when driving vehicles and engaging in other potentially dangerous activities requiring increased concentration and psychomotor reactions.

It is necessary to avoid the simultaneous use of the drug Pentalgin with other agents containing paracetamol and / or NSAIDs, as well as with means to alleviate the symptoms of cold, flu and nasal congestion.

When using the drug Pentalgin for more than 5–7 days, it is necessary to monitor the indicators of peripheral blood and the functional state of the liver.

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

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

The effect of caffeine on the central nervous system depends on the type of nervous system and can manifest itself as excitation and inhibition of higher nervous activity.

During the treatment period, the patient should avoid drinking alcohol.

While taking the drug Pentalgin with barbiturates, tricyclic antidepressants, rifampicin, ethanol increases the risk of hepatotoxic action (these combinations should be avoided).

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

Prolonged use of barbiturates reduces the effectiveness of paracetamol.

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

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

Diflunisal increases the plasma concentration of paracetamol by 50%, which increases the risk of developing hepatotoxicity.

Naproxen can cause a decrease in the diuretic effect of Furosemide, enhance the effect of indirect anticoagulants, increase the toxicity of sulfonamides and Methotrexate, reduces the elimination of lithium and increases its concentration in the blood plasma.

The combined use of caffeine and barbiturates, primidone, anticonvulsants (derivatives of hydantoin, especially phenytoin) may 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 its excretion and increasing blood concentrations).

Simultaneous consumption of caffeinated beverages and other CNS stimulants can lead to excessive stimulation of the CNS.

With simultaneous use of drotaverine may weaken the anti-Parkinsonian effect of levodopa.

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

- Symptoms: pallor of the skin, anorexia (lack of appetite), abdominal pain, nausea, vomiting, gastrointestinal bleeding, agitation, anxiety, confusion, tachycardia, arrhythmia, hyperthermia (fever), frequent urination, headache tremor or muscle twitching; epileptic seizures, increased activity of hepatic transaminases, hepatonecrosis, an increase in prothrombin time. Symptoms of abnormal liver function may appear 12-48 hours after an overdose. In severe overdose, liver failure develops with progressive encephalopathy, coma, or death; acute renal failure with tubular necrosis; pancreatitis. If you suspect an overdose, you should immediately seek medical help.
- Treatment: gastric lavage followed by intake of Activated carbon. Acetylcysteine ​​is a specific antidote for paracetamol poisoning.The introduction of acetylcysteine ​​is important 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; maintaining lung ventilation and oxygenation; with epileptic seizures - in / in the introduction of diazepam; maintaining fluid and salt balance.

Store in a dry, dark place at a temperature not exceeding 25 ° C.

2 years.

Pentalgin