Composition, form of production and packaging
? Tablets covered with a film membrane from light green to green, biconvex, in the form of capsules with bevelled edges, with a risk on one side and embossed "PENTALGIN" - on the other; on the cut a light green tablet with a color with white impregnations.
1 tab.
paracetamol 325 mg
naproxen 100 mg
caffeine 50 mg
drotaverina hydrochloride 40 mg
Pheniramine maleate 10 mg
Auxiliary substances: microcrystalline cellulose - 128 mg, potato starch - 55.38 mg, croscarmellose sodium - 32 mg, giprolose (hydroxypropyl cellulose) - 32.52 mg, citric acid monohydrate - 3 mg, butyl hydroxytoluene (E321) 0.3 mg, magnesium stearate 7.2 mg, talcum - 16.12 mg, dye quinoline yellow (E104) - 0.4608 mg, indigocarmine (E132) - 0.0192 mg.
The composition of the coating: hypromellose (hydroxypropylmethylcellulose) - 12.17 mg, povidone (polyvinylpyrrolidone median 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, indigocarmine (E132) - 0.0127 mg,
or Otopaday Shell 13A210001 Green (OPADRY 13A210001 GREEN) - 25.0007 mg [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, DF & C blue # 2 / indigocarmine - 0.0127 mg].
2 pcs. - packings of cellular contour (1) - packs cardboard.
2 pcs. - packings cellular planimetric (2) - packs cardboard.
4 things. - packings of cellular contour (1) - packs cardboard.
4 things. - packings cellular planimetric (2) - packs cardboard.
6 pcs. - packings of cellular contour (1) - packs cardboard.
6 pcs. - packings cellular planimetric (2) - packs cardboard.
10 pieces. - packings of cellular contour (1) - packs cardboard.
10 pieces. - packings cellular planimetric (2) - packs cardboard.
12 pcs. - packings of cellular contour (1) - packs cardboard.
12 pcs. - packings cellular planimetric (2) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
The combined preparation has analgesic, anti-inflammatory, antispasmodic, antipyretic effect.
Paracetamol - an analgesic-antipyretic, has an antipyretic and analgesic effect due to blockade of COX in the central nervous system and exposure to pain centers and thermoregulation.
Naproksen - NSAIDs, has anti-inflammatory, analgesic and antipyretic effects associated with nonselective suppression of COX activity regulating the synthesis of prostaglandins.
Caffeine - a psychostimulating agent, causes the 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.
Drotaverin - has a myotropic antispasmodic effect caused by inhibition of PDE 4, acts on the smooth muscles of the digestive tract, bile ducts, urogenital system, vessels.
Phenyramin is a blocker of histamine H 1 -receptors. Has spasmolytic and mild sedative effect, reduces the phenomenon of exudation, and also enhances the analgesic effect of paracetamol and naproxen.
PHARMACOKINETICS
Data on the pharmacokinetics of PentalginВ® are not available.
INDICATIONS
- pain syndrome of different genesis, incl. pain in the joints, muscles, sciatica, algodismenorea, neuralgia, toothache, headache (including caused by spasm of cerebral vessels);
- pain syndrome associated with spasm of smooth muscles, incl. with chronic cholecystitis, cholelithiasis, postcholecystectomy syndrome, renal colic;
- post-traumatic and postoperative pain syndrome, incl. accompanied by inflammation;
- Catarrhal diseases accompanied by febrile syndrome (as symptomatic therapy).
DOSING MODE
The drug is administered orally 1 tablet. 1-3 times / day. The maximum daily dose is 4 tablets.
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 doses of the drug.
SIDE EFFECT
Allergic reactions: skin rash, itching, hives, angioedema.
On the part of the hemopoietic system: thrombocytopenia, leukopenia, agranulocytosis, anemia, methemoglobinemia.
From the side of the central nervous system: agitation, anxiety, increased reflexes, tremor, headache, sleep disorders, dizziness, decreased concentration of attention.
From the cardiovascular system: palpitation, arrhythmia, increased blood pressure.
From the digestive system: erosive and ulcerative lesions of the gastrointestinal tract, nausea, vomiting, discomfort in the epigastrium, abdominal pain, constipation, impaired liver function.
From the side of the urinary system: a violation of kidney function.
From the sense organs: hearing loss, noise in the ears, increased intraocular pressure in patients with closed-angle glaucoma.
Other: dermatitis, tachypnea (rapidity of breathing).
If any of the side effects indicated in the manual are aggravated, or the patient notices any other side effects not listed in the instructions, he should inform the doctor about it.
CONTRAINDICATIONS
- erosive and ulcerative lesions of the gastrointestinal tract in the phase of exacerbation;
- gastrointestinal hemorrhage;
- complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including in anamnesis);
severe hepatic impairment;
- severe renal failure;
- oppression of bone marrow hematopoiesis;
- condition after aortocoronary shunting;
- severe organic diseases of the cardiovascular system (including acute myocardial infarction);
paroxysmal tachycardia;
- frequent ventricular extrasystole;
- severe arterial hypertension;
- Hyperkalemia;
- Pregnancy;
- the period of lactation (breastfeeding);
- children and adolescence under 18;
- Hypersensitivity to the components of the drug.
Caution should be used in patients with cerebrovascular diseases, diabetes, peripheral arteries, peptic ulcer lesions in history, renal and hepatic insufficiency of mild or moderate severity, viral hepatitis, alcohol damage of the liver, benign hyperbilirubinemia (Gilbert syndrome, Dubin- Johnson and Rotor), epilepsy, with a tendency to convulsive seizures, a deficiency of glucose-6-phosphate dehydrogenase, in elderly patients.
In the presence of any of the listed diseases and conditions, the patient should consult a doctor before using the drug.
PREGNANCY AND LACTATION
The drug is contraindicated for use in pregnancy.
If it is necessary to use the drug during lactation, breastfeeding should be stopped.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in patients with severe renal failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in severe hepatic insufficiency.
APPLICATION FOR CHILDREN
Contraindication: children and adolescence under 18 years.
APPLICATION IN ELDERLY PATIENTS
With caution should be used in elderly patients.
SPECIAL INSTRUCTIONS
Avoid simultaneous use of PentalginВ® with other products containing paracetamol and / or NSAIDs, as well as with funds to relieve the symptoms of colds, flu and nasal congestion.
When using the preparation Pentalgin В® for more than 5-7 days should 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, PentalginВ® should be discontinued 48 hours before the study. It should be borne in mind that naproxen increases the time of bleeding.
The effect of caffeine on the CNS depends on the type of nervous system and can be manifested both by excitation and inhibition of higher nervous activity.
During the treatment period, alcohol-containing drinks should not be consumed.
Impact on the ability to drive vehicles and manage mechanisms
During the treatment period, the patient should be careful when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
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, fatal outcome; acute renal failure with tubular necrosis; arrhythmia, pancreatitis. If you suspect an overdose, seek medical help immediately.
Treatment: gastric lavage followed by activated charcoal. A specific antidote for paracetamol poisoning is acetylcysteine. The introduction of acetylcysteine ​​is important for 8 hours after taking paracetamol. 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 administration of diazepam; maintaining the balance of liquid and salts.
DRUG INTERACTION
With the simultaneous administration of PentalginВ® with barbiturates, tricyclic antidepressants, rifampicin, ethanol, the risk of hepatotoxic effects increases (these combinations should be avoided).
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.
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 application with diflunizalom plasma concentration of paracetamol increases by 50%, which increases the risk of hepatotoxicity.
Naproxen is able to cause a decrease in the diuretic effect of furosemide, enhance the effect of indirect anticoagulants, increase the toxicity of sulfonamides and methotrexate, reduce lithium excretion and increase its concentration in blood plasma.
With the joint use of caffeine and barbiturates, primidon, 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 CNS stimulating agents may lead to excessive stimulation of the CNS.
With the simultaneous use of drotaverine can weaken the antiparkinsonian effect of levodopa.
With the simultaneous use of phenyramine with tranquilizers, hypnotics, MAO inhibitors, ethanol, it is possible to increase the inhibitory effect on the central nervous system.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
Store at a temperature not exceeding 25 В° C. Keep out of the reach of children. Shelf life - 2 years.
