Pentalgin pills №12

Coated Tablets

Composition

1 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 (Klucel EF)), citric acid monohydrate, butylhydroxytoluene (E 321), Magnesium stearate, talc, quinoline yellow (E 104 E), indigo charcoal

Packing

12 pcs.

Mechanism of action

Pentalgin is a combination drug with analgesic, antipyretic, anti-inflammatory, antispasmodic action.

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

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

Caffeine - causes dilation of the blood vessels of skeletal muscles, the heart,the 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.

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

Pheniramine is a blocker of H1-histamine receptors. It has antispasmodic and mild sedative effect, reduces the phenomenon 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, menstrual pain, neuralgia, toothache and headache (including headache caused by spasm of cerebral vessels).
- Pain syndrome associated with spasm of smooth muscles, including chronic cholecystitis, cholelithiasis, postcholecystectomy syndrome, renal colic.
- Post-traumatic and postoperative pain, including accompanied by inflammation.
- Catarrhal diseases with febrile syndrome (as a symptomatic therapy)

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 polyposis and paranasal sinuses and intolerance to Acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs history, severe hepatic and / or renal failure, inhibition of bone marrow hematopoiesis, condition after aorto-coronary shuntyro Ania; 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, history of gastrointestinal ulcers, mild to moderate renal and hepatic insufficiency, viral hepatitis, alcoholic liver damage, benign hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndrome) epilepsy and susceptibility to convulsive seizures, deficiency of glucose-6-phosphate dehydrogenase, old age.

Pregnancy and Breastfeeding

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

Dosage and administration

Pentalgin taken orally 1 pill 1-3 times a day. The maximum daily dose is 4 tablets.

The duration of treatment is not more than 3 days as an antipyretic and not more than 5 days as an anesthetic. Continuation of drug treatment is possible only after consulting a doctor.

Adverse reactions

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

From the side of blood-forming organs: thrombocytopenia, leukopenia, agranulocytosis, anemia, methemoglobinemia;

Nervous system: excitement, anxiety, increased reflexes, tremor, headache, sleep disturbances, dizziness, decreased concentration;

Since the cardiovascular system: heartbeat, arrhythmias, high blood pressure;

Gastrointestinal: erosive and ulcerative lesions of the gastrointestinal tract, nausea, vomiting, epigastric discomfort, abdominal pain, constipation, abnormal liver function;

Urogenital: impaired renal function;

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

Other: dermatitis, tachypnea (increased breathing).

Special notes

The simultaneous use of Pentalgin with other agents containing paracetamol and / or other nonsteroidal anti-inflammatory drugs, as well as with agents to alleviate the symptoms of cold, flu and nasal congestion should be avoided.

When using the drug for more than 5-7 days, you should monitor the indicators of peripheral blood and liver functional status.

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

If necessary, determine the 17-ketosteroids drug should be canceled 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 period of treatment should not consume alcoholic beverages.

In some cases, the concentration of attention and the speed of psychomotor reactions may decrease, therefore, during the period of treatment, care must be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration and psychomotor speed.

Drug Interactions

With the simultaneous use of drugs that have a depressant effect on the central nervous system (including sedatives and tranquilizers), the intensity of the sedative effect and the inhibitory effect on the respiratory center are likely to increase. Enhances the effect of ethanol on the psychomotor response.

Metamizole reduces the concentration of cyclosporine. Metamizole sodium, displacing oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids and Indomethacin from the connection with the protein, increases their activity.

Tricyclic antidepressants, oral contraceptives, Allopurinol violate the metabolism of metamizole in the liver and increase its toxicity.

The simultaneous use of the drug with other non-narcotic analgesics can lead to increased toxic effects.

Barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the effect of metamizol.

Overdosage

Symptoms: pallor, anorexia (lack of appetite), abdominal pain, nausea, vomiting, gastrointestinal bleeding, agitation, restlessness, 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 ingestion 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.

In a dry place protected from light, at a temperature not higher than 25 ° C. Keep out of the reach of children.

2 years.